Pfizer

Patient in clinic for chief complaint of possible side effect of the covid vaccine which she received yesterday. She states that she woke up at 0200 with chest tightness, achyness and headache. She rates the discomfort 7/10 last night and improved now to 5/10. She denies any worsening with any type of exertion and states that she can do simple things like take a shower, walk across the room, down the street or even stairs without any worsening. She denies any SOB or chest pain--just feels tight. Doesn't feel like she can't get a full breath or get the air out of her lungs either. She received her first of two doses of the Pfizer vaccine yesterday (4:23pm) and had no difficulty with the injection itself and then 9.5 hours later woke up from sleep with this chest tightness as well as achyness and headache.  She states that she had the exact same symptoms when she had positive covid test back in August of this year with the addition of fatigue which lasted for 5 days. At that time it was not felt necessary to do any further testing nor treat with steroids according to cardiology. She does have history of LV non-compaction cardiomyopathy and her last visit with cardiology was about 2 years ago and she had a normal EKG and echo only showed "mild LV non compaction at the apex" at that time. He did not need to see her again until she is 18 unless she has problems. She states that she generally does very well and other than this tightness she does not have any other significant symptoms.

Approximately 20 hours after vaccination patient felt faint, lost all color and fainted. She was in and out of responsiveness. Patient was transported to the ER. Patient was treated with fluids and discharged after observation. According to patient's mom the EKG and lab work were unremarkable. Patient has fully recovered.

A minute after receiving vaccine, client lost consciousness for approximately 30 seconds paired with facial twitching. No history of seizures and history of syncope due to holding breath and anxiety with medical procedures and vaccinations in the past.EMS was called, client was evaluated by EMS upon arrival, parent was called and history verified. It was discussed with parent that PCP and client have a plan in place for these kinds of reactions to go home and continue monitoring, so client was driven home by friend.

"Pfizer-Bio-Tech COVID-19 Vaccine EUA" : Individual received the Pfizer Covid-19 vaccine. She began to feel dizzy and flushed at 1:00 pm. Her vitals were 82/46, 22, 68, 98% RA at1:00 pm. We applied ice to back of neck. B/P 72/42,20, 76 P, 98 % RA. 1:20 pm. Individual report that he had not drink any fluids and only had a few bites to eat. Patient swallowing intact. She was given bottle of water. 1:46 pm vitals were 82/54, 100% SATS, 81, 14. Individual stated she felt better and was not longer dizzy. 1:55 pm vitals 79/54. 14, 78, 98% RA. Individual went home with family with no noted distress.

My daughter became very dizzy, pale, and hot (sweating through her clothing) almost passing out after receiving her first dose . Paramedics were called, vitals taken, and she was taken to an observation area. She started to feel a bit better after about 15 minutes. She was observed by paramedics and a nurse for another 30 mins and we were able to leave and go home. At home she was exhausted the remainder of the night.

Patient received the 1st dose of the Pfizer vaccine on Feb. 17, 2021. On or about Feb. 22 or Feb. 23, 2021, she began to notice trembling in her jaw. She told me (her mom) about the trembling on Feb. 25. She had just increased her dosage of Venlaxafine on Feb. 21, 2021, so we actually thought that the jaw tremor was due to that. As a result, at the direction of her psychiatrist, we began to taper off the Venlaxafine beginning on March 1. Over time, the jaw tremor was less noticeable. However, on March 10, 2021, patient received the 2nd does of the Pfizer vaccine. The next day, March 11, 2021, the jaw tremor was worse than ever. I can see the tremor - basically, her lower (?) jaw trembles and you can see the trembling in her mouth and chin. It does not cause pain, and she does not have any other symptoms (no chills, fever, body aches, rashes, difficult breathing, etc.). We talked to her pediatrician and to her psychiatrist. Neither one could say what is causing the tremor; perhaps it is the COVID vaccine; perhaps it is the Venlaxafine (she's not all the way off of it yet); perhaps something else. However, given the timing of the tremor, and given that the strength of the tremor seemed to get better but then got worse again the day after the 2nd COVID vaccine shot, I wanted to report it.

Patient was sitting in the observation area. Patient stated that she was feeling "off" and we helped lower her to the ground into a sitting position. She stated that she felt dizzy and we lowered her onto her back and raised her legs onto a chair. 911 was contacted. Patient remained responsive and was able to answer questions throughout. Patient stated that her shoulder felt like it was burning where she received the injection. She also stated that her face felt numb and her lips felt funny (tingling). Patient was still able to breathe and respond appropriately to all questions. Care was taken over by Ambulance service. After speaking with patients mother later in the day, it was determined patient had a vasovagal episode.

Patient mother reported patient began to shake and she was unable to speak or respond. Upon observation patient was pale, awake, and clammy, responding appropriately . Pulse ox placed on patient O2 sats 98-100, pulse 57, BP 87/45. Patient oriented to person, place, and time. Patient reported feeling weak, complains of headache and neck hurting. Patient reported tingling in her left hand and reported her tongue was tingling. . At this time ambulance was called to transport the patient to the ED.

Vaccine admin at 04:15pm on 03/17/2021. Patient began to have difficulty breathing and cold sweats at 04:20pm. Paramedics were alerted and arrived at 04:31 pm. They treated her for high CO2 level with oxygen and let her go.

Fever, chills, extreme fatigue, lightheadedness and very sore arm, but more importantly chest tightness that became increasingly worse over 48 hours. My daughter dealt with the other symptoms but her asthma became less treatable over the two days since the second shot. I finally administered the nebulizer and inhaled steroid today after all other treatments failed to relieve her symptoms. She is doing better but I will follow up with the pediatrician.

Patient briefly lost consciousness immediately following vaccine administration. Had shaking, chills, flushed and nausea. Pt had not eaten at all today. Administered oral water, snacks. VS within normal limits. Discharged with mother after 40 min of monitoring.

Right arm immediately went numb down its length and immediately noticeably swelled up, from wrist to shoulder. It was hot to the touch. The arm also developed a rash. Patient was monitored by paramedics, who confirmed her pule, oxygen levels and blood pressure were normal. Conditions improved after about a half hour, but did not resolve completely. Arm is still slightly swollen (after providing Benadryl) and is very painful around injection site, 24 hours later..

20 minutes after shot. Sharp pain in arm. Daughter said it feels like the needle was left in her arm. Feels dizzy and out of it. 25 minutes after shot having trouble swallowing. No difficulty breathing. Very thirsty. 40 minutes after shot legs feel very heavy. Daughter was sliding them across floor instead of walking regular. She said it was like her legs forgot how to walk. She was very irritable. Two hours after shot she said she was feeling better except for sore arm. Still felt somewhat sick. Next day she said feels like she had the flu but was feeling much better except for sore arm.

Within 30 minutes after the shot, my daughter had a headache and sore arm. Other than that she was fine until midnight on Monday morning when her tremors increased and spread up from her legs to her torso and arms. The tremors persisted all day Monday even through her cranio-sacral therapy at Medical Center. Her therapist tried to calm down the tremors through frequency specific micro current with no success. Her therapist could tell that her whole system was in "overdrive" which was vastly different than her previous session a week ago. The tremors were so bad that my daughter wanted her wheel chair again. I took a video of her tremors after her therapy session. Her therapist told us to contact her DO, Dr. about it. I did. She was able to crash around 10pm on Monday. On Tuesday, when she woke up around 2:30pm, she still had the tremors but they weren't as severe. We had a telehealth appt with her sleep neurologist, Dr. at 3pm and showed her the video but she doesn't recall ever seeing her tremors in the past. When I spoke to Dr., I shared the video and she was going to discuss it with the therapist as they know each other. My daughter's tremors have never been this bad. She had one major tremor episode in her legs only over 2 years ago which we attributed to her meds at the time; but again, not this bad ever.

anxious & numbness to the back of the head. Medics present. Hx of anxiety & Abhb. Symptoms resolved with comfort measures. BP 114/72- HR=64

Experienced extreme onset of symptoms 12 hours after the 2nd dose w/ intense headache, severe leg pain, painful chills, fever and extreme fatigue and arm weakness in both arms, lasting approximately 12 hours and then subsiding for 12 hours for 4 days - extreme symptoms for 12 hours and then subsides - severity of the symptoms remains the same and doesn't lessen w/ each 12 hour episode. The leg pain is severe. Alternating Tylenol and Ibuprofen provides minimal relief and doesn't break the fever.

Immediate intense headache. Feeling faint. Lay down on floor, semi conscious. Ems staff moved her to sitting position where she completed blacked out. They struggled to hold her, so they lay her on the floor where she had convulsions similar to a seizure. Completely unconscious at this point.

On Tuesday late morning, she texted from school - that her heart was racing. shaking, headache, tummy ache. We brought her home from school. These symptoms - especially the severe headache, nausea, dizziness lasted for 3 days. She missed school as she stayed in bed.

Patient received her vaccination and stated that she was feeling lightheaded. Patient was cool and clammy, sweating and stated she didnt feel good. EMS notified and hooked up to monitors. IV line was started and patient was transported to the hospital. Patients mother and sister were on site.

She almost fainted. BP dropped to 72/30. flushed pale skin. Pulse ox 96. Alert and felt dizzy throughout the stay. Paramedics arrived onsite and as requested by parents EMTs transported the client to the parents' vehicle.

patient said she started losing vision in one eye for few minutes, and started having numbness or tightness in arms. Paramedics were called and she felt fine after first few minutes

Anxiety Felt like fainting Dizziness Tingling and cramping in hands Weakness EMT came to Observation area Vitals BP #1) 173/133 Pulse 86 O2 Sat 100% #2) 95/72 Patent refused transport to hospital

Patient became unresponsive within 15 minutes of getting vaccine. Her eyes were wide open, lips were turning blue, and had appeared to stop breathing.

Patient had syncopal event about 5-7 minutes after vaccination. She came to within a minute or two, but was very anxious and visibly upset. She stopped shaking within another minute or two and had calmed down enough to sit up upright. She drank a few sips of water and said she was feeling better. EMS as called as a precaution and arrived in about 15 minutes. Patient's BP was normal (120/80) and blood sugar within normal range.

Feeling faint, extreme fatigue, vomiting without nausea (no warning)--foul/sour. Kept complaining that she felt like she was crawling in her own skin, all through her arms and her chest, like an itch from the inside. NO HIVES. No difficulty breathing. Kept her home from school and she slept a lot. Only vomited the one time. She was fine by late afternoon and all symptoms seemed to have resolved by then.

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

Patient presented for her first COVID-19 vaccine. Approximately a minute after vaccine was given, she was noted to be seated upright in the passenger seat of her car, with head bent forward and eyes open. She was unresponsive, stiff posture, and was placed into a reclined position. She then had some posturing with head turned to the left, no eye deviation or nystagmus, no tonic-clonic movement. Radial pulse was thready, bradycardia was noted, with normal respirations. She was noted to become diaphoretic and pale/ashen color noted to the face and arms. She became responsive within a few minutes, however initially was not able to answer questions clearly. She had no loss of bowel or bladder function. EMS assisted with evaluation. Initial blood pressure 78/31, HR 54, SpO2 100%. EMS then transferred her to the stretcher and she was transitioned from her car to the ambulance. She continued to improve spontaneously with BP 94/61 then 103/60 and HR 86 then 74. SpO2 remained stable at 100%. Skin color improved. She had normal responses to questions, no complaints of headache, dizziness, chest tightness, shortness of breath, numbness or tingling. She had some shaking/voluntary movement of the limbs and body noted, but she could control and stop this voluntarily, no myoclonic or tonic-clonic jerking noted. After syncopal event occurred, mom reported that the patient has a history of syncope routinely with blood draws and vaccines in the past, however this episode was slightly more prolonged and seizure-like activity was different. She has had some jerking movement previously with syncope which lasts 20-30 seconds, different from today's response. No known history of seizure disorder.

Asthma Attack started at 1 pm while seated and attending virtual class. She was under no distress and was not in any way exerting herself. She described the attack as a feeling of someone sitting on her chest and began to hyperventilate. The color drained from her face and her hands felt numb. Her asthma attacks are generally exercise-induced, so this was highly unusual. She took a dose of albuterol ( 2 puffs with a spacer) and followed her asthma action plan. She laid down and slowed her breathing. 20 minutes later her facial color returned to normal. Two hours later her hands returned to normal. She was disoriented for about 5 hours.

By 4:30 started having chest pains and could not take deep breaths, by 7:00 she was running a high fever of 102, body aches and extreme fatigue. She had a fever all day on 8th and experienced severe fatigue. She is still weak, having body aches and a low grade fever on Friday the 9th. Her chest pains stopped on Thursday.

Patient received first dose of Pfizer covid-19 vaccine on 4/9/2021 at 1800 with her mother in attendance after consent was acquired. At 1805 patient began to feel hot and nauseous. The patient thought she was going to vomit, so she left her chair in the waiting area to head to the restroom at the back of the store. at 1807, Upon rising the patient became weak in the knees and began to collapse. The patient's mother initially supported the patient and I was called to assist the patient to the floor. The patient was very pale in appearance as she was assisted gently to the floor, avoiding any injury. EMS was called shortly after the event around 1810. The patient remained conscious however was a bit disoriented initially while lying on the floor. The patient recovered quickly, however remained nauseous and complained of feeling hot. Upon questioning the patient, she had not eaten since lunch at school at 1300. The patient was given a cold water and a sprite, of which she had a couple of drinks out of each. The patient was relocated back into a chair at 1815 as she was feeling much better. EMS arrived at 1821. EMS performed a general assessment and a blood pressure check resulting in 130/80. The patient's mother dismissed any further treatment from EMS. EMS exited the building at 1827. The patient and mother waited in the store for a while longer. Both patient and mother exited on their own, denying escort from associates at 1840.

Within a few hours of vaccine she began to have a very sore arm and headache. Around 1:00 A.M. on 04/09/2021 she began having chills and joint pain, but no fever as the headache continues. The event that concerns us was she began to have tingling in her fingertips both hands. This has been going on since 1:00 A.M. Her NP was notified and they said to watch it over the next few days and report to CDC/ FDA. Patient had Covid December 24, 2020. We waited the 90 days to get vaccinated and had clearance from her doctors.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: 2 minutes post vaccine, pt complained of feeling hot and was unable to see. pt was feeling dizzy and faint. nurse had pt lay down at vaccination site, legs levated. bp 112/63, hr 67, regular and lungs clear and no difficulty breathing. @1449: 116/63, hr 67, 1453: gatorade and water intake, bp 111/69, hr 61. @1459 up in chair, no complaints from pt, sx has resolved. bp 116/72, hr 72. @1504 121/79, hr: 70. pt states feeling well and refused any er tx. pt wants to go home.

Pt syncopal episode post vaccination likely due to vaso vagal response. Diaphoretic and unresponsive slumped over at chair. Quickly regained consiousness was alert and oriented NAD, Given water allowed to lay down. Feeling much better. Discharged POV in NAD with father. Diaphoretic and unresponsive slumped over at chair Quickly regained consiousness was alert and oriented NAD

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Additional Details: Patient started feeling dizzy within 5 minutes after vaccine administration. Patient vomitted once during observation period. Patient also stated feeling ringing in ears and vision darkening right before throwing up. Patient felt better after throwing up. Patient was observed for total 30 minutes.

Systemic: Fainting / Unresponsive-Mild, Systemic: passed out for less than 1 minute immediately after shot given-Mild, Additional Details: passed out immediately after shot given for less than 1 minute, after coming to, had her lay on floor with legs up, blood pressue and pulse normal 111/88 , 70bp, was okay. had her stay over 30 minutes for obeservation, her dad with her

My daughter has red facial breakout that is tender to the touch and continues to spread. It is now covering her entire face to the hairline and going under the chin. She also has red breakout on the injection site.

Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Medium, Additional Details: was laid down and legs elavated once calmed down, ems were called and further treated by them

Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Hypotension-Medium

Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Medium, Additional Details: was laid down, epi given by imer, legs elavated once calmed down, ems called and treated, recovered soon after

Patient has a history of dizziness, headaches and Tourette's syndrome. Immediate complaints of headache, nausea, arm tenderness and being dizzy. Patient was laid down, given water and a snack. She was discharged with her parents after 30 min of observation.

Within 1 minute of receiving vaccine, patient started to shake and appear to loose consciousness for about 30 seconds. She then came to and was disoriented for just a minute then could answer all questions asked of her (name, dob, where are you) She stated she had an intense headache, had trouble hearing but hear a buzzing sound. Mom was in the room as well, we gave her water and sat with her for about 10 minutes and she seemed weak but okay. They remained in the waiting area for another 15 minutes, she was feeling better and mom was comfortable to take her home as Mom is a Doctor.

Systemic: Fainting / Unresponsive-Mild, Additional Details: Sycope with twitch, fully awake and oriented within a minute.

Patient started feeling a numbness/tingling sensation in her right pinky that slowly moved up her arm and to her elbow about 20 minutes after she received the vaccine. Her right eye started to droop as well and her right pupil was slow to react to light upon assessment by EMT. Patient usually feels dizzy at baseline but felt even more dizzy after the vaccine. The numbness and tingling sensation in the right arm started to subside at 1500 and was completely gone by 1520. Vital signs were taken by EMT, BP 110/70, O2 99%, and P 73 which is patient's baseline. Patient's side effects subsided and she was escorted out to the car by her mother and EMT and her mother drove her home. RN and EMT advised patient to call her primary care provider to explain the adverse effects of the vaccine.

Approximately 10 minutes after patient was given the vaccine, she reported feeling slight lump in her throat. We brought her into the clinic room and sat her down. Never had trouble swallowing and did not have any swelling. Felt hot and bit sweaty and light headed. Reports has felt similar ways in past when had blood drawn. We laid her down and she immediately started feeling better. Mom and sister were with her. Refused ambulance or transfer to physician. They were all comfortable her leaving on her own, after we have observed her for over 45 minutes from vaccine.

Patient received vaccine around 4:30pm. After 10 minutes patient reported that she was having a headache, felt like her breathing was a little bit heavy. Patient was brought to exam room with mother present. BP was 150s/100, O2: 99%, HR: 65, RR 20. No distress noted. Patient was slightly anxious, continued to complain about headache. Denied any blurred vision, changes in vision, nausea, vomiting. Around 4:45, patient was asked to lay down for a while to be observed further and to give her time to relax. Patient was given cold wash cloths for forehead. Patient suddenly became more increasing anxious at 4:49, complained of excruciating headache and bilateral arm pain. Oxygen remained at 100%. 911 called at 4:50pm. Paramedics arrived at 4:55pm. Paramedics checked patient's blood sugar: approximately 345. Patient reported last meal around 12:30pm. Patient was crying and continually stating that her head hurt. She was alert throughout the entire process and able to answer questions. Mother elected to have patient sent to ER for further evaluation. Followed up with family on 04/14/2021. Mother reported that patient was held at hospital for 5 hours, was given norco for headache. Diagnosed with panic attack. Mother reports that patient is doing better today.

Patient stated in evaluation form that she had passed out once before after giving blood for labwork. She and her mother decided to continue with the vaccination as it had never occurred before after getting a vaccine. A few minutes after the vaccine the patient lost consciousness. Mom stated that her face tensed up right before hand. The patient remained in her chair for the duration of the event. She regained consciousness about 30 to 60 seconds later, and within a few minutes she was conscious but still very shaky, pale, and hot. She was able to sip some water and we put a cool, wet paper towel on the back of her neck. The patient and her mother remained seated and under observation for an additional 15 to 20 minutes with no further issues, at which point they left the store. I followed up with the patients mother the next day and she said her daughter was exhausted last night, but this morning she woke up feeling well and went to school like normal.

Patient became clammy and fainted after vaccine administration. Episode lasted about 10-15 minutes. Patient became alert and oriented and felt fine.

Pain between the breasts on the ribs. Started out as seconds of slight pain the day after shot until about 9:30pm when the pain became consistent but was a slight pain. I woke up at 2:30am and my chest hurt really badly. It was a constant pain but the amount of pain was back and forth. It hurt more to lay down and if I bent down it was very painful. I stayed up for an hour and a half until the pain went away. When it did I had sweat a lot and was very hot. I then woke up with little discomfort until an hour after I woke up with slight pain. The pain then has gone off and on but not as painful as it was during the night.

Parent reports seizure on 4/8 at 4:15 an child transported to Hospital. Sent home with ibuprofen. 4/9 at 10:30 PM seizure taken to Hospital. Sent home at 2:00AM with script of Kefir. 4/10 3 seizures back to back went back to Hospital. EEG done and told the are not epileptic seizures may be stress induced . Sent home on 4/11 with appt set up to see neurologist June 28. 4/12 had more seizure went to Med Cent then transferred to Hospital. Stay there and was released on the 13th told seizure could be cause by Migrain and IUD or homones Sent home on reglin and ibuprofen.

After the vaccination the patient was sitting in the chair outside of the immunization room, and started to feel faint. The patient had cold and clammy skin, and she appeared to be very weak. The patient was comforted while she remained seated, and she never lost consciousness. The patient was given water and the emergency services were called. After a couple of minutes the patient vomited, and she started to feel better. The patient indicated the she has a fear of needles, and that she was holding her breath while she was being vaccinated. The were no signs of allergic reaction. The emergency services checked the patient's vitals, but the patient refused to be transported to the hospital.

Vasovagal syncope. She began to get very warm, then fainted and became very pale. She was better within 5 minutes.

Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: tingling in left hand and fingers

PT SUFFERED APPROXIMATELY 4 SEIZURES, 1 IN LINE TO VACCINE CLINIC AND 3 IN OBSERVATION POST VACCINATION. SEIZURES WERE MILD LASTING NO MORE THAN ONE MINUTE EACH. PT CAREGIVER ADAMANT THAT SEIZURES WERE WITHIN SPECTRUM OF NORMAL FOR PATIENT.

Acute Infarct of R internal capsule and R basal ganglia; Acute Infarct of R internal capsule and R basal ganglia; Left (L) sided motor deficits; L facial droop; This is a spontaneous report from a contactable physician. A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered in left arm on 24Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included truncus arteriosus (status post (s/p) right ventricle-to-pulmonary artery (RV-PA) conduit and prosthetic aortic valve s/p automatic implantable cardioverter defibrillator (AICD) placement) and arrhythmias. The patient have no known allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included sotalol taken for arrhythmias and warfarin. The patient was therapeutic on warfarin (INR 2.68) at admission and has been historically very compliant with medication. On 29Mar2021 14:00, the patient experienced acute infarct of right (R) internal capsule and R basal ganglia as diagnosed (dx) on magnetic resonance imagine (MRI), concerning for (C/f) cardio-embolic etiology in the setting of patient's complex cardiac history. However, cannot rule out other causes of infarct. Left (L) sided motor deficits on exam, L facial droop. Transthoracic echocardiogram (TTE) was unchanged from prior. The patient was hospitalized for the events from 29Mar2021 to 05Apr2021. The patient underwent other lab tests and procedures which included COVID-19 nasal swab test was negative on 29Mar2021 and on 30Mar2021. Therapeutic measures were taken as a result of the events and included treatment with anticoagulation. Outcome of the events was recovered with sequel on 2021. The following information on the batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect vaccine BNT162B2 cannot be excluded. Consider also possible contributory effects from patient's pre-existing cardiac history. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Patient unable to stand, was feeling hot. Reported unable to see or hear for a few minutes. Recovered after a few minutes. called 911 and measured BP and pulse . readings were 109/60 and pulse of 68. Patient regain strength and was able to leave on her on.

Day 0 (4/1/21) had mild arm soreness. On day 1 (4/2/21), she had chills and sweats and body aches. Took Tylenol and improved her symptoms. On day 2 (4/3/21) in the morning she felt well, but later that afternoon she had severe abdominal pain. She had worsening symptoms over the next few hours, with recurrence of sweats, nausea and then vomiting. She had resolution of symptoms after 15 minutes, but recurred about 1-2 hours later with vomiting and abdominal pain. Mom reports her pain was crippling, doubled over and on the floor due to pain. Took to urgent care for evaluation. UA and UPT negative. ED records show abdominal exam was normal except for "increased peristalsis". Treated with Zofran with resolution of vomiting. discharged home. Abdominal pain self-limited and resolved without further intervention within a few hours.

Shaky feeling, dizziness, tingling in bilateral upper extremities. Dr at bedside examined and monitored for 15 mins then discharged in stable condition

After giving the injection the patient had severe pain at the injection site. A few minutes later she struggled to make a fist with her same hand and reported having pain going up her neck. The injection site did swell up a few minutes after the injection as well and she felt tingling in her hands shortly after. Patient was given 25 mg of benadryl after she reported the tingling in her hands. She did not have any difficulty breathing though. She was able to stand up and walk with her parent to the car and was driven to ER by parent to be checked out.

pt informed mom that she was not feeling well. nurse in observation lane witness seizure. pt was unconscious for 5-10 seconds. pt vomited as well. bp was 104/54 at 1154a, 107/52 at 11:52a, rest of vitals WNL. Md assessed, observed for additional 30 minutes. pt stated she was feeling well and was driven home by her mom

Patient was given a Pfizer covid vaccine and then immediately passed out. She was completely unresponsive and given 1 dose of epi and she responded to the epi. Her dad was with her and said that she has anxiety issues and this is probably the reason she passed out. EMS was called and it was decided between EMS and Dad that there was no reason to transport her to the hopital as she was doing fine after being checked out by EMS; Dad signed a waiver with EMS declining transport to the hospital.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild, Additional Details: Tingling in face and legs

The patient passed out completely while sitting after having her 1st covid vaccine. She was alert shortly thereafter but had blurry vision and low blood pressure. She said she was very hot and was sweating somewhat. We gave her some water and gradually she started feeling better. In the meantime, we had call 911 and when they evaluated her, they felt it was somewhat of a panic attack since she did have anxiety before getting the vaccine.

"Administered - 13:50 Adverse event started - 13:55 Patient had flushing/sweating, lightheaded. Patient states did not eat. BP 100/53 (63), HR 60, RR 16, O2 98%. Crackers, water given. Patient stable, released from vaccination site."

Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Seizure-Medium, Systemic: Weakness-Medium, Additional Details: Patient fainted in chair shortly after receving vaccine. She came to within a minute, but body became very rigid and she began to seize throughout her whole body. This lasted less than 30 seconds and she was very pale and lightheaded. Patient decsribed feeling extremely nauseous with chills, slowed breathing and lightheadedness. Moved patient to a new area to elevate feet, stated feeling better but was extremely nauseous and unaware that she had fainted or seized. 911 called per parents request

Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypertension-Mild, Systemic: Shakiness-Mild, Additional Details: pt complained of dizziness. lied down w/ feet elevated + used ice packs. stated this has not happened before. BP very high on 1 reading (233/108) and decided to call EMS out of precaution. begain shaking after a few minutes of ice packs but stopped after a few minutes of removal. EMS evaluated, sat pt up, and once pt was sitting up began shaking again and they decided to take to hospital to get checked out.

Customer was unresponsive, clammy, pale. Customer received 0.3 mg of Epi IM in right thigh, 911 called and customer laid to floor with legs elevated. Customer became responsive after Epi. EMT arrived and vitals wnl. Customer and her mother declined hospital transfer.

All night so far: Severe headache, body aches, excessive vomiting throughout night, dizziness, almost passing out, confusion, weakness

It was reported by the safety officer that the guest was walking up the stairs to observation after receiving the vaccine and stated to her mother that she was feeling lightheaded and sat down on the stairs. Guest appeared pale, skin was cool and clammy. EMS was called. Guest remained sitting on the stairs when EMS arrived. Vital signs were taken and were WNL. Guest was transferred to a cot and monitoring continued. Guest was talkative. About 15 minutes later she sat up and began sipping juice. Denied lightheadedness and vertigo. Vital signs remained stable. She was released by the medics. Went home with her mother.

Pain and swelling in both feet and ankles, pain started evening of injection, swelling 2 days later. Still tender/swollen 4 days later. Headache/Nausea on day 2.

About 10:30 today, Meredith's teacher noticed she was breathing heavily after a trip to the restroom. She was taken to the school clinic with a seat heart ate of around 110. She was seen by her pediatrician and came home. She slept much of the day with her heart rate while laying down reaching up to 136. She reports feeling hot at times, but does not have a fever. She also is very thirsty.

Patient was on observation having a conversation with her father when suddenly she started passing out and exhibiting twitching like having Petit mal convulsions and not able to arouse, and later in 2 minutes she recovered eyes open appears pale in face and lips, not aware that she had passed out, and became responsive. Father claims that HR is always running on low side because she is an athlete. On around 4:40pm she was released under the care of her parent and recommended to get an appointment with her PCP for further evaluation Patient status was checked the following day 4/22 and Pediatrician said that it must be a vasovagal Syncope per Neurologist he consulted no further appointment will be needed at this time

My daughter has been diagnosed with catamenial epilepsy, and typically only had seizures very sporadically (months apart). However, she recently had a cluster of seizures, which was very atypical for her. I read a news story last night about the vaccine affecting some women by making their period come back after years of not having it. In reviewing my daughter's seizure events, a pattern emerged in relation to her Covid shots: -Dose 1 of Pfizer on March 17, and the worst seizure she ever had was on March 27 (10 days after first Covid shot) -Dose 2 of Pfizer on March 31, and the second worst seizure she ever had was on April 10 (10 days after second Covid shot) Prior to the Pfizer Covid shots, the shortest frequency between seizures was one month, and that was prior to her starting epilepsy medication (Keppra). She was taking her Keppra (morning and night) at 1000 mg twice daily as prescribed, and had not missed any doses when the seizures occurred. We now suspect that the two recent seizures might be adverse reactions to the Covid shots.

pt started feeling really dizzy and nauseated immediately after taking the vax. she started having a seizure and made a growling type of noise and urinated on herself. The nurse at the vax site helped bring her back and was told to take her to a doctor. She was monitored and released from the vax clinic when her BP was 107/76. She was taken to medical center where she saw. She was told she had Syncope due to the stress of the situation of getting the vaccination. She is resting today and seems to have some fatigue.

Low fever, chills, vomiting, disoriented, bad headache, adversion to light and sound, weakness, tired

Patient felt weak and dizzy and had syncopal episode. Patient received vaccine, walked out to sit in observation area and had syncopal episode after sitting down. Lasted about 1-2 minutes. Mother provided water and held patient up to prevent from falling over. Declined requesting ambulance. Patient became responsive after 1-2 minutes and continued to feel weak and dizzy. The patient was instructed to stay for at least 30 minutes. Mother left with patient after 45 minutes and were instructed to go to urgent care or emergency room if condition of weakness/dizziness does not improve.

16 y.o. female who received the Pfizer-BioNtech COVID-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot EW0158 on 4/23/2021.The patient experienced the following reaction(s) during the immediate of observation: Tinglings, blurry vision, diaphoretic. Patient was treated/managed as follows: Pt brought to treatment area to lay down on mat with legs elevated. VS: 4:15 pm BP: 100/80 R: 18 HR: 58 O2: 98% Pt reports feeling much better after laying down. 4:30 VS: BP: 105/78 HR:60 O2: 99% Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. Pt escorted to car with mom by nurse.

1130 RN called. When this RN arrived patient was sitting up in a chair and was found to be pale, clammy, and non responsive verbally. Ammonia salts placed under nose and patient immediately aroused. Blood pressure at 1132 was 95/54 pulse-58, and 02 sat was 99% sitting. 1136 Blood pressure at 1136 was 76/44, pulse 66, 02 sat 99%, and Patient was still responding but somewhat dazed. Still alert and oriented. Ice pack applied. Sweatshirt removed. Patient was given water and a granola bar. Patient transferred to guerny and repeat blood pressure taken. 911 called by RN. Patient talking and awake.1138 blood pressure lying down was 113/62, pulse 67, and 02 sat was 98%. Transferred to nurse treatment room by RN RN. Patient's Mother present. 1147 Paramedics here and report given. 1158 Patient is awake and stable and transported to ER via ambulance.

Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Lymph Node Swelling-Severe, Systemic: Vomiting-Medium, Additional Details: Patient experienceing muscle twitching in neck, head, face, and upper torso, pain behind both ears, and blurry vision

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: patient briefly fainted post vaccination, was accompanied by mother, immunizing pharmacist assisted with care, provided ice pack for head, laid patient on back with feet elevated, patient returned to conciousness, after returning to seated position patient complained of nausea so we returned patient to laying on back feet elevated. Patient was observed by immunizing pharmacist and mother prior to leaving under own ability. BP 123/81 HR 87 at 555pm, injection was at 517pm.

Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild

I got the shot at around 4 in the afternoon and after sitting in the waiting area for around 15 minutes I was allowed to leave. When I left I only had a slight headache, but nothing that seemed very noticeable. I felt a tad woozy but it was nothing serious so I went on with my day and went to my sports practice for an hour and a half. After I got home and had eaten, I was working and started to feel the effects. It started with an increasingly worse headache at around 9 and as the night went on it got worse and I constantly needed to lie down. My arm had started to feel sore but it was nothing much. I thought I could sleep it off but woke up feeling horrible. My stomach could not hold any food down and my headache had become really bad. I had to go to my sports game but on the car ride over (around 45 min) I got very nauseous. Throughout the course of the day my headache would get worse any time I tried to run and all I wanted to do was lie down and sleep. I was barely able to stand, let alone run and I felt sleepy all day. My arm had also gotten very sore and any contact on it made me flinch back. I was not able to eat or drink anything until about 4 in the afternoon and my stomach was not sitting right the entire time and I constantly was burping and feeling like I was going to vomit despite having only water in my stomach. After I was able to eat the stomach ache went away a bit but the headache lasted through the night and has finally started to subside two days later.

(name) had a seizure within 5 minutes or less of the first dose.; This is a spontaneous report from a contactable consumer or other non-HCP. A 16-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8729) via an unspecified route of administration in Right Arm on 09Apr2021 00:30 as single dose for covid-19 immunization. Medical history included depression and seizure. The patient's concomitant medications were not reported. On 09Apr2021 00:30, the patient had a seizure within 5 minutes or less of the first dose. Therapeutic measures were taken as a result of had a seizure within 5 minutes or less of the first dose. The outcome of event was recovering.

After shot felt light headed, dizzy, Requested water. Sat down put head back started snoring loudly. Stating seizing, eyes rolled back in head. Nurse had to wake up with smelling salts. Low blood pressure 60/40 All happened within 10 minutes.

Received first dose of Pfizer , within 1 minute fathe noted she "passed out". Called staff to car ad observed pt with clonic/tonic movement of hands, eyes closed, respirations slowed but even pulse approx 58/min. Responded to verbal Stimuli. Said she felt failt, lips pale, skin clammy. 911 called had additional same incident 9 minutes later. Transferred pt to medical facility by ems after 2nd episode .

Friday : soreness at injection site,3 hours later severe migraines; fatigue Saturday - severe migraines, fatigue Sunday,- -Vomiting, severe migraines, joint aches Monday - awoke with swollen face - centered around eyes and cheeks area, achy headaches, fatigue - went to ER and received Steroid shot.

An hour after Pfizer vaccine administration, the parents of the 16 year old patient returned to the pharmacy and reported that their daughter was complaining of trouble breathing in the parking lot. The immunizing tech asked the parents to bring the patient back to the pharmacy. The patient returned and while crying and gasping for air, she reported that it felt as if someone was constricting her throat. She also complained of stiff fingers and feeling numbness/tingling in her upper extremities. Assuming anaphylactic reaction, one dose of epinephrine was administered. The patient said she felt slightly better after the first dose but then 2 minutes later, said her breathing was getting worse, and again described feeling her throat tightening. Five minutes later, a 2nd dose of epinephrine was administered. The patient was taken to the hospital by paramedics.

Patient was vaccinated and left with her mother to sit in her car for 30 minute monitoring period. Patient's mother stated patient was experiencing extreme anxiety getting the vaccine and after 20 minutes was wheezing. She brought patient inside and a Pharmacist came to check on her and her mother stated that she has had a reaction to a medication in the past and just needed Benadryl. Benadryl was given to her and she took it orally. Her pulse and blood oxygen were measured with a finger pulse oximeter and were both normal. Shortly after she was panicking more and had a seizure. Her mother reported that she has frequent seizures when she has anxiety/panic episodes. Her seizures were persisting so 911 was called. Paramedics arrived shortly after and took patient to the hospital. A few hours later the patient's mother came back to us to inform us that she was released from the hospital and was feeling fine and back to normal.

After RN administered vaccine she spoke to my daughter for some time afterwards 5-6 minutes and my daughter was fine answering her questions and just visiting with her. She directed us to the table to schedule her second vaccine which was directly in front of us. We went to this table and spoke with two other ladies choosing a date and time and she was also fine talking with them and answering questions of eat time offered and then suddenly she went straight back with warning passed completely out and struck the back of her head on the concrete floor. EMS and RN?s who were there went to her aid immediately and she was unconscious for a little over a minute. They initially couldn?t get her to respond and finally she came to and had no idea what happened and no recollection of falling. She had blurred vision and bleeding a bit from the back of her head and they wanted her to have CT of her head after hitting it that hard. They took her by ambulance to hospital and they assessed her and ordered a CT. The CT thankfully came back clear and she has follow up appointment with concussion doctor first thing in the morning. On discharge she was describing her pain from hitting head a 7/10 It was very scary and everyone around us was visibly upset as well. She has never fainted or had a reaction to any other shot, vaccine or needle before today so that was a very unusual reaction.

Soreness in the left arm with slight swelling. patient was complaining of hot flashes. Patient said only had a muffin and coffee to eat and drink all day. No aberrations Vitals- HR: 55 - RESP: 14 - BP: 129/85 Sp02: 99%

Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: Patient has been fasting and did not mention to immunizer that she passed out twice today because she is not eating anything only water. Paramedics came and check on her and patient was stable and recovered at the time.

Pt's mom called 4/23/2021 connection call center regarding of pt fell down in 5 hours after covid vaccination yesterday. Verified pt with 2 identifiers. Pt denies emergency s/sx. Pt states she felt dizziness and leg lost power after covid vaccine(Pfizer) at clinic @ 3pm 4/22/2021 then pt fell down in 5 hours. Pt intervened to lay down by herself and drank water. Pt also mentioned she had stomach aches after vaccination yesterday. Pt states she does not have dizziness, leg weakness, stomach aches at this time, it happened yesterday in 5 hours after covid vaccination. Pt advised to follow-up with PCP at Pt made aware. Pt is educated for covid 19 vaccine side effects. Pt agreed and verbalized understanding.

Pt completed vaccination and was at check out station with mother scheduling her second appointment. The patient suddenly fell backwards and landed on the concrete floor hitting her head. She was unconscious for about 30-60 secs.

Got her COVID-19 2nd dose yesterday afternoon, woke up around 0300 hrs this morning with fever, chills, body aches, headache

Patient fainted and unconscious less than 10 seconds. Patient flushed and admitted she had not eaten since the am. No further treatment required.

Paresthesia in left foot upon awakening the morning after receiving the vaccination. The symptom began to subside on day three following the vaccination. By day four the symptom lessened to tingling in the toes of the left foot. By mid day on the fourth day the symptom had gone away.

Patient was a client at a drive-through COVID-19 clinic. Patients Father was driving and the patient was seated in the front passenger seat. After receiving vaccine, FOC drove forward and parked in an observation lot that was staffed by 3 RNs. FOC reported to an observation lot attendant that patient, Patient was losing vision (narrowing), shaking, and then stopped responding. The observation lot attendant noted loss of consciousness, reclined patient in the seat and elevated feet above the heart by placing them on the car dashboard. At 1535, 911 was notified by RN. When car door was opened by the attending observation lot worker, client began regaining consciousness. Client was given apple juice and crackers and vitals were taken. At 1540, Patient blood pressure measured 91/60, pulse oximeter reading of 96% saturation, and heart rate 72bpm. Paramedics arrived to the scene at 1545 and assessed the client; patient was not transported. Father was instructed by paramedics of warning signs and when to seek further care. FOC and patient were advised to inform PCP and to report this instance when receiving future vaccines. FOC and patient remained onsite for 15 minutes following Paramedic care and were dismissed when patient and FOC reported that they felt comfortable leaving.

patient became immediately flushed, states she felt light headed, asked for water and was given, mom elevated patient feet on chair. patient stated she was ok to stand, was escorted to the observation area and asked to lay down on gurney, EMT's tended to, patient vomited 200 ml, rested, observed for 30 min, vitals initially 114/66 in L, P 89, 14 R 5 min later 120/78, P 80, R 14, then 10 min later 120/82 in L, 86 P, 14 R. After 30 min observation, regained color, no longer flushed, denied weakness and nausea, patient mother present during episode, states states no reaction after first vaccine, states this was a normal reaction for the patient when needles and vaccines involved. Mother denied further medical care. Left facility without difficulty.

Severe diarrhea, chills, hot flashes, nausea. Evening of 4/2 and all day 4/3. Mostly okay in the morning of 4/4. Normal diarrhea treatments like plain diet, lots of water, and anti diarrhea meds (loperamide HCl 2mg pills and 3 were taken over the course of 4/3 with no relief). Severe stabbing abdominal pain that came in waves

Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: shakes-Mild, Systemic: Shakiness-Mild, Additional Details: pt fainted and had shakes/ convulsions for a few seconds. after 30 seconds pt awake and stated ok , after 30 min pt stated ok after 30 min observastion. mom n dad brought to hospital dad called and said pt was ok . no unusual findings

Patient fainted post-vaccination. Observed patient beginning to lean forward and RN was able to prevent her from falling. Patient's eyes observed to roll upward while patient became unresponsive to stimuli and diaphoretic. No incontinence. EMS called while patient assisted simultaneously to gurney by multiple staff. Upon lying down, patient awoke and become alert and oriented to person, place, time, and situation, though stayed pale and diaphoretic for several minutes. VS @ 12:55: BP 120/80, P 59, SAO2 99%, resp unlabored. VS @ 13:00: BP 138/83, P 62, R 20, SAO2 99% VS @ 13:04: BP 123/73, P 54, SAO2 99% VS @ 13:10: BP 100/69, P 78, SAO2 98% Sitting at edge of bed without symptoms at 13:05, alert and conversing with staff and mother. EMS arrived at 13:07 - their monitor showed NSR, random blood sugar = 93. Ate a snack and drank juice, symptoms completely resolved. Mother declined transport to ED. Discharged home with mother with post-vaccination instructions, will receive 2nd dose while lying down.

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium

Patient Received her first dose Pfizer vaccine (LOT#: EW0173 EXP: 8/2021) at 1140 on 4/30/21. Mother of patient alerted EMT. Mother stated that patient wasnt feeling well. Patient stated that she felt weak and nauseous. Patient was moved to anti-gravity chair to make patient more comfortable. Patient then experienced a syncopal episode at 1155 which lasted about 30 seconds. Patient denied SOB. Patient did not hit head. EMT took patients vital signs at 1157. BP: unable to read, pulse: 70, O2: 100%. EMS was activated. EMS arrived on scene at 1205. EMT transported patient to outside area on wheelchair. EMS transported patient into AMR vehicle and put patient on a 12 lead. Paramedics stated that everything was within normal limits. Patients parents were informed on patients health. Patients parents denied care and signed AMA form. Patients parents stated that they would take patient to hospital themselves. Parents and patient were educated on worsening symptoms of syncopal episode. Patient left vaccination site with a steady gait, unassisted with her parents at 1215.

Seizure; This is a spontaneous report from a Pfizer sponsored program COVAX US Support from a contactable consumer (patient's grandmother). A 16-year-old female patient received bnt162b2 (Pfizer COVID vaccine), via an unspecified route of administration, administered in arm on 24Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included epilepsy from 2016 to an unknown date. There were no concomitant medications. The patient experienced seizure on 25Mar2021 03:00 with outcome of recovering. It was added that the patient did not have a seizure for 3 years and took her off after 2 years. She had not been on seizure medications for 4-5 years. She had been seizure free and had not been to her neurologist for 4-5 years. Epileptic but never had a seizure for the past 6 years. She is going back to the same doctor. She was diagnosed as being epileptic 5 years prior. Time the vaccination was given: 14:00-14:30. Her neurologist is informed not to get second dose. NO ER required. The patient went to the doctor. Last Friday, she had an EEG and results are unknown now. They have not had follow up appointment yet to get results. The patient underwent lab tests and procedures which included electroencephalogram: results are unknown on an unspecified date. Information on the lot/batch number has been requested.

her right hand started twitching shaking uncontrollably; her right hand started twitching and shaking uncontrollably; Her temperature also started rising but did not reach above 100*F; This is a spontaneous report from a contactable consumer (Parent). This consumer (patients mother) reported for a 16-year-old female patient (daughter). A 16-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via unspecified route of administration in left arm on 19Apr2021 (at the age of 16-year-old) for SINGLE DOSE for COVID-19 immunization. She received Pfizer vaccine on 19Apr2021 in left arm and within 2 minutes of receiving it left arm, her right hand started twitching and shaking uncontrollably on an unspecified date. The nurse and the fire department were with her and monitored her for 45 minutes until they suggested her to contact her primary care provider and go to the hospital. In those 45 minutes her right arm started twitching with her hand twitching more. It started going up and down with a flopping motion. Her temperature also started rising but did not reach above 100*F on an unspecified date. She was observed by several doctors in the hospital and was given Adavan (Ativan) for her symptoms which did not subside. She was dismissed from the hospital and was given Adavan (Ativan) again in the hopes that her symptoms would subside in the morning. This morning, only her right hand was still twitching. She is right-handed and could not use her right hand at all as she could not hold a pencil at all, which caused her to be absent from school today. She mentioned that her daughter was healthy, athletic, and had no underlying conditions. Her twin sister also had the vaccine yesterday and experienced nothing but nausea last night with some of the listed side effects. She is asking if there has been reports of this. Waiting to hear from hospital she may need to see a neurologist. Outcome of the event reported as recovering. Response: Referenced PI Section 6 and Section 18 LAB-1457-7.0 Revised: 06 April 2021 No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient had fainting episode immediately after vaccine administration. She became responsive in few seconds. she said before fainting she felt tingling, rapid HR and really cold. she reports nausea and confusion right after becoming responsive. Mother denied the need for EMS said she is fine and she has had fainted once after flu shot. Her blood pressure was 100/62 and 95/82 with Heart rate of 99 and 89. She lied down for 30 minutes. she reported feeling fine before leaving.

Within about 5 minutes of receiving her first Pfizer Covid19 vaccine, the patient passed out and hit her head on the floor. She regained consciousness quickly (within seconds) after I got to her. She stated she had felt nauseas and tingly before fainting. She has not experienced this before with other vaccines. Ambulance was dispatched due to her hitting her head. Parents and paramedics determined she was ok to go home.

Patient passed out with associated convulsions within 2 minutes of vaccine being administered. No previous Hx of this post vaccination but did occur once after donating blood. Patient was lowered to flat position on floor.

My daughter developed a rash to her inner arms, inner legs, and hands. Warm to touch. Raised rough textured rash. The skin that is affected is swollen. Benadryl taken orally did not help decrease the rash, nor did topical Benadryl. She also complains of pain to her left leg from her hip to her knee that intermittently bothers her starting 4/30 and still continues to bother her. The day after the vaccine was given she had injection site pain, tiredness, extreme headache, fever of 101.8, nausea, chills, body aches. No swelling or redness to injection site. No lymph node swelling.

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Tingling at site of injection. Patient was seated after receiving the vaccine and suddenly collasped. Patient maintained consciousness throughout the episode and her symptoms have improved.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe

FIRST VACCINE WAS ON 04/11/21 NO SIDE EFFECTS. SECOND VACCINE WAS ON 05/02/2021 AND HAD THE FOLLOWING SIDE EFFECTS: HEADACHE, STOMACH ACHE, HOT FLASHES, NAUSEA, FATIGUE, FEVER 101

Shaking of the hands and legs while being in extreme pain and uncontrollable. It started in the morning and got worse overtime throughout the day.

Bell's Palsy noted on 5/4/21. Did have some mouth pain on 5/3 that was attributed to potential wisdom tooth eruption, then cranial nerve 7 palsy noted on 5/4/21.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tachycardia-Mild, Additional Details: pt released to her father. spoke with father a few hours later. pt is fine.

Immediately after second dose, patient reported feeling tingly, light headed and "off". She had had this same reaction in the past with her 1st dose and was prepared that it may happen again. Her mom and dad were both with her. She laid down for awhile and was monitored directly in immunization room for 30 minutes. She reported feeling better, back to normal before leaving with direction supervision of her parents. They report that she often has these reactions to shots or medical procedures. This is the same reaction she had to the first shot.

This is a spontaneous report from a contactable consumer (patient's father) via Medical Information team. A 16-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the right arm on 02Apr2021 at 10:15 (batch/lot number and expiration date were unknown) as a single dose for COVID-19 immunization. The vaccination facility type was reported as a "drive thru COVID-19 vaccine clinic." The patient's parents thought it was best for the patient to take the Pfizer COVID-19 vaccine, since she was eligible to get it so she would be protected. Relevant medical history included acne on the face from an unknown date and unknown if ongoing. Concomitant medication included isotretinoin taken for acne on the face, which she took for almost 3 months from an unspecified start date to 19Apr2021. The patient had no history of previous immunization with the Pfizer vaccine, since this was her first dose. There were no additional vaccines administered on the same date of the Pfizer suspect vaccine. The patient had no prior vaccinations (within 4 weeks) and had no adverse events (AEs) following prior vaccinations. The patient had no family medical history relevant to the AEs. On 17Apr2021 at about 16:15 in the afternoon, the patient experienced seizure. It was further reported that the patient had a side effect after receiving the Pfizer COVID-19 vaccine; the patient had a seizure 15 days after receiving the vaccine. The reporter was asking if seizure had been reported with the vaccine. The reporter had no idea for sure if it was the vaccine, but he wanted to let Pfizer know. The reporter was hoping the patient would be okay and it won't happen again. The patient would see her physician at the time of the report on 21Apr2021 in a few hours. They would listen to the doctor at the appointment, and they had an appointment with the neurologist to see if she should get the second dose on Friday. They didn't know yet. The reporter didn't have the vaccination card with him. The patient had no conditions other than this event. The patient went to the emergency room for the event on an unspecified from which she had blood tests, urine tests, and a computerized axial tomography (CAT) scan of her brain and they said they couldn't find anything wrong at that time. They needed to follow up with the hospital in the area to see a neurologist, which they would be doing the following day. They told them to follow up with the neurology department at their Hospital and told them until they find out more information; the patient could do what she needed to do, but she couldn't drive a car. The reporter asked if Pfizer has had any reports of this and wondered if there had been other reports of seizures. The outcome of the event was unknown. Information on the batch/lot number has been requested.

Accompany minor with dad received vaccine for first time. Pt complain of dizziness, diaphoretic, pale to face, body stiffness and started jerking once on floor. Pt placed to floor for safety precautions. V/s obtained w/ b/p 80/54, HR 92 O2 98%. Jerking stopped with v/s obtained again w/ b/p 82/56 HR 95 O2 99%. EMS arrived and taken over care. Pt was more a/ox3. Taken to hospital via EMS.

Systemic: Fainting / Unresponsive-Mild, Additional Details: mom said she passes out after shots, fainted less than 1 min, had her lay down with feet up for 15 min, then sit up for 15min before leaving,

12:12 Patient is in the Observation Area post VAccination on her LEft Arm 2nd dose, suddenly complaints of dizziness, lightheadedness, clammy, pale and cold skin. Vitals were taken as follows: 77/40, HR 68, Oxygen SAturation 93%, Temp 97. Kept attended, both parents are with this 16 years old lady. Patient remained alert and oriented. When Emergency TEam came and evaluate the patient, BP was 103/66, HR 84, O2 saturation 95% and felt better. Patient was advised to go to the emergency room for further evualtion but declined. EMS team left

Numbness in tongue, right sided facial droop, difficulty closing right eye, headache, jaw pain. dx with Bell's Palsy

Developed headache, chills, hot flashes, body aches, burning eyes, nausea, and fatigue 4 hrs after vaccination. Symptoms wax and wane in severity, but have not resolved. She was seen by pediatrics and family practice by telemedicine. Treated with Tylenol and Advil. Then presented to Hospital ER 5/3/21 with worsening fatigue and weakness. ER work-up included normal/ negative CBC, d-dimer, monospot, CMP, ESR, CK, UPT, UA, RP Covid, and Influenza. Only noteworthy finding was mildly elevated CRP at 0.51. Treated with Zofran. Outpatient follow-up work-up included normal ECG, normal repeat CBC, CMP, CK, ESR, A1C. CRP 3. EBV, CMV, Parvovirus, Covid antibody, ANA, and RF pending. She briefly D/C'd Amitriptyline, so advised to resume.

Approximately after 1 minute from receiving her first pfizer vaccine the patient reported to her mother that she feels like she is going to pass out. This RN was alerted about the situation by the patients mother and when approaching the patient this RN noticed the patient losing consciousness and drawing her arms to chest and curling her hands with tremors throughout her body. This RN placed the patient on the floor for safety out of the chair and had other staff member contact 911. Tremors lasted approximately 30 seconds and patient regained consciousness however appeared tired and stated she is unware of what just happened. Vitals were taken which were within normal limits and continued to be taken frequently until EMS arrive to transport patient to Hospital

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Seizure-Mild, Additional Details: Parents were with patient. says it happens every time she gets shots or blood work. possible NES and/or hypotension. says its happened in docs office before and they're testing her for pots and her sister has non epileptic seizures. She was fine after about 15 minutes. gave her a cold packet to put on the back of her neck and just monitored her for further symptoms.

16yoF was accompanied with an adult who was present for the vaccination. The COVID-19 Vaccine Pfizer-BioNTech 0.3mL administered IM in right deltoid while patient was sitting. Patient remained sitting for 10 minutes after administered dose. Patient reported feeling well after the injection. Patient stood up while we continued to talk, after 2 more minutes passed out while standing. Suddenly, patient begain to go limp and her eyes crossed and rolled back. Patient fell backwards into the privacy curtain and into aisle 13 of the store. Patient's head bounced off the floor. Immunizer knelt next to patient. Patient was unresponsive until immunizer placed cold hand on back of neck and front of chest to check if she was breathing, immunizer calmly guided patient to breath, slow deep breaths into the belly and patient's eyes fluttered open. She said her head hurt really bad. Immunizer offered to the accompanying adult to call EMS because patient should be evaluated after hitting her head so hard. The accompanying adult denyed EMS, then stating that patient had previously fainted while walking and said that she would be fine. Immunizer advised patient to remain laying down while immunizer got some ice. Ice was then placed on the back of the head. Patient slowly stood up after laying for 10 minutes and was walked over to a sitting area to put feet up and continue with ice for another 5 minutes before the accomanying adult wanted to leave.

After counseling and giving the patient her vaccine, the patient walked to the waiting room and sat down. 2 minutes after receiving the vaccination the patient leaned back, tensed up, became unresponsive and had a vacant look in her eyes. We called 911. Her lips started turning blue. I administered 0.3mg epinephrine auto injector and the color in her lips came back. Paramedics arrived evaluated her and transported her to the hospital.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Medium, Systemic: Shakiness-Mild, Systemic: Vomiting-Medium, Systemic: Weakness-Mild, Additional Details: Within a few minutes after receiving second dose, she threw up and was very pale. She was drinking water and we got her crackers and candy. She laid down on the floor for about 10 minutes and started to vomit again. I asked her dad if he would prefer me to call an ambulance to have her checked out. He said yes so they were called. Her vitals were good when they checked her when they got here. They did take her to the hospital.

While in seated observation area, pt reported feeling faint. Brief loss of consciousness, while supported by pharmacist, legs stiff, arm twitch then relax as regained consciousness, lasting few seconds. Feet elevated, called 911 for care. Evaluated by paramedics in parkinglot, returned back to pharmacy after recovery for checkout.

worst seizure; First Pfizer Covid Shot on 17Mar2021# Second Pfizer Covid Shot on 31Mar2021; This is a spontaneous report from a non-contactable consumer (parent of patient). This report is for the second dose. A 16-year-old non-pregnant female patient received BNT162B2(PFIZER BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 31Mar2021 (Batch/Lot Number: ER8727) as single dose for COVID-19 immunisation. Relevant medical history includes catamenial epilepsy and attention deficit hyperactivity disorder (ADHD). Patient had no other vaccines in 4 weeks. Patient had no known allergies. Patient had not had COVID prior to vaccination. Concomitant medications included levetiracetam (KEPPRA) taken at 1000 mg twice daily to help control seizures, start and stop date were not reported and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported. Patient historically took first dose of Pfizer BNT162B2 (Lot number EN6206) on the left arm at age 16 years on 17Mar2021 at 10:30AM for COVID-19 immunisation and experienced worst seizures. Reporter's daughter has been diagnosed with catamenial epilepsy, and has been taking 1000 mg KEPPRA twice daily to help control seizures. The shortest duration between seizures was approximately 1 month, and that was before her epilepsy diagnosis and starting on the KEPPRA. She has recently suffered a cluster of seizures which is atypical for her. Last night, reporter read an article about some women starting their periods after years of not having it soon after receiving the COVID vaccine, so reporter looked back at her daughter's seizure record and noticed a potential link.Patient had her first Pfizer COVID Shot on 17Mar2021, and she experienced her worst seizure ever on 27Mar2021 (10 days after COVID vaccine). On 31Mar2021, patient had her second Pfizer COVID Shot and she experienced her second worst seizure ever on 10Apr2021 (again 10 days after the second COVID vaccine. Again, her daughter has never had seizures occur in such a short duration, with the minimum time between seizures being one month. The adverse reaction resulted in doctor or other healthcare professional office/clinic visit. Patient was treated for the event which is increase in KEPPRA dose to 1250 mg. Patient had not been tested with COVID-19 post vaccination. Vaccination facility was at a public health department. The outcome was unknown. No follow up attempts are possible. No further information is expected.

worst seizure; This is a spontaneous report from a non-contactable consumer (patient parent). A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6206 and expiration date not provided), via an unspecified route of administration, administered in Arm Left first dose on 17Mar2021 10:30 at single dose for covid-19 immunisation. The patient's medical history included catamenial epilepsy has been taking 1000 mg Keppra twice daily to help control seizures. The shortest duration between seizures was approximately 1 month, and that was before her epilepsy diagnosis and starting on the Keppra. Additionally, patient's medical history included ADHD. The patient was not pregnant at time of vaccination. The patient's concomitant medications included levetiracetam (KEPPRA) for catamenial epilepsy at 1000 mg, 2x/day, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), and unspecified medication. On 27Mar2021 08:30, the patient experienced her worst seizure ever. Also reported as suffered a cluster of seizures which is atypical for her. Last night the reporter read an article about some women starting their periods after years of not having it soon after receiving the Covid vaccine, so I looked back at my daughter's seizure record and noticed a potential link. Treatment included increased her Keppra dosage to 1250 mg. The event caused the patient for physician office visit. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.

Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: itching of eyes, feeling warm-Mild

Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild, Additional Details: Patient felt faint after void vaccine. She had some changes in vision and sat down to relax and drink an orange juice. Vitals were examined. (BP: 90/56 & 90/60; pulse: 62). Parents stated that patient has a history of feeling faint after vaccine administration. Patient was able to walk out under own power. A follow up call was placed and the parents stated that the patient was stable and doing well.

The complaint is characterized as a skin rash. The onset of the symptoms have been rapid and they have been occurring for 3 days. The course has been decreasing (pain had improved by visit on 5/10). The skin complaint is described as moderate to severe. The location is described as on the right side of trunk. There has been associated itching. She has a history of chronic back pain: aches. She said this is occurring as well as the new and worse sharp pain. It was worst last night. She was achy Wednesday morning into Thursday after vaccine. She felt a little better Friday morning, Friday evening she became tired and her back was hurting again. The rash and itching started on Saturday morning, Sunday was worse. There was burning, sharp pains on her side with the rash. Diagnosis of Shingles (B02.9). Started Acyclovir 5%. Apply 3 times daily for 7 days. Follow up in office if symptoms don't subside or get worse.

pts arm hurt immediately after taking the vax. Later that night her legs were feeling very heavy, her arm still hurts, joint pain in both hands, slight fever, has body aches and pains. On 5/12/21 they contacted her PCP and was told to give them a call back if her symptoms get worse.

pt was shaking and not feeling well at 3:10pm (10 minutes after vaccine was administered at 3:00pm). pt was given 2 oranges because pt describes having episodes of low blood sugar. Clinical staff spoke to mother and informed about event.

Pt developed chest pains and heart racing that night along with high fever 102 with very bad headache. Chills and fever and weakness latest through Friday afternoon Fever started to go down Friday afternoon and weakness improved. Headache remains strong

received vaccine and stood up. During walking out of room, fainted and potentially had seizure as she fell. Head hit the ground. Stayed awake, alert after she fell. Generally knew who, what, when, where and that she just had vaccine. EMS called who arrived and transported to ER for evaluation.

Patient received vaccine, 1-2 minutes later stated she was feeling dizzy and passed out and began to seize. 911 was called. patient was monitored and given water and an icepack upon regaining consciousness. Paramedics did a physical assessment, including checking blood pressure and blood sure. Patient's guardian refused going to hospital. After 30 minutes patient and guardian went home as patient stated she felt fine. Pharmacy planning to follow up with patient the next day.

Adverse event: PT here for first dose of Pfizer COVID vaccine. PT reported feeling anxiety before vaccination, but indicated that she was ready for her vaccination. Immediately post-vaccination, PT experienced an apparent vasovagal response, presenting with palor, slumped posture. PT's eyes were open, but PT was unresponsive and later reported no memory of events. PT became responsive within 2 minutes, but remained "shakey" and pale. RN was in attendance and provided initial assessment/response. RN also responded to PT. Aid was called at 1251 and EMTs arrived at 1253. Aid assessed PT, took vital signs (1256: BP 104/56 laying, HR 70, SPO2 98% on room air, 1303 BP 110/62 laying, HR 87, SPO2 99% RA, 1307: BP 96/58 sitting, SPO2 99%RA, 1311: BP 106/62 sitting, SPO2 99% RA). Treatment: PT was assisted to lay down on cot, water and juice were provided and consumed, cool compress were provided. Psychosocial support provided. Education to PT and mother to monitor for further s/s and to seek out urgent care if more were noted. Outcome: PT's color improved soon after laying down, PT reported "feeling better" after consuming juice and water. PT sat at edge of cot without difficulty, walked down hallway without difficulty. PT medically cleared by EMS at 1223, exited facility with mother in private vehicle.

Child was complaining of pain and knot on the left side of her chest and her left shoulder and arm as well. Parent took child to the doctor on May 12, 2021 because the pain was unbearable. The doctor stated to the parent that she needs to consulted with the infections disease doctor to get his opinion on what it is and how to treat it. The infections disease doctor stated to the other doctor to treat it with antibiotics. The doctor wanted to do a follow-up with child in two to three days to see if the antibiotics is working. Childs follow-up is schedule for May 15, 2021. Child was saying that she cannot sleep on her left side because it hurts so much.

Patient has a seizure history. Mother stated they have had numerous vaccines in the past without a problem though. Patient was waiting the period of time afterwards. Mother then stated she was having a reaction. Mother stated she is a nurse and said she believed the patient was having a seizure. Mother later was not sure if patient had fainted also since she was nervous about receiving the shot in the first place. After paramedics arrived, they took her glucose and was 77. Paramedics let mom then take patient home to get food.

Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Parademics/911 called, patient's parent refused transport to the hopsital. Patient waiting in recovery with NP and nurses, RPH to check

Immediately after receiving vaccine patient stated that her entire hand was tinging and numb feeling. This was the hand of the arm the vaccine was administered in. Patient said no other symptoms of syncope were present and it was just the left hand with this issue. 10-15 min later she said for a short time it went up to elbow but did not last there. Had her stay an extra 15 min and by the time the patient left she said it was better.

The first signs of the event developed after observation time at the vaccination when child was at home. Mother of the child walked into the vaccination clinic 11 days after the occurrence to report her child still started to develop a "different sensation" on her hands and feet and the next day could not walk or move. She was taken to the ER 2 days after occurrence. The child was taken to her PCP on 05/17 and was referred to a neurologist. The initial appt is scheduled for 05/28 and PCO is trying to secure an earlier appt.

A few moments after receiving the vaccination, patient fainted and had some tremors afterwards. We picked her up off of the floor and placed her in a chair. She was pale and had some discoloration around her nose area. She was able to speak to us. She felt cold and was sweating at the same time. Her body temp was 97 degrees F. According to her mom, she's had a previous reaction similar to this but not to this extreme with the HPV shot. We called 911 to have her assessed by the paramedics

PT HAD A SEIZURE APPROX. 30 MINS AFTER RECEIVING THE COVID VACCINE, PT FAINTED, STIFFENED UP, AND BEGAIN TO CONVULSE. PT WAS PLACED ON COTT IN THE RECOVERY POSITION, 911 WAS CALLED AND VS OBTAINED. P74, R22, BP118/80, O2SAT 98% ON RA. SEIZURE LASTED APPROX 10 SECONDS, AMBULANCE ARRIVED WITHIN 10 MINS, AND TOOK OVER PT'S CARE. PT'S COLOR REMAINED PINK THROUGHOUT, AND SHE WAS SLEEPY BUT ABLE TO ANSWER QUESTIONS APPROPRIATELY. VS: P83, R24,BP116/80, POX99% ON RA. PT TAKEN IN AMBULANCE TO HOSPITAL FOR FURTHER EVALUATION

The patient had a Vasovagal response. She had a 15 second seizure ,blood pressure dropped, was flush, tired and nauseated. She has no memory of the event.

Patient started experiencing numbness and tingling on her right side and then all over on Sunday evening 5/2/21. It affected her gait and the numbness and tingling in her legs caused her to have to catch herself and hold on to something to keep from falling. She described that her legs felt weak for a few seconds when walking. This sensation gradually decreased in intensity and duration. When I saw her at 5 pm on 5/3, she had normal gait and only felt the numbness and tingling very briefly. Her exam including her neuro exam was normal on 5/3 when I saw her. The sensation of numbness and tingling completely resolved by 5/4. She also experienced HA, nausea and fatigue, but did not have syncope, dizziness or fevers.

arrhythmia, heart palpitations, pain in left arm, pain in chest (particularly left side) radiating into shoulder blade, fatigue, muscle aches

Fainted; Didn't know if it was a convulsion or a seizure; Shaking; was very anxious; This is a spontaneous report from two contactable pharmacists. A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0167, expiry date: Aug2021), via an unspecified route of administration, administered in the left deltoid, on 30Apr2021 15:30, as 1st dose, single, for COVID-19 immunisation, at a pharmacy/drug store. There were no medical history and concomitant medications. On 30Apr2021 15:30, the patient received the first dose of the COVID-19 vaccine and was very anxious. She wanted her mom to be present. On the same day, 30Apr2021 15:35, five minutes later, the patient was shaking, and she fainted. The reporter did not know if she was having a convulsion or a seizure. A few minutes later, the patient was sitting and becoming more alert. The patient was given water and one dose of Benadryl. The patient's vital signs were checked (unknown result). The reporter talked to the patient's mother and contacted the patient's pediatrician. The events resulted to emergency room and physician's office visits. Later in the evening, the reporter followed up with the mother and she confirmed that the patient was doing well and better. The mother asked the reporter if the patient should get the second dose of the COVID-19 vaccine. The outcome of the events fainted, shaking, "didn't know if it was a convulsion or a seizure" and "was very anxious" was recovering. The reporter assessed the events fainted, shaking, "didn't know if it was a convulsion or a seizure" as serious (medically significant). The reporter considered that BNT162B2 has a causal effect to the adverse events. Follow-up (18May2021: New information received from a contactable pharmacist includes: reporter information, lab data, suspect drug details (vaccination site and vaccination time), event details (onset time provided, outcome updated to recovering, causality and seriousness assessment provided). Follow up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information, and on a reportedly closed temporal association, the company assessed that a reasonable possibility could not be excluded that the reported events (fainted; didn't know if it was a convulsion or a seizure) were related to the suspect product BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE). 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.

4 days after vaccination (on 5/18/21) she presented with right facial droopiness (unable to close right eye, unable to smile on right side etc) consistent with Bell's Palsy. Symptoms are (unsurprisingly) persistent now 3 days later

Covid vaccine administered on 5/20. 1704 - in observation room pt complained of feeling warm and a sore throat. 1706 - 50 mg Benadryl PO given, VS HR 93, POX 99, BP 128/68 1710 - VS HR 97, POX 98 1712 - pt states throat feels better. 1715 - pt states throat feels okay. 1720 - pt states she feels fine. No dizziness, throat all better. 1723 - VS HR 97, POX 99 1725 - VS HR 93, POX 98 Pt monitored by 2 RNs for 30 minutes throughout this encounter prior to leaving observation.

Knumbness and tingling in fingers and toes. Both feet knumb. Large swollen lump under armpit on same arm as injection.

Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Severe

I am her mother reporting and also an RN. She rarely complains of symptoms whenever I?ll. C/O 12 hours post vaccination began feeling of throat closing- able to breath ok/safely but short of breath (O2 says 99% HR 60?s - WNL), feeling floaty and light- as if not on ground, body feels tingling and numb, difficulty sleeping, right pupil dilated greater than left but both pupils reacted to light appropriately with check. Pupil over dilation one side resolved by next morning. Other symptoms still continue. Other SE?s are common: HA, low grade fever 100.9, body aches. Currently 33.5 hours post vaccination at submission. Pfizer #1 on 4/30/21 Lot# EW0173 Pfizer #2 of 5/21/21. Lot# EW0187

Fever, body aches, headache, tingly limbs. Symptoms started around 4am, so about 17 hours later. Symptoms were gone by 48 hours later.

Systemic: Fainting / Unresponsive-Medium, Systemic: See statement below-Medium, Additional Details: Minor patient with parents in attendance. After receiving immunization, patient stood up, took a few steps and fainted, falling backward and hitting head on the floor. Pharmacy staff immediately called 911 and provided supportive first aid. Patient quickly regained consciousness, RPh had her continue to lay in the floor, provided pillow for head, elevated feet and ice pack was applied to back of head. Paramedics arrived to evaluate patient's condition, patient was released home with parents.

Pfizer-BioNTech COVID-19 Vaccine EUA I woke up at about 4:30 AM and couldn?t fall back asleep, I kept feeling sleepy until I would get jolted back awake over and over. My joints were hurting, I had somewhat severe nausea, my head started throbbing. At about 6:40 AM my migraine started, my arm felt hot to the touch, and I got dizzy so I took some acetaminophen. At 10:00 PM I noticed the area under my left armpit was a little swollen and really sore, my throat and right tonsil was also sore and it hurt to swallow. The next day (today) I have another migraine, my throat and left armpit are still sore, and my muscles hurt. I?m getting better though.

Dizziness, Migraine, no visual disturbance. First Migraine accured on 05/12/2021 lasting 24 hours, Second migraine on 05/19/2021, lasting 24 hours

hives developed in the evening after first vaccination, treated with otc oral benadryl. Hives of scalp, neck, face and shoulders developed after the second vaccination on 5/19/2021, which was partially treated with otc oral benadryl. The day following the 2nd vaccination, the patient developed nausea with vomiting, fever, sweats, shaking and chills for one day.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Medium, Additional Details: Patient had seizure with 1st vaccine, pediatritian informed mother to have patient lay down if it happens again. Patient said she felt out of it (at 11am) after administration of this vaccine so we helped her lay down on the floor with her head proped up. Gave her water and turned on the fan to try and make her more comfortable. Patient decidede to try sitting up slowly after 10-15 minutes, then after another 10 minutes she was able to stand and felt back to normal and left the store 11:30am.

Faint, anxious, clammy Vital Signs: BP 85/60 HR 72 Resp 18 O2Sat 98 Skin Signs: Clammy Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally Initial Treatment: Brought to triage and assisted to supine, Hx of anxiety 12:43 PM Vital Signs: BP 97/61 HR 68 Resp 16 O2Sat 98 Skin Signs: Warm and dry Circulation: Cap refill <1sec Respiratory: Breath sound clear bilaterally Vital Signs: HR 79 Resp 16 O2Sat 99 Skin Signs: Warm and dry Circulation: Cap refill <1sec Respiratory: Breath sound clear bilaterally Notes: Physician advised patient to seek further medical treatment should symptoms return or worsen. Home with parent.

got her 1st dose of the Pfizer Covid Vaccine in her right deltoid. About 1 hour after she got her vaccine she developed a tremor in her left hand/forearm. It was most vigorous when she would reach her hand toward her mouth, elbow bent. I would have her straighten her arm and hold if firm to stop it while massaging the muscles in her right forearm and bicep area. She continued to move her arms and massage her left arm, bending and straightening. Her hand would vigorously shake when she reached her hand toward her mouth. This went on for about one hour and then gradually became less vigorous and then went away completely.

This patient received the Pfizer vaccine on 5/24/21 at 4:30pm and was feeling fine until the next morning at 5:30am when she felt dizzy and passed out. She then was able to get back up and passed out again. Her guardian states that she was gray in color and was very weak. She was able to communicate but was very tired and stayed at home for 2 days. Today she is feeling fine and guardian was asking if she should get the 2nd dose. I said that she should contact her physician.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Mild, Additional Details: Patient temp at time of incident was 96.8. About 8 mintues after vaccination was given patient became pale and passed out for several seconds. Patient was dizzy and vomited. No other symptoms. Called paramedics to make sure patient was okay. Gave patient some water and spoke to patient until the paramedics arrived. Paramedics took her vitals and after while they cleared her. She was able to walk out on her own and went home with her father and brother.

Presented to ED on 5/13/21 with trouble breathing, chest pain, back pain and numbness. Had been exposed to boyfriend with flu like symptoms 3 weeks prior and had had some symptoms around that time but had been improved. SARS-CoV-2 PCR negative in ED. patient afebrile but workup in ED revealed troponin of 0.71, no EKG changes. Symptoms resolved in ED but given troponin was admitted to the hospital for further evaluation. Echo performed and normal. Troponin trended in hospital and patient discharged without events.

103 degree fever, migraine, severe joint pain, GI got significantly worse (pain in stomach); went to ER; admitted overnight to hospital since they could not get the fever and migraine resolved; spent two days in the hospital treated with various medications including Tylenol and magnesium

Patient has hyper eosinophilia and myositis, both of which are new and accompanied by severe leg cramping. This started shortly after her first Covid vaccine was given. Patient is being followed for repeat labs by PCP and seeing specialist at hospital.

Patient experienced seizure activity after receiving 2nd dose of pfizer vaccine. Sx started approximately 5 mins after receiving injection. fell and hit head. B/L upper extremity contractures noted that did not resolve and was associated with extreme pain and muscle rigidity.

Approximately 10 minutes after vaccination, patient's brother yelled out for help. The pharmacy cashier then observed the patient convulsing. Her body was leaned back on the bench, with head tilted back a bit. When I came out, patient appeared very pale. I immediately ran back into the pharmacy, instructed a fellow employee to reach out for assistance from front end management, and I called 911. While on the phone with 911, I walked out to check on the patient. At that point, she appeared to be coherent and said she was okay, and doesn't need any medical help. At that time, her brother explained that a reaction like this had occurred in the past when she got other vaccinations/injections so they were familiar with the symptoms. We continued to monitor patient for further reactions. After about 30 minutes, patient appeared to have no further reactions and left.

Patient sat about 2 minutes after getting vaccine and started to walk away to sit in our designated area. She immediately turned around to sit down again. She then proceeded to start falling to her right and passed out. I was able to catch her and then she started shaking as if having a seizure. This lasted about 5 seconds . She stopped and then it happened again for about 5 seconds. When she came to, she tried to walk away again and had to return to sitting. Then she vomited twice. Upon checking her blood pressure after about 30 minutes, it was 97/66. She sat for a total of about an hour before feeling good enough to leave. She was nauseous for the remainder of the day and the next day as well.

The afternoon of May 4th, (the patient) had a headache at the back of her head. She took an Ibuprofen and went to bed. Over the course of the next 3 weeks, the headache would return, but was alieved with Ibuprofen. On the evening of May 23rd, 2021 (the patient) came to me and said she had a twitching in her neck. I looked, but did not see anything that was concerning. It was just a twitch. On the evening of May 24th, (the patient) went to dinner with her father. On the way to dinner, they were having a regular conversation when (the patient) began to stutter really bad. Her father pulled the car over and looked at her. He noticed her head was shaking uncontrollably and she could not talk. He immediately took her to the emergency room. When I arrived, it looked like she was having a seizure. (The patient) has never had any kind of speech problem, so she has never stuttered. the drs told us that they did not have a neurology dept, so we took her to another hospital. After numerous tests, we were told to take her home and it was probably something like stress and she should see mental health

PT WAS SITTING AT THE CHAIR WITH HER PARENTS FOR 15 MINUTES WAITING (OBSERVATION) PERIOD AFTER THE COVID VACCINE. 5 TO 10 MINUTES AFTER THE COVID VACCINE, I HEARD HER DAD CALLED SAYING I THINK MY DAUGHTER NEEDS HELP, I THEN RAN OVER WITH THE EPIPEN AND MY TECH IS CALLING 911. WHEN I CAME TO THE PATIENT, I ASKED HOW'S SHE DOING, SHE SAID SHE'S OK NOW. I ASKED IF SHE CAN BREATH, SHE SAID YES. WE GAVE HER A LITTLE WATER. HER DAD SAID SHE WAS OUT, LOOSING HER ALERT BUT NOW LOOK LIKE SHE'OK. PARAMEDIC CAME AND TOOK HER.

Patient began to loose vision and fainted. after about 5 minutes she began to make jerking movements and fainted again 911 was called and they took over the situation

Migraine headache with aura occurring for the first time on indicated date. Woke 2 days later (April 20th) with severe headache and nausea. Taken to ER. Had headache again (moderate) for 2 days following ER visit.

Patient had second Pfizer vaccine on 5/22/21. She complains of sore arm and raised area like a bump. RN reviewed supportive measures, and to notify provider since area swollen with bump.

arm pain, mild chest pain, mostly around the sternal area, more with on palpation, extremely elevated troponin levels (high normal is 0.04 for our labs, patient had 20) echocardiogram negative transferred to a more complex center, Hospital

PATIENT EXPERIENCED DIZZINESS, BLURRY VISION, HEARING LOSS AND BECAME SHAKY AND PALE ABOUT 2 MINUTES AFTER GETTING THE VACCINE. SHE WAS STILL SEATED IN THE IMMUNIZATION ROOM AT THE TIME THE ADVERSE EVENT OCCURED. SHE REMAINED SEATED IN THE ROOM FOR ABOUT 20 MINUTES BEFORE FEELING WELL ENOUGH TO LEAVE. SHE WAS GIVEN WATER AND AN ICE PACK.

PATIENT'S FATHER REPORTED AFTER PATIENT SAT DOWN IN OBSERVATION AREA, SHE REQUESTED A WATER. PATIENT AND MOTHER WALKED TO RETRIEVE WATER AND AS SHE ENTERED THE TENT PATIENT REPORTED DIZZINESS AND VISION DISTURBANCE. PATIENT STATED SHE BEGAN TO SEE BLACK AS SHE WAS SEATED. NURSE WAS CALLED OVER. DAD STATED PATIENT'S BODY SLUMPED OVER AND HE SUPPORTED HER IN THE CHAIR. THE NURSE WITNESSED FULL BODY UNCONTROLLABLE SHAKING FOR LESS THAN 20 SECS. LOC ASSESSED AND PATIENT WAS AOx4 IMMEDIATELY FOLLOWING THE SHAKING. NURSE ALSO OBSERVED PALE LIPS. FLUIDS OFFERED AND CONSUMED. MD & EMS PAGED. DAD REPORTED TO MD, PATIENT HX OF FAINTING. PATIENT BECAME PALER. MD ADVISED AGAINST PLACING PATIENT ON GROUND. GURNEY PROVIDED. PATIENT FEET ELEVATED. VS OBTAINED #1 BP: 76/48; #2 83/52, p: 60, RR: 16; O2: 98%; #3 BP: 85/53, P: 81 at 1540. PATIENT OBSERVED WITH FEET ELEVATED FOR LESS THAN 10 MINS. MD RECOMMENDED PATIENT REMAIN IN OBSERVATION FOR 15 MINS PRIOR TO LEAVING. PATIENT MOVED TO CHAIR SEATED UPRIGHT POSITION WITHOUT ASSISTANCE FOR 15 MINS. 15 MINS ELAPSED, MD MADE AWARE AND DECLINED TO REEVALUATE PATIENT AT 1555. PATIENT EXITED OBSERVATION AREA ACCOMPANIED BY PARENTS AND BROTHER WITH FLUID IN HAND IN STABLE CONDITION.

Shortly after receiving vaccine (about 5 minutes), pt complained about difficulty breathing. I went to check on her and she appeared pale and seemed very drowsy and unresponsive to questions. She continued to complain about dizziness and nausea. Her parents grabbed some water for her and still there was no improvement. I called 911 to report the symptoms and was advised to administer EpiPen. When asked if her breathing improved, she nodded yes, but she did not appear to have improved. She continued to be unresponsive to questions and appeared extremely drowsy. Within 15 minutes, the ambulance arrived.

Approximately five minutes after injection, patient began feeling faint, nauseated and weak. Her parents had her sit down. She began vomiting and sweating. We called 911. Her Dad starting taking vital signs. He is an ER Dr at local hospital.

Patient received the Pfizer vaccine. Patient left to sit in out waiting room after vaccine. Patient's mother informed in a few minutes that the patient was not feeling well. She stated that the patient felt hot. I grabbed an ice pack on my way out to her. I put the ice pack behind her neck. Patient passed out within a minute of me getting to the patient. She came back to quickly and stated that she was having a hard time seeing and hearing. She then again passes out. At this point I made the decision to call 911. I delegated to my tech to call 911. She called 911. I asked my other tech to come help me thinking the patient my have needed to be lower to the ground. The patient again regained consciousness. At this point I asked tech to call our Store Director and inform them. I also asked that she get me a water for the patient. The patient was feeling better and drank some water. She then again passes out. This time we were struggling to get her to regain consciousness. I used sternal rubs to help the patient regain consciousness. I was having a hard time finding her pulse. This lasted for a minute or two and then she stared responding. Right then EMS arrived and took over. I gave them the information I had and they took her vitals. EMS decided that she was stable and could go home to be monitored by mom. I did call the Mother the next morning to check on the patient. The patient did well last night and was feeling good this morning.

4-to-5-minute after administrating the vaccine, pt start having a very short episode of seizure. It didn't last for more than 1 to 2 seconds. It was very quick that most of us didn't see it. Then pt laid down the pt down for few minutes. She felt fine and her mom took her home.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium

delerium; Severe myalgia; full body rash; swollen legs; facial swelling; slurred speech; stomach pain and cramping; nausea; headache; injection for vaccine received same date; injection for vaccine received same date; injection for vaccine received same date; This is a spontaneous report from a contactable consumer (patient). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 15Apr2021 (Lot Number: EP7533, at the age of 16-year-old) as single dose, and second dose via an unspecified route of administration, administered in right arm on 15Apr2021 (Lot Number: EW0171, at the age of 16-year-old) as single dose for covid-19 immunization. Medical history included post streptococcal reactive arthritis and bee sting allergy. The patient's concomitant medications were not reported. On 16Apr2021, the patient experienced severe myalgia, full body rash, swollen legs, facial swelling, slurred speech, delerium, stomach pain and cramping, nausea, headache. Headache and stomach pain have lasted 7 days. Rash and myalgia lasted 5 days. Delerium, facial swelling, leg swelling and slurred speech lasted 12-24 hours and were relieved by Benedryl. The treatment for the event included Ibuprofen, Acetaminophen, diphenhydramine. The injection for vaccine received same date on 15Apr2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not pregnant. The outcome of the events severe myalgia and full body rash was recovered on 21Apr2021, for events stomach pain and cramping and headache was recovered on 23Apr2021, for other events delirium, swollen legs, facial swelling, slurred speech, nausea was recovering.

Patient reports immediately after receiving the vaccine she developed chest tightness and pain that has continued to wax and wane the past two weeks. Has some intermittent difficulty breathing and fast heart rate that each last about 20- 30 minutes. Also accompanied by dizziness or lightheadedness. Reports her whole right leg feels tingly and her joints hurt, but denies weakness, redness or swelling of the joints or right foot. Also has a continuous headache that started within an hour of receiving the vaccine and worsened over the next few days. This too has waxed and waned.

Mother reported daughter fell in bathroom in the middle of the night- said she couldn't see then sight came back. Then again Mother checked on daughter later on and daughter was unresponsive when mom was tapping her in the face-she was just looking at her mom but not seeing or hearing her -like a black out-- couldnt be woken up easily- and when she did wake she couldn't see. But since those 2 episodes daughter's sight is back but she feels nauseous and has an upset stomach.

5/31/21 10:50a vaccine administered. Pt anxious and feel like vomiting. Pt vomited. Pt didn't eat breakfast. Pt reported felt clamish. Pt then felt like she will move her bowel. Pt escorted to washroom and had diarrhea. 11:07a pt had a bowel movement. Pt was monitored and after drinking orange juice felt better. 11:19a Pt felt better and left with Mom and Grandmother.

1st dose: fatigue, slight headache, pain in left arm. during arm circles, would be pain during movement pain for a day or two. Took Tylenol 2 tablets 500mg each on the night of the vaccine. 2nd dose: received vaccine at 5pm, during night of vaccine day, got a fever and headache and chills. flu-like symptoms for 24 hours. fever of 101F. soreness of muscles. on second day, fever was almost gone. lasted 2 days total. most severe symptoms on first day. Took Tylenol 2 tablets 500mg in the morning, 2 tablets 500mg in the evening. Took 1 tablet of Advil 200mg on day 2.

Syncope x 3 in the early morning hours (around 3am) about 14-15 hours after vaccine. She had had headaches that is intermittent, throbbing, phonophobia but no photophobia, from back of head to top of head and behind eyes, taking Advil or Excedrin intermittently with relief for a week prior to covid19 vaccine. Syncope, longest lapse was two minutes, her sister found her. She went to Medical Center ER at 0400, was assessed and scanned, neg CT scan of head, and was discharged home. Has felt some fatigue today due to not sleeping early the night before, has returned to school since concussion, with normal learning, and denies any exertional physical activity due to pre-existing torn ACL, torn medial meniscus L knee. After evaluation by ER, was given IV fluids, determined cause to be dehydration.

Patient appear to have seizure just after receiving the vaccination. After apparent seizure or loss of consciousness patient appear weak and had a hard time answering questions. 911 was called and patient transported for medical care.

My daughter had a mild seizure 5 minutes or less after receiving her first vaccine. She fell out of her chair, her eyes fluttered and rolled in the back of her head, her teeth were clocking and chattering and her body was shaking mildly. She lost consciousness for approximately 2 minutes. At 8:33 pm she felt a second seizure begin, her step father grabbed her before she could fall and again, her eyes fluttered and rolled in back of her head, her teeth were clicking and chattering and her whole body was shaking. The second episode lasted approximately 2 minutes as well, with her losing consciousness again. She was taken to the emergency room and stayed overnight for observation.

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: blurry vision-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Patient reported leg weakness and blurred vision and dizziness/slight difficulty breathing upon getting ready to leave observation area. Said she hadn't eaten in a while and felt cold due to A/C in the store as well. BP was low and HR high, so called 911 to get her emergency help as she didn't feel like she could walk out of store safely. Felt strange and that her legs might give way. EMS arrived, vitals looked good, pt refused ambulance.

At about 3pm on 05-01-2021, my daughter started acting crazy. She does have a history of leukemia which was treated 07-03-2020. She has history of neurological problems from chemotherapy. She also has down syndrome. She has headaches since the vaccine. She is non speaking, non-verbal. After her Pfizer vaccine, my daughter repeat things over and over, at night she cries, moves her hands a lot, yells when she is at school. My daughter did not have a fever, body aches after her vaccine. I feed her, bathe her and take care of her and since receiving the Pfizer vaccine she is not the same person. Before the vaccine, my daughter was sociable, respected, educated but since the vaccine she has been out of control and acting crazy. My daughter received the Pfizer vaccine at a clinic and the doctors there said that she should not get the second dose. At this time, my daughter is scheduled for an MRI appointment on 06-18-2021.

Pt had loss of consciousness x 2 immediately after injection. , shaking of extremities described. Lasting appx 1 min each. return to baseline after . Differential was seizure vs. more likely vagal syncope

Pfizer COVID-19 Vaccine Vaccine Lot Number: Ew0178 2nd dose; vagal faint. Pt got dizzy after immunization, assisted to ground. Ambulating from vaccine site to chairs, slow faint to ground no LOC no sz no DOE VSS. glucose 93; weakness taken to ground, observation in EMS tent, home with parent. 5pm-94/60 p-93, r-20; 5:10 104/60 p-79, r-20, pox 99%

Patient experienced mild nausea and lightheadedness about 10 minutes after her shot. Some alternating warmth and cold feelings. No chills. No symptoms to suggest allergic reaction. No near syncope or syncope. Symptoms were self limiting and resolved on their own. VSS throughout her stay. no orthostasis.

atient was in for 2nd covid-19 (Pfizer lot was EW0167, exp 8/31/2021): It was her and her brother receiving the vaccine. Brother went first and was fine. She was second. After receiving the vaccine (~30-60sec) she appeared to lose conciseness (not sure if complete or partial) she said she didn't remember all of it, but it was more like a dream. During that she had some twitches/spams (involving circular motions with her arms and leg, leg extended and then retracted, but her head rolled back). Upon coming out/waking she appeared sensitive to light and was nauseous. Left her in the room with her mom to get an ice pack, water, paper towel. Total episode lasted less than a minute, but took about 10-15 minutes (estimate, unsure of full time spent) before she felt good enough to use a wheelchair and get in her mom's car to drive home.

At the time of the vaccine daughter dizzy and started to fade out 20 minutes after the vaccine. She couldn?t see and it seemed like it was a Vaso Vagal response which resolved quickly. At 5am the woke up with a fever of 102 and extreme left arm pain. The fever was controlled with Tylenol. Two days after the vaccine she woke up complaining of chest pain and a knot under her left arm. It felt like something was pressing on her chest. We went to the ER and all tests were negative. The feeling lasted until the end of the day. Three days after the shot the next morning she got a headache for half of the day and resolved with Tylenol. The next day all symptoms were gone. Emergency Room Dr.

Pt w/ hx of allergy to penicillins (rash) & HPV vaccine (unknown reaction). Pt had syncope, flushing/sweating and dizziness. BP 119/76, HR 78, RR 18 -- > 107/61, 72, 18. Recommended to the patient to take 2nd dose supine. Pt stable and released from the vaccination site.

approximately 5 minutes after vaccine, patient experienced paleness, nausea, tingling throughout body, stomach tightness and sweaty

Systemic: Convulsion-Severe, Additional Details: Patient went into a 3 second convulsion episode within a few seconds of receiving the vaccine. She had trouble seeing for about 4 minutes afterwards. 911 was called and paramedics took her vitals, all in range. Her mom had an episode in the past (possible Family History), and she has not eaten since the night before, shot was administered at 10:30AM.

Systemic: CONVULSIONS-Severe, Additional Details: Patient went into a 3 second convulsion episode within a few seconds of receiving the vaccine. She had trouble seeing for about 4 minutes afterwards. 911 was called and paramedics took her vitals, all in range. Her mom had an episode in the past (possible Family History), and she has not eaten since the night before, shot was administered at 10:30AM.

My daughter experienced fatigue, GI issues, heart racing, anxiety, jittery (these are signs that her thyroid is not working). All her thyroid issues were off, her TSH value was up to 6. My daughter still has her symptoms of anxiety, GI issues and anxiety.

Fever and chills on the 8th and 9th; Over the last couple of weeks, several times that I've gone to doctor. On May 18th, she had what was considered to be a pre-syncope event (almost passed out). And she had a pretty large migraine headache as well - the headache lasted for days - for probably three days. 18th, went to dr and they took her vitals. They were under the impression she passed out from having the migraine (her blood pressure is low but normal, in general). Dr was called on Monday 24th - doctor wanted tests. She had another pre-syncope event on May 1st in school and then had a fever the rest of the week. (From 6/1/2021 - 6/6/2021 - fever and threw up and bad headache - fever until yesterday). I did take her pediatrician. Negative for COVID and Strep on 2nd . She had another migraine on Tuesday. Pediatrician said it could be a viral infection of some sort. Neurologist believes the migraines were exacerbated by the viral infection as well. This one has lingered and it's the first time she had a migraine within a week or two weeks of each other. She was out of school was out 2 1/2 days last week and the week of the 18th she was out of school the 19th and got sick again the 20th and was out.

Pfizer COVID-19 Vaccine EUA Patient received 1st dose Pfizer at 1705. Patient stood up and had vasovagal reaction, passed out and seized for 15 seconds. Nurse performed sternal rub, patient was aroused. Patient A&Ox3. Physician arrived at 1708, vital signs obtained at 1711 (BP 113/68, O2 100%, HR 83 bpm. Patient right ear started to bleed at 1712. 1725 obtained another set of vital signs. BP 118/70, O2 96%HR 82 bpm. EMS/Fire arrived 1732.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Hypertension-Medium, Systemic: Shakiness-Severe, Systemic: Tachycardia-Medium, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe, Additional Details: Patient appeared weak, pale, sweaty, shaky about 5 minutes after the first dose was given to her. She complained of visual disturbances and progressive shortness of breath. Stated her throat felt a little tight but was not experiencing and swelling of of any parts of her face. She then complained of an intense headache that was getting worse. Patient was admitted to the hospital to make sure she was ok.

Pt given vaccination in left deltoid at 10am today, approximately 5 minutes later, pt lot consciousness, and had seizure like activity for approximately one minute. Pt's primary provider and pharmacist told pt to come to ER to be assessed.

Patient had a headache this morning. At 11:30am she felt hot, so we took her temperature which was 100.0. She then walked into another room and had a febrile seizure lasting 30 seconds. Her face was pale white, her eyes were open and staring off, she moaned initially and then her jaw was stuck open with her tongue making a clicking sound. She urinated herself and then the seizure ended.

She experienced severe chest pains within the first 24 hours of the vaccine. The pains have lingered on and off for a week after. She has severe fatigue, headaches, nausea, and bilateral arm pain in both arms like pain in her bones. They are giving her Zofran for the nausea which also causes headaches.

Mom stated that patient reported she did not feel well about 6:30 pm (the same evening). She then sat down, eyes rolled back in her head, speech was slurred and finally, became unresponsive for about 10 seconds. She was sweating uncontrollably, had a temperature of 99.1 F. afterwards. After she came to, she reported that she couldn't hear, eyesight became blurry just prior to incident. Mom stated that she was a little confused. Had some bottled water and felt better. Mom states that today (6/10), she is feeling better. She did not take any medications at that time. (The vaccine clinic was held as a drive-through, with people remaining in their cars). The weather was very warm. Unknown what activities patient was engaging in the rest of the day.

Approximately 12 hours post vaccine, she started experiencing intense muscle spasms/twitching and chills. This lasted approximately 3 hours. She stated she was unable to control her hands to work her phone to text or call for help. She stated she could not talk. After approximately 3 hours, she stated she got very flushed and then regained muscle control. She fell asleep amd felt fine when she awoke.

Patient vaccinated on 5/28. She reported having pleuritic chest pain and hemoptysis 3 days after that lasted about a week. Then after she developed right leg pain and swelling x 3 days. Seen at our ER 6/11- studies show DVT of the common femoral vein and other veins of the right lower extremity. Also had b/l pulmonary emboli. Started on lovenox treatment and pending thrombectomy by vascular surgeons in 2 days. (In addition she also had admitted to OCP use for a month prior to this event; no reported FH of clotting disorders)

After nothing occurred x 30 minutes post vaccine, Attendee suddenly became limp, stiffened body and convulsed. Was placed on cit, in recovery position, vital signs checked (stable) and EMS were called. Close monitoring and 2nd set of vital signs. Mother of Attendee was close by at all times. Attendee was awake, answered question appropriately, but slow speech - seemed post ictal. EMS arrived after 10 minutes and transported Attendee to local hospital.

Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt did not have breakfast before her shot at 11am. She got the shot and sit down. Mom came over and said her daughter passed out. Rph and techs rushed over. We laid her down to the floor and call emergency number. After a few minutes, she wake up and feel better. Mom said thank you and took her to eat.

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

headache, ataxia, weakness, loss of DTR in lower extremites, treated with steroids. clinical improvement over 7 days. discharged home to follow up with pediatrician, pediatric neurology, pediatric infectious disease, and pediatric rehab. patient also found to have coronavirus (NOT COVID 19) acute infection during illness as well.

Approximately 1-5 minutes after patient received the vaccine, she began to feel tingling in her face. Patient sat in the pharmacy, removed her mask and was given water and a granola bar. A few minutes later she felt nauseous and vomited. After 15 minutes her mom asked if she could take her home to be more comfortable in her own space.

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Systemic: Tinnitus-Medium, Systemic: Weakness-Medium

PATIENT CAME TO PHARMACY TO RECEIVE FIRST DOSE OF PFIZER VACCINE. PATIENT CLAIMS TO NOT HAVE EATEN THAT MORNING AND WAS ANXIOUS OF RECEIVEING THE VACCINE. AFTER SHE RECEIVED THE VACCINE SHE SAT IN THE WAITING AREA AND IMMEDIATELY TOLD HER MOTHER AND FRIEND (WHO'S MOTHER WAS ALSO THERE) THAT SHE FELT NAUSEOUS. PATIENT BECAME CLAMMY AND FAINTED, THUS FALLING OUT OF THE CHAIR. SHE HIT HER HEAD AND HER MOTHER REPORTS "SEIZING LIKE MOVEMENTS FOR A BRIEF SECOND." THEY CALLED FOR HELP AND PATIENT DID NOT HAVE LABORED BREATHING AND WAS CONSCIOUS. WE WERE ABLE TO SIT HER UP, PUT A COLD TOWEL ON THE BACK OF HER NECK AND FOREHEAD AND SHE WAS ABLE TO DRINK SOME WATER AND A COKE. ADDITIONALLY, AFTER A FEW MINUTES SHE GOT BACK UP IN THE CHAIR AND ATE SOME GOLDFISH TO TRY AND CALM HER STOMACH. PATIENT THEN WAITED AROUND FOR 30 MINUTES BEFORE FEELING BETTER AND WAITING THE ALLOTTED TIME AFTER RECEIVING AN IMMUNIZATION. I CALLED MY DISTRICT MANAGER TO EXPLAIN THE SITUATION AND IT WILL BE REPORTED AS VASOVAGAL SYNCOPE. COUNSELED PATIENT AND MOTHER THEN THEY FELT COMFORTABLE LEAVING. STATED I WOULD FILL OUT INCIDENT REPORTS.

16-year-old one day status post Pfizer vaccination #2. Other than the typical, known side effects of the vaccination, patient has right sided and fasciculations at rest and with movement. Additionally she reports numbness of the hands and feet although sensation is intact to light touch and remainder of exam is reassuring. The exam is not consistent with tardive dyskinesia, however in order to give patient symptomatic relief she was given Benadryl 25 mg by mouth ×1 with resolution of the fasciculations. Incidentally, the patient did develop a fever while in the urgent care, was given 650 mg of Tylenol. Patient was discharged from the urgent care in good condition, reassuring vital signs, well-appearing with instructions to take Tylenol and Benadryl as below as needed. Peds follow-up Monday

Patient experienced fever to 103 and seizure about 28 hours after vaccine administration. Also had some fatigue. Since vaccine notes ongoing fatigue and weakness. Having some chest discomfort without wheezing that has been responsive to albuterol.

Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional Details: bp was 105/78 and hr was 85

After receiving her 2nd shot of Pfizer about 8 hours later her left ankle became weak and numb and her left toes became numb, tingling and in pain. It was painful to wear a shoe or even a sock. She had trouble even walking (putting weight on her ankle). This went on for almost 1 week. By May 6th her ankle was still weak and she still has numbness in her left big toe and the one next to it. To this day, she is still in the same condition.

After the second dose, she had a sore arm for a couple of days, but then she started having tangling in the arm the injection was given and then the entire arm went numb. There is no feeling in the left arm from shoulder to fingers. And the tingling and weakness is spreading to the left leg. She was completely fine before the shot.

PT is a 16-year-old female with a history of dysmenorrhea and dyslexia who is otherwise healthy, and is presenting after various neurologic symptoms after second Covid vaccine on 6/9/21. PT was in her usual state of health until she had her second Covid vaccine on June 9 around 2:30 PM. She reported that initially about 10 to 15 minutes after the vaccine she began experiencing a headache and blurry vision. However this resolved after 10 to 15 minutes of resting, and patient did not think much of it at the time. She thought it was likely either due to dizziness or to anxiety around the shot. For the rest of the day she felt like her typical self. On June 10 she woke up feeling normal and went to school. Around 1:30 PM she began experiencing a severe headache that she described as pounding. She did feel like this was the worst headache of her life and rated it about a 7 out of 10. This headache continued and she began experiencing also some numbness and tingling in her right thumb that then spread to her hand. During the symptoms she suddenly had an episode of abnormal speech. She was attempting to talk to friends when she began and having difficulties forming words. She remembers being able to think logically and could think about what sentence she wanted to say, but when she tried to speak the words came out as nonsensical sounds. Eve was confused and scared by this and immediately went to the school nurse. This lasted for about 2 minutes where she was having complete aphasia. The school nurse monitored her and suspected she was having a panic attack. After 2 minutes she began being able to form words properly but was still having difficulty forming sentences that were sense of call in finding words. This lasted for about 10 minutes, and then patient returned back to baseline. School nurse called mom and mom picked patient up and immediately took her to the pediatrician. Pediatrician saw her about an hour after this episode and by the time they examined her she was completely back to her baseline. Pediatrician then referred her to neurology. Since this episode on June 10 pt has experienced intermittent symptoms including: Periodic headaches, numbness and tingling of right forearm and thumb, muscle cramping and pain. She has not had any further events of blurry vision or aphasia. She has not had any weakness or clumsiness. She has been able to engage in normal life activities. However her intermittent symptoms have persisted and have been concerning to family. She was seen by neurology outpatient on June 11 who evaluated her and at that time suspected that her vaccine may have triggered a hemiplegic migraine. They recommended brain MRI to rule out other intracranial abnormalities. Family was waiting for this MRI but her symptoms were continuing and were concerning to family. Today on June 14, Eve was experiencing muscle cramping in bilateral lower extremities and upper extremities and continuing to experiencing numbness and tingling of bilateral forearms and thumbs intermittently. The pain from cramping was more severe today than prior days, and because of this family felt more comfortable presenting to the ED for further evaluation and not waiting for outpatient MR. PT has never had a blood clot or bleeding disorder that family is aware of. She does take OCPs. There is no family history of blood clots or strokes. She otherwise has been well. She has been afebrile emesis, diarrhea, URI symptoms, abdominal pain. Briefly, 16yoF otherwise generally healthy who p/w persistent HA and paraesthesias following 2nd COVID vaccine. Initially evaluated on Monday this week by Neuro who recommended outpt brain imaging, but presented tonight due to persistence of symptoms. Has been neurologically intact here, asymptomatic aside from mild HA that resolved with tylenol. Labs wnl. Neuro consulted in the ED, ddx cerebral venous sinus thrombosis vs. post-vaccine GBS vs. COVID vaccine-associated neuropathy. MRI/MRV brain w/ contrast and MRI entire spine w/ contrast revealed "Punctate principally bifrontal T2/FLAIR hyperintensities, of indeterminate significance at this point in time. This could relate to demyelination, migraine, or be nonspecific. Follow-up MRI may clarify as clinically desired. No evidence of prior or acute ischemic insult. Unremarkable intracranial MRV. No cerebral venous thrombosis. No significant abnormality seen of the spine." Per Neurology, these lesions are not in a pattern that would be consistent w/ MS, and more likely represent an incidental finding with no correlate on neurologic exam. They recommend follow-up MRI in 6 mos to 1 yr to evaluate for any interval change. They will also continue to follow her for headache management as needed. Discussed this plan with patient and family and they expressed understanding and agreement with this plan for discharge and follow-up. Patient was discharged to home in stable condition.

felt exhausted; Blood pressure low, after the seizure: 73/49 and 68/42; skin pale and sweating, after the first vaccine; skin pale and sweating, after the first vaccine; Tired and weak, with some lightheadedness, after the first vaccine; Tired and weak, with some lightheadedness, after the first vaccine; Seizure: described as staring, passing out, stiffening of arms, talking like a toddler and giddy, after the first vaccine.; Seizure: described as staring, passing out, stiffening of arms, talking like a toddler and giddy, after the first vaccine.; Seizure: described as staring, passing out, stiffening of arms, talking like a toddler and giddy, after the first vaccine.; Seizure: described as staring, passing out, stiffening of arms, talking like a toddler and giddy, after the first vaccine.; Seizure: described as staring, passing out, stiffening of arms, talking like a toddler and giddy, after the first vaccine.; felt funny; This is a spontaneous report from a contactable consumer(mother, a nursing assistant, years ago) reported for a patient(daughter). The 16-year-old female patient received bnt162b2 (BNT162B2, Pfizer vaccination, Covid vaccine) at the age of 16-year-old, dose 1 via an unspecified route of administration, administered in Arm Left on 28May2021 11:52 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history included seizure from 28May2021 to an unknown date (doctor wants to schedule an EEG, for further evaluation of the seizure ,because they did not do that test in the hospital.), ongoing Feels down at times (Consumer states the doctor originally prescribed her daughter another medication. Because all the appointments were by video, Consumer felt the doctor was not understanding her daughter's issue. Consumer states the original medication for ADHD was helping her daughter, but it made her daughter uncomfortable, as her daughter had no problems with attention, or school. Caller states then the doctor changed the medication to Zoloft. Name of previous medication was Zenzedi.). No family Medical History. Concomitant medication included sertraline hydrochloride (ZOLOFT) taken for depressed mood from 19May2021 and ongoing. Consumer states that her daughter is not depressed, but just feels down at times, and it is not severe. Consumer states the doctor had her daughter on another medication before Zoloft, that is used for ADHD. Consumer states that her daughter has not been diagnosed with ADHD, and the doctor switched the medication once her issues were further understood, as clarified in later part of report. The patient experienced seizure: described as staring, passing out, stiffening of arms, talking like a toddler and giddy, after the first vaccine on 28May2021 with outcome of recovered, felt funny on 28May2021 with outcome of recovered , blood pressure low, after the seizure: 73/49 and 68/42 on 28May2021 11:52 with outcome of recovered , skin pale and sweating, after the first vaccine on 28May2021 with outcome of recovered , skin pale and sweating, after the first vaccine on 28May2021 with outcome of recovered, tired and weak, with some lightheadedness, after the first vaccine on 28May2021 with outcome of unknown, tired and weak, with some lightheadedness, after the first vaccine on 28May2021 with outcome of unknown, felt exhausted on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included blood pressure measurement: 73/49 on 28May2021 low , blood pressure measurement: 68/42 on 28May2021 low , blood pressure measurement: normal on 28May2021, heart rate: 55 on 28May2021, heart rate: 70 on 28May2021. The clinical course was reported as follows: Consumer states she took her daughter Friday, to have her first Pfizer vaccination, later reclarified as the Covid vaccine. Consumer states her daughter had a seizure after the vaccine. Consumer states Height maybe 5'8" or 5'9". Consumer states her daughter was weighed at the hospital. Consumer states that the experience was terrifying for her, to watch her daughter have the seizure. Consumer states her husband got the vaccine, and was fine. Consumer reports that her daughter got the vaccine at 11:52 am and within 30 seconds, her daughter said she felt funny, and then rolled her eyes and passed out. Consumer states after a minute, her daughter was conscious and the staff was rushing to her aid, as the Consumer called 911. Consumer states that for the next 25 to 30 minutes, her daughter was talking like a toddler, and was pale and sweating. Consumer states that the paramedics, told her daughter that she had a seizure, as they took her to the hospital. Consumer reports her daughters blood pressure, around the time of the event. Consumer states the first blood pressure, when her daughter awakened, after the seizure about 2 minutes later was 73/49, pulse 55, and a few minutes after that it was 68/42 and her pulse was 70. Seizure: Time: 11:52 am, almost immediately after the vaccine. Outcome: caller answers as she is monitoring her daughter closely. Consumer states that during her seizure, her daughter started to stare, and then passed out. Consumer states her daughter did have some stiffening of the arms with the seizure. Blood pressure low: Consumer states he daughter's blood pressure, began to elevate, before they transported her to the emergency room. Time: 11:52 am, almost immediately after the vaccine. Outcome: Consumer answers as her daughter's blood pressure was stabilized enough by the time she was transferred to the hospital, where it normalized. Consumer reports later that her daughter's skin was pale and she was sweating, at this time. Reclarified, Consumer states that when her daughter was talking to the medical staff, she was talking like a toddler, and giddy. Consumer states she was trying to tell the staff that this is not normal for her daughter. Consumer reports her daughter feels tired and weak after all the events. Consumer states she signed up for VSafe. Time: Consumer states sometime, after the vaccine. End: Consumer answers as her daughter is not as tired and weak, as she was the first day the event happened. Caller states that the next day, her daughter relaxed all day, and the day after that, her daughter went to work and felt exhausted, but felt that she could still go to work. Consumer states that yesterday at work, her daughter said she felt weak, and lightheaded. Consumer states that after having a snack and a break, her daughter felt better and worked the rest of her shift. Outcome: Unknown. Reclarified, Caller states she does not want to assume anything, and is monitoring her daughter, and that this event may be due to another reason, as well. Consumer clarifies her daughter went to the emergency room and then was released. Vaccination Facility Type was pharmacy. No Vaccine Administered at Military Facility. No 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).No additional Vaccines Administered on Same Date of the Pfizer Suspect. The event Seizure required a visit to Emergency Room, not Physician Office. Prior Vaccinations (within 4 weeks), list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was none. No AE(s) following prior vaccinations. Caller reports some prior vaccinations that her daughter had without any events. Consumer states that her daughter is not going to get the second vaccination. Consumer states that she does not know the potential risk, if her daughter gets another vaccination. Information about lot/batch number has been requested.

Not being able to sleep well, shaking at night, anxious, not eating well 2 days after getting the vaccine

Date of Vaccine: June 10th 2021 Onset of Symptoms: June 13th In the evening headache June 14th- threw up 3 times during the day. In the late evening severe headache and light sensitivity during evening of the 14th severe throwing up, dizziness and weakness Early morning of June 15th-More throwing up(uncontrollable). weakness. room spinning, noise sensitivity and light sensitivity. LEFT TO GO TO EMERGENCY ROOM Admitted right away. Suspected Meningitis CT scan, Lumbar punch IV fluids. drugs to reduce vertigo symptoms. ADMITTED TO HOSPITAL IV continued, more medicines, continued room spinning 16 and 17th in hospital Released 10PM from hospital with severe Labyrinthitis and Vestibular Neuritis diagnosis. Continues to be weak and dizzy.

Patient received first dose Pfizer Vaccine and developed a reaction about 5 minutes later. patient complained of "dizziness" and "weakness" . Vitals checked: BP 90/50, HR 72, O2 sat 88%. EMS was called. Five minutes later BP 90/60, HR 72, O2 Sat 98%. Patient was alert and oriented to time, place and person. Ten minutes later, BP 110/70, HR 80, O2 Sat 99%. Fully alert, oriented and stable. Patient said she had not eaten since morning. EMS arrived, checked Patient and declared patient ok. Patient was asked to go home in a very stable condition

Chest pain, upset stomach, elevated heart rate and blood pressure Performed tests, gave them water and advised to drink electrolyte rich fluids and take Tylenol or Ibuprofen every 6 hours for discomfort.

Unable to fully move left arm due to severe pain.; Supraclavicular lymphadenopathy; This is a spontaneous report from a non-contactable consumer (patient). A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 22May2021 17:00 (at the age of 16-year-old) as unknown, single dose for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. There is no known allergies, no other medical history. The patient experienced unable to fully move left arm due to severe pain and supraclavicular lymphadenopathy on 31May2021 09:00. There is no other vaccine in four weeks, no other medications in two weeks. There is no covid prior vaccination. The patient did not test covid post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There is no list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. AE resulted in emergency room/department or urgent care. The patient received treatment (Pain reliever) for the adverse event. The outcome of the event was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Pt began to feel dizzy, warm and faint within 10 minutes of her second pfizer vaccine. Pt did not lose consciousness but was dizzy, clammy, sweaty, pale, faint feeling. Pt responded to commands but felt faint.

Site: Pain at Injection Site-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Seizure-Mild

The patient has a history of fainting after shots. She became warm and faint after receiving the injection. She was very weak and put her head on the table for about 10-15 minutes until she was feeling better.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Additional Details: Within 5 minutes of received 2nd dose of Pfizer Covid-19 vaccine, patient became very dizzy and fainted. We layed her down and elevated her feet and she immediately regained consciousness. The patient was assessed by paramedics and they did not transport her to the emergency room and instructed her to drink lots of water over the next 24 hours.

Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Numbness settled in 5 minutes after the vaccine. Patient has full range of motion with no pain. No pain at the time of injection.

Patient became lethargic within 5 minutes. Within 10 minutes she developed tightness in the chest, difficulty breathing, and numbness in both hands. We administered an Epi-pen and symptoms began to improve in 10-15 seconds. She then was evaluated by emergency medical personnel and taken to a local hospital for follow up.

patient was seated in waiting area when fainted and fell out of chair and hit head - was responsive - ems came and took to hospital to be checked out - Mom reported Doctor said normal reaction to teen receiving shot - mild concussion from hitting head

pins and needles sensations that came and went in the fingers and toes, mostly the fingers. getting better, but was "constant" and now a couple times a day.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Approxiamately 5 minutes after the vaccine the patient felt light headed and dizzy. She then fainted forward and her mom lifted her back and at that point she appeared to shake (2 jerking motions) and then became alert. The patient was instructed to lay down. Her blood pressure was taken and was normal. The ambulance was called due to the shaking motion which appeared to be a possible seizure. The patient and her mom did not wish to be taken to the hospital. Follow-up call not answered

Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Severe

Started developing paresthesias in bottom of feet 2 days after 2nd Pfizer vaccine. That progressed ascending up to legs and arms over the course of 3 weeks. She went to the hospital and was diagnosed with Gullain-Barre syndrome based on the CSF studies and MRI imaging.

Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hyperventilation-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Vomiting-Mild, Additional Details: Approximately 5 minutes after administration, patient fainted while seated in chair. After awakening, patient reported feeling faint and tingling in her extremities. Patient was breathing heavily. After breathing normalized, patient reported severe menstral cramps. Patient was given Midol, water, and pretzles. Shortly after, patient stated that she was still light headed so she laid on the ground. Patient eventually recovered and left pharamcy.

Patient received vaccine and returned two hour later with complaints of fatigue and weakness. Patient mother stated they went to the gym immediately after vaccination and patient began to feel these symptoms when they retuned to the car. Patient vital signs BP: 112/82, HR 75, O2 98%. Patient and mother informed of possibility of overworking after vaccination. Patient remained alert and oriented throughout care. Patient stated she ate very little before the gym. Patient was given orange juice and water and stated she felt a little better. Vital signs were repeated, BP: 116/84, HR 77, O2: 100%. Patient was instructed to try eating a meal and getting some rest. Also, if symptoms worsen to go to the hospital.

an uncontrollable head movement/functional movement disorder; stuttering really bad; complain of a twitch in her neck; a headache in the back of her head; This is a spontaneous report from a contactable consumer. A 16-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0176) via an unspecified route of administration on 04May2021 (age at vaccination 16-year-old) at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received first dose of BNT62B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: ER8731) via an unspecified route of administration on 13Apr2021 at single dose for covid-19 immunization. On 04May2021, patient stated that she had a headache in the back of her head after receiving their second dose of the vaccine. On 23May2021, patient complained of a twitch in her neck. On 24May2021, patient experienced stuttering really bad and developed an uncontrollable head movement. One physician indicated that it was a nervous tic while a neurologist indicated it was a functional movement disorder. However, she did not have these symptoms prior to the second dose. Adverse event resulted into Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and hospitalization. Patient was hospitalized for 2 days. The outcome of event was unknown. No follow-up attempts are needed. No further information is expected.

Extreme swelling, redness, and pain of the left arm (where the vaccine was given and around the surrounding area) at around 8:30pm on June 25, 2021. Hive-like appearance for 5 hours that was itchy, and there are two big red circular raised marks currently (June 29, 2021) that are itchy and painful to the touch that will not resolve with Benadryl or acetaminophen.

PATIENT RECEVIED VACCINES AT 1050 IN OUR OFFICE, PATIENT WAITED 30 MINUTES AFTER VACCINES WITH NO S/SX OF REACTIONS. AT 1220 DAD CAME IN WITH PATIENT WHO WAS REPORTING FEELING DIZZY, HEADACHE, FEELING LIGHT HEADED. PATIENT WAS HAVING A HARD TIME KEEPING EYES OPEN. CLOSE TO PASSING OUT. PATIENT WAS SHAKING AND PALE. ALSO C/O ARM PAIN

Started early afternoon on June 27, 2021. Patient had hiccups. Parent treated with the hiccups with water, holding breath, brown paper bag breathing. The patient had continuous hiccups Sunday, went to sleep, woke up Monday and didn't have the hiccups. Monday afternoon the hiccups started back up and were more frequent. Tuesday neck twitching started in addition to hiccups. Wednesday neck twitching, blinking of eyes, and hiccups/gasping for air continuous. Only when in deep sleep does she stop.

Patient began to experience dizziness, nausea, vomiting, and tremors 3 minutes after vaccine was administered. A code blue was immediately called and patient was examined by provider. Vitals were take and paramedics were called immediately. Patient was transported to Hospital for further evaluation.

Attendee became pale and momentarily lost consciousness - did not initially respond to verbal of tactile stimuli - required sternal rub, awakened after 1 minute. Vital signs normal. EMS were called. Glucose 86. No transport - mother of Attendee refused this.

The 1st vaccine my daughter had a sore arm (a few days) very tired (a few days) and very nauseous. she was nauseous until her 2nd vaccine. about 12 hours after her 2nd vaccine she had a fever off & on for 3 days threw up off & on for 3 days had a headache off and on 4 days. extremely tired for 3 days, stomach ache and nauseous for almost 2 wks.

L distal internal jugular venous thrombus found on 6/29 after pt had three days of squeezing sensation on upper arm followed by acute pain on day of presentation to ED. In ED upper extremity Doppler demonstrated clot. Pt transferred to our hospital where she started on anticoagulation therapy for treatment.

At approximately 3-4 minutes after vaccination patient complained burning pain in her arm. Mom notified RN. RN evaluated. Left arm red from shoulder to wrist. Her left arm was hot to the touch. Cold water bottles and then ICE applied to her arm. Mom instructed to call PCP. Mom put a call into PCP. RN noticed patientss chest becoming red. Paramedic requested to evaluate. The RN administered 50 mg PO Benadryl per standing order. By 7:35 pt. arm starting to appear less red and pt. reported less burning sensation. Mom reports pt is doing fine this morning.

Systemic: Fainting / Unresponsive-Mild, Additional Details: After vaccination patient and mom were directed to the waiting area and asked to wait for 15 minutes. Mom and Pt decided to leave the waiting area and walk around. Shortly after pt fainted and hit her arm. She had mild scrapes on her arm. We had her lay on the pharmacy bench with her feet up for 30 minutes. We gave her apple juice to drink. After that she was fine

After receiving vaccine, patient fainted. She recovered after about 10 seconds and immediately became sick to her stomach, shaky, and clammy.

Tired Dizziness right after. 8 hours later tired. Next day fever chills sweating migraine headache tired.

Patient's mother reports patient c/o of chest pain with inhalation, swollen/sore throat, weakness, and dizziness with change of position. Pt's mom was advised to take pt to ED or urgent care for evaluation.

Patient went to urgent care 1 day after vaccine for feeling tremors and pains in her lower extremities. She also began to feel shaking in her entire body and had lightheadness, shortness or breath, and nausea. She vomited one time. EKG showed Sinus Ventricular Tachycardia/Sinus Tachycardia and was sent to ER by EMS. In ER fluids were given and all further testing normal. Discharged and told symptoms due to dehydration.

Pt reports she was fine the day she received the Vaccine, but when she woke up the next morning she reports her face felt like it was on fire and she noticed it was bright red and covered in Hives. pt went to the ER for evaluation where they administered IM steroids and Benadryl. pt came to PCP office 7/12/21, with some erythema and fine bumps noted to face where the hives had been present. (pt and PCP unsure if ER filled out a VAERS report)

Fatigue 6 days Fever about 12 hours after 2nd dose, then again 6 days later (chills, sweating, shaking) Racing heart, 6 days after 2nd dose. Shortness of breath, 6 days after 2nd dose. Acetaminophen and ibuprofen.

While completing paperwork in immunization room, patient's mother stated she thought her daughter was starting to react to the vaccine. It appeared patient was starting to pass out so pharmacist and mother lowered her down from the chair to the floor to prevent injury. Patient's pulse was very faint to the touch and patient was difficult to arouse. Pharmacist delegated pharmacy technician to obtain AED. Patient's mother stated patient was beginning to shake and was becoming very hot and sweaty. 911 was dialed. No health conditions or medications were noted that would cause this reaction. Pharmacist was beginning to take BP when EMS arrived. EMS continued taking vitals. BP 100/65, HR 84, SPO2 96%. Patient started to become alert again as vitals were being taken.

Major reaction. Field vaccination by Strike Teams of Department of Public Health. At ~13:01, patient vaccinated with Pfizer COVID-19 vaccine. Within a few minutes of vaccination with Pfizer COVID-19 vaccine, patient showed urticaria + generalized chest pain (6/10) + postural weakness + convulsions. Field RN assessed an immediate, severe clinical deterioration. Epinephrine 0.3mg given by auto-injector to same left arm. Field RN summoned EMS. Field LVN provided postural support and second-eye VS measurement. EMS arrived at ~13:22. Taken by EMS to ED. VS: BP 90/40; HR 70; Pain 6/10 general chest. ? BP 110/60; HR 90. S/S: Physical weakness; ALOC. ? AOx4 upon EMS arrival. Current disposition unknown at time of this report. Department to attempt contact with family or admitting facility.

After about 1 week after taking her first vaccine, she started to have rashes on her legs along with her feet swelling and hurting. And after her second vaccine which was given on May 15 (Lot # EW0168) her whole body had rashes and her feet pain got worse. Her joints (knee and elbow) started to hurt her too. I took her to her pediatrician and her doctor thought it was an allergy but the allergy medicine didn?t work so we did blood extraction and they said to take her to hospital immediately. After staying for 5 days, the doctors were suspicious with the diagnosis Lupus so they prescribed her Hydroxychloroquine 200 Mg Tablet, Phytonadione 5 MG Tablet, and PresniSONE 10 MG Tablet. Now she is sick at home and taking the medication. She has never been sick or diagnosed with anything before the vaccination. I told the hospital my concerns and everything should be there too.

Systemic: Fainting / Unresponsive-Severe, Systemic: PT FELL AND HAD 2 LACERATION TO HEAD-Severe, Additional Details: PT WAS STILL IN IMMUNZATION CHAIR WITH FATHER AND IMMUNIZER PRESENT AND SUDDENLY FAINTED AND FELL OFF THE CHAIR AND HIT HER HEAD ON THE DR SCHOLLS FOOT SOLE END CAP BEHIND THE IMMUNIZATION SCREEN

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Mild, Additional Details: After injection was administered spoke with patient and mother about waiting the 15 minutes. Returned to pharmacist station, heard mother call out, patient was laying face first in floor, went to grab epi-pen. Mother said patient fainted, she said she thought it possibly could have been a seizure because her whole body shook before she fainted. Patient said she felt like she was going to vomit, grab a trash can and the patient dry heaved a few times. While this was going on tech called 911.

About 1 minute, or so, after her daughter received her COVID-19 Vaccine injection, her daughter passed out, and ended up in the ER; She said her daughter vomited twice after she passed out, and then vomited again in the Emergency Room; It was not normal for her daughter to gurgle like she was; Her daughter wet herself, clarifying her daughter involuntarily voided when she passed out.; Her daughter bit her lip really hard when she passed out; Her daughter had a really bad headache; Her daughter said she heard a nurse say as she was coming to that she was only breathing 6 breathes per minute; When her daughter received her 1st COVID-19 Vaccine, her daughter arched her back, and her daughter's arms drew in.; Her daughter may have been a little tired after getting her first COVID-19 Vaccine, but no more than normal; Her daughter said her throat was sore afterward (vomiting); This is a spontaneous report from a contactable Nurse. This Nurse (patients mother) reported for a female age 16 years old patient (reporters daughter) that patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number was EW0168), via unspecified route in right arm on 24Jun2021 13:21 as single dose for COVID-19 immunization. The patient medical history included mild asthma for a good 10 years. She did not even use an inhaler for the mild asthma, and the last time she used a rescue inhaler was in the last couple years and Dermatographia from 05Aug2020 and was ongoing she could be allergic to something, and then down the road, whether it be a few months or a few years, would not be allergic to it anymore. She had passed out from blood draws in the past, but that she would come to a few seconds afterwards. She would never get upset when she had blood draws. The patient concomitant medication included Cetirizine hydrochloride (ZYRTEC). On 24Jun2021 patient experienced for About 1 minute, or so, after she received her COVID-19 Vaccine injection, she passed out, and ended up in the Emergency Room and she vomited twice after, and then vomited again in the Emergency Room. It was not normal for her to gurgle like she was. She involuntarily voided and she bit her lip really hard when she passed out. She had a really bad headache. She heard a nurse say as she was coming to that she was only breathing 6 breathes per minute. When her daughter received her 1st COVID-19 Vaccine, she arched her back, and her daughter arms drew in. She might had been a little tired after getting her first COVID-19 Vaccine, but no more than normal and her throat was sore afterward. Patient was not given any treatment at the COVID-19 Vaccine facility but was taken by ambulance to the Emergency Room and the Emergency Room gave her daughter an Ativan 0.5mg tablet and placed an IV in her. An emergency Room ran an IV infusion of 999ml of Sodium Chloride 0.9%. On 24Jun2021 patient did an EKG, chest x-ray, urinalysis, and blood work and results of EKG, chest x-ray, urinalysis, and CBC were normal, but electrolytes were a little low. She had followed-up with her pediatrician after her Emergency Room visit. pediatrician scheduled an EEG for her daughter on 28Jul2021 because of her daughter losing her bladder control, and other things that happened when her daughter passed out. The outcome of event (sore throat, Fatigue) was unknown, event of (Passed out and bite wound) was unknown and event of (Dyskinesia, Respiratory rate decreased, Urinary incontinence and Abnormal behavior) was recovered on an unspecified date 2021 and event of (headache) was recovered on 25Jun2021.

Migraine with aura; Burning pain along her right side; prolonged nosebleed; bruise developed under right eye; mouth ulcer; Joint pain; Stiffness; Stomach pain; headache; arm soreness; Severe fatigue; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7534) via an unspecified route of administration in the left arm on 20Mar2021 at 12:00 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patients medical history included Bechet's disease. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 since having the vaccine. The patient experienced normal headache and arm soreness after 48 hours of vaccination and severe fatigue on 22Mar2021 and prolonged nosebleed, a bruise developed under her right eye, mouth ulcer, joint pain, stiffness, and stomach pain on 23Mar2021 and had another nose bleed on 24Mar2021 and migraine with aura and unusual burning pain along her right side on 25Mar2021. The patient did not receive any treatment for the reported events. The clinical outcome of the events headache, arm soreness, fatigue, nosebleed, bruising, mouth ulcer, joint pain, stiffness, stomach pain, migraine with aura and burning pain was not recovered. No follow-up attempts are needed. No further information is expected.

During the patient's 15 minute waiting period, patient developed chills, hot sweats, vomiting, and dizziness. patient had stated that they had not eaten all day.

Patient was given her second covid19 vaccine at approximately 1045. She stood up and walked to a chair in the waiting room. At 1048 she passed out and had a small seizure. Mom said she normally passes out after a shot for a short period of time but this was the first time she had a seizure. She was moved to the floor. She was sweating, eyes glossed over, said she felt like she couldn't breathe and couldn't feel her extremities. She stayed on the floor until EMS arrived approximately 10 minutes later. She was moved to a chair and once she tried to stand up she was moved back to the floor. She left in a wheelchair and was taken to her moms car.

Patient received the dose at 5:15pm. I was alerted by father at 5:25 that she was not feeling well. I went to check on her and she had lost consciousness in her father's arms. I told the technician to call 911 at retrieved and epipen. I opened the epipen and checked the patient for response. She woke up and appeared very weak and confused. She responded that she could breathe. The epipen was not administered. EMS arrived and checked for vitals. Vitals were within normal range. The father decline transportation for further care. She remained sitting until 5:50 pm and she left on her own power with her family.

Three days after vaccine,case reported blurry vision, hands and legs numbness and tingling, near syncope. Ten days after vaccine case reported near syncope while riding bike.

PATIENT WAS PALE, CLAMMY, FELT HOT, NAUSEA, VISUAL AND AUDITORY DISTURBANCES--- PATIENT GIVEN COLD COMPRESS TO NECK, BP CHECKED TWICE AND INCREASED ON 2ND READING, PATIENT LAID ON BACK/FEET UP--- OVER 10 MINUTE PERIOD, PATIENT FELT BETTER AND WAS ABLE TO LEAVE ON OWN.

16 year old female with history of juvenile dermatomyositis that was in remission for several years off medications, started having a disease flare that mainly involved her skin (erythematous Gottron's papules and ulcerations) along with mild weakness. The patient is still under evaluation about the extent of her disease flare but was found to have severely worsened pulmonary function testing parameters (reduced DLCO and lung volumes). Treatment is pending the completion of diagnostic evaluation. Muscle weakness is still not prominent but skin findings are more prominent a month after the onset of disease flare.

PT is reporting involuntary trembling and shaking of her arms and/or legs that lasts for a short period. She is reporting that this has happened about four times since getting the shot, with the first time occurring in the middle of the night the day after getting the shot. Last instance was tonight around 8pm.

Patient felt uneasy and fainted shortly after dose. Her mother caught her from falling. She remained unresponsive for 1 hour. She was breathing, 911 was called. Blood pressure, breathing, pulse normal.

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: IMMEDIATELY AFTER VACCINE ADMINISTRATION, PT FAINTED FOR A FEW SECONDS, STARTED JERKY MOVEMENT. WHEN CAME BACK SHE DID NOT REMEMBER ANYTHING. THEN AGAIN SHE FAINTED TURNED EXTREMELY PAIL WITH EXCESSIVE SWEATING AND FEELING HOT, SHE SEEMED STUNNED GAZING TO ONE POINT NOT ABLE TO TALK OR MOVE. RPH ASKED TO CALL 911 IMM. PT TURNED BLUE WITH VERY LOW PULSE AND SHALLOW BREATHING. RPH ADMINISTERED EPIPEN TO THE UPPER OUTER RIGHT THIGH TO HELP RAISE BP AND PULSE. PUT PT IN SUPINE POS W/ ELEVATED FEET

Headache, nausea, fatigue and chills. About 8 hours she took medicine and fell asleep. She said she was just overall uncomfortable and doesn?t want to get her 2nd dose.

Fainted, flushed colored skin, breathing limited, tachycardic. EMS called and recommended a doctor visit for the day of. Was not transported to the hospital by EMS personnel.

My arm hurt a lot right after the shot. A few hours after like about 5 my entire right side went numb and I couldn?t feel it. I also get intense headaches everyday after I got the shot. I was also very tired for the next 3 days.

after 15 minutes started to feel light headed, had patient lay down with feet up, VSS - 120/68, pulse 78 strong and regular, Resp 18 non labored, skin warm and dry, sat up to take a drink of water as she was laying back down she started to have mild tremors of both arms and legs and then became rigid, pupils were dilated and non responsive to light, no verbal response, VS continued to be stable, O2 98%. Patient was transported to the local ED. She was started to respond when the ambulance arrived and was able to walk to the gurney.

had arm pain at injection site; her arm is numb to her hand on injection site side which is the left side.; From the injection site up to her neck is hurting; feels weak and tired; feels weak and tired; she can't feel her hand up to her fingers; This is a spontaneous report from a contactable consumer (patient's mother). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0198, Expiration Date: not reported) via an unspecified route of administration on 12Jul2021 as dose 1, single for COVID-19 immunization (at the age 16-year-old). The patient's medical history and concomitant medications were not reported. The patient experienced had arm pain at injection site, her arm was numb to her hand on injection site side which was the left side, from the injection site up to her neck was hurting, not horrible pain just aching, feels weak and tired, feels weak and tired, she can't feel her hand up to her fingers on an unspecified date in Jul2021. It was reported that, it was patient's first vaccine and getting the second dose on 02Aug2021. The outcome of the events was unknown. Information about lot/batch number is requested.

Patient became dizzy, cold and clammy, Starring and not responsive for 1 minute. Jaw was clamped down but upon asking the patient then spoke 2 minutes into episode. Vitals were stable. Rapid response was called. Patient was observed, given fluids and sent home.

Patient is a 16 year old female here with mother, complaining of right deltoid pain since MCV4 and Men B vaccination on 07/20. Injection pain up to her neck, later radiating down to wrist. No medication yet.

Goosebumps, tingling and numbness on the left side of her face and left side of her arm; Goosebumps, tingling and numbness on the left side of her face and left side of her arm; Goosebumps, tingling and numbness on the left side of her face and left side of her arm; Goosebumps, tingling and numbness on the left side of her face and left side of her arm; Pain at the injection site; This is a spontaneous report from a contactable Nurse or Other Health Care Professional. This nurse reported for a 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Batch/Lot Number: EW0185; Expiration Date: Aug2021) via an unspecified route of administration on 15May2021 (at the age of 16 years) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No illness at time of vaccination. No family medical history relevant to ae. It was unknown if any AEs following prior vaccinations. Patient was not taken any medications within 4 weeks, prior vaccination. No additional vaccines administered on same date of the Pfizer suspect. No history of all previous immunization with the Pfizer vaccine considered as suspect. The caller stated that on 15may2021, the same day of vaccine in the afternoon after the first dose, patient experienced goosebumps, tingling, numbness to the left side of her face and left arm, and pain at the injection site in her arm. All the adverse events resulted in physician office. Relevant tests were none. The outcome of events was not recovered. Further follow up excepted. Batch/lot number can be obtained.

within 15 hours had increased seizure activity lasting for the next week which eventually tapered down

30 mins after IM injection: Left arm tingling 45 mins after IM injection: Left arm, Left shoulder, Left upper back tingling, Headache, chills, fatigue

The patient began to experience dyspnea, then shortly thereafter began to develop flushing of the face.

Pt got very light headed and dizzy, did not pass out. She was also feeling very hot. This happened after first dose but not as severe . Pt laid down with and ice pack for 30?minutes and then was feeling much better

Patient is 17yo here for COVID 19 Pfizer Vaccine; Within 15 minutes of the shot, she developed unresponsiveness. She has snoring, seizure disorders, OSA, hypertension, developmental delay, elective mutism. Her mother called us to the room Per mother , She was unresponsive, her lips were blue and she was pale She has had no recent seizure; compliant with Keppra She was very anxious prior to the vaccine. She was at baseline this am per mom prior to the shot.

female here with mom mom multiple siblings for Covid vaccine. Within 30 minutes of the Covid vaccine patient had a vomiting episode. Pulse ox was 99. There is no labored respirations. She did not respond to commands but according to his sibling she does not always respond to commands. However when I took her hand to get her to squeeze my hand and gave it back to her she purposefully put it back on a CD which she was holding to her chest. Blood pressure was stable heart rate was approximately 130. The home care aide was not able to tell me whether or not this was her baseline. Her brother said that she does not does not answer questions depending on the day. However I am not sure he is the appropriate historian. She has a history of multiple medical issues including autism, quadriplegia, asthma, and food allergies. As such she was kept here for a full 30 minutes. At no time was there any color change. No labored breathing or wheezing on exam. There is a little bit of nystagmus and appeared to focus when questioned about how she was doing but without a verbal response. She will be transferred to the emergency room in stable condition emergency room has been notified.

Felt light headed, ringing in her ears, c/o nauseated. BP 110/68 Pulse 68. Removing Jacket. Offered water. Offered oxygen but refused.

Patient started to feel strange within 1 minute of receiving the vaccine. Within 5 minutes of receiving the vaccine, patient felt very faint, dizzy, nauseous, tingly, lost feeling in lower body, blurry vision, and started shaking. EMS was called at vaccination site. EMS arrived about 5 minutes later and took patient's blood pressure. First reading was 102/70, second reading a few minutes later was 108/76. By that time, patient could sit up and was alert and oriented. Patient never lost consciousness. Patient was not taken to the ER. Patient remained on-site for another 45 minutes until symptoms resolved enough that she felt it was safe to leave. Patient has not had a reaction to vaccines or other medical treatment in the past.

The doctor was called STAT to evaluate this patient who was having feelings of weakness and feeling faint in the observation area after she received her first Pfizer COVID vaccine yesterday morning at the vaccination cite. She had already been given an IM Epi Pen injection of epi by the PA prior to my arrival. I had her lie supine with head down and legs elevated and she felt better. She declined EMS transport to ER. Further talk with her dad revealed she had been up since 2 am and had no breakfast. I don't think an allergy.

Flushing, sweating, anxious, tingling in ears, nausea, blurry vision. Vitals within normal limits. Patient stabilized.

A few hours after I had chills and a really bad body ache. I could barely move without hurting. I couldn't go to work. I had a low grade fever. Tylenol helped. It was better after the second day. For the second dose the symptoms were similar. My arm is still sore.

Fever of 103 F, received Tylenol, then developed tonic-clonic seizure activity for about 20 minutes (received 10mg intranasal midazolam and 0.5mg buccal clonazepam while awaiting EMS)

Within 2 minutes of vaccine developed dizziness, nausea, within 5 minutes developed mild tingling in her throat, felt cold and chest felt heavy. Lungs clear to auscultation, no rashes, no lip swelling. She received Benadryl 50 mg po at approx. 5-10 min post vaccine and was transferred to the ED. In the ED she had receive epinephrine im, Solumedrol iv and albuterol neb. Patient is still in the ED at 12:18 PM

Weakness, muscle fatigue started after 1st dose. 3 days after second dose had labs and elevated ANA. Rheumatology work up unremarkable, except increased anti-thyroid. Full body Tremors and involuntary movement started 3/16. ER visit.

At approximately 49 hours after the first dose, patient experienced unusual sudden tiredness, soreness at the injection site, visibly flushed face and sensation of heat emanating from the face. No treatment was given. All symptoms were resolved within 8 hours from onset.

17 YEAR OLD PATIENT: AFTER RECEIVING VACCINE PATIENT SAT IN OVERVATION AREA, UPON SITTING DOWN EXPERIENCED DIZZINESS, SHORTNESS OF BREATH, FATIGUE. PATIENT DEMONSTRTING RAPID EYE MOVEMENTS, RESPONSIVE TO DIRECET QUESTIONS AND TO PAINFUL STIMULI THOUGH UNABLE TO SPEAK IN FULL SENTENCES. DENIED CHEST PAIN, COUGH NAUSEA, VOMITING. MOTHER STATES SIMILIAR BEHAVIOR WHEN SHE DEVELOPED BLOOD CLOT IN THE PAST. PATIENT THEN STATED FELT LIKE THROAT WAS SCRATCHY.

Pt received injection and 10 minutes mother noticed face was flushed and patient complained of a hot arm at the injection site. Pt appeared with flat red blotches on her left deltoid which progressed to her arms neck and face. No blotches noted on her trunk. Pt was given 50 mg of Benadryl and monitored by EMS and NP for further reaction. Patient denied difficulty breathing or swelling in the oral area. Upon release patients mother instructed to monitor for any worsening symptoms or difficulty breathing. EMT counseled calling (!! if on a major highway and encountered any problems.

Began having seizures; Presented to the ER on 17 March 2021 for headache with blurry vision; Presented to the ER on 17 March 2021 for headache with blurry vision; Also had persistent nausea and subsequent vomiting; Also had persistent nausea and subsequent vomiting; Fever X1 to 100.4F on day of presentation/no further sz; This is a spontaneous report from a contactable physician. A 17-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly in right arm on 08Mar2021 (lot number: EN6206) at single dose for COVID-19 immunization. Medical history included headache and irregular periods, ongoing hospitalization. No known allergies. Concomitant medications included birth control pills. No other vaccine in four weeks. No COVID prior vaccination. Vaccine received during existing hospitalization. The patient began having seizures (hospitalization prolonged, life threatening) on 16Mar2021 12:00, presented to the ER on 17Mar2021 for headache with blurry vision (hospitalization prolonged, life threatening) on 16Mar2021 12:00, also had persistent nausea and subsequent vomiting (hospitalization prolonged, life threatening) on 16Mar2021 12:00, fever x1 to 100.4F on day of presentation/no further seizure (hospitalization prolonged, life threatening) on 16Mar2021 12:00. Clinical course: Presented to the ER on 17March2021 for headache with blurry vision. Patient reported symptoms for 1 day prior. Also had persistent nausea and subsequent vomiting. Presented to the ED at 23:00. Began having seizures. EEG shows localized to the occipital region. Fever X1 to 100.4F on day of presentation no further sz. LP shows 1 WBC, Gram stain negative. Cultures negative. HSV pending. On ceftriaxone and acyclovir. Continues to have focal sz on EEG now on 3 AEDs. MRI with contrast negative. CBC unremarkable. CRP elevated to 0.8 (normal less than 0.5). Tox screen negative. COVID tested post vaccination: Nasal Swab (SARS-CoV-2 Cepheid) with result of negative on 17Mar2021. Therapeutic measures were taken as a result of all the events which included treatment with IVIG, Antibiotics, Steroids, Antiepileptics. The outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events cannot be completely excluded based on temporal association and known drug safety profile. 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.

Called to Pod 3 green chair 5 at 8:45. Pt awake leaning over feeling shaky and dizzy. pt cool and clamy to touch weak pulse. given water to drink. Denies eating breakfast. wheel chair transport to observation to stretcher. :Apple juice po. 8:55 BP 111/67 Pulse 67 Pulse Ox 86 Resp 24. Head of bed elevated. Apple juice po. 9:05 BP 109/76 Pulse 67 Pulse Ox 87 RR 20. 9:20 99/64 Pulse 83 Pulse ox 100 RR 22. Apple juice po. Pt sat on edge of bed and remains shaky and layed back for further observation. 9:30 pt reported feeling better sat on side of bed BP 103/68 Pulse 79 Pulse Ox 100 RR 24. feeling well enough to walk accompanied to exit with Nurse and mom. Discharge to home in care of mom

after recieving the vaccine, patient turned very pale and appeared to lose conciousness as well as have convulsions. 911 was called. nurse had patient lie on the floor. o2 was measured to be 96 and bp was 103/74

Almost immediately after receiving the vaccine the patient started feeling nauseous. Patient's mother then reported that she experiences the same side effects from blood draws from the doctors office. Patient then started to become pale and was clammy. The pharmacist then took action to lay the patient on the floor and prop up feet on chair and took the patient's BP 127/81 HR 97. No epinephrine was given or indicated. The patient had some vomiting about 15 minutes following the vaccine. Patient stated that she did not have any food or fluids prior to receiving vaccine. Fluids and food was not given to the patient. The patient's color returned at 25 minute post vaccination. At 30 minutes patient was feeling much better and was escorted by the pharmacist to the car to ensure safety and no other events or side effects occurred.

Patient received second dose of pfizer covid19 vaccine. Then while she was sitting during the 15 minutes after receiving the vaccine, she was found slipped out of her chair unconscious. 911 was called and her parents were called. After several minutes, she regained consciousness. When asked how she felt, she stated that she was hot and dizzy. Patient remained sitting on the floor, leaning against the wall. An ice pack and water was brought to her to help cool her down. Paramedics came and assessed her. Patient then left with her mother who said she was taking her to the doctor.

Body aches, feelings of hot cold, dizziness, temp 101, chills, mild joint pain, resulting in loss of sleep. She drank fluids(some electrolytes), and took two Advil.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: patient became nauseas, lightheaded, and had mild flushing post administration. patient was given water and was sat down. patient recovered fully 10 minutes later and left with no further issues.

Patient was sitting in chair, then slumped down, stating she could not see about 5 minutes after the vaccine. She then became unresponsive for about a minute. After laying her down and elevating her feet she began to feel better. Patient's respiration and pulse remained normal throughout

Patient had initial dizziness and syncopal episode. Patient reported "vision went dark and felt heavy". Patient vomited x1. Patient given cold pack and water. After 10 minutes patient denies headache, dizziness, double vision, or ringing in ears. No report of difficulty breathing, SOB, numbness or tingling in extremities. Patient successfully discharged from observation at 4:05 pm.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Systemic: Weakness-Mild

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient felt some lightheadness and felt she was having a panic attack. sje slumped but patient was responsive

Following the vaccine admin patient felt a wave coming over her and passed out she experienced tunnel vision and was clammy. She was placed on the floor and was then placed on a back board and taken to medical observation, patient wears a continuous glucose monitor and her mom reported that her bld glucose was 129, patients vital signs upon arrival was 120/65, P 71, Ox 98% on room air @ 10:35, at 10:40 her blood presure was 120/78. she was then placed in a sitting position and bp was 119/79 and then standing after 1 minute was 121/74- patient was released from observation via wheelchair she was taken to the exit with her mom and she exited the building.

Fainted for 2 seconds. Sweating. Pale lips but the color got back on after few minutes. Tingling. Could not lift up her arm (but could feel squeezing thumb). Shaken hands and feet. Lied down on the ground around for 10 minutes and elevated feet. Had her to keep breathing in/out. Kept drinking water and gave orange juice. Called 911. EME arrived and took care of patent. Pt didn?t want to ride on the ambulance and said fine. Was able to walk in the end. Left the scene with her mom.

Pt had reaction in the waiting room. Pt became pale, diaphoretic, passed out and had brief seizure x 3-5 seconds. She suddenly became aware again with no recollection of what happened. She continued to be pale and diaphoretic and c/o confusion and blurry vision. Pulse ox 98-100, HR dropped to 40's and BP 90/60. Squad was called, they assumed care and transported pt to ER with her mother present.

About ten minutes after injection, face and ears became flush and throat became itchy. Complained of mild dizziness and growing lump in her throat. Medical staff checked throat, blood pressure, O2, laid her down on cot with feet elevated. After 20 minutes of stable BP called the chief of immunology who recommended she go to Urgent Care for follow up. While waiting at Urgent Care for 30 minutes, her face, tongue, and throat became swollen, hives developed on face, and had increased difficulty in swallowing and felt short of breath. She was taken to a patient room, IV started and Epi-shot was given. Additional allergy meds were given (Benadryl and Solu-Medro). She the. Slept for the next 90 minutes. Swelling decreased and throat felt better. Monitoring for a couple hours and sent home.

Presented at 0905 for vaccine. 0912: Staff were called to the patient vaccine area. Patient did seem vaso vagal post vaccine (loss of color and diaphoretic), patient then appeared to have a Grand Mal type seizure with arm contracture and vomiting x4. Patient was unresponsive for around a minute. Only meds patient: BCP Patient accompanied by her mother. o2 98% HR 81 BP taken at 920 130/80. 0935: Patient seemed post-dictal, very sensitive to touch and disconnected. As per Mother, the patient had a history of a prior Grand Mal seizure 4 years ago; that was never worked up. Patient complaining that she is "Very Lightheaded." Spoke with patients primary PCP MD, she stated that it was not likely a seizure and that it was extreme vaso-vagal response and that the patient could go home if now drinking and responsive. Patients mother also spoke with PCP and I gave her the option to decline EMS or to go be evaluated. Patients mother chose for her to be evaluated. EMS was contacted by the local police who were working the vaccine clinic. Vitals taken by EMS: BP 127/61 Blood Glucose 97 0955: EMS arrived / Patient transported to ED.

Syncopal episode within 1 minute of injection, seizure like active posturing, unresponsive. Alert and oriented by the time she was transferred to ER.

Patient experienced an episode of syncope almost immediately after her first dose of Pfizer covid vaccine. She was unresponsive for approximately 20-30 seconds. Her vaccinator held the patient steady until help was available. When the patient came to, her pupils were not of equal size, left being larger than right. Cap refill was about 5 seconds. She felt hazy/dizzy and was clammy. First pulse readings were 39-45 bpm. Vitals recorded 1545 BP 73/40, P 48, O sat 99 1558 BP 91/55, P 58, O sat 96 1607 BP 106/62, P 68, O sat 98 BP 111/70, P 57, O sat 100 At the time of dismissal, patient reported that she felt fully recovered. She was accompanied by her father who was her mode of transportation. It was recommended that she be scheduled for an appointment with her PCP for baseline/well visit as she had not been in some time.

Patient received vaccination at 1556. Pt reported right hand tingling/numb and lightheadedness. Pt requested anti-gravity chair and reported decreased dizziness immediately. Vitals assessed: 102/62 BP, 118 pulse, and 99% O2. Pt received diphenhydramine 25 mg/10ml oral solution at 1613. At 1628, pt reassessed. Right wrist slightly numb and dizziness diminished. Pt reported no pain and left facility with steady gait. Pt left with mother at approximately 1638.

Patient passed out. tingling in finger. light headedness. chest pain related to anxiety. occurred after about 15 minutes

Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Medium, Systemic: Shakiness-Mild, Systemic: Weakness-Mild

Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Tinnitus-Mild, Systemic: Vomiting-Mild

Events happened about 5 mins after shot was given. Patient experienced lightheadedness, loss of consciousness for a couple seconds, uncontrolled urination, hot flashes, headache. Patient was given water and a snack to consume. After about 10 minutes of resting and consuming food, she feeling better afterwards, said it could have been to fear of getting injections, and was able to go home with her family.

Patient had a reaction to the Pfizer Covid-19 vaccine. While waiting for 15 minutes after the shot, patient had a 'seizure' according to patient's mom. She was flapping her hands, staring, and sliding down the chair. 911 was called. Patient was pale and calm but responding to the immunizer (technician) and pharmacist. Patient said she was fine. EMS came and checked the patient and said patient is fine. Patient said she was fine again. EMS left without the patient since she was fine.

Patient received dose 1 of Pfizer vaccine LOT ER8733 on 4/6/21 at 0955. Patient had witnessed seizure at 0957. EMS called at 1000. Seizure lasted 15 seconds. Patient alert after seizure. Appeared very pale. Advised patient mother that she needed to be seen at the ED for further evaluation. 1004 attempt made to call ED Lead but unable to reach. 1005 called House Supervisor to confirm correct number for ED Lead. 1007 EMS arrives. Pt mother declines transport to ED. EMS assists patient to car. Patient and mother sat in car for long period of time prior to leaving lot. Further follow up documents there is no documentation of visit to ED.

Patient felt week and fainted, came to without Epipen and was had nausea and vommiting and was very thirsty. Pale, EMt's called. Blood pressure was normal. She went home with mother. Mom said she has done this before with medical procedures, very anxious.

The patient experienced the following reaction(s) during the immediate of observation: 1240- pt received first dose of Prizer vaccine at 1220. Pt was ready to leave and had a syncopal episode in her chair. Pt was lowered to the ground and was not alert or oriented. Mother was at the patient side. Pt was able to open her eyes and state her name. At this time the patient was placed into a wheelchair and during movement to post vac area, pt lost consciousness and had generalized muscle twitching resembling seizure like activity. At no time did patient have airway compromise. Pt was placed on the floor with feet up on the wheelchair. Vitals are as follows BP: 92/52 P: 72 R:18 99% sp02. Pt continued to answer questions appropriately with mother at her side. 1246: repeat vital signs BP: 118/64 P: 85 R:18 98% sp02 on RA Pt A&Ox4. Mother stated pt had same type episode 4 years ago while they were out of the country. EMS Was called to assess pt with possible transport to a higher level of care. 1259: BP: 110/72 P: 83 R:18 99% Sp02 Fire Department on scene speaking with mother and pt. All pt care given released at this time to FD. Mother spoke with FD and decided against transport to the hospital. Pt was observed 10 minutes longer and final set of vital signs done prior to pt leaving the facility. BP: 102/82 P: 75 R: 18 99% Sp02. Pt A&O x4, placed in a wheelchair and helped to vehicle. All questions answered prior to leaving the facility.

Systemic: Abdominal Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Additional Details: Patient lost of consciousness for a few second after received the vaccine. She was feeling better with taking rest and hydrating with water. Patient's father reports this has happened with vaccination in the past. Vitals signs@12:30pm: BP 110/60; HR 72; O2 Sat 99%. One tablet of 25mg Benadryl was given to patient.

Patient had anxiety prior to receiving vaccine and after. She said she felt very nauseas and wanted to puke. Was having trouble breathing. Patient did end up puking a few times. She was sweating and overheating, her tongue was starting to go numb, but she said her throat was not closing up. Her lips started to become white and she said she was having trouble seeing. her vision came and went at different times. EMS arrived and did diagnose her with an allergic reaction, gave her benadryl, and an ice pack. And sent her home.

Flushing/Sweating, Dizziness, Nausea. BP 84/50 HR65 RR18, then 3 minutes later improved to 104/64, HR88, RR18. Received water, symptoms resolved, discharged with father

My daughter is having ticks/twitches. Her head keeps having small jerks. She?s never had this before.

Within about 20 minutes of administration, the patient reported feeling nauseous, hot, faint, and sweaty. She stated she could "hear the lights". Her temperature was normal at 96.2 degree Fahrenheit. She stated that these same symptoms have happened before with other vaccines, Within another 20 to 25 minutes she felt better and left with her mother. I checked in 5 hours later via the phone and she was feeling better. She only reported a sore arm at that time.

Reportedly had some redness and blotchiness at the time but currently no signs of anaphylaxis with no urticaria, no respiratory involvement, no intraoral swelling or voice changes, no GI symptoms. He is warm and well-perfused although is slightly tachycardic but appears anxious. His reported inability to move her arms and legs does not seem consistent with a neurologic etiology of this complaint and more likely consistent with anxiety/conversion reaction in the setting of a vasovagal episode. Will give zyrtec at mother and patient's request, PO challenge and reassess.

While waiting during the 15 minute monitoring period patient (17 year old female) fainted in her chair. Mom noticed that patient's arms went rigid right before she passed out. Patient was still breathing and was laid on the ground to her side and 911 was called immediately. Mom was massaging her thighs and arms to increase blood flow and she regained consciousness within a few minutes. She was very pale and felt weak. She was given water and remained laying on the ground for another 10 minutes before EMS arrived. She explained she gets anxiety about any medical procedure, has had history of fainting after shots/blood draw/blood pressure reading. EMS took fingerstick reading and gave her oxygen to ensure she doesn't faint again from blood glucose fingerstick. Vitals came out to be normal. Mom explained this is very normal and she doesn't see the need to take her to the hospital. EMS offered to have patient with them in the ambulance for another 15-20 minutes before she's free to leave.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: she was sitting for 15 minutes observation she fainted and fell from the chair. She wa unconsious for about few seconds. called 911 for her. she looked paled. paramedics took her in. checked all her vital sign she was fine , her dad took her home. Spoke to dad at 6 pm in the afternoon. she is home resting and having dinner.

The shot was given on Friday around 1 pm. Blurry Vision immediately after vaccination, then felt fine until 7 pm. At 7 pm she fainted at Lacrosse practice. The following day, Saturday, she fainted at work and was sent home. Sunday, she slept most of the day. Monday, she fainted at school and was sent home. Symptoms have been feeling of her heart racing, blurry vision, fainting, weakness, and major fatigue. No fever.

At approximately 6:20pm on 03/30/2021 patient during 30 minute observation (high risk due to immunosupression) had dizziness without syncopy. On assessment at 6:20 PM HR:121, BP:102/70 R:18 O2:99%, patient was AA&Ox4, answered questions correctly. 6:30 HR:83, BP:90/70, R:18, O:99%. Patient states: "I can not drink water." Patient appeared less alert and hard to rouse, Transportation to ER was advised repeatedly. Mother stated: "I don't want to take her to ER, because it is too dangerous for my daughter because she is on steroids. We have been in ER 3 weeks ago due to migraine and they check all labs." Mother refused to call 911 and said she would transport the patient to ER of Hospital.

She had COVID-19 infection on January 5. She received Pfizer vaccine 3.28.2021 - er8733 lot. she was feeling well prior to the vaccine with no seasonal allergy symptoms. No nasal congestion or itchy eyes. No NSAIDs the day of vaccine. Tired 20 minutes later. She woke up 4 hour later with fever 101. Took Tylenol 5-6 hours later. No ocular swelling at that time. had some nausea that evening and some abdominal pain. No muscle pain. Some chest tightness that evening. The next miring was very hot and nauseated and then vomited. Two days later swelling around eyes, not too itchy. Swelling was more severe in April 4. the swelling is slightly improved over the last week. On April 4, antecubutal fossa were itchy and red. lasted 1-2 days. No runny nose, sneezing or itching. Low grade fever lasted 1 hour. fatigue lasted a few days. No muscle or GI symptoms. No NSAIDs, but Tylenol initially. no sore throat. No mucous membrane involvement. No leg swelling. No change in urine output. No joint pain. No headache. No vision change. No bleeding gums. No hives. No enlarged lymph nodes. No SOB. No chest pain. No change in bowel habits. Energy level good. No night sweats. SAR symptoms well controlled. Mild swelling at left arm injection sight that lasted 1 day. swelling is worse in the AM when waking up; both upper and lower eyelids.

Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient fainted in waiting are 5 minutes after shot. Patient's muscles stiffened up and she hit back of head on shelf. Pharmacists lowered patient to recovery position on floor, where pt recovered consciousness and relaxed. Patient's mother said that patient has vaso-vagal responses to shots and that she was having one of those. Patient was well and was able to leave without further assistance.

Severe left arm with minimal swelling x 2 days so far. Tingling in left fingers and able to move left arm but limited due to pain. Patient reports pain extends armpit and left side of upper back. -Symptom onset was 4/12/21 after receiving the vaccine. She was unable to sleep that night due to the pain. -Yesterday 4/13/21 symptoms persisted and went to ER where she was given a dose of oxycodone for the pain which helped her to sleep. -Today 4/14/21 symptoms continued. I spoke with her rheumatologist who recommended holding her Meloxicam and starting Ibuprofen 600 TID for a few days until symptoms resolution.

Sore arm after shot. Fever, body aches same night into next day. (as expected) Breakthrough bleeding started 2nd night after shot with full blown period starting 3rd morning after shot. She is on the pill, did not miss a dose and has never had breakthrough bleeding. We are on day 3 so no known outcome resolution of bleeding.

Patient arrived with mom for Covid vaccine at 12:48 pm. Mom reports a history of fainting so nurse decided to administer vaccine with client lying down. Vaccine was administered and client immediately stiffened arms and appeared to seize while her eyes rolled back. Nurse reported she turned the client onto her side and she "came to within 20-30 seconds." She reported blurry vision but could read when asked to do so. She quickly became alert and oriented. Her mother reported that she had a previous episode one time in the past year with painful menses. Her vitals remained stable but each time she attempted to stand up, she reported feeling "sick." She developed a headache within minutes of the vaccine and took 2 Tylenol while still there. Client left with parent to follow up at hospital.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Confusion-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: symptoms started after they had waited the 15 min in store and were well on their way home. they included: speaking overly slow or oddly, left arm tingling, chest pain/SOB, developed into shooting pain down right leg. pt laid down for nap and awoke with swollen eyelids. pt still experiencing shortness of breath and having to limit activities

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: Patient was close to vomiting, benadryl was given, patient recovered.

immediately after vaccine patient asked if she "could sit for a minute"; became pale, diaphoretic and limp in the chair; responded immediately to spirits of ammonia and position change; patient given oral fluids and responded well; patient observed for 45 minutes before being allowed to leave vaccine clinic

pt looked pale 10 minutes after vaccine went out to check on him he was getting faint and lips looked purple, was NOT having breathing problems and BP was normal at 104/54, called 911 patient was very clammy and sweaty, stayed with patient until paramedics arrived, patient was feeling much better a little before paramedics arrived, but they decided to take him to hospital

The rash first started on her hands on 4/2 and was originally attributed to powdered gloves she used during her job at a restaurant. She had her wisdom teeth out on 3/24 and started amoxicillin and steroids for the wisdom teeth on 3/25. She had her first COVID vaccine on 3/30 with arm pain only on 3/31. She was seen in the urgent care on 4/4 . Rash felt to be due to amoxicillin or contact dermatitis (gloves). She stopped amoxicillin. The rash has continued to evolve. Originally maculopapular and only on hands, nby 4/13 there was both a maculopapular rash in addition to urticarial lesions primarily on her lower extremities, but also present on her trunk and in her groin. It is intensely pruritic. It seems to change over time, though the family is not entirely sure about that. Certainly, they describe confluent erythema and swelling over her right ankle the morning of 4/13 which was not present by the time she saw me that afternoon. She has had ankle arthralgias as well. as of 4/16, rash is gone other than feet.

Hx: Anxiety Allergy: Amoxicillin; Flushing/sweating, BP 104/61; HR 65; RR 18. Pt c/o "I feel like I'm going to faint". Pt denies eating x24hrs. Pt D/C w/ , mother and no c/o @D/C, BP 112/61, HR68, RR16. Patient stable and released from vaccination site

General fatigue, feeling slightly unable to speak or text in clear sentences (i.e., patient said she feels "loopy"), coughing for a little while, chest (lungs) feels heavy

17 Y/O FEMALE UNRESPONSIVE POST VACCINATION. PT APPEARED COOK, PALE, PUPILS DILATED, NON REACTIVE PT ASSESSED BY EMS PLACE ON STRETCHER IN TRENDELENBURG POSITION. PT C/O VISION LOSS AND UNABLE TO HEAR. 02 SAT UNDETECTED THEN 98%. PT PLACED ON OXYGEN. BOTH PARENTS PRESENT AT TIME OF INCIDENT. PARENTS ALSO STATED PT HAD MENINGITIS VACCINE APPROX 2 WEEKS AGO. NO OTHER HX. PT REGAINED CONCIOUSNESS, HEARING AND VISION. TRANSPORTATION T(JFRD) ARRIVED. PATIENT DECLINED TRANSPORTATION TO ER. CLEARED BY EMS APPROX 9:50 A.M.

Woke up around 2AM the morning after the vaccine was administered and noticed pain in hands when washing hands. Woke up officially around 9AM. Entire body hurt, most notably headache, backache, and neckache. Pain was intense, took Ibuprofen and muscle relaxer. Stayed in bed in the dark for most of the day because of pain. When standing, dizziness and weakness, fell over once. The pain finally subsided enough to function close to 7PM, disappeared completely by the following morning.

Ms. Young was observed post Covid-19 immunization for 15 minutes. During the observation period, she experienced an adverse reaction with the following symptoms: Facial rash/bilateral checks. No itch. Warm to touch. Assessment : Patient left after check out in while in her car noticed the rash/flushed face on her face. Patient returned at 12:23pm and rash was noticed by RN to be red to the cheeks bilateral and warm to touch. It was noted that rash followed the outline of the patient's mask. Patient reports she has worn the mask before with no issues. Mask no washed in the past 2-3 days per patient. Alert and oriented. Patient reported itchy throat at 12:35. No difficulty swallowing. At 12:51 patient states she no longer has an itchy throat. Rash in still present. Not worsen in appearance. Patient reports no other symptoms. Patient stable and orientated x4. Walked patient out to door at 12:58 and gave Pfizer information sheet along with symptoms to look out for such as worsening in rash, difficulty breathing, swelling of the face and neck, fast heartbeat and dizziness or weakness. Actions taken: Vitals sign taken VAERS form completed Paramedic on site. Vitals Signs at 12:36, BP= 116/64 HR = 76, 02 = 100, Temp: 97.9F (Temporal) ,Vitals Signs at 12:55, BP= 119/54, HR = 72, 02 = 100. Medications administered: Loratadine (Claritin) 10 mg by mouth. Time: 12:25 pm. Administered by, RN. Famotidine (Pepcid) 20 mg by mouth. Time: 12:30. Administered by, RN, Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. Instructed to follow up with PCP for evaluation for second dose. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat. The Patient was provided with Vaccine Information Sheet and instruction to access the system. Immunizations Administered, Name, Date Dose VIS Date, Route Pfizer COVID-19 Vaccine, 4/19/2021 12:00 PM, 0.3 mL 2/25/2020 Intramuscular, Manufacturer: Pfizer, Inc, Lot: EW0164, NDC: 59267-1000-2.

Felt dizzy at work the next day after the second shot. Passed out and then was sitting down and I felt nauseous. I threw up 5 times and my arms started to get numb. I had a fever when I got home and I couldn?t move because my body hurt so badly. Migraine and dizziness has been persistent ever since and is interfering with my daily life. Been treating with tylenol which helps a little but not completely. As soon as I stand up and move I feel like I?m going to pass out.

04/21/2021 11:48 AM Patient says she was lighted headed and dizziness. wasnt speaking dropped her phone and was not aware. BP WAS 79/37 Pupils were fixed with some movement.. mother was outside, called in. mother had stated earlier that she was afraid of needles. felt clamy and sweaty. patient taken to ER in wheelchair with mother for evaluation

Fell to floor from chair in observation area. OC related to vaccine administration. Pain in right cheek. Pain level 2.5/10. Vaso-vagal response post vaccine injection. Vital Signs: BP 100/60 HR 85 Resp 20 O2Sat 98 , Skin Signs: Cool and dry, Clammy, Circulation: Cap refill <2sec, Respiratory: Breath sound clear bilaterally, Initial Treatment: Water/observation/elevated les bilateral. Assessed/evaluation by Dr. 10:25 AM, Vital Signs: BP 100/72 HR 85 Resp 20 O2Sat 72, Skin Signs: Cool and dry, clammy, Circulation: Cap refill <2sec, Respiratory: Breath sound clear bilaterally Follow up Treatment: Mask Oxygen administration for 10 min. 10:25-10:35 AM. Ice pack to right cheek, approx. 4 L and reduced to 2 L/min\, 10:35 AM\, Vital Signs: HR 98 Resp 20 O2sat 99, Skin Signs: Cool and dry, clammy, diaphoretic Circulation: Cap refill <2sec, Respiratory: Breath sound clear bilaterally 10:45 AM, Vital Signs: BP 120/82 HR 76 Resp 20 O2Sat 97, Follow up Treatment: 10:45 skin warm and dry, alert and oriented x3. Cap refill <2sec ,Notes: Recommended parent to contact peds office for injury to right cheek. Continue to maintain good hydration at home the rest of the day. Home with father at 10:55 AM

Patient had dizziness and felt her arm get hot. Patient then felt cold, unsteady gait ,had patient lay down with feet elevated, given sips of water, symptoms resolved within 15 minutes. pulse was 65, O2 97, BP cuff did not fit, pediatric size unavailable. Assumed vasovagal response

emale client received her first dose of Covid Vaccine (Pfizer, Lot # ER8729, Expiration date: 07/31/2021) at 1132. This minor client, accompanied by her mother proceeded to the observation room for her 15 minute wait period. Co-lead RN, was present in the observation room assessing another client. At 1137 this client's mother loudly voiced from the back of the room, "she's feeling dizzy" and co-lead observed client was hanging her head. Co-lead and EMT1 hurried to her side, and client stated she was feeling lightheaded and dizzy and was suddenly pale and diaphoretic. EMT1 immediately transferred her from chair to floor with full assistance to prevent a fall/injury. Client was placed in trendenlenburg position by elevating feet and placing them on the chair. Client was unresponsive for about 15 seconds until she regained consciousness and returned to baseline mentation. Client verbalized she "blacked out" and did not remember being placed on the floor. Client denied pain and respiratory distress. EMT1 called 911 at 1138. Client and her mother deny she has any medical issues, allergies, medications, or previous incidence of syncope. At 1145, first set of vitals taken by EMT1 indicate hypotension and bradycardia as follows: BP 68/44, HR 58, and RR 16. At 1145 paramedics arrived and assumed care after receiving report from EMT2. At 1150 medics took VS with BP 70/50, HR 54, and blood glucose 95, and determined they would start an IV to administer a 500cc bolus for dehydration and to improve BP. Client was also placed on 2L O2 for comfort, no desat noted. At 1200, medics advised client's mother and co-lead they would transport client to the Hospital for further evaluation. Medics departed at 1205 to transport client to the hospital.

Patient became pale and unresponsive in post vaccine waiting area within 3 or 4 minutes while waiting 15 minutes with mother. When assessed patient was breathing and had pulse but was only responding partially to verbal stimuli. Placed cold compress on neck and once alert and fully responsive gave glucose tablets. EMS responded and checked vitals but did not share results. Patient fully recovered and left with mother after we verified contact info.

A few minutes after receiving the vaccine, the patient complained of feeling hot, flushed, and faint. She then wanted to lie down on the floor. I called an ambulance, as she refused to let me take her blood pressure. When the EMTs arrived, she was sitting up and feeling notably better. She and her mother declined going to the hospital.

Patient felt light-headed about 15 minutes after shot. She stood up and fell. A gentleman caught her so she wasn't injured. She said she was hot. She said her heart wasn't racing. I took her pulse and it was normal.

Left arm sore. Severe migraine headche with blurry vison in left eye( vision corrected later in the day) Onset of mentrual cycle with severe abdominal cramping , nausea, heav bleeding and headache.

Left arm ache, sore with slight bruising. Headache and mild fever. Pain ful menstrual cycle with abdominal cramping and heavy bleeding with the cycle lasting for 6 days ( more than normal ).

Bad pain with injection-needle went too deep for teen female. Instant pain afterwards increasing. Next day can't move arm-pain spreading to shoulder and neck

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Headache-Mild, Systemic: Hyperventilation-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Tachycardia-Mild, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Mild

about 5 minutes after administration, patient became unresponsive and was going in and out of consciousness. Her pupils became dilated and she would not respond to stimuli. Her respiratory status was unclear. No hives or rash could be observed. Patient became pale in the face. An allergic reaction could not be ruled out and the patient became less responsive so an EpiPen 0.3mg was administered in the left thigh. Patient was placed on her back on the ground. She became more alert and seemed to have normal breathing. EMS arrived and took vitals. Blood pressure was 138/77 with a heart rate of 88 bpm. Patient's father is taking her to her PCP for follow up this afternoon.

After receiving vaccine, patient became light headed and passed out sitting in chair. diaphoretic and clammy. Heartrate 60, BP 60/29,SPO2 100%. Medical response called, patient taken to ER, accompanied by mother

COLD SWEATS, DIZZINESS, DROWSINESS, BP WAS TAKEN 74/44, THEN 5 MINS LATER 99/60, PT WAS LAID DOWN TO PREVENT FALLING, PT WAS NERVOUS AND ANXIOUS

15 post vaccine administration patient reported feeling week and also having numbness in her legs as she tried to stand up to leave. Assessment performed and VS as follows at 0900: BP 114/63, HR 79, O2: 98% at 0905 BP 123/70, HR 88, O2: 99%. Pt observed for approximately 10 minutes and reported improvement in symptoms. Pt discharged home in stable condition accompanied by family member

Pt received vaccine at 306p and at 316p began to have seizure like activity for 30 seconds. VSS EMS here to assess pt, pt to ER

i couldnt sleep, woke up many times with chills and a really bad headache, the whole day ive been sick to my stomach and my head hurt. i even threw up a lot

2:00 am: chills 8:30 am: 102.2 fever with chills and throbbing headache fever continued throughout day

One day after the second dose I felt tired, weak, cold, and with a sore arm. After, I took 3 Tylenol capsules to feel better. Today my left arm which I got the vaccine in, feels itchy and my hand is swollen and red. Now my left feet is starting to feel itchy and swollen-red.

Patient arrives from vaccines site, having a witnessed seizure after receiving Covid -19 vaccine injection. Patient has no previous history of seizures.

Patient had flushing/sweating, dizziness, anxious, sweating. Low BP 84/46 -- > 116/75 -- > 121/82. Patient stated did not eat since 4/24/21 6PM. Patient stable, released from vaccination site.

ON 4/21/21, SHE BEGAN TO EXPERIENCE SHORTNESS OF BREATH, COUGHING, CONGESTION, SEVERE BACK ACHE, WEAKNESS, FATIGUE, FEVER, CHILLS, VOMITING, DIARRHEA. I TOOK HER TO THE HOSPITAL WHERE WE WERE TOLD THAT IT WAS DUE TO VACCINE AND SHE WAS SENT HOME WITHOUT MEDS. SHE BECAME WORSE AND WORSE AND DEVELOPED HEART ATTACK SYMPTOMS: CHEST PAIN, WHEEZING, TIGHTNESS AND HEAVINESS IN CHEST, INTENSE BACK PAIN. WE RETURNED TO THE ER AND SHE WAS DIAGNOSED WITH PERICARDITIS. WE WERE ALSO TOLD THAT HER HEART WAS SLIGHTLY ENLARGED.

Immediately following my shot I felt brain fog and dizzy but continued with my day. The next morning I woke up with extreme nausea and a migraine. I am prone to migraines. I was hot and chilly but never read a fever. It's hard for me to sleep due to discomfort.

Dizziness and nausea; rest and sips of juice; calming breathing exercise to prevent hyperventilation (pt had tingling fingers). All sxs improved. Pt's mother did not want to call 911. EpiPen was available but was not needed

At 2am 4/22 patient started to feel sick and sent a text that I didn't read until 630 as I was asleep. She had severe muscle aches, hurt to move, hurt to breathe and felt like she was having a heart attack. She felt like she might pass out and had some blurred vision. At 630am, I saw her texts and immediately brought her 2 tylenol and a large glass of water. She went back to bed. She woke up around 10:45 and was feeling decent except for a headache but no fever or anything so we went to try on some Prom dresses. At the dress shop, she collapsed and had a seizure lasting around a minute. She lost her bladder and was completely confused and incoherent. She's never had a seizure before. I scooped her up, brought her to the ER where they ran every test and scan imagineable. Full blood work up and cultures, a chest xray, a CT scan of her brain and lungs. Her temp was high 103-104 and she had full body chills and a pounding headache. Her BP kept dropping and got as low as 81/36. They threw 2 bags of IV fluids into her and admitted her to the hospital. She had also developed a heart murmur. Over the course of the night, her BP stabilized but her temp continued to spike and come back down with Tylenol/Ibuprofen. She also had IV Tordahl for the headache. Her inflammatory markers were high at 15.3 which we were told should be less than 1. They reran labs in the morning but everything can back really low which they felt was a dilution effect from all the fluids so wanted us to follow up with her primary care on Monday. On Saturday night, he lymph nodes were swollen to the size of ping pong balls but have since slowly reduced in size although still there. Her labs were better from discharge and her white blood cell count was within range and her inflammatory marker was down to 1.7. Her blood sugar was a little low. She did pass out and have seizure like response to giving blood in the doctors office, lost bladder control again, shot pupils, etc. She is still stuttering over words, has some short term memory retention and has some motor function issues which they think is a result of the initial seizure and should resolve itself over time. Her liver function tests were totally normal in the hospital but are a high now so they will be checking her out again next week.

Right hell swelling, redness, tenderness first noted on awakening 4/27 (3 days post vaccine). Swelling a bit decreased when seen 1500 on 4/27. No fever. Mild pain when walking.

Passed out right after vaccine; muscle aches; tired; chills; migraine; This is a spontaneous report from a non-contactable consumer (patient). A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 14Apr2021 at 14:15 (Batch/Lot number was not reported) as single dose for covid-19 immunization, administered at the Pharmacy or Drug store. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Mar2021 at 14:15 in the left arm for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient was not pregnant at the time of report and vaccination. The patient did not receive other vaccines in four weeks. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. The patient passed out right after vaccine, also experienced muscle aches, tired, chills, and migraine; all on 14Apr2021 with outcome of unknown. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.

Arm pain, slight swelling in injection site area. Swollen lymph nodes on both sides of neck, overall malaise/body aches, fatigue, light-headedness resulting in fainting episode, headache

Recipient is a 17yo who presented for second dose of COVID-19 vaccine. She reported some anxiety related to receiving dose #2, and had some nausea after dose #1. She was alone as a driver of her own POV. Consent was obtained from the recipient and her custodial grandparent by phone, witnessed by doctor. She initially did well after the vaccine, but after approximately 5 minutes began to complain of feeling nauseated, lightheaded, and tingling extremities (hands and feet). She was noted to be hyperventilating, and was placed in a supine position but continued to feel some lightheadedness and difficulty breathing. Breath sounds were clear without wheezing noted, HR 70s with RRR. She was noted to have ongoing anxiety, nausea and symptoms progressed and although she remained normotensive to hypertensive (initial BP 128/74), she had repeated episodes of syncope. She was transferred to the ambulance and further vitals and EKG were obtained. She had some confusion after episodes of syncope and some seizure-like activity with syncope, with very brief episodes of LOC, with noted tachycardia with HR up to the 140s during episodes of syncope. BP ranged 129/86 to 140/84. IV access obtained and she was given NS and started on oxygen at 2 liters, but saturations remained in the 98-99% range. She was ultimately transferred to the local ER for further evaluation and management given ongoing symptoms, evaluated at hospital.

patient felt dizzy, lightheaded, nauseous after receiving pfizer covid-19 vaccine. I checked her blood pressure, it was normal 127/96; pulse was 87. I gave patient ice pack and she said she was feeling numbness in her left arm and fingers. After 5 minutes she was feeling some chest pain and wanted me to call 911. She said she was feeling anxious and hadn't eaten all day. patient takes weekly methotrexate injections.

Not sleeping well at night due to pressure feeling in her chest up; Not sleeping well at night due to pressure feeling in her chest up; shivers; jaw got paralyzed; she got shaky; feeling bad/ brain fog; burning sensation in her body; She couldn't talk; slight elevated temp (99.7F max); She has been off balance this week since getting her vaccine; This is a spontaneous report from a contactable physician. A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Apr2021 (batch/lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome, panic attacks, migraines and acne. The patient was not pregnant at the time of vaccination. It was unknown if there were other vaccines in four weeks. The patient did not have Covid prior to vaccination and was not Covid tested post vaccination. Concomitant medications in two weeks included ondansetron hydrochloride (ZOFRAN) taken for anti-nausea, start and stop date were not reported; doxycycline taken for acne, start and stop date were not reported. The patient previously took glycerol (GLYCERIN) and experienced allergies. The patient got her vaccine on 12Apr2021. Two nights after her vaccine (14Apr2021), she got shaky and feeling bad and burning sensation in her body. No fever at that time, but slight elevated temp (99.7F max) the day after the vaccine (13Apr2021). Mother gave her anti-nausea medication (ondansetron hydrochloride 2 mg) and within 5 minutes her jaw got paralyzed. She couldn't talk. It lasted about 30 min. Mother called ambulance and patient was brought to ER. ER didn't do bloodwork or any evaluation. ER didn't know what happened per mother. She has been off balance this week since getting her vaccine (Apr2021). She feels better this morning but she still feels off balance. Not sleeping well at night due to pressure feeling in her chest up and she shivers to get the feeling away per patient (unspecified date). Slept better last night as of 17Apr2021. No facial drooping. She can smile and lift her eyebrows. Patient had "brain fog" this week as well after the vaccine. The adverse events "she got shaky", "feeling bad", "burning sensation in her body", "jaw got paralyzed" and "she couldn't talk" resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. There was no treatment received for the adverse events. The outcome was recovered on an unspecified date for the events "jaw got paralyzed" and "she couldn't talk"; recovering for the event "not sleeping well at night"; not recovered for the event "off balance"; and unknown for the rest of the events. Information on the lot/batch number has been requested.; Sender's Comments: Based from temporal relation of event and vaccine administration, Trismus as an event in relation to suspected drug BNT162B2 cannot be totally 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

nausea; headache; began having left eye twitches and they progressed to spasms and the nose and left side of her face. It then included both sides of her face; pinching in her left shoulder; began having left eye twitches and they progressed to spasms and the nose and left side of her face. It then included both sides of her face; patient could not open her eye or control her face; her left leg had goosebumps and chills; her left leg had goosebumps and chills; This is a spontaneous report from a contactable consumer (patient's mother). A 17-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: ER8731) via an unspecified route of administration on 07Apr2021 at 15:15 (at the age of 17-years-old) as a single dose in the left arm for COVID-19 immunisation. Medical history included asthma from an unspecified date and unspecified if ongoing. Family medical history relevant to the adverse event was reported as none. Concomitant mediations included ethinylestradiol/levonorgestrel (JOLESSA) taken "to decrease her periods" from 2019 ("about two years ago") and ongoing and at an unspecified dose, cyclic, for three months straight with no placebo. Then takes a placebo pill for one week straight and biotin taken "for hair and nail growth" from an unspecified date ("she began taking within the last 6 months") and ongoing. There was no history of previous immunization with the Pfizer vaccine, there were no additional vaccines administered on the same date as the COVID-19 vaccine and there were no prior vaccinations within 4 weeks. It was not provided whether there were adverse events following prior vaccinations. On 07Apr2021 the patient experienced began having left eye twitches and they progressed to spasms and the nose and left side of her face. It then included both sides of her face, patient could not open her eye or control her face, her left leg had goosebumps and chills, pinching in her left shoulder, nausea and headache. The reporter called to report that her daughter had a severe reaction to the first dose of the COVID-19 vaccine. The clinical course was reported as follows: The patient received the first dose of the COVID-19 vaccine in her left arm. Less than an hour after receiving the COVID-19 vaccine, the patient developed goosebumps and chills in her left leg. The reporter was not very concerned about it at the time. About 9:00PM that same night, the patient started complaining of pinching in her left shoulder. The reporter was not too terribly concerned. By 9:30PM, that same night, the patient started to have left eye twitches. Then they increased to eye spasms, then the patient could not open her eye or control her face. Then, it progressed to patients nose and left side of her face. At that point, the reporter tried to contact a nurse with the health insurance advice line. She waited for 30 minutes. The patient's symptoms continued to get worse, so the reporter took the patient to the emergency room. While the patient was in the emergency room triage, while hospital staff were getting her blood pressure and temperature, her symptoms also started to involve the right side of her face. Around 10:15PM, that same night, the patient started to get nauseous and a headache kicked in. The emergency department took patient straight back to a room. The patient was not admitted to the hospital. The emergency department started an IV on the patient, and they administered Reglan, Benadryl, and Toradol to treat her symptoms. The emergency department ran blood tests, preformed a urinalysis and a CT scan. The reporter did not know what all blood testing that was done revealed; however, the reporter did know that they told her that none of the testing revealed anything and were all normal. The patient was eventually discharged from the emergency department at about 1:50AM. She was sent home with Butalbital, for headache and was advised to take ibuprofen. She was still having the twitching but not as bad when discharged. On 08Apr2021, the patient's symptoms had not completely subsided, but were significantly better. On 08Apr2021, the patient woke up with nausea, chills and a headache. The reporter expected the patient to have these side effects. The side effects continued until very late in the day on 10Apr2021. The patient never vomited, was only very nauseous. The reporter also stated that when the woman was administering the first dose of the COVID-19 vaccine, the woman said "oops" and it was not explained what "oops" meant. The reporter asked if it was possible that the patient received the dose subcutaneously and that was why she had these side effects. The reporter also stated that the second dose was scheduled for 28Apr2021 and she asked if the patient should receive the second dose. The clinical outcomes of the events began having left eye twitches and they progressed to spasms and the nose and left side of her face. It then included both sides of her face, patient could not open her eye or control her face, her left leg had goosebumps and chills, pinching in her left shoulder, nausea and headache all recovered/resolved on 10Apr2021. No follow-up attempts are needed; No further information is expected.

Within a couple of minutes of receiving the shot, my daughter felt hotness running down the length of her vaccinated arm and into her hand. Started feeling hot and started to produce a small patch of hives on the outside of the throat and chest. Did vigorous windmill motions with vaccinated arm. She had a feeling of slight unwellness that was followed by a rush of energy. As we leave the store and start to drive home her hives are a little bit worse and she says she feels a little lightheaded and has some heart palpations. But is still reporting a rush of energy. By the time we get home 10 minutes later hives, lightheadedness, and heart palpations have resolved. She feels great the rest of the day. Next day slight redness around the injection site and arm a bit sore. The following day redness is gone but a slight rash is starting to show up around the neck. 5 days later, the rash becomes inflamed, sore, hot and itchy, hives are full upper-body flareups. She takes Allegra 24 for hives control. Rash comes and goes daily. Acts more like hives. Allegra 24 controls hives mostly along with icing. After a few days, the effectiveness of the Allegra 24 is not as efficient with the neck rash. Switches to Zyrtec 24 which seems to provide better relief from both hives and rash around the neck. Sees Dr. April 29th. He advises not to take a second dose of Pfizer at this time and prescribes her an EpiPen.

After a few minutes of receiving vaccine, patient reported dizziness, light headedness, and blurry/dots in vision. She then became more upset leading to hyperventilation and crying. She then said she had tingling in her fingers, which progressed to difficulty moving her fingers/stiff fingers, and coldness and redness in tips of fingers. She then reported she was loosing sensations in her feet and legs. 911 was called. We tried to have the patient take slow deep breaths. We offered an ice pack and water up front and a heat pack for her fingers. Paramedics arrived. Her blood pressure, heart rate, oxygen saturation, glucose were within normal limits. She was given oxygen and the paramedic was able to help her slow her breathing. Her fingers went back to normal and she felt fine before leaving. She did not feel the need to go with the paramedics.

Hours after injection i had a small welp about the size of a nickel now the welp has flattened out and is very hard and the size of a half dollar and bright red and hot to the touch And tender.

"Approximately 2 minutes after vaccination the 17 year old female had a "tonic seizure". Became unresponsive for about 2 minutes. Mother reports daughter has a history of fainting/seizure after blood draws ("she's afraid of needles")" Patient left with family ambulating.

Woke up at 6:30 AM on May 2 with chills and moderate-severe headache, took 2 Ibuprofen at 7:00 AM. Took nap and then stood to speak to my mother, followed by a severe headache for a few seconds and then a seizure lasting less than 1 minute. Hospital released and recommended follow up with PCP for referral to neurologist. No further events as of May 2nd at 9:15 PM

First 3 days, arm was sore, fever, nausea and day 3, vomiting. Every single day since, off and on throughout the day: fever (99-101.9), nausea, headaches in the front part of the head, clammy feeling and lethargic. Starting 5/1, now been dizzy every day. We are on day 22 since the vaccine and this is still happening.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Seizure-Medium, Systemic: Vomiting-Mild

Patient become unresponsive and faint approximately 5-10 minutes after receiving dose 2 of the covid vaccine. After consuming some water patient vomited and remained unresponsive. Pharmacist went to get epi-pen to administer but upon returning with it the patient was responsive again and reported no difficulty breathing. Epi-pen was not administered.

left-side facial drop with left mouth corner; stroke symptoms; transient mild headache; blurry vision; left side of tongue affected; slurring speech; felt confused; drowsy; This is a spontaneous report from a contactable consumer (patient). This 17-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8734), via an unspecified route of administration in the right arm at 17 years old on 30Mar2021 at single dose for COVID-19 immunization. Medical history included acquired brain injury (C-PVL) from pneumococcal strep infection, hypoxic ischemic encephalopathy, premature birth, quadriplegic dyskinetic cerebral palsy. Concomitant medications were none. The patient was not pregnant at time of vaccination. The patient previously received T-Dap vaccine at 10 years old and had prolonged migraine reaction. 12 days after, the patient developed stroke symptoms with transient mild headache, blurry vision, and left-side facial drop with left mouth corner and left side of tongue affected causing slurring speech also felt confused and drowsy which lasted for 8 hours. Events were started on 11Apr2021 at 03:30 PM. Events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient went to ER, they did stroke work-up. No evidence of stroke. The patient received treatment including CT scan, MRI, EKG, labs. The patient had no covid prior vaccination, no covid tested post vaccination. Outcome of the events was recovering.

03May21-daughter C/O obstruction in throat. upon view, left tonsil is enlarged, red, 'puffy', striated with white patches. Uncomfortable to swallow. slight runny nose, congested voice, puffy eyelids (slight). Went to urgent care, was tested for Mononucleosis and results positive.

White blister rash that started at injection site then spread quickly over back, chest, other arm, legs. Light headedness, and tingling and numbness in lips and face. Was given Benadryl 25mg and 2 Tylenol. The rash and numb feeling persisted for 3-4 hours. Several hours later symptoms were followed with a fever and nausea. These symptoms remedied within 24 hours and she was just tired and sore.

non-epileptic seizures onset 3 days after 2nd dose. 5-6 hours in the ER, trying to figure out if it was epilepsy, then 48 hours of observation once valium was given to calm the muscle spasms down. 5-5-2021 patient still has seizures less frequently, but they still occur. patient did not have these prior to 2nd dose of vaccine.

Site: Pain at Injection Site-Mild, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Fever-Medium, Systemic: Headache-Severe, Systemic: Unable to Sleep-Mild, Additional Details: mom called to report adverse reaction to 2nd dose of pfizer vaccine. pt had chills on monday, fever on tuesday, wed morning child passed out in the kitchen mom heard her fall, she did call 911. child was transported via ambulance to strong ER. pt was diagnosied with syncope. pt is now home with mild headache/lethargy and recovering. mom has called pcp waiting to talk to her.

At 1130 pt reported feeling anxious. OxSat 94%, HR 55, BP 94/58, sweaty, clammy, At1142 Spoke to father, informed him of reaction and treatment. Parent verbalized understanding. @1157 BP 110/68, HR 65, OxSat 98%

Patient arrived to post vaccine area after receiving second dose of Pfizer COVID 19 vaccine. Patient reported to post vaccine nurse feeling lightheaded with tongue tingling, headache, nausea and feeling flushed/itchy. Initial vital signs 123/83 85bpm 99% O2. At 1730 patient given 25mg PO Benadryl per standing orders. Patient monitored by post vaccine nurse. Symptoms resolved at 6:15pm, and requested to leave. Last vitals: 117/78 HR 90 O2 99%. Patient had arrived with mother and agreed not to drive. Instructed to call 911/emergency services if symptoms return/worsen.

Patient developed nausea, dizziness, lightheadedness, tingling and contraction of hands within 5 minutes of receiving vaccine. Resolved with po fluids only.

Patient describes feeling nauseated, lightheaded, and dizzy about 20 minutes after vaccine while in waiting observation area. Mom states she looked over, patient's eyes were rolled back, she was shaking, and not responding to mom. Patient does not remember this part. She states the next thing she remembers is looking up at nurses looking down on her. Mom thinks she was out for a few minutes. Of note, patient had not had anything to eat or drink on day of vaccination. She also has a history of syncopal episode after a toradol injection, and with illness.

While sitting in vaccination chair, patient immediately started c/o of dizziness, and hearing sounding muffled, diaphoretic and hot. Alert and oriented with BP 110/88 P52 and O2 99% on room air. Cold water given with gatorade insert. Cold compress also placed on patient. After 5 minutes, patient stated she "felt better." Alert and oriented x3. Left with mother. No acute distress noted.

Dizziness, Migraine, and nausea. 8:40- assisted to the floor. vitals checked P: 95 , O2 100% RA, assisted to the floor. BP 123/61, R 19, Temp 93.1. Client was offered water and emisis bag. Parent was called to pick up client. Client states she has chronic migrains and is suppose to take migrain medication daily, but hasn't taken it in the last two week. Client was cleared by nurse

HPI Pt is a 17yo female, otherwise healthy, who presents with right side of her face with decreased movement, some pain, and eyebrow twitching x 5 hours. Symptoms started out of the blue. No trauma. No hx of similar symptoms in the past. No fevers, upper respiratory infection symptoms, cough, sore throat, nausea, vomiting, diarrhea, rash, dysuria. Does have a blister on her lip x 2-3 days. No weakness to her muscles. No slurred speech. No headache, dizziness, vision changes. She is having trouble blinking her right eye and closing her right eye. Normal oral intake, urine output and activity level. No sick contacts. No known COVID exposures. Got the Pfizer vaccine #1 on 4/27/21.

Red bullet Mark on arm lasted three weeks. Has pins and needles off and on in feet. Losing muscle function in hands that is not going away. Having hard time holding onto objects or writing. Primary doctor referred to neurologist.. waiting for appointment

Patient received second dose of Pfizer COVID-19 vaccine and experienced symptoms of difficulty swallowing while waiting in-store for 15 minutes afterwards. Patient initially reported feeling warm and a slight tingling sensation in her arm, after an additional 5 minutes (20 minutes total post-injection), reported feeling a throat tightening sensation and difficulty swallowing. Patient was not short of breath, was able to speak without difficulty, and reported to be able to breathe normally. No epinephrine was administered and EMS was called for evaluation. EMS assessed that the patient was stable, had no signs of swelling in or around the throat area, and did not suspect an allergic reaction. Patient was released home with parent shortly after assessment.

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

When I first got the shot I had some soreness and some pain from mid upper are down to elbow. The next day I could be rly wake up, my arm was incredibly sore and I felt sick to my stomach in waves. (rolling nausea) During the day I had off and on headaches that became a full on migraine my dinner. My arm stayed sore and hard to use all day and at night about 7:30 - 8:00 a sharp pain started lancing through my thigh to my knee, after a half hour or so it moved to include down to my ankle, then spaced out between the three randomly till about nine wen it moved to my side for about twenty minutes or so before becoming a dull throb in my leg till I fell asleep. The next day I felt a slight ickyness that last off and on all day as well as a light headache that got worse in the evening. The soreness in my arm dulled down and was just about gone by night, as well as rolling nausea all day though light. Today I woke up a little icky, very tired, and with a headache that has lasted all day and worened during the night, the soreness in my arm is gone.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild

Patient received Pfizer Covid vaccine dose #1 at 4:07pm, 10 minutes later patient said that she was not feeling well. She felt her left arm was going numb, light headed, dizziness and chills. at 4:10 BP was 127/81 pulse 70. At 4:25 bp was 136/82 pulse 83. She was still feeling light headed, cold, and shaking. Pt given orange juice. At this point patient stated she has a hx of losing hearing and then a feeling of passing out. This has occurred more than one time. Pt also stated having lost feeling in both legs with no explanation as to why. 4:35pm bp 133/82 pulse 85, she was feeling cold and shaky. 4:42 pm patient stated she was getting colder and was still light headed. 4:56pm very cold, chills and dizziness. Pt was given another blanket. Both pt and father were asked if emergency services should be called. 5pm per parent;'s request were ok to give 480mg of tylenol, she was very dizzy and cold bp 132/85 pulse 89. Father approved of us calling for emergency services. Pt symptoms not improving. Emergency services arrived pt was able to get onto her feet and walk to the stretcher. Pt stated she is still very dizzy.

Patient presented for second dose of Pfizer COVID vaccine. Per mom, patient had anxiety attack after first dose last approximately 45-60 minutes. Patient transferred from vaccine clinic to private room with stretcher prior to vaccine administration. Post vaccine administration, patient exhibiting typical symptoms of panic attack per mom (seizure-like activity, unable to respond to verbal stimuli, sternal rub or fingernail pressure). EMS arrived at 0925. Patient regained consciousness after EMS arrived, back to baseline at 0940. Patient and mother declined EMS transfer to ED for further evaluation. Patient and mother informed to seek medical attention immediately for any worsening/concerning symptoms. Patient discharged via wheelchair with mother.

While in observation, patient reports being lightheaded and hot. Patient became diaphoretic and pale. Mother and patient state she does this after every injection. Ice pack, cold water, and snack provided. Pt feet propped on chair. Pt. waited additional 15 minutes and states she was feeling better and ready to go. ER/UC precautions given.

Immediate sever pain at injection site, immediately followed by flushed face, racing heartbeat, tingling and inching of face, watering eyes, itchy throat that felt like it was closing in, lump in throat, difficulty breathing, unable to speak. Was able to speak after a couple minutes and the other symptoms started to gradually improve at that point. Most of the above symptoms subsided within around forty minutes. The lump in the throat remained for weeks eventually coming and going.

Client states she was feeling flushed and light-headed. EMT assessed and BP 104/56; 112/62, O2Sat 98%, HR 82 ACC check 132.

Pt rec'd Pfizer vaccine, completed 15 minute observation period without complaint, then returned to clinic around 10:30am reporting numbness in entire left arm. Pt states she was not able to move fingers in left arm. Upon initial evaluation by nurse left arm was pale and cold to the touch. Paleness and coldness resolved within a few minutes. There was slight weakness in left hand when patient was asked to squeeze nurses hands. Right Arm- b/p: 112/82, O2: 99%, heart rate: 91 BPM. Left Arm- b/p: 98/77, O2: 98%, BPM: 87. Pt was asked again to squeeze nurses hands, pt was able to squeeze slightly harder, however slight weakness compared to right arm was still noted. Pt verbalized improvement in feeling and movement, however states still did not have full feeling or movement back. Advised to stay with school nurse for 1 hour and re-evaluate weakness. If weakness persisted, advised to call physician. Upon f/up from school RN, pt remained in clinic until 11:40am when student stated she felt "much better" and strength of left hand was almost that of the right. School nurse states "vitals remained good".

immediately felt tingling in her arm. About 3 hours later, she started having side effects. As of this report, it has been 28 hours since she received the 2nd dose. Her side effects are at their worse right now. They include: injection site pain, severe lymph node pain in her armpit, feeling unwell, nausea, low grade fever under 101 degrees, muscle pain in arms and legs, chills and sweats, some joint pain. dizziness and weakness and labored breathing.

Patient complained of tingling/numbness in her hands. She became dizzy and needed to sit down. Symptoms progressed to what the nurse practitioner called "strokelike symptoms". She was conscious but could not respond to requests such as smile or say your name. Her blood pressure was high when taken. It was probably 30 minutes before the EMTs took her to the hospital.

The patient had a first time seizure a few minutes after having the vaccine; This is a spontaneous report from a contactable physician. A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot number: unknown), dose 1, intramuscularly on 25Apr2021 at 12:00 PM (at the age of 17-years-old) as a single dose for covid-19 immunisation. The patient's medical history was reported as none. Concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. No other medication was received within 2 weeks of the vaccination. On an unspecified date, the patient had a first time seizure a few minutes after having the vaccine. No therapeutic measures were taken as a result of the event. The event seizure did result in an emergency room/department or urgent care visit. Clinical outcome of the event first time seizure a few minutes after having the vaccine was resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Follow up attempts needed. Further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of seizure due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EEG and Head CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is 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.

Patient received shot and sat down in waiting area, after about 5 minutes started to feel lightheaded. Mom noticed she started shaking and then slumped over in chair, mom immediately grabbed hold of pt and stabilized her while calling out for help. Within a few seconds of me running over, pt was already awake and answering questions. She removed her face mask for better air circulation, asked for some water. Mom and I continued to hold pt until she felt ready to sit on her own accord. I asked mom if she wanted me to call, EMT, She declined. Pt has had this reaction before during blood draws. I asked them to wait at pharmacy for 30 minutes, periodically checking in. After 30 minutes mom and patient left pharmacyand she said she felt better

back pain; Left leg it keeps shaking alone; This is a spontaneous report from a contactable consumer (patient's mother). A 17-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Apr2021 09:30 at 17-year-old at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Reporter (caller) calling about her daughter. Asked if these were normal symptoms and should be worried. Caller reported that her daughter took her first vaccine dose at 0930 this morning. She reports that her daughter has never had a flu shot or vaccine of this kind. She reports that they waited the recommended 15 minutes after getting the vaccine. They got home and about 30 minutes after the vaccine (15Apr2021 10:00) her daughter started having back pain, slight back pain and her left leg it keeps shaking alone. She reports that when she stands up it shakes, and it comes and goes. She asks if this is normal or should she be concerned. Caller reports that she already spoke with safety, no reference number for that encounter. Caller reported that she wanted to end the call so she could call her doctor, she did not provide any additional information at this time. Outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

back started hurting; Left leg started shaking/When stands up, left leg keeps shaking; This is a spontaneous report from a contactable consumer or other non hcp(patient's Mother). A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration, administered in arm left on 15Apr2021 09:30 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced about 25 minutes after the vaccine, back started hurting and her left leg started shaking. When she stand up her left legs kept shaking, both on 15Apr2021 09:55 with outcome of unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Per parent report: Friday 4-30-21. Vaccine was given at 1500, at 1730 client displayed a rash on face and chest with extreme fatigue and chills. client took Benadryl. Saturday 5-1-21. Rash gone, but extreme fatigue, crushing pain on chest and pain in arm. continued to take Benadryl. Sunday 5-2-21. Extreme fatigue. continued to take Benadryl. Monday 5-3-21. Still extremely fatigue, DC'd Benadryl. Tuesday 5-4-21. some improvement in fatigue, but experienced some brain fog. Wednesday 5-5-21. attended school where she presented to the health office with medical concerns, see quote taken from an email with the school nurse: "She missed school on Monday and Tuesday due to the reaction. On Wednesday, she presented to the health office with extreme redness to the face and chest. Emergency services was called and she was transported to the hospital. Benadryl was given in the rig to which she responded to well." parent reported that ER doctor ran many tests but did not determine cause. Tuesday 5-11-21. saw Primary Care provider. client is still having significant "brain fog". she is very confused more than half the day, not remembering things or events, and will zone out or fall asleep in inappropriate places with out realizing it.

lIght headed, tingling of fingers, pale, diaphoretic, c/o tingling of the throat briefly. sips of gatorade. hypotensive: 80/40, 88; placed on stretcher semi-trendelenberg . BP: 120/P, No LOC.

Approximately 5 minutes after receiving vaccine client became quiet, clenching fists, and started crying. RN asked if she was okay, stated she was scared and that her arms felt weird and her chest was tight. RN asked some questions about her health history, she then offered a granola bar and water. Client drank some water, declined snack. Clients hand began to shake, RN offered to lay client on a cot but client declined. Her dad came to check on her, she broke down saying that her arms were numb and chest was tight. The 15 vaccine minute timer went off, client stood but legs were week. She sat down and then slid herself onto the floor. She at first went into a fetal position then laid out flat on the floor. Client began acting more panicked and frantic with short quick breaths and her hands appeared to be contracting some. Clinic team made the decision to call 911 and administer 0.50 mg epinephrine. Ambulance arrived quickly and client was taken to the Medical Center via ambulance.

Pfizer-BioNTech COVID-19 Vaccine EUA 101.9 F fever, severe right arm pain, not being able to move any part of body without my right shoulder hurting. Nausea, and mild fever for 24 hrs

school nurse filled out incident report per their policies. Incident highlights: "Pt got her mom?s attention and started to slump down, Mom and volunteer? Were able to assist her to the floor. No injuries during the episode, did not hit her head. She has twitching of her extremities which appeared to be a seizure. Mom stated there was no seizure history. EMS was called. Pt was alert when EMS arrived, they assessed her and it was determined that she should get an evaluation but EMS gave the option to transport themselves for follow up as she appeared stable." unable to contact mother, no additional information available.

She began experiencing regular arm numbess on the 3rd when she received the vaccine and it became fully developed by the next day. Over the next week or so the arm numbness became arm and hand numbness. The arm and numbness was intermittent, but the finger numbness has continued to persist. No treatments performed.

Patient got vaccinated at 4:03 p.m. At 4:10 p.m., patient had involuntary muscle movements and lost consciousness. Per parent, patient has history of panic attacks presenting like same symptoms observed., vital signs taken: BP 154/89 and 120/77, PR: 138; blood glucose: 124, EKG: sinus tachycardia; oxygen given at 4:26 p.m. and discontinued at 4:37p.m.; patient transported to hospital at 4:45 p.m.

Approx 2 minutes after receiving dose, patient became dizzy. Per pt's father, patient became stiff and tremored some. He lowered patient to the floor at which time there was LOC. Reaction clinician used smelling salts which brought patient to (pt was out for approx 1 min per staff) No loss of bowel/bladder. Pt was brought to med obs 1 via stretcher. Vitals taken, water and crackers given Pt feeling well and discharged to home with father and sister Vitals: 11:46 HR 82, Resp 16, BP 109/70, O2 100 12:02 HR 86, Rep 16 BP 102/70, O2 100

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: syncope/seizure like activity-Medium, Systemic: Hypotension-Medium, Additional Details: Patient experienced a syncope/fainting/hypotensive event immediately post vaccination that had characteristics of possible seizure activity. Patient regained consciousness after a few minutes and seemed disoriented but stable (still hypotensive). Transported to reading hospital (tower health) emergency room for evaluation

Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient was administered the Pfizer Covid Vaccine. A few minutes later, while watching her mom receive the vaccine she fainted. Patient was unresponsive for less than a minute. Upon regaining consciousness patient seemed to recover fully after resting and drinking some water.

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient waited 15 minutes after receiveing vaccine and felt fine, on the drive home the patient says she had some difficulty swallowing water that caused pain in her chest, then passed out momentarily, patient returned to the pharmacy where we checked her BP which was 107-67, patient mom was on the phone with her physician, monitored the patient for additional 10 minutes and patient said she felt well enough to return home. Gave patient chocolate bar since she had not eaten anything.

Tingling sensation in tongue and face. Reports swelling to left side of face with most evident swelling being to lips, cheek and eye lid. Denies any difficulty breathing or swallowing. All symptoms resolved within 24 hours, used OTC Benedryl

about 5 minutes after receiving injection, patient's BP dropped. She was sitting when it happened and we rushed over to put feet up. She was non-responsive for about a minute and then started to come back for syncope episode. Water was provided until ambulance arrived to check on patient.

Patient passed out as soon as she got to the waiting area post-vaccination. She was unresponsive for less than 15 seconds before waking up. She was breathing the whole time. We moved her to the ground to avoid any injury if she was to pass out again. We called paramedics who were at the pharmacy within 5 minutes. They checked vital signs and deemed she was ok. Patient walked out of the store on her own with her mother.

Patient was waiting in the waiting area for 6 minutes after getting the pfizer covid vaccine when she started to feel like she was going to faint. Her mom was with her. Her mom had already given her a snack when I was notified. Pt stated her vision was blurry and her hearing was "like she was in a tunnel". She was feeling cold and was feeling scared of that feeling. I asked if I could apply a cold pack and asked her to rest the back of her head against the wall and to close her eyes. I applied the cold pack to her forehead and observed her. She started to sweat and was calmer. She was feeling better and her hearing and vision was back to normal. I had her wait for a total of 30 minutes and had my technician stay with her at that time. She was feeling better and I asked her mom to hang on to her while walking to their car. I followed up with the patient 4 hours later and she was doing well. She said she was feeling well and her arm was not even sore just some fatigue.

- Pain/tenderness at injection sight for ~72hrs after vaccination -Small red bump (size of quart) at injection site( was gone after 72hrs.) ***- Abnormal vaginal bleeding, heavy bleeding occured, o clots within blood, cramping*** - General malaise

patient experience dizziness after receiving immunization and later fainted . Patient sat on ground before completely fainting to floor with help of mother and regained consciousness about 1 minute later. patient complained of muffled voices and trouble hearing for about 4 minutes, sweating , dizziness and shakiness. patient received water and Gatorade and cool cloth behind neck area. patient able to leave after approximately 20minutes in care of mother feeling better.

Shot given 11:58am. Within 2 minutes symptoms began with feeling symptoms: nauseous, hot forehead. I asked CVS for the nurse to help. By 12:01 patient was feeling extreme pain in her stomach, was sweating profusely, felt tingling sensation from head down to her stomach (including her arms and hands). Patient began screaming in pain. Her hands became rigid and paralyzed. She was completely unable to move both hands. Patient was able to feel if someone was touching her hands. Her face began tingling and feeling numb. Patient was lying down and almost passed our. I asked CVS to call 911 and if they should administer an epi pen. The epi pen was not administered. I (mother) went w/ child in the ambulance to Hospital. EMT monitored her vitals, which were normal. Patient was still unable to move her hands until after she was admitted to Hospital. Patient did not receive any IV r medication at Hospital. The sensation in her hands slowly came back with the numbness subsiding after about 1.5 hours in the ER. Patient was discharged at about 2:00pm on 5/16/2021.

Patient began to feel nauseous about 10 minutes after receiving her vaccine. She stated she was having pretty bad arm pain, and tingling in fingers. Patient was brought back to obsservation and stated that she was feeling better, but arm pain persisted. Upon assessment , Patient was vaccinated very close to acromion process. Patient remained seated for monitoring and after having vitals reassessed she was released home with her parent.

Fever; chills; severe arm pain; nausea; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8736 and expiration date was not reported), via an unspecified route of administration in right arm, on 11May2021 at 19:15 (at the age of 17 years old) as second dose, single for COVID-19 immunization at a pharmacy or drug store. Medical history was reported as none. The patient had no known allergies. Concomitant medications included sertraline hydrochloride (ZOLOFT), loratadine (CLARITIN) and birth control (unspecified). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0170 and expiration date was not reported), via an unspecified route of administration in right arm, on 17Apr2021 at 13:00 (at the age of 17 years old) as first dose, single for COVID-19 immunization. The patient was not pregnant and 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 never tested for COVID-19. The patient experienced fever, chills, severe arm pain and nausea on 12May2021 at 05:00. No treatment was given to the patient for these events. The outcome of these events was recovering at the time of report. No follow up attempts are needed. No further information is expected.

While waiting for 15 mins monitoring after getting Pfizer covid vaccine, she fainted and fell off the chair. She fell on the ground and hit her head. Nurse and pharmacy staff rushed to her aid. She appeared to have convulsions for about a couple seconds but regained conciousness right away. We checked vital signs : low blood pressure but high heart rate, oxygen level was good. We placed ice pack on her head where said was hurting. She and her mother refused to call 911. She felt better, however we recommended her mom to take her to urgent care for further evaluations

Attendee developed tingling in the left arm and felt slightly dizzy 5 minutes after receiving the vaccination. Assisted to a cot and her legs were elevated. HR 69 BP 118/62 RR 18 O2Sat 99%. One minute later reported that her left leg was also tingly. One minute later she was given some water and she said that she was feeling better. She was assisted to a chair and her vital signs were Hr 80 BP 120/60 O2Sat 100%. 15 minutes after receiving the vaccine she denied symptoms and was discharged to home with her mother. They were both educated on adverse reactions and she was advised to rest and drink plenty of water. Attendee walked out of the clinic independently with her mother at 5:15 pm.

Systemic: Fainting / Unresponsive-Medium, Additional Details: Pt fainted after vaccine, hit head on nearby object. sustained approx 2 cm laceration to scalp with moderate bleeding. applied saline wound wash and gauze. bleeding stopped. VS normal BP110/72, P90,RR14,O297%RA. Pt revived after1-2 min. She sat up and was able to walk. Mom at work. Mom called neighbor to pick up pt. Mom agreed to have FM take pt to ER/urgent care.

Patient's parent reported that patient started developing a bruise after her 2nd shot of the pfizer vaccine. Her arm was hurting more from the 2nd dose. After checking in with the parent 2 days after the vaccine, parent reported arm improving. Patient's parent denies use of NSAIDs prior to vaccination.

Systemic: Chills-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: patient was feeling cold, hot, shaky, weak, a heavy chest feeling, numbness in extremities a few minutes after her vaccine. Her pulse went from 80, 99, to 110 after 3 readings. Her BP was normal. Her brother said she just had a unspecified chest procedure. It wans't noted on her intake. She wasn't feeling after lying down for 30 minutes with legs propped up and wanted to paramedics to come. They sent her home after another 30 min. She doing well before she left.She went to school day after.

After receiving dose, pt experienced Vasovagal response which she never had before when receiving a shot. When they woke her she had a lot of jerky arm movement. About half an hour to 1hr after injection she said she had an odd taste in her mouth and her tongue was numb. Her chest felt tight but was not wheezing. About an hour later when she was home (~6pm) gave her "click it albuterol" and it relieved the tightness in the chest. She had pain in her left breast area. Around 6:30pm she continued to comment about her tongue being numb and pain in her breasts. She fell asleep right away and the next afternoon around 1pm she had a temperature of 99F. After motrin the temperature went back to normal and she felt better. No further chest tightness after that and she is feeling normal.

Observed pt. sitting in a wheel chair with mom and EMT. Pt. awake, alert, verbal, complaining of feeling flush after taking 1st dose of Pfizer vaccine@12:43pm. Vitals taken by site EMT. Vitals within normal range. BP 114/72, O2Sat 100%. 12:55 pt. stated, "I'm feeling better now." Pt. observed by staff for 30 min. before leaving to go home. 1:20pm pt. left vaccine site to go home with mom with no signs of acute distress. Patient and parent educated by staff about Pfizer vaccine. Verbalized understanding.

Patient was extremely nervous prior to vaccine. Got shot, walked out of room to waiting area. about 2-3 minutes post vaccine, realized did not feel well. Passed out. Mom said patient felt a touch rigid and twitched a couple times, then came too. Did hit head when patient fell to floor, although was not a major hit. Patient was worked up after coming to.

The day after the vaccine, she had an episode of syncope while in the bathroom. She does not remember the event, but was at a friend's house and was found in the bathroom after they heard a bang and was noted to be shaking. She then passed out again and continued shaking. She texted her mom and was given a cold rag on her forehead but has no recollection of any of that. Afterwards, she returned to normal.

Patient felt light-headed and was not responding to questions. She was lowered to the ground by the pharmacist and technician. She became responsive and was confused. EMS was contacted. Blood pressure measured 110/68. Patient remained on the floor until EMS arrived and took over care.

PATEINT RECEIVED INJECTION AND ABOUT 6 MIN LATER SHE FAINTED AND HAD A 5 SEC SEIZURE. WOKE UP ON HER OWN

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

She developed 3 isolated episodes of 30-90 minutes where she has tingling and burning in bilateral hands, worse in right, and worst in the thumb. No symptoms in feet.

On 5/19 she got her first Covid Vacc (Pfizer). The following day she had mild fatigue and chills, but it did not interfere with activity. Then 5/21 PM she noted a discomfort in her chest. By yesterday she had marked chills, felt burning hot, c/o a mild ST and mild nausea and abd pain. Her chest discomfort (poorly characterized in location) worsened and she was brought to ER with concerns that she had another effusion. At the hospital, she had 24 hours of fever and hypotension.

Foggy head; Sore arm; This is a spontaneous report from a contactable consumer (reporting on herself). A 17-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0150 and Expiration was not reported) via an unspecified route of administration in Arm Left on 08Apr2021 13:00, as 1st dose, single for COVID-19 immunization. Medical history included seasonal allergy, hypersensitivity, food, food allergy all from an unknown date and unknown if ongoing. Concomitant medication(s) included cetirizine hydrochloride (ZYRTEC ALLERGY); mometasone furoate (ASMANEX) both taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. It was reported that after the first dose of the vaccine she had a foggy head, sore arm. The outcome of the events was recovered on an unspecified date. No follow-up attempts are needed. No further information is expected.

Less than 1 minute after received the shot, patient became clammy and pale while sitting in chair. Her eyes rolled back in her head and her body went slack. Myself (parent) and the nurse who had given the shot braced her on either side while she appeared to fade in and out of consciousness for several minutes (she seemed to occasionally interact with us, mumbling responses to 'yes' or 'no' questions). The nurse did not want to lower her to the floor, but wanted to keep her propped on the chair. Her head kept rolling to the side. At one point, she began to jerk rhythmically. Just as I was about to bring this to the attention of the nurse, the patient returned to consciousness. Patient was moved to a rolling recliner chair and taken to a recovery area where I (parent) did not see her for another 30 minutes as I was receiving my own shot. The chair she had sat in was wet, but it was assumed this was due to sweat (patient had sweated profusely). On the way out of the clinic, noticing a wet stain on the back side of patient's pants, I asked if she had wet her pants (quietly) two separate times. Patient denied it both times. However, upon returning home, patient confirmed that she had wet her pants. Patient was monitored during the evening for similar adverse events ; none noted. Patient ate lunch approximately 1 hour before receiving shot and was given crackers while at clinic. Patient is a well-hydrated individual, and also drank water while on-site. No fever either before or after shot. A slightly elevated BP the next day (135/83). However, patient complained of headache, fatigue, and pain at injection location; elevated BP may be related to headache and/or ordeal from day of the shot.

Site: Pain at Injection Site-Medium, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: BP 103/65 Pulse 62-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Additional Details: EMS was called but she went home with her mother and slept the rest of the day, she had a sore arm on Tuesday but was otherwise fine per mom.

Site: Pain at Injection Site-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Fever-Medium, Systemic: JAW AND THROAT PAIN-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium

1-20 minute bouts where tics appear "seizure-like," repetitive; many persistent involuntary tics including coprolalia and violent motor tics; had one minor chronic tic before vaccination/many persistent involuntary tics including coprolalia and violent motor tics/Noticed increase in severity and frequency; many persistent involuntary tics including coprolalia and violent motor tics; Tics often include hitting oneself and banging head against things/violent; significant distress; persistent headache; chronic fatigue/sleepiness; lightheadedness; decrease in appetite; feeling of pressure in certain locations inside the head; intermittent earaches in both ears; persistent feeling of brain being "on fire," and "like a parasite has invaded the brain."; chronic fatigue/sleepiness; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female non-pregnant patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration, administered in Arm Right on 26Mar2021 as first single dose and on 16Apr2021 as second single dose (Batch/Lot number was not reported) for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Other. Medical history included asthma, allergy to nuts, penicillin and ongoing chronic tic. No other vaccines within 4 weeks prior to the COVID vaccine. No covid prior vaccination. Concomitant medications included duloxetine; atomoxetine; hydroxyzine; loratadine. The patient previously took amoxicillin and experienced allergies. The patient experienced neurological symptoms included many persistent involuntary tics including coprolalia and violent motor tics. Smaller tics can be suppressed for minimal amounts of time before uncontrolled, violent/loud tics occur in rapid succession. Tics often include hitting oneself and banging head against things. The patient had one minor chronic tic before vaccination. Initial onset occurred nine days after vaccination from 04Apr2021. Noticed increase in severity and frequency approximately nine days after second dose of Pfizer vaccine. Symptoms cause significant distress. Additional symptoms included: persistent headache (from date of first vaccine to present); chronic fatigue/sleepiness; light-headedness; decrease in appetite; feeling of pressure in certain locations inside the head not related to the skull or skin; intermittent earaches in both ears; persistent feeling of brain being "on fire" and "like a parasite had invaded the brain, start date was 26Mar2021; and "1- 20 minute bouts where tics appear "seizure-like," repetitive, violent, and controlling". The patient underwent lab tests and procedures which included Spit test: negative (other) on 26Mar2021 and Apr2021, Covid test: negative on 26Mar2021 and on Apr2021. The events resulted in: Doctor or other healthcare professional office/clinic visit. No treatment received; the patient was not recovered. Information on lot/batch number has been request.

Patient upon seated for the 15 minutes post-vaccination fainted. When she was coming through, she started shaking as if she was having a seizure. When I reached the patient, she was shaking and then came through and stopped shaking. Patient was still pale, sweating, and didn't feel okay. 911 was already called once the patient was shaking. As I am checking in on the patient, the mom discloses that she has fainted at least twice before and when she comes through she shakes but it is not seizures. However, during the screening process, patient and mom stated the patient never had any problems when getting vaccinated. I got her BP checked and it was 102/61 and HR of 92. We had the patient sit still and drink water. When EMS arrived within 5-10 mins, they took her vitals and it was 112/70s and HR of 84 with 98% O2 sat. Patient and mom decided to be taken to the ED to make sure she is okay.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient recovered in about 20 to 25 minutes.

She had been bleeding since May 2. We took her to Hospital Pediatric ER on Thursday, the ambulance took her in because she had a seizure on Wednesday (the Ambulance - they stabilized her that day and took her vitals and was sure she was okay - they knew we had an appt to go in the next day at 10:00 am for tests (previously scheduled); Thursday morning she had another seizure - we gave her seizure meds and she came out that - she ate breakfast after and then took her regular meds and the next thing we know ,50 minutes later, her head drop forward and her arms go completely limp and there was no response. She was breathing but she was out. I called the ambulance. And they took her in to ER. What they put in the paperwork was that she had a seizure and they wrote that she had had syncope episode - it took 20 minutes to come out of it. Which she has never had anything like that. We were in the ER for 7 hours. Was admitted to Hospital -from 24th -28th.

She fainted and collapsed about 18 hours after receiving the second dose (6:30 am). She was confused for about an hour after she fainted. She was on ibuprofen (400 mg taken at 5:30 am). Other than weakness, headache, and fever, she has had no other adverse reactions so far besides the single fainting episode.

Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Medium

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Headache-Mild, Systemic: Shakiness-Medium, Systemic: Weakness-Severe, Additional Details: Patient was given Pfizer vaccine, told to remain in waiting area for 15 minutes. Immediately after shot she seemed and and was conversing with me normally. 2-3 minutes later her dad noticed that she was tipping over and called for help. When I rushed over, pt was moved to the floor, close to passing out, very weak and shaky. We called 911 - she was responsive. she laid on the floor until ems arrived at which point they took over and took patient to get further checked out.

PATIENT FAINTED IMMEDIATELY AFTER VACCINE ADMINISTRATION. PATIENT DID NOT INJURE HERSELF, WAS CAUGHT IN MOM'S ARMS. PATIENT WAS EXTREMELY WARM AND CLAMMY AND SHAKY. SHE KEPT SEATED, FAN BLOWING, PROVIDED WITH GATORADE AND FELT NORMAL AFTER 10 MINUTES. PATIENT ADMITTED TO NOT EATING PRIOR TO VACCINE.

The patient felt dizzy and weak then fainted while her mom was holding her . Her mom gradually led her to the floor from a sitting position. She felt nauseous and dizzy. I laid her on floor with her feet elevated on a chair with her head to the side so she would not aspirate if she vomitted.. She felt better after a while and wanted to sit. When she was sitting in the armchair she vomitted and said she felt worse, so I then called 911. They evaluated her and her blood pressure was very low and they gave her iv fluids and took her to the emergency room

Within 2-3 minutes she felt sick and dizzy, then became clammy and unresponsive. She was moved to the floor and regained consciousness within 1 minute. Was given water and a snack and felt better. She left happy and healthy, she does not like needles/vaccination - so she had anxiety from the vaccine.

Right sided facial numbness, worse in the right upper lip and right gumline. No facial paralysis or drooping. Symptoms started 3 days after her first vaccine dose.

Pfizer-BioNTech COVID-19 Vaccine EUA Right side of the face has different levels of numbness. On a scale of 1-10, the numbness varies from 2-4 at different parts of the right side of the face.

Patient was very anxious and breathing heavy. About 5 minutes after the vaccination they started to hyperventilate and ended up throwing up. After letting them sit and relax for 5 minutes, the patient then had to throw up again and told their mother they felt like they were going to faint. Mother and myself stood by, while patient did end up fainting. We slowly lowered them to the ground, and on the way down their body got stiff and patient had uncontrollable movements and was hardly responsive. Mother and myself finally got her safely to the floor as they came to and was responding to verbal ques and stimulation from mother. Mother went to get water and i stayed with the patient to ensure no other things happen. Patient ended up doing alright after relaxing for a few and then i walked them and mother to their car and ensured they were feeling good enough to go home. I then advised the mother to seek medical attention.

First on Saturday May 22 had sore arm, then pain that thought was possibly heartburn/indigestion, fever over 100. Took acetaminophen and tried Tums. Then on Sunday May 23 chest pain that didn't feel quite like indigestion and fever over 100. Continued acetaminophen and Tums. Monday May 24 felt like heart was fast, hot flash type feeling like could faint and some light headedness/off feeling, continued chest pain. Pediatrician prescribed omeprazole to see if helped, did EKG. Checked in on Wed May 26, no change except no fever and light headedness improving. Referred to cardiology.

Patient reports muscle aches and significant fatigue for 3 weeks following the second vaccination. Initially just with sore arm, then a few day later developed the fatigue

2 hrs after vaccine started having chills and fever by Thursday April 22 her legs starting hurting pain moved from toes and all the way up to back then it stated moving to her hands and fingers. got admitted to hospital because they wanted to make sure she wasn't having syptoms of MS they did blood work, MRI, covid test, xrays, lupus test, physical therapy, nerves test, lime disease test and everything came back fine by sunday they sent her home and she started having stomach pains and had to go back to Dr. she has experience hair loss and it started her menstrual cycle early. was having alot of fatigue and its's been a month and she is now finally started to feel a little better but Dr dont know how long it will be before she is fully herself

Patient developed warmth, clamminess, nausea and lightheadedness shortly after her shot. She admitted to near syncope, but there was no LOC. No tunnel vision. Symptoms resolved on their own. VVS throughout. No orthostasis.

After receiving the shot she experienced the "Covid's bullseye", a circle on her arm at the site of administration; tired; her arm was a little sore; the girl got a rash of the diameter of a lemon on her inner thigh, next day on both legs; This is a spontaneous report from a non-contactable consumer (patient grandmother). A 17-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 20May2021 (age at the time of vaccination 17-year-old) as 2nd dose, single for covid-19 immunisation. Medical history included allergic to sulfa drugs. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient concomitant medications were not reported. It was reported that after receiving the shot patient experienced after receiving the shot she experienced the "covids bullseye", a circle on her arm at the site of administration, tired, her arm was a little sore. On Saturday, the patient got a rash of the diameter of a lemon on her inner thigh, so the reporter told her to only use sunblock, next day (Sunday) both legs were covered in a rash. Reporter looked on the Pfizer's website and saw that rash was reported in 0.001 percent of people who had the vaccine. Also, on Sunday, reporter took the patient to the doctor but he was not there, so she called a service (reporter did not elaborate on this) and a person told them that the rash could be from a serious disease called "petechiae rash" and told them to take patient to ER where she got the shot. Once in the ER, they told them that it was not the serious condition "petechiae rash" but that it was a "rash" and that they had never heard before of anybody experiencing a "rash" after the administration of the vaccine. Reporter wanted to know if "rash" has been reported as an adverse event of the Pfizer's COVID-19 vaccine, how long after the administration of the vaccine appears and how long it lasts. She would also like to know if we can call the facility to let them know that "rash" was reported as a side effect of the vaccine, since she was upset because she does not understand how someone in the ER does not know that "rash" was an adverse reaction and they had them thinking for a couple of hours that patient could be suffering of a serious disease. Reporter does not want someone else to go through this situation. Reporter mentioned that in the ER told them to wait 2 days and give Benadryl to patient, so she wanted to confirm if this was the right treatment for patient and if she should wait those 2 days to see if the rash was gone before she calls the doctor. Reporter wanted to know how long after the administration of the vaccine the rash appears and how long the rash would last. The outcome of the event was unknown No follow-up attempts are possible. No further information is expected.

Patient experiences blurred vision, hot, dizziness at the observation area after the vaccination. Her pupils were dilated and her lip was pale. She felt better after zip of water and felt normal after few minutes.

on 05/28/2021 at 0815 patient experienced tonic-clonic grand mal seizure lasting approximately 1 minute. A second tonic-clonic grand mal seizure lasting approx 1 minute was also experienced and witnessed in pt's home on 06/02/2021. Second grand mal resulted in hospitalization of pt overnight and adjustment of AED's was made. Prior to these seizures pt had been seizure free for 3 months.

Patient presented for second vocid-19 vaccine. after receiving vaccine, mother reported that patient had chest pain and grabbed chest and was experiencing leg numbness. Patient's parent reports that prior to receiving vaccine, aptietn has had history of one sided flank pain and tardive dsykinesia induced by medication. After vaccine mother reports patient is experiencing flank pain on opposite side. Mother wanting patient to be seen by provider so patient taken to hospital ED

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: Patient received 1st dose of pfizer vaccine. Less than 1 minute later patients mother alerted us that the patient had lost consciousness. She was immediately laid down and gained consciousness within 10 seconds. She stated feeling lightheaded, sweaty, looked pale and felt like she was in a trance. 1st BP reading (111/67), 2nd BP reading done 15 min later (106/59 & HR 65). After 30 min of monitoring patient was able to leave.

Patient tolerated administration of vaccine well and was monitored in observation room by two RN's for 15 minutes and patient felt fine to leave. Patient left room and came back shortly after feeling very fatigued, nausea, and pain in both calf's- L leg worse than R , with red toes. Bilateral pedal pulses +2. Vitals: BP 130/67 HR 92 Sat 95% on room air. Gatorade given to sip on. RRT was ultimately called and patient was taken to ED.

After receiving the vaccine we moved to waiting area. Within minutes she told me she was not feeling well she began sweating profusely, her skin became pale and clammy, her eyes rolled back she lost consciousness and began convulsing. She came to and said she could not hear well. She was taken to ED for observation and testing.

Patient told us that she has passed out and vomited after receiving vaccines in the past. After getting the vaccine, she didn't feel well. We monitored her in the vaccine room for about 5 minutes. She had a drink of water, then when she was ready, her family helped her into the lobby I returned to the pharmacy, and continued to watch her. The patient's mom came to the window and said patient had fainted. I went to her, and said we need to lower her to the floor. At that point, mom said patient was not breathing I quickly lowered her to the floor, while dad supported her head. I didn't have time to verify that she wasn't breathing, because as soon as she touched the floor, she began convulsing, then sat up and w was immediately awake. She sat up, and we explained that she had passed out and I had her lie down. I stayed with her for a few minutes, asking if they wanted an ambulance (which mom and dad declined) while making sure she was ok. She was just resting at this point, so I returned to the pharmacy, and ask them to let me know if anything changed I continued to watch her from the pharmacy window, and the patient said she was nauseated. We gave mom a bag, and patient vomited in the bag. After a couple more minutes, she seemed to be recovering, and mom and dad helped her out of the store. I followed up with mom at 4:15pm, and mom said patient was still nauseated and had vomited a couple more times. I followed up one last time at 4:45pm, and patient was feeling a bit better, but mom was going to keep an eye on her I recommended that mom take her to a doctor to be evaluated, but mom said she would just keep an eye on her through the night. I told mom that I would follow up again in the morning.

Systemic: Abdominal Pain-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Mild, Systemic: Vomiting-Medium, Systemic: Weakness-Medium, Additional Details: Following 2nd covid-19 vaccination, patient became very lightheaded and fainted while seated in chair. After coming to again, she was very pale, having a hard time controlling her breathing and stated she couldnt see. 911 was called and upon the paramedics arriving, blood pressures both sitting and standing were taken, as well as a blood glucose reading. The patients blood pressure was low but stable, and her blood glucose reading was normal. Patient walked out of store with paramedics and Mom.

5 mins after administering vaccine pt had difficulty breathing, chills, sweats, blurry vision, nausea, temp was 95, numbness in hands, and ringing ears. Possibly a seizure her mom said her arms were shaking a little I didn?t see anything

Dose 1, headache. DOSE 2 Five hours later severe headache, extensive heat being generated from head, body not, then followed by high fever 101.8 with heart rate going up to 155, followed by twelve hour later breaking fever. Extensive headache continues. At 24 hour mark hives on face under eyes, big welts and red. Continued migraine. This is not safe!!!!!! I will sue the agency for this product, emergence use yet mandate by colleges and employers. SOMEONE NEEDS TO PAY FOR THIS!!!!! I WILL CONTACT A LAWYER.

went to urgent care c/o bilateral arm "muscle twitching and neck. Urgent care transferred her to ER. ARNP reports 17 YOF who comes to ER after 4 hours of receiving her second vaccine shot for covid-19 , presenting upper extremity fasciculation. TOE: 1800 TOA; 2200 To PE bilateral fasciculation in arms and neck. NO SOB , no difficulty to swallow or talk. |BP=122/74, HR=120.0 bpm, Temp=96.62 F Oral, Resp Rate=20.0 bpm, Pulse Ox=99.0 on Room Air Patient discharged at 0325

The day after the second dose of the vaccine she started to have pains in all of her joints. Her chest felt painful and even her finger joints. It was a constant pain that got worse with movement. The pain scale without the medication was an 8 but with the medication a 5 on the scale of 1-10. Ibuprofen and Hydrocodone helped control the pain but it did not make it totally go away. The joint pain lasted for three weeks to date but the chest pain has improved. Heat pads also help. She has never experienced these symptoms before. There were similar symptoms after the first vaccine but it is much more intense after the second dose. It has been consistent since the second dose of the vaccine but the medication and heat application does seem to help. Hospital after the first dose for chest pain.

Patient exhibited a seizure like episode that lasted approximately 15 seconds. Patient was placed on the ground in a supine position where she regained consciousness. 911 was notified at 1401. Patient with clammy and pale skin. At 1405 BP was 122/69, HR 100, RR 18. Attempted to put patient in chair, once in chair she began to feel dizzy and was placed back on the ground in a supine position.. At 1410 BP was 122/58, RR 20. Blood sugar at 1413 was 92. Patient was able to sit up on the ground and was given juice and crackers. Patient continued to have pale and clammy skin. Alert and oriented x 3. EMS arrived and patient transported to hospital.

Day after vaccination, patient reports intermittent fevers (Tmax 104F), neck pain that radiates down her back, and is interacting a lot less than usual, The following day, she was unable to walk at all and required being carried to use the bathroom. Patient denies and fevers, cough, gi distress. She does states that she is not feeling short of breath at this time, but is having weakness in her hands as well as her legs. Additionally patient states that she has been having chest pain today that comes and goes. On neuro exam Mental status: Appears to be distressed due to photophobia. Lethargy, however easily arousable, able to have a conversation, attention intact to spelling "globe" backwards, intact to high and low frequency words. Able to name and repeat. Speech: Mild dysphonia Cranial Nerves: II: Pupils equal, round reactive III/IV/VI: EOMI. Pupils move in all four cardinal directions VII: Face symmetric when talking, however limited effort to excursion on command VIII: Responds to voice IX/X: Voice normal XI: Turns head side-to-side XII: Tongue midline Motor: Normal bulk and tone. Resistance met to passive motion of BLE RUE/LUE: shoulder abduction 4/5, elbow flexion/extension 5/5, wrist flexion/extension with give-way weakness up to 4+/5, finger flexor 4/4 RLE/LLE: On command, 0/5 -however able to support her legs in a flexed position bilaterally, with encouragement 5/5 on dorsiflexion. Able to support her weight on her legs, however does not walk slowly sits back on the bed. Sensory: Intact to light touch, proprioception intact Coordination: No obvious dysmetria on FNF testing DTR: 2+ brachioradialis, bicep, patellar, ankle b/l. Plantars mute. Absent pathological reflexes: Hoffman, cross adductor

Patient received Pfizer vaccines on 5/7/21 and 5/28/21. On June 1, 2021, she started to notice LEFT arm weakness while texting. She presented to the emergency room June 2 2021 with LEFT arm and leg weakness, difficulty walking, and slurred speech. Over the next few days, sx progressed to dense hemiplegia of the LEFT arm > leg.

received the first dose of the Pfizer COVID-19 vaccine and also recently started taking Depo-Provera. After receiving the first dose of the Pfizer COVID-19 vaccine her daughter developed a blood clot; tired and frail; feels lost and light headed; cramping pain; This is a spontaneous report from a contactable consumer (Patient's mother). A 17-year-old female patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Right on 03May2021 15:00 (Batch/Lot number was not reported) as 1ST DOSE SINGLE for covid-19 immunization and medroxyprogesterone acetate (DEPO-PROVERA), route of administration, start and stop date, batch/lot number and dose were not reported for contraception. The patient's medical history and concomitant medications were not reported. The patient experienced received the first dose of the pfizer covid-19 vaccine and also recently started taking depo-provera. after receiving the first dose of the pfizer covid-19 vaccine her daughter developed a blood clot, tired and frail, feels lost and light headed and had cramping pain all on unspecified dates. It was reported that after receiving the first dose of the Pfizer COVID-19 vaccine her daughter developed a blood clot. Her daughter, who is currently on Depo Provera got her first dose of the Covid 19 vaccine. The daughter has been experiencing blood clotting and would like to further document this experience. Is also seeking medical advice to inform her daughter. Her daughter Has been on Depo Provera for 4 to 5 months. Since she had the Covid vaccine, she has been having bad blood clotting and has been having a continuous period. When she got the shot, she has been getting blood clots straight for three weeks. Patient is Tired and frail: She is a waitress, so all of this has made it hard. It started right when she got the shot and has pretty much stayed the same. She will feel like she is lost when she wakes up and is light headed from the loss of blood. It occurs when she is doing activities, like working. Patient took some Midol one day for cramping pain but it barely did anything. The action taken for medroxyprogesterone acetate was unknown. Outcome of tired and frail was not recovered. Outcome of all the other events was unknown. Information on Lot/Batch number was not available. Additional information has been requested.

Arm hurt; Tired; Rash all over both of her legs; This is a spontaneous report from a contactable consumer (patient's grandparent). A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration in the left arm on 20May2021 16:30 (Batch/Lot number was not reported), at the age of 17-years-old as 2nd dose, single for COVID-19 immunization. Medical history included allergic reaction of Sulphur drugs. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient had her second Pfizer shot on Thursday 20May2021 at 4:30, the only side effect she seem to have, was her arm hurt and she was tired and the reporter don't know, her aunt was a pharmacist and said that circle that she developed at the site of the shot, and called it as a Covid bullseye. On Saturday 22May2021, the patient had rash about the size of a diameter of a lemon on the inside of her leg, the reporter didn't think anything out she has been out in the sun so they just observed until Sunday, 23May2021 she got the rash all over both of her leg. Previously she was has an allergic reaction of Sulphur drugs so with this rash all over both of her legs what they did was they called her doctors office Sunday and they haven't answering. They have a service that you can call about medical things, person that answers, there was a woman and said she know nothing about a rash they thought it would may be side effect from Pfizer because the reporter looked on the website and in the website rash was listed, usually rare. The patient does not have anaphylactic shock any of that there was a rash they think it was 0.001 they tried to explain this to the woman and she insisted it was something called Petechiae rash, which is a serious rash. She insisted not take the patient to the urgent care, she said they should take her to the ER and not urgent care, they took her to the ER they said they didn't know, it was definitely not the Petechiae rash which was a released that's a serious problem. They said it was okay to just give her Benadryl which they could have decided to give at home, but they didn't know if Benadryl was okay to take if the patient took the COVID vaccine. They were advised to bring her back to the doctor in 2 days if it doesn't go away. ER said they had never seen anyone who had a rash, they don't know any rash. The reporter tried to tell that it's on the website it's on a Pfizer website and thought she was thinking she should alert them about this because this was a lot of lot of gut ranching and anxiety that if this person calling from the doctor saying that the rash was a Petechiae rash which was a serious blood disease. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: PT fainted several minutes after vaccination and fell out of the chair. Pt regained conciousness immediatly after fall but suffered minor injuries to the face and knee (rug burn). She felt nauseous, light headed, dizzy and was pale and had cold clammy skin. She regained her complexion after 15 minutes and rested for 45 minutes before leaving.

Pt reported that she felt dizzy and sleepy and endorsing weakness after covid vaccine. Pt was sent to the emergency department. Pt felt better after eating and was able to ambulate with no dizziness or weakness. Pt stated she "feels better" and left.

17 y/o F with a hx of asthma and GBS presents to the ED for weakness and difficulty moving beginning on 6/7/2021. Pt got her second COVID-19 vaccination on 6/6/2021 and has had an intermittent fever since (Tmax 104 F). Pt has been taking Motrin and Tylenol; last dose was at 07:00 today. Note, pt only had a fever after the first COVID-19 vaccination. Mother reports pt's baseline includes normal range of motion. However, in 2016 pt was diagnosed with GBS and was hospitalized for temporary paralysis for 1 month. Pt was also diagnosed with mononucleosis in 2017. Mother reports pt has also had neck pain that radiates down her back, and is interacting a lot less than usual. Pt denies any confusion, but admits to a mild headache. Differential Diagnosis: Guillain-Barre Syndrome, status post vaccine, tick paralysis, thyrotoxicosis, consider meningitis and other infectious causes like UTI, URI. Patient admitted to hospital.

Angioedema. Pt with facial swelling and rash. Swelling was mainly to lower part of face, including lips. Also reports numbness of face and numbness to a section of her R hand.

Per the caregiver, the patient developed dizziness after the 15 minute post COVID vaccine observation. Caregiver advised the patient to tell the nurse about it but patient stated that she wants to just leave. While walking to the car, the patient was still conversant and still dizzy. In the car, the patient was noted to be none conversant. Caregivers asked for assistance. Code Assist was called at 3:50 PM. MD and nurses arrived, VS were within normal, patient was just having blank stares and not responsive to verbal commands. 911 was called. EMS arrived and took over. At 4:08 PM, the patient got out of the car and transferred to the gurney. Patient was awake and still not responding to questions.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: PT fainted and fell out of the chair several minutes after administration of vaccine. Pt regained conciousness immediately after fall. Suffered minor injuries to the face and knee (rug burn) and felt dizzy, lightheaded, and nauseas for at least 15 minutes before regaining complexion. PT discloses after incident that she has issues fainting with blood draw and some injections. PT rested for 45 minutes in the store before leaving. Vitals reviewed are normal before leaving the store

17 y/o F with a hx of asthma presents to the ED for weakness and difficulty moving beginning on 6/7/2021. Pt got her second COVID-19 vaccination on 6/6/2021 and has had an intermittent fever since (Tmax 104 F). Workup including brain and spine MRI, and Lumbar puncture with CSF studies all normal. Of note patient had Guillan Barre Syndrome in 2016 which required 1 month of hospitalization.

After 2 hours of receiving the second vaccine, Patient started to experience involuntary movement at the left arm where she received the injection. It escalated that either the left arm, the right arm, or the neck was involved in the involuntary movements. I have video evidence available upon request. Upon arrival at the ER, various visual tests were performed and after 2 hours and after consulting a pediatric neurosurgeon, Benadryl 20 mg was provided. The symptoms slowly subsided but repeated within 24 hours and 40 hours. A CT scan, full blood, and urine analysis were completed and everything came back with normal results. We visited her pediatrician on Tuesday and a Pediatric Neurologist on Wednesday following the incident, where an EEG was made.

This was my daughters second shot. She experienced 90 minutes of uncontrollable shaking around midnight with whole body. Also, with headache and overall body aches and hot and cold spells.

Within seconds of receiving the 2nd PFizer covid vaccine, the patient slumped over sideways in her chair, losing consciousness. Next, her arms went straight and locked, both her hands locked in a curled position. I looked up at her face and her eyes had rolled back into her head and her body started jerking. Shortly after, she sat upright in chair with her eyes open and didn't realize what had happened. She said a tingling sensation had gone up her arm. She was extremely pale. My tech called 911. I took her blood pressure which was 88/46 with a pulse of 45. As we were waiting for paramedics, she said she was sweaty and started getting abdominal cramps. Paramedics arrived and took over her care.

Patient had gotten dose 1 of the Pfizer COVID vaccine on 5/27/21 and was accidentally scheduled by pharmacy staff for 2nd dose on 6/10/21. This was overlooked upon administration of second dose and patient received 2nd dose at 2 week interval instead of 3 week interval. Spoke with patient on 6/11/21 and she has not experienced any adverse effects other than "muscle spasms" in the vaccinated arm.

Patient had vaccine administered at 10:11AM. Patient returned to pharmacy with parent (mom) visibly weak and incoherent approximately 15 minutes after receiving vaccine. Patient was moved to pharmacy waiting room and blood pressure was immediately taken. Patient did not report difficulty breathing, swelling of lips, tongue or throat. Just that she was very dizzy and could not hear. Blood pressure 75/30, Heart Rate 44 bpm. with first reading. Second reading 75/30, Heart Rate 50 bpm. EMS was activated immediately and arrived approximately 5-7 minutes. Patient was provided with bottle of water and remained under pharmacist observation until EMS arrived. Patient did not lose consciousness and reported feeling better after sitting down. EMS reported her blood pressure was 80/54 and patient was taken to the hospital for fluids and further observation.

Approximately a minute and a half after the show was administered my daughter passed out and started convulsing for approximately 2 minutes.

seizure like event; Dizzy; Her head, neck, back and legs stiffened up/her entire body stiffened; This is a spontaneous report from a contactable pharmacist. A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 27May2021 (at 17-year-old) (Batch/Lot number was not reported) at 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On Thursday 27May2021, a few minutes after the shot she started having a very small episode of seizure that lasted for maybe 1 or 2 seconds then after that she felt a little dizzy after that and then she was fine. It's described as a very brief seizure like event. Her head, neck, back and legs stiffened up and if she would have been sitting on a stool she probably would have fallen out of her seat. She was sitting in a chair that had a back to it, though, so she did not fall out of the chair. She did not every lose consciousness and he stated that this was not a syncopal event. He reported that it happened very quickly and multiple people did not even notice that it happened. Her entire body stiffened, however, "she stayed with us throughout the entire event and it only lasted a couple of seconds before her body went back to normal position, The reporter offered to call an ambulance the day of the event but the mother of the patient declined. The mother was advised to have her daughter seen by a medical provider for follow up care given the event. The mother also told the pharmacist that the patient would not be receiving the second dose and the pharmacist encouraged her to have this conversation and make that decision with the pediatrician or medical provider. Caller stated that he personally gave about 100 doses of the Pfizer BioNTech COVID-19 vaccine on that day and this was the only serious reaction that he witness. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based from timing of occurrence, the event that occurred with the patient post vaccination which Is seizure like phenomenon cannot be totally ruled out to be not related suspected drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate

Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Tinnitus-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium

High fever; Tired; So cold; Headache; Sore arm/achy; This is a spontaneous report from a contactable consumer. A 17-years-old female patient received BNT162B2 (Pfizer COVID Vaccine: Solution for injection; Batch/Lot Number: EW0175), via an unspecified route of administration, administered in Arm Left on 11May2021 as 1ST DOSE, SINGLE DOSE and received BNT162B2 (Pfizer COVID Vaccine: Solution for injection; Batch/Lot Number: EW0182) via an unspecified route of administration, administered in Arm Left on 03Jun2021 at 13:00 as 2ND DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously got a flu shot 6 or 7 or 8 years ago. She lost the pigmentation on her arm. She has not had a flu shot since. She gets allergy shots but that is weekly. She has not had one in over a month. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her first vaccination last month and she did have a reaction of soreness, high fever, tired, and headache on an unspecified date of May2021. Yesterday she got her second dose and now she is back to the way she was with the first dose. Fever went as high as 99.3 which is not high, but the last time with first dose she got up to almost 103. It was 102.98 or something like that. Time of fever with first dose: it was within that night of getting it. Second dose was same thing. She got it yesterday at 1:00 and by 8:00 she was crying about being tired, so cold, achy, and fever. Caller clarified that all adverse events with second dose started at the same time around 20:00 the night of the 2nd dose. Patient had not received any treatment. Caller reported that the last time she did call the hospital and they said it would subside, which it did within 48-72 hours. Then she was back to being normal except with sore arm. Caller clarified it was left arm soreness. The outcome of the events was unknown. Information on lot/batch number was available. Additional information has been requested.

At around 9:25 am on Thursday, June 17th, 2021, seventeen-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 around 9:35 am. The Pfizer vaccine was administered at 9:39 am. Observation nurse reported that around 10:06 am the patient complained about having a severe headache, ?seeing stars?, feeling very dizzy, and not feeling well. Nurse assisted patient to lay down on the mat in case the patient may faint. Charge nurse obtained a pulse oximetry reading of 95% and a pulse of 96. Charge nurse checked if the patient experienced any symptoms of hives/redness, shortness of breath, or any difficulty breathing or swallowing. The patient complained to observation nurse that she was having a hard time breathing, severe headache, and chest pain. Observation nurse instructed patient to be calm and to relax. Charge nurse instructed the patient to take deep slow breaths to help increase O2 levels but the patient complained to the observation nurse that she cannot breathe through her nose. At 10:15 am charge nurse continuously monitored the patient?s B/P, pulse, and O2 level readings. The BP reading was 117/64 with a pulse of 78 and an O2 level of 100%. At approximately 10:16 am, patient started showing signs of change in LOC and lost consciousness for a few seconds. First responder paramedics from the first minor incident were still at the scene waiting for the 2nd ambulance to arrive. The first responder paramedic did a sternum rub using his knuckles with a closed fist to the center of the patient?s chest and immediately after the patient gasped for air and regained consciousness. The patient remained in a sitting position on the floor to be able to breathe easier. At approximately, 10:18 am charge nurse took another BP reading of 121/76, a pulse of 96, and O2 level of 99%. At approximately 10:20 am, patient started exhibiting a change in LOC and was very disoriented again. Observation nurse kept calling the patient?s name but did not get a response. This lasted for around 30 seconds while the patient gasped for air before becoming responsive again. At this time observation nurse observed that patient could not recall her name and did not know how she got there. At approximately 10:22 am, charge nurse took another BP reading of 165/133, a pulse of 122, and an O2 level of 96%. At around 10:24 am, the charge nurse took another BP reading of 112/78 and pulse of 112 with an O2 level of 96%. The second ambulance arrived at approximately 10:26 am and took over. The second ambulance?s first responder paramedics left with patient at approx. 10:29 am and took her to hospital for further observation.

Headache, stuffy nose, sore throat, nausea and vomiting. Sore arm. overall fatigue child had covid 19 in October 2020 confirmed positive with parents test

around 7:00 pm in the evening, she had a syncope episode. Video footage shows she is standing in line with other children, and just faints and falls to the floor. Initially she was not responding much to EMS and to FNP that received her, EKG was completed, and VS were within normal limits. She received lab work, UA, and CT of Head as she appeared to have hurt her head at time of fall. Few hours later, when FNP checked on her again, about 9:50 pm, she was more responsive, answering his questions and doing much better than when she initially arrived to hospital around 8 pm. She was verbal, and VS were within normal limits during my time with her at the hospital

Systemic: Body Aches Generalized-Medium, Systemic: Hyperventilation-Medium, Systemic: Joint Pain-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Pt began to display symptoms related to anxiety that progressed to hyperventilation/nausea/full on body aches/ pt states she was then unable to move her arms/legs/hands due to body aches. Pt reported that her body was aching and that she was feeling nauseated. Pt's fingers were turning blue due to intense clenching. Paramedics/Ambulance called for so pt can be further evaluated.

Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient nervous/anxiety about shot, patient received shot. Approximately 5 min after vaccine, during patient's 15 min, patient became lightheaded, then fainted. Patient then became responsive less than a minute after fainting. 911 was called at 6:58pm. EMT arrived, took over and patient/mother declined to hospital transportation. Patient left pharmacy on own.

About 5 minutes after shot, pt felt extremely unwell, really hot, pale, blurry vision, confusion, and feeling of fainting. After an ice pack , and Gatorade pt felt well enough to go home approx. 30 minutes after shot

About 5 minutes after receiving the Covid vaccine patient fainted, she was pale and reported feeling very tired and had tingling in her hands. After drinking water. Patient was feeling better but still felt tired. After 10 minutes paramedics arrived and took her vitals. Her blood pressure and pulse were normal.

Patient parents reported their daughter "froze 2 times like a seizure happened" a few days after the second Pfizer dose had been given. Patient also reported dizziness, arm soreness, and many severe headaches. patient mom said her daughter has recovered, however she continues to have some headaches.

Rash & Fever - went to ED. + burning & itching on back. Joint pain in fingers, joint pain rt elbow and wrist. Pain soles of feet. Started one week prior to 5/31/21. Dx'd with macular rash. Elevated C-reactive protein. Elevated sed. rate. Arthraligia of both hands. (Date of visit 5/31/21)

daughter might have also gotten the vaccine injected in fatty part of her arm because the same person administered it; The daughter is experiencing the same arm soreness as her mother/her arm is extremely sore/sore arm; This is a spontaneous report from a contactable consumer. This female consumer reported for her daughter. This is report two of three. This is a clone report for the first daughter. A 17-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EW0172, Expiration Date was not reported), via an unspecified route of administration, administered in arm on 09Jun2021 (at the age of 17-year-old) as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. No prior vaccinations within 4 weeks. On an unspecified date the daughter experienced the same arm soreness as her mother. Her arm was killing her. It was reported that, she might have also gotten the vaccine injected in fatty part of her arm because the same person administered it. Reporter's daughters both had the first dose and they had sore arms but she didn't see them get the shot and she doesn't think this happened to them. it hurt for a week. They were both sleeping and can't get information from them. Reporter also stated that if she touched it, she thinks her daughter would complain. Adds both our arms are killing us and it looks like this daughter got the vaccine injected from that same tech at pharmacy. She has not had anything happen yet, except that her arm is extremely sore which it was not the first time. The outcome of the event the daughter is experiencing the same arm soreness as her mother/her arm is extremely sore/sore arm was not resolved and unknown for the other event. Additional information has been requested.

Prevaccination, patient reported history of anaphylaxis with "cillins". Asked to stay for 30 minutes observation. Denied other medical history. 10 minutes after vaccination complained of headache. Mother present (patient was 17). About 5 minutes later patients head tipped back, limbs posturing (contracted), eyes open but no response to verbal stimulation. Lowered to floor. 911 called. BP 132/84; P 52. At this point mom stated "this isn't an unusual response to an injection." Paramedics arrived. Patient became fully responsive within 3 - 5 minutes of being lowered to floor. BP 106/72; p 56. After thorough assessment by paramedics, released to care of mom for observation.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Mild, Additional Details: She has a history of vasovagal reaction to needles and blood draws. Provided her with water and crackers and observed for about 30 minutes.

Patient began on June 3rd with pain in her right lower and foot, the leg and foot felt cool to touch and was discolored.

Fainted and had a slight seizure. Left hand seized up. Lasted for about 45 seconds. Lost color in face and sweating all over.

The patient came in for her first dose of vaccine. I verbally asked if she had any health conditions, allergies, andy reactions to previous vaccines. The mother answered for her and declined all. Once the patient filled out the paperwork and received the vaccine she stated she felt light headed. I noticed quickly she was about to faint. We put a chair under her and sat her down. She became unresponsive, but was breathing fine. She began to sweat and her pulse decreased. I asked for someone to call 911 and find her mom. I attempted to check her blood pressure but was unable because of her positioning. She was breathing fine and was answering short sentences but was speaking slow. Right after we called the ambulance she asked what happened and said she was feeling better. Shortly after the ambulance arrived and checked her out. Her mother declined transport to the hospital.

Vaccine given at 1845 @ 1851 Raven describes feeling dizzy, hot, and ringing in her ears Was in standing position , encouraged to sit, denied nausea- offered juice, applied pox/HR monitor HR 78 , pox 98% on RA 1855 ringing in ears subsided, verbalized feeling better drank full offering of apple juice and some sips of water Continued to monitor for full 15 min post vaccine Escorted to door at 1900, verbalized feeling well

Pt stated her feet felt numb and felt overall high. Doctor addressed pt and advised pt to eat crackers as well as wait 15 minutes after. Pts vitals were stable.

patient began on Wednesday with funny feeling face that then progressed to numbness of the right side of her face. no numbness or weakness of any other extremities.

Threw up at 6pm that night. Felt OK for a few days and then has suffered from extreme nausea and heat flashes ever since.

Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: Patient fainted 5-7 minutes after receiving the vaccine. She regain consciousness within 3 minutes before the paramedic arrived. Patient felt nauseous and vomitted. Her vitals were checked and they come out normal. Patient stated she was nervous and did not drink water and only had a bagel before getting her vaccine.

Systemic: Fainting / Unresponsive-Mild, Additional Details: PATIENT WAS GIVEN COVID VACCINE AT 9:13AM. Patient was slightly nervous, covid vaccine was adminstered as normal routine. Patient was tense, slight blood at adminstration site. Left arm was wiped with pad, and given band-aid. After 30 seconds patient passed out on chair with faint response. I IMMEDIATELTY called 911 and ambulance came to observe patient. Ptaient became response, mother assured she had "Anxiety" and she left pharmacy.

Violent involuntary twitching / shaking of left arm, then right arm, then Neck and Head; This is a Spontaneous case report a contactable consumer(patient). A 17-years-old non pregnant female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0196), via an unspecified route of administration on 05Jun2021 at 18:30 into left arm as a single dose for COVID-19 immunization (at the age of 17 years). The patient medical history and concomitant medications were not reported. The historical vaccine includes the patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0172), via an unspecified route of administration on 04May2021 at 19:00 pm into left arm as a single dose for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.On 05Jun2021 at 20:30, patient had Violent involuntary twitching / shaking of left arm, then right arm, then Neck and Head. The patient underwent lab tests and procedures which included blood test, computerised tomogram, electroencephalogram, urine analysis was unknown on an unspecified date. The patient was visited to Emergency room/department or urgent care for the events. The patient had received Benadryl as a treatment for the adverse event. The outcome of the events was recovering.

Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: left pharmacy in ambulance, gave iv in ambulane

Blurred Vision; Rapid Heart Rate; Tingling in extremities; This is a spontaneous report from a contactable healthcare professional. A 17-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8734), via intramuscular route in the right arm on 26Mar2021 at 09:45 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient had been tested for COVID-19 since the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via intramuscular route in the right arm on 05Mar2021 at 12:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 26Mar2021 at 09:45, the patient experienced tingling in extremities, blurred vision, and rapid heart rate. The adverse events resulted in emergency room/department or urgent care. It was unknown if the patient had received any treatment for the events tingling in extremities, blurred vision, and rapid heart rate. The clinical outcomes of the events tingling in extremities, blurred vision, and rapid heart rate were unknown at the time of the report. No follow-up attempts are needed. No further information is expected.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Pt fainted/blacked out while sitting down on her mothers shoulders. She blacked out for a few seconds may have had a mild seizure or could have been shaking. Laid patent flat and used moms soft backpack to put under her head. Had bystander call 911 when onset of shaking/seizure that lasted for a couple seconds 2-3 minutes. Fire department came to evaluate pt. All vitals were normal. They think it was sycopy and pt was scared and nervous of needles and only had a protein bar for lunch.

First vaccine 3/24/21 Second vaccine 4/14/21 In early may, mom can't remember date, patient c/o left leg and foot pain. Went to podiatrist - no diagnosis made - was told to monitor. Mid to late May developed dry cough. Not seen for this. On June 10 taken to ED lower left leg extremely painful and swollen and mom reported discoloration to back of leg. Diagnosed with DVT and put on blood thinner Xeralto and discharged. A week later went to hematologist who said to continue Xeralto and monitor. A week after seeing Dr. and two weeks after initial ED visit, on a Wednesday, patient started to cough up blood. Went back to Dr. and patient was taken off of Xeralto. PE scan ordered. The next day patient developed chest pain and went to ED. PE scan done and diagnosed with two PE's on right lung. Was informed had six blood clots in lower left leg. Admitted to ICU. Was an inpatient for 5 days then discharged. Now patient is taking Lovenox injections twice daily.

Pt is a 17 yr/o female who presents with numbness to right side of her face that started on Thursday. She reports Wednesday it felt funny but no numbness or paralysis. Patient reports Thursday she went to PMD for vaccinations face still felt funny but not numb or inability to smile or raise eyebrow. Patient reports Friday and today she is unable to lift eyebrow or smile on the right side. She has not had any blurry vision, no speech abnormality, no headaches, no extremity weakness. Patient with no difficulty ambulating. She has not had any recent illness, no hx of HSV or herpes, no hx of tick bites or removal of ticks from body and no recent fevers or rash. Mom did mention that she did have the covid vaccine pfizer on 6/15. She did not have any symptoms after the vaccines and did well until Thursday. She did receive vaccinations on 7/1, hep a and menigococcal B and conjugate vaccine. She has never had any previous reactions to vaccines. She is otherwise interactive gcs 15.

continuous tingling in her hands; This is a spontaneous report from a contactable consumer. and from a Pfizer sponsored program This consumer (patient's mother) reported for a 17-year-old female patient (reporter's daughter). A 17-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0173, Expiration date: unknown), via unspecified route, administered in left arm on 20May2021 (at the age of 17-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 21May2021, 1 day after the vaccination, the patient experienced continuous tingling in her hands. When the patient woke up both of her hands were tingling, almost like when they fell asleep, it was non-stop,; felt like needles in her hand. The tingling was worse when the patient first woke up. The tingling was always there but it changed with pressure. Second dose scheduled on 10Jun2021 from her school. The outcome of the events was not recovered. No follow-up attempts possible. No further information expected.

Patient stated she was nervous and received the vaccine without incidence. After receiving the vaccine while sitting the patient had what appeared to be a vasovagal response. She became pail and her eyes rolled back in her head. Patient appeared to have a seizure stuck both arms straight out and was incontinent. Patients was moved to the floor where her color returned and her pulse improved. Patient was taken to hospital via ambulance.

After we left pharmacy and was in the car at a stoplight, my daughter starting feeling very uncomfortable. She complained that she did not feel well, she could not see and that her ears were "foggy". When I looked over at her, her face was pale as can be and her lips had bluish tinge to them and she looked limp laying in the passenger seat of the car. It came on very quickly and lasted about a minute or so and was extremely scary. It took close to 30 minutes for her to regain her color. We sat in a parking lot for thirty minutes to make sure she was stable and gave her water. Went home and gave her benadryl. She slept through the night fine and this morning so far is ok.

Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient passed out in waiting area 5 minutes after being given vaccination. 911 was called, NP assisted, patient came to and was given water and something to eat. Paramedics checked vitals and patient was okay to leave on her own.

Severe muscle spasms in which her legs from her waist down was jerking upward. It would lift off the bed or off the floor. She couldn't walk. The jerking was every two minutes. Uncontrolled twitching or muscle spasms. It lasted from 05:00 am until about 11:00 pm. We took her to the ER. She also had a migraine and then her left foot where she has the nerve pain was inflamed. They gave her the Taradol and that and the calcium seemed to calm it down. They followed up with the neurologist at the hospital while she was there as the doctor in ER said she hadn't seen anything like that before.. We were sent home at midnight and by the following morning, it was gone. Doctor's notes: lower body twitching/lower extremity twitching. No treatment at home after the ER visit.

Patient developed blood in the stool 10 days following vaccination. It has been persistent, daily with formed stool except for one day where she had cramps and diarrhea. She has been using a stool softener without improvement in her symptoms.

The Chief Complaint is: 17 y/o F with history of PCN allergy (reports "anaphylactic shock" as a child) presents for first COVID vaccine. Discussed risk of remote PCN allergy and merits additional observation here after vaccination. Patient agreed to vaccination. During observation period the patient became tearful and stated she was feeling dizzy. This was about 15 minutes after the injection. She was taken to the treatment area for assessment. Endorsed dizziness, headache, twitching, anxiety. Denied dyspnea, itching, globus, chest pain (or pain of any type), abd pain or swelling. 17 y/o F with dizziness, anxiety but does not appear to be having a vasovagal or anaphylactic reaction. Recommend further observation - called EMS for evaluation and transport to medical facility No treatment given as BP normal, no rash or symptoms of anaphylaxis. Will file VAERS follow up but most likely cause for symptoms currently is anxiety.

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tachycardia-Severe, Additional Details: pt was very complusive and her eyes rolled back. Started sweating, pulse rate going up, light headed

After the shot was administered, patient was asked to sit for 15 minutes for monitoring. Within 5 min after administration, patient said she was feeling hot and sweaty. We provided patient with a cold bottle of water and ask her to take small sips. Also gave her ice pack to apply to get her to cool down. After few more minutes, patient stated that she was itchy and having burning feeling thru her body. We asked the mother to see if she would like us to call 911 but the child told the mother she will let us know if that was necessary. We asked her to sit longer at this point because of how she was feeling. Few more minutes passed by and patient was starting to feel a little better but the burning didn't go away. She tried to take a walk with her mom in the store to see if she can shake it off, but returned after about 10 min stating that when she walks, the burning feeling is getting to be excessive in her feet. So I asked her to sit for few more min and said they are ok to leave when they feel comfortable but if condition worsens, they should go to ER. I told mom to keep very close eye on her and that she should lay down when she gets home. Next morning, I followed up with a phone call. Spoke to patient and she said everything seems fine now and that it started going away after few hours of administration.

Fever; she was dazed/she didn't feel good; Her arm was hurting; Sleepiness; sick; This is a spontaneous report from a contactable Nurse (patient's mother). A 17-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 30Jun2021 15:30 (at the age of 17-years-old) (Batch/Lot Number: EW0172) as single dose for COVID-19 immunisation. There were no medical history and concomitant medications. The patient had been a healthy child, she had not ever had any problems. No additional vaccines administered on same date of the Pfizer suspect. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). There was no AE(s) following prior vaccinations. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 09Jun2021 (at the age of 17-years-old) (Batch/Lot Number: EW0150) for COVID-19 immunisation and with the first dose she was aright. The patient was 17 years old and got the 2nd dose of the Pfizer BioNTech Covid-19 Vaccine last day (30Jun2021) and was currently experiencing sleepiness and fever. With the first dose she was aright this second one was hitting her hard. She had came down with a fever and she was pretty much been sleeping all day. On 01Jul2021, morning at 4:30 AM, the patient got her mother up telling that her arm was hurting and that she didn't feel good after that mother gave her some Tylenol. She felt her and she was pretty warm so she gave her the couple Tylenol and they would go from there and she had been asleep ever since. The patient woke up at 4:30 AM this morning (01Jul2021) and it was hitting her hard, she woke up and the caller gave her Tylenol to break the fever. She confirms the fever started 01Jul2021. The fever seemed to have broken with the Tylenol but when she checked on her she was dazed, she had been sleeping all day she has never had her sleeping like this. When asked when sleepiness began she said, they all went to bed around 10 or 10:30 last night and her daughter had been asleep ever since then, it was ongoing. She had been a healthy child, she has not ever had any problems with her being sick. Her fever had improved but the sleepiness it seems had gotten worse. They wanted to know if sleepiness and fever are included among the commonly reported side effects after the 2nd dose of the Pfizer BioNTech Covid-19 Vaccine. She wanted to know if that was a normal situation. They were referred to HCP. The AE(s) did not require a visit to: Emergency Room/Physician Office. There were no relevant tests and investigation assessment done. Outcome of the event fever was recovered on 01Jul2021, sleepiness was not recovered and other events was unknown. Follow-up actions are needed. Further information has been requested.

Fainting; slight seizure of the left hand; Loss color in face; sweating all over the body; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female patient received BNT162B2, via an unspecified route of administration, administered in left arm on 29Jun2021 12:15 (Batch/Lot number was not reported) at the age of 17 years old as dose 1, single for COVID-19 immunization. Medical history was none. Patient was not pregnancy at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive 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's concomitant medications were not reported. On 29Jun2021 12:15, the patient experienced fainting with a slight seizure of the left hand. Lasted about 45 seconds. Loss color in face and sweating all over the body. No treatment was provided for the events. Outcome of events fainting and slight seizure of the left hand was recovered on 29Jun2021, while other events were recovered on unspecified date on Jun2021. The report was assessed as not serious. Information on the lot/batch number has been requested.

Client reported chest pressure from her neck to her chest to the EMT's at 4:47 PM. The client was alert and oriented to person, place, time, and event. The client stated her current symptoms were less intense than her initial reaction. Vitals obtained at 4:49 PM were as follows: BP 126/78, HR 64, and O2 98%. The client denied any other s/s of anaphylaxis. At 4:52 PM the client stated the chest pressure was still present but mild. The client reported less chest pressure at 4:54PM. At 4:58 PM the client reported mild neck pain and chest pressure. At 4:59PM activated EMS. The client denied feeling cold or clammy. Vitals obtained at 5:03PM were as follows: BP 130/70, HR 64, and O2 96%. Felt similar chest pressure after she received the four doses of vaccines at her medical provider in the beginning of July but did not report the chest pressure to her mother. Fire Dept assumed care at 5:09PM. Client and mother refused medical transport at 5:16PM. At 5:20PM the client denied any chest tightness or pain in her neck. The client ambulated unassisted with a steady gait out of the observation area at 5:23PM.

Client received first dose of Pfizer Covid 19 Vaccine in left Deltoid; Client complained of tingling and numbness in fingers of left hand 10 minutes into waiting time after the vaccine.

pt was nervous about getting covid 19 vaccine before entering store and after vaccine she said her heart felt like it was beating strongly and her vision was blurred she got extremely warm to touch and clamie skin she was "tingeling" felt weird

Fainting with seizure-like appearance not before experienced.; Fainting with seizure-like appearance not before experienced.; This is a spontaneous report from a contactable consumer (patient) reported for herself. This 17-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 26May2021 09:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. Patient was not pregnancy at time of vaccination. Medical history was none. No known allergies. Concomitant medication included sertraline hydrochloride (ZOLOFT). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fainting with seizure-like appearance not before experienced on 26May2021 09:00 with outcome of unknown. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received. Patient received second dose on 16Jun2021 09:00 AM in left arm. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on lot/batch number has been requested.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Additional Details: Patient fainted immediately after vaccine administration, she remained seated upright and came to within seconds of fainting episode. She state she was nervous before hand and mentioned in the car that she felt like she was going to pass out, and has passed out while receiving other vaccines in the past. RPh was not made aware of this by mother prior to administration. She was monitored for over 25 minutes, ate a small snack her mother had and drank some water, we gave her an ice pack/fan.

Pt.initially had acute onset left arm pain with left sided chest pain worsened with deep breathing with nausea and vomiting. She gave herself her stress dose hydrocortisone, but when she did not improve she presented to the ED on 4/25/2021. EKG was performed and was normal. She was discharged with ad vice to rotate tylenol and ibuprofen and to stress dose her hydrocortisone. She, however, continued to be very symptomatic and developed tachycardia and symptoms of orthostasis. Large workup was done to assess the status of her endocrine diseases and to assess for onset of new autoimmune endocrine conditions. Laboratory evaluation was normal. troponin testing was not sent. She was referred to her primary pediatrician for further evaluation. Her pediatrician did a full evaluation and could find no cause for her symptoms. Arm pain gradually resolved but palpitations, mild sinus arrhythmia with tachycardia and symptoms of orthostasis continued. She tolerated wean of her hydrocortisone poorly and required large doses and slow weaning. Symptoms were still present and bothersome on 5/17/21 but had slightly improved, although she remained unable to attend full days of school (she is an excellent student). Case was discussed with infectious disease, who recommended delaying the second COVID vaccination, so this was done. Eventual working diagnosis was marked vasomotor instability of unclear origin, likely post inflammatory, concern for triggered by COVID vaccination. cardiology referral was placed. She was seen by cardiology 7/6/2021. EKG showed sinus arrhythmia and borderline right axis deviation, unchanged from ED presentation 4/25/2021. echocardiogram revealed only previous PDA closure. Cardiology placed event monitor and noted low suspicion for myocarditis, but consideration of cardiac MRI in future if no improvement.

syncope type reaction, briefly blacked out. hands became cold and patient looked pale. Also stated that throat felt slightly tingly starting about 20 minutes after vaccine. Checked blood pressure and it was normal. Called 911. Paramedics arrived within 10 minutes. Patient was some better but parents decided to let her be taken to ER to be checked out since she had recently been diagnoses with an autoimmune disorder.

Immediately after receiving the vaccine, she was seated in the pharmacy, where myself and another person witnessed her eyes roll back, body slump forward, then legs at the knee flew up into the air twice. Then upper body stiffened at shoulders, entire upper body made several flailing movememts to the right. Upon standing over her calling her name she then began to respond. She was then brought an ice pack, a granola or protien bar, a chocolate bar and some water. She was asked questions by the Pharmacist and was a little confused with some of the questions but began to improve. She was followed up at the Emergency Room.

Dizziness; Hot flashes; Cold flashes; So much sweating; Headache; Full body soreness; Vision started to get blurred; Felt weak when standing; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Apr2021 at 11:45 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included depression. Concomitant medications included bupropion hydrochloride (WELLBUTRIN SR). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 12:45 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Apr2021 at 17:45, the patient experienced dizziness, hot, cold flashes, sweating, headache, full body soreness, vision started to get blurred at the dudes and felt weak when standing. It was reported that the patient had to take the day off school because she could not get out of bed. The patient received treatment with TYLENOL for the reported events. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event dizziness, hot, cold flashes, sweating, headache, full body soreness, vision started to get blurred and felt weak when standing were resolving at the time of report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Patient seemed to faint / look like they had a seizure, no seizure history, color recovered to face once we laid her down and lifted legs up. EMS was called and assessed patient.

received the 1st dose of the Pfizer covid vaccine but tested positive to covid 5 days after; Vomited; got really shaky; not able to drive; bad headache; This is a spontaneous report from a contactable pharmacist. A 17-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 vaccine, formulation: solution for injection, Batch/Lot Number: EW0198), dose 1 via an unspecified route of administration, administered in Deltoid Right on 29Jun2021 (17-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history reported as none. Concomitant medication(s) included fluoxetine hydrochloride (PROZAC) 40 mg once daily taken for an unspecified indication, start and stop date were not reported. On 30Jun2021, the patient experienced Vomited, got really shaky, not able to drive and bad headache. The patient received the 1st dose of the Pfizer covid vaccine but tested positive to covid 5 days after sars-cov-2 test positive on 05Jul2021. The reporter stated her daughter received the first dose and then ended up testing COVID positive. She received her first Pfizer Vaccine and she ended up with Covid positive, 5 days later. So, my question is with her second vaccine, do they recommend any way or not, should we, because she had the first one and became infected. She also had side effects from the first vaccine. Side effects: Pharmacist stated," I know she vomited, she got really shaky, really bad headache and she was not able to drive." Laboratory test: Pharmacist stated, "No lab but she tested COVID positive e on 05Jul2021 from 'PCR' (Not spelled) COVID test. The outcome of the events were unknown. The patient underwent lab tests and procedures which included PCR sars-cov-2 test: positive on 05Jul2021. No follow-up attempts are possible. No further information is expected.

exhaustion; after first and second vaccine; headaches; after first and second vaccine; sore arm; after first vaccine/ Sore arm: she had a sore arm from the first vaccine after 2 days. This is worse. Caller confirms the sore arm was only after the first vaccine and lasted 2 days.; This is a spontaneous report from a contactable consumer (Mother). A 17-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0164), Solution for injection, via an unspecified route of administration, administered in Arm Left on 10Jun2021 (at the age of 17-year-old) as single dose for covid-19 immunisation. The patient medical history was reported as none. Family medical history Relevant to AE was reported as none. Concomitant medications were not reported. On an unspecified date in 2021, the patient experienced exhaustion; after first and second vaccine, headaches; after first and second vaccine and sore arm; after first vaccine/ sore arm: she had a sore arm from the first vaccine after 2 days, this was worse. It was reported that she had headaches both times the next day when she woke up, for both of them. She had a sore arm from the first vaccine after 2 days. This was worse. Caller confirmed the sore arm was only after the first vaccine and lasted 2 days. Caller confirms the sore arm was only after the first vaccine and lasted 2 days. No test was performed. After the first vaccine, she got her meningitis vaccine. She got it 5 days after the first Pfizer Covid-19 Vaccine. Patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0164), Solution for injection, via an unspecified route of administration, administered in Arm right on 12Jul2021 as single dose for covid-19 immunisation. The outcome of events was unknown.

Arm hurt after vaccine but developed numbness radiating from shoulder to fingers and around should to back. Arm is painful with tingling and numbness. Started 14 days after getting vaccine

Systemic: Chills-Mild, Systemic: patient reported some dizziness and tingling and anxiety. Patient had a pulse of 125 and temp 98.4 Called emergency services and continued observing patient till they arrived; symptoms lasted 0 days

2 minutes loss of sight after having COVID-19 injection. Patient has no history of allergic reactions in the past no history of loss of vision in the past. Patient states that she is somewhat clammy and may have low blood sugar. No fever chills sweats no nausea vomiting diarrhea. Symptoms have completely resolved.

APPROXIMATELY 12 MINUTES AFTER VACCINATION, DEVELOPED LIPS TINGLING, FLUSHING, SLIGHT WEAKNESS IN LEGS AND REPORTED FEELING 'OFF'. RECEIVED 50MG DIPEHNHYDRAMINE IM AT 1:43PM. STAFF MEMBER REPORTED SHE FELT GOOD ENOUGH TO DRIVER HERSELF HOME AT 3PM. WAS INSTRUCTED TO CALL PCP OR GO TO URGENT CARE/ER IF SYMPTOMS PERSISTED/WORSENED.

Systemic: cramping fingers, tightness in the chest, trouble breathing, dizziness-Severe; symptoms lasted 1 day

Vasovagal episode. pt briefly passed out after reported blurred vision, dizziness and tingling arms. Staff supported patient by moving pt to ground and elevated pt feet. pt did not lose consciousness and reported feeling better after laying down for a few minutes. We moved her to a sitting position on the ground, then to the chair. continued to monitor and pt reported feeling fine. Patient recovered within 10 minutes of episode.

a headache started; I felt sick with fatigue, chills and muscle aches.; muscle aches began; cold chills began; my temperature was slightly elevated for me but still not a fever at 99.1°/99.7°/went up to 100°/100.5°/ 100.2°/99.8° but still elevated; I was really fatigued; my energy levels weren't 100%; This is a spontaneous report from a contactable consumer (patient). An 18-year-old female patient (not pregnant) received the first dose of bnt162b2 Lot Number: EL8982, via an unspecified route of administration on 16Jan2021 12:15 at single dose at Left Arm for COVID-19 immunisation. Facility type vaccine was other. Medical history included Congenital Partial Aortic Bicuspid Valve, Aortic Dialation, Postural Orthostatic Tachycardia Syndrome, no known allergies. The patient didn't have covid prior vaccination. The patient's concomitant medications were not reported. There were no other vaccines in four weeks and no other medications in two weeks. Patient stated when she woke up, her temperature was slightly elevated for her but still not a fever at 99.1°. At 1:00 pm, she was really fatigued with her temp still at 99.1°, at 2:30 pm, cold chills began and her temp was 99.7°, at 2:45 pm, her temp went up to 100° & muscle aches began, at 4:00 pm, her temperature was 100.5° and she felt sick with fatigue, chills and muscle aches. At 5:45 pm, a headache started and at 7:30 pm, it got horrible and her temp was 100.2°. At 10:15 pm, her temp went down to 99.8° but still elevated and she was very fatigued. The next day, Jan18, the fever was gone and she woke up with a 98.2° temp which was consistent throughout the day but she had a persistent headache most of the day and her energy levels weren't 100%. She didn't take any medications any of these days. Adverse events started from 17Jan2021, 01:00 PM. No treatment was received for the events. The patient had recovered from the events. COVID was not tested post vaccination.

1 min post inj cc/lightheaded, dizzy, blurry vision, ringing in ears. Pt reported vasovagal effects with needles. Subsided after 5 mins.

The day of the vaccine, my arm started to hurt, and the day after, I felt sore all over, and felt like I had a fever. Have been feeling very lethargic and have a headache as well.

patient starting shaking and fell down to the ground from chair. No LOC or confusion. Also felt light headed with VSS. EMS called. no known history of seizures. Transported to the ED

Patient received second dose of Pfizer vaccine on 2/5. Patient was anxious during administration of vaccine. Discussed how patient felt after first dose vaccine and SE experienced (sore arm only - tolerated well). After she calmed down, then administered vaccine when pt felt ready. ~10/15 min later patient reported flushing, trouble catching breath, pulsing headache & shaky. Gave 2 Benadryl, monitored BP/HR (normal), injection site (normal), no angioedema/blocking of oral cavity/throat. Patient advised to lay down and reported feeling better ~ 1 hour later.

Staff at facility informed staff that a staff member had passed out. RN from drug store found client sitting in a chair, awake and alert, no signs of injury. Had client lay down and elevated legs. BP at 1:50 PM is 122/86, HR is 100, regular and strong, color is good, mentation is good, no signs of injury, client state she feels "weird and tingling". Patinet monitored for over 30 minutes with multiple BP and HR checks and mentation checks. One dose of Bendaryl 25 mg given at 1:57 PM. Orthostatics completed at 2:00 PM. Both HR and BP remain WNL and client continjues to be awake and alert,. Ambulated to bathroom with RN at side. Patient declines need for EMT and went home with her boyfriend at 2:20 PM, BP at 132/88, HR at 80.

Pt presented by EMS for acute epigastric pain radiating to the back. While waiting for lab results, she was found down in her room and in post-ictal state. She was moved from an urgent care room to an ER bed and returned to near baseline when she had witnessed seizure activity and subsequently required multiple medications to break her status that lasted around 30 minutes

After receiving first mRNA COVID vaccine, patient experienced flushing, headache, chest tightness, shortness of breath, and nausea. Patient was initially monitored in an observation area, given crackers and juice. After 35 minutes she was transferred to the ED. IV line was placed, labs drawn, and given acetaminophen and ketorolac, fluids and ondansetron. Patient was later discharged after remaining stable.

Asthma; Syncope; Dizziness; Nausea; Vomiting; Severe headache; Fever; Muscle weakness; Muscle twitching; Fatigue; Chest tightness; This is a spontaneous report from a contactable consumer (patient). A 18-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: Em9810), on right arm via an unspecified route of administration on 23Feb2021 10:30 at single dose for covid-19 immunisation. The patient medical history was not reported. There was no known allergy. Concomitant medication included sertraline, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). Historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Feb2021 04:45PM on Arm Left for covid-19 immunisation. On 23Feb2021 10:30 patient experienced syncope (medically significant), dizziness, nausea, vomiting, severe headache, fever, muscle weakness, muscle twitching, fatigue, chest tightness, asthma. No treatment was received for the event. Patient not having COVID prior vaccination. Patient not tested COVID post vaccination. Outcome of the events was recovering.; Sender's Comments: Based on the strong temporal association, the association between the event syncope and the vaccine BNT162b2 administration cannot be completely ruled. 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.

During 15 minute waiting period after receiving vaccine, the mother of the patient called staff over and reported the patient had experienced seizure like activity. When staffed arrived to assess the patient was startled, however was lucid and coherent. Staff then directed the patient to the hospital emergency department for further evaluation.

c/o visual disturbance - no change acuity- "bright white" everything; acting dazed & confused - turning head side to side though able to answer appropriately & follow commands; A&O x 3 (reported never doing well with "shots", anxious today as always - mask removed - car door opened- emotional support - waited 15 mins in observation X 1.5. symptoms resolved - driven home by parent.

Progress Notes (Nurse Practitioner) ? ? Nurse Practitioner Cosigned by: MD at 3/18/2021 2:51 PM Expand AllCollapse All 3/18/2021 Subjective Patient is a 18 y.o. female who was seen at COVID Vaccine site today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience left arm numbness and tingly.. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency area. Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting. Complained of numbness and tingling in the left arm (shot arm) after shot. ALLERGY REVIEW OF SYSTEMS: All other systems negative Patient complains of muscle aches CONT negative HENT negative Eyes negative Respiratory negative Skin negative GI negative Neuro negative Previous Reactions: None Objective Vitals Vitals: 03/18/21 1120 03/18/21 1140 BP: (!) 141/81 125/74 Pulse: 88 85 SpO2: 99% 99% Physical Exam Constitutional: Appearance: She is well-developed. HENT: Head: Normocephalic and atraumatic. Right Ear: External ear normal. Left Ear: External ear normal. Nose: Nose normal. Eyes: Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Abdominal: General: Bowel sounds are normal. Palpations: Abdomen is soft. Musculoskeletal: General: Tenderness present. Normal range of motion. Cervical back: Normal range of motion and neck supple. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Neurological: Mental Status: She is alert and oriented to person, place, and time. Comments: Numbness in left fingers Assessment/Plan Treatment included: water Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) Pt left at 12:06. Numbness resolved in left hand Electronically Signed 3/18/2021 12:07 PM

Within 15 minute waiting period after vaccine administration, patient's mother alerted staff that patient had just had a seizure-like episode after becoming light headed. Patient started flaring with flexion and shaking of upper extremities, nonverbal during event. Staff examined patient and found no signs of a seizure. Patient was sent to the emergency room for further evaluation. Mother states that patient had a similar episode at age 8, but no further details provided. Patient was stable and discharged from the emergency room with a referral to follow-up with primary care physician.

Patient received the 1st dose of the Pfizer Covid Vaccine (Lot: ER8732, EXP: 7/21) on 3/27/21. Shortly after the injection the patient's arm started itching and a rash developed. Patient was dizzy, hot, and had an elevated blood pressure. Patient was transported to Emergency Department by EMS.

About two hours after getting vaccinated, Patient had her first ever migraine and the pain was so intense she passed out. Paramedics transported her to ED where she had altered consciousness for about another 4 hours.

48 hours after the vaccine, patient had a drop in glucose down to 40 which triggered grand mal seizure. Admitted to the hospital for 2 days, thought it was possibly due to UTI, however because of how soon it was to the vaccine I wanted to report it just in case it were linked.

migraine at rhe base of my Head; My heart rate rose to around 133 just laying down; extremely nauseous; inability to control temperature regulation; stomach began to have a really intense stabbing pains; Not the worst pain I have experienced but definitely not pleasent; lethargic; getting extremely cold and then hot within a matter of minutes; Her ribs and lungs hurt; Her ribs and lungs hurt; This is a spontaneous report from a contactable consumer (patient). An 18-year-old female patient received second dose bnt162b2 (Pfizer COVID 19 vaccine), via an unspecified route of administration, administered in Arm Left on 24Feb2021 10:15 (Lot Number: EN6202) as single dose for COVID-19 immunisation. Medical history included known allergies to Red dye, postural orthostatic tachycardia syndrome (POTS), heart murmur, Wilkies syndrome. The patient was not pregnant. There were no concomitant medications. The patient did not take other medications in two weeks. The patient previously took Excedrin and experienced allergies. The patient previously received first dose bnt162b2 (Pfizer COVID 19 vaccine), via an unspecified route of administration, administered in Arm Left on 03Feb2021 09:45 AM (Lot Number: EL9269) for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. On 24Feb2021 at around 7:00pm she started getting a migraine at the base of her head. She then was lethargic, and became extremely nauseous. She started getting extremely cold and then hot within a matter of minutes (inability to control temperature regulation). Her heart rate rose to around 133 just laying down. Her ribs and lungs hurt. And her stomach began to have a really intense stabbing pains. At one point it felt as if she could feel every cell in her body if that makes sense. Not the worst pain she had experienced but definitely not pleasant. On a scale of 1 to 10 (10 being run over by a car and 1 being a paper cut) she would say it was a 5-6. The patient did not receive treatment for the events. Facility type vaccine was facility. The patient did not have COVID prior vaccination and did not have COVID test post vaccination. The outcome of the events was recovered on an unspecified date.

I was already dealing with C Diff and still am, but it caused me to become extremely motion sick in the car ride home and I had to keep pulling over to vomit. As soon as I got home my injection arm started to hurt really bad and now the morning after I can't move my arm due to the pain.

My face has been twitching since I got the vaccine. It feels like I have muscle spasms in the arm I got the shot in and in my back. The arm that I got the shot in still hurts a day after. .

Red slightly itchy rash on elbows, inside of mouth felt swollen and irritated, sore throat, arm slightly sore where the shot was given

Acute DVT in left LE. Patient presented to ED on 3/22/21. She had 2 day h/o leg discomfort and leg was taught and painful on the day she went to the ED. Study was limited due to pt lack of cooperation. Lovenox started.

client received covid vaccine approx 5-10 min later c/o feeling sick to stomach and light headed. client vomited moderate amount of brown liquid. client was pale and clammy. client was checked by ems.

17 y/o female, 5 minutes post vaccination c/o lightheaded ness, pt. Fainted for <15secs, upon assessment pt is pale, cold, clammy. Paramedics V/S taken, HR 72, BP 107/75 (sitting), standing HR 92, BP 80/50, NS bolus was given and pt still c/o lightheaded ness, dizziness, nausea. Taken to Hospital for further evaluation. Taken by Paramedics.

with 1st shot - numbness in her whole arm 2 days later for 10-15 minutes. would occur 2x a week since. with 2nd shot - increasing arm pain and numbness, fingers going numb 2 days after. occurring almost daily now. only her left arm is affected

Pt received vaccine and approximately 5 minutes later pt got light headed fainted and hit head on the floor of the waiting room. Pt begun to seize for approximately 30 seconds then regained consciousness. Pt was stabilized and monitored. 9-1-1 contacted immediately and handled pt care once they arrived.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Additional Details: Patient fell out of chair #7 in pharmacy. This author caught patient and brought to floor. EMS called at 12:44. Nurse on site took patients BP 108/66. Could not get HR. EMS arrived at 12:52. EMS evaluated patient. Gave patient cold water. Patient declined hospital transfer. Patient was over 18 and EMS gave her paper that stated she declined hospital care. EMS left 12:57.

Immunization was given at 4:20PM and at 4:30PM in the store they sat and said they were feeling hot and had trouble breathing. She was conscious but had trouble speaking to EMTs when they arrived. She was taken to an emergency room and was able to walk out of the store with support.

Patient with known allergies to PEG. Had a slight reaction of hives following 1st dose. Patient consulted with her PCP and oncologist and her oncologist was adamant that she was to receive her 2nd dose, not an option to not receive despite documented PEG allergy. After receiving 2nd dose approx 5-10 min later in monitoring area reported to EMS RN feeling dizzy, flush, and eye flutter. EMS evaluated, vitals HR 104, RR 21, BP 137/98, PulseOx 97%. RN noted patient was very anxious and this contributed to the patients symptoms. However, the patient did begin developing mild flushing and small red patches on arms, legs, trunk. Hives and flushing resolved within 30 minutes. Approx 45 minutes post reaction symptoms, patient reports feeling better, flushing resolved. Denied wanted further workup or transfer to ER and left with her mother.

Took Benadryl before getting the shot at 2:30pm Allergic reaction resulting in facial and throat swelling, red welts at the back of the throat, wheezing, going unconscious and shaking all within 2 hours of receiving the vaccine Took second Benadryl to try and calm down the reaction (no effect) Epipen was given at the advice of my physician at 6:30pm Was directed to the ER Given medication in the ER Released after 4 hours

fainting, followed by seizure like involuntary movement for 15 secs. patient regained consciousnees and left with family to healthcare providers.

Fever, 11pm 04/09/2021-10am 04/11/2021 (peaked at 101.5°) Headache 04/10/2021 Left arm pain 04/09/2021/04/11/2021 Nausea 04/09/2021-04/10/2021 Chills 04/10/2021 Treated with tylenol extra strength, took 2 times over the course of 10 hours

after vaccination while waiting 15 minutes, patient felt dizzy. mom noted eyes rolled up , head tweisted to left side, body stiffened. mom put her to floor and called for help. episode lasted 20 seconds with also shaking of her upper body not sure if lower. taken to er . in er continued to be dizzy. given ivf 1 liter

Patient was given vaccine in left deltoid. Approximately 10-15 minutes later, father came to the window to report patient's throat feels tight and closing and patient is getting flushed. I verified with patient if she can breathe, and she stated she could only breathe through her nose, and her throat is tight and closing. I went out of the pharmacy and administered the EpiPen dose on outer left thigh as the other pharmacist was calling 911. The mother arrived at the pharmacy and stated to us she is an ER nurse and told us to cancel the 911 response as she would take the patient to ER immediately. Patient was given the vaccination card and mother took patient away to go to ER, as patient could still walk. The patient appeared stable.

The day after the vaccine was received, the patient noticed arm and face swelling. She also experienced shooting pains and tingling in the same arm she received the vaccination. At work, it hurts when she carries things and has dropped items, which is unusual. Pain is mainly in the shoulder, but sometimes in the forearm. She has tried Tylenol, ice and naproxen with no relief. She received methylprednisolone on 4/12, and now feels that she is having an allergic reaction. Complaints of increased wheezing, shortness of breath and swelling of her skin, she has used her albuterol inhaler at home which has provided no relief. On 4/13 she received albuterol by nebulizer and an IV dose of methylprednisolone at the emergency department. She is going to start albuterol nebulizer at home, continue OTC antihistamine, discontinue the methyprednisolone and start prednisone tomorrow.

Heavier than usual menstruation, lower back and stomach cramps radiating down the legs (from thighs to feet)

There was a miscommunication between the pharmacist and the nurse and the shot did not get reconstituted so patient was injected with 0.3mL of the concentrated stock solution which probably ended up being about 4-5 doses worth. She complained of a sore arm the next day and said it was moderate pain (4/10). This was the only adverse event that was reported by the patient we followed up with her on 4/14/21 and she said she had fully recovered.

Right after patient received vaccine, she experienced severe dizziness that she had to sit down. She also had shivering, warmth, nausea and vomiting

Red and hot rash on left arm, cheek and leg; spread to right cheek, treated with calamine lotion and two benadryl taken. Began day after vaccination.

Dizziness/weakness post vacination. Refused transport, Medic assessed, PT was stabilized, symptoms improved, EKG and pulse ox, vitals normal

Within 5 minutes after being vaccinated patient started feeling really warm with extreme pulsating headache and major tremoring in her hands. These symptoms started to worsen for her as she also started getting facial tics and sensitivity to light, so patient's Mom did take her to the emergency room to be assessed/observed/treated.

Patient came to clinic with mother to get COVID 10 Vaccine. Patient received vaccine at 1515 and stated she felt nervous and asked for water and she vomited right after and was trembling. NP was notified. Patient was then escorted by nursing to another room to have her lay down. Patient was assisted to bed and VS were take BP LA Laying 122/89 HR 132 Oxygen Saturation 99% RA appeared pale. Patient awake and answering questions. BP at 1530 105/79 HR 101 Pulse Oxygenation 100% RA. VS at 1542 102/74 LA Laying HR 95 Pulse Oxygenation 99%. NP cleared patient to leave at 1545 stable vital signs patient stated she felt better no pallor noted no difficulty walking left with mother.

[April 10; Evening]: Headache with small pounding feeling, a slight fever. [April 11, Morning]: Slight pressure on injection sight, weak limbs, vomiting, fatigue. [April 11, Evening]: Unconsciousness, nausea, delirious, fever. [April12-14]: Extreme Migraines, dizziness, loss of balance while walking, unconsciousness, loss of appetite. Took Pedialyte and liquid pain reliever everyday.

Chills: 13 - 37 hours after injection Sweating: 20 - 37 hours after injection Leg muscle pain: 23 - 26 hours after injection Hard itchy red lump appeared below injection site

pt told her dad that she was not feeling well and lost consciousness and had seizure for about 5 seconds. vitals monitored, WNL. Pt A&Ox4, observed for additional 30 minutes while constantly monitoring vitals, stated she felt better and was driven home by her dad.

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

shortly after vaccination patient began to feel light headed and dizzy and became flushed and hot. Patient broke out in splotches over chest. Pt was given 25mg of diphenhydramine. Pt began to feel better after 30 minutes of observation .

Pt and father moved into the waiting area with vehicle. According to dad, pt began seizing in the car one minute after the vaccine administration. Dad called out to waiting area Monitor. Monitor called for help. LT and SPC appeared on scene. 1257 Pt was visibly having tonic clonic seizure. SPC administered EpiPen in Right Leg. 911 was called. Pt stopped seizing and was awake and confused. She then became AOx4. Pt visibly distressed and hyperventilating. 1259 Pt had tonic clonic movements and seizure again. Seizure last less than 15 seconds. Pt then became AOx4 again, distressed, and became nauseous. HR 56 SpO2 98% 1300 Pt vomited while sitting up. Still distressed and hyperventilating. RR 30. Post vomiting HR 116, SpO2 97%. Pt moved to stretcher and moved to shade. 1306 Firefighters arrived. HR 114 BP 141/46 SpO2 97% RR 24 AOx4 1312 Ambulance arrived. 1320 Pt left for medical center.

Patient reports she felt dizzy two hours after the shot. She went to a quiet area and had a witnessed syncopal episode and seizure like activity for 10 seconds with urine incontinence. She said she woke up on the ground. She did not go to the ER or call 911. She didnt report the episode until April 20, 2021, when she showed up for her second vaccination. She was declined the second vaccination.

1:50 Called into observation room by RN. for assistance with this patient. Pt had Dose 2 of Phizer at 1: 16 pm and was now complaining of nausea and lightheadedness. Pt asissted to floor, legs elevated up on a chair. Pt is alert .He stated, his name is (unlisted). Skin: pale, hands diaphoretic. Immediately, pt 's chest was pounding;HR was elevated , pt's eyes closed and he appeared attempt to answer this RN's questions as to how he feels, however, could not. Would not/could not open eyes. It appeared that he was shaking/mild jerking as with the chills, however, this RN was discerning if it was seizure like activity. Upper body flushed/red. This lasted about 30-45 seconds. Then pt.'s shakiness slowed down, heart pounding resolved and he opened his eyes. Able to squeeze nurse hand. 1:53 pm DPN Came to assist.Ice pack to forehead Pt was still shaky, but now responding. Still w/ complaints of nausea, lightheadedness. 2:05 still lying on floor with legs elevated. 2:10 Sat up for 5 minutes. C/o nausea. Placed in wheelchair. Within 1 minute, pt. Is pale, shakiness returns, and c/o nausea. Returned to the floor , legs elevated and 9-1-1 initiated. HR steady, respirations -steady. MOC now present.Pt. now responding to MOC or RN's commands to squeeze hand or Speak. Eyes closed. HR and RR steady. 9-11 arrived at 2: 15 pm and pt. Left facility with paramedics and MOC.

Approximately 5 minutes after vaccine administered, patient started feeling nauseous and dizzy. She was also pale and clammy. Offered patient water and allowed to remove face mask. Instructed on breathing slowly in through the nose and out through the mouth. This helped briefly but then patient verbalized that she was feeling more light headed and thought she should lie down on exam table. Remained at patient's side but did not allow her to stand up in order to relocate from chair to exam table. Approximately 7 minutes after vaccine administration, patient briefly lost consciousness for less than 30 seconds and had slight jerking movements during this time. Remained at patient's side and prevented her from falling out of chair, hitting head, or other injury during syncopal event. After patient regained consciousness, she began sipping on water. A cold, wet paper towel was placed to the back of her neck. Continued to observe patient in exam room for another 5 minutes then she was escorted to waiting area by provider. Waiting area was just outside exam room and patient remained in the presence of a patient care technician, as well as her mother. Patient remained in waiting area for a total observation time of 30 minutes. No other adverse events occurred. Patient and mother both reported that patient does not do well after vaccines and has had similar symptoms after other vaccines in the past.

Around 1 am (4/20/21) following the second dose (4/19/21), felt body ache symptoms and chills. At 8 am on (4/20/21), had a fever of 101.7 degrees F, a large headache, chills, and body aches. By (4/21/21) the fever, chills, and body aches were gone but the headache remained until the evening of the 21st.

The first time I had the vaccine my throat started burning and chest tightness I stayed with the nurse for a good half hour and I started to feel better so I left by the time I made it to my car I throw up I decided to go home in about an hour later calm down. The second time I had the vaccine 04/21/2021 my throat was burning my chest was tight I had hives I was vomiting and having hot flashes for a good hour at that point my symptoms were not coming down so I was sent by ambulance to the hospital I have to give him Benadryl on a steroid I was at the hospital for a good five hours my symptoms were gone. The next day 04/22/2021 I had some soreness in my arm my body was sore and I was really tired later that night I started feeling really hot and my legs were stinging and burning I looked at my legs and there was a rash and a rash on my face and a rash on the left arm where I had the vaccine

She received the shot walked a couple steps had a blank stare on face sat her in a chair where she sat for a couple seconds and just stared at me then head jerked and right hand curled and eyes rolled back into head. tried shaking her to respond she passed out .She came to opened eyes wasn't speaking but followed my command to spit out gum then again went limp with head shaking and hands twitching. Got her to the ground with help and called 911. She laid on ground then came to . She did not remember incident but was responding appropriately to questions. drank orange juice and placed ice bag under neck while laying. By the time paramedics arrived she was awake and appropriate. Pulse ox, blood sugar and EKG normal. Blood pressure was low but not unusual for her. Prior to shot she was well hydrated and had eaten. After being checked out by paramedics we denied need to go to hospital and she did walk out on her own. Observed her closely over night and had no further symptoms.

pt's mother states patient was instantly sleepy, waited 30 minutes inside tented waiting area, walked to car and became difficult to arouse/respond.

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Severe, Systemic: Visual Changes/Disturbances-Medium, Systemic: Vomiting-Mild

Patient is a 18-year-old, female. No known medical history. No known allergies. At 3:18 pm, the patient received her first dose of Pfizer vaccine (lot number EW0179, expires on 08/2021) on left deltoid, given by RN. Patient informed RN that she has a history of fainting after vaccines. RN recommended the patient wait in the zero-gravity chair. Patient continued to be A&Ox3, walked herself over to the EMT waiting area with a steady, balanced, and sat down in zero-gravity chair. At 3:20 pm, patient checked in with EMT and stated she feels "fine". At 3:27 pm, while waiting in observation area, patient stated "I don't feel good" and went unconscious. EMT reclined patient into supine position. Patient remained unconscious for approximately 10 seconds. RN called 9-1-1 at 3:28 pm. Patient regained consciousness at 3:28 pm and stated "I need something sweet". At 3:30 pm, the patient's BP 69/44, RR 8/min, HR 63 bpm and weak, skin dry and cold to touch, lips pale and cyanotic. At 3:33 pm, the patient's BP was 87/60. Fire Department arrived on site at 3:34 pm. Patient was transferred to gurney by FD. Patient left facility at 3:34 pm .

1240pm: Mother called nurse to the car. Pt was crying and feeling shaky. BP 92/58 HR 62 RR18 sats 99% T 98.4 Denies pain and SOB Emt called to the car, patient evaluate. Pt calmer and denies shakiness after 10 mins. Parent refuses emt to transfer to the hospital.

After receiving the vaccine the patient became clammy and fainted. Patient faints every time she gets a vaccine. We let the patient lay down to regain consciousness and she did after about 30 seconds. After patient sat for a few minutes she was feeling well again

PMS symptoms (bloating, headache, acne, cramps, tender breasts), delayed or possibly missed period, headache directly after getting first dose of pfizer, sore arm.

symptom started 4/21, with pain and tightness in the left arm, progressively spreading up the arm over the following 48 hours, and then to the distal right arm, and legs. The leg symptom were present when seen 5 days ago, though were not discussed as Patient wasnt sure if thats what was really starting. This is associated with a feeling of "not being able to feel muc" and "doesn't feel right", as if it "feels foreign... body says this is weird," and feels heavy. Also notes that different extremities feel different - left is worse than right. Seen 5 days ago, and noted to have been advised by hematology to stop eliquis approximately 2 weeks prior to onset of symptom after PE/Renal artery embolism 1/2021. At that visit was referred to ER, where workup for repeat clot was normal (CTA, b/l upper extremities dopplers, head/neck CT, CXR). EKG was notable for Sinus tach and nonspecific T wave abnormalities. Discharged home with close follow up. Since then the intensity of the symptom as worsened and the leg symptoms have gotten more pronounced and consistent with the upper extremities symptom. Today notes new difficulty getting dressedon because clothes were getting stuck/he couldnt pull them down. Also notes when his left arm is touched it causes burning pain that shoots up the arm. Reports headache. 2-4/day, last 30 minutes, 5/10 in severity. Worse with movement of head. Frequent nausea, no emesis. but not specifically associated with headache. No waking from sleep. Since PE, has complains of intermittent left sided squeezing chest pain, which he wonders may be due to his anxiety. Lasts a few minutes Received Pfizer COVID vaccine 3/29, hasnt received 2nd dose yet ROS: general: no fevers or weight loss. CHRONICALLY C/O FATIGUE AND TROUBLE FOCUSING. has had evaluation for executive function difficulty in the past (interdynamics), now purusing evaluation at Neurology and awaiting EEG with this. HEENT: no sore throat. + VISION CHANGES - TROUBLE FOCUSING, but not specifically blurry vision. CV: LEFT SIDED CP, NONSPECIFIC T WAVE CHANGES ON LAST EKG W/SINUS TACH. Pulm: SOB, with walking up and down stairs, since PE. not worsening. No Cough. GI: +NAUSEA, no vomitting, no abdominal pain. No current diarrhea. Neuro: + HEADACHES. + SENSORY CHANGES. + family h/o MS

18 yo female requests to have injection in supine position due to previous history of passing out with injections. Mom at pts side and sts pt first passed out at the age of 4 years old when she witnessed her father having blood drawn for a health screen. She also reportedly passed out after receiving a vaccine at Pharmacy in 2017. Due to her history of injection related syncopal episodes, pt is placed in a supine position on the cot as precaution. Approximately 30 seconds after receiving the injection, the pt was witnessed becoming unresponsive by this HCP. Pt was then witnessed having her eyes roll up and back followed by a few seconds of generalized seizure activity. HCP remains at pts side. The cot has a suspended cloth and is soft, therefore, pt is safe from harm on it. Seizure ends after seconds and pt awakens. She is initially confused but orients quickly. She remains AOX4 and has no complaints. Spoke with mom extensively about pts condition and presenting symptoms. VS- HR initially 52 but quickly improves to 77, BP 107/64, RR 16, sats 98%. Pt will follow up with pts pediatrician. Mother and pt do not want pt evaluated at the ER today and do not want an ambulance. VAERS info given.

Red Face. The redness developed 24 hours after first dose Pfizer. (received shot at 12PM Friday, face began to itch noon Sat)There was no associated SOB, DOE, dysphagia, and no enlarged tongue. Face was hot and itching Neg PMH, No Meds NKA, + seasonal allergies. No new exposure history Resolved completely within 24hrs following single dose of Zyrtec .

I was on my menstral cycle and the cramps were more intense. Dizziness and feverish though no fever. Tired and pain in shot arm

Patient; writer was called by family member, patient observed sitting in chair with episode of unresponsiveness. No head trauma, No SOB, No respiratory distress. Paramedic notified. Patient had episode of fainting lasting about 30secs then returned to baseline mental status post covid vaccination. MD notified. Family member present stated that she history of fainting. Patient discharged home, in stable condition.

writer was called by family member, patient observed sitting in chair with episode of unresponsiveness. No head trauma, No SOB, No respiratory distress. Paramedic notified. Patient had episode of fainting lasting about 30secs then returned to baseline mental status post covid vaccination. MD notified. Family member present stated that she history of fainting. Patient discharged home, in stable condition.

After about 6-8 hours I began to have flu-like symptoms such as feeling feverish, feeling achy, & having a headache. I also felt like it was hard to breathe. But, today May 3rd, 2021, 2 days after the vaccine I developed a rash on my left side (vaccine side) from my armpit down to the top of my ribs. It?s red & looks & feels like sunburn.

04/30/2021 Before the vaccine, Patient had a small rush on her face-right cheek. 05/01/2021 12:30 am, the same rush on her face expanded, and appeared a big rush on her left leg. 8:am, her face was warm, swollen, red, and itching. A big rush on her lower and upper back; the rush on her leg expanded and is very red.

Severe cramps, moodiness and Menstruated more frequently (was on a 28 day cycle prior to vaccination): 3/17/21 6 days, 4/4/21 6 days, 4/17/21 6 days, 5/2/21 still bleeding. Long term effects still unknown!!

Adverse events: Extreme chest pain, couldn?t move arms very much, hands went numb and tingly, throat pain Treatment: went to the doctors and the hospital and have tried over the counter pain medicine which didn?t work, prescribed prednisone which didn?t work, prescribed naproxen 500 which didn?t work, prescribed famotidine which didn?t work, all blood and heart and lung tests came back fine Outcome: still in a lot of pain and nothing is helping and nobody can figure out what is wrong

The patient was very nervous of the vaccine and of needles & informed the certified technician of this. She talked to her to calm her prior to administering the vaccine. Said patient was shaking during the administration. The technician informed her we would have her sit & wait for 15 minutes & when she got up she was shaking and said she was going to pass out. The technician called for assistance & told the patient to sit back down. Pharmacist came and patient did faint in the chair. We tapped her a few times and held her up in the chair for a short time until patient came to. Patient called her mom & we gave her crackers, orange juice and held ice packs on her and talked with her until her mother came.

Bilateral Rash and itching / burning sensation on hands (reported 20 minutes ago, no treatment / outcome determined yet)

Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Mild

Approximately two minutes after vaccine injection, pt started to feel dizzy, saw spots, felt like she was going to pass out. Someone got a wheelchair and we took her back to observation/treatment area. Patient was very drowsy, felt nauseous, hands were tingling, and was cold and clammy. We asked her to text her Mom, who was sitting out in the parking lot, to have her come inside. Pt reported passing out with HPV vaccine and on blood draws. We moved patient to pt bed and took vitals (listed below). Patient was able to recover without any medication administration under close observation. After about 20 mins in obs/treatment area, she was feeling better and we moved her to the observation room with her Mom. We had leftover vaccine syringes, so Mom received her first dose of vaccine. They waited together until Mom's 15 mn obs time was over. Patient and someone left the clinic feeling fine and under their own power around 1845.

Patient became very pale and whole body sweating. Patient reported ears ringing and black spot in vision. Also, said arms were tingling. lasted approximately 15 minutes

1. nerve pain/tingling in feet after getting out of bed or after moving from sitting to standing/walking/no treatment/ongoing 2. lack of menses since initial shot/no treatment/ongoing

vomited; nauseous; visibly distressed; hyperventilating; began seizing/visibly having tonic clonic seizure; HR 116/ HR 114; HR 56; RR 30; BP of 141/46; This is a spontaneous report from a contactable nurse. An 18-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EW0170), intramuscular, administered in the right arm on 20Apr2021 at 12:45 as a single dose for COVID-19 immunization. Medical history included anxiety from an unknown date and unknown if ongoing. Concomitant medications included fluoxetine hydrochloride (PROZAC) taken for an unspecified indication, start and stop date were not reported. The patient did not have COVID prior to the vaccination. The patient did not receive other vaccines in four weeks. The patient had not been tested for COVID post vaccination. On 20Apr2021 at 12:45, the patient and her father moved into the waiting area with vehicle. According to the patient's dad, the patient began seizing in the car one minute after the vaccine administration. The dad called out to waiting area monitor. At 12:57 the patient was visibly having tonic clonic seizure and was administered with EpiPen in the right Leg. 911 was called. The patient stopped seizing and was awake and confused. She then became AOx4 (oriented to four spheres; time/place/person/situation). The patient visibly distressed and hyperventilating. At 12:59 the patient had tonic clonic movements and seizure again. The seizure lasted less than 15 seconds. The patient then became AOx4 again, distressed, and became nauseous. Heart rate (HR) was 56 and SpO2 was 98%. At 13:00 the patient vomited while sitting up. The patient was still distressed and hyperventilating with respiratory rate (RR) of 30. The patient's post vomiting HR was 116 and SpO2 was 97%. The patient moved to a stretcher and moved to the shade. At 13:06 firefighters arrived and the patient had an HR of 114, BP of 141/46, SpO2 of 97%, RR 24 and AOx4. At 13:12 the ambulance arrived and the patient was taken to (Place). The events resulted in a visit to the Emergency room/department or urgent care. The outcome of the events was unknown.; Sender's Comments: Based on the available information, and on close temporal association, a reasonable possibility cannot be excluded that the suspect drug BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) contributed to the occurrence of the serious event Generalised tonic-clonic seizure. 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.

8:00pm - left arm soreness 2:00am - chills, difficulty sleeping 9:00am - tiredness, body aches, fever 12:00pm - felt mentally out of it 11:00pm - throat soreness

Patient received the 2nd dose of the Pfizer COVID-19 Vaccine in her left arm on 4/28 at 12pm. At 9pm that even she developed symptoms of heaviness, weakness, numbness, tingling and intermittent pain from her left upper arm to her left hand and fingers. She had fever for 2 days. The symptoms resolved after 48 hours. She started having the same symptoms in her left upper arm to her fingers yesterday. She started to have right lower leg pain, numbness and tingling yesterday. She has had no chest, pain, cough, SOB, headaches, blurred vision, dizziness or fever. She has no neck or back pain. She has no rash or bruising. She received the first Pfizer Vaccine on 4/7/21.

Systemic: Confusion-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Feeling of passing out, in and out of consciousness, general weakness, sweats, weakness in breathing-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Weakness-Severe

Uncontrollable muscle spasms/tremors, whole body pain ,very difficult to do much because of the pain.

Shortness of breath, dizziness, faint, anxiety, headache and arm pain. Transported to ER and not able to reach patient for follow up.

5/5/21 Wednesday - got 2nd Pfizer Shot. 5/6/21 Thursday - 2am awoke with shakes/chills and throughout the day had body aches, temperature increased from 98.6 to 101.2, stiffness, nausea, headache, chills and sweats. 5/7/21 Friday symptoms continued from previous day but had strong abdominal pain. I went to my doctor and they suspected I could have appendicitis and also symptoms from the vaccine. They suggested going to the ER after 3 days if systems persisted. I went home after the doctor visit and was nauseous. I had sprite, ate white rice and chicken broth. My abdomen felt a bit better but I had a bad headache. 5/8/21 - Saturday I awoke at 6am with stabbing/burning chest pain that increased as time progressed. The chest pain was increasing and getting worse after 1 hour and 30 minutes. The pain was in the middle of my chest. My mom took me to the Emergency Room.

Pt received vaccine soon after began to c/o syncope episodes. Pt able to walk to cot and lay down. No sob noted. Pt cold and clammy. 911 called paramedics out to assess pt refused to go to hospital. after 30 minutes pt began to feel better. 1st set V/S 530 pm p-88, 02 sat 97, BP 104/80 waited 1.5 hrs for husband to pick pt up. Pt stable no c/o no distress able to ambulate on own home with husband.

seizure; This is a Spontaneous report from a contactable other healthcare professional (HCP). An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Apr2021 at single dose for COVID-19 immunisation. Medical history included Bipolar disorder, Depression, Attention deficit hyperactivity disorder (ADHD) and sleep (disorder). Concomitant medication included cariprazine hydrochloride (VRAYLAR) orally from 18Mar2021 to 02Apr2021 at 1.5 mg, daily for Bipolar disorder; escitalopram oxalate (LEXAPRO) at 10 mg for Depression; amfetamine sulfate (EVEKEO) 2 times a day for ADHD; bupropion hydrochloride (WELLBUTRIN) and mirtazapine (REMERON) for sleep (disorder). It was reported patient experienced seizure on 02Apr2021 after using concomitantly Vraylar, Lexapro, Evekeo, Wellbutrin and Remeron, experienced seizure after using concomitantly Lexapro and Wellbutrin. The initial report from the United States was received via Company representative originating from a nurse on 15Apr2021, regarding an 18-year-old female patient who experienced seizure, drug interaction, and labelled drug-drug interacton medication error following the administration of cariprazine hydrochloride, amfetamine sulfate, escitalopram oxalate, mirtazapine, Pfizer Covid-19 and bupropion hydrochloride. Company received the report on 16Apr2021. Reportedly, the patient began cariprazine hydrochloride 1.5mg daily orally for Bipolar disorder on 18Mar2021, had the Covid-19 vaccine on 01Apr2021, and had a seizure on 02Apr2021. The patient had no history of seizures. The reporter did not believe the seizure was caused by the cariprazine hydrochloride (causality for seizure was also reported as unlikely). The patient was taken to the emergency room but not admitted, treatment and outcome unknown other than the emergency room staff advised the patient to "discontinue everything". The reporter assessed the relationship between cariprazine hydrochloride and the event of seizure as unlikely. Laboratory tests were not reported. The patient experienced the seizure one day after Covid 19 vaccine. Considering the short onset latency, the vaccine was also considered co-suspect. The case in confounded by patient's use of co-suspect medications that could have lowered the seizure threshold. The following important missing medical information will be helpful for further case evaluation: medical history, indications and therapy dates for all suspects, action taken, lab results (drug blood levels), investigations, treatment, outcome. Treatment information was not provided. At the time of the report, the outcome of seizure was reported as unknown. This case was considered serious due to the following seriousness criterion: medically significant. Information on batch number has been request.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. Contributory role of concomitant medications should also be considered. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

slight chills; cold; Extreme nausea/slightly nauseous; Extremely fatigued; Dizzy; Shakiness; Fever/ 101.6 fever/temperature was 100.3; Dehydration; Headache; Muscle ache; Arm pain; Pain; This is a spontaneous report from a contactable consumer. A 18-years-old non-pregnant female patient received bnt162b2 (Pfizer, Solution for injection, Lot Number: EL9264), dose 2 via an unspecified route of administration, administered in arm left on 06Feb2021 12:45 (at the time of 18-years-old) as second dose, single for covid-19 immunisation. Medical history included partial aortic bicuspid valve, aortic dialation, sulfa wellbutrin allergies (known allergies) and postural orthostatic tachycardia syndrome. No other vaccine administered in four weeks. The patient had not covid prior vaccination. The patient had not tested positive for covid post vaccination. Concomitant medication included ethinylestradiol/ferrous fumarate/norethisterone acetate (JUNEL FE) for an unspecified indication, from an unspecified date and unknown if ongoing. The patient previously took bnt162b2 (Pfizer, Lot no EL8982,Administration time=12:15 PM,Vaccine location Left arm, Dose no 1) on 16Jan2021 for COVID-19 immunisation. She received the vaccine at 12:50 PM and my temperature was 98.6 with no symptoms. At 1 am, her temperature went up to 99.6° and a headache, muscle aches and slight chills started. At 4:20 AM, woke up with a 101.6 fever, extreme nausea, dehydration and shakiness. In the morning at 9:00 AM temperature was 100.3 and when I got up around 12:00 PM, was extremely fatigued, dizzy when standing, and slightly nauseous which made it hard to eat normal foods. At 1:20 PM, temperature was 100.7. At 7:00 PM, nausea subsided slightly and was able to eat normal foods. At 10:00 PM, cold chills began in and at 11:00 PM, temperature was 100.4. The next day (08Feb2021), my temperature was at 97.8 upon awakening and felt dizzy, tired and winded with regular activities throughout the days but no fever. By the next day (09Feb), patient was completely syptom free. Arm pain was very minimal, pain level 1, on the day of vaccination and the day after and gone after that. The patient underwent lab tests and procedures which included body temperature: 101.6 (at 4:20 patient temperature was 101.6), 100.3 (at 9 temperature of patient was 100.3), 100.7 (at 13:20 patient temperature was 100.7), 100.4 (at 23:00 patient temperature was 100.4), 99.6 (at 13:00 patient temperature was 99.6F) on 07Feb2021, and 97.8 (patient temperature was 97.8) on 08Feb2021. The patient not received treatment for events. The outcome of events recovered on Feb2021.

About 10 mins after receiving the vaccine, patient dropped phone and was slumped in chair. Nurse approached patient and patient could not hear or see her. Hands were trembling and body was distorted. Arm felt heavy and she could not hold anything.

Prior to vaccination, the patient reported a history of feeling light headed during and immediately after procedures involving needles. Patient completed pre-screening checklist for Pfizer COVID-19 vaccine and was administered 0.3mL of Pfizer BioNTech vaccine IM in left deltoid at 3:28pm. At 3:30pm patient began to appear pale and lethargic. Patient reported that she felt light headed and dizzy. Patient's mother encouraged her to drink water. Patient was assisted to lie down on ground. The first set of vital signs were taken at 3:34pm. Pulse was 68, regular and thready. Respiratory rate was 12 breaths per minute and unlabored. Blood pressure 73/43. Oxygen saturation 98%. Pt reported soreness in left arm and no other pain. An ambulance was called. At 3:40pm, vital signs were PR 71, RR 12, BP 86/59, O2 Sat 98%. Patient reported minor nausea. At 3:45pm vital signs were PR 71, RR, 14, BP 106/70, O2 Sat 96%. Patient reported a headache. Ambulance arrived at 3:48pm. Patient was assisted to stand and walk 10 feet to stretcher. Ambulance Unit transported patient to Hospital.

5 minutes after administration, she started having a headache and then nausea. Afterwards she felt hot and was shaking. She reported chest pain. Vitals were stable. EMS transported her due to inability to reach parents and inability to drive herself home.

5 minutes after receiving the vaccine, she reported headache, nausea, shaking, and some chest pain. Vitals were stable. Transported by EMS due to inability to reach parents or drive herself home.

Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Mild, Additional Details: got emotionally excited after shot fainted for 25 seconds, patient was tired bur responsive

Patient frequently faints following vaccinations. About 2-3 minutes after receiving vaccination, patient fainted while sitting in a chair. Once patient began to come to, she convulsed. Pharmacist and nearby customers helped lay her on the ground. Patient came to and was given water and a glucose tablet. EMS was called at the start of the incident. Patient remained lying down until she felt ok to sit up. EMS checked her blood pressure, which was normal and she was ok to go home.

burning sensation all over/her skin felt like it was on fire; burning sensation all over/her skin felt like it was on fire; breaking out in hives; This is a spontaneous report from a contactable consumer, the patient's mother. An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot ER8735, second dose) solution for injection intramuscular in the right arm on 03May2021 (at the age of 18-years-old) as a single dose for COVID-19 vaccination. There was no relevant medical history. There were no concomitant medications. Historical vaccine included BNT162B2 (first dose, Lot ER8731) for COVID-19 vaccination on 11Apr2021 with no adverse effect reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 06May2021, the patient was breaking out in hives. On 09May2021, the patient had burning sensation all over/her skin felt like it was on fire. The patient was taken to the doctor (office visit). By Sunday (09May2021), the patient was completely covered and went to the ER (emergency room) where she was treated with IV diphenhydramine (BENADRYL) and steroids. The patient was not admitted to the hospital. The outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.

Patient was administered Pfizer COVID-19 vaccine and fainted during her 15 minute observation time. Mother alerted pharmacy staff. Pharmacist observed patient regain consciousness. Patient reported feeling warm, was sweating, and saw spots of light. Patient was given a bottle of water and and instant cold ice pack. Patient observation time was continued. After fifteen minutes patient was feeling better and left pharmacy with mother.

-Bleeding from vagina (I don?t start my period for another two weeks) -Nose bleeds -Heat flashes (feels like a fever) -Gets cold really easily (shivering and chattering teeth) -Large rash on arm -Unable to eat as much -Fainting -Stomach ache -Headaches

1) Major rash on face, chest and stomach. Very painful, swollen, itchy and uncomfortable. Started day of vaccine. Still present, 4 days later. 2) Lots of vomiting. Started day after vaccine. Lasted 1 day. 3) Abdominal pain. Started day after vaccine. Lasted 2 days. 4) Lots of diarrhea. Started day after vaccine. Lasted 2 days.

arm hurting, sore arm; vaccine was mixed with sterile water instead of saline; vaccine was mixed with sterile water instead of saline; felt unwell after her 2nd dose; tired and does not feel great; This is a spontaneous report from a contactable consumer (patient's mother). An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot Number unknown, expiration date unknown) 2nd dose, single dose, via an unspecified route of administration on 18May2021 11:45, for covid-19 immunization (at the age of 18-years-old). Medical history included covid-19. It has been a couple of years since patient had not received any other vaccine. There were no concomitant medications. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number unknown, expiration date unknown), via an unspecified route of administration on 27Apr2021, as single dose for covid-19 immunization at the age of 17-years-old and had really high fever, ears really hurting, Ears got so puffy and filled with fluid. It was stated, that her 18-year-old daughter already received both doses of the Pfizer-BioNTech Covid-19 Vaccine. She said her daughter was 17 years old when she received the 1st dose, but was 18 years old when she had her 2nd dose. She said her daughter had a really bad reaction to the 1st dose, and also felt unwell after her 2nd dose. The reporter stated that on 18May2021 11:45 the patient received second dose of vaccine and stated that someone from pharmacy told that patient's vaccine was mixed with sterile water instead of saline and after receiving the vaccine the patient felt unwell and she was tired and does not feel great on an unspecified date in May2021 and on 19May2021 patient's arm was hurting and had sore arm. Reporter wanted to know if her daughter gets revaccinated or whether she was still fully vaccinated. She was referred to her health care provider for that information. Pfizer has not tested the effects of using sterile water for injection as the diluent for the current formulation of the Pfizer-BioNTech COVID-19 Vaccine. The diluted vaccine using sterile water for injection as the diluent should be appropriately discarded and not used for vaccination. The Pfizer-BioNTech COVID-19 Vaccine has not been tested with sterile water for injection as the diluent. The outcome of the events was unknown. Information on Lot/Batch number has been requested.

Problems with her heart; Shortness of breath; Pain the chest; Low blood pressure; Passed out; Started shaking "like a seizure"; Started shaking "like a seizure"; Dizziness; Tiredness; Stomach pain; Chills; Fever; Sweats; Nausea; Vomiting/throwing up; Inflammation in the chest, muscle or maybe heart inflammation; Inflammation in the chest, muscle or maybe heart inflammation; Inflammation in the chest, muscle or maybe heart inflammation; Pain in the heart; Not feeling well; Had a severe allergic reaction; Headache; Weak; This is a spontaneous report from a contactable consumer (patient's mother). An 18-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0169; Expiration date was not reported) on the left arm on 20Apr2021 as a 1st dose, single dose, with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history and concomitant medications. On 20Apr2021, the patient had passed out; started shaking "like a seizure"; dizziness; tiredness; stomach pain; chills; fever; sweats; vomiting/throwing up; and nausea. The patient was brought to urgent care/emergency room (ER) due to the reported events. On 21Apr2021, the patient had shortness of breath; pain in the chest; and low blood pressure. On 22Apr2021, the patient had problems with her heart. The patient was brought to urgent care/emergency room (ER) due to the reported events, and for cardiac work up. On an unspecified date in 2021, the patient was not feeling well; had a severe allergic reaction; headache; and was weak. In Apr2021, the patient had "inflammation in the chest, muscle or maybe heart inflammation". The patient received treatment for the events, pain in the chest and "inflammation in the chest, muscle or maybe heart inflammation" (double dose of naproxen. The patient's laboratory tests included normal blood pressure on 22Apr2021; chest x-ray on 21Apr2021 (results were not provided); echo sonogram on 22Apr2021 (results were not provided); electrocardiogram (EKG) was normal on 21Apr2021, 22Apr2021 and 23Apr2021. The outcome of the events was not recovered for tiredness; was recovered on an unspecified date in 2021 for chills, sweats, vomiting/throwing up; was recovering for pain in the chest; and was unknown for all the other events. The patient's primary care provider was writing a doctor's note recommending that she not receive the second dose based on her reaction to the first dose, and the PCP recommended that the mother call Pfizer as well.

within 34 hours of the 2nd dose of the Pfizer Covid shot, patient began to break out in welts/hives behind her knees. She woke up in the middle of the night with her scalp itching and her ears hot as well as the welts behind her knees. Given Benadryl which helped a little for about 2 hours but then the hives just kept spreading and growing into huge swollen itchy patches on her body. By Friday afternoon, she had tried Benadryl and calamine lotion only to have it continue to get worse. We ended up with the Urgent care by 4pm Friday, 4-30-21. They gave her Prevacid and prescribed steroid cream. They told us if it got worse or affected breathing to go ER. We went home and kept taking the benedryl every 6 Hours and using the steroid cream. as one welt would begin to disappear, others would pop up. the steroid cream did not help in that regard. the benedrul would give about 50% relief for about 2 hours before the itching got very bad. Unable to sleep to do anything, we took patient to the pediatrician that Sat morning 5-1-21. She examined her and told her to take Claritin in the morning and Zyrtec at night to help. She was hestiant to prescribe any steroids due to unknown interaction or affects with the Covid shot. She told us to keep checking in with her and also if it got worse or spread to her face/mouth or any trouble breathing to go to the ER. We went home and tried to take an oatmeal bath. It only made things worse. By 10pm that Sat night 5-1-21, the hives had spread to patient's face and lips and were affecting her throat. Her voice got very raspy. we decided at that point to take her to the ER. They started her on steroids that night. She continued taking the steroids for 5 days after that. The steroids did help make her hives go away. However, within 2 days of finishing the steroids, patient noticed that she still did not feel 100%. That Saturday 5-8-21, She began to feel light-headed and off. She also began to feel fatigued. She came home from an errand needing to lay down and feeling dizzy. A few days after that, she began to have gas and indigestion, feeling like something caught in her throat and feeling nauseous. She also noticed that there a few nights in all of this that she would wake up shivering for no reason. The shivering would continue until she woke up in the morning. This report is being filed on 5-30-21. Since her 2nd shot and after the hives, we have been dealing with ongoing dizziness, fatigue, tiredness, lightheadedness and nausea to varying degrees. She has not been able to resume regular activates of being active or working out. WE have been back to the dr.

Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Additional Details: patient said she felt dizzy, and the pasted out. Her boyfriend was with her, and helped me lay her on the floor. She Shook or seized for a few seconds and then came to. She was confusion at first, but then recognized her boyfriend. She asked him to call her Mom. I talked to her Mom on the phone while she was starting to feel better. We got her some water and a fan. I had her wait an extra 30 minutes after she come to.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient got the pfizer vaccin 11:00am and after 2-3 min after din't answer back my question like you have to stay 15 min then i'll give your immunization card which will be 11:15am but was mummering and showed syncope symptomes soI make th patient kind of lie down and check patient in 2 min. but she was still said feld so dizzy so I had to call 911 and 911 came check bp & Temp. BP was low so 911 team took her ER. About 4:33 pm patient came home checked 5-30-21 she was fine

Approximately 10 minutes after the shot, patient reports not feeling well, rapid heart beat, shakiness, and has difficulty breathing (feels like her throating is closing up). Gave one dose of 0.3 mg Epi-Pen 15 minutes after the vaccine. Called paramedics and arrived at 5:35 pm when patient was taken to the hospital. Patient was alert when she was picked up by the paramedics.

36h after "broke out with hives and patches all over the body with extreme itching; 36h after "broke out with hives and patches all over the body with extreme itching; her ears turned red and became very hot, the hives spread to her face and into the throat; her ears turned red and became very hot, the hives spread to her face and into the throat; gastrointestinal issues; very gassy feeling of something stuck in the throat; skaes and shivered out of blue; felt lightheaded and dizzy with extreme fatigue; felt lightheaded and dizzy with extreme fatigue; nausea; This is a spontaneous report from a contactable consumer (Patient's Mother). An 18-year-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 an unspecified date as 2ND DOSE,SINGLE DOSE for covid-19 immunization. The patient's medical history included Hashimoto's Disease. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 on 31Mar2021 for covid-19 immunization and experienced severe indigestion, vomiting and did not feel well. On an unspecified date (36 hours after receiving the second dose of vaccine), the patient broke out with hives and patches all over the body with extreme itching, her ears turned red and became very hot, the hives spread to her face and into the throat. The patient was prescribed steroid creams, and she self-administered three antihistamines included Zyrtec, Claritin, & Benadryl. The hives went away. After that on an unspecified date, the patient had gastrointestinal (GI) issues, she had very gassy feeling of something stuck in the throat, and had nausea to the point of being unable to eat. Also, she shivered and shakes out of the blue, felt lightheaded and dizzy with extreme fatigue. The patient received treatment with steroid creams, and antihistamines included Zyrtec, Claritin, & Benadryl for the events 36h after "broke out with hives and patches all over the body with extreme itching and her ears turned red and became very hot, the hives spread to her face and into the throat. The caller (reporter) mentioned that she heard that the vaccine causes problems in fertility hence caller asked for information on fertility studies with regards to the vaccine in response she was explained reports on the possible side effects, mentioned no information found for non-reported AEs, and referred to health care professional (HCP) for further guidance. Further, caller asked for information on how to treat or go about with the side in response she was informed that Pfizer was unable to make treatment recommendations specific for individual patients and referred to HCP for further guidance. Again, Caller asked, "how the vaccines work" in response she was explained about vaccine mechanism and CDC information. Caller asked if there was a way to measure the spiked proteins in the body as caller wanted to know how to measure/assess immunity after vaccination in response she was being explained about CDC recommendation, and referred to HCP for further guidance. Moreover, caller asked if there were other proteins in the body/organs/cells that were similar to the spike protein that our body could possibly react to in response mentioned that no information found on body components similar to the SARS-CoV2 Spike Protein, and she was referred to HCP for discussion. Caller complained and mentioned "reporter don't think all this information is being made public, it just seems to me like the issues for the vaccine is much worse for her than as if she got COVID19. Reporter really hope that the Doctors/ CDC / Pfizer and all organizations would reconsider this, especially on the possibility on the issue on the body attacking its own self." The outcome of the event hives was considered as resolved while the outcome of all other reported events was unknown at the time of this report. Information on Batch/Lot number has been requested.

Systemic: Flushed / Sweating-Medium, Additional Details: at 12:11pm pt was sweating and very hot, turned on fan whil ewaiting for 15min, pt left with mom at 12:36pm no other issues reported

fell straight over on her face, hitting her chin and splitting it open; felt dizzy; cold sweating; panic attack; significant memory loss; mild concussion; dehydration; fell straight over on her face, hitting her chin and splitting it open; insufficient food intake (had not eaten yet); felt more sick then usual; This is a spontaneous report from a contactable consumer. An 18-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8736, expiration date: not reported), via an unspecified route of administration on 14May2021 as single dose for Covid-19 immunisation (Age at Vaccination: 18years). The patient medical history was not reported. Concomitant medications included fluoxetine hydrochloride (PROZAC) 10mg/day (as medications in two weeks) taken for an unspecified indication, start and stop date were not reported. No known allergies and no other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 15May2021, the patient felt dizzy, had cold sweating, was scared, and thought she was having a panic attack but felt more sick than usual. On 15May2021, the patient stood up from couch, walked 15 - 20 steps and then fell straight over on her face, hitting her chin and splitting it open; she was conscious when rolled over by her parents but had significant memory loss (knew her name but not her school grade or which classes she was taking). She was taken to the hospital, computerized tomogram (CT) Scan, electrocardiogram (EKG) was normal, and no evidence of seizure were there. On 15May2021, the patient was diagnosed with mild con-cussion and got stitches on the chin as therapeutic measure for her chin splitting. Doctor suggested dehydration may had been a factor, also insufficient food intake (had not eaten yet) (start date: 15May2021). The patient stayed home from school for a week with memory improving each day and still did not remember completely a period of 48 hours starting around time of vaccination however, other symptoms had resolved. The patient had never fainted before. The treatment for rest of events was unknown. The patient underwent lab tests and procedures which included CT scan and EKG both as normal, both on 15May2021. The outcome for mild con-cussion and significant memory loss was recovering; and rest all events were resolved.

patient first felt dizzy and nausea. she also has blur vision and tingling on extremities. up on checking blood pressure first it was error, than switch arm it was 70/52 HR 66; 2 minutes later blood pressure went back up to 103/77 HR 90; continue monitor patient for the next 20-30 minutes, sent patient home with her mother who is the ER nurse when the patient was stable at blood pressure 128/88, HR 99. vision came back, no more tingling sensation when she was leaving the facility.

That night I was feeling groggy in the head which I knew is a normal side effect. But later that night I couldn?t go to sleep and began to shake all over my body. I did not have shortness of breath, or heart pains- I just couldn?t stop shaking. I tried to control my breathing to help but it did nothing. After the shaking stopped I tried to sleep again but I threw up twice and could not fall back asleep.

she fell on the floor and become unconscious; she fell on the floor and become unconscious; She got sick; she lost all energy; She hurt her throat its like she can read but she has very heavy under her neck; She hurt her throat its like she can read but she has very heavy under her neck; This is a spontaneous report from a contactable consumer (Father). An 18-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot Number: EW0185), dose 1 via an unspecified route of administration, administered in Arm Left on 28May2021 16:00 as 1ST DOSE, SINGLE for covid-19 immunisation. Patient Medical history and concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. It was reported that, On 28May2021 caller stated that we took our daughter to get vaccinated on 28th and she loss of conscious and she got sick, and it took almost 24 hours to recover so we need to get the forms, so she does not get her second shot and we do not want to have a second shot for her because of the lot reaction on her body. In the 22nd day later she fell on the floor and become unconscious, and she lost energy and you know it takes time to come up and it take 2-3 minute to come up and she lost all energy and she hurt her throat it's like she can read but she has very heavy under her neck. The event loss of consciousness, fall and illness was recovered on unspecified date in 2021.The event musculoskeletal discomfort oropharyngeal pain and asthenia was unknown. Therapeutic measures were taken Tylenol and green juice as a result of she fell on the floor and become unconscious (loss of consciousness), she fell on the floor and become unconscious, she got sick, she lost all energy, she hurt her throat it's like she can read but she has very heavy under her neck, she hurt her throat it's like she can read but she has very heavy under her neck (oropharyngeal pain). No follow-up attempts are possible. No further information is expected.

On the same arm around the area lower than the armpit towards the breast she felt pain.; On the same arm around the area lower than the armpit towards the breast she felt pain. The caller thinks it was just the lymph nodes; having pain in her left arm, which is the arm she had her COVID vaccine in, under her armpit towards her breast area; This is a spontaneous report from a contactable nurse (parent). An 18-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in left arm on 24May2021 (at the age of 18-year-old) (Batch/Lot Number: EW0179) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient had no relevant medical history and no concomitant medications. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EW0165) on 03May2021 (at the age of 17-year-old) as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The nurse was calling about her daughter who experienced some side effects after receiving the Pfizer COVID Vaccine on 24May2021. The daughter had the vaccine administered on the left arm. On the same arm around the area lower than the armpit towards the breast she felt pain. The nurse thinks it was just the lymph nodes and nothin to worry about but the daughter wanted to hear that from someone else and not form her. The nurse was asking if this what the daughter was experiencing was normal and was it the lymph nodes. The nurse further reported that her daughter was having pain in her left arm, which was the arm she had her COVID vaccine in, under her armpit towards her breast area and she was wondering if that was normal. The nurse stated that personally she thinks that it was from her daughter's lymph nodes but since the nurse was the patient's mom, she would rather hear this from someone else. The events started on 25May2021. The reporter considered the events as serious medically significant. The patient had not yet recovered from the events.; Sender's Comments: The events Breast pain, Lymph node pain and Vaccination site pain are assessed as possibly related to the suspect bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), based on strong temporal association.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

The patient was in her usual state of health until the morning of Saturday 5/29/2021, when she woke up with an acute-onset right-sided headache and started screaming, followed by encephalitic presentation with urination on her mom's office desk and altered mental status. She also had right-sided facial droop. Patient was not oriented to person, place, nor time. The patient was started on acyclovir 650mg every 8 hours for 14 total days (day 1 = 5/30/2021) and had relatively rapid improvement over the course of the first 2-4 days despite negative HSV 1/2 PCR. She was continued on this treatment for the duration of her hospitalization as well as for one week as an outpatient via PICC line (final day = 6/11/2021). She has not had another episode of altered mental status since the onset of treatment and is now symptom-free with mild, transient headaches lasting a matter of seconds to minutes.

After vaccination, patient was sitting in a chair and got up to say she was feeling lightheaded then fainted. Patient regained consciousness within seconds. Patient was helped up in a seated position in a chair and was instructed to take deep breaths and keep head between knees. Patient was also given water and fruit snacks. An ice pack was also placed on the back of patient's neck because patient complained she was feeling hot. Patient was able to communicate and remember details. Patient did not complain of any pain anywhere on the body. Pharmacy technician was at the patient's side the entire time after she regained consciousness. Patient was able to call her mother to pick her up and drive her home.

Friday night chills, fever, muscle spasms and headaches. Everything went away except headache, fingernails and toe nails turned purple Saturday.

Pain in arm, then got really tired and headache felt hot yet cold, woke up around 3 AM needing to use restroom. Couldn't fall back asleep then checked temperature, 100.7 Took Tylenol but didn't really help. Fever went away around 10 A.M. that morning, but I was super tired and fatigue

The evening after receiving the vaccine, pt began having headache, lightheadedness, shortness of breath, nausea, loss of appetite. Th next day (6/10) she notedmyalgias in lower back and hips with shooting pains in her knees and vomiting. She also noted mild fever and chills, nasal congestion and discharge with mild sore throat, and substernal chest discomfort. She described it as tightness with radiation to her throat and jaw, and right arm, witout radiation to her back, not associated with nausea, but is associated with shortness of breath and diaphoresis. Chest discomfort worse with lying down. Rapid COVID test negative. Upon arrival to ED on 6/11, her troponin was mildly elevated (0.039ug/L), D-dimer elevated at 348ng/mL, CRP also elevated at 5.96 mg/dL. ED physician diagnoses acute myopericarditis and patient was admitted to Critical Care Unit. On 6/13/2021 patient was discharged stable (limited bedside echo showed small pericardial effusion). Pt denies pleuritic chest pain on day of discharge.

On June 13 Bell's palsy was noticed in left lip area and had lasted since then with no improvement as of yet. Follow-up with doctor on June 18

Patient received IM Pfizer dose in Left arm at 4:10pm and moved to the waiting area. About 5-10 min later she had developed a red, slightly raised blotch area around the injection site and down her left arm. She said it did not itch, but felt warm and slight burning feeling. Patient complained of being hot and nervous, but breathing was normal no chest tightness. We had her get up and go outside (with 2 nursing staff members) to see if fresh air and no mask would help calm her. On coming back in, the rash was still present and a small patch developed on her other arm. WE gave her a cold compress and measured out 75mg of liquid diphenhydramine. She took the diphenhydramine. After about 5min, we saw the rash spread to her chest and connect the upper right and upper left arm area rashes. We then called EMS to come assess the patient. After assessment by the EMT and speaking with her PCP the patient decided not to go to the hospital for observation. Rash was still present 1 hour later when patient left. Breathing remained normal throughout the entire event and no swelling of face/tongue.

First dose 4/10/21 after face flushing and dried and skin tighten, itchy took Benadryl at nite for relief, rashes show on legs and body area. Second dose 5/1/21 after 2 days body hive, face red and dry tighten skin, itchy head flaky. Patches of rashes head to toes and dry skin. Contact allergist recommend taken Benadryl at nite, Zyrtec 1 pill during day.

6/16/21 patient had an episode of syncope within 5 minutes of vaccine administration - fell and hit tailbone first, then hit head against the ground and had brief seizure witnessed by mother (full body shaking), LOC, unresponsive, pale and cold/clammy. lasted for several seconds. no PMH of syncope, seizures. no medical problems

I started experiencing pain in my calf on 4/21 that same night of the vaccination. There was a tight feeling in my knee and every time I took a step with my right leg there was pain that radiated down my calf. It almost felt like a muscle pain so I ignored it for a few days. By 4/24 the pain had gotten so bad that I didn't want to walk anywhere and cried when I walked. My mom came and picked me up and took me to the urgent care center. They asked me a few questions and told me that I needed to go to the ER to get checked for a blood clot. I went to hospital on 4/24, and an ultrasound of my knee was done. The doctor diagnosed me with a blood clot and told me to stop taking the Xulane which was my birth control at the time. They told me to follow up with my OBGYN and a hematologist. (I had been on my birth control for about 6 months and I have never had any issues with blood clots and they do not run in my family. The NP is who told me to report my blood clot to the CDC because she is a little suspicious that the shot is where it come from.)

immediately post vaccination pt arm felt tingly she said. 15 mins later it radiated to her lower arm. pt waited additional time and pt wanted to leave. bp is 113/80 pulse rate 91

AFTER VACCINATION, PATIENT SAT AT THE WAITING ROOM. WITHIN A FEW MINUTES HE BECAME PALE WITH COLD CLAMMY SKIN, THROAT SWELLING, SLOW THREADY PULSE, SEIZURE LIKE SYMPTOM, BARELY RESPONDING WHEN WE TRIED TALK TO HIM. 911 WAS CALLED IMMEDIATELY AND EPIPEN WAS GIVEN WITH DADS PERMISSION. AFTER A FEW SECONDS, PT BECAME ALERT AND CAN RESPOND WITH US. I MONITORED HIS RESPIRATION AND PULSE RATE WHILE WAITING FOR EMS. EMS TOOK OVER APPROX. WITHIN 10 MINUTES AND TOOK THE PATIENT TO THE EMERGENCY ROOM.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: After vaccine, pt bled slightly at injection site. She saw the blood and started to feel faint, tingly lips, flushed and then lost color in her face. I instructed her to deep breath and elevated her feet since she felt she couldn't move to be laid down. Finally she was able to stand up, I assisted her to the floor the pharmacy, elevated her feet, and she improved immediately in the supine position w/ feet elevated. She recovered 100 percent without fainting or losing consciousness.

Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Shakiness-Severe, Systemic: Weakness-Severe

looks like fainting but she begin to convulse in her legs in her arms; seizure event; looks like fainting but she begin to convulse in her legs in her arms; seizure event; She couldn't see that her vision was blurry and she was seeing spots in front of her eyes; Dizzy; She couldn't see that her vision was blurry and she was seeing spots in front of her eyes; This is a spontaneous report received from a contactable pharmacist. An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0185 and expiration date 31Aug2021), on 07Jun2021 (at the age of 18-year-old) as 1st dose, single dose (reported as first COVID vaccine) for COVID-19 immunization. The patient's medical history was reported as no appointment history. The patient's concomitant medications were not reported. It was unknown if patient was taking concomitant medications, reporter believed they said like birth control pills. The pharmacist stated that he/she did not believe that patient received other vaccine within 4 weeks, he/she did not know, they did not report that. Pharmacist stated that he/she administered the vaccine to the patient, about he/she would say less than 5 minutes later she said she had been having the reaction to the vaccine she said that she could not see that her vision was blurry and she was seeing spots in front of her eyes. Pharmacist saw, wanted step down and he/she asked her if she was having any signs of the anaphylactic reactions like swelling of the face or top of the lip or tongue if she could swallow correctly, If she felt that she could breath and all of those things were normal however she said that she felt very dizzy so he/she suggested to lay her on the floor because he/she assumed that she was like she was going to faint and then started to, like her eyes sort of curl she looks like fainting. Pharmacist also stated that so, he/she would asking for questions about how she felt and then she said she felt dizzy and he/she suggested that they potentially put her on the floor in case she might faint and then she started to looks like fainting but she began to convulse in her legs in her arms and he/she would say that it happened for roughly he/she did not know 5 seconds only the mom and his/herself the mom really pulled her on the floor urgently and once she was on floor all of all of it stopped and she regained consciousness and the mom was not it was just normal thought she was fainted or she had a seizure event. The mom said that this was not something that ever happened to her daughter before with the vaccination. Pharmacist stated that the event was resolved but she was going to the hospital for a neurological (as reported). Pharmacist did not know if lab data were performed. Pharmacist stated that as he/she know of no treatment due to the event was administered. Reporter's seriousness was not specified. The outcome of the events was resolved.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Seizure and Fainting cannot be 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.

Flare of underlying Evans Syndrome, with onset of severe thrombocytopenia occurred 2 weeks and 6 days after the first injection.

Pt arrived for first dose of Pfizer vaccine, no history of reactions to vaccines and no known allergies. Patient did fine initially after her shot, dad denies patient feeling anxious and nurses noted patient seemed calm before and after her vaccine. Pt was sitting/leaning on dad towards the end of her 15 mins, he then felt her become heavy on his arm and noticed she had passed out. Observation nurse and another nurse working the clinic got the patient on her side (she was on a bench seat) and took vitals, put a cold water bottle behind her neck. Initially her bp was low (88/62) and progressively became higher, getting up to 146/98 at one point. Pulse/Respirations were WNL. Patient was in and out of consciousness so EMS was called and transported to Hospital emergency department. Patient evaluated with EKG, labs, and neurology consult. Urinalysis consistent with urinary tract infection. Patient discharged from emergency department with antibiotics and follow-up with primary care provider.

She did experience left arm pain, headache, swollen lymph nodes, hot flashes, and feeling blah; She did experience left arm pain, headache, swollen lymph nodes, hot flashes, and feeling blah; The 18 year old daughter has experienced nausea, upset stomach (no diarrhea), and tiredness that continues.; The 18 year old daughter has experienced nausea, upset stomach (no diarrhea), and tiredness that continues.; The 18 year old daughter has experienced nausea, upset stomach (no diarrhea), and tiredness that continues.; She did experience left arm pain, headache, swollen lymph nodes, hot flashes, and feeling blah; She did experience left arm pain, headache, swollen lymph nodes, hot flashes, and feeling blah; She did experience left arm pain, headache, swollen lymph nodes, hot flashes, and feeling blah; This is a spontaneous report from a contactable consumer (Patient's Mother) via Medical information Team. The reporting mother stated that she and her two kids (son and daughter) received the first dose of the Pfizer Covid 19 Vaccine on 07June2021. Herself and her son too experienced headache, soreness in arm, and she additionally had nausea for a short period. This case is for daughter. A 18-year-old patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN0179), via an unspecified route of administration, administered in left arm on 07Jun2021 at 14:45-14:55 (Monday) (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Patient has taken vaccine as everybody was getting it and was strongly suggested. Medical history included ongoing anxiety and egg allergy (reaction to egg at the age of 2 and swelled up and went through testing, she can't take a flu vaccine because it has egg in it, highly suggested to never eat an egg, she can eat cake and that has egg in it, but they do not want her to have the flu vaccine. States they have got to make sure any vaccine does not have egg in it). Patient can't take a flu vaccine because it has egg in it. Reporter stated that she panicked a bit but they told her it doesn't have egg in it, she doesn't know what the ingredients are. Patient is overweight (190- something). No familial history relevant to AEs. There was no history of previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date. Concomitant medication included vilazodone hydrochloride (VIIBRYD) taken for anxiety (started this 6-7 weeks ago), patient been on some other stuff and trying to figure that out. Sees a therapist too. Assuming Antianxiety. No prior vaccinations within 4 weeks. On 08Jun2021 (in the morning), patient had upset stomach (no diarrhea), and tiredness, left arm pain, headache. On 10Jun2021, the patient felt yucky and nauseated, lymph nodes were swollen and feels kind of blah. It was reported that the nausea has come and gone but she still complains about an upset stomach and patient has not thrown up. Those symptoms have subsided at this time. On an unspecified date, patient felt hot flashes. Patient consulted a therapist too. Patient took Advil on 08Jun2021 as a treatment as the arms were sore. Patient did not have any visit to emergency room or physician office. Reporter asked if it's normal to continue to have symptoms. The patient second dose was scheduled on 28Jun2021 and reporter asked about the chances of the same side effects with the second Pfizer Covid 19 Vaccine. The outcome of the events nausea, headache, lymph nodes were swollen, and sore left arm was recovered, while event hot flush was unknown and other events were not recovered.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient was seated at the post vaccination area on a bar stool provided by the store when she felt light headed and fainted. Upon falling off the bar stool she hit her head on a water fountain located next to her. Her ankle was also tangled within the constructs of the chair and was broken upon falling. 911 had to called for assistance and she was taken away.

Adverse event: Involuntary musclejerks started on 4/14/21. Muscle jerks started with shoulders and now affects arms head, shoulders, and sometimes whole body. Outcome: diagnosed with myoclonic jerks involving head, neck, and extremities. Treatment: low done Keppra trial advised

She had a pass out instance and She ended up being diagnosed with seizures; This is a spontaneous report from a contactable nurse This nurse (patient's mother) reported. A 18-year-old female patient (reporter's daughter) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration on 03May2021 (age at vaccination 18-year-old) at DOSE 2 SINGLE for covid-19 immunisation. The patients medical history was not provided and concomitant medications were not reported. The patient previously took first dose of BNT62B2 (PFIZER-BIONTECH covid-19 vaccine, formulation: solution for injection, lot number: unknown) on an unspecified date in Apr2021 (age at vaccination 18-year-old) via an unspecified route of administration as DOSE 1 SINGLE for covid-19 immunization. Reporter stated, her daughter received the second Pfizer vaccine on the 03May2021 and she had a pass out instance and she ended up being diagnosed with a seizures on at the morning at the 08May2021 and they, we took her to the hospital. patient was in the Emergency Room on the morning of 08May. Reporter asked that was there any reaction that have occurred from Pfizer related to that. Because it was within 5 days of her receiving the vaccine and she has never had any instance like this in her life. patient received treatment with Keppra, 500mg, twice a day. The patient underwent lab tests and procedures which included test Investigation which was all fine on an unspecified date.The outcome of event was unknown. Information about Lot/Batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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 and Investigators, as appropriate.

left arm at the injection sight developed a huge (between golf & tennis ball) itchy bump that was painful to touch; Arm is still a bit tender; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208), via an unspecified route of administration in the left arm on 11Mar2021 at 17:15 (at the age of 18-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma. The patient was allergic to dogs, pollen, mould, guinea pigs and dust. Concomitant medication included isotretinoin (CLARAVIS) 40mg; from an unknown date for unspecified indication. The patient did not receive any other vaccines within four 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 Saturday, 20Mar2021, the patient developed a huge itchy bump (between golf & tennis ball) on the left arm at the injection sight, that was painful to touch. The arm was still a bit tender and the bump had reduced in size. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events vaccination site lump and pain in arm was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.

left arm numbness; tingly; muscle aches; This is a spontaneous report from a non-contactable other healthcare professional. An 18-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: EN6207) via an unspecified route of administration on 18Mar2021 (at the age of 18-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 18Mar2021, during 15-minute waiting period after the vaccination, the patient experienced left arm numbness and tingly. The patient denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, light-headedness, dizziness, facial swelling, lip swelling and tongue swelling. The patient also complained of muscle aches. The patient was treated with water and she had an excellent response to the treatment. The patient was stable to go home and follow up with primary care physician. The clinical outcome of the events arm numbness, tingly and muscle ache were unknown at the time of report. No follow-up attempts are possible. No further information is expected.

Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Vomiting-Mild, Additional Details: 911 was called. Evaluated and all vitals were good. Rescue felt it was a panic attack. Mom told to follow up with ER visit- rescue offered to call ambulance but mom denied. Patient left feeling better.

Pt experienced mild symptoms in the first 24-48 hours after the vaccination, including sore arm, low grade fever, chills and fatigue. These symptoms faded within 48 hours. Approximately one day later, Laila experienced an acute onset headache (tension) which has been constant for the past two months. She describes this tension headache as a band of pressure all the way around her head that never goes away. The constant headache does not interfere with her sleep but impacts her quality of life. She also has intermittent headache pain a few times a week that is more intense but which responds to Excedrin Migraine. She has been taking Topiramate for the past 3-4 weeks to try to address the tension headache but so far it has not relieved the constant headache.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient fainted after several minutes of the vaccine administration. She hit her head and twisted her ankle when she fainted according to witnesses/mother.

Covid vaccine on the late afternoon of 7-5-21. At 11pm, general body aches turned into horrific pain all over her body. Described as stabbing pain and electric shocks. Headache, stomachache and crying. At 10am on 7-6-21, she had chest pains and a heart rate of 170. We drove to the ER. By the time she was checked into ER, heart rate was 150 and she had a fever of 101.9 Tachycardia treated with large dose of Versed given in IV?did not work. Toroidal given for pain to reduce fever. That worked. Heart rate staying at 130 and she is in horrible pain. X-rays, lab work. Atavan given at 3:40pm which helped calm her. But heart rate stayed at 130. Inflammatory blood work was elevated. D-Dimer test was elevated. CT scan normal. At 2:30am on 7-7-21, Pt finally fell asleep. She woke up with a normal heart rate in the 80s by 7am. Critical care doctors consulted with cardiology and examined her. Pain was gone, fever gone, and heart rate was normal. They think the Covid vaccine caused her tachycardia and caused a fibromyalgia flare up with her extreme pain. Extreme pain all over body ?electric pain. Headache Stomachache Chest pains

Extreme bleeding; Cramping; Tightness in chest; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 18-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 23Jun2021 (at the age of 18-year-old) at dose 1, single for covid-19 immunisation. Medical history included acne. Family medical history relevant to adverse event was none. Patient did not administer additional vaccines on same date of the Pfizer Suspect. History of all previous immunization with the Pfizer vaccine was not considered as suspect. Patient did not have adverse event following prior vaccinations. Patient did not have prior vaccinations within 4 weeks. Concomitant medication included trimethoprim (TRIMETHOPRIM) at 100mg taken for acne from an unspecified date in Dec2019 and ongoing (Trimethoprim: Patient has been taking this medication for over a year and never had any issues with it. She started it and stopped it and then they had her start it again. It has been sporadic based on her acne). The patient experienced extreme bleeding, cramping, tightness in chest on 24Jun2021 08:00. Patient had an adverse reaction. Patient stated that she had extreme bleeding, cramping and tightness in her chest. Another person came on the line and stated that patient had these symptoms last night and was on the way to the doctor now. Clarified with patient that she was on the way to the hospital. Did not think patient will be receiving the second shot. That person stated that the date of onset of the adverse events was last night, but patient clarified onset date for each event as 24Jun2021. Relevant tests were none. Outcome of the events was not resolved. Information about lot/batch number has been requested.

I was having trouble breathing.; I felt like I was going to faint/I was dizzy.; I was dizzy and hot; I broke out in a sweat; This is a spontaneous report from a contactable consumer (patient). A 18-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0217), via an unspecified route of administration, administered in Arm Left on 26Jun2021 at 13:15 (at the age of 18-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Patient had no medical history and past drug history. Patient had no known allergies. The patient's concomitant medications were not reported. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not received any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 26Jun2021 at 13:30, the patient experienced patient was having trouble breathing, felt like patient was going to faint, patient was dizzy and hot, patient broke out in a sweat. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Events resulted in Doctor or other healthcare professional office/clinic visit/physician Office Visit. No treatment was received for events. Patient had no prolonged hospitalization. On 27Jun2021, the outcome of events was resolved. No follow-up attempts are possible. No further information is expected.

Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium

I took the first dose of vaccine (lot number EW0196) on 06/16/2021, and I took the second dose of the vaccine (lot number FA6780) on 07/08/2021, The injection site started to swell and be very painful, I also had tiredness and a headache, and I don't really get headaches. The whole left arm was also very painful. This lasted for two and a half days.

Patient received vaccine at seemed ok initially. No history of adverse reaction to vaccines previously and felt ok after injection, so went to pick up prescriptions and was asked to stay in store for monitoring for 15 minutes. While checking out at counter after approximately 3 to 5 minutes, patient tensed up and passed out, falling backward and hitting her head on the floor. Patient came to within 15 to 30 seconds, but complained of being hot, slightly nauseated, and was very pale. Patient was brought back into private health room with her mother and monitored by pharmacist and RXOM, and ambulance was called. Patient showed improvement and after EMT vitals came back normal, patient declined ambulance ride but was advised by pharmacy staff to contact PCP in regards to her reaction. Patient chose to leave after a few more minutes saying she felt ok.

I dropped a considerable amount of weight; headaches; weakness; diarrhea; experience stomach pains; This is a spontaneous report from a contactable consumer (patient). An 18-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 25May2021 10:00 AM (Lot Number: ER8735) as dose 2, single (at age of 18-years-old) for covid-19 immunisation. No pregnancy at time of vaccination. Medical history included covid-19 prior to vaccination. The patient's concomitant medications were not reported. Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EW0179) on 04May2021 11:00 (at age of 17-years-old) in Arm Right for COVID-19 immunisation. The patient previously took acetylsalicylic acid (ASPIRIN) and experienced Drug allergy. On 27May2021 07:00, the second day after receiving the shot, she began to experience stomach pains. On 28May2021 (the third day after the shot) the that symptom increased in strength and transitioned into severe diarrhea. In addition, she also began to suffer from headaches and weakness. She dropped a considerable amount of weight, approximately 10 pounds well experiencing the diarrhea. The events were not received treatment. Since the vaccination, the patient had been tested for COVID-19 included rapid test: negative (nasal Swab) on 28May2021. No Hospitalization Prolonged. Outcome of the events was not recovered/not resolved. Follow-up attempts are completed. No further information is expected.

Neck, left arm and chest pain; Neck, left arm and chest pain; Neck, left arm and chest pain; Unable to work; discomfort; Pain; This is a spontaneous report from a contactable consumer or other non-Health care professional (patient). A 19-year-old female (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on 19May2021 13:00 (age at vaccination 18-years-old) as dose 2, single for covid-19 immunisation. The patient medical history reported as none and concomitant medications were not reported. The patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 28Apr2021 13:00 as dose 1, single for covid-19 immunisation with no reaction on previous exposure to vaccine. Prior vaccination, the patient had no Covid. It was unknown if patient tested covid, post vaccination. On 24May2021 12:00, the patient experienced neck, left arm and chest pain. Patient was unable to work because of the pain and discomfort. The events resulted in doctor or other healthcare professional office/clinic visit. Events considered as serious with disability or permanent damage. The patient received treatment and doctors are still working this up for the events. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

pulse over 140, no temp; Woke up at 2 am. Uncontrollable shaking; Teeth were chattering so much thought my teeth would crack; blood pressure was high; This is a spontaneous report from a contactable consumer (patient). A 18-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration, in the right arm on 28Mar2021 at 16:00 (at the age of 18-year-old) as dose 1, single for COVID-19 immunization. Medical history included obesity from an unknown date and unknown if ongoing. No allergies to medications, food, or other products. Concomitant medications and other medications the patient received within 2 weeks of vaccination were not reported. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. The patient did not receive any vaccines within four weeks prior to the vaccination. On 29Mar2021 at 02:00, the patient woke up at 2 am. Uncontrollable shaking, pulse over 140, no temp. Teeth were chattering so much thought her teeth would crack. Patient was taken to local emergency room. Vitals where a high pulse, 143, blood pressure was high. The shaking continued in the ER until 3:30 ish. Therapeutic measures were taken as a result of events. They administered 1000 mg of Tylonol. Events were considered serious nut seriousness criteria not reported. Adverse events resulted emergency room/department or urgent care. The patient underwent lab tests and procedures which included blood pressure measurement was 143 mmhg on 29Mar2021, heart rate increased was 140 on 29Mar2021, negative rapid, nasal swab, sars-cov-2 test on 17Mar2021, negative PCR nasal swab sars-cov-2 test on 17Mar2021. Outcome of the events was not resolved. Information of the Batch/lot number has been requested.

15 minutes post vaccination patient complained of shortness of breath and numbness of left side of body

Within 2-3 minutes post vaccine, dizziness, felt like I was going to faint, weak, nauseated, loss feeling both hands, burning pain pressure back of nape of neck which spread to overall head. Sat down right away, pharmacist (? tech ; administered vaccine) were both very attentive. Stayed there 30 minutes. My grandmother who is a nurse was right there with me. I live with my grandmother; and she checked my BP at home: 120/86, Apical pulse 88 regular; rechecked today 7-20-21 and it was 98/78, Apical pulse 72. That night and next one to two days some dizziness and diff. sleeping due to pressure sides of head which is slowly improving and no more dizziness.

Sore arms. No other adverse reaction, however patient received Pfizer vaccine for 2nd dose. Patient received Moderna for her 1st dose of COVID vaccination series

Woke up at 4:00 AM with nerve pain followed by weakness in both legs. Difficulty walking: unsteady and shaky. Went to the emergency room immediately, and the neurologist claimed that it was most likely nerve inflammation.

My first three days after my shot, I had typical side effects of headache, fatigue, chills, sore arm at injection site and stiff/achy legs. All the side effects subsided after three days except my legs ached along with my arms and shoulders too. The shoulder and arm pain occurs occasionally now...every two or three days for several hours. My leg pain has not stopped. I describe the leg pain as an ache that does not have sharp pain or tingling. It is less intense if I have a sedentary day. On a normal day on a pain scale of 0-10, I rate my leg pain as a 6. Ibuprofen diminishes the pain by a small amount.

Blood rushing from head to arm of injection. Also, tingling in arm of injection. Also, feeling light headed just after injection.

Chest tightening; Chills; Heat all over the injected arm; Sweating; Hand shaking (on injected arm); Difficultly breathing; Nauseous; Lingering chest pain; Heat all over the injected arm, chest and head area; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP 9655) via an unspecified route of administration in the left arm on 02Apr2021 at 14:45 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history included multiple allergies and pollen allergy. Concomitant medications included mometasone furoate (FLONASE) and cetirizine hydrochloride (ZYRTEC); both taken for allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 03Apr2021 at 21:00, the patient experienced chest tightening, chills, heat all over the injected arm, chest and head area, sweating, hand shaking (on injected arm), difficultly breathing, nauseous and lingering chest pain. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events chest tightening, chills, heat all over the injected arm, chest and head area, sweating, hand shaking (on injected arm), difficultly breathing, nauseous and lingering chest pain was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

achy; skin hurts; Tired; sore arm; low grade fever; This is a spontaneous report from a contactable consumer. An 18-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8732), via an unspecified route of administration on the right arm on 24Mar2021 as a single dose for COVID-19 immunisation. It was reported that medical history was unknown. It was unknown if patient has received any other medication within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. It was unknown if the patient has any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Mar2021, the patient experienced tired, achy, sore arm, low grade fever and skin that hurts. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. The clinical outcome of the events tired, achy, sore arm, low grade fever and skin hurts was recovered on an unknown date. Amendment: This follow-up report is being submitted to amend previously reported information: Protect Confidentiality unticked in slide 1. No follow-up attempts are needed. No further information is expected.