Pfizer

Last night I broke out into a bunch of itchy spots that resemble hives all over my body. The hives went away in the morning. Just now, 3:57pm today, I have puffy eyes and a swollen throat.

The child was administered the vaccine at about 11:15 a.m on 2/7/2021. She woke up about 14 hours later with vaccine side effects the family was prepared for, including headache, chills, nausea, vomiting and fatigue. This all resolved within 48 hours. Approximately one week later, the child woke up again in the night with severe chills in the middle of the night. It was a sudden onset following a week of feeling well. She had to sit in a warm/hot shower for an hour to get warm. She described it as "freezing to death." She has never experienced anything like this before.

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.

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.

Felt dizzy about a minute after vaccine administration, patient described blurry vision and then she fainted and fell to the floor. Patient described no prior history of reactions to prior vaccinations. After about a minute she regained consciousness and was able to walk, talk, and function normally. Mom did intend to follow up with primary care doctor regarding the fainting episode.

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

Patient is a 16yo seen for her first dose of the COVID-19 vaccine. She was seated in the back seat of the car. Shortly after receiving her vaccine (within a few minutes), she chose to move to the front passenger seat of the car, and after sitting in the passenger seat she became lightheaded and lost consciousness. Syncopal event was witnessed and lasted a few seconds. She spontaneously regained consciousness, and complained of some lightheadedness and tunnel vision. No significant confusion was noted, her responses to questions were appropriate. Initial pulse was thready and heart rate initially difficult to auscultate. Pale color noted on the face. Initial pulse approximately 50bpm. Breath sounds clear with good air exchange. Patient was placed in a reclined position with feet on the dash. She quickly recovered and repeat heart rate was auscultated at approximately 70bpm, stronger pulse noted. She was noted to have improvement and she was then driven out of the vaccine site after obtaining consent from her mother (who was the driver) and parked beside EMS. BP was 100/50 and HR 68-72, SaO2 97%. Lightheadedness resolved and she was feeling well, at her baseline. She was monitored for 30 min then allowed to leave with her mother, she was at her baseline at last evaluation. Per history review with her mother, she has had 2 prior episodes of syncope with pin removal from hand after surgery and IV placement.

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-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.

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.

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.

Pt received her covid vaccine, pt did not wait, was walking around withfather, she felt dizzy and dad reported she fell. we did not see her fall. She was sitting on 20 when dad came toget us. Pt felt dizzy, ringing in ear, had her lay down on floor with feet elevated. BP pressure reading were 128/75 hr 70, 130/72, 75, pt now feeling better and sitting 108/76 64 108/76 64 and 118/76 76. Pt father declined ems. Pt waited until she felt normal, drank bottle of water, no longer dizzy, went home. Father instructed on emergency care. Followed up call with father at 5:08pm. Fahter reported she was tired, sometimes sob and advised to take pt to e.r. for evaluation.

Lost of taste on Day 6 after the first vaccination and already lasted 6 days and still has not resolved the symptom yet.

patient reports lump in throat, dry mouth and dizziness. Benadryl given, lump in throat sensation resolved.

Immediately following injection, patient notes "clogged feeling" in right ear, along with blurry vision. Arrived to observation unit at 4:48pm. Blurry vision resolved. EOMI. No nystagmus. Hears snapping in ears bilaterally upon testing. 4:57, denies all symptoms. Lungs CTA bilaterally. Negative romberg.

Pre vaccine anxiety. Post vaccine pt developed some visual changes and then muffled hearing. Pt was assisted to the ground by staff and legs elevated on chair. Transported to obs at 1652 via stretcher and accompanied by mother. Vitals obtained and monitored. No other symptoms developed and previous symptoms resolved. Pt was released to home with mother at 1710. Vitals as follows: 1655 LYING BP 115/82 HR 73 RR 18 SPO2 97 1700 LYING BP 117/76 HR 81 RR 18 SPO2 97 1705 SITTING BP 123/79 HR 66 RR 18 SPO2 98 1708 STANDING BP 105/71 HR 79 RR 16 SPO2 98

Admitted to hospital on 4/10 with 2 day history of mydriasis, diplopia with blurry vision, dizziness and balance difficulty. Found to have enhancement of 6th and 3rd CNs on MRI. Patient continued to have blurry and double vision during her stay and mild gait instability. She developed mild frontal headache managed with Tylenol. Her exam was remarkable for mydriasis, mild lateral gaze limitation R>L, mild dysmetria, dizziness and unsteady gait without notable ataxia. No papilledema. Her reflexes were 2+ in her BL UE and LEs. Pediatric Neurology and ophthalmology consulted and followed patient. Eye exam remarkable for bilateral cranial nerve 6 palsy but no other element of CN3 palsy and bilateral dilated but unreactive pupils. Patient treated with IVIG 1mg/kg/day x2 days for likely miller fisher syndrome variant of Guillain-Barre.

Per pt she started to feel lightheaded, nauseous and have ringings in the ear about 5 minutes after the vaccine. Pt tearful, brought over to the observation area in a wheel chair and placed on cart. First set of vitals @ 1753 : BP: 115/73 HR: 80 SPo2: 98% Pt given water. Second set of vitals @ 1758: BP: 118/76 HR: 82 Spo2: 100% Pt states she is feeling better and head of bed brought to 90 degrees. Last set of vitals @ 1805: BP: 111/72 HR:84 SPo2: 98% Pt states she is feeling better. Reminded to keep up with fluids. Feels okay to go home at this time.

She had received COVID testing several times in the past. Each time, she feels tunnel vision, spinning, lightheadedness, and then she loses consciousness. This has happened in the past with each COVID test. When she received her vaccine today, she again had this same episode. She quickly regained consciousness after about 10 seconds. She continued to have lightheadedness afterwards.

Client suddenly began to feel "woozy" during her post-vaccination monitoring period. She put her head down and said "I'm seeing colors". Client's responses were appropriate. Onsite EMS was called, client "perked up" and said, "I feel better". Client was evaluated by the medics, they cleared her to discharge home. Patient left facility of own volition.

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.

Patient complained of feeling "dizzy and seeing black" at 1200. Patient assisted to zero gravity chair. Vital signs taken at 1200 (Blood Pressure 116/70, heart rate 65, SPO2 99%). Patient appeared diaphoretic. Patient offered water. Vital signs taken at 1210 (Blood pressure 116/74, Heart rate 72, SPO2 99%). Patient stated "I am feeling better." Vital signs taken at 1215 (Blood Pressure 110/64, Heart rate 74). Patient advised to follow up with primary care provider. Patient stated at 1230 that she is "feeling much better." Patient left facility unassisted with a steady gate.

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.

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

pt give vaccine AM of 4/21. woke up 4/22 w/ facial swelling, periorbit swelling and itchines. Similar to sx after allergic reaction to foods, etc. (tho so far less severe). sx improving after zyrtec. no lip swelling, throat itciness, shortness of breath or nausea/emesis. After video visit, to use benadryl as needed and to ED if w/ worse sx, using epipen which she already has.

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.

Pt. received her second Pfizer dose at 3pm. By 11:30pm she had significant swelling on both of her eyes, mouth, and the start of red splotchy skin on arms and legs. We took her to ER. They gave her 50mg of hydroxizine and sent us home. 5min after leaving the ER at 12:30am on 4/23 she felt a golf ball sized lump in her throat and was having difficulty breathing. We brought her back to the ER. At this time they gave her an ekg, and at around 1:30am gave her an epi pin and an oral steroid. Within 5min of the oral steroid and epi pin she no longer had difficulty in breathing and the lump in her throat was gone as was the res splotches. By 5am the swelling in her face had reduced drastically to 90% normal in her left eye and 70% normal in her right eye and 70% normal in her lip. She was released from the ER at 5:45am and went home to sleep. At 11:30am on 4/23 her swelling in her face remains the same and she is complaining of a headache. She was given 50mg more of hydroxizine.

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

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.

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

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.

Red rash starting from left arm between the shoot and elbow in ~5-6 hrs and spread to both arms, legs, face and neck by ~18hrs. Included swelling of face and lips. No breathing trouble or throat swelling. Treatment giving Benadryl starting ~18 hrs. after shoot. 50 mg Bendaryl every 6 hrs. treatment on going today (4/25/21) >72 hrs after shoot. Will continue treatment and observation.

Intense headache for 2 days 102 degree fever for 2 days light sensitivity for 2 days fatigue, nausea, and body aches for 2 days treatment: 500 mg acetaminophen every 6 hours while headache lasted, cold washcloth on forehead and eyes, lots of sleep and water

Pt received her first dose of Pfizer vaccine and at 1148 started to c/o tongue and throat "beginning to swell". Pt states hx of the same with penicillan. Pt is with mother. Pt was given 25mg Benedryl PO at 1200. EMTs called to evaluate Pt and released by medics home with mom. VS per medics at 1215 BP 114/68 HR 70 RR 16 O2 sat 98% RA

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.

Patient was with her mother and she fainted while walking down the aisle. We got her water and a chair to sit in. She stared feeling nauseous and seeing "dark". 911 was called and she was assessed. was found to have low blood pressure (patient reported not having food or drink yet). Ambulance advised she go to the ER , She did with her mom.

Nurse was giving injection and small amount splashed into patient's eye. PT C/O BURNING. Mom flushed eye with bottle of water from car. Eye was flushed with saline by medical personnel. Eye was not red swollen or drainage was noted.

NEAR SYNCOPAL EVENT APPROX 2-3 MINS AFTER INJECTION. PT REPORTED MUFFLED HEARING AND BLURRED VISION DENIED CP, SOB, ITCHINESS, INITIAL VITALS UPON ENTERING OBSERVATION UNIT: BP-79/43 HR-46 RR-18 SPO2-100%--AOOX4 REPORTED A HEADACHE APPROXIMATELY 10 MINS INTO OBSERVATION PT DISCHARGED WITH CAREGIVER ASYMPTOMATIC WITH NEGATIVE ORTHOSTATICS. LAST SET OF VITALS: BP 109/76 HR 70 SPO2 99% RR18

Patient fainted while seated minutes after vaccine was given. Mother was next to her to prevent her from falling to floor. She complained of nausea and blurred vision. She was given water and Gatorade and began feeling better 5-10 minutes after fainting.

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.

From 2 days post vaccine, fever, fatigue, sore throat and headaches, lasting about a week. Persistent symptoms of headaches, dizziness, and blurring of vision still present at 19 day post vaccine.

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.

Patient had diarrhea the morning of 4/29/21, and her upper lip swelled up for approximately one hour on the morning of 5/1/21. I have no idea if these events are related to the vaccine, but I am reporting them out of an abundance of caution.

fainted for a few seconds; I started seeing blurry; my ears were ringing; This is a spontaneous report from a contactable consumer (patient). A 16-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0161, expiry date not reported), via an unspecified route of administration, administered in the right arm on 16Apr2021 16:45 (age at vaccination was 16 years) as single dose for COVID-19 immunization. Medical history was none. The patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a pharmacy or drugstore. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications were not reported. The patient reported that on 16Apr2021 17:00, "I started seeing blurry. I stood still so my vision would clear. Then I fainted for a few seconds. When I came to my ears were ringing." The events resulted to emergency room/department or urgent care. Therapeutic measure was taken as a result of the events that was seen by a doctor. Clinical outcome of the events was unknown. No follow-up attempts are required. No further information is expected.

At 1045 patient started experiencing eyes swelling and mild hives. 5/1/21 in morning had severe hives head-to-toe and swollen eyes worse. Took Benadryl 2 tabs, which totally resolved symptoms. This morning, 5/3/21, reoccurrence of hives and eye swelling. Taking Benadryl currently to manage symptoms.

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.

At approximately 1:04pm on 04/30/2021 patient during 10 minute observation had a syncopal episode and fall from standing to floor with loss of consciousness. Trauma assessment found contusion to occipital region of skull. No bleeding, no other trauma findings. Pt moved to wheelchair, and then to cot without incident. Pt AA&Ox4, airway patent, breathing shallow and non-labored. Pulse strong and regular with delayed perfusion. Pt skin pale, cool and dry. Pt eyes PERRL bilaterally. Pt complains of pain 7/10, dull, localized, to the base of skull, and ringing of ears, as well as dizziness without nausea. Pt administered 650ml oral water with improvement to skin and respirations. Vitals and report continued on next page Pt however post oral hydration still stated no change to headache, and new onset tinnitus to left ear. Pt parent was consulted for transport to emergency department for assessment for potential injury post fall, and consented. EMS was contacted, who transported patient to hospital. Vital signs as follows 1312 108/68 93p 14r 98%RA 1323 106/62 82p 17r 98%RA 1335 104/60 74p 16r 97%RA

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.

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.

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

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

3 days post vaccination, patient reported multiple ulcers in her mouth, on her tongue and sides of cheeks and inside of lips, no previous history or reports of any flares/cases of HSV1. 4 days post vaccination, patient reported significant tongue swelling, did not interfere with breathing, however, swallowing was difficult. Patient was given Benedryl by parent and reported to pediatrician for counseling on 2nd dose of vaccine.

Adverse events : PT c/o "feeling weird in [her] throat." No shortness of breath noted. Treatment: PT directed to lay down, vital signs were obtained, water was provided and consumed, aid was called at 1149 and arrived at 1150. (Vital signs at 1150: HR 90, RR 16, SPO2 100%. At 1153: BP 130/62, HR 82, SPO2 99%). Outcome: PT reported that she felt better, denied other c/o. EMS medically cleared PT. PT departed in private vehicle with mother. HCP responding: RN, RN, EMT, EMT.

Patient complained of feeling dizzy and blurred vision, headache and eyes hurting. Denies any c/o nausea. BP 114/64 HR= 99 O2 Sat= 99% Patient/mom verbalized that she had a half of subway sandwich prior to her vaccination. Placed patient in supine position, took vital signs and instructed to remove her jacket since the observation area was warm. Gave her cold drinks, bar of candy and Tylenol 500 mg 1 tablet for headache. Continued to monitor patient then 30 minutes later RN walked her on the hallway. Still a little wobbly . Instructed to take some deep breaths. Mom did mention that her menstrual period is almost due. 10 minutes later she claims she is doing better but still have mild headache and sleepy. Discharged home with her mom and was instructed RN will follow up on her. Instructed if headache persists and start having dizziness to go to ER.

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.

loss of smell / rancid Slightly nauseated Sharp taste Loose stool/ cramping Dairy products > loose bowels

The patient felt tired and describes her eyes going dark, then passed out a few minutes after vaccination. She was vaccinated and then left the immunization room to sit down for a 15 minute waiting period. When she went to sit down, she collapsed on the floor. Her mother assisted her into a chair. She continued to be incoherent and have her eyes rolling back into her head for a few minutes. We used a cool cloth on her forehead and the back of her neck. The parents requested that we call 911. EMS arrived shortly and evaluated her. Heart rate, blood pressure, pulse ox, blood sugar and chest sounds were all within normal range. The patient stated that her arm felt heavy and "funny". She then stated that her tongue felt funny. EMS evaluated her tongue and said it looked normal. To err on the side of caution, she was taken to the hospital to determine whether or not she was having a delayed onset anaphylactic reaction. This patient has no history of seizures.

12 hours post vaccine she had severe myalgia, rash on both arms and legs, headache, nausea, stomach pain, and mild swelling in legs. Over the next 48 hours the rash darkened and spread to the entire body causing pain in her skin. The myalgia became nearly unbearable and both Ibuprofen and Acetaminophen didn't put a dent in the pain. One side of her face swelled so that one eye could only partially open. The nausea and stomach pain worsened so that she couldn't eat. Headache became intense. By 48 hours post vaccine she became delirious - her speech was slurred and difficult to comprehend. She would fall asleep for a few minutes and wake up unaware of where she was or what was happening. She never got a fever but did have chills. Around this time I called a relative who is a doctor to seek advice and Diphenhydramine was recommended. Benedryl helped immensely. 30 minutes after taking it she could speak clearly, was more alert, pain became tolerable, and her appetite returned. Symptoms and swelling returned when the Benedryl wore off so she continued taking it every 4 hours for the next two days until it wasn't necessary any more. The myalgia, stomach pain and headache persisted for 7 days. At 8 days post vaccine (today) a mild headache, mild and intermittent stomach pain, and mild fatigue are her only remaining symptoms. Her pediatrician cannot see her until next week but we have an appt for the 22nd.

"No significant PMH. She reported that she tolerated Pfizer dose #1. 20 minutes post vaccination, on her way walking out of the clinic with her father, she felt dizziness and very thirsty. She was alert and oriented x 4. Did not pass out and was able to walked to the Medical facility for further observation."

Right after receiving Pfizer Covid-19 vaccine, patient began to feel queasy. I asked her whether she had eaten recently and she said she hadn?t. Her eyes rolled back and up then her head fell backward. I supported her head and her dad was checking her for awareness. I gave her a bottle of water and she drank some of it. She indicated that her vision was still not accurate. Her dad brought her a candy bar and she ate the majority of it and drank the majority of the contents of the water bottle. We gave her a few more minutes to feel comfortable then I asked whether she was ready to stand up. She was not. We gave her a bag of chips and she ate some and finished the water bottle. After a few more minutes, she stood up and was able to walk without assistance. Her father indicated that she had an incident like this before, but patient did not remember the previous incident.

At approximately 1:04pm on 04/30/2021 patient during 10 minute observation had a syncopal episode and fall from standing to floor with loss of consciousness. Trauma assessment found contusion to occipital region of skull. No bleeding, no other trauma findings. Pt moved to wheelchair, and then to cot without incident. Pt AA&Ox4, airway patent, breathing shallow and non-labored. Pulse strong and regular with delayed perfusion. Pt skin pale, cool and dry. Pt eyes PERRL bilaterally. Pt complains of pain 7/10, dull, localized, to the base of skull, and ringing of ears, as well as dizziness without nausea. Pt administered 650ml oral water with improvement to skin and respirations. Vitals and report continued on next page

Lightheadedness & ringing in ears. BP 95/60; HR 89; RR 16. Pt AOx4; VS stable; pt escorted home with mother

Client received 1st COVID vaccine Pfizer (Lot#EW0185 expiration 05/22/21). At 4:28PM Client reports headache, no dizziness, no lightheaded, no blurred vision, no chest pain, no shortness of breath. Client has already completed 20 minutes of observation. EMT obtained vital signs blood pressure 116/71, heart rate 87, oxygen saturation 98%. At 4:33PM, RN responded to the event. Client and father reports history of asthma and no known allergies. Offered supplemental nutrition and fluids. Client accepted. Client reports to RN about no chest pain, lightheaded was improving, headache is going down. At 4:39PM vital signs are blood pressure 130/84, heart rate 96, oxygen saturation 99%. Client reports lightheaded, blurred vision, no shortness of breath. RN educated Client and father in regards to ED precautions and common adverse effects of COVID vaccine. 4:44PM vital signs are blood pressure 121/79, heart rate 92, oxygen saturation 98%. Client reports no chest pain, no shortness of breath, lightheaded is improving, headache is going down, no blurred vision, no dizziness. Client remains sitting in a chair and eating/drinking supplemental nutrition and fluids. At 4:49PM vital signs blood pressure 118/78, heart rate 89, oxygen saturation 99%. Client reports all symptoms has resolved. Client has a steady gate and is waiting for other siblings to complete observation.

6 days following vaccination, patient was exercising for the first time. started feeling dizzy. She had some water and realized that her skin was red. She had a rash on face and puffy lips. Mom came to get her she stood up and was extremely dizzy. Mom did not notice that her lips were swollen but did notice that her skin was rashy and red. Mom, who is a nurse, also thought she appeared pale and diaphoretic. By the time they got the ED she was hypotensive. She got a cocktail of meds in the ED including a couple doses of EPI. She got IV fluids. She started to improve quickly after giving the medications.

Patient states she exhibited dizziness and blurred vision. Patient was given orange juice and symptoms were resolved.

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

With in 5 minutes patient began having throat itching, tongue tingling, and lips swelling. Face broke out in hives and patient was shivering.

5 days after vaccination- loss of smell and taste, shortness of breath, sneezing, coughing, ear infections, fatigue, and headache.

Pt has history of anorexia. When she arrived at 1:00pm stated she had only eaten 1/2 banana today. Stated she has lightheaded and dizziness frequently and right then. RN instructed her to go and eat something before her vaccine could be given. She returned at 2:15 after eating a whole roast beef sandwich. Vaccine was given and she immediately began feeling even more lightheaded than her norm, per her. She was assisted to lay flat on the floor and feet placed up on the chair. She stated that helped but still was feeling poorly. 911 was called. She was diaphretic and got a severe headache, stating she was blacking out and unable to see. She never lost consciousness. Mother remained at side. EMT took her to hospital.

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

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.

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.

Shortly after receiving vaccination client became pale and diaphoretic, c/o blurry vision and fell from chair. She received a minor injury to her right knee which was treated on the scene by EMS. BP 91/50, 02 99%, HR 46

I woke up not feeling well. I was pale in color and felt nauseous, light headed and my ears were ringing. I took my blood pressure and the reading was 120/71 with a pulse of 54 which is really low. I went to the Dr. to be evaluated. Dr. felt it was a vasovagal response. I will continue to monitor myself and if it continues, I will see a cardiologist.

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.

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.

Client received 1st dose in seriers of Pfizer on 5/18/2021. Client started with itching and hives on 5/25/2021 and treated by parent with OTC ibuprofen and benadryl. No improvement noted and symtoms progressed on 5/26 and 5/27. On 5/27 symptoms worsed with swelling of lips and tongue and finally difficulty breathing. Parent took client to Hospital ER on 5/27 where she was treated with IV benadryl and steriods. Symptoms have not re-occurred. Client given EpiPen and has not used. Parent denies any other ideas of what could have triggered this allergic response.

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.

Within minutes of receiving the 2nd dose of Pfizer vaccine the patient start to feel light headed, she saw stars, she vomited, she started to look pale and felt tightness in her chest. We called the EMTs and we advised the patient that syncope is something we have seen in children receiving the vaccine and the EMTs advised of the same thing. They took her vitals all normal and the patient began to see the symptoms disappear. The patient once better and cleared by EMTs went home per their advise.

Immediately following administration, patient walked out of room and sat down in waiting area. Patient felt very dizzy and almost fainted. Complained of hearing loss then tinnitus. Initial BP was 82/31 then gradually increased back towards normal over 20-30 minute period. Hearing loss recovered after 1-2 minutes then complaint of tinnitus which then stopped after 5-6 minutes. Approx 30 min after admin, pt felt much closer to normal and parent felt comfortable bringing her home.

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.

After a few days, my daughter noticed ringing in one ear and then in the other. The noise seemed to vary in volume and intensity and by ear...sometimes in both but sometimes just in one. The sound seemed to get quieter as she approached her second vaccine, but when she got the second dose on May 21, the symptoms and reactions returned and intensified.

patient reports blurred vision and light headed. Vitals stable. patient asked to lay down with legs elevated. cold water given patient became fine in 15 minutes

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.

Bleeding & bruising happened instantly as the injection was given. Within 2 minutes (walking to the waiting area) she was feeling dizzy. By the time we sat down she said she felt like she was going to be sick. She began sweating - it was dripping off her head and neck and her eyes kept closing. She was extremely pale and her lips were white. She was like this for approximately 10 minutes.

Approximately 15mins. after receiving 2nd dose PT. c/o "tingling"to her lips. PT. moved to treatment area where she was assessed and vitals and history obtained. PT. denied any other symptoms other than the tingling. PT. given 25mg of Benadryl and observed. After approximately 20mins. pt. stated the tingling had subsided. PT. vitals taken again and PT. observed another 10mins. PT. released with her mother and both were advised to seek further medial attention or call 911 with any further problems.

5/28 - swelling of right eyelid, 5/30 - swelling of left eyelid, burning eye pain, itchy, felt dizzy, trouble focusing, fatigue

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.

3:40pm pt. c/o lightheadedness, ringing in ears and getting sweaty. Patient requested water. Water was provided. BP 117/66, HR 66, O2Sat 99% on RA.

Pt was laying down for 2nd Covid vaccination as she fainted for 1st Covid vaccination. After 2nd vaccination was given- she had a vaso vagal reaction. BP 102/72 Pt has had 4 episodes of ears ringing & pressure both sides of head. Recommended to see her primary Dr. after leaving clinic.

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.

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.

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.

Extreme Hive Break Out for three days. Extreme Lip Swelling. I have plenty of pictures if you want them. We went to Emergency room on Friday and they gave her an IV with Antihistamine and Steroids and Pepcid. She got better and we went home. She broke out again all over her body on Saturday and this time we went to Emergnecy room. They observed her and basically told us when they discharged us to keep her on Benadryl every four hours for the next 48 hours. I think it's important to note that she did test positive for COVID 19 on December 11, 2020 and had a fairly mild case of the virus. ALso, that she has never had this reaction to anything ever before.

Patient states she had a loss of sense of smell and taste after receiving both doses of the Pfizer vaccine. She states that foods taste like gasoline or urine and she has lost a lot of weight from not being able to eat. She has not tried anything to fix the loss of taste or smell, but is frustrated that it has been over one month and the symptoms have not resolved

ocular swelling; allergic reaction; This is a spontaneous report from a non-contactable pharmacist. A 16-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 16 years old on 26May2021 on left arm at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced ocular swelling and allergic reaction in May2021. The events were resulted in Emergency room/department or urgent care. Treatment was received for the events. Since the vaccination, the had patient been tested for COVID-19 with unknown results in 2021. The outcome of the events were not resolved. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided, the events are considered related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).

Pt. received COVID-19 vaccine on 06/05/21 and developed a mild fever on 06/06/21, but had not had a fever since that day when coming to the ED on 06/10/21. On 06/07/21 while the pt. was at school pt. became dizzy and pupils dilated. Pt. was picked up from school and rested for 3 hours and she did not remember how she got home or how she got to the school nurse..Pt.in ED for similar symptoms 6/7/21 and 6/9/21 before coming again on 06/10/21 with a negative work up. Pt. has been on school zoom meetings and has been looking at pillows and thinking they are people and they were moving and talking to her. Pt. walking into walls, trouble walking and intermittent confusion and multiple episodes of conversations that she does not recall and time periods which she can not remember. Pt. was transferred to a higher level of care in another facility.

Attendee received first dose Pfizer vaccine at 10:03 in the Left arm. Lot# ER8737. Attendee was directed to observation area. At 10:10 the observation RN noticed redness in the attendee's left arm. Upon palpation the arm was firm not just directly at the injection site but above and below the site as well. The observation RN did an assessment and noticed that the attendee's tongue seemed to be swelling. Attendee did not complain anything; she was very stoic, did grimace x 1 with palpation of the arm. Attendee's skin was warm and dry. Attendee's respirations were not tachypneic or dyspneic. No difficulty with swallowing or speech. HR: Not done BP: 110/70 RR: Not done Temp: 98.3 10:12 – Benadryl 50 mg was administered orally. 10:15 - 911 was called. The mother seemed upset about 911 being called and so the EOA had the mother feel how firm the attendee's arm was and then the mother seemed to understand why the site team was so concerned about the attendee. The EOA was then informed that the attendee was a current participant in a medical study and received an injection of an unknown medication in the same arm, in the past 24 hours. Medical Group is where she is doing the clinical trial. Neither the parents or the attendee were able to tell the site staff what the study is about or what injection she might have been given in the same arm as the Pfizer vaccine site. 10:20 –EMS arrived and took over care of the attendee. Unsure of time – EMS left as the attendee was having no trouble breathing, swallowing, or speaking and the parents refused transport of the attendee to the emergency room. 10:45 - Care Practitioner educated on home discharge/adverse reaction instructions and attendee. Advised to check on her every 30 minutes and if she developed any other or further symptoms to take her to the emergency room. They were also advised that if she develops any difficulty in breathing to call 911 instead of attempting to transport the attendee to the emergency room. She was then discharged to home with her parents, were she will be monitored by the parents.

EVENT: 5 minutes after receiving 2nd Pfizer vaccine, patient reported she wasn't feeling good. she was already seated, so we had her bend forward with her head between her knees. That wasn't providing enough relief so we had her grip fingers into a fist and tense her arms. Got the patient cool water bottle to put on her neck. After approximately 2 minutes, patient was recovering and drank some water. She sat up again and her eyes started to lose focus and she said her ears were ringing. Had her put her head back down. She was too unstable to have lie down on the floor so we had her elevate her legs on another chair. Syncope symptoms resolved but patient said she was starting to have what she believed was a panic attack. Tried to have patient list 5 things she could see, hear, etc, but she was too anxious to do so. Asked patient about school/summer break and she started to relax. After 15 minutes of additional observation, patient was able to stand by herself. Guardian walked with her through the store for a few minutes before leaving.

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

Onset of diaphoresis, dizziness, and visual changes shortly after shot given. Dark vision described without tunnel vision. No nausea or LOC. Initial BP 95/60, Pulse 74, O2 sat 96%. BP consistently 103-112 systolic thereafter without orthostasis. Returned to feeling normal. Patient dismissed with father feeling well. She stood while father made off-site 2nd vaccination arrangements at exit desk. Walking out the door she had sudden classic tunnel vision, and brief LOC. She was eased to the ground by her brother and had no injury. Second stay in Observation was for 40 minutes with resolution of symptoms and consistently normal vital signs. No orthostasis.

After receiving first COVID vaccine, patient walked out of the immunization room and up towards the photo department where she reported tunnel vision then fainted into her mother's arms. Patient instantaneously recovered and sat on the floor. Technician was told about the incident where she gave her a bottle of water and a granola bar. Patient reported not having anything to eat or drink prior to the vaccine. Pharmacy manager called 911 for EMS to tend to patient. Patient did not go with ambulance.

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.

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.

After receiving her 2nd dose she was feeling dizzy, ears clogged and had blurred vision for a few minutes while was in the post vaccine waiting area. After a few minutes, she started feeling better and left the pharmacy.

After receiving the vaccine she had redness and swollen in her left eye. It started in the corner of her left eye then spreaded to her whole eye which has since then spreading to the right eye, with peeling of the skin. Any exposer to sunlight irritates it. She also has a crusty nose with peeling skin. Have seen a eye doctor it is not pink eye.

DIZZINESS, PALE, DIAPHORETIC, BLURRED VISION, LAUGHING AND CRYING AT SAME TIME. ICE PACK APPLIED AND PT WAS FEELING FINE AFTER SOMETIME.

Patient was fine when receiving vaccine,(350 pm) patient and parents were instructed to wait 30 and to stay close in case there was a reaction. after a few minutes parent and patient started to walk to a nearby park bench and when she was sitting she "Looked like something was wrong" per parents, they (Parents walked her back over to mobile unit and the Nurse immediately called 911 at 3:56pm. Patient was talking at this time, she stated she lost hearing, appeared pale and Diaphoretic, patient was sat down and given water, her color started to return to her lips and face, patient stated after a few minutes she started to feel better. the emergency squad arrived at roughly 4:05 pm. Patent walked to squad car and they took her vitals. Patient and family refused to go the hospital. After squad left patient stated that "She only had coffee all day"

18 hours after the 1st vaccine shot... healthy female while in the shower....blacked out, couldn't see, called for mother who she knew was not home, passed out, and was not coherent, felt dizzy, had a bad headache, and face was swollen, Called her doctor's office, told them about the vaccine and the incident, they said to go to the emergency room. Went to emergency room. She had a full list of tests. Was given a saline drip, hydration unit. Level V emergency code. Name vasovagal syncope, reaction to vaccine, electrolyte abnormalities, dehydration, dysthymia

Headache started within hours of vaccine dose given. Headache intermittent throughout the day for 1.5 weeks. Treated supportively with Motrin and rest. Resolved after 1.5 weeks. Also report of right eye drainage, clear, present for 5 days. Currently resolved.

patient returned to the lobby area and begin to turn pale and fainted briefly but came back to consciousness quickly and complained of blurred vision in the left eye and ringing in ears. patient was given cold water while awaiting service from EMS that was called by the pharmacy department. patients' color came back and EMS checked the patient vitals.

Nausea; She was very limp, she was throwing up and very dizzy; She was very limp, she was throwing up and very dizzy; She was very limp, she was throwing up and very dizzy; Severe Headache; Light sensitivity; 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, Solution for injection, Batch/Lot number: Unknown) via an unspecified route of administration on 10Jun2021 (at the age of 16-year-old) as single dose for Covid-19 immunization at a Hospital. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The reporter stated that patient was very limp, she was throwing up and very dizzy and with a very severe headache and light sensitivity. Patient never had any of those type symptoms before and happened four days after she got the COVID shot. Reporter stated that, the evening of the 13Jun2021. It was headache and the headache got very severe through the next day. Reporter stated that, she had no idea and do not think it was anaphylactic reactions. She thought it was a severe headache which been reported and the MRI they were looking for blood clot as patient was experiencing severe headache that need her throw up, she did not know 100 times, and that end up in the hospital. There was light sensitivity when the CT scan and lumbar puncture was done to see if there was meningitis. CT-scan and spinal patch were done and patient was given nausea and dizzy medications and reporter and patient were waiting for the MRI. The events were serious (hospitalization) on 16Jun2021. The patient underwent lab tests and procedures which included computerised tomogram: unknown and lumbar puncture: unknown on an unspecified date in Jun2021. Therapeutic measures were taken as a result of events dizzy and nausea. Outcome of the events was unknown. Information about lot batch number has been requested.

Otherwise healthy 16 yo female developed brain fog, confusion, visual disturbances, inability to focus, and somnolescence approximately 2 weeks after 2nd Pfizer covid-19 vaccine. Given persistence of symptoms with no improvement, patient was taken to the ER to rule out any acute brain hemorrhage or pathology on May 31, 2021. Subsequent work-up revealed normal MRI findings, a positive ANA of 1:320, and a high positive RNP antibody. Patient was subsequently seen bu Rheumatology on June 3rd and subsequent work-up and findings were consisted with a diagnosis of Mixed Connective Tissue Disease. Patient as of today is still symptomatic and is taking Prednisone 15 mg po qd and Hydroxychloroquine 200 mg po bid and vitamin d3 supplement 50,000 u q week.

Patient received vaccine in right Deltoid, immediately following administration pt stated to nurse ?I feel like everything is going dark and I'm going to pass out. Nurses then escorted the vehicle the pt was in to observation where they assisted the ambulatory pt from the passenger side of the vehicle to the observation tent. Pt was placed on the stretcher in a very mild trendelenburg position. Skin Vitals, BP, Pulse Rate, Oxygen Saturation, Respiratory Rate/ Quality, pupils were all assessed with unremarkable findings. A BG test was performed with a reading of 110. Water was provided to pt and supportive care was continued for 15 minutes. At which point the pt stated ?I feel much better. Pt was encouraged to stay another 15 minutes for further observation. Pt did remain in observation for an additional 15 minutes but she stayed in her brother vehicle with her brother. Upon completion of the 15mins pt stated I feel fine. Providers then felt comfortable with her leaving the site as she was with her brother and would be with family all day.

HIVES, GENERALIZED EDEMA OF FACE AND HANDS, LIP SWELLING ONSET 3 HOURS POST VACCINATION. TX: PO BENADRYL AND PREDNISOLON GIVEN IN OFFICE TODAY (07/08/2021). DISCHARGED HOME WITH RX: PREDNISONE AND HYDROXIZINE. RECHECK IN 24 HOURS.

Pain behind right eye, headache, leading to redness and pain moving eye. Dx: Scleritis, sent for bloodwork and auto immune markers elevated.

full body onset of hives with severe itching in ears, throat. hives noted to neck, anterior and posterior torso, bilateral lower extremities. Benadryl 25 mg orally given. methylprednisone 4 mg given. Full recovery in 1 hour after medication administration Parent of the patient is a nurse practitioner who managed care in the home setting

vomited x1 yesterday and has been having nausea all day today. Patient c/o headache, congestion, loss of smell, and fatigue.

Patient felt light-headed, said she lost some sense of hearing, stomach was upset. Her blood pressure was 88/60, HR read irregular when measured manually. When EMTs arrived at 10:40 A.M., her BP was around 117/89, HR 91.

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.

Pt reported itching to the bilateral eyes approximately 25 minutes after vaccine administration. No swelling, redness, or hives noted to the face or throughout body. No anaphylactic symptoms. Pt speaking in clear and full sentences, breathing unlabored, and in no apparent distress. Pt and mother declined further observation or ED transfer and preferred to go home and take Benadryl. ER precautions given.

pt had swelling of lower eye lids after injection similar to her reaction when exposed to mosquito repellent. I observed the patient for an extra 20 minutes (in addition to the original 15). Pt was fine otherwise....no SOB, chest tightness, throad constriction, or light headedness. Pt's mom felt comfortable taking her home and giving her an antihistamine.

extreme fatigue, nausea, ear pain, that persisted 7 days after the second dose especially ear pain and pressure and nausea

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.

The day following the vaccine, patient developed a headache with right sided head pain, mild photophobia and occasional nausea. Patient is treated with diphenhydramine, ketorolac, prochlorperazine and IV fluids. Her headache resolved completely.

HALF OF PATIENTS UPPER LIP SWELLED UP THE DAY AFTER THE 2ND VACCINE WAS ADMINISTERED THEN FULL UPPER LIP WAS SWOLLEN THE FOLLOWING DAY . PATIENT WAS TOLD TO GO TO URGENT CARE OR PCP IF ISSUES DOESNT RESOLVE, SPREADS TO OTHER AREAS OF THE FACE OR OTHER AREAS OF THE BODY BEGIN TO SWELL.

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.

Patient said she lost her hearing last Thursday (1/7/2021) around 6pm. She said she totally could not hear anything at all and she went to the ER at 11pm and stayed till 3am. Her hearing loss happened in her left ear and lasted for 5 days and started to hear sounds since Sunday and recovered. She described it as "there was pressure inside the ear" and she said she also went to her doctor and doctor said she had her hearing back 90% to 96%.

nausea, vomiting, sensitivity to light, hearing was muffled, a bit of dizzines. She vomited 3 times. in a span of 30 minutes.

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.

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

Post 15 minute observation, patient developed irritation/rash around lips/underneath mask. After additional observation of 15 minutes, the rash did not worsen. Patient stated it seemed to be improving.

PATIENT BECAME DIZZY AND PASSED OUT ABOUT 10 MINUTES AFTER RECEIVING HER VACCINE. WHEN SHE REGAINED CONSCIOUSNESS, SHE SAID THAT SHE COULDN'T HEAR OR SEE ANYTHING AND SHE ALSO WANTED TO VOMIT. WE CALLED EMERGENCY SERVICES. EMERGENCY SERVICES CAME WITHIN 10 MINUTES AND SHE SAID THAT SHE WAS FEELING BETTER; BOTH SIGHT AND HEARING IS NORMAL AGAIN. THEY RECOMMENDED SHE REMAINED SEATED FOR A LITTLE BIT MORE BEFORE LEAVING, BUT DECLARED THAT SHE WAS OK.

5 minutes after administration of vaccine, Patient had visual white-out of vision, diminished hearing, disoriented, severe pallor and then vomitted.

I took a nap and now I can not move my head without my ear hurting anytime she moves significantly she has sharp pain

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.

After 2nd vaccination, client felt throat itchiness and swelling, and tongue swelling 15 minutes after. Client and guardian verbalized same adverse effects after 1st dose, and risks explained prior to 2nd dose vaccination. Client had difficultly swallowing and guardian gave client oral Benadryl which decreased some symptoms. No s/sx of resp distress, no SOB. client and guardian verbalized they did not need to be transferred to ER for further evaluation. Client and guardian left clinic @ 2:45 PM

Patient received COVID 19 Pfizer vaccine IM in right deltoid and remained on site ot be monitored. 20 minutes later post-vaccine, the patient (accompanied by her mother and aunt) reported feeling itchy around the neck, mouth, and upper extremities. EMS on site assessed the patient, and she (and family) was transported to Hospital.

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.

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.

Patient complained of stuffy sensation in ears during vaccine administration. Patient was alert and oriented. Denies shortness of breath. No allergic reaction observed. No intervention needed as patient began to feel better after a few minutes.

We waited the 15 minutes after the shot before leaving. On the drive home, throat became "scratchy" - her description. And her nose started to bother her. She took a Benadryl, a two hour nap, and then she was fine. She's never had an allergic reaction to anything, but it seems like she may have just had her first. I received the same vaccination at the same time, and no reaction at all for me.

One minute after receiving the vaccination, she developed ringing in both ears. She was monitored for 20 minutes. Her symptoms resolved within several minutes.

Eyes started itching about 12 minutes after injection. Started getting very dry mouth and throat 15 minutes after shot. Felt lump in throat and throat tight about 17 minutes afterwards

5-10 minutes post vaccinating while waiting 30 minutes pt began hyperventilating with fluctuating LOC. Family member reported hx of allergies so she was waiting 30 minutes, EMS onsite, pt began drooling so EMS took her to local hospital. Nurse reports v/s remained stable. I have not heard back from pt or family as I attempted follow up calls and emails.

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.

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.

Pt reported having an uncomfortable scratchy feeling in back of throat. Pt has experienced anaphylaxis in past and was anxious about experiencing it again. Pt moved away from waiting area to be evaluated by RN. RN Assessed pt. Lung sounds clear, Pt denies having difficulty breathing, O2 sat remained 98% or better for the duration. BP initially 141/89 while sitting with HR at 75. Pt laid down with feet propped on chair. Vital signs reevaluated 15 min later: O2 98%, BP 118/89, HR 77. Pt still reports itchy throat but does not have difficulty breathing. Contacted on-call physician, recommended pt be evaluated at ED or urgent care. Pt parent refused ambulance; opted to drive pt to ED for further evaluation.

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.

6 am following day (4/6) after injection on 4/5/21, my 17-year-old daughter complained of sore right arm (injection site), tinnitus, syncope, nausea, fever. Day before had also been treated for vaginal yeast infection. Treated with miconazole and fluconazole (tablet and vaginal cream). Also complained that her ovaries hurt. She self-administered Motrin and applied heat. Went back to bed. Has rested without waking, suspect fatigue as well.

Itchy Body, itchy mouth, trouble breathing started about 10:00 am, 10 minutes after getting the shot. Went to Hospital Er and was intravenously given: diphenhydramine 50 mg, ND (0.9 % sodium chloride) bolts 1,000 ml, and methylprednisolone sodium succinate 60mg at 11:19 am. I was also injected with EPINEPHrine 0.3 mg at 11:20 am, and an albuterol nebulizer solution 5mg at 11:18 am. Stayed at the ER until 2:30 pm, got sent home and feel much better now.

Patient passed out, fell out of her chair and hit her head hard after receiving her shot. Once she went down, two nurses ran to her assistance where they propped the patient's feet up on a chair and got her some water. Patient reported blurred vision, had a goose egg on the back of her head but did not appear to be mentally foggy.

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

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.

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.

less than 10 minutes after vaccine administration patient was kneeled over on floor bent over on chair . extremely pale, feeling lightheaded, head pounding, ears with sudden onset of lots of pressure. mother said never reacted to vaccine like this before. called EMTs they said her blood pressure was fairly low and wanted to take her to the ambulance for further evaluation.

Patient and Father were at desk to schedule follow-up vaccination when patient fell to the ground. Writer and additional clinic manager responded to event. Patient was rigid, eyes rolled back and not responding. Writer and manager attempted to arouse patient, with no response. Per father, patient has passed out in the past with blood draws. Feet were elevated and ice pack applied behind neck. Patient's fists were clenched, teeth clenched, back arched and appeared to have urinary incontinence. Episode lasted approximately 1-2 minutes. ED responded. Patient regained consciousness and was able to interact with writer appropriately. Bp 124/78, pulse 80 bpm, oxygen saturation 100%. Patient assisted to stretcher and transported to ED

At 12:20 p.m, patient began to experience dizziness and the eyes began to roll back into the head. Initial blood pressure reading was 80/160 with a heart rate of 60 and an O2 saturation of 100%. This patient has a history with passing out with shots. Patient was given juice and multiple blood pressure screenings were recorded with results being 100/80, 112/78 and 104/75. At 1300, patient's heart rate was 68 bpm while sitting. Once the patient stood, blood pressure went to 90/60 and heart rate went up to 115 bpm. Patient was pale. Over next 15 minutes blood pressure and heart rate were routinely taken until patient felt better. Patient entered the vehicle safely and left with parents at 1:15

Received 1st dose of Pfizer on Monday April 12. States started loosing hearing to RT ear on Tuesday April 13th. On Wednesday April 14th, started having ringing of the RT ear. No dizziness, vertigo, nausea, vomiting, fever. Referred to ENT for f/u

12Apr- Developed full body rash with extreme itching from scalp to soles of feet and palms of hands. - took Claritin and applied Benadryl cream in AM, used Aveno Lotion and took Benadryl in PM. 13 Apr- rash worsened - continued at-home remedies with no relief. Saw PCM and received prescription for prednisone and steroid cream. Unable to get prescription filled and rash worsened. Saw Urgent care in the evening and received steroid injection and advised to continue with PCM instructions when I received prescription. 14 Apr- Rash continued to worsen, lips swollen and blistered, sores/blisters inside mouth and on tongue. Picked up prescription prednisone and cream and used them with no relief yet. Returning to doctor or ER on 15 Apr if it continues.

Immediately after receiving the vaccination, patient presented to be lightheaded and rested her head on the table. Upon assessment, patient states that she felt lightheaded, seeing orbs, dilated pupils. Upon arrival from EMS, patient did faint for no longer than 10 seconds and regain consciousness.

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: 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

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.

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.

1705- Pt passed out right after vaccine. Pt regained consciousness about 3-5 seconds later, stated that she couldn't hear anything. Pt moved to the observation area in a wheel chair. 1715- Pt passed out again, ammonia inhalants used. Regained consciousness 3 seconds later. Pt sweaty. Ice placed to back of neck. Pt moved to cart. First set of vitals @ 1717: Spo2: 100% HR: 53 BP: 83/42 Water and snack given to pt. Second set of vitals @ 1720: Spo2: 95% HR: 54 BP: 88/48 Third set of vitals @ 1726: Spo2: 97% HR: 64 BP: 102/64 Pt sitting up and talking with staff an mother, color in face improving. Pt states she is starting to feel better. Fourth set of vitals @1732: Spo2: 99% HR: 67 BP: 103/66 Pt sitting at 90 degrees, eating and drinking. States she does not feel nauseous. Last set of vitals @ 1537: Spo2: 100% HR: 62 BP: 94/63 Per mother she normally faints with vaccines. Pt states she is feeling much better. Reminded pt and mother to keep up with fluids.

Dizziness, mild sweating, and a temporary loss of hearing a few minutes after the shot before brief LOC. Mother reported "eyes rolling up" and a respiratory gasp. Rapid recovery with fully orientation on the floor. VS stable in observation. No nausea or visual changes reported by the patient. No orthostasis.

Sense of taste/smell has been off since ~3/14. Certain smells/tastes like scented shampoo & soap, minty toothpaste, the taste of meat are weird to me now.

Brownish purple plaques on dorsal hands. Appears similar to Phytophotodermatitis but history not appropriate. Symptoms started 2 days after vaccine administration, and symptoms are still present at this time.

pt states queezy after one min after receiving vaccine, vision went dark while sitting and pt felt ringing in ears and muffled sounds. mother with pt due to being minor, mother helped lower pt to floor pt states never lost consciousness placed feet on chair with knees bent OBS team arrival pt feeling better while laying on ground,. with little assistance stood and pt back to laying on stretcher in trendelenburg position taken to OBS 1, VS as noted pt feeling better while in OBS, given water tolerating well. after a few minutes out of trendelenburg, then high fowlers position, to dangle to standing position change over 20 minutes first time standing pt felt dizzy back to sitting in bed given more water and apple juice then dangle then standing second time. bp stable upon standing second time and pt feeling better feeling okay to go home, pt sent home with mother ambulated to exit per request at 0850. VS 0815 bp 99/61 hr 81 rr 16 o2 100 0820 bp 109/62 hr 74 rr 18 o2 100 out of trendelenburg, 0825 bp 108/66 hr 88 rr 16 o2 100 high fowlers, 0830 bp 102/54 hr 86 rr 16 o2 99 standing,, 0834 bp 109/61 hr 78 rr 16 o2 98 high fowlers, 0836 bp 91/67 hr 71 rr16 o2 100 dangle, 0840 bp 95/66 hr 90 rr 18 o2 99, 0845 bp 104/57 hr 76 rr 18 o2100, 0850 bp110/61 hr 85 rr 18 o2 99 standing

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.

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Additional Details: pt stated visual disturbance. having trouble seeing. lightheadedness, vomited once. called ems monitored pt and mom refused to go to the hospital. pt stated feeling better when she left. called at end of shift no answer laeft message

AFTER VACCINE, PATIENT HAD TUNNEL VISION, FELT LIKE SHE WAS GOING TO PASS OUT (BUT DID NOT), MOM WITH PATIENT AND STAFF ASSISTED TO FLOOR, LEGS ON CHAIR UNTIL ASSISTED TO W.C. AND TAKEN TO OBS. TRENDELENBERG ON STRETCHER, STATES RELIEF. SAT UP FOR SNACK/WATER. S/S RESOLVED AND ESCORTED TO EXIT WITH NO ISSUES AT 1210. 1145 INITIAL BP 117/72 HR 73 RR 18 SATS 98% ON RA 12P STANDING BP 118/75 HR 79 RR 18 SATS 98% ON RA

Pt received vaccine. Patient moved to waiting area. After a few minutes, pt reported dizziness, vision changes, and feeling faint. VS were taken: BP46/31. EMS called at 12:25. Patient moved to cot and laid supine with legs raised on chair. VS taken two more times: 96/60 and 110/90. EMS Arrived at 12:35. Patient reported improvement in symptoms. Patient refused EMS Transport and chose not to go to ED.

after shot administered pt reported worst dizziness they have ever experienced, ringing in ears, and blurred vision, had pt lay in supine position with feet elevated, all sx resolved within 15-20 minutes, advised pt to follow up w/ PCP

Patient not seen in office. History obtained via phone from father of patient and patient herself. Very early on 4/19/2021, 8hrs after receiving her 2nd Pfizer COVID-19 vaccination, patient began developing nausea, chills, sweating, fever and malaise. Highest fever was 102.3', with symptoms treated with Advil 600mg. Had x1 episode of vomiting that day, none since. The next day 4/20, patient woke up with new-onset lip swelling, progressing to periorbital swelling and swelling of her facial cheeks & rash. She then began having a cough with some throat tightness with some mild discomfort with breathing in her throat, but no chest tightness or wheezing. Tongue not swollen per patient. Benadryl 25mg PO given multiple times and patient used her Albuterol MDI a few times as well, which helped. She continued to have fevers to 101' throughout the day, treated with Advil again. At night, patient then developed semi-itchy red "hives" on her legs. Per patient, she didn't feel she needed to go to ER for her symptoms or throat tightness/breathing issue. She was still drinking & urinating well and had been consuming light solids foods. The same day 4/20 in the afternoon, patient was prescribed over the phone Prednisone 60mg PO x1 which she first took after 5pm, with tapering dose over the next 4 days, in addition to increasing Benadryl to 50mg PO and starting Qvar 80 MDI BID, while using Albuterol prn. Via phone call to father this morning 4/21, patient reportedly slept well last night and woke up this morning with significantly less symptoms. No longer having throat tightness/breathing issues, with much less periorbital/facial swelling. Still fatigued but no longer having fevers, either.

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.

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.

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

Dizzy, decreased vision, BP 85/42 (pulse 94). Given crackers and water. F/u BP 102/62 (pulse 97). Blood glucose 110.

After vaccination patient described stomach hurting, nausea, sweating, and loss of hearing. Patient felt immediately better after moving up from chair and being transferred to Med OBVs at 17:18. First set of VS were taken at 17:21, HR:83, RR:20, BP: 121/68, SPO2: 98. Patient then stated that she had not eaten a meal before the vaccine, only a chewy bar. Second set of VS were taken at 17:28, HR: 89, RR: 20, BP: 116/67, SPO2: 98. Patient stated she felt fine and was comfortable heading home, last set of VS were taken at 17:45, HR: 82, RR: 20, BP: 112/63, SPO2: 98. Patient was released at 17:45 with her father.

After only an hour outside in low 60s weather, I had felt symptoms similar to heat exhaustion. My vision got extremely spotty, and couldn?t see much. There was a loud ringing in my ears and everything else sounded muffled. I felt dizzy and my skin felt like tissue paper. It faded after I went inside and got water. However, I still have a headache, 6 hours later.

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.

On day 6 post vaccine pt woke up with swelling of upper lip. Took OTC loratidine. Denies difficulty breathing, emesis, throat itching. No hives noted. No prior hf of allergies. No new foods. No new meds

After receiving the vaccine on 4/26, she developed headache and temperature to max 99-100 as well as muscle pain in the arm where she received the vaccine. Progressed to diffuse myalgias on 4/27 and 4/28. Was having a slight cough that is typical for her during this time of year due to allergies, no other respiratory symptoms. Then acutely developed severe jaw pain that radiated to the throat and into her chest when she woke up on 4/29 in the morning. She had 10 out of 10 crushing chest pain.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient has a history of Sycope during shots and in medical setting. She was put in a prone position to recover which she did within 15 minutes

Pt recieved her vaccine, then was waiting for her 15 minute period post vaccination. ABout 10 minutes in, pt reports that she felt extremely light headed, saw bright lights, had difficulty hearing, and then went limp. Pt vomited. PT responded when asked if she was ok.

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

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.

Patient said she was feeling dizzy, vision was blurry, sweeting. Was able to breath, asked for water which was given to her. She had some rash on the face, provided diphenhydramine liquid 50mg. She was feeling feverish, took tylenol.

Sudden sweatiness, nausea and tunnel vision. Very brief LOC. Immediately better when placed supine. More scarred than anything else. No fall or injury. BP/pulse/O2 saturation all Normal Initial 126/89, 69, 100%. No orthostasis. Classic vasovagal reaction. Resolved.

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.

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.

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.

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.

Pt reports on the evening of 5/5/21 her bottom lip started to swell. Pt reports taking Benadryl w/ some effect. Pt stated the next morning - 5/6/21 - she noticed both her top & bottom lips were swollen

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.

Pt reported blurry vision and lightheaded. @1115 BP 110/54, HR 63, OxSat 92%. At 1125 BP 108/70, OxSat 98, HR 64. At11:39 BP 106/62, HR 74.

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.

Immediately after giving the injection, patient felt lightheaded, nauseated, had a decrease in her hearing and became pale. She slumped down in her chair and became limp and was carried to a reclining chair where her legs were elevated. Ice packs were placed on her neck. Her pulse was 70 and a few minutes after this her BP was 100/60. Dr. and an EMT were onsite and did help to monitor her status.She drank water and ate some food and by 10:25 was feeling well enough to return to her classes. She was escorted to class by a teachers aide.

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.

Syncope following vaccination. Patient reported blurry vision, dizziness. Had patient rest with feet elevated and gave patient bottle of water. Observed patient for 30 minutes. After 30 minutes patient reported feeling back to normal.

Evening of 5/6 hives started. Father gave no medications, just watched and waited. Pt went to school on 5/7, came home around 1400, hives noted on neck, arms, legs, groin, back, stomach, all over per father. Father gave benedryl Friday around 10 am, then took to emergency room Saturday morning due to eyes being swollen shut, left arm was swollen hand and wrist. ER gave 2 injections - immediate reacting and long acting, along with 2 benedryl, pepcid. Pt was discharged from ER after about 1 hour. Hives persist today, May 10th. Pt is now on 40 mg 5/9 and 5/10. Hives remain persist on feet and hands today.

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.

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.

Pt states she cannot hear out of her left ear; This is a spontaneous report from a contactable pharmacist. A 17-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscularly, administered in left arm on 24Apr2021 05:00 (Batch/Lot Number: EN5318) as a single dose (at the age of 17 years old) for COVID-19 immunization. Prior to vaccination, was the patient was not diagnosed with COVID-19. The patient's medical history and concomitant medications were not reported. On 26Apr2021 13:00, the patient experienced she could not hear out of her left ear. The event resulted in a doctor or other healthcare professional office/clinic visit. There was no hospitalization for the event. The outcome of the event could not hear out of her left ear was unknown.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of "could not hear out of her left ear" cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

faint; Fever; chills; body ache; diahhrhea; nausea; light headed ness; unable to move cause in so much pain- arms felt like lead weights; unable to move cause in so much pain- arms felt like lead weights; ring in ears; lethargic; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 29Apr2021 13:00 (at the age of 17-year-old) (Batch/Lot Number: EW0172) as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Medical history included seasonal allergies and known allergies to non-steroidal inflammatory drugs (NSAIDs), tree nuts, and pitted fruit. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) and mometasone furoate (ASMANEX). Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, batch/lot number: EW0150), administered in left arm on 08Apr2021 at 01:00 PM for COVID-19 immunization and experienced foggy head and sore arm which was treated with Tylenol. On 29Apr2021 at 23:30, the patient experienced fever, chills, body ache, diarrhea, nausea, light headedness/faint, unable to move cause in so much pain- arms felt like lead weights, ring in ears, and lethargic. Therapeutic measures were taken as a result of all events. On an unspecified date, the patient recovered from all events.

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.

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.

customer states she took her second shot of the vaccine and she has been having eye inches and running noise and not feeling well. Called her and she is ok.

Pt c/o feeling dizzy, muffled hearing & sweating. Pt escorted to observation and placed on cot in supine position. Pt's VS obtained by clinical staff and (EMS) called. EMS assessed and monitored pt. VS WNL. Medical incident duration from onset to medically cleared by EMS was 7 minutes. Pt reports "I am feeling much better." Pt cleared by EMS that it was safe to go home and driven by her mother.

Patient was given dose at a vaccination site through County Health Department. Today in clinic she reported an allergic reaction to Pfizer vaccine. Approximately 30 minutes following vaccination had hives. Following morning had swollen lips and itchy throat with continued hives. Symptoms only treated with benadryl and improved. She then had hives again 4 days later. She did not report this to the vaccination clinic.

Blurry vision, near syncope after receiving vaccine. Onset of symptoms was 3-4mins after vaccine administration. Did not eat breakfast this morning Given juice and crackers Exam was normal Discharged to home

Client saw black dots, didn't feel well EVMS assess. BP110/76, P71, O2Sat 99% BS 95, Had chips and Oreo cookies for lunch. Mother came to bring child home. Instruct for second vaccine needs to eat and drink liquids prior to vaccination. Let vaccinator of experience from first shot.

17 y/o female received 1st dose of Pfizer and was sitting in the observation area. She had a witnessed syncopal episode, lasting approx. 45-60 secs. When pt. regained consciousness she was placed in a wheelchair and moved to a private area. VSS at that time. Pt. was given some water to sip on and stated she was feeling better. Pt. denied any other complaints at that time. Pt. denied any PMH/ Meds./Allergies. Pt?s grandmother is with her and states pt. appears to be back to baseline. Approx. 30mins. after syncopal episode, pt. stated ?my heart is racing and my throat feels dry?. VS reevaulated, pt?s HR was 122, BP 130/66. Pt. stated she wanted to go to the ER. She was t/p BLS to ER. See PCR for further.

Initially developed hives then swelling of lips, face and difficulty breathing with cough (anaphylaxis reaction). Treated by school nurse with epipen then ambulance paramedics arrived and administered nebulizer treatment, IM benedryl, dexamethasone and transported to ER for follow up stabilization. ER administered additional antihistamine. Patient was discharged from ER stable and in much improved condition.

Linear isolated raised erythematous areas on left arm. Benadryl given at 3:13p. Pt complains of right side of tongue and throat feeling full. Refused EMT, another Benadryl given at 4:05p. No visible swelling upon assessment.

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.

Immediately after injection pt stated: "I feel like I'm going to pass out" complained of "ringing in ears" EMS lowered the patient to cot, felt nauseas at that time. Vitals: 94/56, HR 74, OxSat 98%. At 1320 pt feeling a lot better. At 1320 VS: BP 106/60, OxSat 94%, HR 66. After standing patient has no complaints and is ready to be discharged with mom.

Pt diaphoretic, pale, nauseas, blurred vision, difficulty hearing, lightheaded, SOB, 10 minutes after receiving pfizer. Given water, vital signs obtained. HR low into the 50s, O2 sat 93-94%. Placed on a stretcher. After vitals obtained pt color returned and she stated she started feeling better. HR improved to 70s, O2 sat 97% on RA. BP stable throughout.

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.

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: 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

Patient began to sweat, complained of blurred vision, and turned very pale in the face. We called 911 and I stayed with the patient monitoring heart rate and symptoms. Patient was slightly tachycardic upon initial assessment. Once EMS arrived, patient had had resolution of blurred vision and the sweating. Her vitals were normal. Her mom refused further treatment to the hospital. I recommended to follow up with pediatrician.

PT father states that two days after her second dose Pfizer vaccine his daughter developed allergies in her whole body. Her skin became dry with little bumps all over her body, face, arm, hands and feet. He also states his daughter?s lips, hands and feet swelled up. Also that on her inner thighs and vaginal region her skin was also dry with cuts of dry skin. PT father states his daughter went to the doctor where they prescribed Cephalxin, Triamcinolone and Acetonide as medication. As of today, PT father states she continues with the dry skin and little bumps on her whole body, face and arms. PT father states that for her first dose vaccine, his daughter only had soreness to her left arm.

Site: Pain at Injection Site-Mild, Systemic: mentrual changes-Mild, Additional Details: headaches, no appetite, stomach ache, light sensitivity, fatigue, mentrual cycle distrupted. Patient states she got her period 2 weeks early. She takes an oral contraceptive pill, she did not miss any

Pt experience dizziness & temporary blindness post vaccination. BP 88/56; HR 73; RR 17. Rechecked BP 10 min later 97/68; HR 72; RR 16. Pt was stable & released from vaccination site

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.

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.

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.

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

patient was nervous/anxious about the shot. Sat in chair and received shot in the left deltoid with no issue. Stood up to leave a minute later and told her mom that she felt dizzy and nauseous. We had her sit back down and she got a little shaky. Face seemed to loose all its color. she said everything went black and she was dizzy. she closed her eyes and laid her head back against the wall. I left the vaccine room to alert my pharmacist and as I walked out the door the patients brother said that she had started shaking like she was having a seizure and she passed out. She was seated and mom was supporting her while we called 911. patient came to within 30 seconds or so and was lethargic and dizzy still. Pharmacist too her blood pressure while waiting on emt and it was 102/52, heart rate 64. emt arrived and took over. emt was with the patient for about 10 minutes then left with her on a stretcher. emt left notes that her vitals while sitting were 93/56, heart rate 66, o2 100%. standing 80/50

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

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.

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.

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

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 became dizzy, had heaviness in her limbs, was pale,had blurred vision - none of these symptoms improved, so 911 was called.

She woke up this morning complaining of a severe headache, left sided neck pain. She reported she could not see out of both eyes and then vomited. This episodes lasted~10 min and then resolved with residual neck pain.

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.

Received Pfizer vaccines on 3/18/21, 4/8/21 Tested positive for COVID 19 by PCR on 6/11/21. Hospitalized 6/11-6/14/21. symptoms of fatigue, myalgias, diarrhea, dysgeusia, cough Received four doses of Remdesivir.

Patient was seen in COVID vaccine clinic for first dose of Pfizer vaccine. Patient has a history of penicillin allergy where she developed hives and also a contraindication to the flu vaccine when she was 6 months old. The contraindication listed in the chart was "crying for 3 days." Patient received COVID vaccine and 20 minutes later reported her throat felt as if it was swollen and her tongue was tingling. 50 mg Benadryl given to patient. Vital signs all stable, pule ox on RA 100%. Mother called PCP who recommended being seen in the Emergency Dept d/t complaint of swollen throat. RRT called to help facilitate transfer to ED.

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

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.

Vaccine received at 0914, reaction occurred at 1008. Difficulty breathing, swelling to upper and lower lips, throat tightening, audible wheezing, rash to neck and chest. Two doses of Epinephrine and Benadryl given, oxygen administered, EMS called and taking to hospital via EMS at 1027.

17 year old female received Pfizer COVID vaccine and was told to sit and wait 15 minutes for monitoring after the shot. Patient attempted to leave before the time elapsed with her father and collapsed in the aisle. She was able to be assisted to a nearby chair and 911 was called. I was told she did not hit her head or any other part of her body when she fell. I attempted to take her blood pressure, but it was too low. Patient appeared very pale and was responsive but stated she was seeing black and couldn't hear properly. She did not eat anything that morning. Patient continued to talk and answer questions updating me on her improvements but still appeared very lethargic and eyes were not focused. EMTs arrived and her BP was 81/46. EMTs, store management and health care ambassador remained with patient. Patient began to feel better and did not go to the hospital. EMTs left and management and associate remained with patient. Once patient felt better, she walked out of the pharmacy/store with her father.

Client received the Pfizer COVID vaccine (lot #EW0187 and expiration date 7/15/21) at approximately 3:30pm. Client came in for first dose Covid-19 vaccine and PHN submitted medical consult regarding concerns from mother due to client having a reaction to a vaccine at the age of 7 where she broke out in a rash and then had to go to the hospital. Mother of client reports she has no allergies and they never figured out what caused the reaction. When she was younger she had asthma and used an inhaler. Per Mother client has not needed an inhaler or had any asthma symptoms for a long time. Client reports she is just getting over a mild cold (runny nose) because her sister is a doctor and said it was not COVID and she's on antibiotics. Client states she "feels fine" today. Per Supervisor, client approved to receive first dose with 15 minute observation. Prior to arriving to the observation area client reports feeling a little nervous due to nearby emergency with another client. PHN walked client over to observation area and client reports "feeling fine." At 3:35PM EMT alerts PHN and PHN client is having reaction. PHN and PHN arrive at 3:38pm. Client reports headache 7/10, nausea and chest pressure. Client denies feeling throat closing, chest pain or shortness of breath. At 3:38 pm, pulse 75 and oxygen sat 95%. PHN calls 911 at 3:38pm. Current medications: ampicilina 500mg, guaifenesina clorfenamina metamizol 250mg. Vitals by EMT at 3:41pm: blood pressure 160/82, pulse 66, oxygen sat 98%. At 3:42pm client reports headache on temples. At 3:44 client reports headache radiating from temples to occipital area and pain level 7/10. Vitals at 3:45pm: blood pressure 140/70, pulse 66, oxygen sat: 98%. Client reports feeling a "pinching feeling in throat". PHN clarified with client if she felt swelling, closing of throat, itchiness or shortness of breath. Client denied all, stated just "pinching feeling". During assessment, mother of client reports client is allergic to nuts. At 3:47pm Fire department arrived and assumed care. Blood pressure done by paramedics at 3:50pm 165/108. Client transported to hospital via ambulance. Client left facility with paramedics at 4:01PM.

The patient had an apparently spontaneous anaphylactic type reaction with facial hives, eye redness and swelling, diffuse hives on trunk, lips, and extremities, tongue swelling, difficulty swallowing, and itchy tongue. The only thing had had had to eat or drink was a cows milk latte with hazelnut 2 hours prior to the reaction. No fever. The family gave her 2 tabs of Benadryl (50 mg total) at home and brought her to urgent care whereupon her hives and tongue swelling had decreased substantially. They showed photos of her face and skin prior to the Benadryl. She was given 60 mg prednisolone and observed for over 30 minutes. She improved substantially and was discharged home with her mother pending results of allergy testing.

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

Severe neck and upper back pain, headache, dizziness, and vision disturbances began 5/22/21. She was seen at urgent care about 5/27/21 and at her doctor the following week- misdiagnosed twice with myofascial pain. Symptoms mostly persisted. On 6/22/21 she saw an optometrist for the visual disturbances and was diagnosed with bilateral papilledma. Optometrist called us 6/23/21 and advised us to take her to the emergency room immediately. After many tests (below) she was diagnosed with Idiopathic Intracranial Hypertension.

Metallic taste and smell after second dose; Metallic taste and smell after second dose; This is a spontaneous report from a contactable consumer (Pfizer colleague). A 17-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: ER8730) via an unspecified route of administration in left arm on 26Mar2021 at 09:30 (age at vaccination 17-year-old), single dose for covid-19 immunisation. The patient's relevant medical history included vasovagal syncope and Covid-19. The patient did not have any known allergies. The patient's concomitant medications included ethinylestradiol, norethisterone acetate (JUNEL). The patient previously took first dose of BNT62B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EN6203) on 05Mar2021 at 12:00 via an unspecified route of administration in left arm at single dose for covid-19 immunization. Prior to vaccination patient was diagnosed with Covid-19. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Since the vaccination, the patient had not been tested for COVID-19. Reporter stated that patient texted her that, on 26Mar2021 at 09:30, after getting her second dose, she had metallic taste (tasted metal in her mouth) and smell. Patient did not receive any treatment for the adverse event. The outcome of event was recovering at the time of reporting. No Follow-up attempts are needed. No further information is expected.

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

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.

For the 4 weeks following the first COVID vaccine dose the patient had significant loss of taste and smell, mild nausea, mild aches and pains and increased anxiety. This resulted in an approximate 8 lbs weight loss, an acute drop in school performance & psychiatrist increased her SSRI medication dosage. She went to the doctor for blood work and a celiac disease panel, all of which were grossly normal. Unsure if she was tested for epstein-barr virus. Her escitalopram dose was increased. After the second dose of the vaccine the patient became lethargic, lost interest in things she used to enjoy, had poor tolerance for conflict and activity. She began having panic attacks, severe abdominal pains with worse nausea and intermittent vomiting. Her menstrual periods were lasting twice as long (10 days) and she was fatigued to the point of exhaustion. As the symptoms progressed the patient started having thoughts about hurting herself, definitively not suicidal, but so overwhelmed she felt the need to hurt herself.

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.

started with a "scratchy throat", the next morning 6/30/21 slightly sore throat and blisters in the mouth and throat. took her to the walk-in clinic and was told it is Herpangina. Starting on 7/1/21 she began coughing and continues to cough almost 2 weeks later. on 7/2/21 she began having symptoms of a head cold. Runny nose, watery eyes, and coughing

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: 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

Taste was different and still hasn't gone away; Really nauseous; metallic taste; This is a spontaneous report from a contactable consumer. A 17-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on arm left 13May2021 (Age at Vaccination: 17 years) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history was reported as none. Prior Vaccinations (within 4 weeks) and adverse events following prior vaccinations was reported as none. Family Medical History Relevant to Adverse events was reported as none. The patient Concomitant medications were not reported. Historical Vaccine included She received allergy shots. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 22Apr2021 (at the age of 17 years) as DOSE 2, SINGLE for COVID-19 immunisation. She got her second dose 6 weeks ago and on 15May2021, the patient experienced taste was different and still hasn't gone away. She was reading that it is kind of uncommon to still get a metallic taste. On an unspecified date in May2021, after the second dose, the patient experienced really nauseous and then started noticing her taste was different and she just stopped eating things that taste weird mainly meat. Treatment received for Taste was different and still hasn't gone away was reported as no. The Relevant Tests was reported as none. The outcome of the event nausea was unknown, while other events was not recovered. Information on the lot/batch number has been requested

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

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.

17 year old patient getting vaccine with her mom. She was scared to get the vaccine. Stood up too quick after getting it felt faint and dizzy couldn't see or hear. got her some water she was sweaty. medics were called they checked her out. she did not go with them or to hospital she went home with mom.

Approximately 3 minutes after injection, pt. reported that her vision had gone black, her ears were ringing, and she felt faint. I notified the nurse immediately. Within another minute her breathing became rapid and faint. She was given water and coached to breath slowly and deeply. The nurse checked her blood pressure with a result of 67/22. A second BP check resulted in 70/27. The nurses transferred her to the ER. In the ER, a third BP check 20 minutes after injection resulted in a normal reading of approximately 110/70. She continued to take oral fluids for approximately one hour before being released. The medical staff reported to us that this is a completely normal reaction for many people to all vaccinations, and suggested that she should get the second dose of Pfizer vaccine in 3-4 weeks. However, when we check the CDC website we find that these are anaphylactic symptoms and should not get the 2nd dose of Pfizer, so we are greatly concerned and decided to report the event.

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.

Aphthous ulcer in mouth and gums; Sore throat; This is a spontaneous report from a contactable physician. A 17-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP 7533) via intramuscular route in the left arm on 16Apr2021 at 13:30 (at the age of 17-years-old), as single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medications within 2 weeks prior to the COVID vaccine. The patient's past drug was reported as peanuts. 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 vaccination within 4 weeks prior to the COVID vaccine. On 17Apr2021 at 13:30, the patient experienced aphthous ulcers in mouth and gums and sore throat. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events aphthous ulcers in mouth and gums and sore throat and included treatment with prednisone and listerine. The clinical outcome of the events aphthous ulcers and sore throat were recovered on an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.

swollen, itchy lips, some small bumps around the outer border of lip tissue, bumps were also itchy. top lip was more swollen than the bottom.; swollen, itchy lips, some small bumps around the outer border of lip tissue, bumps were also itchy. top lip was more swollen than the bottom.; some small bumps around the outer border of lip tissue; 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, Formulation: Solution for injection, Lot number: EW0173), via an unspecified route of administration in arm left on 30Apr2021 at 15:00 (at the age of 17-year-old) as a dose 2, single for COVID-19 immunisation. The patient's medical history was reported as none. The patient had no known allergies. The patient's concomitant medications received within 2 weeks of vaccination included bifidobacterium bifidum, bifidobacterium lactis, lactobacillus acidophilus, lactobacillus brevis, lactobacillus bulgaricus, lactobacillus casei, lactobacillus paracasei, lactobacillus plantarum, lactobacillus rhamnosus, lactobacillus salivarius (PROBIOTIC 10), taken for an unspecified indication and multivitamin. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0153), via an unspecified route of administration in arm left on 08Apr2021 at 10:45 AM (at the age of 17-year-old) as a dose 1, single for COVID-19 immunisation. It was reported that, the patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as yes, (COVID test type post vaccination was nasal swab). On 08May2021, the patient experienced swollen, itchy lips, some small bumps around the outer border of lip tissue, bumps were also itchy, top lip was more swollen than the bottom. Treatment received for the events was reported as yes, self-administered over the counter antihistamine. The device date was on 23May2021. The patient underwent lab tests and procedures which included nasal swab, resulted as negative on 19Apr2021, nasal swab, resulted as negative on 26Apr2021, nasal swab, resulted as negative on 03May2021, nasal swab, resulted as negative on 10May2021 and nasal swab, resulted as negative on 17May2021. The outcome of the events was recovered on an unspecified date in 2021. Follow-up attempts completed. No further information expected.

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.

FACIAL SWELLING. EYES SWELLED SHUT. TOOK DIPHENHYDRAMINE ORALLY AT 09:30PM ON 12/30/20. WENT TO SLEEP SHORTLY AFTER TAKING DIPHENHYDRAMINE AND FACIAL SWELLING WAS RESOLVED UPON AWAKENING THE FOLLOWING DAY. RESIDENT STATES SHE TESTED POSITIVE FOR COVID-19 ON 11/10/20

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.

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.

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

Patient felt light headed and needed to sit down, she said her tongue we itchy, paramedics were called, Breathing was fine, Pulse was fine, blood pressure was fine, paramedics thing patient had anxiety

3 days after I got the vaccine I started losing flavors, everything tastes like acid metal, everything smells the same as it tastes, and it?s being like that since the moment that start

Patient with history of allergy to IV contrast received first Pfizer vaccine and was sent to 30 minute observation area. A few minutes later, complained of numbness of lips, tingling of lips and perhaps some upper lip swelling. Exam was normal. Calm with strong pulse. Clear breath sounds, normal voice. No hives. Given Benadryl 25 mg po and observed. Symptoms resolved and patient went home.

Patient developed urticarial rash on 3/13/21 which began on her lower extremities and progressed to most of her body by the following day. She was seen on 3/15/21, and had no other symptoms besides the rash and was treated with zyrtec and benadryl but prescribed an Epipen (Auvi-Q) in case of worsening. The next day, 3/16/21 she awoke with swelling in her mouth and worse rash, used her Auvi-Q and called 911 and was taken to ER where she was treated for anaphylaxis with IV solumedrol,, IV fluids and IV benadryl and was sent home on Prednisone and benadryl and Pepcid.

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.

Immediately following vaccination, patient "saw black", became diaphoretic and pale. Patient was laid on floor with feet up on chair. Vitals: 1600 BP 87/52 HR 52 98% (laying 1602 102/68, 57, 98% (laying) 1604 103/74, 66, 100% (laying) 1605 111/69 73 100% (sitting on floor) 1609 106/69, 64, 100% (sitting in chair) Pt was eating, talking and drinking water. Symptoms resolved. No further treatment needed.

6:45AM- blurred vision and chills upon getting out of bed followed by loss of consciousness for ~30 seconds. Vomiting upon regaining consciousness. Fever of 38.5C. Took Tylenol, drank water, and slept from 7AM-8AM. At 8AM, chills and blurred vision had resolved. Was able to eat, drink, and take medication without further vomiting. Fever persists. New mild headache starting around 8AM.

After getting my second shot, I felt extremely dizzy and disoriented. My vision became blurry and I had trouble breathing. I also threw up several times. I felt lightheaded for a few more minutes and then I was able to stand again.

My throat partially closed up for several hours. I did not get treatment as I could still breath. Caused me to loose my voice with has not yet come back (today?s date 03/20/2021)

On Friday 3-19 she had a swollen lip. It went down and she had her first dose of COVID vaccine. Saturday she was well and had a fever on Sunday. Fever went away and she felt better until Tuesday when she had a high fever on Tuesday night. Wednesday she had swollen puffy eyes but they were never red in her conjunctivae. Thursday seen by Dr. Labs showed mild increase in LFTs and Cr. She had lymphocytosis and atypical lymphs consistent with a viral infection. She was negatvie for EBV and had a negative COVID swab. She does not have history of exposure to COVID a month ago. She is careful at school. They are tested frequently and no one has been sick, however one of her roommates had mono. Friday and Saturday fevers continued. Saturday repeat labs showed higher LFTs and negative CMV. ESR and CRP and ferritin are elevated. She has no rashes, cough or congestion. She is mentally clear and not light headed. She has a headache when her fever is high but otherwise is okay. No conjunctivitis, No sores in mouth or lips, and no swollen LNs.

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

Approximately 45 minutes after the injection, patient's tongue felt rough and textured. Upon viewing, her tongue was red with tiny bumps on the front half. An hour after that, her saliva felt thick with mucous and her tongue was red and mottled. 4 hours after the injection the red color dissipated, but the tiny bumps remained. The next morning. her tongue was back to normal.

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.

The patient reports experiencing blurred vision, vertigo, throbbing unilateral headache upon arrival to her seat. The medical team assessed her and found her HR to be 76 bpm, BP 142/80, BG of 72, and her oxygen saturation was 99%. She reported that she had not eaten all day and had not had a lot of water during work. She reported that she typically gets migraine headaches lasting for several hours. She was given some water and her symptoms started to resolve. She asked if she was able to go home.

Intense soreness, tiredness immediately after for 3 days Starting on 4/11 loss of taste and smell Starting on 4/12 loss of taste and smell plus sore throat, runny nose and difficulty breathing

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

immediately after vaccine pt states feeling sweaty, spots in vision, muffled hearing, brought to OBS via wheelchair by reaction nurse. given water and transferred self to stretcher, placed in tredelenburg, vs monitored as noted. pt feeling better once laying down, pt slowly positioned to sitting up to dangle and then to standing. feeling better with position changes pt states normally has lower BP no further symtpoms. ok to discharge home pt ambulated to exit at 0935 vs 0913 bp 97/60 hr 73 rr 18 o2 96, 0919 bp 109/65 hr 77 rr 18 o2 98, 0924 bp 108/76 hr 91, rr 18 o2 97 low fowlers, 0926 bp 98/64 hr 92 rr 18 o2 98 dangle 0932 bp 110/64 hr 86 rr 18 o2 98 0933 bp 111/72 hr 92 rr 20 o2 98 standing

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 received 1st dose Pfizer 2:15pm (Mother was present) with a minute, patient states that she can't see anything and her body was feeling fatigue. I sat her down, she couldn't talk and answer any questions. I quickly got my tech to call 911, they came quickly and monitored her and took her to the hospital.

Patient had anaphylaxis reaction. Tongue swelling, SOB, rash, Given benadryl. Taken to ED for observation. Epi pen, benadryl, pepcid, and solumedrol administered.

At 2:58 pm, Pt. reported feeling light headed and her vision getting blurred. Pt was alert and oriented X4, BP=137/82, hHR=88 , RR=22. Pt. was laid on a flat surface, legs were raised, cold ice pack applied at the back of the neck, slow deep breaths were encouraged and performed. at 3:02 pt reported symptoms had subsided, pt. was offer room temperature water and observed further for 20 minutes. At 3:39 pt. was d/c home in a stable state with mom.

Shortly after receiving vaccine the patient developed lip swelling, throat swelling. EMS evaluated patient and found tonsils were swollen. Vital signs BP 152/100 RR 20 HR 104 Oxygen sat-98% on room air. Patient received IV benadryl and was transported to local hospital ED for further evaluation and treatment.

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.

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

losing vision; almost passing out; After second dose: fever; chills; headache; body ache; pain at injection site; dizziness; This is a spontaneous report from a non-contactable consumer (patient). An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, at 18 years old. The patient medical history was not reported. There were no concomitant medications. No other vaccines if four weeks. Patient received the first dose of bnt162b2 at 12Mar2021 16:30, arm left for covid-19 immunisation, at 18 years old. Patient is not pregnant. The patient experienced after second dose: losing vision, almost passing out, dizziness, fever, chills, headache, body ache, pain at injection site on 10Apr2021 00:00 (12AM). Treatment was not given. Outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

full body blistering hives; full body blistering hives; eyes swollen shut; lips started to swell; This is a spontaneous report from a contactable consumer reported for herself. A 18-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in left arm on 26Mar2021 12:00, at the age of 18 years old (Batch/Lot Number: EN6208) as single dose for covid-19 immunisation, at the hospital. The patient had received the first dose of BNT162B2 on 05Mar2021 02:00 PM from lot # EN6200 in the left arm. Medical history included hypersensitivity. The patient's concomitant medications were not reported. The patient was not pregnant. Patient had not Covid prior vaccination, patient has not tested positive for COVID-19 since having the vaccine. No Covid tested post vaccination. The patient experienced full body blistering hives, eyes swollen shut, lips started to swell on 27Mar2021 12:00 AM with outcome of recovering. The patient was treated for the events with an injection of steroids and Benadryl at ER. No follow up attempts are possible. No further information is expected.

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.

Began to have paresthesias of L upper lip No swelling of pharynx or other signs or symptoms of anaphylaxis - no rash, nausea, vomiting, diarrhea, wheezing, dyspnea Given steroids/benadryl Swelling was stable and patient was discharged home

After the Covid-19 vaccine, Patient said that she had back, ears and neck pain. She also felt dizziness and shortness of breath. A few minutes later, these symptoms was improved. After about 10 minutes, the patient was back to normal.

her eyes are currently very puffy/swollen, watery and itchy; her eyes are currently very puffy/swollen, watery and itchy; her eyes are currently very puffy, watery and itchy; her eyes are currently very puffy, watery and itchy; She says she has the other normal side effects like a headache; This is a spontaneous report from a Pfizer-sponsored programt. A contactable consumer (the patient) reported that an 18-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number for second dose: EW0162 or EWO162, expiration date: 30Jul2021, NDC number: 59267-1000-02) via an unspecified route of administration in left arm on 14Apr2021 19:15 at age of 18-year-old at 0.3 mL, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No family medical history relevant to AE. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8730) in left arm on 24Mar2021 at age of 18-year-old at 0.3 mL for COVID-19 immunisation and experienced no event (reported as "no AE following prior vaccination"). The caller declines being sick at the time of vaccination. No relevant tests. She said her eyes were currently very puffy/swollen, watery and itchy, start date 15Apr2021 ongoing improved. She said she had the other normal side effects like headache, start date 15Apr2021 ongoing improved. She did not elaborate on any other side effects. She said she was wondering what to do about her eyes, they were still swollen. She said she took an allergy pill to help that the pharmacist told her to take, her eyes were still somewhat swollen. She asked if she should call her doctor. The outcome of the events was recovering. No follow-up attempts are needed. No further information is expected.

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.

At 10 minutes post-vaccination, patient had noted a dry, scratchy feeling in her throat and asked if I (mom) had brought a water bottle with us (I had not). At 20 minutes post-vaccination, patient began feeling her throat tightening, tongue swelling, and stated that her lips/mouth/tongue had a tingling sensation. At this point she was taken to the nurse/paramedic to be monitored with EKG, pulse oximetry, and given a bottle of water to drink. After 30 minutes of monitoring, the nurse/paramedic asked patient if her symptoms were improving and if she felt well enough to go home. She said that her symptoms were not gone, but improving, so she was told to sign a waiver/refusal of care form and released. However, at 11 hours post vaccination (1:30 AM), the symptoms returned (tongue swelling, throat tightening, tingling sensation in and around her mouth). I administered Benadryl (2 tablets), monitored for 30 minutes, and symptoms improved. No further symptoms after that point.

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

Patient called pharmacy in evening to report extreme blurred vision in right eye. Patient was instructed to have someone take her to urgent care.

On 5/9 at approx 8 or 9pm patient started experiencing a severe headache. Given her history of allergies and angioedema, I had her take 25 mg of oral Benadryl in addition to 500mg of Tylenol. This morning (5/10) when she woke up her upper lip was severely swollen. This sometimes happens with her angioedema, but it is always unilateral, stopping abruptly at midline. This time the swelling was bilateral, involving the entire upper lip, and was more severe than she has ever experienced. She took 240mg Allegra and 40mg Prednisone per MD instructions. Swelling started improving in the afternoon. Patient has known triggers for angioedema, but had none recently, nor had she experienced any angioedema in the last few months.

Patient had right sided facial redness and itchiness about 20 to 30 minutes after injection, no swelling, no rash, that lasted about 10-12 hours, patient then had right periorbital swelling about 1-2 hours after injection, with slight scleral injection and itchiness of the eye, this lasted about 24 -36 hours then resolved completely Flu like symptoms ( body aches, fever, chills) within 24 hours that last about 36 hours post vaccine

Itching; Tongue is numb and tingling; Tongue is numb and tingling; allergic reaction; at the injection site she broke out; rashes on both arms/saw other red dots appear; Rash; This is a spontaneous report from a contactable consumer.A 18-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 26Apr2021 18:00 (Batch/Lot Number: EW0153; Expiration Date: Jul2021) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced rash on 27Apr2021, itching on 28Apr2021, tongue is numb and tingling on 27Apr2021, allergic reaction on 27Apr2021, she thought it was acne at first, but at the injection site she broke out on 27Apr2021, rashes on both arms/saw other red dots appear on 27Apr2021. Clarified allergic reaction as: She thought it was acne at first, but at the injection site she broke out. She has rashes on both arms. Rash seems to be spreading. Really started to show on day two and day three. Hasn't taken anything for it. She tends to break out on her arms, that's just her own body, but she saw other red dots appear that hadn't been there on her arms. She was itching last night and that was new. Is not itching as of now. She went to the hospital and was told to take Benadryl. Clarified she went to the vaccination facility, which was the hospital, and she was asked what was going on. She was not a patient of the ER and was not admitted to the hospital. Forgot to mention her tongue has been numb and tingling for a couple of days. First noticed it when she had something cold, but has persisted even without drinking something cold. Started Tuesday, 27Apr2021, night. Wondering if that is a side effect. Read in the pamphlet it is part of an allergic reaction. Read that rash is a part of a severe reaction.Outcome of all events was not recovered. Therapeutic measures were taken as a result of all events.

PT REPORTED BEING DIZZY, SAW SPOTS, HEARING WAS MUFFLED BP: 90/70 HR:88 02:98 PT. OFFERED WATER AND WAITED IN OBSERVATION LONGER-SIGNED WAIVER AND LEFT ON THIER OWN

Rash over left arm, neck, and face as well as ear swelling in both ears. After taking Allegra ear swelling and much of rash on neck has dissipated, but face and arm still have rash/getting more red.

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium

Full body rash - itchy, red, painful - spreading over 24 hour period to cover 90% of body. Swollen, red ears, warm to touch

Back pain requiring Naproxen, canker sore outbreak in mouth followed by same type of sores in genital area, headaches, spiked temperatures, chills, sweats, body acne, fatigue. Back pain, headaches & fatigue continue today; genital sores and acne improved after several weeks; mouth sores lasted over a month but better now.

Patient given vaccination ID unclear if this was the LOT number. She developed a mild skin rash one day after vaccination, which spread over her face, neck and chest and arms, with lip swelling, but no other oropharyngeal edema. The rash was itchy and pruritic, raised macules that were slightly erythemaic on the face, and sparsely papular on the arms. We prescribed benadryl and prednisone, with instructions to call our service line and also see us in the office on Monday. She had unresolved blood tests, hyperglycemia, which we were trying manage with our staff however she was not adherent to follow up with us due to college coursework. My associate is her primary care attending, and had requested assistance in filling out the VAERS form.

During her observational 15 minutes, patient was having dizziness and blurred vision. Patient had a loss of consciousness for 30 seconds. After regaining, patient was alert and oriented. Patient was given water and asked to sit for 15 minutes.

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.

Within 2 hours of getting the second COVID vaccine I started to have frequent sharp shooting pains in my heart making it hard to breathe as well as having erratic heart beats and blurry vision. The symptoms worsened approximately 24 hours after to where it has and continues to be sharp shooting and constant pain in my heart that travels into my left arm. Simple things like walking and breathing make it extremely painful.

Nausea; Food intolerance; Smell also affected-lingering 10 days after vaccine admin; This is a spontaneous report from a contactable other Health Professional. A 18-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via intramuscular, administered in left arm on 25Feb2021 at 10:00 am (at the age of 18-year-old) as 2nd dose, single dose for COVID-19 immunisation. The patient medical history includes Polycystic ovarian syndrome (PCOS), obesity and COVID-19, the patient had covid prior vaccination. The patient not tested covid post vaccination. No known allergies reported. concomitant medications includes Metformin and Oral contraceptive, which were received by patient in two weeks. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via intramuscular, administered in left arm on 04Feb2021at 04:00 pm (at the age of 18-year-old) as 1st dose, single dose for COVID-19 immunisation. The facility type for vaccine was Hospital. The patient was not received other vaccine in four weeks. On 01Mar2021, the patient experienced nausea and food intolerance. Smell also affected-lingering 10 days after vaccine administration. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events with antiemetics. The outcome of the events was reported as not recovered. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

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.

Difficulty walking. Blurry vision. 2 Emergency room visits 3 weeks after shot. Diagnosed with FND cohen's hospital.

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.

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.

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.

At midnight that night she experienced a hemorrhagic stroke which led us to the ER and subsequently her being admitted to the stroke ICU for 19 days - where she had a brain surgery via angiogram to embolize the hemorrhage. It was successful with lingering vision problems and headaches

The patient began to feel dizzy within a few minutes (2 to 3 minutes) of receiving the vaccine. We had the patient sit and drink a small water bottle and called 911. They complained of ears ringing, nausea, stomach pain, and black spots in their vision. We had them lie down on the floor until the paramedics arrived (within a few minutes, approximately 3). They took a BP reading of around 80/60 and advised the patient to go to the hospital and the patient agreed and was taken out on a stretcher.

Very tired and whole body aches the next day after 2nd vaccine, and over the following few days I was very very tired and could fall asleep anywhere and almost instantly if I closed my eyes long enough, my jaw was extremely sore after and the preexisting issues got very bad after (muscle tension and knotting). Had bad poops for about a week after and even pooped myself so that was awesome

Acute right posterior cerebral artery stroke, symptoms (headache, vision change) started 06/26/2021, patient sought medical attention and diagnosed 06/28/2021

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.

light sensitivity; fatigue; increase in hay fever symptoms; post nasal drip, sore throat; injection site soreness; post nasal drip; sore throat + lymph nodes around jaw; This is a spontaneous report received from a non-contactable other health care professional. An 18-year-old non-pregnant female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Lot number: Unknown) via an unspecified route of administration on an unknown date (at the age of 18-year-old) as a single dose for COVID-19 immunization. Medical history included eczema. The patient was allergic to pistachio and had hay fever allergy. The patient previously had taken fluoxetine, retinoids and had experienced allergy. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 09:30, the patient experienced light sensitivity, fatigue, increase in hay fever symptoms, post nasal drip, sore throat and lymph nodes around jaw, injection site soreness (24+ hours). Therapeutic measures included extra dose zyrtec allergy pill, ibuprofen and rest. The clinical outcome of light sensitivity, fatigue, increase in hay fever symptoms, postnasal drip, sore throat and lymph nodes around jaw, injection site soreness was unknown at the time of report. Amendment: This follow-up report is being submitted to amend previously reported information: 1. patient's initial added in first name field in patient tab. 2. final sentence updated to No follow-up attempts are possible; information about lot/batch number cannot be obtained. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Itchy tongue, a little hard to swallow for about 30 minutes, progressed to being itchy on entire body. Took loratadine 10 mg at 9:45pm. No more difficulty with swallowing around 10:45pm. Parent assessed possible hives and or swelling of tongue and found none. No itchiness the following morning.

Presented dizziness; tight chest; blurry vision; This is a spontaneous report received from a non-contactable consumer. An 18-year-old female patient (unknown if pregnant at time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jul2021 at 12:00 PM (Lot number: EW0172) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. Unknown if covid prior vaccination; unknown if covid tested post vaccination. On 06Jul2021 at 12:00 PM, patient presented dizziness, tight chest, blurry vision; refused EMS. Treatment received for events including first aid, vitals. Outcome of events was unknown. No follow-up attempts are possible. No further information is expected.

2 hours later after vaccination, patient started feeling uncomfortable. She felt better the next day, but started having persistent symptoms on 06/30/21 with difficulty to take deep breath and felt uncomfortable in the throat as well. Patient also felt dizziness on 07/01/21 - not anymore on 07/03/21. Provider scheduled a F/U visit on 07/05/21. On 07/05/21 televisit, patient chest discomfort persistent but stable; prev episodes of shortness of breath, throat discomfort, and dizziness still recurring intermittently. Provider recommended immediate evaluation; patient declined. Provider scheduled a F/U visit on 07/06/21. On 07/12/21 televisit, chest discomfort persistent but stable. Patient was no show on 07/06/21 and self reported to ER. Patient stated that easily fatigued and needing to take deep breaths; denied palpitations, LOC, MS change, or other neuro/cardio/pulmonary symptoms. Provider referred patient to F/U with cardiologist.

Tingling in throat after injection, but subsided after 5 minutes. About an hour after injection, I checked injection site and found a half-dollar bill sized red welt that was hot to the touch.

09:22: complained of throat and roof of mouth feel warm and itchy A: no difficulty talking, swallowing, breathing; clear speech, concise sentences 09:33 Per patient, her "throat feels better, it's almost gone". She left with her mom. Patient instructed to seek medical attention if any breathing difficulties.

Shortly after the vaccination I developed a headache with changed to severe migrane with extreme sensitivity to light and sound. Went to the urgent care and was given Ketrolac and Compazine. The headache lasted about 48 hrs in migrane status and lessened and finally resolved within 3 or 4 days.

While in monitoring area, patient stated she got nauseated, lightheaded, dizzy, sweaty, and was getting tunnel vision. This was at 16:07. She was wheelchaired to monitoring area, VS taken: BP 100/60, HR 76 BPM. Pt returned to baseline, she felt better with rest, gatorade, and water PO. Wheeled to vehicle, mother driving home stable.

Patient began feeling sweaty, shaky, and nauseated. Eventually started ?seeing stars.? BP 40 min after vaccine was 90/50 pulse 110. Patient advised to drink water. 1 he 10 min after BP 140/80 pulse 80 stated she was feeling a little better but wanted to go home with roommate. Advised if symptoms are still present would prefer she stay on site but she declined. Counseled on signs and symptoms which would warrant further follow up. At no point did the patient complain of difficulty breathing, sore throat, mouth or facial swelling, or itching.

Swelling and tingling of tongue, rash at vaccination site, hives on chest and neck. Given a steroid and Benadryl in emergency department. Was real eases with a prescription for steroids and direction to continue taking Benadryl.

non stop vomiting; headache; eyes hurt; cloudy feeling in my head; done nothing but Sleep; This is a spontaneous report from a contactable consumer (reporting for herself). A non-pregnant 19-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 15Jan2021 12:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunizatio. The patient experienced non-stop vomiting, headache, eyes hurt, cloudy feeling in my head and done nothing but sleep on 15Jan2021 14:00. There was no treatment received for the events. The outcome of the events was not recovered. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.

Client while being monitored complained of tingle in her tongue and swelling. Injection site red and jaw on right side. Tongue doesn't appear overly swollen . Client c/o more tingle than swelling. EMS evaluated client . Client sent to ER with IV. Client given Solumedrol and Benadryl in ER. Stayed a little over an hour and then discharged from ER.

Patient became lightheaded and her vision was getting darker. Vital signs within normal limits. Symptoms resolved.

off breathing patterns; Headache; Chills/shivering; body aches; extreme thirst; weak; high temperature; This is a spontaneous report from a contactable healthcare professional (patient). A 19-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ez3249), intramuscular at the left arm on 25Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included Type 1 diabetes and hypothyroidism. Concomitant medication included insulin. The patient previously took the first dose of BNT162B2 on 04Jan2021 intramuscular on the left arm for COVID-19 immunization. The patient experienced off breathing patterns, headache, chills/shivering, body aches, extreme thirst, weak, and high temperature on 26Jan2021 12:00. The patient did not receive any treatment for the events. The outcome of the events was recovered with sequel.

Patient was administered the vaccine around 6:15 pm on 2/23/21 and she waited in the pharmacy recovery area for the full 15 minute time. Patient called the pharmacy after she had just returned home (around 7 pm) and said her throat felt funny and she had a metallic taste in her mouth. Confirmed no difficulty breathing at that point, but that her throat felt a "little thick". As patient was already at home and not near the pharmacy area, recommended that she immediately go to ER to be seen as felt the delay of driving back to potentially get epi injection and then be sent to ER could be detrimental to the patient. She confirmed that she would head to the nearest ER.

Awoke the next morning with severe headache, fatigue, muscle pain (?felt Like being hit by a truck?). Slept 1.5 days, out of breath walking to bathroom from bed. Treated with sleep and sips of water, soup. However, her mild daily migraine became more severe 2 weeks after the 2nd dose, her vision has worsened, and her eyes spontaneously dilated with pounding headache a few days ago along with nausea. It appears this 2nd dose has made her daily (mild) migraines much more severe.

1530: Approximately 10 minutes after receiving vaccine patient reported having itching to throat, and hands. Patient stated she did have a Depo-Provera Injection after 1st vaccine approximately 3 weeks ago. Pt did state she pre-medicated herself with Benadryl 50mg orally at approximately 1300hrs today. Mom was present with patient while covering physicians and EMS on duty assessed patient. VS:112/82-B/P, 123-HR, 18-RR, SaO2 98% on RA. Allergies: Steroids, fish FMHx: Sports induced asthma and gallstones. 1550: Patient had notable facial swelling eye redness and flushing. 0.15 Epinephrine IM via home Epi-Pen self delivered by patient's mother for increase SOB, and tightness in chest. EMS transport called to transport patient to location. VS:118/86-B/P, 100-HR, 18-RR, Sa02 96% on RA. 1600:Transfer of care to EMS staff assisting in transfer of the patient.

One hour after vaccination, she experienced itchy throat, facial flushing, tongue swelling, respiratory distress, and abdominal pain and cramping. Patient self-administered epinephrine injection 0.3 mg in the car on the way home. Administered a second dose at home 45 minutes later. Then went to Hospital ER. she was given injections of benadryl and phenergan. observed and released.

Pt stated that she had become light headed and dizzy just after getting her shot. Pt stated that she also started to feel like her vision was starting to narrow. Staff stated that she had passed out for a couple of seconds and had become alert after laying her down.

Got second dose of vaccine the morning of March 10th. Had the "expected" symptoms of fatigue, headache, and chills the evening of March 10th. Woke up on March 11th around 6:50am and felt the same symptoms as the night before but also really hot and nauseous, stood up and began to slowly lose vision. Went to parents for help and they saw me pass out and collapse. Went to Emergency Room and they found I had a really high heart rate and I received an IV to help with rehydration. Was released after that and have continued to have the same symptoms plus muscle soreness but no longer feel as dizzy and haven't had any issues with vision or consciousness since.

Swelling of the face and eyes, high fever, loss of appetite, rapid heart rate. The swelling of the eyes has lasted 5 days now but the face swelling went away after 3 days. I still have a high fever on and off and the rapid heart rate went away a few hours after injections

12/17/2020 patient vaccinated with Pfizer COVID 19 vaccine. A few minutes after receiving vaccination patient reported feeling very dizzy,weak,lip swelling, "pressure" and "tingling and swelling" in her throat. A rapid response was called. EpiPen 0.3 mg/0.3mL administered IM into the right thigh. In ED patient was treated with Decadron 10 mg IV x1, Benadryl 50mg IV x1, and sodium chloride 0.9% 1 liter x1. Patient was discharged home after 4 hours of observation and no further complaints. Patient was instructed to follow up in the family medicine clinic and take all medications as prescribed. No follow-up in clinic related to allergic reaction noted in records.

Approx. 3min after administration pt became pale and light-headed. Pt reports feeling weak, blurred vision, and difficulty speaking. Denies SOB or LOC.

Felt fine the night before. Woke up at 6:00 a.m. with fever, chills, puffy bottom eye lid, watering, irritated eyes, redness and swelling on upper cheeks, swollen at site of vaccination, slight redness at vaccination site, headache, and my body felt heavy and slow. Towards the Evening, I still had symptoms such as redness in eyes, slightly swollen bottom eyelids, redness and swelling in upper cheeks, fever, chills, watering, irritated eyes, headaches, and my body feels slow, but not as slow as in the morning.

Conjunctivitis ? woke up the day after the vaccine (3/21/21) around 9:45 AM to notice eyelids swollen and pink. No pain associated.

Temporary loss of taste started on 3/21 that lasted 12 hours. Fatigue and chest tightness from 3/20-3/23. Occasional nausea

Around 7-7:30 PM, I started to feel weird tingly feelings run up and down all of my limbs at the same time but it was over in about 2 minutes. Then I couldn?t stop my eyes from continuously rolling back into my head. That happened for about 4 minutes or so sometimes it would happen like 3 or 4 times in a row and sometimes it would be every 20 seconds or so. I was extremely confused and forgetful for the next 40 minutes and then I slowly began to be able to recall stuff.

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: difficulty hearing-Medium, Systemic: Joint Pain-Medium, Systemic: Weakness-Medium, Additional Details: We called 911. EMT came in. All the vital signs were normal. After 30 minutes, the patient recovered.

Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Blue lips, white face, blurry vision-Severe, Systemic: Hypotension-Severe

Approximately 5 minutes after vaccine administration patient reported feeling an itchy tongue and some swelling. I examined patients tongue and it did not appear swollen. Patient denied and shortness of breath or trouble swallowing. Patient states she had a reaction in the past to a medication that caused severe swelling of her tongue in which she now has a prescription for epi pens Vital signs were taken and were normal (BP 110/70, HR 80, O2 SAT 100%). Patient was given water and asked to sit for an additional 30 minutes. Patient reports itchy sensation had gone away and she believes it was more anxiety related.

Patient received first dose of COVID-19 vaccine. Within a few minutes after vaccination, patient reported feeling lightheaded with blurred vision and rapid heart rate. Patient drank some juice and sat for an additional 10 minutes; patient reported she felt better and opted to leave. Suspected vasovagal reaction.

Pt states felt vision get dark and hard to hear and slumped over in chair slowly going down to floor. Partner said she hit her head at temple on left side . Pt taken to triage to be assessed by MDs and EMTs. Pt reports she has not eaten or had anything to drink today. Provided PO hydration. Pt DC home at 1300 in stable condition and has recovered.

Systemic: Abdominal Pain-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Vomiting-Severe

Patient didn't think she fainted. Thought she fell asleep. However, a customer saw her phone and personal items fall. She did state she has a history of fainting from taking blood, so it's possible she fainted. She was feeling light headed and woozy and her ears were ringing just before the episode. I asked her if she wanted me to call 911 and she said no because when it had happened in the past, she had been fine. I took her blood pressure and it was 95/52. She waited in the area till 12:25 and I took her blood pressure again and it was 115/60. She did not have any other incindent. She left with her companion. I called her at 1:27p. She had arrived home and was still doing ok.

" Called to vaccine table for pt feeling faint. Pt reports similar response to vaccinations in the past. No hx of allergies. Patient presents to the peds ED after experiencing dizziness, vomiting, and vision changes after receiving her first dose of the COVID vaccine (pfizer). Pt states she normally gets lightheaded with needles, but never to this extent in the past. Pt states that immediately after receiving her COVID vaccine, she became lightheaded, had tunnel vision, and vomited. Pt states that she was taken to another room where she vomited. In that room, she was noted to be cold and clammy. EMS notes pt's systolic BP was in the 80's, but improved to a high of 116/69. Pt noted vomiting x3. Pt notes she did take plan B on 3/21 and LMP was about 5 days ago. Pt denies any PMHx, medications, allergies, family history, or surgeries. In the ED, pt noted that she was feeling a lot better and was no longer dizzy/lightheaded. Reports Nausea, dizziness and weakness. Pt transferred to triage area. Pt had uncontrolled vomiting. Transferred care to onsite EMS for transport to local ED."

Following the injection, I made my way to the observation room to wait for 10 minutes. After about two, my left arm began to get extremely hot and I called the nurse in the room over. I began to ask her if it was a normal side effect and began to lose my vision and hearing while talking. I passed out and was wheeling to the side of the room where the doctor was. Upon waking up (after 2/3 minutes) I threw up. The doctor took vitals and such and said everything looked okay. After about 15 minutes I was able to stand and head home.

Upon resting later the day of my vaccine at home, my left arm because extremely painful and sore. Which I found to be normal and expected. However, I became very exhausted suddenly and ended up falling asleep 2-3 hours before my normal bedtime. I woke up 12 hours later unable to motivate myself to get out of bed. Finally, I did and went to go take a shower. I had chills as soon as I got out of bed and had to sit down in the shower for 10 minutes out of exhaustion and had the water running extremely hot but I was still cold. My arm was still in extreme pain. Finally, I arose from the shower floor and began showering when I started to feel as if I was going to puke right away. I laid down in the shower quickly becoming dizzy, and tried to puke. I dry heaved once to no avail. Immediately after dry heaving, my ears went numb and the shower noise was barely audible. My hands went completely numb. Home alone, I knew I needed to get out of the shower before I passed out. I managed to step out of the shower before immediately falling and possibly blacking out for some seconds and fell to the floor and laid there for a minute. Finally, I was somehow able to grab a towel and struggle to my bedroom and laid there numb for about 10 minutes. This episode ended at about noon but for the rest of the day, I had to sleep on and off, it exhausted me to try and eat, I had hot flashes, more dizziness, arm pain, and nausea. I called the doctor and they said there was nothing they could do and my symptoms were normal since I had COVID-19 in December.

4/11/2021 Pt was observed post Covid-19 immunization for 15 minutes . During the observation period, she experienced an adverse reaction with the following symptoms: dizziness, weakness and jittery, loss of vision. Assessment : Time of assessment ** 415pm*. Alert and oriented and Pallor. Actions taken: Vs taken at 510pm BP- 69/45, P-59, O2- 100%, juice, water, cookies and potato chips given, patient is consuming, feet elevated in chair, recheck of VS at 525pm- BP- 89/57. P- 58, O2-100%, she is alert , answering questions appropriately, continues to drink and eat, recheck of VS at 540pm, BP- 104/72, P- 57, final BP at 543pm 101/67. Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. The Patient was provided with Vaccine Information Sheet and instruction to access the system. Patient left with friend. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 4/11/2021 5:06 PM 0.3 mL 12/11/2020 Intramuscular Manufacturer: Pfizer, Inc Lot: EP7533 NDC: 59267-1000-2 Electronically signed by RN at 4/11/2021 5:58 PM Immunization on 4/11/2021 Detailed Report Note shared with patient

19-year-old with no significant past medical history presenting to ED after experiencing lightheadedness, vomiting, vision changes after receiving her first dose of Pfizer Covid vaccine. History is consistent with vasovagal syncopal episode given resolution of symptoms in a quick period of time. Must also consider anaphylactic reaction to vaccine given patient had vomiting and low blood pressures following vaccine administration. However, this is less likely given that patient returned to baseline blood pressures without any additional interventions and has had no additional episodes of vomiting since presenting to the emergency department. Must also consider pregnancy given vomiting and recent Plan B usage

Patient began feeling dizzy immediately after administration. She said she could not open her eyes/ see. She became extremely sweating and pale. She never lost consciousness but could not regain her strength/ color.

The night I got the vaccine I was studying and all of a sudden I couldn?t finish my sentence and felt like I was going to pass out. My eyes unfocused, I got slightly nauseous, I went absent, and my heart raced. I couldn?t focus the rest of the night I felt very off and strange. It was very sudden and scary. I shook for like 30 minutes after. It has been happening on and off in very short durations for four days now.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Visual Changes/Disturbances-Medium

Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Additional Details: a few minutes after the patient took the vaacine she started getting lightheaded and she came to the pharmacy counter and passed out there. i carried the patient and sat her straight in a chair. i gave her water and orange juice. patient was confused and not aware of her surrounding and said she barely could hear. once she drank the OJ she felt better. took her vitals everything was fine. pt said she felt all good

The morning after my vaccine, my ear started ringing for a few minutes. It went away for a while and then came back again a few days later and is now perpetual. I have never had any history of ear ringing.

Patient was walking to observation room when she began to feel dizziness, vision changes and tinnitis resulting in syncope 1-2 minutes. Patient was on floor in sitting position supported by staff member. Diaphoretic. Pale. Unresponsive <1 minute. No head or face injury noted. No bleeding, swelling or ecchymosis noted. Full ROM to neck, LE and UE. Denies pain, CP, SOB, HA, palpitation or vision changes. BP 94/53 HR 99 O2 99% Patient was assisted to chair. A&O x 4. Reports that she was fasting x 1 month, reports eating small amount of granola bar and small amount of water. Patient was observed for 30 minutes. d/c home in stable condition w/ dad. ED warning s/s discussed. Patient and father repeated instructions w/ good understanding.

Face felt numb at 12pm Lips started feeling weird which they turned out to be swollen 12:37 Mouth started twitching into a smile 12:45pm Face started swelling 1pm Face started becoming red 1:50pm Went to doctor at 1:54pm Low grade fever at 2:10pm Hives started forming on eyes 2:30pm Face still twitching and mouth still stuck unable to open mouth 2:35pm Zertec provided by doctor and swelling went down and was able to open mouth but the involuntary twitch still occurring 2:40pm Mouth has involuntary twitching since April 16 and currently the same as yesterday it?s April 17th

Patient received 1st dose of Pfizer COVID-19 vaccine and was placed in Observation area for monitoring, subsequently left the clinic in stable condition. Patient later took PO Benadryl and had no relief of itching. Patient came back to the Vaccine Clinic and reported to the EMTs on site post vaccination experienced itching, nausea and vomiting x 1, slight mouth swelling and new complaint of chest discomfort. VS: Stable. While walking patient experienced a syncopal episode lasting 2 seconds. Post A&O x 4, pt placed in trendelenburg position, ice applied to itchy areas of neck. VS and O2 sat stable. Visible rash, mouth swelling and itching present. Benadryl IM administered by EMT, patient continued to be assessed for an additional 15 minutes, then complained of more chest pain. VS remained stable, EMTs transferred to ER. Later received epi IM x 1 with relief.

Nausea; Passed out; Felt a little dizzy; Mumbling, slurred speech; Developed a "static" feeling in her head; Eye shutting; Weakness in her left arm and leg; This is a spontaneous report from a contactable physician. A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), intramuscular on 23Mar2021 as single dose for COVID-19 immunization. Medical history included seasonal allergies from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient has been tested for COVID-19. Concomitant medication included fluoxetine 60 mg taken for an unspecified indication, and an unspecified oral contraceptive. It was reported that on 23Mar2021, the patient received Pfizer Covid vaccine and felt a little dizzy on 11:00. She also started noting mumbling, slurred speech, passed out for about 15 (unspecified) after using the bathroom, developed a "static" feeling in her head and then noted her left eye shutting and then weakness in her left arm and leg. She was taken to the Emergency Room (ER) for evaluation. Symptoms lasted about 5 hours. She fell asleep in the ER. Symptoms seemed to clear by about 8:30 PM. She had lab and head CT at the hospital which were essentially normal. She felt okay the next day, but had some nausea for a couple days starting on the 3rd day on 25Mar2021. She stated she feels fine at the time of report in the Student Health Clinic and asked whether she should receive her second Pfizer dose scheduled on 20Apr2021. The adverse events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. No treatment was received for the adverse events. The outcome of the event nausea was recovered in Mar2021, and for other events was recovered on 23Mar2021 20:30. Information about lot/batch number was requested.; Sender's Comments: Based on the information currently available and temporal association, a possible causal relationship cannot be excluded between the suspect product BNT162B2 and the reported event Passed out. 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 is a 19-year-old female who presents for an allergic reaction s/p receiving her 1st COVID vaccination at 1640 today. About 15 minutes later, the patient developed a tingling sensation in her tongue, tight scratchy throat, and swelling in her upper lip. She denies any rash or shortness of breath. She denies having any drug allergies, but does note an allergy to macadamia nut in the past. She denies taking any anti-histamines or epinephrine prior to arrival. She reports a history of ADHD and took 30 mg of Vyvanse, which typically causes her heart rate to elevate in the low 100s. LNMP: 3-4 weeks ago. She denies any chance of pregnancy.

On 04/24/2021, 2 minutes after the Pfizer immunization given to patient, complained of not feeling well. As soon as the pharmacist ran to help her, she looks seriously pale, nauseous, sweaty, and then lost all her faculty. She said she could not see anything and started to feel difficult of breathing. The pharmacist immediately gave her EpiPen, and called 911. While waiting for EMS, she started to feel a bit better, could see things. EMS came, measured her blood pressure, and told that she got syncope. They transported her to the hospital.

Patient was taken into Med Obvs for throat tightness. Patient describes that she experienced tightness and dryness in the throat after receiving the second dose vaccination. VS were checked at 14:36, HR: 90, RR: 19, BP: 122/83, SPO2: 99. Patient was encouraged to relax and have sips of water. Next VS were taken at 14:53, HR: 73, RR: 19, BP: 119/81, SPO2: 100. She was made comfortable on the stretcher with head of bed elevated to allow expansion of her lungs and reduce the risk of aspiration while sipping on water. Last VS were at 1508, HR: 65, RR: 20, BP: 121/83, SPO2: 100. Patient was released at 1511 by herself after symptoms lessened.

Within 5 minutes of receiving vaccine daughter felt something was not right as we sat in 15 minute holding period. She was holding her chest. I advised her to sit and I would get help. as I turned she was standing next to me holding her chest saying she isnt feeling right. they put her on a bed and was looking for a blood pressure cuff. they placed a pulseox on her finger which showed 100. then they placed another clip on her other finger and it showed her heart rate increasing to 138 from 93 in seconds. her face was red her neck was red and she said her heart was racing. they finally found a BP cuff and her blood pressure was 148/94 which they said this was normal. it was not. they they told us to seek medical attention. She continued to complain about chest pain and racing and her face and next continued to be red. the nurse then gave her 50ml of benadryl with no relief. She was taking out by wheelchair to a waiting ambulance then to the Hospital Emergency Room. They treated her with a Steroid and IV. She was released after about 3 hours. we came home and 2 hours later went back to the same Emergency room for the same chest pain and racing at which point she now had a rash on chest and neck. this time they gave her medicine to slow down her heart which made her feel better. she was then released. Since then she continues to have heart papatations and rashes, and a heard time swallowing with a continue feeling something is stuck in her throat.

Right eye swelled shut, hurt, itched, turned red, and had discharge. Swelling went down by itself starting the next morning.

During observation, member stated that she could not see and was getting hot. Started to talk and could not speak and her eyes began rolling to the back of her head. ADULT EMERGENCY CALLED. Pt assisted to wheelchair, member still unresponsive, unable to talk, blinking her eyes with eyes rolling back. Placed on stretcher. BP 126/96 HR 100 SPO2 100. EMS arrived and transported patient to hospital for further eval.

Patient stood to approach her father, when she slumped over and lost consciousness and was unarousable. She had normal breathing and pulse. The clinical team transferred patient to the Assessment Tent, where she was observed to have seizure-like jerking of her upper & lower extremities and fluttering of the eyelids while she remained unconscious. She had normal pulse and respiration during this time, no tongue biting or urinary or stool incontinence. Within approximately 10 minutes her seizure-like movements resolved, and she gradually regained consciousness. I spoke with the patient afterwards: she recalls having stood to meet with her father, and then she has no recollection of the event.

Blurry vision, light headed, sweating, nausea. Had patient remove mask and take some deep breaths. Offered some water to drink to re-hydrate. Patient felt much better right away. Pharmacist sat with patient for an additional 15 minutes to monitor for worsening or additional symptoms. Patient showed only signs of improvement. Helped patient stand. No lightheadedness or dizziness upon standing. Patient left pharmacy.

Roughly an hour after vaccination, experienced light-headedness and dizziness. During the night, a mild fever and nausea. The next day, four episodes of vomiting, fever, dizziness, headache, and body aches. During the second night, fever rose to 101. The second full day, worse headaches, sensitive to light, chest tightness (hurt to breathe deeply, cough, and laugh) and body aches. Third full day, mild chest tightness. Only medication taken to treat adverse affects was ibuprofen.

Shot given 4/23/2021 at 1pm. 4/25/2021 around 1pm started losing vision in both eyes while at work, also passed out & fell down multiple times. By evening of 4/25/2021 had extreme nausea when trying to consume any food or drink any liquid. Went to urgent care 11am-ish on 4/26/2021 for continued nausea symptoms and overall body pain. Was told symptoms likely an adverse reaction to the COVID vaccine received days prior. If anything else worsened to go to ER. Felt better during day of 4/27/2021 until a migraine came on at 7pm. Went to ER. Was given a COVID test (awaiting results at this time) as well as some muscular shots of Toradol, Benadryl & Reglan. Felt better within 30 mins and was discharged to go home.

patient's upper lip and lower lip started to swell ( a thin line on the mucosa just undereath the vermillion bordre.

Shortly after injection patient was light headed, had blurry vision, was pale, and was having trouble hearing.

At 7:40 pm on 04/27 I received my second Pfizer COVID19 shot. I felt okay for the rest of the night and went to bed around 2am that night. The next day, I woke up around 10:30am and was sore until about 12pm when I began to feel completely awful. I was tired and no pain reliever helped with the muscle aches in my shoulders and back. I felt like my chest was being weighed down and it felt like a horrible chore to even breathe. About 24 hours after the shot, under my jaws began to hurt terribly and ice didn't do much to help it. I finally fell asleep on 04/28 around 2am and woke up on 04/29 without any pain.

Hot and cold flashes 14 hours after Fainting/ Passing Out 20 hrs after Lightheadedness Starting 8am continuing to present Nausea currently Ringing in ears ( temporary after fainting)

Fever started at 7:30 PM on the same day. About half an hour later I started to get chills, and could not stay warm. Every time I got up to use the bathroom I got goosebumps and I was shivering. I went to bed around 9:30 and was still shivering and could not get warm. Woke up to a mild fever, a headache, and a metallic taste in my mouth. Symptoms seem to be gone now on 05/01/2021 in the morning.

Caller states she received her second vaccine dose of Pfizer, yesterday May 1, 2021 and started experiencing s/sx that night such as fever, runny nose, cough and swollen eyes. Caller states she woke up today and the swelling has not resolved. Advised caller to seek medical treatment so they can assess and advise her further

pt received shot at 14:35. at 14:40, pt reported feeling tingly and was given bottle of water. at 14:44, pt was given benadryl 25mg tablet. 2nd tablet was attempted at approx 15:02pm but unsuccessful (pt couldn't swallow) pt complained of feeling cold, was given blanket and taken outside to sit in warm sunshine. bp strong, as reported by RN. 136/40, pulse 80. pt's lethargy increased and 911 was called at 15:09. epi-pen was adminsitered at 15:11 upon pt unable to open eyes and beginning to drool. caller remained on phone with 911 until medics arrived at 3:16pm. emts assessed pt, loaded onto stretcher & departed approximately 15:30 to hospital.

Pfizer-BioNTech COVID-19 Vaccine EUA Received Pfizer-BioNTech COVID-19 Vaccine EUA on April 26th in left shoulder. Left shoulder hurt on April 27th - could use it but it hurt a lot to use. Also had a headache and diarrhea. April 28th Left arm still hurt to use about the same as the 27th (didn't use it much). April 29th Left arm felt different than other arm hard to describe it didn't hurt to use it was just weaker than right arm but not too much weaker. Left leg started feeling tingly like ants were crawling up it. April 30th same as the 29th left arm felt different than other arm hard to describe it didn't hurt to use it was just weaker than right arm but not too much weaker. Left leg still felt tingly. May 1st Left arm felt weaker than before but I could still lift things with both arms without noticing a considerable difference. Left leg felt weird not tingly anymore just different than right leg kind of numb. Had a limp when walking slowly. May 2nd felt like left arm and left leg were somewhat numb and weaker than right side. Also noticed I have to concentrate more to move my toes on the left. May 3rd left arm and left leg felt worse left side of face felt kind of numb like when dentists give you Novocain my face felt numb like that ( no difference in my tongue) but I didn't notice anything physically different about it. Left eye achy a little and it got a little blurry May 4th left arm and leg numb and weak, still hard to move my toes, and left side of face feels weird I guess numb is the best way to describe it. Left eye still blurry a little achy but not much. Summary: Left arm hurt at injection site, then whole arm hurt, now it feels weak and numb. Left leg felt tingly now it feels weak and numb. Left side of face feels kind of numb, left eye is blurrier than normal (I wear glasses), and I have had an off and on headache spanning this whole time.

5/4/2021 Pt was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: very nervous, complains of itching to face and lips Assessment : Time of assessment 1445. Alert and oriented and redness and visible stratching to face and lips. Actions taken: Vitals sign taken VAERS form obtained and completed by RN. VS- BP- 155/83, O2- 100 % at 1445, recheck at 1455- BP- 135/90, O2- 99%, drinking water, 1510- BP- 133/91, P- 72, O2- 100 %, 1522- BP-144/101, 1549- BP- 138/88/ P- 71, O2- 100 % Medications administered: Loratadine (Claritin) 10 mg by mouth. Time: 1505. Administered by RN. Diphenhydramine (Benadryl) 25 mg capsule, by mouth. Time: 1522. Administered by RN. Diphenhydramine (Benadryl) 12.5 ml (25 mg) by mouth. Time: 1445 and 1455. Administered by RN. Famotidine 20 mg 1 Po x 1 at 1518 by RN Disposition: Reports no further symptoms of adverse reaction after observation for 60 minutes. Discharged home. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 5/4/2021 2:35 PM 0.3 mL 2/25/2020 Intramuscular Manufacturer: Pfizer, Inc Lot: EW0167 NDC: 59267-1000-2 Electronically signed by RN at 5/4/2021 4:40 PM Immunization on 5/4/2021 Detailed Report Note shared with patient

Left arm pit pain Extreme Hypersensitivity all over body, skin burning, blistering and peeling, extreme teeth sensitivity, brain feels swollen hurts.

After receiving my first vaccine on 4/13/21, I had a small asthma attack after about 20 minutes that went away quickly. After my second dose, I started feeling out of control of my muscles almost immediately. I also noticed the injection site was bleeding more than the first shot. 30 minutes later, the shaking became extensive and uncontrollable. I returned to clinic and the paramedics told me I was having an anxiety attack. The shaking continued on and at about 4:00pm I felt that my throat was puffing up. I went to the hospital and they put me on a variety of medications (Benadryl, Pepcid, and methylprednisolone). I felt better soon after. The next morning I have a sore throat, feel feverish and have a headache.

Patient expressed anxiety and a headache before vaccination, but was able to ambulate to the waiting area. After about 5-10 minutes, she slumped in her chair, then fell to the floor. She seemed to hit her head on the concrete floor. She was unresponsive at first, but had pulse and clear airway. Staff turned her on her side and protected. Her eyes were fluttering and rolling back. Within 3 minutes, she was able to respond to questions with her name, though she was disoriented. EMS was called at that time. She stated she had not eaten anything today, so she was given small sips of apple juice. After 5 more minutes, she was more oriented and responding to commands. EMS arrived and assisted her to a seated position. She was transported by EMS to hospital.

About two minutes after being vaccinated patient states she felt nauseous, lightheaded, weakness, blurred vision. Told her brother who was sitting next to her that she "thought she was going to pass-out". Brother held her in chair and patient lost conscious for about three seconds but was supported by brother. I, , PA-C was alerted during the event and visually witnessed it and went to the patient who was regaining consciousness at that time still in her chair. I asked her how she was feeling and she said "okay". There was concern for possible anaphylaxis due to paling of skin and epinephrine was given in the left thigh without complications. No other signs of anaphylaxis were noted including no lip/tongue/mouth swelling; no wheezing; no hives. The patient was layed on the ground with her legs elevated which she states greatly improved her symptoms; and the patient was given orange juice to drink which she tolerated well. EMS arrived and evaluated the patient within about 10 minutes and the patient was feeling well at that time. Patient never hit her head during the episode. Patient who was accompanied by mother decided not to go to the ED at this time for further evaluation as the patient states her symptoms felt similar to previous episodes of syncope. ED precautions were given to patient and patient to follow-up with PCP recommended.

Suspected vasovagal episode, blurry vision, sweaty, hypotension, eval by EMS, transported to ER via ambulance.

I almost fainted; Nausea; Feeling sick and throw up; Feeling sick and throw up; felt very light headed/dizzy; Ear pain (right); This is a spontaneous report from a contactable consumer (patient). A 19-year-old female patient received first dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on 21Apr2021 at 18:00 (Lot Number: EW0162), as single dose, for COVID-19 immunisation. Medical history was not reported. Concomitant medication included unspecified nasal spray. The patient experienced almost fainted (medically significant) on an unspecified date with outcome of unknown, nausea (non-serious) on an unspecified date with outcome of unknown, feeling sick and throw up (non-serious) on an unspecified date with outcome of unknown, felt very light headed/dizzy (non-serious) on an unspecified date with outcome of unknown, ear pain (right) (non-serious) on an unspecified date with outcome of unknown. No follow-up attempts are needed. No further information is expected.

nausea; passed out; seizure; enlarged heart; hurt knee; sore mouth; This is a spontaneous report from a contactable other HCP (patient). A 19-year-old female non-pregnant patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration, in the left arm on 20Apr2021 at 11:00 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient has no history of COVID-19 prior to vaccination. The patient had received other vaccines within 4 weeks prior to the COVID-19 vaccine: 2nd dose of Human papilloma virus (HPV) vaccine on 06Apr2021 in the right arm. On 20Apr2021 22:30, the patient experienced passed out, seizure, hurt knee, sore mouth, enlarged heart, and nausea. The patient reported, "I was fine all day until around 10:30 pm I went into my mothers room and she was asking me how my arm feels I told her it was fine and right after saying that she said I passed out in front of her and then I began to have a seizure for about 50 seconds and then I woke up. After waking up from the event I had a hurt knee and sore mouth as well as an enlarged heart. I have no history of seizures in the past so it was definitely scary." The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 20Apr2021. Therapeutic measures taken included anti seizure meds, fentanyl, and paracetamol (TYLENOL). The patient recovered with sequelae from the events, passed out, seizure, hurt knee, sore mouth, and enlarged heart. Outcome of nausea was unknown.; Sender's Comments: A contributory role of BNT162B2 to the reported events cannot be fully excluded based on close temporal relationship and lack of alternate explanation at this time. However, the information provided is very limited and does not allow for a complete medical assessment. Case will be reassessed if additional information is received. 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.

19 year old female with a history of tachycardia syndrome (on carvedilol) presented to ER with acute chest pain radiating to jaw and bilateral arms. Episode occurred 3 days after second shot of Pfizer COVID vaccine.

She first complained to me of dryness in her left eye. it progressively got worse by the end of the night. I gave her lubricant eye drops but she said it didn't help much. The following morning, she began feeling a tingly sensation on the left side of her face. Ever day or every other day, she complained of worsening symptoms. The tingling feeling has grown to numbness and lack of feeling, which has begun to spread to her ear, tongue, neck. She unknowingly bites the inside of her cheek when eating. Her muscles and facial movements on the left side are less apparent than on the right side.

Left arm hurt at injection site; Whole arm hurt; Left arm hurt at injection site, then whole arm hurt, now it feels weak and numb/Left leg felt tingly now it feels weak and numb; Left arm hurt at injection site, then whole arm hurt, now it feels weak and numb/Left leg felt tingly now it feels weak and numb/Left side of face feels kind of numb; Left leg felt tingly now it feels weak and numb; Left eye is blurrier than normal; Left eye is blurrier than normal; This is a spontaneous report from a contactable consumer (patient). A 19-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0170), via an unspecified route of administration in left arm on 26Apr2021 at 16:30 (at the age of 19-years-old), 1st dose, single for COVID-19 immunization. Medical history included left eye was blurry and wear glasses. Concomitant medications included loratadine (CLARITINE), vitamin B complex (VITAMIN B) and ascorbic acid, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine mononitrate (ONE-A-DAY). Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. The vaccine was administered at public health department. On 27Apr2021 at 6:30, the patient's left arm hurt at injection site, then whole arm hurt, and then it felt weak and numb. On the same day of 27Apr2021 at 6:30, the patient's left leg felt tingly, then it felt weak and numb. Her left side of face felt kind of numb and the left eye was blurrier than normal. No treatment was received for the events. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.

Lips begin to swell ( minor) about 2.5 hrs. after second dose of Pfizer (5/12). Continued to swell the day after but not too bad ( 5/13) . Swelling on 5/14 and 5/15 continued with itching lips, and looking like she had dermal fillers. Day four swollen a little more with tightness in lips and bleeding from cracks of lips, but no itching. was diagnosed with Covid in Nov. 2020 and was admitted to for the same response, but worse, Lips were so swollen, cracked and bleeding , and painful.. Inside of mouth also became swollen and drained with pus. Throat and mouth were sore and she was not able to eat or swallow for about 5 days

Pt stated that within 15 minutes the fingers on her left had were tingling. Pt stated that, later, her left leg also began to tingle and felt like it was numb and was "dead weight". Pt stated that at one point her knee went out. Pt also stated that her head was cloudy and that things in the background seemed blurry. The pallor of the left hand was different than that of the right hand. Pt was able to lift and move her left arm and hand. Pt was also able to walk without assistance. Pt was released to the custody of her father and symptom progression will be monitored by family members. Pt stated that she would seek medical attention at the ER if symptoms progressed.

lost vision in both eyes; passed out; dizzy; severe nausea set in with severe body pain; severe nausea set in with severe body pain; worst migraine of my life; low blood pressure; This is a spontaneous report received from a contactable consumer (patient). A 19-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 19-years-old), administered in Arm Left on 23Apr2021 13:00 (Lot Number: EW0169) as 1st dose, single for COVID-19 immunization. Medical history included anxiety, and allergies to mosquitoes, hotdogs, and sausage. The patient was not pregnant at the time of vaccination. Concomitant medications included citalopram and drospirenone, estradiol (EOS), IUD, daily supplements. The patient previously took oxycodone ("oxicodone") and percocet [oxycodone hydrochloride;oxycodone terephthalate;paracetamol] and experienced allergies. The patient, 48 hrs later, lost vision in both eyes, became dizzy, passed out multiple times. Later severe nausea set in with severe body pain. Went to Urgent Care the following day and was told side effects. That night had worst migraine of her life, low blood pressure, and continued nausea. Given some meds and sent home to rest. Took 2 full days to feel okay again. Onset date and time of events reported as 25Apr2021 13:00. The adverse events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events. Treatment received for the adverse events included Toradol, Benadryl, and Reglan. The patient underwent lab tests and procedures which included sars-cov-2 test: negative (Nasal Swab) on 27Apr2021. The outcome of the events was recovered with sequelae. The events "lost vision in both eyes" and "passed out" were considered as serious (medically significant). Facility where the most recent COVID-19 vaccine was administered was Clinic/facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. No follow-up attempts are possible, no further information is expected.

I was partially blind in both eyes; extreme headache; fever; pain; malaise; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 19-year-old female patient received BNT162B2(Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, administered in left arm, at age 19 years, on 12Apr2021 14:00 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included seasonal asthma from an unknown date and unknown if ongoing and taking birth control medications in 2 weeks. Patient had no known allergies. Patient did not have COVID prior to vaccination. The patient's concomitant medications were not reported. Patient had not had other vaccine in 4 weeks. Patient received vaccine on 12Apr2021 14:00. Six hours later (12Apr2021 20:00), she experienced extreme headache, fever, pain, malaise that lasted through Monday night, Tuesday, and early Wednesday morning (14Apr2021). Fever broke early Wednesday morning and when she woke up later in the morning, She was partially blind in both eyes. All other symptoms were gone. COVID was not tested post vaccination. Treatment was received for the events by ER, personal physician, opthamologist. AE resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Patient had not recovered from partially blind; while recovered for all other events on 14Apr2021. Information on the lot/batch number has been requested.

Dizziness and fatigue in head developed and lasted for two weeks after the shot that was administered on April 25th.. About 5 days after the shot in the evening, I experienced hot, shooting pain in left leg that felt like a band around my thigh but would sometimes shoot down into my calf and feet. My feet would feel tingly and sore. I experienced shooting pain on and off again in my left and right arms as well as my right leg, but the pain in my left thigh stayed for over a week. The feeling in my legs made it difficult to sleep. Two weeks after the shot on Wednesday May 12th at 11am, the dizziness and fatigue made me lightheaded and I could not keep my eyes open. My head got really hot and my vision blurred and I could feel my heart beating in my head loudly and all over my body. I tried to walk to my thermometer to take my temperature but struggled to hold things in my hands or walk properly. My sister called my mother who took me to the Emergency Room around 11:50. The doctors took urine and blood samples, X-rayed my chest and did an EKG but could not figure out what was wrong with me and discharged me at 3pm.

19 yr female overweight, received SARS - Pfizer vaccine on 3/10 and 3/31. Presenting headaches and visual disturbace the first week of April. Seen by ophthalmology DX papilledema. Referred to IFH on 4/16, DX pseudotumor cerebri and abnormal thyroid test.

After receiving covid vaccine, and receiving patient education of Pfizer COVID vaccine pt states "I can't see." Nurse placed pt in supine position and provider was called to the exam room. Pt denies history of passing out with previous vaccines, denies LOC, loss of bowel/bladder and reports "I feel hot" and "I can't feel my hands and feet." Pt also reports she has not had anything to eat or drink prior to arrival to clinic. 1411 Vital signs: BP 107/69; HR 70; RR 20; pulse ox 99%. Upon provider exam mild pallor/diaphoresis noted, pt is awake alert and oriented to person/place/time/situation; No stridor, wheezing, sensation intact in all 4 extremities; pt has wrists and elbows in flexed position but able to straighten all upon request to place pulse ox and blood pressure cuff; 1415 BP 99/69; HR 102; RR 22; pulse ox 98%; Pt is continuing to report numbness bilat hands/feet and began to complain of nausea. EMS contacted. No hives, wheezing, stridor noted by provider, no emesis. Per provider sensations continue to be intact. 1423 VS BP 102/62 HR 67 pulse ox 99% pt remains awake alert and oriented x4; pt asked mom to contact her employer and call off work today. EMS arrives at 1430 and evaluates pt. After EMS evaluation, pt declined EMS transport states she feels better and just wants to go eat something. Pt reports symptoms resolved.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient was vaccinated at about 4:45pm, felt dizziness & lightheadedness shortly after. Following that patient states that her field of vision became black and foggy, she then was witness dropping to a knee. Pharmacist helped her to a chair and father got her some water. Patients skin appeared pale and felt clammy at this point. Her blood pressure was check at 3:57pm (81/50) and then again at 4:05pm (113/67). She felt and looked better, so the pharmacist walked both her and father to vehicle.

At 10:52 am patient stood up to schedule her second dose appointment because she stated she did not have the appointment yet. She was up front with the PCT, when this NP was called to come to the front because the patient had passed out and hit her head. EMS was called. Upon coming up to the patient, the patient was conscious. Examined patient for head or neck injuries. She denied any neck pain but stated the back of her head hurt. patient placed into chair with assistance, and given a bottle of water and an icepack. Upon inspection, patient had no lacerations or bleeding from the head. A 4 cm "goose egg" was noted to the back of the head. Neuro exam was normal. Patient alert and oriented times 4. Stated vision got blurry prior to passing out, however it was normal at the time of the exam. noted. Patient refused EMS transport at time of arrival 11:08 am. patient refused to go to ER. AMA form signed. Patient educated on signs and symptoms that mean she should seek immediate medical attention. Patient verbalized understanding of these teachings.

headache; dizziness; heaviness; ringing in the ears; numbness; black spots; This is spontaneous report from contactable consumer (patient, self-reported). A 19-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: ER8734 and expiration date was not reported), via unspecified route of administration in right arm on 05Apr2021 at 14:15 (at 19-years age) 1ST dose single for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient had received the other vaccine (not specified) same date 5Apr2021, 2 ND dose, batch no: EW0170, in Left arm. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received other medications in 2 weeks prior to vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 27Apr2021 at 12:15 the patient had experienced headache, dizziness, heaviness, ringing in the ears, black spots and body numbness. The patient had underwent the lab COVID-19 test negative (nasal swab). The patient did not received any treatment for the adverse events. The outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested. Follow-up (PRD 28Apr2021): This is a follow up-spontaneous report from a contactable consumer, added the suspect drug details, added the events, added the lab data.

19 yr old complains of nausea dizziness dry mouth had gyro 6 days ago but no food poisoning type symptoms immediately after. also had Pfizer vaccine at in 6 days ago had vaccine and unknown food poisoning she thinks doesn't eat meals snack on pretzels yogurt etc. had 4 packs vitamin c 3 days ago and vomited one time(this was the only time she has vomited) appetite poor the smell of food bothers her. she feel like she wakes up dizzy and with dry mouth

Patient start having nausea and vomiting symptoms about 10 min after administration. She also mentioned blurry vision and loss of vision in one side. She was fainting too. Patient was positioned on her side in the waiting room Her blood pressure was 111/71 and pulse 60 when checked by the pharmacist. EMT was notified. They arrived and check her vitals, she was doing better. they didn't consider that any future evaluation is needed.

We left the store and got a bite to eat at the drive through. After driving about 7 minutes she grabbed her throat and started acting like she was not able to swallow. I asked her was she ok? She stated no in a raspy voice. She shook her head and said she felt like molasses was in her throat. She seemed pale and began to sweat. I am a former EMT-Parmamedic. I remembered there was a store about 2 miles away. I called and got the Pharmacist on the phone. I ran into the after driving 92 miles an hour and she converted children's Benadryl for me and stayed on the phone. I gave her 1/2 a bottle. began to be more responsive. I had a medical bag with me with airways and other medical devices I use for work but no Epi Pen. After giving her all the Benadryl she said she felt better but she stayed hoarse for the remainder of the day and was sleepy. I kept an eye on her an Called her physician on Monday morning as this was a Saturday and they called in Epi pens in case this happens again. The first shot she felt like she swallowed a potato chip wrong and started acting the same way then through up but never got this bad. We just thought she ate something and it went down the wrong way. Never giving it a second thought. Then after the second shot it was much worse. Had I not the pharmacist on the phone, Benadryl liquid and a medical bag, I would have called an ambulance. In the county we live in though we do not have enough ambulances and I am afraid she would have went into full anaphylaxis and died. I did what I thought was the best for my only child.

hypokalemia (2.9 mmol/L); hypocalcemia (6.4 mg/dL); puffy eyes; respiratory symptoms; possibly stridor; This is a spontaneous report from a contactable physician. A 19-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 19May2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included food allergy, anaphylactic reaction. The patient's concomitant medications were not reported. The patient woke up the next morning on 20May2021 with puffy eyes and respiratory symptoms (possibly stridor) and self-administered epinephrine, then was taken to the nearest ED where she received additional epi and albuterol. Those symptoms eventually subsided, but what triggered the study stop was her lab findings consisting of hypokalemia (2.9 mmol/L) and hypocalcemia (6.4 mg/dL). In the AE grading scale that the study is using (the FDA's scale used in vaccination studies), these values are considered Grade 4 As such, we met the study stopping rule of a single Grade 4 event and since they were detected one day after vaccination, the site PI indicated that they could be "possibly related" to the vaccine. These abnormalities were promptly corrected and the participant is doing OK, based on the most recent update. There is no report that the reporter could identify that these electrolyte abnormalities are vaccine related and I am contacting you to confirm that this is, indeed, the case. We believe other explanations should be considered (e.g. epinephrine plus beta agonist administration can lead to both hypokalemia and hypocalcemia through beta2 effects; alternatively, or in addition, hyperventilation could result in respiratory alkalosis that has similar effects). The patient underwent lab tests and procedures which included blood calcium: 6.4 mg/dl on an unspecified date Hypocalcemia , blood potassium: 2.9 mmol/l on an unspecified date Hypokalemia. Therapeutic measures were taken as a result of puffy eyes, respiratory symptoms, possibly stridor. The outcome of the events was unknown. Information regarding lot/batch number has been requested.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported puffy eyes and respiratory symptoms (possibly stridor) and the use of bnt162b2 is possible. Considering that these events likely occurred under the context of an allergic reaction based on the temporal association and the positive response to epinephrine and albuterol. The patient also has a history of food allergy, anaphylactic reaction which place the patient at risk. As for the events , hypokalemia and hypocalcemia, agree with the reporter that the use of the beta 2 agonist , as well as the respiratory alkalosis explain the occurrence of these events. 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.

Very Bad Chills; She is Shaking Right Now; Her Chest Hurt; Jaw Hurt; arm pain; This is a spontaneous report from a contactable consumer (patient mother). A 19-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24May2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. On 24May2021, the patient was experiencing the very bad chills right now and her chest hurt, and her jaw also hurts. The patient received ibuprofen (MOTRIN) at 800 mg for the arm pain (noted in 2021). Outcome of the event of arm pain was unknown while not recovered on the remaining events. Information regarding the lot/batch has been requested.

Pfizer COVID vaccine administered 04/27/21. Reports that she started feeling unwell almost immediately after injection. Immediate Reaction (onset <5 min) associated with the following symptoms: ? Visible swelling and pain at the injection site ? Increased nasal secretions and eye tearing ? Chills Around 30 minutes after, she had also developed: ? Swelling of the tongue (felt "heavy") ? Flushing, diaphoresis, and nausea, followed later by vomiting ? Dizziness/lightheadedness/weakness ? Dyspnea, wheezing, and cough ? Hives on arms and chest No throat tightening or tachypnea. She did not attempt speech. No one in the clinic took her blood pressure or pulse ox The patient brought her epi pen with her but elected not to use it. Left after 30 minute observation period. Thinks that the people at the vaccine clinic did not recognize that she had hives because of her dark complexion. The people administering vaccines were not medically trained Patient's mom recognized that she was not feeling well when she picked her up. She took benadryl which helped with allergy symptoms. She then developed fever up to 102.3, chills, headache, nausea, and myalgias x 5 days

kidney stones; severe left flank pain; extreme thirst; This is a spontaneous report from contactable consumer (patient). A 19-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 10May2021 14:00 (Lot Number: EW0168) as single dose (at the age of 19-years-old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. There was no medical history. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), cefalexin monohydrate (LEXIPRON), ethinylestradiol, levonorgestrel (VIENVA), all taken for unspecified indications, start and stop dates were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 19Apr2021 02:00 PM (Lot Number: EW0162) as single dose (at the age of 19-years-old) for COVID-19 immunization and experienced Heavy period off schedule from pill pack. The patient experienced extreme thirst since second dose (10May2021). Then, on 27May2021, had severe left flank pain causing an emergency room visit. Preliminary diagnosis is kidney stones. At ER, patient received pain medication, saline hydration drip. The outcome of the events was recovering. The event kidney stones was considered as serious (medically significant). Facility where the most recent COVID-19 vaccine was administered was the Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the was not patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Follow-up attempts are possible; further information has been requested.

PATIENT LOST CONSCIOUSNESS WITHIN A FEW MINUTES OF RECEIVING HER COVID-19 VACCINE (PFIZER- 1ST DOSE). HEART RATE TAKEN BY NURSE REPORTED TO BE IN THE 40S. PT WAS DIAPHORETIC. PT REGAINED CONSCIOUSNESS WITHIN 2-3 MINUTES. UPON REGAINING CONSCIOUSNESS- PATIENT REPORTED BLURRED VISION.

Patient is a 19-year-old female with no significant past medical history BIBself with report of midsternal chest pain (described as soreness) that started around 8:20 AM when she woke up with associated jaw pain and L>R upper extremity pain. She reports pain is worse with deep breaths and has improved significantly since it started (currently rated 2/10). She took three ibuprofen tabs (presumably a total of 600 mg) prior to presentation but took no other pain medications. Denies abdominal pain, nausea, vomiting, fever, chills, leg pain or swelling. Denies cigarette, alcohol, or drug use. Patient received her 2nd Pfizer COVID vaccine 4 days ago, with initial side effects of chills, body aches, and intermittent headaches resolving yesterday. Emergency Department to Inpatient.

Has problems when looks to the left and looks to the right, looks up or looks down; Suffering from migraine headaches that are severe ever since receiving the second dose Pfizer Covid 19 Vaccine; This is a spontaneous report received from a contactable consumer. A 19-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 26Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 26Apr2021, the patient experienced suffering from migraine headaches that are severe ever since receiving the second dose pfizer covid 19 vaccine and the headaches were very debilitating. On an unspecified date, the patient has problems when looks to the left and looks to the right, looks up or looks down, it began a few weeks after the patient received the second dose Pfizer Covid 19 Vaccine and then it has worsened. The reporter stated that to know if the patient will have long term issues because of this and need the patient to see an optic nerve specialist. The outcome of the events was not resolved. Information about batch/Lot number has been requested.

It started with itching with the left side of my scalp, through out the day while I was at work, at night the itching and burning spread down the scalp and into my eye all of the left side. I went to urgent care, the doctor did not know what was happening, they used a topical scalp treatment and cortisone cream for my face. I work at an exotic animal care, we saw a rare case of unknown hair loss on a rabbit so I do not know if that was related. The symptoms went away after 3 days of using the medications.

About 72 hours after receiving my first dose I experienced all expected symptoms of second dose, it was like a bad head cold and really painful ear pressure. Ear congestion continued throughout second dose. I also had a really severe episode of vertigo. It is still happening now. Continuing fatigue. Went to allergy clinic. OTC sudafed seems to alleviate some of the vertigo and fatigue.

during pt's observation period reported signs of tunnel vision, pale and clammy skin, and chills. Pt vitals were taken and Dr. called for pt vasovagal. Pt was given snacks and water then observed for an hour with vitals taken every 15 min. released after an hour after Dr. final evaluation.

Patient received first dose of Pfizer covid vaccine. About 1 minute after receiving the vaccine, while Rph was counseling the patient, eyes suddenly rolled back, her body stiffened and patient became unresponsive. She began to slip off of the chair. Rph yelled 911 and patient spoke to them and stated okay and didn't want ambulance sent. She stated this happens when draws blood. Patient had friend with her and left about 20minutes afterwards.

Dizziness; Hungry; Tingling lips; Shakiness/ trembling; Fast heartbeat; Easily irritated; Confusion; Slurred speech; Muscle weakness; Memory issues; Foggy brain; Exhaustion; This is a spontaneous report received from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via unspecified route of administration in left arm on 20Mar2021 at 12:00 as a single dose for COVID-19 immunisation. The patients medical history included type 1 diabetes, celiac disease, asthma, vasovagal syncope, chiari malformation and major depressive disorder. The patient was allergic with naproxen, nonsteroidal anti-inflammatory drugs (NSAIDs), avocado and almonds. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior vaccination. Concomitant medications included Humalog, Cymbalta and Remeron. On 21Mar2021 at 18:00, the patient experienced dizziness, hungry, tingling lips, shakiness, trembling, fast heartbeat, easily irritated, foggy brain, confusion, slurred speech, muscle weakness, memory issues and exhaustion. After vaccination on 21Mar2021, the patient underwent lab test for COVID-19 (nasal swab test; RT-PCR for SARS-CoV-2) and the result was pending. 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 these events. The clinical outcome of the events dizziness, hungry, tingling lips, shakiness, trembling, fast heartbeat, easily irritated, foggy brain, confusion, slurred speech, muscle weakness, memory issues and exhaustion was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

After 4 hours from when the shot was administered, I had an extreme itch starting with my head, wrists, and armpits. I began to see rashes and welting. I took Benadryl which calmed it down for an hour. However, that night my vision became very blurry and I was extremely dizzy. The following day, I woke up with hives all over my legs, arms, chest, and back. I took more Benadryl, however these rashes and hives remained a problem all day long. That night, my lips trippled in size and were very swollen. My hands and feet began to burn and rash. I contacted a doctor and was told to to go to the ER if my breathing was compromised. My throat was a little swollen, however it went down and was not as swollen as my lips. By the fourth day, I was feeling better with little to no rashing.

I can not taste or smell the same. Toothpaste, rice, onions, coffee and many other things do not smell and taste quite right.

Patient's mom reported her having dizziness. Patient later said she's having blurry vision and chest tightness. Pharmacy staff called 911 and personnel from the fire department came, awaiting the ambulance. When patient's vitals were checked they were normal. Patient's mom said, patient has a history of anxiety and she had told patient not get the vaccine; so she thinks patient got anxious after having blurry vision. Patient later reports of feeling fine, paramedics arrived and patient and mom went with them. Patient said she had Hep A and Meningitis vaccine about 3 weeks ago and was ok.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Pale and slight pain on left cheek/gave water. Patient stated she didn't eat anything all day except Chexmix.

3rd visit to ACC secondary to persistently high fevers and diffuse skin rash, swelling over the past 5 days. Patient states symptoms began the day after receiving her 1st covid vaccine. Has been taking steroids, benadryl, and pepcid 2 days prior. Returned to ACC yesterday with fever up to 104.5 and then broke out into a diffuse rash. had swelling around the eyes.

Immediately following the administration of the vaccine pt complained of blurry vision and dizziness. The pt was put into a supine position with her legs elevated while her vitals were taken. Pt's vitals were all normal with the exception of her blood pressure. It was 94/60, which was low compared to other BPs we have on file for this pt. Pt was given a snack and water while she recovered. The pt reported she had not eaten yet and is very afraid of needles and believed this contributed to the event. The pt never lost consciousness. The pt was monitored for 30 minutes and at around 12:30 PM the pt felt well and asked to leave.

Spot in right eye vision would not go away, saw ophthalmologist and diagnosed with clot in retinal capillary.

About 5 minutes after receiving the vaccine the patient felt light headed and fainted into her dads arms while scheduling her second appointment. Dad sat her into a chair and by the time the pharmacist reached her she was already coming to. She did report some trouble hearing and focusing her eyes. She drank some water and sat for about 15 more minutes before she felt back to normal. She then left with her father.

Eye twitch in left eye bottom lid; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199), via an unspecified route of administration in the left arm on 08Mar2021 at 13:45 (at the age of 19-year-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN2613) via an unspecified route of administration in the left arm on 29Mar2021 at 13:45 (at the age of 19-year- old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included microgestin (MANUFACTURER UNKNOWN) for unknown indication. 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 vaccine. On 08Mar2021 at 13:45, patient experienced eye twitch in the left eye bottom lid all day and every day. It started the day, when patient got first dose. The patient did not receive any treatment for the reported event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event eyelid twitching was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Sense of smell is distorted; Can't taste normally; This is a spontaneous report from a contactable consumer (patient). A 19-years-old female non-pregnant patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EW0168, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 19May2021 as dose 1, single (at the age of 19-year-old) and received for BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EW0176 and Expiration date was not reported), via an unspecified route of administration, on an unspecified date of 2021, as dose 2, single (at the age of 19-year-old) for COVID-19 immunisation. The patient medical history included COVID-19, prior to vaccination from an unknown date to an unknown date. Patient concomitant medications were not reported. On 02Jun2021, patient's sense of smell was distorted and can not taste normally as well, specifically, coffee and toothpaste does not taste good, onions and rice also smell bad. Other things as well do not smell or taste quite right. Patient had been tested for COVID-19, post vaccination by nasal swab on 15Jun2021 and results were negative for COVID-19. Patient received no treatment for both the events. The outcome of both the events was not resolved. Follow-up attempts are completed. No further information is expected.

Pfizer-BioNTech COVID-19 Vaccine EUA non-severe allergic reactions- facial rash (7/20/21), right auricular pruritus (7/20/21), right periorbital edema (7/19/21), abdominal pain (7/18/21)

Blister in upper right corner of cheek inside the mouth; This is a spontaneous report from a non-contactable consumer, the patient. A 19-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735), via an unspecified route of administration in the left arm on 29Mar2021 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included norethisterone acetate; ethinylestradiol; ferrous fumarate (MICROGESTIN FE 1.5/30) taken for an unspecified indication from an unspecified date. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021, the patient had a blister in upper right corner of the cheek inside the mouth. The adverse event did not result in a doctor or other healthcare professional office/ clinic visit/ emergency room/ department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event blister in the upper right corner of cheek inside the mouth was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.

Reoccurring taste and smell of chicken soup dumplings consumed day after vaccine when not eating/near said food.

Tingling and numbness of the upper and lower lip (left side) Narrative: Patient stated she felt a slight tingling and numbness of left side of the lower and upper lip. Symptoms resolved after about 30 seconds post-vaccination.

Shot was given at 11:45 am. Patient started to feel numb both arms. Tingling of left arm and left hand, tingling chest and both legs within 10 min of shot. She saw black/white spots at 12:45pm. Called EMT and they took her to the hospital.

Patient complained of face feeling swollen. Patient asked to look at reflection and patient states face is visibly swollen and cheeks red. Patient given 25mg Benadryl IM in right deltoid. 15 minutes post Benadryl, patient stated that she felt like her tongue was swelling. Patient denies SOB, no wheezing, no stridor. BP 114/78 manual in right arm. HR 74, pulse ox 100% on Room air. SWAT was called and patient went to ED for further evaluation.

Experiencing numbness in lips; Hives after first dose; This is a spontaneous report from a contactable consumer. A 20-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Patient medical history included severe allergy to grass (carries an EpiPen). Concomitant medications were not reported. The patient experienced numbness in lips and hives after first dose on unspecified date. Patient was not sure if she should get the second dose which is scheduled for 21Jan. Event took place after use of product. Outcome of the events was unknown. Information on the batch/lot number has been requested.

Roughly an hour after started getting numb feeling in the roof of my mouth. Feeling went away rather soon but was back by around 9 am the next morning. Over the course of six hours the feeling was moving into the tongue and back of throat. Throat and mouth started hurting as well.Stopped being able to swallow properly. Was given Benadryl and a steroid at urgent care and have not had any more swelling over the past two days.

Tachycardia and sensation in throat 15-30 minutes after vaccination. HR-140 BP-180/120 HR went back down to 115 and BP 136/67. Received Solu Medrol for reaction. Advised not to received 2nd dose per CDC guidelines.

mental fogginess; headache; body ache; 99.5 temp; swollen lymph nodes; sore jaw (from lymph nodes); swollen lymph nodes; sore jaw (from lymph nodes); swollen injection site; severe tiredness; muscle pain; muscle stiffness (neck and upper extremities); This is a spontaneous report from a contactable consumer (patient herself). A 20-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL8982, expiration date was unknown), via an unspecified route of administration on the left arm on 25Jan2021 at 13:45 at a single dose for COVID-19 immunization. The vaccination facility type was reported as the hospital. Relevant medical history included asthma and glucose intolerance; both from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications included metformin and etonogestrel (NEXPLANON) for birth control. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in 4 weeks. The patient had no COVID-19 prior vaccination. On 25Jan2021 at 15:30, the patient experienced mental fogginess, headache, body ache, 99.5 temperature (temp), swollen lymph nodes; sore jaw (from lymph nodes), swollen injection site, severe tiredness, muscle pain, and muscle stiffness. The patient did not receive any treatment for the adverse events (AE). The patient was not tested for COVID-19 post vaccination (pending clarification). The patient was not recovered from all the events.

I have extreme sharp pain in my spine/back and it is burning, Its sort of hard to walk it happened hours after my vaccine I have fever extreme loss of appetite dry mouth headache Pain in arm

This patient was given the COVD vaccine and then had an adverse reaction. She experienced a racing heartbeat, couldn't feel her tongue, and she had difficulty breathing. One of the pharmacists who was monitoring the patient administered an epi-pen and after 20 minutes or so the patients symptoms subsided.

Severe chills. Could not move body for one hour. Whole body hurt for hour and a half. Thirst. Finally went back to sleep. Morning had a severe migraine. Took Tylenol and a nap and I felt my fever break. Had that fever from 4am until 11:30am. Had headache for the rest of the day until 7pm but was not a migraine after the nap and Tylenol. I would never get this vaccine again. I would rather have covid 1000 more times. (I had it in October and no sickness I?ve ever had will ever compare to that two hours of hell.

Patient reported symptoms of: tachycardia, shakiness, vision changes, tongue numbness and shortness of breath following the first dose of the COVID19 Pfizer-BioNTech Vaccine on 2/5/2021. Patient said that historically has experienced tachycardia and shakiness after getting a flu shot or booster a few years ago. Symptoms reported by patient were enough to suspect potential anaphylaxis, and patient consented pharmacist to administer epinephrine. Patient was then advised by the pharmacist to follow-up with her primary care doctor as soon as possible to report the incident and to discuss the risk versus benefit of the vaccine, whether recieving the second dose would be appropriate for her. Patient returned to assisted living facility for her second dose of the COVID19 Pfizer-BioNTech vaccine on 2/26/2021. Patient said that she discussed the incident with her doctor, was told it would be appropriate to get the second dose despite her reaction and was advised to take "cautious measures". Pharmacist reviewed the patient information and screening questions, discussed the potential side effects and reiterated her risk of experiencing the same reaction with the second dose. Patient stated that she decided on getting the second dose because "her boyfriend is high risk and I'm doing this for him". Patient stated that she decided on getting the second dose because "her boyfriend is high risk and I'm doing this for him". Pharmacist asked patient if she had any questions/concerns or additional information to add prior to getting her vaccine, and patient denied having any at that time. After administering her second dose, pharmacist instructed patient to stay in the observation area for at least 30 minutes and to ask the staff for water given her experience with the first dose. Patient asked pharmacist how common it was for someone to get a reaction from the vaccine, and then mentioned that her family memeber had to drive her to the emergency room after her first dose becuase her throat was "burning", and was told that her throat was "a little swollen" and recieved a second dose of epinephrine at the emergency room. Patient included this information after the fact her second dose was already administered. Approximately 5 minutes after receving her vaccine, the patient reported similar symptoms that she experienced on 2/5/2021: tachycardia, vision changes, shortness of breath and chest tightness. After monitoring patient with no resolvement of her symptoms, patient was then given a dose of epinephrine by the pharmacist, and the paramedics were called in to assess patient and take her to the emergency room.

48 horus after second vaccine Right eye periorbital swelling and mild drainge Throat swelling described as feeling like it was hard to swallow - no acute distress Question of increased respiratory rate - normal respirations noted in clinic 2.5 x 2.5 cm nodule, well demarcated and moveable with sudden appearance to forehead Onset of floaters in B/L eyes occurred 4 hours later, after administration of oral benadryl and prednisone Tx: Patient was given Benadryl 50mg orally and Prednisone 60mg orally. Withing one hour throat tightness resolved, respiratory rate reamined normal, left eye swelling was improving and nodule to forehead was decreasing in size. Floaters were persistent. 24 hours later pt reports no recurrence of throat tightness, normal respiratory rate, resolution of left eye swelling, some decrease in size of forehead nodule. Floaters have been persistent and unchanged. *24 hours after second vaccine pt has onset of palpable lymph nodes to anterior cervical chain, single node to left supraclavicular chain and left axillary swelling. This was not considered an allergic reaction and attributed to immune response to vaccine.

My arm was numb after the shot and i began to feel faint a few minutes after, my ears were ringing and thought i was going to pass out. I became very flushed and sweaty and my bangs were tingling

shingles; temporary vision loss; dizziness; Extreme fatigue; body aches; nausea; This is a spontaneous report from a contactable other Healthcare professional (patient herself). This 20-year-old female patient, not pregnant, received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), Lot EL9265,via an unspecified route of administration in the left arm on 03Feb2021 at 02:00 PM (at the age of 20-year old) single dose for COVID-19 immunization. Relevant medical history included suspected allergy to penicillin. Historical vaccine included first dose of BNT162B2, Lot EL3248, on 13Jan2021 at 11:45 AM single dose in the left arm and recombinant human papillomavirus vaccine (GARDASIL) on 15Dec2020 dose 1 in the left arm. Concomitant medication included one a day women's Vitamins. After 2nd dose of vaccine BNT162B2, the patient experienced extreme fatigue, body aches, dizziness, and nausea. She was unable to go into work 2 days after receiving the vaccine due to temporary vision loss because of dizziness. On 21Feb2021 at 9:30 AM, a painful rash on the left side of torso and on spine had shown up. The patient went into her school doctor on 24Feb2021 and was diagnosed with shingles. The patient specified that she have never had this condition before, she was healthy and she did not have any significant stressors. The patient was treated with acyclovir due to the event. The outcome was not recovered for all events. This is a spontaneous report from a contactable Other HCP. This 20-year-old female Other HCP reported herself that: Report about covid vaccine: Yes Reporting type: AE Reporter type: Patient Age group: Adult (18-64 Years) Current age: 20 Current age unit: Years Gender: Female Is pregnant: No Medical qualification reporter: Other Health Professional Covid vaccine details: [{product=COVID 19, brand=Pfizer, lot number=EL9265, lot unknown=False, administration date=03Feb2021, administration time=02:00 PM, vaccine location=Left arm, dose number=2}, {product=COVID 19, brand=Pfizer, lot number=EL3248, lot unknown=False, administration date=13Jan2021, administration time=11:45 AM, vaccine location=Left arm, dose number=1}] Facility type vaccine: Other If other vaccine in fourweeks: Yes Other vaccine 4weeks details: [{other vaccine 4weeks product=Gardasil, other vaccine 4weeks vaccine date =15Dec2020, other vaccine 4weeks dose number =1, other vaccine 4weeks vaccine location=left arm}] Other medications in two weeks: One a day women's Vitamins Adverse event: Extreme fatigue, body aches, dizziness, and nausea following 2nd dose of the vaccine. I was unable to go into work 2 days after receiving the vaccine due to temporary vision loss because of dizziness. On 21Feb2021, a painful rash on the left side of my torso and on my spine had shown up. I went into my school doctor on 24Feb2021 and was diagnosed with shingles. I have never had this condition before, am 20 years old, and am healthy. I do not have any significant stressors. Adverse event start date: 21Feb2021 Adverse event start time: 09:30 AM AE resulted in: [Doctor or other healthcare professional office/clinic visit] If patient recovered: Not recovered If treatment AE: Yes AE treatment: Acyclovir prescription If covid prior vaccination: No If covid tested post vaccination: No Known allergies: suspected allergy to penicillin Other medical history: N/A; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported temporary vision loss together with the reported dizziness and vaccination cannot be excluded. The case will be assessed further upon receipt of additional information. 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 BEGAN FEELING VERY DIZZY ABOUT 10 MINUTES AFTER RECEIVING VACCINE. SHE THEN STATED SHE COULD NOT SEE. WAS ALERT AND TALKING, JUST FEELING VERY DIZZY AND UNABLE TO SEE. CALLED EMS, GAVE WATER, NO OTHER TREATMENT GIVEN. BEGAN FEELING BETTER AND COULD SEE WITHIN 10 MINUTES OF CALLING EMS. EMS ARRIVED, ASSESSED PATIENT. PATIENT DID NOT GO TO EMERGENCY ROOM

Part one: Within one minute of injection, I was extremely dizzy and had to force myself to breathe. My hearing became muffled and I couldn't hear. I was hot and cold, pouring sweat. My tongue was numb and my mouth became dry. Part two: As the dizziness began to subside, the second phase of the reaction started. I had nausea. I felt EXTREME abdominal/uterine cramping, which was the worst part. The cramps came in waves (Ex: cramp for a minute, subside for 10 sec, repeat). I thought I was going have an uncontrollable bowel movement as a result, but thankfully did not. The cramps lasted about thirty minutes. The dizziness became mild during this phase but was still there. I was in excruciating pain and debated calling an ambulance. This pain felt worse than when I broke two bones. During the entire reaction I felt extreme anxiety and impending doom (I did not feel this way prior to receiving the vaccine). For the rest of the day I felt tired and extremely anxious (impending doom).

Patient received the Pfizer Vaccine around 4:00 PM. Patient proceeded to sit at the observation area for monitoring then patient flagged down staff with c/o dizziness, blurred vision, hearing loss, slight pallor noted. Patient was noted sitting at the observation area with LVN next to her side. Patient was offered to lay down. Ice pack was placed on the back of patients neck, patient ate a candy bar, Nurse encouraged fluids. VS were taken and noted to be stable. Patient was monitored for 30 mins before departure. Patient stated having needle anxiety in the past. Nurse instructed patient and patient mother on signs, Symptoms of Severe Adverse Reactions to report to health care provider or to go to the emergency room. Patient/Family verbalized understanding.

One minute after receiving her vaccination, she started feeling itchy nose and her throat, then subsequently started feeling swelling in her town. Evaluation by physician so no swelling of the tongue. Her lungs were clear auscultation bilaterally. Her heart rate initially was in the 130s. She was taken to a private section of the arena and monitored. Her heart rate gradually decrease to the 110s. She remains normotensive. One minute after receiving her vaccination, she started feeling itchyness in her throat, then subsequently started feeling swelling in her tongue. Evaluation by a physician showed no swelling of the tongue. Her lungs were clear auscultation bilaterally. Her heart rate initially was in the 130s. She was taken to a private section of the arena and monitored. Her heart rate gradually decrease to the 110s, then to normocardia. She remains normal tensive. Prior to monitoring, she already taken a 50 mg dose of oral diphenhydramine (which she brought herself). Recommended she switch to J&J vaccination instead of getting the 2nd dose of Pfizer.

Approx 10 minutes after vaccination, patient in waiting area noted L arm tingling, head feeling "fuzzy" and blurriness to vision L eye only

Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: WAS CLOSE TO FAINTING BUT DID NOT.-Mild, Systemic: Hypotension-Severe, Systemic: Shakiness-Severe, Additional Details: COMPLAINED OF DIZZINESS, VISION DISTURBANCES. STORE CALLED EMS BUT BY THE TIME THEY GOT TO STORE THE PATIENT WAS ALERT AND RESPONSIVE. PATIENT ALSO COMPLAINED OF THURST AND WE GAVE HER WATER TO DRINK. THEY DID A FULL WORKUP ON HER BUT DID NOT TRANSPORT HER TO HOSPITAL. SHE LEFT WITH HER MOTHER , EVENT LASTED ABOUT 45 MINUTES .

Fever of 100.0°, chills, body aches that lasted 10 hours. Headache and sensitive to sound with fatigue for 72 hours.

20 y/o female, s/p 1st vaccine. C/o blurred vision, pale, diaphoretic. Code green called by clinic staff, med consult, and medic with patient, laid down onto cot. Cold water bottle applied to neck, ice to head by staff. Speech clear, he of allergies to MMR per mother. Symptoms resolving, pt signed out AMA with medic. Cleared by med consult Dr to go home. Requested pt to remain on site for additional 15 minutes. Head of cot raised, eating Cliff Bar and drinking Gatorade. C/o feeling tired. Escorted to car via wheelchair with mother. Denies any symptoms.

Patient reported throat tingling similar to a fruit allergy she has. She was given 50mg benadryl 30 minutes post-vaccination. Patient developed wheeze/voice change 1 hour post-vaccination. EMS was called. 90 minutes post-vaccination, patient condition was worsening and she was transported to ED via EMS

patient began having hives that continued to spread and then patient stated lip numbness, patient was given PO benadryl, IM epi, and transported to ED for further monitoring and intervention.

After about 30 minutes post-injection, throat started to get tight and scratchy. After about an hour and a half, tongue went numb and throat did not get better, and was still tight and closing. Gave me prednisone and Benadryl and took albuterol inhaler that opened throat and that helped open throat and Benadryl helped with the scratchiness.

PT FELT DIZZY AND COULD NOT SEE CLEARLY. PT CAME TO OBSERVATION VIA WHEELCHAIR WITH WATER AND SALTINES IN HAND. NO S/S OF DISTRESS NOTED. PT VS: 9:59 BP110/66 02 100 RR 16 HR 74 VS9 :05 BP 106/65 RR 17 P 68 02 100 VS9:10 BP 108/74 RR16 P 72 02 100 VS SITTING BP 118/74 HR 75 02 100 VS STANDING BP 99/65 P 91 02 100. PT WAS ESCORTED VIA WHEELCHAIR WITH STAFF. PT WENT HOME WITH HER MOTHER.

Awoken the next morning with bilateral eyes edema and right blurred vision. Improved over the course of 90min. Blurred vision resolved within 90 min. Bilateral periorbital edema persists at 11:30AM but improving. Prescribed Medrol dose pack. Suggested cold compress and benadryl.

Within the first 20 minutes her arm was heavy. By 9:30 pm extreme arm soreness, chills, swollen and burning throat. That night intense fatigue but couldn?t sleep because of nausea and vomiting. By morning a cough developed, sneezing and clogged and mucus dripping from nose. By 1:00 pm 4/17/2021 fever of 99.9. By 3:20 pm it is 101 degrees with a headache, body aches and straining eyes.

Starting one day after my vaccine, i began to feel a clogging and muffled sensation in my right ear. Slowly throughout the day i lost my hearing in that ear. I also have difficulty breathing through my nose, especially my right nostril.

Full body aches starting the day after i received the vaccine. The next day the body soreness was severe enough to where it was painful to clench my fist or walk even a small distance. I also experienced nausea, loss of appetite, migraines and light sensitivity, and was unable to do normal tasks around the house for about 3-4 days. The full body soreness was the most debilitating symptom and certain aresa like elbows, knees, wrists and hips were painful to the touch. I think my joints were most affected. The soreness and pain can be compared to a flu but it was more intense than anything i have experienced before.

A mild?severe allergic reaction that caused massive swelling (face, tongue, and neck), severe pain, a rash/hives, shortness of breath, and minor asphyxiation.

headache in my eyes so bad i couldn?t open them. terrible nausea that resulted in vomiting at 6:30 A.M. the next morning. Internal bleeding in kidneys that resulted in blood and foam in urine - blood cleared in 4 days; foam cleared in 4 days. Back pain where kidneys are located. Shortness of breath when lying down for 3 nights; had to sleep propped up.

Symptoms are - sore armpits, lightheaded, tingly lips / fingers / tongue but the tingly sensation only happens when I get dizzy from being lightheaded. All happened yesterday and today (within 2 days) of the vaccine

Woke up about 12hrs after vaccine and felt incredibly nauseous and had chills. I was walking downstairs to take Tylenol and I felt like I was going to pass out. Luckily I sat down and then proceeded to pass out, although I am not sure what really happened. My mom found me about 10 seconds later confirming I wasn?t out for that long, but she was slapping my face and talking to me and I was unaware. She reported that my eyes were open. When I came to I was having cold sweats, I was clammy, and my ears were ringing. I was very scared and I don?t know what happened to me. I felt like I was dreaming when I woke up, but once my Tylenol kicked in I felt better. But it still was a very strange out of body experience.

20 yr old Female patient received first dose Pfizer covid19 vaccine in left arm administered by pharmacy intern at 3:27pm . supervising pharmacist was (Name) pharmD. Prior to patient receiving the covid19 vaccine pharmD reviewed and went over all the DUR and digital patient questionnaire questions. Mother of patient was present and mentioned that in the patient's past , the patient had fainted after receiving a vaccine. PharmD told patient that because this occurred in the past, the patient will have to wait 30 minutes after vaccine administration for observation. Patient was sitting in post-vaccination area, and about 3 minutes later patient's father notified staff , that patient felt dizzy and looked pale and had blurry vision and patient was sweating. PharmD asked the patient if she had any difficulty breathing and if she felt itchy or had any rash as a result of the vaccine reaction. We immediately called the pharmacy and notified (Name) of the situation. The patient refused us to contact 911 and refused 911 care. The pharmacy manager immediately arrived to the Clinic fitting room area. Upon arrival, the pharmacy manager provided alcohol swabs to patient to inhale because at that moment we did not have ammonia inhalants. PharmD quickly made his way to the pharmacy to obtain the ammonia inhalants , which is a respiratory stimulant. The pharmD returned to the Covid19 clinic with ammonia inhalants, which were never used, because we did not see the need. Patient remained conscious the entire incident. We decided not to use epinephrine. The pharmD measured the patient's blood pressure at 3:38pm . bp reading was 109/65. Pharmacy manager took pt temperature at 3:45pm, reading was 97F. Pharmacy manager retook blood pressure at 4pm. bp reading was 93/63, pulse of 72. The pharmacy manager advised the patient to seek medical attention if patient continues to get worse. bp was lower the second reading. The pharmacy manager asked patient a second time at 4pm if patient wanted us to call 911 again, and again patient refused us to contact 911.

On 04-21-2021, my muscles started to feel fatigued and I had chills. I woke up on 04/22/2021 at 5 am throwing up. I was throwing up all morning, having diarrhea, blurred vision, extreme fatigue, dizziness, shortness of breath, and tachycardia (160.)

syncopal episode; dry mouth; chills; nausea; This is a spontaneous report from a non-contactable other health professional (patient). A 20-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on 12Jan2021 12:00 (Batch/Lot number was not reported), second dose on 02Feb2021 14:30 (Batch/Lot number was not reported), both via an unspecified route of administration administered in left arm, at 20-year-old female (not pregnant at the time of vaccination) at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No allergies to medications, food, or other products. The patient was not patient diagnosed with COVID-19 prior to vaccination. The patient experienced dry mouth, syncopal episode, chills, nausea on an unspecified date. The events did not result in emergency room visit or physician office visit. No treatment was received for the events. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on an unspecified date. The outcome of the events was recovered on an unspecified date. No follow-up attempts are possible, information about batch/lot number cannot be obtained.; Sender's Comments: Based on the current limited available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be totally excluded/assessed. 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 RAs, Ethics Committees, and Investigators, as appropriate

Fever, chills, lack of appetite, fatigue (beginning ~24 hours after vaccine 1, 9 hours after vaccine 2- took ibuprofen and rested on both occasions) as well as gum swelling, moderate gum pain (2-3days after vaccine 1, and getting worse until I could not chew without pain, I drank soups instead of eating and put cold compress on my gums for relief. Symptoms diminished starting 6 days in and symptoms ended on day 8 after the vaccine. Felt gum pain again 2-3 days after vaccine 2, experienced much milder gum swelling and pain, no need for a cold compress but I did avoid hard foods for a few days until symptoms disappeared around day 5-6)

Patient received her first dose of Pfizer vaccine and began feeling nausea, vomiting x1, reported seeing black spots, and difficulty hearing. Pulse was 70 bpm, SpO2 was 98% RA. Patient was given water and snacks and felt better. Patient stayed in observation for a longer period until symptoms went away. Patient left in stable condition accompanied by mother.

Received vaccine on April 6, 21 and on April 10,21 I began to notice a change in my taste when I ate meat. Soon I noticed it wasn?t just meat but chicken as well. What I was tasting was not metal but a real ugly taste that I would get mid chew that would make me spit it out. As the month went by I noticed it with random foods. Now I can sometimes just smell something and know it won?t taste good especially with foods that have a strong smell. Some foods are worse than others on how strong of an ugly taste the food has.

Headache behind the eyes, sore arm, sore shoulder, back pain, stomach ache, drowsiness, bloating, nausea These side effects began around 10pm on 04/26/2021, and continued to present day

Iron deficiency; arm soreness; tingling in her toes that gradually kind of was in her legs then her arms too; weakness in her legs; altered sense of touch; Numbness of tongue; trouble moving her lips; This is a spontaneous report from a contactable consumer(patient). A 20-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), second dose via an unspecified route of administration, administered in left arm on 09Feb2021 13:00 as SINGLE DOSE for covid-19 immunization. Patient was 20 years old at the time of vaccination. Patient medical history and concomitant medications were not reported. On 12Jan2021 at 07:30PM patient received her first dose of Bnt162b2 and experienced sore arm. On an unspecified date patient stated that her arm was sore again after the second dose, then she started having tingling in her toes that gradually kind of was in her legs then her arms too. She said that she has weakness in her legs , and an altered sense of touch, when she kind of touches her skin it feels not normal, like an altered kind of touch, she says her tongue is numb, and her mouth has trouble moving. She says that when she rubs her lips together like to swish mouthwash, it is difficult. She says she saw someone yesterday, a nurse practitioner, who got labs and her blood work came back, and the nurse practitioner said she had a possible iron deficiency and recommended a supplement. The patient underwent lab tests and procedures which included blood test: unknown. Outcome of the events was unknown. Information about lot/ batch number has been requested.

Tinnitus/intense ringing in ears, no treatment. Has occurred approximately twice per day since 4/23/21. No previous history of this.

Left arm rash within minutes of receiving vaccine. Then resolved. Headache, dizziness, difficulty concentrating, difficulty focusing vision, right ear pain-intermittent. Shortness of breath-improved with albuterol inhaler. History of asthma.

Starting April 7th, then again April 11th and continuing until the present day, an uncomfortable and itching rash had covered the majority of my body. This led to 2 UrgentCare visits and a course of steroid pills (that helped for a few hours before the rash would start to reappear each day) After completing my second dose of the vaccine on April 25th (Lot# EW0169) around 7pm I woke up April 27th with the rash the completely covered my legs/groin/hip area and started spreading up my spinal and trunk as well as swelling fingers, face and lips, resulting in a hospital visit, more steroids and on the morning of April 28th a new rash began on my trunk, arm, neck and face in addition to the hive-like rash on my legs.

Client received first dose of COVID vaccine at 11:00 am in zero-gravity chair due to history of fainting with injections. Client complained of feeling faint and vison and hearing going out @ 11:05am. Client provided with water and cold pack, reported feeling better, also reports not eating prior to vaccination. Client complained of headache @ 11:30am. Vital signs within normal limits. Client reports feeling better, headache only symptom @ 11:40am. Client able to leave observation area with steady gait, her friend present to drive home @ 11:45am. Client advised to follow up with primary care.

hives; swollen face; red bumps on her face; eyes were swollen; This is a spontaneous report from a contactable consumer ( Patients Grandmother). A 20-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration was not reported), via an intramuscular route of administration as a single dose for COVID-19 immunization. The patient's medical history included allergy to pencillin. Concomitant medications were not reported. It was reported that consumer calling on behalf of her granddaughter who received the first dose of the Pfizer vaccine on Friday, after 24 hours by Saturday night she had hives, swollen face, red bumps on her face, her eyes were swollen, (all reactions on her face) it was severe for like 2 days and next three days was not so severe and began to cool down after 3 days. She had appointment on 30Apr2021 for next vaccine, is there anything she can do or take prior to the vaccine to prevent it. She had allergy to penicillin she would get hives. last time she had penicillin was about 5 or 7 years ago. Is there any information about getting the second vaccine after side effects after the first dose, A lot of people have a problem after the second dose. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

After vaccination the patient started voicing that they were seeing black dots, feeling lightheaded. Patient laid down for 10 minutes, consumed glucose and drank water. Patient voiced that they were feeling better soon after.

I woke up at 2 am feeling sick. As soon as I got out of bed I passed out. It took about 10 minutes for me to become conscious again. I was shaking, hot and cold, slight fever and it sounded like I was underwater. Everything was spinning. I took Tylenol for body aches and keep the fever down. I was sweating a lot. I was better by noon that same day.

I woke up with a fever and extreme thirst. I had a hard time sleeping, but at some point during the night my fever broke. When I woke up (~5 hours later) I felt significantly better, though I was experiencing a headache, eye pain, and fatigue. I got up and then went back to sleep after eating something, and when I woke up I felt completely fine.

Pt received 2nd dose vax and was in observation area w/ her sister. Pt denied any reaction after first dose, did report hx of asthma.Ten min post-vax, pt called observation nurse (RN) w/ complaint of "lung pain," some SOB and abd pain. Pt had also developed hives on her chest and neck, visible to observation nurse. Pt was transferred to EMT area for assessment and observation. Pt was alert and oriented to place & time and answering qx w/o WOB or apparent distress. However, during assessment of VS, pt developed add'l hives on face, w/ eye swelling. EMTs and charge nurse recommended transfer to ED d/t multiple early sx of possible severe reaction. Pt and parent agreed. Pt transferred to Hospital via ambulance d/t risk for emergent allergic reaction.

Fever up to 101.4 for 24 hours, body aches/muscle fatigue, sore throat and loss of voice, headache, chills. 30 hours later still no voice but other symptoms have resolved. Took Tylenol to bring down fever

Dizziness, loss of vision, cold sweat, chest pain. Vital signs are taken, "Dextro" sample is performed. Everything is normal and after a few minutes sitting, she reports feeling good.

passed out/Loss of consciousness resulted in concussion; concussion; became dizzy; Was experiencing body aches; increased thirst following vaccination; This is a spontaneous report from a contactable physician for a patient. A 20-year-old female patient received second dose bnt162b2 (PFIZER COVID-19 VACCINE), intramuscular, administered in Arm Right on 28Apr2021 08:30 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. The patient previously received first dose bnt162b2 (PFIZER COVID-19 VACCINE), on an unknown date (Batch/Lot number was not reported) for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant at time of vaccination. Concomitant medications (received within 2 weeks of vaccination) included celecoxib (CELEXA), trazodone, oral contraceptive nos (reported as oral birth control) taken for an unspecified indication, start and stop date were not reported. The patient got up at 2am 29Apr2021 to use restroom, became dizzy and passed out. She was experiencing body aches and increased thirst following vaccination. Loss of consciousness resulted in concussion. The adverse events result in: Doctor or other healthcare professional office/clinic visit. The events did not result in death, cause/prolonged hospitalization, was not life threatening, disabling/incapacitating, congenital anomaly/birth defect. The patient was not diagnosed COVID-19 prior to vaccination. Since the vaccination, the patient had not the patient been tested for COVID-19. The patient did not receive treatment for the events. The outcome of the event was recovering. Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, the event Loss of consciousness is considered most likely associated with intercurrent or underlying medical conditions, appears unrelated to the suspect drug.

Patient received Pfizer vaccine at 1054am Reaction started at 1105am. Patient stated blurred vision, diaphoretic, salty mouth, and nauseous. RN requested help and patient was laid back down on the ground. Cold washclothe applied to neck and forehead. 12.5/5ml Diphenhydramine given oral solution After about 20 minutes, patient verbalized she felt better - she was brought inand iupright postion and seated in an chair w/o issue. Blood pressures taken at time of incident and through out monitoring - Vital unremarkable. Rn called patient mother , who was able to come to the clinic to pick up patient. At time of pick up patient started to feel additional reaction, CF team at medical facility called for additional intervention. FNP from CF team advised to get orthostatic BP and record. Ortho Static taken with a drop in BP from laying to standing. BP was as low as 50/30 P:66 O2: 98 on RA 911 activated as patient conitnued to have sudden decrease in BP. Patient went to the hospital via EMS. Patient parents and twin sister with patient. Admin notified - chart documented.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient noticed blurred vision prior to fainting. Was clammy and unresponsive. Patient came to quickly, but had another episode a few minutes later. No prior history with fainting after vaccinations.

Immediately after receiving the Pfizer injection, I began to feel lightheaded and dizzy. Moments after that, I felt a general sense of unease and began feeling too hot. I was nauseated, sweating, shaking, experienced tingling in the hands and feet, tunnel vision, and temporary loss of hearing. Within 10 minutes, these had all subsided, and after my 15 minutes of waiting was up, I was allowed to leave with no further adverse reactions.

Swollen, sharp pains in right tonsil. Pain is intermittent, tends to come and go within hours, and started one day after administering Dose 2 of the COVID vaccine and still persists. White spots were also seen above both tonsils. No medical treatment was sought, since I could still go about daily life normally.

dizziness; seeing spots; rash on face, arms. upper back; This is a spontaneous report from a contactable consumer. A 20-years-old (non pregnant) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number=PF12EREL9207; Expiration date: UNKNOWN), via an unspecified route of administration in Right arm on 16Feb2021 at 02:30 PM as single dose for COVID-19 immunizations. Medical history includes known allergies to foods-bananas, pineapple. The patient had COVID prior vaccination. The patient previously received the first dose of BNT162b2 on an unknown date for COVID-19 immunisation. The patient did not receive any other vaccines in four weeks. It was unknown if COVID tested post vaccination. Concomitant medication (other medications in two weeks) included ethinylestradiol, levonorgestrel (ALTAVERA) (MANUFACTURER UNKNOWN), sertraline taken for unspecified indication at unspecified dose from an unspecified date and unknown if ongoing. On 16Feb2021 at 11:45 PM patient experienced dizziness, seeing spots and rash on face, arm and up-per back. Patient received benedryl as a treatment for the adverse events. The outcome of the events dizziness, seeing spots and rash on face, arm and upper back was reported as not recovered.

At approximately 1040 patient reported dizziness and dry mouth to co-lead nurse. Nurse assessed patient vitals: blood pressure 110/70 mmHg, pulse 84 beats/minute and SpO2 98%. Patient denied itchiness, rashes, hives, shortness of breath, difficulty swallowing, and difficulty breathing. Patient stated " I don't drink water". Patient given water and advised to stay 30 minutes for observation. At 1045, patient vitals reassessed: blood pressure 110/70 mmHg, 84 beats/minute, and SpO2 98%. At 1101, patient reassessed. Patient reported she felt better and vitals were 100/60 mmHg, pulse 80 beats/minute, and SpO2 99%. Lead nurse educated patient on signs/symptoms of when to seek emergency care, signing up on v-safe, and to follow up with primary care provider. At 1105, patient left facility with steady gait and unlabored respirations.

Client received her first Pfizer shot (Lot# EW0182 EXP 08/31/21) from RN at 18:40. RN stated within 20-30 seconds after administering shot, client's eyes rolled back, and she began to pass out. The client's friend was also in the room. RN stated that she and the friend grabbed the client, held her, and she started responding to their voices within 15 seconds. RN stated she simultaneously called for help. 2nd RN ran down the hallway to grab EMT and 3rd RN called 911. From the Lead's room, Lead RN and Co-Lead RN observed 2nd RN running down the hallway. Leads proceeded to the hallway and observed a cluster of individuals at vaccination station 5. Lead RN & Co-Lead RN arrived at station 5 at 18:42. Leads observed client conscious and sitting in a chair. Thirty seconds later EMT arrived. Leads observed client was pale in color. Client stated she got dizzy, and her eyes got blurry within seconds after the shot was administered. Client stated she was hot and sweaty, but was not experiencing SOB or trouble breathing. Client was alert and oriented times 4. Co-Lead RN opened the window. RN put a wet towel on client's forehead and client was transferred to a zero-gravity chair. Client stated she had eaten and drank plenty food and fluids earlier in the day. At 18:48 client stated she was feeling better. EMT took vitals at 18:50. (BP: 82/54 HR: 42). RN took client's pulse again and stated HR: 76. Client stated she has no known allergies and takes no medications other than birth control. Client also stated she used to take medication for anxiety, but stopped taking the medication 6 months ago. Firefighter EMTs arrived at 18:54 took vitals (BP: 106/74 O2: 99 HR 68) and performed a 12-lead ECG. At this time client stated that she has never given blood because she starts to pass out when she sees blood. She also stated that she passed out 9 months prior when she saw her sister's blood drawn at the hospital. At 18:58 client's color was coming back. She stated she was no longer dizzy and felt better, but was now cold because the window was open, and her jacket had been taken off to perform the ECG. RN closed the window. Firefighters took vitals again at 19:00 with client sitting (BP: 104/70 O2: 99 HR: 70) and standing at 19:01 (BP: 106/70 O2: 99 HR: 72). Client stated she felt much better. Client declined transport to hospital. Lead RN provided client with a Pfizer fact sheet and educated client on the common side effects vs the adverse effects of the Pfizer vaccine. Lead RN instructed her to contact her HCP if the common side effects persisted beyond 2-3 days and to go to urgent care or the ER if she experienced any adverse effects. Lead RN also instructed client to call 911 if she experienced any respiratory issues once she was home. RN walked client to observation room for additional 15-minute surveillance. Client walked with a steady gait.

Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hypertension-Medium, Systemic: Hyperventilation-Medium, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Shakiness-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Medium, Additional Details: Patient was given the vaccination and she moved from the immunizing chair to the waiting area. While in the waiting area, the patient passed out briefly (less than 15 seconds), revived and was complaining of blurred vision and that her brain felt "funky." She then broke out in full body hives and was administered 2x25mg benadryl tablets orally. 911 was called. Patient then began complaining that her face and body felt numb and tingly all over. Paramedics arrived and took patient to the hospital.

Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium, Error: Booster Given Too Early, Additional Details: GIVEN 3RD DOSE IN ERROR. INITIAL SX: FATIGUE, HA, CHILLS, THROAT DISCOMFORT. DELAYED RESPIRATORY SYMPTOMS DEVELOPED OVER WEEKEND

Adverse effects began 3 to 4 hours after vaccination. Patient reports arm soreness with pain moving down arm and into chest, back and top of jaw. Patient got up and felt dizzy. Fell over and blacked out with eyes open for a few seconds. She does not remember falling over.

My heart beats weird, i feel like i?m having a constant anxiety attack, i can?t eat much. my jaw hurts sometimes, same with ears i feel like i have an ear infection

While patient was waiting in the waiting area after the vaccine, patient started to experience breathing issue, along with neck congestion and tingling in the mouth. Called 911. After 15 min of evaluation still didn't get better, so started IV diphenhydramine and Epi-pen and then take her to ER for further observation.

Lost my voice; Abdominal cramps; Vomiting non stop/ still been throwing up; Body aches; They thought I was having an allergic reaction; Sick; Felt dizzy/ lightheaded; Arm was very sore/ arm ached; Couldn't see straight; This is a spontaneous report received from a contactable consumer (the patient reported for herself). A 20-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 25May2021 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history included Latex allergy. Concomitant medications included methylprednisolone taken for an unspecified indication, start and stop date were not reported and unspecified nausea medications. No COVID prior vaccination. Post vaccination tested for COVID with negative result. No other vaccine received in four weeks. On 25May2021 10:00, (since the day that the patient got shot) she was sick, felt dizzy, couldn't see straight and arm was very sore. The consumer reported that "The day after I was vomiting non-stop, arm ached, light headed, abdominal cramps, body aches, and overall not doing well. I was transported via ambulance to the ER as they thought I was having an allergic reaction. Since then I haven't really gotten better, I've been having issues and been out of work for over 2 weeks. I lost my voice about a week ago (Jun2021) and still been throwing up and just really over being sick at this point." On 26May2021, the patient underwent lab tests and procedures which included Nasal swab COVID test: negative. The events were assessed as medically significant. Adverse events were treated with steroids and unspecified nausea and abdominal pain medications. The outcome of events was not recovered. Information about the Lot/batch number has been requested.

It started with a numbing feeling in my left arm and somewhat of cramping in that same wrist. About 2 minutes later, I felt extremely dizzy and lightheaded. My boyfriend realized that I stopped responding to him and my eyes rolled back. I ended up passing out, falling to the floor, and having convulsions for about 45 seconds before waking up extremely confused.

Approx 20 min after receiving vaccine she complained of feeling light headed. Facial complexion was slightly sweaty Her BP at this time was 94/60 Sp)2 = 98% and pulse 61 R Water was offered and she was agreeable and drank some 10 min after her light headed episode she stated she felt much better and got up to use restroom Approx 30 min after initial episode she complained of slight headache Vitals at this time wer 110/60 Sp02 = 99% and Pulse 74 R Approx 35 min after initial episode she complained of numbness in jaw and back of throat with tingling in lips; However, just prior to this her friend was also brought in for additional follow-up as she was experiencing some symptoms as well. The challenge was determining how much of the situation was based off of the other since they were in the same room. Vitals at this time were SpO2 = 99% and pulse 74 R She was given Benadryl 25mg po approx. 40 min after her initial complaint of light headed. In approx. 10 min she stated her symptoms had resolved other than the slight headache

I administered Covid 19 immunization and pt was waiting the 15 minutes for observation. About 5 minutes later, companion said pt said she felt like she was going to faint. We gave her a cold pack for neck and I was monitering breathing and consciousness. Pt said she sill felt faint, was having difficulty breathing, difficulty seeing and hearing. Lips turned faintly blue so technician called 911 and I administered 1 dose of Epipen in left thigh. A few minutes later I gave 10ml of Dihphenhydramine liquid. EMTs responded quickly, checked pt but symptoms resolved and she was not transported. After event patient did say she had not eaten that morning.

Fever, swollen eyes, swollen throat, fatigue, body aches , still present almost 2 weeks after vaccine. Allergic reaction (swollen eyes abs throat) occurred 5 days after vaccine

Anaphylaxis (raised heart rate, rash, nausea and vomiting, swollen lips and throat) difficulty breathing - anaphylaxis under control Cause may be a salad Breathing still doesn?t feel normal

4/21/21- developed cough. 5/12/21 developed shortness of breath and exertional dyspnea. 5/15/21 developed substernal chest discomfort, blurred vision. Went to local ED- no significant findings. 5/19/21 transthoracic echo showed LVEF 52%. 6/7/21 -symptoms resolved except for mild congestion. 6/27/21 cardiac MRI: demonstrated normal biventricular function (LVEF 63%), mild epicardial scar (mid inferolateral and lateral walls), mild patch mesomyocardial scar (mid septum), mildly elevated T1, T2 in the septum.

Patient experienced rigid fingers, nausea, fever, and stuffy ears about 8 minutes after the vaccine was administered. Patient was given a cold water bottle, an ice pack to place on her forehead, and bucket in case she needed to vomit. EMS was called right away. They arrived and checked her out. She was not transported to the hospital. She waited approximately for 30 more minutes and then felt well and left.

I have complete hearing loss in my left ear and I was given 3 steroid shots in my ear and the hearing has came back partially now but have complete hearing loss in high frequency.

2nd dose Pfizer shot administered at 9:37am. Pt was noticed to be really out of it near the front of the store. No previous history of allergic reactions and no issues with 1st dose. Patient said head was hurting bad and throat felt weird. Her eyes were rolling back in her head and she was in and out of responsiveness. Ice pack was given at 10:07am, EMS was called, at 10:10am bp 129/101 pulse 89, ems arrived on scene at 10:15am and took patient to the hospital.

On Monday the 5th day, I started getting chills, feet tingling burning sensation in my lips and face. I also had pressure in my head as well I went to the ER where they told me it was allergies or a thyroid issue. They told me to take Zyrtec but I continued taking Claritin D. I went back to the ER the next day because my head pressure was worse. they gave me a migraine cocktail, steroid and allergy meds. My feet tingling and burning sensation has increased since last Saturday. I went to the Dr. where they did bloodwork. That came back normal. I have been using heat and trying to stretch more, I also use ibuprofen.

Within about 5 minutes of receiving the vaccine became sweaty, clammy, pale and vision became very blurred. This lasted about 10 minutes before symptoms subsided.

Patient reported geographic tongue with increasing pain / inflammation and difficulty eating 3 days after second dose of Pfizer vaccine

Pt fainted approximately 5-10 minutes after vaccine administration; pt had symptoms of light-headed, dizzy, loss of vision and hearing briefly, numbness and tingling in face and hands. Pt was very pale. Pt's feet were elevated and given a drink. Paramedics were called and assessed patient; paramedic reported normal blood pressure but slightly pulse. Pt was released without recommendation to transport. Pt mother told to call 911 if symptoms of allergic reaction occurred such as nausea, vomiting, diarrhea, rash, hives, or swelling in face, eyes, or tongue.

Bodyaches , painfull joints ( more the knees), Fever(102 farenh) and chills the first day followed by swollen lymph nodes on both sides of my neck, super swollen tonsils , which were red with white patches. Then there was a sharp pain on my chest that ran down my left arm but lasted less then a minute.

Following vaccination patient was dizzy and seeing stars. Moved patient to floor and checked blood pressure 118/68 heart rate 70. Patient did not faint and felt better. Observed patient and patient left with family member feeling fine and did not want further intervention.

Swollen lip; Brain fog; Headache; Arm pain; This is a spontaneous report from a non-contactable consumer, the patient. A 20-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was unknown if the patient was diagnosed with COVID-19 . Since the vaccination, the patient had not been tested for COVID-19. On an unknown date the patient experienced headache, swollen lip, brain fog and arm pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of headache, swollen lip, brain fog and arm pain were unknown at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Symptoms onset 7/15/2021: cough, sore throat, fever, chills, headache, nausea, vomiting, abdominal pain, loss of smell and loss of taste. Tested 7/14/2021 for COVID-19 after being in close contact with a positive case.

Tested after being in close contact with a COVID + patient. Tested on 7/14/21. Sx onset was 7/15/2021 with cough, fever, chills, headache, sore throat, nausea, vomiting, abdominal pain, loss of smell & loss of taste.

Patient was pale and complaining of her ears feeling full and would pop when she drank. She was sweating and having flu like symptoms including nausea. We had her sip water wait in the pharmacy waiting room and discussed how she was feeling. after about 20 minutes she was starting to feel better.

On both my first and second shot I got really bad brain fog. I went to the ER after my first shot on June 29, 2021 but they told me it was a psychological thing and that I was freaking myself out and that it was not vaccine related but I knew the at wasn?t the case. After my first shot the pressure in my head remained for about a week and the brain fog and vision/auditory issues only occurred on the first day mainly. On my second shot today (07/20/2021) it occurred again and so I know it?s vaccine related, not psychological. On both shots it was an immediate reaction. As soon as the person began to inject the vaccine into me I would feel immediate pressure in my head (on the first shot it felt like the vaccine literally traveled to my fingertips in my left arm and up into my head, it was very strange). Then about 2-5 minutes after I got the vaccine on both occasions my vision became filled with floaters and my coherency decreased. The first vaccine was the worst as the floaters stayed longer and my vision would go in and out of bluriness more. On the second shot the floaters were very obvious for the first hour and then slowly decreased over time but it is currently 6 hours after my shot right now and I still see a couple. On my second shot my vision did blur but not as bad. Both times I felt tremendous pressure in my head and I couldn?t think straight or focus. My speech was very slow and the ordering of my words were inaccurate. My texting was bad because I couldn?t spell and the structure of my sentences was incorrect. I have issues putting words together to say what I want to say and I can?t concentrate. Both times I have stared at a wall in fixation for hours which is not normal. It?s not so much as a headache, just a lot of pressure and I?ve never experienced it with anything else in my life. After my second dose I was also extremely exhausted but could not sleep because of the pressure in my head. My memory is also affected as I cannot remember things very well. It takes me about 30 seconds to understand what someone says because I just can?t think. I feel like my cognitive processes are faulty. It?s like a very intense brain fog that affects my vision and on the first vaccine also affected my hearing as stuff sounded muffled.

Systemic: Confusion-Severe, Systemic: Headache-Severe, Systemic: Nausea-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe, Additional Details: pt developed severe headache within minutes of vaccine felt like eyes were bulging out of head. She had tingling/numbness in arms then couldn't move arms. Her mental cognition declined and she was unable to speak. Patient had fluid coming out of her nostrils and eyes. Transported to ER by ambulance.

Patient received a COVID vaccine. A couple minutes after administration. Patient stated that she was feeling faint and dizzy. Patient mentioned that she was having blurred vision. Pharmacist provided a cool compress to the patient's head, neck, and wrists. Patient was also provided water. Patient's blood pressure was taken several times which read extremely low (90s/ 50s). Patient mentioned that her hands were going numb and stiff. EMS was called for patient for assessment. Patient was observed by EMS in which it was concluded that patient experienced what appeared to be a panic / anxiety attack. Patient believed that the vaccine was giving the patient covid. Once the EMS told her otherwise, patient was able to calm down. After about 25-30 minutes after the vaccine, patient felt better and left with her mother.

had a short pain in my armpit in the one that, in the arm that I got the vaccine; Headache/head would hurt to; my body would get really hot and really cold at the same time and then my whole body aches; my ear would hurt too; Chills; my body would get really hot and really cold at the same time and then my whole body aches; my nose would bleed from my right nostrils for about a week and then head would hurt to and my ear would hurt too; This is a spontaneous report from a contactable female consumer or other non hcp (patient). A 20-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0181), via an unspecified route of administration, administered in arm left on 19Jun2021 (at the age of 20-year-old) as dose 2, single for COVID-19 immunization. Medical history included anaemia (patient stated, I am anemic. You can probably say low iron (later confirmed as anemic). The patient concomitant medication included ferrous sulphate (FERROUS SULFATE) taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0187), via an unspecified route of administration, administered in arm left on 29May2021 as dose 1, single for COVID-19 immunization and experienced I had short pain in my armpit in the arm, I had mild headache. The patient experienced had a short pain in my armpit in the one that, in the arm that I got the vaccine, headache/head would hurt to, my body would get really hot and really cold at the same time and then my whole body aches, my ear would hurt too, chills, my nose would bleed from my right nostrils for about a week and then head would hurt to and my ear would hurt too, all on an unspecified date in Jun2021. Adverse events: patient stated, Okay, after the 1st dose, I had short pain in my armpit in the arm that I got my shot in, this is the few days after and then I had mild headache after that too. Then after the 2nd dose I had short pain the next day in my armpit again and then I had really bad headache and I have aches and chills like all over my body, my body would get really hot and really cold at the same time and then my whole body aches. Patient stated, Yes, I felt a little bit better after that the 2nd shot but about a week later I started to get a nose bleed for a week. So, every like morning my nose would bleed from my right nostrils for about a week and then head would hurt to and my ear would hurt too. Patient stated, I still have headache and I never had headache or nose bleed before. Date of vaccination: Patient stated, On the first dose it was June on a day like 4, this is actually the 1st dose. I had a short pain in my armpit in the one that, in the arm that I got the vaccine impetrated. When confirmed the date, patient stated, No, the 1st one dose on the 5th of 29th, I mean May, 29th. 2nd dose that was on June 19th. The patient underwent lab tests and procedures which included general blood test showed it was like a iron, lipid, comprehensive metallic, metabolic. Outcome of the event headache/head would hurt to was not recovered and rest of the events was unknown. Follow up attempts are needed. Further information is expected.

The patient reported swelling of her upper lip that began on 7/28/2021. It was more pronounced this morning.

tested positive for Covid test; tested positive for Covid test; difficulty breathing; chills; fluctuating fever; nausea; weakness; weakness/extreme fatigue; loss of taste and smell; loss of taste and smell; muscle pain; cough; sore throat; nasal drip; dizziness; fast heartbeat; injection site pain; anxiety; crying; This is a spontaneous report from a contactable healthcare professional. This 21-year-old female patient reported for herself that she received BNT162B2 1st dose on 31Dec2020 10:00 AM intramuscular at left arm for COVID-19 immunisation. Medical history included known allergies: Penicillin and Covid-19. Concomitant therapy included BC as reported. The patient experienced difficulty breathing, chills, fluctuating fever, nausea, dizziness, weakness, fast heartbeat, tiredness, loss of taste and smell, muscle pain, injection site pain, anxiety, cough, sore throat, nasal drip, crying, extreme fatigue, Etc on 31Dec2020 at 06:00 PM. The events resulted in doctor or other healthcare professional office/clinic visit, emergency. The patient was hospitalized for 1 day and received treatment included blood thinner rivaroxaban (XARELTO) and had 2 weeks quarantine. The patient had Covid prior to vaccination and tested positive for Covid test post vaccination on 01Jan2021. The outcome of the events was not resolved. Information on Lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the suspected LOE, SARS-CoV-2 test positive and the other reported events due to temporal relationship. Of note, it is reported that the patient had history of COVID 19 infection prior to the vaccination. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, 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.

5 days after administration- heavy uterine bleeding; constipation; severe knee/shoulder joint pain; light sensitivity; dizziness/ light headedness; thigh numbness; pain when prodded on either sides of thighs; harsh headache; This is a spontaneous report from a contactable Other healthcare professional (patient). A 21-year-old female patient received BNT162B2 first dose on 31Dec2020 03:15 PM intramuscularly on left arm at single dose for COVID-19 immunization. Medical history included Depression, Anxiety, Factor V Leiden, Known allergies to Penicillin and Onion sensitivity. Patient is not pregnant. No other vaccine in four weeks. Concomitant medications in two weeks included unspecified medications. "5 days after administration" (also reported as 01Jan2021)- heavy uterine bleeding (resulting with trip to ER), constipation, severe knee/ shoulder joint pain, light sensitivity, dizziness/ light headedness, thigh numbness, pain when prodded on either sides of thighs, harsh headache. No treatment received for the events. Events resulted in ER and physician office visit. No covid prior vaccination. No covid tested post vaccination. The outcome of the events was not recovered. The seriousness was reported as no. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported uterine bleeding cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Headache; body aches; joint pain; chills; fever; general malaise; dental pain; soreness at injection site; pain; Loose stools; Stomach upset; Dose Number:1/ Date of start of drug: 21Dec2020/ Dose Number:2/ Date of start of drug: 07Jan2021; Dose Number:1/ Date of start of drug: 21Dec2020/ Dose Number:2/ Date of start of drug: 07Jan2021; This is a spontaneous report from a contactable Other healthcare professional (patient). A 21-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EL0140), via an unspecified route of administration on left arm at 09:45 AM on 07Jan2021 at single dose for COVID-19 immunization. Medical history reported as none. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) and Women's Daily Multivitamin, Hair Vits. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EL0140), on right arm at 11:30 AM on 21Dec2020 for COVID-19 immunization and experienced only mild discomfort. The patient experienced headache, body aches, joint pain, chills, fever, general malaise, dental pain, pain and soreness at injection site, loose stools, and stomach upset at 21:30 on 07Jan2021. The events were reported as non-serious. The patient did not receive any treatment for events. The outcome of events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the had not patient been tested for COVID-19.

Upon arrival to observation room, just after vaccination, patient c/o decreased vision, feeling hot and as though she was going to pass out. Pt. appeared anxious stated she did not like needles. Removed face mask to take slow deep breaths, sipped water. BP 81/51, pulse 84, pulse ox 98%, skin mildly diaphoretic. Did not lose consciousness, answered questions appropriately. Continued to drink water and take slow deep breaths, felt better after 4-5 minutes. Felt well enough to walk to the first aid room for additional observation (30 minutes). Sitting in the first aid room she continued to drink water (16 oz) and ate several crackers; symptoms continued to improve and patient she felt much better, ready to leave the clinic. Patient was calm, conversant, BP improved to 97/57, skin was warm and dry, pulse 74-78 and pulse ox 100%.

some pain in both sides of her chest; Bad taste in mouth; Pain injection site; Arm and fingers went numb; This is a spontaneous report from a contactable consumer (patient) reported for self. A 21-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EJ1689) via an unspecified route of administration in left upper arm on 11Jan2021 at single dose for COVID-19 immunization. There was no medical history. There were no concomitant medications. The day of the vaccine on 11Jan2021, her arm and fingers went numb, she had pain at the injection site and had a bad taste in her mouth which has all resolved, states the following day after the vaccine, 12Jan2021, she woke up and had some pain in both sides of her chest. Wondering if these side effects are expected and about getting the second vaccine. Events outcome of arm and fingers went numb, bad taste in mouth was recovered on 12Jan2021, for pain in both sides of her chest was recovering, for pain at injection site was not recovered.

DEVELOPED ELEVATED BLOOD PRESSURE (181/106) AND TACHYCARDIA (125), SOB, FAINTNESS, NAUSEA, RED EYES. GAVE BENADRYL 25MG PO AT 0940. BP DECREASED TO 143/88 AND PULSE 99.

Patient experienced flushing, tingling, and itchy throat/tongue, rash within minutes of receiving first dose of vaccine. Administered diphenhydramine 25 mg PO in vaccine clinic and called rapid response. Patient was taken to ED where they noted mild lip swelling. The itchy throat and rash resolved in the interval between vaccination and presentation to the ED. In the ED, she received famotidine IV and steroids. Epinephrine was deferred since patient had no shortness of breath or other respiratory symptoms. She was observed in the ED for 5 hrs and discharged with EpiPen and steroid taper.

Employee states that later that eveningwhen she got home she began having some lightheadedness and describes feeling loopy. She described seeing stars at times and then her vision would go black. A friend came over to stay with her and did say that at one point she became unresponsive for about 45 sec to 1 minute. The second day she still had the lightheadedness and felt loopy. On the 3rd day she felt completely fine.

Nausea, insomnia, abdominal pain, fatigue/exhaustion, fever, chills, overheating, dry eyes, muscle aches and joint pain (more/different than usual related to health condition)

Mild swelling of face and lips; Mild swelling of face and lips; This is a spontaneous report from a contactable physician. A 21-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249, expiry date: unknown), intramuscular in the right arm, on 15Jan2021 11:00 at a single dose for covid-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient is not pregnant. The patient was not diagnosed with covid-19 prior to vaccination and was not tested for covid-19 post vaccination. The patient had no known allergies. On 16Jan2021, the patient experienced mild swelling of face and lips. Both the events resulted in emergency room visit. Therapeutic measures were taken as a result of mild swelling of face and lips which included steroid shot, told to take ZYRTEC and PEPCID. Outcome of the events was unknown.

Pt got pfizer covid vaccine on 1/3 (approx 48 hrs PTA) where she a CNA. She got the vaccine in the afternoon. Pt felt well on the day of the vaccine, but yesterday (1/4, one day after vaccine), pt syncoped at work in the evening. She had eaten normal meals that day. After syncopal episode, her blood sugar was normal. Her blood pressure was 76 / 56. Pt felt very lightheaded prior to syncope. No chest pain, dyspnea, no palpitations. Pt was unconscious just briefly. Pt states she did have some tingling in her R arm, R foot, and entire tongue. Pt is still having a HA. No other sxs. Has not taken anything for these sxs. When pt syncoped, she landed on soft bed, did not hit head on anything hard. Pt syncoped once previously at age 9. Pt has soreness at injection site, but no swelling or erythema.

Immediately after receiving vaccine, R arm twitched, pupils dilated, weak, in and out of responding. BP 98/60; HR 78; normally runs low BP. Arm numb; throat tight. No welts; extreme fatigued. Rapid response; epinephrine given via epi pen; transported to ED.

My first dose of the vaccine was on 1/14/2021. I had a mild headache and experienced dizziness and nausea the night of receiving the vaccine. My second dose of the vaccine was 2/8/2021. I felt tired the night of receiving the vaccine and went to bed a 8pm. I woke up at 6:10am on the 9th with a severe migraine, severe nausea and dizziness. I ate a small amount and laid back down. I got out of bed at 9am and noticed both of my eyes and face were swollen and my throat was swollen. At this point I called my doctor and spoke to a nurse on the phone, she was short saying I needed to go to ER. Personally, I did not feel it was necessary at the time so I took a Benadryl and Ibuprofen. Throughout the day I continually got worse experiencing the same symptoms as the morning including sharp chest pain, restricted breathing, a low grade fever of 100.4, severe lower back pain and leg numbness. I took more ibuprofen and placed heat on my back. I took ibuprofen PM and woke up the morning of the 10th feeling better. Still have headache, lower back pain and swelling but is better than yesterday. I will notify my doctor today of the event that occurred yesterday (2/9/2021).

After injection, she was instructed to stay for observation. Upon checking on her, patient stated her heart was racing and she felt weak. She was instructed to remain for 30 more minutes of observation. Checked patient post 30 mins. and attempted to have ambulate. She stated she still felt "woozy". Conversation was had with another RN. Pulse was checked and 104. Pupils were dilated and her speech was delayed. We felt she should go to ED to be checked and she agreed. Patient was taken by W/C to ED

This 21 yo corpsman advised 1/15/2021 she received her first COVID Pfizer vaccine with complaints of elev heart rate sensation and feeling hot immediately after her first COVID vaccine that did resolve within a few moments on it's own. She reports a sore, red, hot are at injection site that lasted for 3-4 days and resolved on own. She reported being in good health until mid February when she noticed sinus/facial pressure, nasal congestion w/nasal voice (no throat issues, just nasal muffling). She denied any fever, sob, cp, rash, ha, or other systemic symptoms and a HCP placed her on Augmentin. She completed her AB on 2/20, 2 days before her 2nd covid vaccine. ------- On 2/22/2021 she received her 2nd Pfizer Covid vaccine to left arm and went back to ER (where she works) for observation. She reported she again had sense of elevated heart rate, feeling hot and now itched all over (now about 30 min post vaccine). She reported symptoms to RN who noted onset of "hives" to midthoracic area on her back and recommended she be seen by ER. She was treated by ER MD approximately 1 hour post vaccination with MD noting a 1x1cm red raised hive to T1 region on back and no other lesions or skin rashes. She denied any SOB, cp, ha, fever, difficult swallowing-speaking, no oral swelling, no angioedema, no recent exposures-insect bites, no new food groups, soaps, detergents, lotions, cloths, etc. She was treated with I liter NS bolus, IV Benadryl, Solu-Medrol, and Pepcid. HR was 81 w/rr 16 and 100% O2 sats on arrival. Afebrile. She was released home on Prednisone, pepcid, atarax, and prn benadryl. ----- On 2/14/2021 follow up, she advised hive has resolved, she still feels itchy on and off but not taking any medications. She c/o "weird ringing sensation to bilateral ears described as a muffled sensation with some pressure. Again s/s similar to previous sinus infection except for ringing sensation. She also has a sore site, again to left arm that looks bruised and is still warm to touch (no swelling, less redness vs 2 days ago). She reports a similar red flushed vaccine site when 13 yo and receipt of first HPV vaccine (name, lot #, details unknown). She does not recall any other s/s except her mother said she was not going to get the rest of the series. Since then she has had a "nodule" in her left deltoid. She has received many other vaccines to both deltoids w/o issues.

Pt experienced dizziness, tunnel vision, blurred vision, felt like she was going to pass out. Pt moved to stretcher and laid flat for 5 minutes. Given juice and crackers at 10 minutes post vaccine. Pt states she is feeling better, color improved, eating snack and VSS. 1802: 106/56 75 12 100% pulse ox 1810: 114/65 65 12 100% pulse ox 1830: 139/56 74 12 100% pulse ox Pt observed additional 45 minutes and released to care of friend to return home.

Progress Notes Nurse Practitioner COVID VACCINE CLINIC Subjective Patient is a 21 y.o. adult who was seen at SVH COVID Vaccine Clinic today for patient's second dose of the COVID 19 vaccination. Patient was given the Pfizer vaccination in the left deltoid muscle. During patient 15 minute waiting period after the injection, the patient began to experience rash, hives, throat tightness and dizziness. Patient denied difficulty breathing, difficulty swallowing, wheezing, hoarseness, stridor, itching, lightheadedness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and patient on was then assessed in the emergency bay 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. ALLERGY REVIEW OF SYSTEMS: Patient complains of frequent throat clearing, itching of skin and headaches CONT negative Eyes negative Respiratory negative GI negative Musculo negative Previous Reactions: Itching with first Covid shot Objective Vitals Vitals: 03/17/21 1501 03/17/21 1508 03/17/21 1523 BP: (!) 157/100 (!) 154/66 (!) 170/65 Pulse: 90 84 90 SpO2: 99% Physical Exam Constitutional: Appearance: Normal appearance. Patient is well-developed. HENT: Head: Normocephalic. Right Ear: Hearing normal. Left Ear: Hearing normal. Nose: Nose normal. Mouth/Throat: Lips: Pink. Mouth: Mucous membranes are moist. No angioedema. Pharynx: Oropharynx is clear. Uvula midline. Eyes: General: Vision grossly intact. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Neurological: Mental Status: patient is alert. Psychiatric: Behavior: Behavior is cooperative. Pt had taken benadryl before her visit. She was given Zytec and still had some rash and hives, but the throat tightness had went away. She was given water and crackers while in the bay. Assessment/Plan Treatment included: antihistamines Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) Left at 3:42 Electronically Signed 3/17/2021 3:40 PM

Patient received Pfizer vaccine Dose #1 at 0750. 0800: Patient reported feeling flushed and warm. Pt appears clammy and diaphoretic. Complained of tasting the vaccine in her throat, "weird taste peppermint like". Vitals: BP: 96/54, HR: 71, O2 sat: 100% and RR: 20, T: 98.3. 0810: Hives noted to patient forehead, itching to nasal bridge and upper back. Patient lying supine, vitals: BP: 108/70, HR: 82, O2 sat: 99% RR: 20. Mildly clammy. Reported feeling improved. 0815: Patient reported feeling "like herself", Still had taste in mouth. Hives noted to have decreased. Vitals: BP: 115/75, HR: 88, RR: 20, O2 sat: 99%. 0830: Vitals BP: 97/66, HR: 93, O2 sat: 98%, RR: 20. Patient reported feeling better. Denies any swelling in face, mouth or throat. Denies any itching or difficulty breathing. Hives resolved. Patient sitting up and speaking in clear sentences, appears in no distress. Advised to follow up with primary providers. ER precautions reviewed or any return or worsening of symptoms. Patient verbalized understanding and left clinic in stable condition.

PT c/o dizziness and lightheadedness immediately following innoculation. Pt states history of panic attacks and anxiety. RN who performed innoculation stated pt eyes rolled back and her arms flexed and she lost consciousness for less than 1 minute. RN notified the MD and on site Paramedics and got them enroute. Medics evaluated pt and she was found to be bradycardic and they recommended she be further evaluated at the emergency room. Fire department arrived and transported pt to medical center in stable condition.

Nerve pain throughout the entire body lasting approximately 18 hours. Felt like ants crawling through all my muscles. Not exactly painful, but aching and deeply affecting. Almost itchy like all my muscles needed to stretch but they were also exhausted. All nerves in my body were highly activated, including my taste buds. Could not taste because I could taste everything and the food ended up feeling like individual particles rather than a cohesive flavor. Some nasal congestion. Overall, felt like being sick, but worse. Exhaustion Soreness in left arm

i received my vaccine right about 12:30 that money and while waiting in the 15 minute clinic at the center i felt relatively fine aside for a dry mouth which i didn't even thing was a adverse reaction at the time. i processed to continue with my day and head to my 2pm class and while sitting in my class my throat which at this point was pretty itchy and felt like it was to some extent tightening. I also started to cough and wheeze profusely which is something im use to as an asthma patient but usually something has to induce that and at this point i was literally just sitting in class. i left the class and at this point it was getting extremely hard for me to breath i was coughing and wheezing essentially in a full on asthma attack. i drove to the clinic where they first gave me an albuterol nebulizer and then tried to give me a Claritin but just a few minutes after i threw up we tried again with a Benadryl and while i was able to keep that in longer i also threw up after taking that medicine. After my breathing calmed down a bit i was released to go home but there i had a fever and headache, body chills, extreme fatigue, exhaustion. nausea and abdominal oain in my lower left side and right below my breast bone. for the rest of the night and even into today (march 23). i continued to take both Benadryl and the nebulizer over night and that has worked to help releeve symptoms but i still feel significantly unwell.

Patient was nervous before the vaccination. After vaccination she started to feel hot and cold. Her hearing started to fade in and out. She sought help and was directed to lay flat on the floor and breathe. She started feeling light headed and that her vision was tunneling. Her appearance was pale and her hands were clammy. Her blood pressure was taken via wrist and was normal for her (112/72). The medical professional tending to her had her continue talking, asked her to state her DOB, name, age, the date, etc. After about 5 minutes she started to feel better- she sat up and had some water and M&Ms. She then laid back down but continued to converse with us. This took place over about10 minutes from first symptoms. She remained laying down for about 10 minutes after and then slowly sat up, and when she felt comfortable sitting she tried standing up. She then went home for the day (was an employee of the store).

1209 HRS: Pt is a self reported 21 yo female who was found to be pale and diaphoretic in past vaccination recovery area with report of narrowed vision with nausea, noting Pfizer vaccine (Lot #: ER8732) was administered IM to Right deltoid @ 1201 HRs. AAOx4 with stuporous gaze. Instant cold pack applied to back of neck with no improvement of symptoms. 1212 HRS: BP-90/58 (M), HR-62, RR-20, SPO2 @ 99% on RA. 1214: Pt moved from chair to floor w/ legs elevated on chair and ice pack applied to right neck vessels. Pt?s skin color improved to pink in hue w/ vision returning to baseline per her report. 1216 HRs: BP-98/68 (M), HR-75, RR-18, SPO2 @ 98% on RA. Pt denies past medical history. Denies currently menstruating or pregnant and currently taking Thiminar birth control. Reports last meal this AM. Pt reports history allergic reaction to penicillin with reported rash when she was 2 ? 3 years of age with unknown treatment provided. Denies prior illness up to 1 month ago, to include no prior COVID-19 diagnosis. 1222 HRs: Pt assisted to sitting position on floor, noting BP-112/82 (M), HR-91, RR-18, SPO2 @ 99% on RA w/ no acute changes noted. Pt reports feeling better with water provided. Transferred to chair w/ stand-by assist x 2 RNs. 1239 HRs: Pt jovial and conversing well and asymptomatic at this time. Pt reports condition at baseline to when she arrived to clinic. 1242 HRs: 1209 HRS: Pt is a self reported 21 yo female who was found to be pale and diaphoretic in past vaccination recovery area with report of narrowed vision with nausea, noting Pfizer vaccine (Lot #: ER8732) was administered IM to Right deltoid @ 1201 HRs. AAOx4 with stuporous gaze. Instant cold pack applied to back of neck with no improvement of symptoms. 1212 HRS: BP-90/58 (M), HR-62, RR-20, SPO2 @ 99% on RA. 1214: Pt moved from chair to floor w/ legs elevated on chair and ice pack applied to right neck vessels. Pt?s skin color improved to pink in hue w/ vision returning to baseline per her report. 1216 HRs: BP-98/68 (M), HR-75, RR-18, SPO2 @ 98% on RA. Pt denies past medical history. Denies currently menstruating or pregnant and currently taking Thiminar birth control. Reports last meal this AM. Pt reports history allergic reaction to penicillin with reported rash when she was 2 ? 3 years of age with unknown treatment provided. Denies prior illness up to 1 month ago, to include no prior COVID-19 diagnosis. 1222 HRs: Pt assisted to sitting position on floor, noting BP-112/82 (M), HR-91, RR-18, SPO2 @ 99% on RA w/ no acute changes noted. Pt reports feeling better with water provided. Transferred to chair w/ stand-by assist x 2 RNs. 1239 HRs: Pt jovial and conversing well and asymptomatic at this time. Pt reports condition at baseline to when she arrived to clinic. 1242 HRs: Pt ready for discharge. Pt instructed if symptoms returned to call 911, proceed to ER or call PCP. Informed pt due to response to this vaccine dose, she will need to coordinate with her PCP for follow-up dose in an appropriately equipped facility. Pt verbalized understanding w/ questions answered. Pt signed COVID-19 VAER Form & discharged ambulating to POV where father was awaiting. RN notified. Pt ready for discharge. Pt instructed if symptoms returned to call 911, proceed to ER or call PCP. Informed pt due to response to this vaccine dose, she will need to coordinate with her PCP for follow-up dose in an appropriately equipped facility. Pt verbalized understanding w/ questions answered. Pt signed COVID-19 VAER Form & discharged ambulating to POV where father was awaiting. (Site Nurse Manager) notified.

Pt complained of itchy eyes with redness on her face. She then started complaining of tightness in her chest and trouble swallowing. We called 911 and rescue came to check her. Upon arrival her BP was elevated and she was lightheaded so they took her to hospital.

Pt came back to pharmacy stating she did not feel good and had ringing in her ears. She was took to the immunization room where she was unable to sit in a chair and was helped to to lie down. She had blank look on her face for a couple of seconds and then started looking around slightly confused then started talking again. She laid there for about 5 minutes and started to feel better so she sat on the chair for about 5 minutes before EMT's arrived as a precaution. After getting check out she left on her own accord. She stated while talking that when she gave blood in the past this has happened.

Extreme blurred vision, light sensitivity, and eye pain the next day. Eye muscles were inflamed and pupils had delay in reaction to light. Have to wear sunglasses even inside due to light sensitivity, otherwise I get very nauseous. Has lasted over a week and have had to see ophthalmologist twice. Got steroid eye drops to take 4 times a day for 2 weeks.

Approximately 10 minutes after receiving the shot, I started to have a bit of swelling in my throat that was almost identical to the reactions I get from foods I am allergic to with my Oral Allergy Syndrome. Another 10-15 minutes later, it had gotten worse to the point where it was harder to swallow, plus I was a bit lightheaded and my mouth was itchy. The people monitoring the post vaccine waiting section didn?t want me walking around, so they sent someone to my car to get my liquid Benadryl, which is what I take for similar reactions to foods. I took about 50-75 mg worth and waited for an additional hour or so until the swelling had gone down mostly. Now (at almost 7 pm on the same day), I still have a tiny bit of swelling in addition to the ?normal? vaccine side effects, tiredness, soreness in my whole body, headache, pain at injection site.

Patient reports itchy tongue ad throat, feeling a slight tightness in her throat and dizziness within minutes after receiving her 1st Pfizer vaccine on April 1, 2021. Patient reports having an allergic reaction to a chemo medication but could not remember the name. Patient was administered 50mg benadryl by EMS. Vitals were taken and within normal limits. Patient did not appear in any distress and texting during her examination. Throat was without erythema and swelling. Patient reported some relief of her symptoms after 10 minutes of Benadryl but not resolved. Patient was later transported to hospital by EMS for further evaluation.

after about 10 seconds of getting vaccinated, the patient kind of rolled her eye a little bit and lips became pale and vomited later too.

My throat / tongue swelled, difficultly breathing and swallowing (anaphylaxis). Urgent care rushed me in and gave me dexamethasone in my right arm to stop the swelling as well as Tylenol. It took about a full week to completely feel normal, mild anxiety attacks happened. But after one week felt good again.

Patient felt weak, lightheaded, confused, tongue tingling, doubled over herself. Called 911 and took BP 118/57, Pulse 56, Temp 79,9. When paramedics arrived, her BP was much lower and they took her to the ER to administer fluids and further observation.

After 5 minutes my arm started burning. Then I got cold sweats. After 20 minutes I was struggling to breathe. It felt like something was sitting on my chest. My lips and throat also got very itchy. I went over to a paramedic who gave me IV benadryl and something for nausea. My blood pressure and HR were initially high but lowered. My O2 was fine. Then I got really light headed and my tongue, throat, and whole face got more itchy. I then went to the ER and got epipen intramusclarly in the ambulance. At the hospital I got steroids and an IV bag. Around 3:30 I started to feel normal again. I stayed under observation for 4 hours. THen got discharged with a prescription of steroids.

Immunization administered, approximately 5 minutes later while being observed, patient was holding head and bending over - I went over to check on patient - she stated she was lightheaded, dizzy and ears were ringing. I stayed next to her as a team member got a cold bottle of water and used as a compress on back of neck. She stated it was intensifying. I had the store manager call 911 she appeared to pass out for a second as she came around she said her tongue was sore. but no problems breathing, itching , hives or swelling of tongue. the other symptoms reduced . the EMS arrived and she was feeling better. EMS took Blood pressure and heart rate - both were normal. She refused to be transported and EMS waited until she could stand. I recommended to call the primary care physician to discuss seconf dose and posssilby have the second dose at a mass vaccination site where there is a physician because it took 15 miuntes for EMS to arrive.

Pt became anxious, sweaty and dizzy. Developed tunnel vision and loss of consciousness. Staff with pt at time of syncopal episode and assisted pt to floor. Pt regain consciousness within 1 minute. Pt placed on stretcher and arrived to med obs at 1558. Vitals obtained. At this time pt states she is feeling normal. At 1611 c/o dizziness and nausea. BP rechecked and notably dropped. Pt placed in the trendelenburg position. BP increased. Nausea and dizziness resolved. Snacks and water given. Pt left facility 1712, friend driving. Vitals as follows; 1600 BP 107/74 HR 85 RR 22 spo2 98% 1611 BP 97/68 HR 78 RR 20 spo2 100% 1625 BP 109/76 HR RR 18 spo2 99% 1705 BP 95/66 (standing, asymptomatic)

Patient stated feeling blurred vision, throat tightness, anxiety, shortness of breath, patient appeared pale Patient provided water and seen by medical team Patients blood pressure was 86/59 and heart rate 97, patient provided with water Patient advised to be seen in hospital, patient refused medical transport and signed AMA form Patient agreed to go to hospital , driven by boyfriend

Patient received her first dose of Pfizer vaccine at 1500, she waited her required 15 minute observation time, was feeling fine and was released by the NP. Patients mother drove her back at approximately 1530 reporting difficulty breathing, throat tightness, numbness and tingling or her face and tongue swelling. RN assessed patient and administered 0.3mg of EPI and EMS was called per protocol. Patient reported some resolution after EPI was given. EMS transported patient to ER for further evaluation.

Patient in clinic to receive first dose of COVID-19 Vaccine. Per vaccinator patient oriented/alert, behaving and talking normally prior to vaccine administration. Pfizer dose administeredd in left deltoid, patient completed 30 minute observation period due to her medical history and previous allergic reactions (swelling after pain medication at dentist, anaphylaxis with carbonated drink and tuna). Per patient's report: was getting in to her vehicle ready to leave and vision in right eye became blurry, came back to clinic. Patient reports this is not the first time the blurred vision has occurred, reports blurry vision to right eye occurs anytime she is stressed or tired and typically lasts about 20 minutes.

Approximately 15 minutes after receiving vaccination, patient complained of tingling in her lips and throat with mild difficulty swallowing. BP 143/101, HR 80. Denies SOB or difficulty breathing. Given 50 mg benadryl IM. Patient monitored for approximately 45 minutes. Campus police and EMS arrived to scene. Patient felt better and police escorted her back to her dorm.

Within 25 minutes of getting the vaccine I had a metallic taste in my mouth. Shortly thereafter, I had a headache and body aches. I felt tired, feverish, and pain at the injection site. The next day all of these symptoms became worse and I had joint pain. The third day I had bad headaches and fever all day. The metallic taste remains constant and I can't taste "sweet" accurately. Most sweet things taste tart and extremly sour.

Day after vaccine normal chills and fatigue. Sore eyes and sore arm where vaccine was administered. Subsequent day woke up with extremely itchy eye (right only) and growing lump in eye which grew throughout day. Called health facility for university and on-call nurse said to go to ER. ER said some allergic reaction possibly due to season (patient has not experienced any allergic reactions to her knowledge prior).

I started to have hives form along essentially my whole body besides my face starting 36 hours after my initial vaccine. My legs are the most concentrated with hives. I awoke up with swelled up hands, eye lids and wrists. Today, I woke up with a swollen upper lip and swollen bottoms of my feet.

Pt reports lightheadedness, tongue swelling, and difficulty breathing after receiving her vaccine. She denies itching/rash on skin, but reports "itchy/tingling" pharynx. On exam, there was no wheezing, no rash. Epipen administered to R thigh @ 11:36am Pt transported to ED by EMS at 12:05pm Vitals as follows: 11:25am HR- 63 RR- 20 BP- 109/73 SPO2- 98 11:30 am HR- 67 RR- 20 BP- 115/74 SPO2- 97 11:36am HR- 79 BP- 110/75 SPO2- 99 11:38am HR- 103 BP- 111/76 SPO2- 97 11:41am HR- 79 BP- 107/73 SPO2- 98 11:46am HR- 85 BP- 111/72 SPO2- 97 11:51am HR- 87 BP- 111/75 SPO2- 99 12:00pm HR- 79 BP- 136/76 SPO2- 99

The charge nurse was called to the scene by the scribe because the patient stated that her vision got blurry and lightheaded. Patient lost consciousness and was caught by one of the nurses. She was lowered to the yoga mat and her feet were placed on top of a chair. When the patient regained consciousness, she stated that she had no allergies, has eaten before getting the vaccine and has no history of fainting or anxiety. She has no medical history that she knows of. After talking to the patient, her vision improved and she stated that she feels better. Patient was transferred to observation and was observed for 30 min.

apr 4,2021- after first dose: only pain and soreness in right arm april 25/26, 2021- (most symptoms on the day after) after second dose: pain/soreness in left arm and whole body, migraine, feverish (dont have a thermometer to check temperature), chills, pain in neck, sharp pain in inner ears (maybe a part of the migraine not sure but it hurts worse than the migraine)

Dizziness roughly 3 hours after injection that lasted for ~2hrs. Ongoing headaches for 3 days straight. Migraine and light sensitivity 2 days after vaccine for the entire day. Followed with a severe migraine later that evening leading to extreme nausea and vomiting.

Patient complained almost immediately of a burning sensation on her entire arm, which progressed quickly into itching on the left arm. She denied any SOB or itching of throat or mouth, however within a few minutes the itching progressed to her right side and onto her chest. She then complained of her eyes watering and then stated her chest was growing tight. EMS arrived at this point and took her to the ER

urticaria and rash started on back, bil elbow and bil knee/lower region on 4/21, 12 days post vaccine. Also noted significant bil upper eye lid swollen(angioedema). Pt was treated aith Prednosone 10 mg dose pack x 6 days and triamcinalone cream for itching. All sx resovled after day #2 of steroid PO.

Dose#2 4/14 at 140am, at midnight that night fever 101, with large swollen lymph node on right underarm, breast pain. Then on 4/25 woke up with droopy left eye, then next day while at gym had twitching at lips, numbness check and eye swollen was seen at ER. Was not able to raise eyebrow on left side with left ear pain. With light sensitivity, states also complaints of chest pain at time of ER visit.

Patient had COVID-19 illness in January 2021. Had anosmia and loss of taste. Those symptoms fully resolved and she fully recovered. Got her first dose of Pfizer COVID-19 vaccine on 4/1/2021 with no major S/S. Got second dose of Pfizer COVID-19 vaccine on 4/23 /2021 and on that same day noted onset of "rancid" or "greasy, nauseating" smells when smelling foods.

She was waiting the advised 15 minutes and passed out. Rapid heart rate with fluttering eyes - unsure if it was seizure. after about 5 minutes she came to and started complaining of being cold with chills .

Feeling sweaty, ear ringing, light-headed, nausea, pins and needles after sitting back up in chest. Vital Signs: BP 96/60 HR 63 Resp 16 O2Sat 97% Skin Signs: Clammy, Other - Pale Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally Repeat BP 120/85 Repeat HR 83 Resp 16 O2Sat 99% Skin Signs: Warm and dry Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally Initial Treatment: Given water, laid down, patient said they felt fine after laying down, vitals returned to what patient said was normal for him. Hx of previous similar symptoms with blood drawn in past. Follow up Treatment: Monitor x30 min Notes: Patient was stable. Home with mom

After waiting for 15 minutes after the vaccination, the patient and her mother returned to the pharmacy. The patient had a heavy feeling in her chest and it felt like a lump in her throat. She was not having trouble breathing. I had her sit down next to her mother to monitor further. After about 5 more minutes, she felt like her symptoms were getting worse. She stated that she was feeling cold and shivering. I had her lay on the floor. I had my technician call 911. I stayed next to her to monitor. I had her also sit up to drink some water. She complained of her jaw starting to hurt and her head was throbbing. The paramedics arrived shortly after.

Bell's palsy; tongue went numb; body aches; regular sore arm; headache; This is a spontaneous report from a contactable consumer reporting for herself. A 21-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EW0153/expiration date: not provided), via an unspecified route of administration, on 15Apr2021 10:45 (at the age of 21 years old) as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Apr2021, the patient experienced regular sore arm, headache. On 16Apr2021, the patient experienced body aches. On 17Apr2021, the patient's tongue went numb. On 20Apr2021, the patient experienced Bell's palsy and described it as getting worse. The outcome of the event regular sore arm was recovered on 16Apr2021. The outcome of the event body aches was recovered on 19Apr2021. The outcome of the events headache, tongue went numb and Bell's palsy was not recovered.

POST VACCINE ADMIN, PATIENT REPORTED "HOT EYES" SENSATION, STATES HAD SOME FLUSHING/SWELLING/MILD REACTION WITH FIRST DOSE PER PATIENT". FACIAL FLUSHING NOTED BILATERALLY, NO ITCHING/HIVES/SOB/WHEEZING NOTED OR REPORTED. REPORTED SOME NAUSEA AS PATIENT WAS CRYING AND ALSO MOUTH NUMBNESS, BUT RESOLVED SPONTANEOUSLY. PER ONSITE MD, BENADRYL 50MG IM GIVEN IN R DELTOID FOR INCREASING RASH/FACIAL FLUSHING/WORSENING S/S. VSS. PATIENT CALLED FRIEND TO COME DRIVE PATIENT HOME POST BENADRYL ADMIN. ONCE S/S RESOLVED, ESCORTED TO EXIT WITH FRIEND WITH NO ISSUES AT 1145. INSTRUCTED TO SEEK FURTHER MEDICAL TREATMENT/EVAL FOR WORSENING S/S. 1045 BP 133/80 HR 85 RR 22 SATS 99% RA 1105 BP 120/80 HR 75 RR 18 SATS 100% RA 1115 BP 128/87 HR 74 RR 18 SATS 100% RA 1128 SITTING BP 135/90 HR 93 RR 20 SATS 100% RA 1145 STANDING BP 138/87 HR 90 RR 18 SATS 100% RA

After the second does that night I had a really bad headache and felt like I was getting sick. It was hard to focus on doing work and bright lights and loud noises made the headache worse. The next morning, I felt very fatigued and got very tired after even walking short distances. The headache was much lessened but still present. Advil was taken for the headache that night and the next day and helped a bit. Just rest was the most effective. My arm was sore for a couple days after each dose and went away over time. Period was late, as it was due in-between the doses but did not arrive until the day after the second dose (This could have been stress related but is very abnormal)

Client complained of dizziness and visual changes @ 10:52 am. Client placed in supine with legs elevated. BP 114/78 Pulse 84. Client recover and placed in chair at 11:10 am. Tolerated. BP 109/87 pulse 97. Client able to ambulate independently out of vaccine clinic at 11:20 am.

Cough Fatigue Muscle or body aches Headache New loss of taste or smell Congestion or running nose Nausea or vomiting

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Headache-Medium, Systemic: Tinnitus-Mild

she woke up with a swollen lip; This is a spontaneous report from a contactable consumer (Patient herself). A 21-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: Unknown. Expiration date: Unknown) via unspecified route of administration on an unknown date at SINGLE DOSE for COVID-19 Immunization. The patients medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: Unknown. Expiration date: Unknown) via unspecified route of administration on an unknown date at SINGLE DOSE for COVID-19 Immunization. The patient got her second dose about 3 weeks ago, yesterday she woke up with a swollen lip, that looks like it's ballooning on the left side. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

I lost most of my hearing ability in my right ear approximately 5 days after the shot. It began returning slowly that day but didn't;t fully return for 3 days. I went to a ENT in Boise, ID to get it checked about 3 days after the initial loss of hearing but by then my hearing had returned to normal so they saw no loss of hearing during the hearing tests. I think my ears are back to normal, but I am not entirely certain.

A week after getting the vaccine, I went back to my routine of exercising about three times a week. When doing planks, I hear a hollow breathing as I am breathing myself. It sounds like I have have another trachea that is making a separate sound. I exercise at home so there is no one around me and this never happened in my life.

The patient stated that she had not received a vaccine in several years but that the last time she did, she blacked out for maybe 30 seconds and felt dizzy. She states she thinks it was because she did not eat that day and stood up too quickly because she felt ok after. I notified (pharmacist) to be on stand by in case any incidence occurred and we had smelling salts and epipen on hand. I had the patient sit in the vaccine chair afterwards and about 3 minutes later, she started screaming to the top of her lungs that she felt like she was going to die. She screamed that she couldn't breathe and that her chest and head were "killing her". She kept screaming to remove the vaccine out of her arm (the liquid). Her eyes were starting to roll, but I knew she was breathing because she was screaming to not let her die. Her mother was with her and was very nervous and wanted emergency services, so We called 911. I took the girls hands and asked her to look me in the eyes and follow my deep breaths, because I began to think it was more of a panic attack. She followed by breaths and regained some composure but was sweating profusely, so I began fanning her. After a while of talking her through taking deep breaths and assuring her she was breathing and we had emergency services on the way, she began to calm down. EMS showed up about 15-20 minutes later and she declined to go with them. I stayed with the patient the entire time. She did not faint. I believe she just had a panic attack from working herself up about the vaccine. She was a little scared since she had fainted with the last vaccine.

after the vaccination, patient walked to the waiting chairs. 10 minutes later, she was pale and light headed. she sat back into the chair and started losing consciousness as the pharmacist called 911 at 1:03 pm. Her eyes rolled back and she started shaking while her brothers were supporting her in the chair making sure that she wouldn't fall out of the chair. she stiffened up and kept shaking while foaming at the mouth slightly. she started coming back to consciousness as she sat up and coughed up mucous. she started to feel better after this event as I also got her some water. Paramedics then arrived and took over care for her a few minutes later.

Patient developed lip tingling and a rash within 15 minutes after receiving vaccination. Patient received 25mg PO Benadryl with improvement in her symptoms.

Both ears felt plugged, "terrible" earache in left ear; achy, sweaty, clammy, vomiting a few times; all the night of vaccination.

Sharp knife piercing pain in left ear. Extremely painful tinnitus. Ringing in ear kept me up all night. Fever, muscle pain and chills.

Bell?s palsy: numb right half of face and tongue. Started as a numb tongue with no taste and next day turned into my whole jaw and cheek being numb. Now my eye won?t close, right facial paralysis. There?s also pain behind my ear along with sensitivity to loud noises.

Body aches; loss of appetite; tinnitus; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), dose 2 via an unspecified route of administration in left arm on 19May2021 13:45 (at the age of 21-years-old) as second dose, single for COVID-19 immunization. Medical history included COVID-19. Historical vaccine included BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), dose 1 via an unspecified route of administration in left arm on 28Apr2021 13:45 as first dose, single for COVID-19 immunization. Prior to vaccination, the patient did not receive any vaccines within four weeks and was not pregnant. Concomitant medications included lorazepam, gabapentin, and mirtazapine. The patient experienced body aches, loss of appetite and tinnitus on 20May2021 12:00. Since the vaccination, patient has not been tested for COVID-19. No treatment was received for the events. Outcome of the events was unknown. Information on the lot/batch number has been requested.

I started to lose my sight, at first it was my entire peripheral vision and it looked like I was looking through a black holed telescope and then I completely lost sight; Crashed into a stand and passed out; I got really dizzy; I sat in a chair where I became incredibly hot; Sweat through all my clothes; Immediately extremely cold; crashed into a stand; This is a spontaneous report from a contactable consumer (the patient). A 21-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0173) via an unspecified route of administration in left arm on 13May2021 18:00 at age of 21-year-old at single dose for COVID-19 immunisation. Prior to vaccination, the patient diagnosed with COVID-19. No known allergies. No other medical history. Concomitant medication included: the patient received birth control medication within 2 weeks of vaccination. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EP7533) via an unspecified route of administration on 19Apr2021 01:15 PM at age of 21-year-old for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 since the vaccination. The patient got really dizzy, then as she tried to walk away she started to lose her sight, at first it was her entire peripheral vision and it looked like she was looking through a black holed telescope and then she completely lost sight. She became very dizzy and crashed into a stand and passed out. While she was passed out on the floor she uncontrollably defected. Once someone helped her up, she sat in a chair where she became incredibly hot, sweat through all her clothes and then immediately extremely cold. The events onset date reported as 14May2021 09:00AM. No treatment received for the events. The outcome of the events was recovering. The report was non-serious.

rash on the back of both arms without itchiness; swelling of lip; I also experience extreme fatigue, headache, body aches and chills that lasted for about 24 hours; I also experience extreme fatigue, headache, body aches and chills that lasted for about 24 hours; I also experience extreme fatigue, headache, body aches and chills that lasted for about 24 hours; I also experience extreme fatigue, headache, body aches and chills that lasted for about 24 hours; fever of 100.5 that lasted for about 24 hours; This is a spontaneous report from a contactable other HCP (patient). A 21-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 26Jan2021 (Batch/Lot Number: EL3249) as 2nd dose, single for covid-19 immunization. Medical history included chronic migraines and seasonal allergy experience reactions to certain things such as changes in laundry detergent, lotions. The patient's concomitant medications were not reported. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: ELY9231, expiration date unknown), via an unspecified route of administration administered in Arm Left on 05Jan2021 as 1 st single dose for covid-19 immunization and experienced swelling of my lip one hour after the vaccination, no other symptoms and it went down with Benadryl and Later that night noticed a rash on the back of both arms without itchiness or raised bumps. On 11Jan2021, patient underwent lab tests which included Nasal Swab, Covid test with negative result. There was no other vaccine within four weeks and no other medications within two weeks. The patient had Covid prior to vaccination and did not test for Covid post vaccination. On 26Jan2021, after second vaccination the patient experienced swelling of lip that went down with Benadryl and the same rash. In addition, about 10 hours after the vaccine, had a fever of 100.5 that lasted for about 24 hours and also experience extreme fatigue, headache, body aches and chills that lasted for about 24 hours. The outcome of all the event recovered in 2021. No follow-up attempts are possible. No further information is expected.

Later that night I noticed a rash on the back of both arms without itchiness; For the first shot I had swelling of my lip one hour after the vaccination, no other symptoms and it went down with Benadryl; This is a spontaneous report received from a contactable other Health Professional (patient). A 21-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ELY9231) via an unspecified route of administration in arm left on 05Jan2021 (at the age of 21-years-old) as single dose for covid-19 immunization at hospital. Medical history included chronic migraines. Patient had reactions to certain things such as changes in laundry detergent, lotions, etc. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks, prior to the vaccination and not received any medications in two weeks. On 05Jan2021, after one hour after the vaccination patient experienced swelling of lip, no other symptoms and it went down with Benadryl. Later that night, patient noticed a rash on the back of both arms without itchiness or raised bumps. On 11Jan2021, patient had nasal swab, covid test with test result as negative. Since the vaccination, the patient had not been tested for COVID-19. Outcome for the event lip swelling was recovering and the other event was unknown. No follow-up attempts are possible. No further information is expected.

Two weeks after first COVID vaccine patient experienced an acute onset of chest pain, dizziness, head pressure, SOB, fast/irregular heart rate, high blood pressure, sensitivity to light, weakness and blackening of vision field.

Severe pain starting at location of shot, spreading through entire arm over course of 30 minutes, then through rest of body over the next 30 minutes. Severe period like cramps on right side of abdomen, naseua, severe eye pain in left eye, trouble focusing, head pain, trouble sleeping, dizziness, all lasting until 1 pm next day after several hours of sleep.

Patient's received first dose of Moderna vaccine on 04/27/2021 (lot # 039B21). Pfizer vaccine was administered for second dose on 06/12/2021. Error was reported to patient immediately. She reported no adverse symptoms after learning this. Patient returned to mobile clinic escorted by fellow workers after an hour and reported having a head ache and blurry vision. Vital signs were taken 142/87BP; 72 HR; 99% O2 sat. She denied rash, pruritus, difficulty breathing, n/v. She did not want to be seen at the ED and stated she was going to be alright. Patient returned to mobile site at 3p reporting h/a and nausea. Patient vomited and asked for an ice pack for her head. Patient reported that she has hypothyroidism and has not taken her medication for almost 1 year. Additionally, she reports a history of anxiety and PTSD. Again Patient denied to be seen at the ED. Patient was encouraged to be seen at the ED if her condition worsen.

PATIENT STATES THAT STARTING THE DAY OF OR DAY AFTER VACCINATION, ALL PROTEIN STARTED TO SMELL LIKE "ROTTING FLESH". PATIENT STATES THAT FOUL SMELLS HAVE CONTINUED & WORSENED. NOW OATMEAL ALSO SMELLS FOUL AND COFFEE SMELLS LIKE "OILY FRIED CHICKEN". PT HAS BEEN DIAGNOSED WITH COVID-19 TWICE (IN MARCH 2020 AND FEBURARY 2021) BUT DENIES LOSS/CHANGE OF SMELL FOLLOWING THOSE DIAGNOSES.

Systemic: SEE BELOW-Medium, Additional Details: PATIENT REPORTED FOUL ODORS STARTING THE DAY OF VACCINATION. PATIENT STATES THAT PROTEIN SMELLS LIKE "ROTTING FLESH". SHE STATES THAT OATMEAL ALSO SMELLS FOUL AND THAT COFFEE SMELLS LIKE "OILY FRIED CHICKEN". **THIS HAS ALREADY BEEN REPORTED VIA THE TRADITIONAL VAERS SITE**

Sat down to wait for 15 minutes like they usually ask after a new vaccine, thought I felt fine then next thing I know the pharmacist is waking me up telling me I went unconscious and I?m puking. I don?t remember where I am or what happened while this was happening, then my whole body goes numb and my vision goes extremely blurry and my chest is tight, then apparently I pass out again because I have EMTs waking me up after. My bp dropped extremely low, my chest and throat was tight, it was hard to breathe, my tongue felt weird, I was anxious, could hardly see for a while and it was hard to hear. I was so out of it for a while it was hard to talk. EMTs took me to the hospital. Was released that evening, but had continuing dizziness, body numbness, chest pain etc for several days before it got better. (Doctor at ER said he couldn?t fully say if it was an allergic reaction because it?s so new he didn?t have that information, but the paperwork I have from the Walgreens RX lists Several of the events I experienced as allergic reactions)

Loss of taste and smell; Loss of taste and smell; sinus congestion; fever; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received first dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EWO176, Expiration date: unknown), via unspecified route, administered in left arm on 08Jun2021 at 11:20 am (at the age of 21-year-old) as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No other vaccine taken within in 4 weeks. On 08Jun2021, after the vaccination, the patient experienced fever and chills at night and headache in the afternoon. And later, 10Jun2021 patient experienced Loss of taste and smell and Sinus congestion in the evening. She explained she experienced some of the side effects, on her information sheet, but she is also experiencing sinus congestion along with taste and smell loss. She states that it has already been a week and, clarified her fever, chills and headache, only lasted a few days. She asks, why did she lose her taste and smell, in the first place and when will they return to normal and they were not side effects that were included on her information sheet and asked whether are they normal side effects to have. The outcome of the events pyrexia, chills and headache was recovered on 08Jun2021 and sinus congestion and loss of smell and taste was not recovered or resolved. No follow-up attempts possible. No further information expected.

not feeling well; viral meningitis; fatty liver; pre-diabetes; weak; pale; couldn't get up; runny nose; congestion; ear infection; Illness; Headache, like someone is poking her head repeatedly, after first vaccine; This is a spontaneous report from a contactable consumer. A 21-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0179), via an unspecified route of administration, administered in right arm on 28Apr2021(at the age of 21-year-old) as single dose for covid-19 immunization. Medical history included ongoing viral meningitis (as her older sister had Viral Meningitis), diabetic, Covid-19 from Oct2020 to Dec2020, ongoing food allergies and medication allergies. Concomitant medications included caffeine/codeine phosphate/paracetamol (TYLENOL WITH CODEIN #3) for an unspecified indication from 18May2021 to 20May2021; paracetamol (TYLENOL EXTRA STRENGTH) for headache from 14May2021 to 17May2021. No additional vaccines administered on same date of the Pfizer suspect. On 08May2021 19:00 the patient experienced headache, like someone is poking her head repeatedly, after first vaccine. On 09May2021 the patient experienced ear infection. On 17May2021 the patient experienced weak, pale, couldn't get up, runny nose, congestion. The patient missed second dose, scheduled for 21May2021. On 22May2021 the patient experienced viral meningitis, fatty liver, pre-diabetes and illness. On an unspecified date the patient experienced not feeling well. The patient was hospitalized for events from 18May2021 to 31May2021 except headache and illness. The patient underwent lab tests and procedures which included lumbar puncture: viral meningitis on 19May2021. Therapeutic measures were taken as a result of ear infection. The outcome of events not feeling well, viral meningitis, fatty liver, pre-diabetic and illness was unknown while the outcome of rest all event was recovering. No follow-up attempts are possible. No further information is expected.

Ophthalmology consult was subsequently obtained with diagnosis of acute optic neuritis. First dose of Pfizer Covid vaccine on 4/22/2021 with onset of symptoms approximately 2 to 3 weeks thereafter. Bilateral vision loss 2/2 optic neuritis that is new. Initially involving only the right eye, transient improvement with Solu-Medrol approximately 1 month prior to admission, but with recurrence and later with development of vision loss in the left eye as well for approximately 1 week prior to admission. Unclear etiology. MS felt less likely with negative oligoclonal bands, NMO antibody negative, though per neuro, still potential for neuromyelitis optica, MOG 1:40. Also consideration that may be a complication of having received COVID-19 vaccine, though relationship remains unclear. 2-3 weeks prior to symptoms patient received vaccine. Short time after was also diagnosed with Mono and UTI. Got IV methylprednisolone of 1 g daily x4 doses without significant improvement. Then required total plasma exchange over 2 weeks, resulted in mild symptom improvement. CDC reports optic neuritis may be related to vaccinations in general (52.4% of cases within 8 weeks of vaccination). No evidence for COVID vaccines at this time. Added Pfizer vaccine to allergy list per neuro recommendations.

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient's mother was with her at time of vaccine administration. A few minutes later she stated her daughter was not feeling well. Patient was confused, stated she was unable to see at that time &dizzy. Then the patient lost conciousness and was unresponsive. 911 was called and epinephrine was administered due to concern for anaphylaxis. Patient regained consciousness and was responsive to questions. EMTs &police arrived, evaluated her & recommened she go to ER. Mom was going to take her to ER

Patient was sitting in chair and head tilted back with eyes rolling back in head. Head started to tilt forward and shaking of arms and legs happened. Shaking lasted for around 3 seconds and stopped. Once done shaking, the patient became highly alert with wide eyes )as if she was unconscious). Lost color in face and lips. Took pulse of patient and was slightly elevated around 70bpm (however, could be normal for her). Placed cold pack on back of neck. Patient was able to talk and was responsive. I had water available for her if she needed.

She stopped breathing; She like passed out but her eyes were still open; her vision started to go; Her vision start to get blurry; She started getting very hot; her vision started to go; Her vision start to get blurry; This is a spontaneous report from a contactable consumer. This consumer reported for a 21-years-old female patient. A 21-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EY0196 and Expiry date was not reported) dose 1 via an unspecified route of administration in Left arm on an unspecified date (21-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history was none. The patient was healthy. Concomitant Medication used for Just birth control (drug name not clarified). On unspecified, same day of vaccination the patient started getting very hot, has stopped breathing, like passed out but her eyes were still open, her vision started to go, her vision start to get blurry. The reporter stated that On unspecified date after 10, 5 minutes when it happened a pharmacy tech did gave her the EpiPen (treatment) because that's how we found out of it she was not with it, she was passed out, she stopped completely. she took the vaccine and they were sitting there you know to wait to make sure she didn't have reactions she started getting very hot. She poured water on herself because she was so hot then her vision started to go and her vision start to get blurry and the patient called the reporter to come stand by her when reporter walked over there she like passed out but her eyes were still open and she was calling my name looking at me but she was looking at me but she wasn't there, she was like looking straight through me. She stopped breathing, it was a horrible experience." The reporter stated that the patient had had a severe reaction after first dose. The reporter stated that She supposed to receive 2nd dose, its the 23rd but she is not getting it. The Reporter stated, "Yes, I would like to speak with somebody in regards to what she went through and what might affect if anything else is going to happened to her." Reporter stated, "So, when I call, I will speak to a medical professional and they'll have this information to discuss it with me and help me you know, because I mean, I wanna know, what I need to pay attention to if she is gonna have more other side effects from this or what." No laboratory tests. The outcome of the events was unknown. Follow-Up: Follow-up attempts are completed. No further information is expected.

Sx onset: 7/12/21 cough, runny nose, sore throat, fever, headache, loss of smell & loss of taste. Tested for COVID-19 on 7/15/21 which returned as positive.

Sx onset: 7/12/21 cough, runny nose, sore throat, fever, headache, loss of smell & loss of taste. Tested on 7/15 for COVID-19 which was positive.

My heart beat gets really slow to where it feels like I?m panicking and can?t breathe correctly. My vision will also get fuzzy. My period didn?t come for two months.

Sx 7/22/21 cough, nasal congestion, fever, headache & loss of smell. Traveled 7/20 to 7/22 Tested on 7/25/21 which resulted as positive.

Sx 7/22/21 cough, nasal congestion, fever, headache & loss of smell. Traveled via airplane 7/20 to 7/22 Tested on 7/25/21 which resulted as positive.

Double vision and couldn't focus; Slept for over 30 hours; Bad arm pain; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6208 6/21) via an unspecified route of administration in the left arm on 13Mar2021 at 15:00 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included bipolar 2, obsessive-compulsive disorder (OCD), anxiety, depression, sensory processing disorder and insomnia. The patient had no allergies to medications, food, or other products. Concomitant medications included doxepin (MANUFACTURER UNKNOWN), venlafaxine hydrochloride (EFFEXOR), gabapentin (MANUFACTURER UNKNOWN), eszopiclone (LUNESTA) started on an unknown date and was taking for close to an year with no issues for sleep, omeprazole (MANUFACTURER UNKNOWN) and patient had been on unspecified sleep medication for 7 years. 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. Since the vaccination, the patient had not been tested for COVID-19. On 14Mar2021, the patient had some bad arm pain. Starting on 15Mar2021 at 04:00 and also on 16Mar2021, the patient slept for over 30 hours and those were her days off. On 16Mar2021, when she did manage to stay awake for 6 hours she had double vision and could not focus. She had to take off on 17Mar2021 as well. The patient stated it was real worrying thing. On 30Mar2021, the patient slept for 18 straight hours, woke up showered and still felt asleep again after only being awake for 3 hours. No one seemed to have any information and the patient was pretty sure when she would go to sleep on the day of report at night, she would sleep for 20 hours again as that was her day off. The patient had never slept for more than 12 hours before. The patient stated that she had been on sleep medication for 7 years and eszopiclone cannot be blamed as she had no issues with it. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. The clinical outcome of the events bad pain in arm, slept for over 30 hours and double vision/couldn't focus were not resolved. No follow-up attempts are needed. No further information is expected.

Patient was monitored 15 minutes after giving 1st COVID vaccine. Once she returned to the worksite approximately 30 minutes after her vaccine was given, she experienced some flushing and severe sweating. Patient was taken to the nearest ED on 12-31-20 @ 5:00pm and per patient stated that ED doctor said it could be a reaction to the COVID vaccine. On 1-1-21, patient started experiencing low grade fever, body aches and a major headache. Patient was told she can take Tylenol OTC to help with this. Patient stated on 1-2-21, she started experiencing sore throat and a metallic taste in her mouth. Patient was told she needed to go see her doctor as soon as she could to follow up with this. On 1-3-21, patient still complained of sore throat and lower back pain. Patient was advised to go to nearest Urgent care if possible. Patient stated that she was going to go to a local urgent care today and she was told to follow up with Public Health after she was seen at the urgent care.

Swelling and sensitivity around eyes. Eczema flare up around eyes. Mild dizziness and general malaise.

On 12/30/2020 I received my 1st dose of Pfizer vaccine. Felt fine, no symptoms or side effects until 12/31/2020 I did get hives on my arm site where I received the vaccine and those hives then started to spread throughout my body. I started having hives and rashes all over for a total of 6 days . Itching, swelling on my ears, arm, wrist, hands, back etc... took Benadryl for the 6 days and it helped for the 1st 2 days of my adverse event after that the Benadryl did nothing. Me and my PCP has agreed it was a possible delayed allergic reaction to the vaccine.

The evening of receiving the vaccine she experienced itching eyes. The next morning her rt eye was swollen and she had red spots on face and forehead. Her arm was swollen and she experienced a knot at the injection site.

Patient was monitored for 15 minutes. After the 15 minutes she stated that she felt itching in her tongue and throat. Patient described it as a "skin peeling" feeling on her tongue and throat. Patient was observed for 30 total minutes, took a Claritin, had something to eat and felt much better.

14:16 COVID vaccine given IM in right deltoid 14:34 Patient states she isn't feeling well, nauseated, pain at injection site 4/10 on pain scale, itching to right arm. VSS 98% on RA, 86 pulse, 131/82 BP, 98.8 temp. BAND AID removed. 14:34 50mg BENADRYL given lot 202906 exp 9/20/23. Sitting in chair with fan. Noted that Pt was drinking a Bang energy drink with 300mg caffeine 1/4 gone. 14:45 c/o pain in right upper abdomen/lower right rib pain with breathing, "trouble breathing- hard to take deep breaths d/t this pain, a little throat pain, 14:49 Dr called/updated orders Tylenol 1000mg PO now. 14:56 Tylenol 1000mg given PO with water, c/o dry mouth, throat "tight", Right arm where injection given- c/o pain 8/10 on pain scale. 98.8temp, 126/83 bp, 100% sa O2 on RA, states not feeling well. 15:02 bilateral lower legs beefy red, capillary refill >8 seconds, pulses present states her feet are tingling. 15:00 Pt states she doesn't feel well and asks to go to the ER to be evaluated. 15:05 Ambulance dispatched. 15:15 Ambulance arrived and assessed Pt and at 15:21 Pt left the facility per ambulance stretcher accompanied by EMT's x2

1416 covid vaccine given IM in right deltoid 1434 patient states she isn't feeling well, nauseated, pain at injection site 4/10 on pain scale, itching to right arm. VSS 98% on RA, 86 pulse, 131/82 BP, 98.8 temp. Band-Aid removed. 1434 50mg Benadryl given lot 202906 exp 9/20/23. Sitting in chair with fan. Noted that patient was drinking a energy drink with 300mg caffeine 1/4 gone. 1445 c/o pain in right upper abdomen/lower right rib pain with breathing, "trouble breathing- hard to take deep breaths d/t this pain, a little throat pain, 1449 Dr called/updated orders Tylenol 1000mg PO now. 1456 Tylenol 1000mg given PO with water, c/o dry mouth, throat "tight", Right arm where injection given- c/o pain 8/10 on pain scale. 98.8temp, 126/83 bp, 100% saO2 on RA, states not feeling well. 1502 bilateral lower legs beefy red, capillary refill >8 seconds, pulses present states her feet are tingling. 1500 patient states she doesn't feel well and asks to go to the ER to be evaluated. 1505 99 called and ambulance dispatched 1515 ambulance arrived and assessed patient and at 1521 patient left the facility per ambulance stretcher accompanied by EMT's x2

within 15', developed tongue swelling, dizziness, palpitations. Transferred to ED & treated with steroids, Benadryl, Pepcid. Observed in ED for 6 hrs, then d/c to home 7 will f/u with PCP re: EKG changes

Customer rec'd first dose of COVID-19 vaccine approximately 18:07 and transferred to post vaccine observation. At 18:20 customer reports feeling nauseated with rapid onset occipital headache radiating into eyes at 7/10. She reports feeling "sweaty" and is flushed in appearance. Customer moved to ante room, closer to emergency supplies. Customer denies feeling SOB, difficulty breathing or tongue/throat swelling. O2 sat monitor not reading to due nail polish. BP 160/105, HR 88 (RRR) R 20 (unlabored). Lungs CTA. History of hypertension when pregnant but does not take medications at this time. History of kidney stones and "stuff." Customer accepts BENADRYL 50mg PO at 18:28. Customer monitored at site. Customer downplays symptoms and is a difficult historian. Does not wish to lay down. States "I'll be fine" and wishes to drive home to lay down. Customer given snack and water. Reports ongoing nausea with blurry eyes. Continues to rub her neck and shrug her shoulders up and appears quite uncomfortable. She reports history of significant nausea post flu shot which resolved within a couple of hours. Denies history of migraines. Denies known allergies and has never been given epinephrine. She denies taking any medications prior to receiving this vaccine. Reports heaviness in eyes and photophobia. TYLENOL 1000mg PO given at 19:00. Customer again begins flushing, feeling nauseated and diaphoretic. Admits to her symptoms worsening. She reports feeling like she wants to pass out and throw up. Continues to deny respiratory symptoms. BP 135/78, HR 86, RR 18. Denies decrease in headache "feels like I can't even hold my head up. It hurts so bad." She becomes tearful and is agreeable to transfer to ED for further work up and evaluation. Customer gives verbal consent to share medical information with mother, who is given ED phone number for follow up. Customer escorted via wheelchair by RN staff member. Handoff report given to, ED physician. Customer is aware that this information will be shared with her PCP Team for follow up. Recommend consult prior to next vaccine appointment to discuss post vaccine course and discuss risks/benefits and/or pre-treatments prior to next vaccine.

A day after the vaccine I got red hives all over my thighs that eventually went away 2 days later. The day after this subsided I started to get extremely itchy rashes on my neck that would come and go. This has continued to occur. Exactly one week after the vaccine was given my lips began to swell up and become numb, again this went away with time.

Shortly after receiving vaccine started feeling foggy. upper lip began to tingle, felt numb, and starting swelling. Started having palpitation and having shortness of breath.

Tingling hands and lips, flushed skin, "feeling hot", increased blood pressure. Had to take 50 mg of Benadryl at facility, then 50 mg of Benadryl before bed due to hands still tingling. Blood pressure returned to normal after the initial dose of Benadryl. Symptoms were resolved the following day.

Complaints of feeling dizzy/light headed, scratchy throat, chest tightness and a rash on her neck. Pulse ox on RA 99%. Facility Nurse sat with her for 1.5 hours and then she returned to work. Was seen by doctor but not an official office visit.

1135 - (L) ear ringing it migrate to (L) neck. V/S BP-116/70, HR-76, O2Sat-97% on RA, R-18 1142 - Diziness and middle back pain start hurting. V/S BP-110/68, HR-75, O2Sat-96%, R-15 1150 - pt. continue to have symptoms, escort to ER.

Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Systemic: Fainting-Mild, Systemic: Visual disturbance ("blue spots," "dark visual waves")

I woke up this morning with a very severe right dry eye. It was not responding to water or eye drops which is the first time that has ever happened to me. After several eye drops, I was able to drive to work where I was fine except for the eye pain until 10am. Then I started getting body aches, light-headedness and weakness. On the drive home (40 minutes), I developed a fever and the body aches worsened. If I do not consume liquid continuously, I get very light-headed and weak.

Stiff joints, fever, body aches, severe fatigue, loss of appetite, headache, increased thirst, muscle weakness

Shortly after the vaccine she had a rash that improved with Benedryl. The day after she received the vaccine she began having a rash, itching, swollen tongue, dry mouth and throat tightness. She went to the ED and received a course of steroids.

Patient is a registered nurse at facility. She reported having slight itchy lips and scratchy throat after 1st dose. Patient very much wanted full protection that 2nd dose offers in order to be safe and keep family members safe. We discussed the possibility of an increased reaction, but she wanted to go ahead and felt the benefits outweighed the risk. I considered the fact that she is a health care professional, was fully informed and that we were at a skilled nursing facility and were prepared in case she had any reaction. About 10 minutes after vaccination she seemed to be coughing and felt like her throat was maybe swelling. She seemed to be breathing ok, but I asked her to take a Benadryl, which she did. Within 5-10 minutes after that she began shaking and seemed very pale. She said her symptoms were getting worse. I told her I was going to administer an epi-pen dose. 911 was called, I administered the epipen, we had heart rate monitor and pulse ox monitor on patient and she was stable, but scared. EMT's arrived and transported patient to ER. She was later released with Benadryl.

Swollen tonsils; Neck stiffness; Congestion; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3246, expiration date: Apr2021), via an unspecified route of administration on 14Jan2021 at single dose for covid-19 immunization. There were no medical history or concomitant medications. The patient experienced swollen tonsils, neck stiffness, and congestion on 15Jan2021. Event details: The patient got the shot yesterday and when she woke up this morning her tonsils were swollen. She had neck stiffness, her neck was stiff, forearms, a lot of congestion. The outcome of the events was unknown.

Presented with extreme chills at first (9 hours after shot), then fatigue, lightheadedness, brief burning at injection site, and nausea. When standing up, burning feeling occurred in the head and ears. Symptom severity lessened 24 hours after the injection.

headache, body aches (shooting pains in ear, lower back, top of head), low grade fever (100.0) for 3-4 hours, fatigue

Since the day of the vaccine, I have had a change in taste. Whenever I eat meat or anything savory, it tastes like gasoline. Some other things taste funny too. It began with my toothpaste, so I just thought it was a bad tube. After buying a new brand of toothpaste, I discovered that it was my tastebuds that were off. Toothpaste and anything minty or savory I once loved eating now tastes like gasoline smells. Once loved smells from cooking food are also unbearable now. Most sweet foods still taste the same, though and are good.

On the night that I received dose 1 of my vaccination, I consumed 4 alcoholic beverages over 3 hours. After 3 hours, I threw up, lost my ability to walk on my own, and briefly lost my vision (5 seconds). I drink socially about 1x per month, sometimes consuming many more drinks than I consumed on this particular night. Never before did I encounter these effects from alcohol when consuming 1-1.5 drinks per hour. The next day I felt very tired, sluggish, and run down all day long.

swollen eyes; a rash on her forehead , around her eyes and both cheeks; very itchy eyes; This is a spontaneous report from a contactable Nurse (patient's mother). A 22-year-old female patient received the first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration on 06Jan2021 17:30 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Nurse stated her daughter received her first Pfizer vaccine on 06Jan2021 around 5:30 pm. The patient's signs and symptoms began shortly after receiving the shot. That evening at 19:00, she had very itchy eyes, the next morning (07Jan2021) she woke up with swollen eyes, a rash on her forehead, around her eyes and both cheeks. She took benedryl and zyrtec on 07Jan2021. The symptoms clear up by 10Jan2021, following a visit to her HCP, on 08Jan2021. She received a steroid shot, a prednisone dose pack her HCP. Her HCP recommended she not take dose 2 and instructed her mother to call Pfizer for recommendations. The outcome of the events was recovered on 10Jan2021. The reporting nurse considered the case as non-serious. Information on the lot/batch number has been requested.; Sender's Comments: The reported events of swollen eyes, itching eyes and rash on face were likely related to first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), due to plausible temporal relationship. 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.

lost her smell; extremely tired; bad headache; congestion/ felt like a really bad sinus infection; felt like a really bad sinus infection; This is a spontaneous report from a contactable healthcare professional (HCP, patient herself). A 22-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL1283, expiration date was unknown), via an unspecified route of administration on the left arm on 21Jan2021 at 19:15 at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was reported as the hospital. The patient had no medical history; she had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On Monday, 25Jan2021 at 04:00, the patient woke up with a bad headache and congestion and it worsened up until Tuesday. It felt like a really bad sinus infection. Then on Tuesday night, 26Jan2021, the patient lost her smell and she was also extremely tired. The reporter assessed the events as non-serious. The patient did not receive any treatment for the adverse events. The patient was not recovered from all the events.

I received my second dose of the COVID vaccine around 12:30 pm. At around 4:00 pm, I noticed that my lips were slightly swollen. I went and bought liquid Benadryl. At around 5:45 pm, I took 20ml of the liquid Benadryl. I proceeded to sleep the rest of the night. I woke up around 8:20 am the next morning and noticed that my lips were significantly more swollen. I took 20ml more of the liquid Benadryl and noticed that my tongue was a little swollen as well. At around 9:40 am, I took 20ml more of liquid Benadryl. I noticed no change in my swelling and my throat started to feel like there was a lump. At around 10:20 am, I drove to the emergency room. The doctor noticed swelling in my lips and some in my tongue and throat. I was given cimetidine and methylprednisolone through an IV, which reduced the swelling. I was discharged 2 hours later after the swelling went down and was given 2 prescriptions to take the next 4 days, which were prednisone 20mg (three tablets once a day) and famotidine 20mg (twice a day). There is some swelling in my lips in the morning (for the last two days) until I take the steroids, then it reduces the swelling. The overall cost of the emergency room visit was $1669.17.

Soreness at injection site; headache; fatigue; slightly swollen tonsils; This is a spontaneous report from a contactable consumer. A 22-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot EL3247, expiry date not reported), via an unspecified route of administration on 26Jan2021 09:00 at a single dose in the left arm for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of the vaccination. The patient had no covid prior to vaccination. Concomitant medication included loratadine and unspecified hormonal birth control. The patient had no other vaccine in four weeks. On 27Dec2021 06:00 AM, the patient experienced soreness at injection site, headache, fatigue, and slightly swollen tonsils. No treatments received in response to the events reported. The patient was not tested for covid post vaccination. The outcome of the events soreness at injection site, headache, fatigue, and slightly swollen tonsils was recovering.

Fever of 102 and dehydration contributed to a syncope collapse early the morning after vaccination (7:15 AM 02/20/21). Just before collapsing, I experienced nausea, dizziness, confusion, weakness, and seeing all black in my field of vision. Emergency Room doctors say it was very likely related to an adverse reaction to the second Pfizer Covid vaccination. Treatment included Tylenol and Ibuprofen, rest, and fluids.

Onset: Started 7:30 pm, had vaccine at 4 pm. Occurrence: acute. Symptoms: Dizziness, blurry vision - both eyes, headache, muscle aches, nausea. Patient then went to the Emergency Department - presents to the ED with a chief complaint of a headache that began today. The patient had her COVID-19 vaccine today around 1600 and began experiencing multiple side effects afterward. The worst symptoms for her are the headache and body aches. Her other symptoms include dizziness, blurred vision, nausea, weakness, and muscle soreness in the left arm where the shot. Eyes: Positive for visual disturbance. Gastrointestinal: Positive for nausea. Musculoskeletal: Positive for muscle pain. Neurological: Positive for headaches, dizziness and weakness DIAGNOSIS at time of disposition: 1. Adverse effect of vaccine, initial encounter Acute patient signs symptoms are consistent with an adverse reaction of COVID-19 vaccine. Patient is experiencing the immune response mediated by the vaccine. She is hemodynamically stable, nontoxic, afebrile, well-appearing. She is not taking any medication for symptoms. She is given oral meclizine here in the emergency department for dizziness and nausea. She is given a prescription for this to use at home in addition to Tylenol or Motrin. Patient was instructed to follow up with primary care provider for ongoing evaluation and treatment of current symptoms. Patient was instructed to return to the emergency department for new or worsening symptoms. Patient understood the results, agreed with the plan, and was discharged home in stable condition.

patient presented with lightheadness and pressure in ears approximately 10 minutes after administration of vaccine.

Woke up in the middle of the night to use the bathroom and I couldn?t see properly; my vision looked like black splotches. I felt faint and dizzy and couldn?t see my bed to lay down. After laying down, my head and body was tingling. I was sweating but felt cold. I took 2 hydroxyzine and fell asleep. I woke up fine but with body aches. The body aches continued through the day but I took acetaminophen and the body aches went away.

right left eye appears normal. the skin around the eyes is erythema and edematous more on right than left No frank nasal or ear discharge.

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient noted an anaphylactic response to hepatitis b as a baby. Was counseled to wait 30 minutes in pharmacy to be monitored after receiving a vaccine. Around 25 minutes later patient approached pharmacist stating felt tongue tingling. Patient drank some water stated she felt better but in next two minutes noted her throat felt obstructed. Technician called 911. Paramedics arrived within 3 minutes. No epipen was given. Paramedics and immunizing pharmacist both mentioned possible anxiety attack

I had tested positive with covid in the ending of December after the holidays. With that I lost my sense of taste and smell. Fast foward, on Monday Feb. 22nd I received the second dose to the covid vaccine, on Friday I was eating tacos and I got this taste in my mouth and my stomach was bothering me I believe from the tacos beings bad (2 other people got sick too) but the taste lingers, The next morning I cook breakfast and lunch and I can smell this smell that I taste as well. It is not March 4th, 1 day shy of it being a week and I am still experiencing this. I can not taste any food flavor except this taste that I have, it has replaced all food flavors and smells. Whenever I cook something I can smell the scent I taste (only when Its food or Im cooking, I can smell my coconut lotion and body spray just fine). I do not know how to describe it I started describing it as it being an old grease taste but it could be a metallic taste I am not sure, all I know it is a very unpleasant taste. Whenever I brush my teeth, immediately when I put the toothpaste in my mouth i immediately taste the taste again its like it almost heightens it. The taste lingers in my mouth after that as well. I do have to say that I tried a chocolate covered pretzels and m&m's and notices that I can taste sweet stuff but immediately get the taste when I eat regular foods thats are not sweet. I tried to eat waffles one time and the syrup taste was fine but I could not eat sausage because of the taste. This is very frustrating because its disgusting that I would rather not taste anything at all. I am unsure if my taste was ever fully back after having covid I was able to start tasting things but not sure if it was 100% as well as I could smell somethings but not sure if that was 100%. I talked to some people who thought maybe it is my senses trying to fully come back because they heard about people experiencing weird smells when their senses were coming back but I am unsure I just want to not deal with this anymore. I think its weird it came 3 days after the vaccine and that I can not taste food other than this taste.

I tested positive for COVID on March 2, 2021 after having all of the symptoms. I had a body rash, no taste or smell, muscle aches, diarrhea, cough, shortness of breath.

Immediately after injection I had itching down my right arm and three bright red stripes underneath injection site appeared. In the following 10 to 15 minutes my lips started tingling and my throat started to tighten up. The itching finally stopped after 10 minutes. The tingling in my lips and throat tightening occurred with both the first and second dose. The staff kept me for around 45-50 minutes for both doses of the vaccine. When going home I took 2 Benadryl.

I received the vaccine at 4:30 PM and later that night, I had a headache and I felt very out of it. By the end of the day; however, I was feeling better. The next day, I woke up around 5 AM and my muscles were all tensing very strongly and I could not stop shaking. This went on for about 30 minutes, and then I stopped shaking and tensing so much, though my muscles still felt a bit tense. I can't really eat in the morning, so I drank two glasses of water over the course of a few hours and took 2 acetaminophen. I stayed in bed until around 10 AM. Then, I took a shower, but while taking it, I felt very lightheaded and my vision had some black spots, and I had to sit down several times. After I got out, I tried to eat something, but then I felt really nauseous and had acid reflux for at least 30 minutes. Afterwards, I drank a bit of water and went back to bed. My muscles started tensing and shaking again, though not quite as intensely as when I first woke up. I felt very cold, so I turned up the heat and put on warm clothes. I fell asleep for about 20 minutes around 12, and when I woke up I felt a little less nauseous and headache-y. I stayed in bed for an hour, and I ate some pudding over the course of an hour or two, but I thinking about eating much else made me feel nauseous. I fell asleep around 5:30 and woke up again around 7:30. I felt better after waking up, but still had a bit of a headache and my muscles were slightly tense. On Sunday and Monday (today) I felt about the same, physically tired but otherwise mostly ok.

I lost my sense of smell and a little bit of sense of taste. I could have a whole cap of lemon juice and it tasted sweet. This lasted about 5 days and slowly got better. My taste would be ok in the morning then would go away again in the afternoon. I had two telehealth visit and they had me tested for COVID, I tested negative. I tested again a few days later and was negative again. My Doctor said it was most likely a viral infection.

Wednesday during the day I noticed a scratchy feeling towards the back of my tongue that I thought was seasonal allergies. Then in the evening, the feeling was more significant and I noticed red bumps on the back of my tongue and inflammation around that area. Woke up Thursday (today) morning with a sore/tender throat and the throat is red and imflamed.

Ear pain/pressure, headache, and body aches started on 3/11 around 7pm. Around 11am on 3/11 through the end of the day I was having waves of feeling very hot. No fever. Body aches, ear pressure, and fatigue on 3/12 with radiating left arm pain which stopped. Radiating arm/shoulder pain came back on 3/13 around 12:45PM.

Shortly after receiving the vaccine, patient started to feel a warm sensation start from her feet and move up her legs up her boday and she started to feel flushed and lightheaded, and was warm and had a tingling feeling in her throat. She denied any feelings of SOB or that her throat was getting thick or that she could not swallow, her lungs were CTA. She was removed from the vaccine cell and taken to the observation area. Vital signs on arrival were 176/110, she was placed on a litter and history obtained. She was assessed and continued to be observed with sequential vital signs. She denied any tunnel vision, and nausea or any bowel or bladder urgency. Her f/u vital signs were 132/95, HR 85, and 100% O2 on room air. Patient was given water, and was observed for a total of 40 minutes. Final vital signs were 108/72. Patient stated that her symptoms resolved, her cheeks were flushed, her throat tingling was gone, and she stated that she felt better. Patient was able to ambulate off of the site.

*TIME OF WRITING IS THE 7th DAY* Onset of incredible fatigue 30 minutes post-vaccination lasting 5 days Fever ranging from 99.6 to 102 which began 5 hours after vaccination and has lasted 7 days post-vaccination Nausea 5 days post-vaccination Headache 7 days post-vaccination Severe arm pain 3 days post-vaccination Eye pain 3 days post-vaccination Intense sweating 7 days post-vaccination Chills 7 days post-vaccination Labored breathing 2nd and 3rd day post-vaccination Significant face swelling 2nd day post-vaccination Decreased mental status 6 days post-vaccination All lymph nodes in neck hard and swollen 7+ days Aggravation of pre-existing sleep paralysis day of vaccination Severe throat pain in the morning, red bumps in back of throat, white pus on tonsils which has worsened and began 1 day after vaccination (antibiotics were prescribed and condition continues to worsen, no one with whom I have been in close contact with has been sick - e.g. boyfriend I kissed the day before vaccine, toddlers I babysat morning before vaccine) - followed eventually by mild cough and congestion

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild

Client felt lightheaded when asked how she was feeling. She was immediately advised to put her vehicle in park. Client started seizing and nurse was called over. Her eyes were rolling and her muscles were tightening up. ALS called over. Client regained consciousness but was confused. Fire Dpt. and ambulance was called as well. PT moved to stretcher. While being moved, car seat was noted to be wet. ALS took PT to ambulance, patient transported to local hospital.

Patient received Covid-19 Vaccine today, 03/24/2021. During the 15 minute post-vaccine observation period, the patient began to feel faint. Her condition worsened to feeling nauseous and blurred vision, so patient asked to lie down. We found a quiet area in the employee break room for the patient to lay down. and provided her a pillow, water, cool compress for her head, and later, orange juice for her comfort. We proceeded to call 911 for medical attention. EMS professionals evaluated patient's vital signs and patient signed waiver refusing to go to hospital, since she was feeling better. Patient left on her own accord with a friend driving her home.

Pharmacy gave wrong dosage of vaccine. I was given 0.8 ml of medication instead of 0.3ml. I have not been given the pharmacy report yet to verify dosage or details of why I was overdosed. Between the dates 02/28/2021 - 03/23/2021, I have been feverish, nauseous, tired, headache, chills, diarrhea, pain and swelling at injection site that last 24 days. Ear pain in both ears. Left arm pain from shoulder to elbow for 24 days. Muscle pain. Left leg pain. Treated with prednisone 20mg.

Rash starting at 8am on 3/26/21 at her feet and ankles bilaterally, itching and painful, spread to face and elbows. Lips began to swell and become painful at 1pm on 3/26/21. Pt treated with diphenhydramine 50mg and epinephrine 0.3mg. Her rash and lip swelling improved starting 10 minutes following these medications. She was monitored for 1.5hrs and at time of discharge her rash was 80% improved and lips were no longer swollen. Pt did not have throat tightening, shortness of breath or dyspnea. She was given epinephrine for signs and symptoms of angioedema.

Brief loss of vision; Faint; Short of breath; Palpitations; This is a spontaneous report from a contactable other health professional. A 22-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), intramuscular in arm left, on 11Mar2021 at 13:00 (Lot Number EN6207), as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient did not have COVID-19 prior to vaccination. The patient experienced brief loss of vision (medically significant) on 11Mar2021 at 13:00 with outcome of unknown, faint (medically significant) on 11Mar2021 at 13:00 with outcome of unknown, short of breath (non-serious) on 11Mar2021 at 13:00 with outcome of unknown, palpitations (non-serious) on 11Mar2021 at 13:00 with outcome of unknown. Therapeutic measures were taken as a result of the events. It was reported that the events were evaluated and advanced life support (ALS) transported the patient to the emergency department (ED). It was unknown if patient was tested for COVID-19 post vaccination. Follow-up attempts are completed. No further information is expected.; Sender's Comments: The possibility that suspect drug may have contributed to the reported events cannot be excluded. 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.

16:13- Patient complaint of flushing, hot, Tingling tongue, itchy fingers. Vital signs within normal. Patient was placed in recumbent position and given water. Patient was sent home at 1636 with no symptoms.

I stayed for 30 mins because after my first shot my arm ended up VERY swollen and I had a rash. So I was okay after the 30 minutes but when I started driving I felt like I was high on strong drugs. Like as if I?d taken an extremely strong marajuana edible and it just hit me. I had to pull over because my eyes wouldn?t stay open, my whole body was feeling very heavy and I was extremely tired and out of it. I didn?t have another way to get home (I had traveled about an hour) so I just kept driving and taking 15 min rests along the way. When I got home I fell asleep as soon as I sat down and slept for about four hours. I feel better now that I?m awake, still light headed but not near as bad.

Patient received the vaccine and felt fine, and then walked out to the observation tent. As soon as she sat down in the observation tent she started to feel dizzy and after 30 seconds her vision started to go black. Patient then fell out of the chair, and regained consciousness after 5 seconds. Patient was then helped into a wheel chair and taken to a cot and waited 30 minutes before leaving and is having a friend pick her up.

I received the first dose of the Pfizer vaccine at 9:15 AM on March 9, 2021. I then returned to work. At about 4:30 PM on that same day, I started feeling dizzy. I felt like I was going to faint at work. Every time I would stand up, I would feel like I was going to pass out. I had someone drive me home because I felt that I was too dizzy to drive. I arrived home at 6:00 PM and began to vomit profusely. I threw up all night and had the chills. In the morning, I felt better but still had a dizzy feeling. The dizziness and vomiting completely subsided by March 11, 2021. On March 12, 2021, I noticed that I had floating black spots in my left eye accompanied by a painful migraine. I have never had eye floaters or migraines previous to this vaccine. My migraine lasted for 5 days straight and I had to be off work to go to the emergency room because I started to loose vision in my left eye. They were unsure of the cause because I did not have any pre-existing health conditions. The migraine finally subsided after the 7th day. I have had eye floaters every since I got the vaccine. I?ve been to an eye doctor and my primary and they all have told me that it could be from this vaccine because I have never had the problem until I received it.

About 10 seconds after receiving her first Pfizer Covid vaccine, she said she had trouble breathing, she mentioned her throat was tingling . She was spitting up mucous but I did not observe any labored breathing or wheezing. We immediately called 911, was read to administer an EpiPen dose, pt wanted to wait for paramedics. When the police arrived, they also did not observe any respiratory distress but offered her O2, then the proceed to take her to Hospital at the pt's request.

PATIENT REPORTED THAT DURING THE FIRST 15 MINUTES POST-VACCINATION SHE HAD TYPICAL SIDE EFFECTS (SORNESS AND REDNESS AT THE INJECTION SITE). SHE REPORTS THAT APPROXIMATELY 2 HOURS POST-VACCINATION HER ENTIRE TONGUE TURNED WHITE AND THAT IT IS STILL DISCOLORED 2 DAYS POST-VACCINATION. SHE ALSO REPORTS THAT SHE IS UNABLE TO TASTE MOST FOODS/DRINKS UNLESS THEY ARE SWEET. AT THIS TIME, I RECOMMENDED A WATCH AND WAIT APPROACH AND THAT SHE REPORT THIS TO HER PHYSICIAN. SHE DOES NOT RECALL HAVING COVID AT ANY POINT IN TIME.

C/O lip tingling/ swelling, chest tightness, tongue tingling and burning 1:12 133/85, P 94, 02-98% R18 Epi O.3 IM, experienced immediate relief 1:16 114/88 p-110 Transported by EMS to ED

At 15 min mark after receiving vaccine: sudden loss of hearing (extremely muffled, underwater sounding), profuse sweating, and then lost vision and passed out entirely when attempted to stand up for help. After laying down, quickly regained consciousness and felt better. After effects and soreness have been minimal. Have not fainted during/after vaccine before.

Arrived at pharmacy for 1:15 PM vaccine appointment. 10 minutes after vaccine injection, I could not swallow. Throat started to close and feel tight like I could not breathe. Tongue swelled and could not feel tongue while biting down. Chest compression on center chest. Around 1:30 PM I told sister to get a nurse and the nurse said due to my allergic reaction I needed to do the EpiPen. She administered properly in my thigh. About 1:35 PM, symptoms started to go away. Stayed until 1:45 PM and when I left I told the nurse I was leaving. Took 2 Benadryl pills in my car with water.

My left eye swelled shut exactly 24 hours following the shot in my left arm. It didn?t completely resolve until 48 hours after onset

developed ulcers/blisters on the back of my tongue around 40 minutes after. Doctor diagnosed as pharyngitis, negative rapid strep a test, gave iv bag, benadryl, and a steroid.

Three days after receiving the first dose of the vaccine, I woke up with a hives-like rash. This was specifically concentrated at both my elbows and both my knees. Here there were red, itchy, risen bumps about 1 cm in diameter. As you moved along the limb away from the concentrated regions, there were similar bumps smaller in size, about 1/4 cm in diameter. I also have a few bumps on my lips. The edges of my ears are also red and itchy. It has been one day since these appeared and I have taken one allergy pill, one Benadryl, and have applied hydrocortisone twice. The rash/hives have not improved or worsened as they appear visually.

delirium; aches; chills; headache; fever; sore muscle in vaccine location; head congestion; earaches; brain fog; This is a spontaneous report from a non-contactable consumer reporting for herself A 22-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8730) on 22Mar2021 at 10:00 am at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included known allergy to sulfa. The patient received first dose of vaccine on 05Mar2021 (Lot #:EN6199) at 12:00 pm, on Left arm. Concomitant medications included ethinylestradiol, norgestimate (TRI FEMYNOR) and minocycline. On 22Mar2021 at 19:00 the patient experienced aches, chills, headache, fever, sore muscle in vaccine location, head congestion, earaches, brain fog and delirium. The patient recovered from the events on an unspecified date. No follow-up attempts are possible. No further information is expected.

Patient received her covid vaccination at 1611. She presented to the observation area where RN was observing patients. She was assessed by ,RN . The pateint stated she was nervous and that she did not do good with shots. Pulse in the 80's, skin warm and dry, metalic taste . Alert and oriented x3, resp 12-18. She had become light headed and was assisted to the floor by her male friend. She was observed for 30 minutes and released in stable condition. No light headedness noted.

Warmth, dizziness, temporary loss of hearing shortly after vaccination. No nausea, diaphoresis, or tunnel vision. Near syncope prevented by lying down quickly. Typical vasovagal reaction for her. Rapid recovery with all normal vital signs. No orthostasis.

I looked in the mirror & saw my bottom right eye orbit swelled.; I had fatigue & chills the following day after i got my vaccine.; I had fatigue & chills the following day after i got my vaccine.; I took ibuprofen for the pain in my back & arm; I took ibuprofen for the pain in my back & arm; When I stared to rest, I felt pressure when opening & closing them; This is a spontaneous report from a contactable other hcp (Patient). A 22-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8737) via an unspecified route of administration at arm left on 30Mar2021 16:45 as single dose for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient medical history was not reported. Concomitant medication included vitamin d nos (VITAMIN D NOS). On 31Mar2021 The patient experienced and had fatigue and chills the following day after she got vaccine and took ibuprofen for the pain in my back & arm and when stared to rest she felt pressure when opening & closing them and looked in the mirror & saw her bottom right eye orbit was swollen and was conserved if she was having a reaction to the vaccine and called a nurse & tell a doc. They advised me to do cold compressions & take benadryl. Therapeutic measures were taken. The outcome of the events was recovered.; Sender's Comments: The causal association between the event bottom right eye orbit was swollen and the usage of the vaccine BNT162B2 cannot be excluded based on strong temporal association. As there is limited information in the case provided, the case will be reassessed once new 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.

Woke up at 3 AM with nausea so went to sit in the bathroom, alternated between feeling better and feeling just about to puke for about an hour. At about 4 AM I was going to the bathroom and then felt about to puke again. I then began to get tinnitus in both my ears and my left eye went black and I thought I was going to pass out. I laid on the bathroom floor for another 30 minutes before going back to sleep. Other symptoms that started on 4/18/21 included chills and fever which lasted until about 6 AM on 4/19/21.

About 20 minutes after injection throat and mouth started to itch. Throat and tongue swelled. Throat was red and scratchy

25mg bendryl 8:20 pm for itching tongue 25mg benadryl 8:40 pm itching tongue patient had "weird" sensation on tongue, breathing and throat were fine, no labored breathing. patient stayed for roughly 20 more min after second dose and then was taken home to father by 2 other friends. Father called and says she has epi pen and allergy medication at home as she has allergy to peanuts. he will monitor and call me back for questions. advised if any concern breathing needs to go to ER immediately.

About five to ten minutes after I received my first shot, I started to feel like my throat was closing a little. I knew it wasn?t an allergic reaction because I could still speak, but I also became very dizzy and sweaty. I stood up to go see the nurse and she took my blood pressure and it was slightly higher than normal and my heart rate was extremely elevated. I sat down on a stretcher and felt incredibly light headed and gained a metallic taste in my mouth. I also felt very nauseous and started experiencing chest pains. It felt like a panic attack but more severe and more sudden. My throat felt very tight but I could still talk, and my cheeks felt like they were on fire. My face was bright red. They gave me some water and monitored me some more and encouraged me to go to the hospital, but my symptoms subsided after about 35 minutes. After that I just felt tired and didn?t have any more symptoms.

Experienced tension headache so severe that vision was blurred and muscles in neck tensed up. To the point where tizanidine and sumatriptan did not help. Felt extremely nauseous and intense pressure in head. Blood pressure dropped and was very sweaty. Had to be transported to ER via ambulance. Vomiting occurred for several hours. Was given Tylenol, Benadryl, zofran, imotrex, Valium, and fluids via IV. Sympoms continued for 8 hrs. 12 days later symptoms are still ongoing.

minty or savory tastes like gasoline smells; This is a spontaneous report received from a contactable consumer (patient). A 22-year-old non pregnant female patient received first dose of BNT162B2 (BNT162B2, COVID 19, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration in left arm on 18Jan2021 at 03:30 PM (at the age of 22-year-old) as single dose for COVID-19 immunization. Patient medical history included dysphagia. Concomitant medication included 40mg omeprazole. There was no other vaccine in four weeks. The patient had covid prior vaccination. There was no COVID tested post vaccination. On 19Jan2021, since receiving the vaccine the patient experienced anything minty or savory tastes like gasoline smells (Dysgeusia). it was reported that "Anything sweet tastes fine still, but anything savory or minty that I once enjoyed now tastes and smells unbearable". No treatment was given for the event. The outcome of the event was not recovered. Information about Lot/Batch number has been requested.

1st reaction Time course-9:50 AM-10 :30 AM (Throat tightness and lips tingling) Doctors gave me Benadryl for symptoms @ vaccination center. 2nd reaction Time course- Around 7:00 PM (Throat tightness, nausea, abdominal pain, numbness in lips) Went to urgent care. Benadryl from earlier may have worn off.

Roughly 12 hours after the vaccine, side effects began. Started with worsened insomnia, chills, nausea, and the usual vaccine site soreness. Has grown within roughly 8 hours to include these symptoms: fatigue, dizziness, soreness, excessive thirst, headache.

Symptoms started five days after vaccine. Symptoms gradually lessened and I am now on week 4, I was bed ridden through week 3. Symptoms included my body feeling strange, visual disturbances, migraine aura (no previous history of migraines), chest pains, hot breath, temperature changes, faint feeling, fatigue, head pains all around head, pain in spinal chord, pain and numbness on entire body (mostly head), confusion, heat around nape of neck, ringing in ears, nausea, weight loss, strange breathing (not soreness)

I got the first dose of the Pfizer Covid-19 vaccine at the Medical University. Approximately 10 minutes after administration, an allergic reaction began while I was driving alone in my car. Most notably my blood pressure dropped suddenly, causing me to almost pass out. I stopped driving and my symptoms worsened. Symptoms included shaking, sweating, nausea, confusion, rapid heart rate, red blotchy face, slightly labored breathing, itching and slight swelling of my tongue and lips, anxiety. I could still breathe, so I did not seek treatment, but sat in the parking lot of a medical building for at least an hour for symptoms to subside. Symptoms were acute for about 45 minutes and gradually decreased over four hours. The rest of the day and the next day I felt extremely weak. The following six weeks I continued to have swollen, dry, painful lips every single day and a very itchy rash on my hands and wrists. Occasionally I would wake up with swelling around my eyes. I also had an unusual reaction after eating a salad where my lips swelled even more and became numb, along with an itchy mouth. These long lasting symptoms did not go away until I got a steroid cream from a dermatologist, who denied that my reactions were from the vaccine after talking to me for only five minutes. I just believe that there are many more cases of reactions to the vaccines that have not been reported.

VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:01/08/21pfizer,Lot#EL3248 2nd dose: 01/29/21Pfizer,Lot# EN5318 Diagnosed covid positive:04/23/21 Exposure:Home Exposure Symptoms:Fever, sore throat,fatigue,chills,muscle aches,runny nose,loss of smell/taste,HA

This is a spontaneous report from a non-contactable consumer (patient). A 22-year-old female patient received bnt162b2 (COVID 19 Pfizer), dose 1 via an unspecified route of administration, administered in right arm on 14Apr2021 15:00 (lot unknown, reason: misplaced/discarded) as single dose for COVID -19 immunization. Medical history included known allergies: penicillin. The patient's concomitant medications were not reported. The patient experienced complete loss of hearing in left ear. White noise sound only. Less than 24 hours after administration on 15Apr2021 with outcome of unknown. The patient is not pregnant. No treatment was given for events. The patient has not received other vaccine in four weeks. The patient was not diagnosed with covid prior vaccination has not been tested for covid post vaccination. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

The day after I got the 2nd dose I was feverish, tired, and achy all over. I also was dizzy and nauseous if I stood for more than a few minutes. At about 30hours after I got the 2nd dose, my eyes began burning and swelling. I woke up the next day with one eye nearly swollen shut, but the swelling has almost entirely gone down after 8 hours.

Itching throat,mild swollen tongue, breathing was ok, no SOB, Oxy sat 97% patient was given diphenylhydramine 25/10ml and the patient was observed for half hour

Pt complained of feeling nauseous and faint, with ringing in the ears and visual disturbances. Pt vomited. BP110/68 O2 100% RA P 86 RR16 Pt reported feeling better " a lot better" after resting and left the vacc site at 1250 pm

Pain behind and around eye space, especially when moving eyes or head. Did not receive any treatment, it is continuing.

SYNCOPE- Patient received vaccination at 1pm, her sister was with her because she sometimes passes out when getting blood drawn. After leaving the vaccination room the patient sat in a chair and felt fine and was talking on the phone, around 1:05, her sister alerted us that she thought she was passing out and was talking to her trying to keep her awake. I grabbed smelling salts and when I got to the patient, she was hard to wake up so I used the smelling salts on her and she came to. Gave water and juice to patient and moved her into the vaccination room to give her space to recover. She complained of being dizzy and ears ringing, we monitored her for 30 more minutes and all symptoms had resolved. Did not seek further treatment.

After the 2nd dose (April 26), on April 29th at 3:00 AM I woke up because I was violently itching my right forearm and my left hand. I had a lot of bumps on my forearm that were itchy and turning red as a result of my itching. My left hand had no bumps but it was completely swollen. My face began to swell at my upper cheeks and around my jaw. The right side of my upper lip swelled up prior to the rest of my face and remained that way. It became difficult to keep my eyes open. This facial swelling lasted for three days and on the third day, my neck began to swell right along with my submandibular lymph nodes. This neck and facial swelling went down on May 2nd after I was advised by a sports medicine staff member to take ibuprofen.

had no sense of taste; had no sense of smell; This is a spontaneous report from a contactable consumer reporting for herself. A 22-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 16Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient stated that she had gotten her second dose of the Pfizer covid 19 vaccine 3 days ago, Friday and since then (16Apr2021) she had no sense of taste and smell. Wanted to know if this was normal. The outcome of the events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Sudden tinnitus which has been constant, doctors have ruled out most causes, have attempted ear flush, antibiotics, antihistamines, diuretics, and decongestants. No previous history of any sort of ear issues or any tinnitus, is currently ongoing.

Nurse Practitioner notified by the observation nurse that PT had complaints of itching tongue and scratchy throat after receiving the Pfizer vaccine. PT reports having similar symptoms after the first dose, she states that she took Benadryl at home and her symptoms were relieved. PT reports no difficulty swallowing. PT was administered 25mg of Benadryl PO with water. PT reports NKDA, no medical history, and reports no current prescription medications. Vitals are as follows; 0945: 161/113, 100% O2, 95 HR, 18 Resp, 98.4 Temp; 0952: 136/110, 99% O2, 83 HR, 18 Resp; 1005: 127/106, 99% O2, 81 HR, 18 Resp. PT states all symptoms were relieved, total time waited after vaccine administration was 1 hour.

April 25th (within 24 hours of vaccine) I felt the typical fever, severe chills, fatigue, etc that I'd often reported. No soreness. This was gone by the end of the day. April 26th I began feeling some light-headedness and feeling faint. My heart was fluttering every time I stood up, my vision went blurry, and I was very unstable (had to hold something to keep from falling). This feeling was bad enough to cause me to become uncoordinated and fall down the stairs while home alone. That evening I went to the ER where they verified that I was "stable" and checked for bigger issues, and sent me home without treatment. These symptoms continued for the next week. Improving a little each day. It is now May 10th and I am still experiencing some light headedness and clumsiness. Still needing to rebalance myself on something if I stand up quickly. At some point over this time, I've started making mistakes in my words and sentences. Just odd things like omitting words from phrases or confusing "up" with "over" etc. I did not notice this at first, but my co-workers did. Before the vaccine, this is not something I ever did. Correlation? Causation? Regardless, I'm still a little unwell and a little worried. But the ER seemed unconcerned, so I've been continuing about my life.

Fatique; Muscle pain; HA; Tinnitus / Ringing in her ears; This is a follow up spontaneous report from a Pfizer sponsored program. A 22-years-old contactable female consumer (patient) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Patient previously took first dose of BNT162B2 for COVID-19 Immunization. The patient medical history and concomitant medications were not reported. Patient received the series for covax a month ago (Pfizer covid vaccine 4 weeks) and still having side effects. Her-side effects started after the 2nd covax with fatigue, muscle pain and HA. Now ringing in her ears, she knew that some of the side effects resolved within a few days, but she is still having tinnitus that has still going. Patient asked how long will side effects last. She wanted to know about the duration of this side effect to know if this is permanent or not. Patient was aware that there were thousands of reports of tinnitus for the covid vaccine. Patient got response that there were no reports of Tinnitus and the duration of each side effect is different between patients. Recommended to consult her physician about treatment recommendations. The side effects reported goes away in some days, but we did not have any report that is permanent. There were unaddressed medical questions referred or forwarded to Medical Information. There was no PQC. Outcome of the events fatigue, muscle pain and headache were recovered on unspecified date. Outcome of the event ringing in her ears was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

1535: Received vaccine around 0850, Denies any sign and symptoms at that time. Around 1500 suddenly felt faint, flush and saw black. Patient denies Nausea/vomiting, SOB. Patient was dizzy but was not clammy. Sat down, felt better after sitting and patient given water. Got back up after 10-15 minutes felt fine until around 1530; again felt faint, flushed and blurry vision and dizziness. Denies every losing consciousness. 1538: VS B/P 90/60, HR 78, o2Sat 92% on RA, RR-16, Sitting 1550: Medical team called; patient brought to first aid by wheelchair 1600: Verbalized feeling "much better" denies feeling flushed, nausea, vomiting, SOB, dizziness, some diaphoresis noted to forehead-cool rag applied. 1600: VS: b/p: 110/80, HR 95, O2Sat 96% on RA, RR 16, Sitting 1610: Provider on duty in attendance; assessed patient cleared for discharge home. Pt states she feels "much better" and is goo to go home. denied any further or new symptoms.

Fever of 99.9 (for 2 days), flu-like symptoms, swollen red eyes and congestion. Broke-out in rash around neck, back, elbow creases, arms and chest.

My taste and smell has been changed in that everything tastes/smells the same - like unpleasant chemicals.

Had extreme sweating and drop in blood pressure to 52/40. Proceeded to lose vision and have chills. Faint when standing. Went to hospital.