Pfizer

Entered observation @ 1935. Mother stated to this nurse @ 1950, that daughter felt "light-headed". Water was given. @ 1954, patient started to gag. Went to restroom. @ 1958, she was walked with this nurse and others to "bed" that's located in vaccination clinic. Mother explained to this nurse and others that her daughter shows s/s of these symptoms upon each vaccination. Lightheadedness and nausea lasted for about 10-15 minutes. Cold compress was applied to help relieve s/s from vaccine. States she felt better around 2005. Left observation @ 2005, showed no s/s of distress.

Went to sit down and passed out; felt dizzy; nausious/nausia; sweaty; sick feeling; as she was ghost white; bad headache.; This is a spontaneous report from a contactable other Health Professional reported for herself. A 16-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318) via intramuscular on left arm on 02Feb2021 03:45 PM, at age of 16 years old at single dose for Covid-19 immunization. Patient was not pregnant at the time of vaccination. Medical history reported as allergies to medications, food, or other products was reported as none known. Prior to vaccination, patient was not diagnosed with COVID-19. Other medications the patient received within 2 weeks of vaccination included multivitamin and melatonin gummies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via intramuscular at left arm on 12Jan2021 03:45 PM for Covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported morning after vaccine 03Feb2021 08:00 patient was felt dizzy and nausious. Told her mom and her mom ran over as she was ghost white. Went to sit down and passed out. Patient experienced sweaty, nausia, sick feeling and bad headache. Patient went to the emergency room (ER), they gave fluids and blood work. No heart issues noted. Felt better around 3 hours after. Headache was bad and continued on 05Feb2021 (reported today). Also, still feel nausious and had to lay down. All events occurred on 03Feb2021 08:00 AM. Patient was recovering. It was reported the adverse event result in emergency room/department or urgent care. The seriousness criteria were reported as not serious, no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. Patient was received treatment for the adverse event included fluids and heart monitoring. The patient underwent lab tests and procedures which included blood work in Feb2021. Since the vaccination, patient had not been tested for COVID-19. Outcome of events bad headache and nauseous was not recovered, for felt dizzy, as she was ghost white, passed out, sweaty, sick feeling was recovering.; Sender's Comments: Based on the information provided and plausible temporal association, a contributory of the suspect drug to the reported events cannot be completely excluded. Case will be reassessed when additional information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

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.

Began complaining that she was short of breath at 10pm on 3/16, needed nebulizer treatment for wheezing on 3/17 at 1am, could not get wheezing under control with 2 nebulizer treatments at home, so went to ER at 2am. Was dosed 16 puffs of albuterol over about 40 minutes. Vomited and then administered IV fluids and blood was drawn/chest x-ray performed. Discharged at 6am on 3/17.

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

Rashes in the face, ears and the whole body and ichy in the face. Difficult in swollow in the throat. The doctor in the urgent care gave her an injection of Benadryl and an injection of prednisone, and gave her pills of prednisone for 5 days and Benadryl too.

Patient seemed fine immediately after the vaccine and walked to a nearby chair to wait for 15 minutes for observation. I was alerted by the pharmacy technician I was needed outside of the immunization room and patient had vomited. It seemed to be mostly stomach acid (no food particles) and was roughly 12oz or less of fluid (hard to tell since it was contained in a plastic bag. Patient sipped on some water, which she tolerated well. She stated she suddenly felt really dizzy and then felt the need to throw up. After the water, she felt better and was looking to see if eating something would help settle her stomach. She did not appear pale or diaphoretic. I encouraged her to stay longer for continued observation by she left before 15 minutes were up after the vomiting. She was in the pharmacy observation area for about 20 minutes total. She smiled and waved as she left.

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.

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

Pfizer 1st dose administered at COVID-19 Clinic. Client reported being diagnosed with COVID-19 during the last week of September 2020. Reviewed with client what to expect with side effects after receiving 1st dose. No questions or concerns voiced. Gave vaccine at 1505. Mother then stated after vaccine administered that client has history of syncopal episodes after vaccines. Provided water to client and recommended for client to be moved to a supine position. Client declined lying down. About 1506, client lost consciousness for 4 seconds. Client returned to consciousness without intervention and was alert and oriented x 4. Client had 10mL emesis after returning to consciousness. Recommended for client to lie down, client declined. Provided graham crackers and cycling floor fan. Client able to tolerate water and graham crackers. After 5 minutes, client stated feeling better. Mother elaborated that about 1 year ago had first vagal response to needles when having wisdom teeth removed. Happened again during IV initiation for tonsillectomy surgery and during flu vaccination 2020. Monitored client in clinic room for 20 minutes, no further reaction. Advised for client to state needing to lie down when returns for 2nd dose. Client and mother verbalize understanding. Mother escorted client from clinic to private vehicle.

POST VACCINATION SYNCOPE. DID NOT FALL, LOWERED TO GROUND. QUICKLY ALERT AND ORIENTED, ASSISTED TO WHEELCHAIR. WHILE WAITING FOR COT HAD ADDITIONAL SYNCOPAL EPISODE, NAUSEATED. MONITORED FOR 25 MINUTES AND SYMPTOMS RESOLVED.

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.

Patient felt lightheaded almost immediately after receiving vaccine. She was walking with her parents to the lobby and they reported pt "jerking" then becoming unconscious. She woke up right away. She was nauseous and pale for another 20 minutes or so. We called 911 and paramedics determined it to be a vasovagal response.

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

Muscle and joint pain - 9:30pm 04/06/2021 - 6pm 04/7/2021 Headache - 9:30pm 04/06/2021 - 10am 04/9/2021 Chills - 3:30am 04/07/2021 - 6:00 am 04/7/2021 Fever - 3:30 am 04/07/2021 - 12pm 04/7/2021 Nausea - 9:30pm 04/06/2021 - 3pm 04/8/2021 Vomiting - one instance 7:30am 04/07/2021

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.

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

started vomiting the next day. We weren't concerned because this was expected and she recovered within two days. She improved the next day but became sick again the day after and every day since. We are now at day 19 and she is still nauseated every day. She vomits periodically about every second or third day. She vomited profusely today on day 19. I am reporting this because the symptoms shouldn't last this long.

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.

Patient reports receiving the Pfizer Covid vaccine on Saturday 10, 2021 and the next day she began to feel an upset stomach, dizziness and swelling of the right side of the face.

Patient presented to the ER following her first COVID immunization. Symptoms started an hour after the vaccine was administered. Stated her heart felt like it was racing, she had increased SOB, headache, was tired, nauseous, and had nasal burning.

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

Shortly after administration of the vaccine, patient began feeling lightheaded and nausea. Patient was crying and had rapid breathing. Patient appeared to be having a anxiety attack. 911 was called. Blood pressure was taken 3 times over the course of ~5 minutes. Emergency response personnel arrived and continued to assess and monitor the patient. The patient eventually left with her father (AMA)

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

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

It was reported that the guest felt nauseous and lightheaded and lost consciousness. EMS was called. She was responsive to sternal rub. She was laid down and her symptoms improved. She did, however, continue to complain of nausea and some stomach pain. EMS took vital signs, The BP was unable to be obtained manually. A doppler systolic was obtained. It did slowly improve. She then was able to get up to a sitting position and denied abdominal pain and nausea. BP continued to improve. Able to stand without feeling lightheaded and BP continued to remain stable. Guest was observed for a total of 35 minutes.

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

Systemic: 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

About 5 minutes after receiving the vaccine, patient was sitting down, and started to feel nauseous, pale, and dizzy. We had the patient lie down on her back and elevate her legs, place a cold compress on her forehead. Within 2-3 minutes, patient was feeling better. She sat around for another 15 minutes and then left after feeling fine.

Patient was nauseous and vomited immediately after vaccination. Has a history of anxiety related to vaccines.

Fever, chills, muscle pain, joint pain, tiredness, headache, injection site pain, injection site redness, nausea

Pfizer-BiNTech COVID-19 Vaccine EUA: dizziness, that started the morning after the vaccine and still lasts for the 2nd day. Nausea on the morning after the vaccine. Headaches off and on.

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

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

Time of shot: 3pm Onset of reaction: 9pm Stomach ache and headache Hour later: fever (99.5) and chills Difficulty sleeping Kept her home from school today (4/22/2021)

Patient became dizzy and nauseous after vaccine. pt was assisted to wheelchair and brought to hallway for assessment. After first set of vitals pt vomits and passes out for about 30 seconds (max). Pt is woken up and reassessed. Pt is A&OX4. After second set of vitals pt states she feels better. Mom and pt decide to leave together instead of calling for a rescue.

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

My daughter was given her 2nd COVID shot at approximately 9:00am on 4-16-2021. We waited 30 minutes after the shot. No issues. That evening at approximately 6:00pm, she had a red rash on her upper chest and throat. She stated that she was having a hard time breathing and swallowing. I gave her a Benadryl tablet and watched her for approximately 15-20 minutes. she continued to feel tightness in her throat and said it burned when she swallowed. She confirmed again that she felt her throat was swelling. I drove her to the closest ER located at. My daughter was seen and it was determined that she was having an allergic reaction. DR recommended continue Benadryl tab every 4 hours for the next 12-24- hours. We were discharged to home. I administered another does of Benadryl at approximately 10:15pm. My daughter went to sleep. I woke her up at 3:00am to check on her and she stated she did not have a rash and her throat was fine. She was running a low grade fever of 100.5. I gave her 500 mg of Tylenol for the fever. When my daughter woke later that morning at approximately 8:30am, she still did not have a rash or throat swelling. Her fever was gone.

PATIENT STARTED FEELING FAINT AND NAUSEA AFTER RECEIVING PFIZER COVID -19 VACCINE. DID NOT RESOLVE AFTER ABOUT 7 MINUTES. WAS GETTING WORSE PER PATIENT. I CALLED PARAMEDICS. PATIENT WAS TAKEN OUT OF THE BUILDING BY PARAMEDICS TO BE ATTENDED TO. FOLLOWED UP WITH MOTHER SINCE PATIENT WAS A MINOR. PER MOM, PATIENT DOING OK NOW. AT HOME. WAS NOT TAKEN TO E.R.

Patient reported nausea and dizziness following the 15 minutes observation period. Patient was advised to sit. She denied any shortness of breath. She stated that she did not eat anything that morning. Juice and crackers were provided to the patient. Vital signs were all within normal limits. Patient reported improvement after hydration and snacks.

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

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

Systemic: 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

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

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

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.

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

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

Pt felt "near syncope" event, with a feeling like she was going to vomit. The sensations relived themselves with several minutes of observation from the EMTs on site.

Tightness in chest, extreme nausea, dizziness, headache, shortness of breath. After receiving the vaccine I had these symptoms for the rest of the day, as of this writing I am still feeling mostly nausea and the tightness in my chest has died down.

16 y/o female c/o upper left quadrant, abdominal px. Pt's mom states that she has a history of anxiety and abdominal px on lower right quadrant, from a previous cist. Px does not radiate and changes with inspiration. Vitals - BP 108/70, HR 66, RR 20. Mom wants pt seen at the hospital. Pt transported to hospital via medical transportation.

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

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.

Arm soreness, tightness in chest, dizziness, nausea, difficulty breathing. Symptoms started pretty much right after getting the shot but the dizziness and tightness in chest stopped after I took a nap about an hour after the shot. As of the submission of the form I am still feeling soreness in my arm but it?s lessened a bit and I still feel nauseous and am having trouble breathing properly.

Lightheaded, Nausea, Seen by onsite EMT,BP: 127/82 , Pulse: 76, 02: 98ed, Patient discharged at 9:45 am to home. Recorded by EMT.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Mild, Additional Details: After patient was vaccinated she went to wait with her mother in the car (vaccinator did not specifiy to wait in the store). Patients mother came to alert us that the patient was not feeling well. I went to the car with the clinic nurse to check in on the patient. She was responsive however was feeling faint/dizzy/nauseas. Vitals were within normal limits however EMT was called by mother. Patient started to feel better and went home. Patient reports feeling fine now.

Patient felt nauseous after vaccination and vomited x 1 in bathroom with RN present. She stated that she felt better afterwards. Vital signs stable. Evaluated by an MD on site and discharged from clinic.

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

Per EMT, patient became diaphoretic and pale suddenly approximately 5 minutes after receiving her first dose of the Pfizer Covid-19 vaccine at a drive-through vaccination site. Patient was in car sitting in the observation area when incident occured. After becoming pale and diaphoretic, EMT lowered the seat and someone held the patient and patient became unconscious for approx. a minute. After consciousness regained, patient wanted to sit-up because she "felt naseous". Patient sat up and the RN called to incident. When this RN arrived, patient was consious and leaning over and appeared pale/grey and cyanotic. 911 called. This RN put pulse-ox on patient and told EMT to get O2. Patient's O2 saturations were in the low 80's and HR 46. Patient immediately layed back in seat of car and put feet up on dashboard and given 5L of oxygen. After approx. 5 minutes on 5L of O2 and laying back, patient's color improved and stated she "felt much better". O2 saturations improved to 100 after a couple minutes on oxygen and remained over 98% on RA X 5 minutes. Patient was not taken to the hospital and someone droved patient home with follow-up. Follou-up the next day: patient was febrile and given acetaminophen and was afebrile the rest of the night with no other adverse symptoms.

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

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.

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

Abdominal pain and vomiting starting the night of April 20, 2021. Went to the emergency department on April 21, but was not diagnosed to be appendicitis. Went again on April 22 and was diagnosed to be appendicitis with possible perforation.

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

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

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

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

Patient reported feeling lightheaded status post first dose Pfizer COVID vaccine (Lot: EW0167, expiration date: 08/31/2021) to medic. Medic noted that the client was CAOx4, her skin was pale, warm and slightly moist, pupils were equal, round, reactive to light and accommodating (PEARRL), respiration rate (RR) was 20. The client's sister stated the client had a history of anxiety and that "she gets this way whenever she gets a shot". Medic walked patient to the zero gravity chair. The client was given water to sip on. At 1213 baseline vitals were taken with client sitting: Blood pressure (BP): 110/82, heartrate (HR): 98, RR: 20, PEARRL. Medic reports she coached the client on her breathing to help alleviate her complaint of feeling lightheaded, mild nausea and anxiety. Client reported she felt anxious prior to her vaccination and that her last oral intake was 15 minutes prior to vaccine. Client denied headache, blurry vision and chest pain. At 1220 a second set of vitals were taken while standing: BP 108/80, HR 86, RR 16, CAOx4. Client stated her symptoms were diminishing. Client's RR slowed down to normal rate and rhythm, vital signs were trending to normal and client was negative for orthostatic pressures. Client was advised to stay for additional 30 minute observation. Client's symptoms resolved completely and she was able to ambulate away from observation site without assistance and with a steady gait.

Pt complained of nausea and feeling dizzy immediately after vaccination. Patient became diaphoretic, pallor to face, patient assisted to wheelchair and taken to stretcher and laid flat since unable to stand. BP 108/67, HR 57, RR 14, o2 sat 99%. Patient later reported she left better, color returned to face and diaphoresis ceased. Updated vitals: BP 109/71, HR 52, RR 16, o2 sat 100%.

0935- Vaccine recipient (VR) received 0.3ml dose of Pfizer vaccine that was reconstituted with the incorrect amount of diluent (0.9mL). VR was asymptomatic during 30 minute observation. Immediately contacted program and was provided guidance and information. 1052 - Consulted School Nurse, VR was in nurses office with chief complaint of a headache, dizziness, and nausea. Left deltoid observed at injection site with no localized reaction found. Per school nurse: Nurse gave VR ibuprofen. Relayed information provided by program to VR. School nurse continued to observe. 1058- Contacted and spoke with VR's parent and relayed and emailed information provided from program (continued in next section) Additional information for Item 18: cont'd- which was the CDC Guidance for vaccine administration errors and deviations. Parent advised to contact primary care provider with any questions or concerns. 12:30 - Followed up with VR - headache and dizziness unchanged, nausea resolved, c/o "going the other way" bathroom. School nurses continued to observe. VR laying flat on bed, dim lights, and on phone.

In the morning I woke up with fatigue and it was difficult to get up. I also had body aches throughout the day. I had a bit of nausea and was dry heaving. Later in the day I had a headache

16 yo female came into our injection site today 05/05/21 to receive her first pfizer vaccine. She was accompanied by her father. Pt received vaccine IM to her left deltoid. Pt completed vaccine at 2:55pm at which she sat down for her 15 minute observation period. As soon as she sat down she called over the staff that administered the vaccine. She explained to her that she felt nausea and was breathing heavily. I then walked over to them and the attendee was very pale and breathing heavily. By that time I had RN getting attendees history from her father, She has no history of allergic reactions, not taking any medications and no current illness. She is "slightly asthmatic" but is not taking any rx. RN was helping me by putting cold pack behind attendees neck. Pt then proceeded to explain that she felt nauseas and starting dry heaving. RN then brought over trash can and attendee started to vomit. I then started to proceed and take her vitals. first set of vitals were taken at 2:58pm BP: 90/60 HR: 132 RR: 24 O2: 100%. Attendee at this point was diaphoretic, pale, breathing heavily and vomiting. We continued to monitor attendee in which she started to feel better by 3:08 pm. She was no longer pale, diaphoretic or vomitting and was breathing normally. We provided attendee with water and continued to monitor her. Now that pt was calm, I was able to ask her some questions. She stated that she had a smoothie and an avocado toast about an hour prior to vaccine. She explained to me that she does have a phobia to needles and was feeling very anxious prior to appointment. I then repeated her vitals at 3:16pm BP: 98/60 HR:89 RR: 20 O2: 99%. I had attendee stand up off chair and walk at 3:22pm. She felt fine and did not feel dizzy at all. No signs of distress noted. She was then discharged and walked out with her dad at 3:25pm.

Vasovagal episode for < 10 seconds, then vomited once and felt better. Didn?t eat anything earlier. Ate crackers and juice and dad drove her home.

Nausea and fevers started at 4:30 am 14 hours after shot, had nausea, body aches, headache, fever up to 101.2 , dizziness, fatigue. Nausea lasted 72 hours after the shot and has not stopped though has gotten better.

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

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.

Patient felt light headed and nauseous. Monitored patient 30 minutes and nauseous went away but still feel light headed.

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

20 hours after receiving the vaccine I felt very dizzy and nauseous for a moment and then fainted and was unconscious for a minute. I had developed a fever about 8 hours after receiving the vaccine, but by the time I fainted the fever was pretty much gone.

Patient received 2nd dose of COVID vaccine on 5/5/21 outside of our clinic. Developed severe abdominal pain and emesis on 5/6/21 per family. Evaluated medical facility on 5/7/21 and abdominal pain was subsiding, able to tolerate PO intake by that time.

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.

Felt dizzy and nauseous at about 7:30pm following a workout 3 hours after I got the Pfizer vaccine. Dizziness has increased and I feel fatigued.

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

7 days of secretory diarrhea, abdominal pain and nausea 5 pound weight loss due to inability to eat/drink regularly

Patient chronic conditions (JIA, UC) previously controlled on adalimumab. Within several days of receiving COVID-19 vaccine dose #2, patient began experiencing worsening/flare of ulcerative colitis symptoms including stomach pain, diarrhea, fatigue, arthritis pain that lasted beyond the reasonable and known duration of vaccine related side-effects. Symptoms treated with dicyclomine and acetaminophen with no relief. Symptoms continued x 2 weeks. Patient ultimately required addition of budesonide to treatment regimen for ulcerative colitis and is currently having relief of symptoms.

Patient started swelling in the left hands on Saturday May 08th and inflammation in the bowel during Monday morning May 10th. She was not able to eat and had nausea. Patient stayed at Hospital until May 13th and got many exams as endoscopy and colonoscopy and did not find any reason for such inflammation. Also, blood exams were ok. The swelling in the hands combined with inflammation on the bowel sound suspect of reaction of Pfizer vaccine as there is no event close to this date to create abnormal effects of swelling and inflammation.

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.

16-year-old medically complex female, JIA, bronchiectasis and chronic nighttime oxygen requirement who presented to the hospital on 5/6 with fever, increased stool output, and perianal skin breakdown. Her course was complicated by respiratory failure (requiring ICU admission for CPAP), pancytopenia, diarrhea with buttock skin breakdown requiring rectal tube for wound and stool management, and extensive workup which was unrevealing for an infectious cause. She clinically improved with respect to pancytopenia with discontinuation of felbamate, and completed a treatment course with Zosyn for suspected buttock SSTI.

ADVERSE EVENT: DIZZINESS/ SYNCOPE AND NAUSEA, PATIENT ALS O TURNED PALE DURATION OF 15 MINUTES. TREATMENT: MONITORED PATIENT ENTIRE TIME AND PROVIDED SUPPORTIVE THERAPY. GAVE PATIENT WATER OUTCOME: PATIENT RECOVERED IN 15 MINUTES AND WAS OBSERVED FOR AN ADDITIONAL OF 15 MINUTES (30 MINUTES TOTAL) AND PATIENT WAS RELEASE TO THE CARE OF HER GUARDIAN

Dizzines, nausea. BP 125/84; HR 94; RR 18. No s/sx of respiratory distress. Pt monitored by RN, sx resolved & released home with father in stable condition

Right after patient received the vaccine she turned very pale and told the technician she felt light headed. She remained seated in the room and closed her eyes a couple times but never appeared to lose consciousness. Her dad joined us in the room and confirmed she was really nervous before the vaccine. We kept her seated for several minutes and then she said she felt sick and vomited. After that she started to regain her color and was able to move to the waiting room. She sat there for about 5 more minutes and then felt well enough to leave with her dad.

anaphylactic reaction; anaphylactic shock; vomiting; broke out head to toe in hives; trouble breathing; face swelling; This is a spontaneous report received from a Pfizer-sponsored program, Support received from a contactable consumer (patient's parent). A 16-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in left arm on 08Apr2021 (Batch/Lot number was not reported) as 1st dose, SINGLE dose (at the age of 16 years old) for covid-19 immunisation. Medical history included asthma from 2018 and ongoing (Has been asthmatic about 3 years and has it under control and hasn't had issues in years). The patient's concomitant medications were not reported. Last time at the doctors office was for her well check in Oct or Nov. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 21Apr2021, the patient experienced anaphylactic reaction, anaphylactic shock, vomiting, broke out head to toe in hives, trouble breathing and face swelling. They are not sure if it (anaphylactic reaction) is related to the vaccine. She does not have any allergic issues of any kind and is not sure if it is from the vaccine. The patient has an appointment with an allergist on 05May2021. The pediatrician recommended she wait to get the second dose until after the mother talked to the allergist. She is scheduled for the second dose 30Apr2021. The consumer stated the daughter will miss her second dose tomorrow. The pediatrician told her to wait until speaking to the allergist. If the allergist clears her, it wont be until 05May2021. How long would it be until she can get the second dose. She is not sure if it is related or not. It was 2 weeks after. She ate some kind of granola bar that may have been the cause. Before she called 911 and they gave her epinephrine, it lasted anywhere between maybe up to 15 or 20 minutes. She went to the emergency room (ER) and had to be observed 4 to 5 hours and then went home. Treatment for the events included Epinephrine, steroids and she believes a dose of Pepcid. She was on steroids for like 4 days. The steroid was prednisone. Outcome of anaphylactic shock, vomiting, broke out head to toe in hives, trouble breathing, face swelling were recovered on 21Apr2021. Outcome of anaphylactic reaction was unknown.

Extreme abdominal pain/cramping. We ended up taking her to the ER department at the Hospital because the pain was so extreme. In the course of the visit to the ER, they took a CT scan of the abdomen, and there saw evidence of Covid in the lungs. They did a nose swab test, and she tested positive. She had some mild symptoms (stuffy head, headache, mild sore throat) earlier in the week (May 8 - May 9), but we thought it was possibly allergies. Turns out it was Covid and we didn't know it. It seems that with the Covid virus already in the system, the shot caused an extreme reaction.

Patient Stated she had a rapid onset of feeling dizzy and Nausious. The patient was laid supine on the floor and assisted py paramedics. Responded, Patients father signed AMA via hospital. Patient released to father.

Briefly, patient is an otherwise healthy 16-year-old female who presents with 12 days of epigastric pain in the setting of getting her 2nd COVID vaccine on 5/5. Did have fever and vomiting during the first 24 hours which has since subsided, but the abdominal pain has persisted. She has had a reassuring work up through her PCP but presents with continued pain. Labs overall reassuring with normal LFTs and lipase. Awaiting RUQ US and urine at this time. 0100: Family requesting discharge home. does not want to wait for US as they have an outpatient US scheduled for Thursday 5/20. Temperature: 36.6 DegC (05/18/21 01:14:00) Systolic Blood Pressure: 118 mmHg (05/18/21 01:14:00) Diastolic Blood Pressure: 60 mmHg (05/18/21 01:14:00) Heart Rate: 80 bpm (05/18/21 01:14:00) Respiratory Rate: 20 br/min (05/18/21 01:14:00) Oxygen Saturation (SPO2): 98 % (05/17/21 20:28:00) On re-evaluation, patient is awake, alert and well-appearing. She has remained afebrile, with normal vital signs for age. Reports improvement in symptoms, has tolerated PO and feel that she is appropriate for discharge home. Anticipated course of illness reviewed. Supportive care (rest, push fluids) discussed. Reasons to return to the emergency department discussed in detail. Written instructions provided. All questions answered. Parents expressed understanding and agreement with this plan. Patient was awake, alert and well-appearing upon discharge home from the emergency department. Final Diagnosis 1. Epigastric pain R10.13 2. Adverse reaction to vaccine constituent T50.A92A

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.

Briefly, patient with history of asthma and food allergies, presenting with hives, nausea, and swelling, in setting of receiving Covid vaccine 36 hours ago. Family had given benadryl and zyrtec without improvement, and symptoms were worsening to presents for evaluation. My exam (after Epipen) showed: Gen: nontoxic appearing; HEENT: no lip/tongue/uvular edema, PERRL, EOMI, normal conjunctiva, neck supple without LAN; Card: RRR, no murmur, good perfusion; Lungs: CTAB, good air entry, no increased WOB, no wheezing; Abd: soft, non-tender, non-distended, no masses; Ext: warm and well perfused, moving all extremities; Skin: hives over hands, arms, abdomen, and legs, including between fingers and on soles of feet Patient presenting with allergic reaction after Covid vaccine, could be more benign allergic reaction such as urticaria multiforme, but given constellation of symptoms and history of severe allergic reaction in past, will treat as anaphylaxis. Therefore given Epipen, steroids, and will plan for observation. Observed 4 hours and continued to be well appearing without symptoms of rebound anaphylaxis. Therefore, patient safe for discharge to home with supportive care and PCP follow up. Given Rx for benadryl and steroids, refilled Epipein. Family in agreement with plan and verbalize understanding of signs and symptoms to return to care. Final Diagnosis 1. Anaphylaxis T80.52XA

vomiting began 3 days after vaccination fever up to 102 began 4 days after vaccination sore throat, congestion, body aches persist 5 days after

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

nausea within 1/2 hour. congested and runny nose within 1 hour. within 24 hours sore throat, cough, vomiting. Still has runny nose and cough.

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

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

Nausea; headache; soreness at injection point; fever; runny nose; This is a spontaneous report from a contactable Consumer (patient). A 16-year-old female non-pregnant patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN5318, Expiration date not reported), via an unspecified route of administration in arm left on 27Jan2021 (at the age 16-year-old), as a single dose for COVID-19 immunization. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL3249, Expiration date not reported), via an unspecified route of administration in arm right on 06Jan2021, as a single dose for COVID-19 immunization. The patient did not receive any other vaccine in four weeks before vaccination. The patient experienced nausea, headache, soreness at injection point, fever and runny nose on 27Jan2021. The patient did not receive any treatment for the events. The outcome of the events was reported as recovering Follow-up attempts are completed. No further information is expected.

pt began to fill light headed about 5 minutes after vaccination. She then had some vomiting. The room was very warm. She was a little diaphoretic. The vomiting happened about 3 times then subsided. Patients color came back. She sat for a few additional minutes. Drank some water and left clinic completely stable. She has had a history of fainting with heat and with injections.

48hrs post-vaccine began with polyarthralgia, progressed to myalgias, arthritis, weight loss, abdominal pain/diarrhea, mucosal ulceration, and dyspnea, now admitted for evaluation which is suggestive of systemic lupus erythematosus.

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

Patient was given the vaccine then sat down and felt dizzy about 5 minutes later. Patient then vomited and felt better after.

Patient experienced an upset stomach after getting her first dose of the pfizer vaccine. She ended up throwing up but felt better afterwards.

Patient reported throat tightness and dizziness exactly 19 minutes after the vaccine was given. Patient could still speak. She was advised for sip of water to see how she does and reported difficulty of swallowing. She verbalized experiencing the same thing when she received her flu vaccine about 10 years ago. Immediately sent to ER via wheelchair. Patient continued to be verbal until the arrival to ER.

Patient received the vaccine at 4:00p. Her mother called us over at 4:05 as Shaelynn was feeling "weird". She began to itch and cough, apparently trying to throw up, felt her throat was itching and swollen. She stated she couldn't swallow and was having a hard time breathing (although she was breathing). We administered an Epi Pen 0.3mg (only one) and called 911. Patient was transported to the hospital by ambulance.

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

1. Headache - for 24 hours. Treated with acetaminophen & naproxen. 2. Nausea when standing - duration 24 hrs 3. Dizziness when standing - duration 24 hrs 4. Fever up to 103 F - duration 18-24 hrs. Unknown due to taking acetaminophen & naproxen.

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

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

Patient experienced minimal sting at time of injection. Observation period of 15 minutes passed and patient then almost immediately experienced vomiting and increased burning in the arm. She was asked to sit near pharmacy for further observation. After another 5 minutes patient's arm turned red from injection site to elbow. She was then allowed to go home with her grandmother. They were given a cold pack for the heat and redness of the arm it was recommended to take Benadryl. Upon follow-up next day patient was doing better was tired but no other side effects.

Felt dizzy and like she would pass out Felt faint and nauseous and very sweaty. MOM noted she was obviously sweating and left wet marks from her arms on the table Did have a syncope episode

Patient fainted and vomited within 15 minutes of vaccination. No treatment needed. Patient released to home with parent.

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

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.

Immediately after receiving vaccine patient stated she felt light headed and nauseous and laid down. mom then stated that it was because she was sick when she came in and was probably from that. We let her lie down for the post observation time, and then we had her sit up for several minutes. after the post observation time was up she was able to get up and leave.

FEEL QUEASY; AWFUL HEADACHE; This is a spontaneous report from a non-contactable consumer, the patient. A 16-year-old non-pregnant female patient received 1st dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number/Batch Number: UNKNOWN), solution for injection via an unspecified route of administration in the left arm on 14March2021 at 10.30 am as a single dose for COVID-19 immunisation. The patient was allergic to gluten (celiac), Zithromax and Augmentin. The patient concomitant medications include Zoloft (Manufacturer unknown) , Junel birth control (Manufacturer unknown) and Claritin (Manufacturer unknown). On 14March2021, the patient experienced awful headache and queasy. The patient has recovering from the event headache and queasy at the time of reporting. Information about lot/batch number cannot be obtained. No further information is expected.

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

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

Patient had fever and nausea with some vomiting roughly 5-10 minutes after receiving vaccine. Patient also had some trouble breathing but it resolved within a five minutes. Gave patient cold compress over her neck and monitored her breathing and nausea. All symptoms resolved and she was able to leave facility.

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

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

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

Fever 37.5C, fatigue, headache, swollen lymph nodes, back of the neck pain, stomach ache, pale complexion. Missed school, stayed in bed at home until symptoms resolved.

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

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.

After leaving the immunization room the patient fainted and fell on the floor. Patient lost consciousness for a moment but then was breathing and talking without difficulty. 911 was contacted. At some point before the patient left the store she vomited. Patient parent was contacted the next day; patient did go to hospital and was checked out and given the all clear and was then at home resting.

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

After receiving the injection the patient fainted. Patient was offered juice and after taking a sip she had a small amount of emesis. A cold towel was placed on patient's forehead and then observed by EMS.

april 29 started complaining about stomach pain, may 10 got hospitalized because still had not been able to poop since vaccine. they gave her a whole bottle of meds to help her go. xray showed the left side was completely blocked. may 18th got 2nd vaccine and still hadn't been able to really use bathroom just a little bit. may 20 was finally able to go to bathroom after Dr prescribed her a different medication but now she is having to remain on that medication. she had covid back in Jan

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.

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.

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

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

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Nausea-Mild, Additional Details: Took BP and pulse shortly after, 109/72 HR 83 (within normal limits). Monitored her for almost an hour, counseled on what to do if symptoms worsen (go to hospital). She left with her nurse guardian. I called her 1.25 hours later, she was doing much better and nurse guardian was still monitoring her. BP and pulse still normal (per nurse/guardian).

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

Systemic: Dizziness / Lightheadness-Mild, Systemic: Vomiting-Mild, Additional Details: patient complained of lightheadedness and then vomitted about 2 minutes after administration of the second dose, father stated this lightheadedness without vomitting happened on the first dose as well

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

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.

About one week after her second injection, patient began to experience intense stomach pain after eating. On April 11, she went into the emergency room (once in the morning and again in the evening) due to right side abdominal pain. She was seen in the ER again on May 9th. She was referred to a pediatric GI specialist and advised to stop eating gluten. Removing gluten from her diet has completely resolved the issue.

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

Patient has primary essential hypertension. Patient undergoes an annual echocardiogram to monitor for ventricular hypertrophy. Prior to this years ECHO, all results have been normal. This year there was an incidental finding of a small amount of fluid around her AV node. ECHO was performed on 5/21/21. She is to have a repeat ECHO on June 11 to monitor for changes. Patient did endorse stabbing like chest pain a couple of weeks ago, but dismissed it as heartburn. Her first Pfizer Covid shot was 3/18/21 and her second Pfizer Covid shot was 4/7/21. Same lot# for both vaccines.

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

Patient slept for about 16 hours a day; Severe fatigue; Vomiting; Nausea; Fever; This is a spontaneous report from a contactable consumer (patient's mother). A 16-year-old female patient (daughter) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 15May2021, as a single dose for COVID-19 immunization. The patient's medical history included ongoing asthma (gotten better in the past year or so but had it almost her whole life investigation assessment: No) and cold. Concomitant medications were not reported. The patient's mother reported that on 16May2021, the patient (daughter) developed nausea and vomiting for about 12 hours and treated with dramamine and went away, completely resolved. She also had fever of up to 102 Fahrenheit for about 3 days that went away and also presents severe fatigue that lasted from 9 to 10 days that started on 18May2021 and was only improving now and wanted to know if that would that be an allergic reaction, when she presented fatigue the patient slept for about 16 hours a day. The hours that she was awake she was normal, she was nor weak. Caller wants to know what can they expect "fatigue wise" with the second dose and why do patients develop fatigue. She also wants to know if a "severe fatigue" could last several days. A higher incidence was reported with the second dose of the vaccine with adults and adolescents. No information on how long the fatigue would last. The outcome of the events nausea and vomiting was resolved on 16May2021 and fever was resolved on an unknown date. Outcome of the severe fatigue was recovering and for the event patient slept for about 16 hours a day, it was unknown. Follow-up attempts are needed. Information on Lot/Batch number is requested.

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

My daughter was vaccinated May 26. When her period started the following week she had a cycle unlike any she's had in the previous 3 years since she started menstruating. Her cycle was sporadic, heavier than ever and lasted longer. Simultaneously, she felt faint constantly for over 4 days, was unable to stand for more than 15 minutes, and was nauseated constantly for 5 days during her period. The ONLY thing that is different in her life this month is that she received her first dose of the vaccine. Her doc had bloodwork done and her results were perfectly normal, meaning there is no other reason to point to other than the fact that she had the 1st vaccine dose.

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

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

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

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

headaches with dizziness; headaches with dizziness; felt feverish; itchiness we're I got my 2nd shot; Diarrhea; stomachache; This is a spontaneous report from a contactable consumer (patient). A 17-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 (Age at vaccination: 16 years) via an unspecified route of administration, administered in Arm Right on 03Jun2021 12:00 (Batch/Lot Number: EW0179 and Expiry date:Unknown) as 2ND DOSE, SINGLE for Covid-19 immunization. Medical history included allergy of big amounts of biotin. The patient concomitant medications was not reported. Historical vaccination included previously the patient received bnt162b2 (BNT162B2), dose 1 (Age at vaccination (years): 16) via an unspecified route of administration, administered in Arm Right on 13May2021 12:30 PM (Batch/Lot Number: EW0179 and Expiry date:Unknown) as 1st DOSE, SINGLE for Covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 04Jun2021, after second dose, first day diarrhea and stomachache. On 05Jun2021 (2nd day) she felt feverish but was not too bad and also itchiness where she got her 2nd shot. On 06Jun2021,(on the 3-4 day) the patient had headaches with dizziness .The patient did not received treatment for the events. The outcome of the events was resolved on an unspecified date in 2021. Information on Lot/Batch number was available. Additional information has been requested.

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

Patient became nauseated and pale after receiving her first vaccine. Patients vital signs were evaluated and patient was kept for an extra 15 minutes. Patients mom was advised that if her symptoms continued to either take her to her family doctor or an urgent care or call EMS if her symptoms became worse. As her symptoms did not completely go away prior to leaving.

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

Admitted to hospital 2 days after second Pfizer covid vaccine. Presented with abdominal/chest pain, found to have a small subsegmental pulmonary embolus on CT scan. No history of prior PE or clots.

Dose 1 (box 11) Pain injection site, reaction to previous exposure to vaccine Dose 2 sleep excessive, nausea, headache, feeling unwell, injection site induration, injection site pain

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.

Previously healthy 16-year-old female presents with syncope after COVID-19 vaccine. In vaccine clinic here. Soon after receiving vaccine, felt light headed and nauseous. Sat down and soon after had a syncopal episode. Quickly came back to. CART called and brought to the ED. On arrival to the ED, continued with some dizziness, but symptoms overall improving. By the time of evaluation, symptoms completely resolved, ambulating without difficulty. Denies other symptoms or complaints. No recent illness. Back to baseline without distress, nontoxic. Tolerating PO. Counseled on likely etiology, strict return precautions, and close outpatient followup. d/c'd home in good clinical condition.

Pt developed severe abdominal pain and emesis. Pt found to have severely elevated lipase and amylase indicative of pancreatitis. Admitted to the hospital for IV hydration.

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

PT WAS GIVEN FIRST DOSE OF PFIZER IM LEFT ARM. APPROXIMATELY 3-5 MIN AFTER ADMINISTRATION PATIENT PASSED OUT. 911 WAS CALLED, PT BECAME ALERT, NO EPI-PEN NEEDED, COMPLAINE DOF HEADACHE AND NAUSEA. SHE USED HER ALBUTEROL INHALER. BP TAKEN 101/67 PULSE 85. EMS ARRIVED AND TOOK MORE VITALS. PT IMPROVED ENOUGH TO WALK TO CAR TO GO HOME FOR OBSERVATION. MOM WAS PRESENT AND OPTED NOT TO GO TO ER

Sore throat; Vomiting; Diarrhea; Anemia; This is a spontaneous report from non-contactable consumer (patient) via COVAES. This non-pregnant 16-year-old 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 25May2021 at 10:45 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Medical history included lymphocytic colitis from an unknown date and unknown if ongoing. The patient had no known allergies, had not been diagnosed with COVID-19 prior to vaccination and had not received any other vaccines in four weeks. Concomitant medications included calcium supplements, macrogol 3350 (MIRALAX), and nutrition shakes, all from unknown dates for unknown indications. The patient previously received the first dose of BNT162B2 (lot number unknown) on 04May2021 at 10:00 (at the age of 16-years-old) for COVID-19 immunisation. On 26May2021 the patient experienced sore throat, vomiting, diarrhea, and anemia, which the patient reported was confirmed with labs. The events resulted in an emergency room visit; no treatment was received for the events. The clinical outcomes of sore throat, vomiting, diarrhea, and anemia were recovering. It was also reported that since vaccination the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot number cannot be obtained.

Patient was originally nervous about the vaccine to begin with. Patient was given the vaccination and sitting their 15 minutes in the waiting/observation area. Patient became nauseous and decided to go to the restroom to possibly throw up. Upon doing so, patient passed out and cracked chin open. Patient was treated by a paramedic already present, so ambulance wasn't called; the offer to call was given to parents. Parents took child to the emergency room of their own accord after patient was sitting up and feeling better, where she was treated and released.

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

fever at 100.5; aching body; Chills; Headache; Nausea; This is a spontaneous report received from a non-contactable consumer, the patient. A 16-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: unknown) via an unspecified route of administration in the left arm on 17Mar2021 at 02:30 (at the age of 16-year-old) as a single dose for COVID-19 immunisation. The patients medical history and concomitant medications were not reported and had no known allergies. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: unknown) via an unspecified route of administration in the left arm on 17Feb2021 02:30, as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Mar2021 at 02:30, the patient experienced fever at 100.5, aching body, chills, headache and nausea. 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 events fever at 100.5, aching body, chills, headache and nausea was recovered on an unknown date in 2021. No follow-up attempts are possible. Information about lot number cannot be obtained.

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

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.

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

Received 1st dose at 3pm on 7/7/21. Observed by facility staff for 30 minutes. Felt fatigued, but otherwise no symptoms. On 7/8/21 at 7:45am went for a run outside. Mid-run felt generalized, severe itching and swelling in throat and facial swelling. Returned home within minutes, reported symptoms to me (mom). Called 911. Epi-Pen 0.3mg injection given in right thigh with no effect. Three minutes later, another Epi-Pen 0.3mg injection given in left thigh given. Benadryl 25mg PO given. Attempted 2nd Benadryl dose...unable to swallow. EMS arrived. Taken to ER. Symptoms slowly improved. Solumedrol IV given in ER. Monitored for 2.5hrs then discharged home with Prednisone PO for 5 days.

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

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

Patient presented after syncopal episode and abdominal pain, was found to have profound thrombocytopenia. CT abdomen was done which was concerning for ruptured ovarian cyst. Hgb dropped to 5.8, plts at time of report were 13. Patient transferred to the ICU for further management

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.

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

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.

Severe nausea; Severe headache; Dizziness; can't sleep; This is a spontaneous report from a contactable consumer (parent reporting for daughter). A 16-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm on 23Jun2021 10:00 as dose 2, single (at the age of 16-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as Doctor office/urgent care. Patient did not receive any other vaccines within 4 weeks, prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. Patient has not been tested for COVID-19, since the vaccination. Patient medical history included depression and exercise asthma. Patient had no known allergies. The concomitant medications included lithium, venlafaxine hydrochloride (EFFEXOR), mirtazapine. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm as dose 1, single for COVID-19 immunization. On 23Jun2021, several hours after the vaccine she was complaining of severe nausea, headache and dizziness. She also reported she could not sleep, even after taking Advil pm. We have not yet sought treatment but may if this continues or worsens. 3 of the 4 of her kids were reporting similar symptoms although 2 are effected much more. The reported case seriousness was non-serious. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Mother was unsure if they will go to the ER or urgent care. It was unknown if any treatment was received for the events nausea, dizziness and headache. The outcome of the events was not recovered. Information about lot/batch number has been requested.

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

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

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

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.

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

Developed Postural Tachycardia Syndrome (POTS) with vomiting and diarrhea, 20 lb weight loss. She was evaluated by pedi GI, who made the diagnosis based on labs, EKG, vital signs, and clinical presentation. Symptoms started 3 days after the 2nd Pfizer COVID vaccination was administered. She was treated with supportive care (fluids, salt, compression stockings), omeprazole 20 mg BID, cyproheptadine 2 mg BID. She received a single dose of decadron (for croup on June 25,2021). Her symptoms have improved though they have not fully resolved. she continues on omeprazole and cyproheptadine.

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

Approximately 15 minutes after vaccine administration, patient became nauseated and pale in the waiting area, asked to lay down. Patient was being escorted to a clinic exam table when she slowly collapsed while dad and technician were at her side and assisted her down. She did not hit head /body according to father and technician. She was assisted in to a laying position on floor with knees up. She was unresponsive to verbal stimuli at the time of event, but responded to sternal rub. Patient pale and bilateral hands and fingers slightly contracted. She became increasingly alert and oriented gradually over about 5 minutes when she was then A&O x4. Vital signs stable throughout. For next 20 minutes this NP and patients father encouraged deep breathing and calming techniques, patient regained color to face and lips, hand contractions released, grips 5/5 bilaterally. Patient was assisted to sit up for a few minutes, then to stand for a few minutes -- tolerated well, felt well. Father assisted patient out of clinic, patient with steady gate, vitals stable at time of exit, and verbally stated she was "feeling better".

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

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

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

17 yo F in post vac are reports nausea, dizziness, headache 4 mins after vaccination. Denies other s/s, speaks clear and complete. No respiratory distress noted. Two set of vitals taken, WNLs. . Monitored for 30 mins, s/s continued and have increased, post vac nurse recommended medical attention. Mom declined EMS transport. Mom stated she would take pt to a local urgent care.

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.

Approx 3 hours after vaccination, patient did describe headache. About 12 hours after vaccination, patient was describing trouble swallowing and felt like her "throat was closing". No trouble breathing was noted. Patient went to local ER and was treated with ketorolac for HA and diphenhydramine. Patient was back to normal self 15-20 minutes after diphenhydramine. No further problems reported 12 hours after this.

pt started feeling light headed, and nauseated. to first aid room vital signs taken , BP 134/74, P 82 R 16 , )2 sat 100% . Md here visited with pt , ordered zofran for nausea, and to continue to obs. .last BP 117/80, 92.

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

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

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 was dizzy and nauseous. She felt heaviness in her head. Her vitals WNL. She had not yet eaten and was given Coke and a snack. Patient's symptoms resolved within 15 minutes.

9:15 am client reported to have lightheadedness and nausea. Also reported has high anxiety and is on Prozac. MD on site evaluated client. Vitals done and was observed for 30 minutes. No further complications and client then drove home.

The day after the vaccine- chills and headaches-lasted for 3 days The symptoms worsened slowly & on 03/10/2021 presented: sore throat, cough, diarrhea, chest pains when coughing. Patient was tested for COVID-19 (PCR), for Strep (RST & THROAT CULTURE), Influenza A& B, EKG, CBC and Basic Metabolic. Patient was treated with AMOXICILLIN for possible Strep until culture was available, ALBUTEROL INHALER & DEXAMETHASONE for bronchitis. *** This patient was Positive for COVID-19 in August 2020. She had the same symptoms as in March.

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.

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

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

Two minutes after receiving her vaccination, she experienced lightheadedness, nausea, and dry heaving. She was taken to a private section of the arena monitored.

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.

Started to have typical flu symptoms night of 2nd vaccine, also followed with dizziness, nausea, and lastly small bumps of a rash developed over chest, neck and back.

Patient presents with a fear of needles. Post vaccination, patient felt nauseous. Patient vomited and nausea dissipated. Patient was given crackers and juice in observation tent and reported improved symptoms.

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.

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

Sudden onset nausea after vaccine. Rest, water, provided, monitored for 30 min. Family called for transport home. Ambulated off grounds.

Patient was feeling very shaky, dizzy and nauseous 2 minutes after the shot. Patient said she felt like she was going to pass out. We laid her on the ground and gave her water and orange juice. Patient stabilized after a couple of minutes. Paramedics came out and double checked on her, but mom said she did not need to go to hospital. Patient walked away fine. Most likely nerves that caused this incident.

Pt became nauseated and lightheaded. Pt vomited x2. Pt stated symptoms improved. Pt declined transport to ED

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

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

Patient 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.

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

Patient fainted within 5 minutes of administration. She came to very quickly and felt nauseous. We monitored and had her drink water. Advised mother to call PCP on Monday

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.

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

Pt anxious at the time of vaccination. Nauseated. BP 88/57, at discharge 104/62. OxSat 99%. HR 65, 71 @ Discharge. Blood sugar 94.

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

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

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.

On March 27, 2021 at 11:30pm started to not feel well, went to sleep woke up on and off through the night with chills, on march 28th felt nauseous on and off throughout the day, also had a slight fever of 101°F took tylenol and it helped

1325- Pt presented to observation room, mom was supporting her as she walked. I got to the patient and supported her to the ground as she started to fall. Pt did not lose consciousness, appeared diaphoretic and pale, stated nauseated and didn't feel good. Mom said she has done this in the past when has had injections or blood draws. Laid pt with feet up on a chair. Ice pack placed on forehead. Answering questions appropriately. 1328- BP 112/72, HR 68, RR 20 1330- pt stated feeling better and sat up slowly 1333- felt well enough to sit on the chair 1338- pt and mom opted to leave premises, pt appeared neurologically intact, stable and walking independently

At 3:50 pm, patient complained of feeling dizzy, started vomiting of undigested food, as she stated she ate just before coming to COVID 19 event. Vitals B/P 82/58, HR 61, R 20 O2 sat 99%. Evaluated by EMT and this nurse. Had patient to rest, gave sips of water and gatorade, and liquids tolerated well. Second set of vitals taken: B/P 92/60, HR 53, R 20. At 4:30 pm patient stated she felt much better, and released to parents.

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

Severe headache, dizziness, nausea lasting approximately 45 minutes woke from sleep on night of 4/11/21. Improved with tylenol. Milder headache/dizziness for one day following, no medication needed.

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

The patient had her second Pfizer covid 19 vaccination at 1835. During sitting in observation area at 1845 the patient felt nauseated and faint. The patient went to ems room with staff to lay down and was given an ice pack and water. She felt ok at 1902 and left reporting no dizziness.

I gave the patient the immunization. She seemed fine after getting the shot. I asked her to go outside the immunization room and wait 15 minutes for observation. Immediately upon leaving the room, she felt dizzy and made it to the chair to sit down, when she said she briefly blacked out. By that time, her father arrived, and gave her some orange juice to drink. She said she was starting to feel better, but that her stomach felt queasy. After15 minutes, the patient was feeling better and walked out with her father with no other reports of problems.

Rashes all over the body with medium to large size blots, redness and raised. The skin has a rough texture to the touch. Headaches, tiredness, chills, and light nausea. Lack of air, and chest pressure, with difficulties to swallow.

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

One hour after returning home.Heaviness in limbs, unable to walk, shortness of breath, nausea, heaviness in chest. PCP provided oxygen, steroid shot, shot for nausea in office. Observed until symptoms subsided. Released with Rx for steroids and anti nausea medications

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.

1135am Nausea, dizzy, light headed, patients legs were elevated, ice pack given, water given, patient was fasting, father went and got patient food. 1205pm BP 115/74, pulse 72. Patient eating, reports no nausea, dizziness, or lightheaded. 1215pm patient walked out with nurse practitioner. Patient verbalized understanding to call PCP and continue to eat and drink today

Patient received her 2nd dose of COVID (Pfizer). She walked out of the immunization room to wait in the store, made it about 2 aisles over, and fainted. Patient's father and the Pharmacist immediately got to her side. She came to within less than 1 minute. In the meantime EMS was called and the Pharmacist waited with the patient until they arrived. EMS looked over the patient and patient was able to leave on her own after waiting out the nausea and dizziness that had occurred. Patient also reported a headache which was most likely from hitting her head on the way down.

Patient became dizzy and passed out after returning to her car. Guardian beeped horn and nurses evaluated patient. Patient aroused easily. Patient very pale. Patient vomited x 1. BP 88/50, P 53, R 14, Spo2 99%. 911 called, arrived within 15 minutes. Vitals and blood sugar stable. Patient denied any further dizziness and reported not eating prior to vaccination appointment. Patient also reported similar incident one other time after receiving a shot. Patient discharged home, no EMS transport. Follow up phone call revealed patient was feeling fine.

Per recovery RN notes: "At approximately 0841, patient stated feeling dizzy. Mother noted with patient. Patient anxious. Pt loss of consciousness for approximately 10 seconds. Rapid response called. Patient regained consciousness. Patient with emesis x1. Vital signs stable BP 109/70 HR 64. SpO2 at 99 on room air. Rapid response team arrived at scene. MD assessed patient. Per mother, patient has a history of syncope after vaccinations. Per MD, ok to go home once stable. Patient noted to leave facility at 0904, in stable condition.".

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

client stated she felt nauseous and had 1 episode of vomiting. After client vomited returned to baseline. observed for 10 more minutes and evaluated by MD. Client advised of follow up care and declined transport to ER for further evaluation. Patient noted to be back at baseline and father drove client home.

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

She became very red; Dizziness; Vomiting; Diarrhea; Hypotension; This is a spontaneous report from a contactable healthcare professional. A 17-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0158), intramuscular, administered in left arm on 09Apr2021 16:30 as single dose for COVID-19 immunization. Medical history included 3 weeks of urticaria prior to vaccination. The patient has had no COVID history prior vaccination. The patient has not been tested for COVID post vaccination. Concomitant medications included fish oil; diphenhydramine hydrochloride (BENADRYL); cetirizine hydrochloride (ZYRTEC); ibuprofen (MOTRIN), and an unspecified multivitamin. The patient previously took Amoxicillin and experienced drug allergies. After vaccine, the patient became very red, had dizziness, vomiting and diarrhea and hypotension on 09Apr2021. The events resulted in an emergency room/department or urgent care visit and hospitalization for 1 day. Treatment included epi, Benadryl, steroids, Pepcid, and fluid boluses. The outcome of the events was not resolved.

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.

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

difficult swallowing post vaccine - tightness of throat. ; Gave Epi 0.5ml at 14;18; Ambulance at 1430

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

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

passing out; Vomiting; diarrhea; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 13Apr2021 at 13:45 (Batch/Lot Number: Ew0161) at 17-years-old as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient's medical history was reported as none (no known allergies). The patient did not have COVID prior to the vaccination. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) taken for an unspecified indication, start and stop date were not reported. On 14Apr2021 at 13:15, the patient experienced passing out (medically significant), vomiting (non-serious), and diarrhea (non-serious). The clinical outcome of the events was recovering. The patient was not tested for COVID post vaccination.

Patient felt dizzy right after her vaccination, she was sweating a lot and wanted to throw up but didn't . No problem breathing . we called 911 and ambulance came and took patient to hospital for further evaluation. we called patient's dad at 3:00 pm, patient was feeling fine and got home already.

Aches and sight nausea/fatigue the day of vaccine, on day of vaccine I was 142 pounds. Two days later I was 145. Today, 5 days post vaccine, I was 147 pounds. My weight has never fluctuated this much in such a short period of time ever. There has been no change to my diet, activity level, medications or any other factors since vaccination. My weight was steady prior to vaccination. The vaccine in question was my second dose. I had no adverse reactions after my first vaccine.

Pt. C/O feeling light-headed and nauseated while sitting at the observation hall. She vomited some undigested food particles after sipping some fruit juice offered by her mother. Writer to her in a wheelchair to the cubicle in the observation hall for further observation. V/S T. 97 degrees fahr. b/p 97/68, rr 14, h rate 85, O2 98% RA. Pt was verbal, A&Ox4. No c/o pain or respiratory distress. At 3:10 p m pt. said she felt well and okay to leave. v/s - b/p 100/77, heart rate 80, O2 98% RA. She left the observation hall in the company of her mother unassisted

Severe abdominal cramping for 2 days and now menstrual cycle has started 10 days earlier than scheduled

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

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

Immediately after administration of vaccine, patient fainted. Patient assisted in to wheelchair and wheeled to private observation area. Patient assisted to gurney. Patient has cool compress to forehead. Patient also nauseous, pale, and sweaty. Patient mother reports patient did not eat today. Given water and apple juice. Patient declined granola bar. Vital signs as follows: 0950-BP 88/59, P 86, RR 20, 95% RA, no pain. 0955-BP 92/60, P 69, 99% RA. 1000-BP 96/67, P 75, 100% RA. Education given to patient and mother regarding eating/drinking before next dose and to tell the vaccinator that patient passed out at last vaccine and to lay on gurney before second dose is given. Patient and mother acknowledged understanding. Patient back to baseline at 1010.

fever 100.9; nausea; back pain; sleepiness; chills; fast heartbeat; This is a spontaneous report from a contactable consumer (parent) reporting for his daughter. A 17-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as single dose and had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as single dose for covid-19 immunization and stated was fine after the first dose. Patient was 17-years-old at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient experienced fever 100.9, nausea, back pain, sleepiness, chills, fast heartbeat on an unspecified date. The outcome of event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

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

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.

The worst abdominal cramps I've ever experienced to the point where I could not walk over the course of about 8 hours

client complained of dizziness and nausea after receiving 1st Pfizer Covid Vaccine. At 1000 client reported to EMTs feeling light headed and nauseous. Per client had not had any breakfast or hydrated today. EMT gave client water and crackers. Per client no allergy to any of the ingredients. First vitals: blood pressure 130/70, pulse 80, oxygen 98%. Client's parent here, states client takes medication for depression, unable to recall name and birth control. Vitals at 1010: blood pressure 110/70, pulse 80, oxygen 98%. Per client still nauseous, light headedness improving. 1015 vitals: blood pressure 110/70, pulse 79, oxygen 97%. Mild nausea, light headed resolved. Vitals at 1020: blood pressure 108/70, pulse 78, oxygen 98%. Per client all symptoms resolved. Client given ER precautions and advised to consult with provider prior to second dose. Parent driving client home. Client left facility with steady gait at 1022.

Pt has had a rash on neck and face X 3 days. She reports its slightly itchy, swollen and red. Not painful. It started on neck and spread to face. No fever, no trouble breathing. Very slight tight feeling in her throat yesterday with mild difficult in swallowing, but otherwise no issues swallowing/breathing today. Had first dose of covid pfizer vaccine 10 days ago. Has tried benadryl and hydrocortisone (one dose/application each) with no significant improvement.

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

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.

The day after the 2nd vaccine patient got horrible cramps and it immediately bleed although it was not time for her period. She bled for 2 days then stopped. This month her period is so painful she thought her appendix ruptured. The pain was so intense it caused her to vomit. Patient's flow is incredibly heavy , thoroughly saturating a super plus tampon in an hour.

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

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

Vomitting (cant keep anything down at all),headache, body ache to the point she was crying some of the time, diarrhea, exhausted No fever so far It started at 3:00 am and it is now 7:30 am and she is finally able to fall asleep.... hopefully she improves throughout the day (still early)

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

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

I had administered the vaccine, pt tolerated well, pt given discharge instructions and instructed to wait for 15 minutes at the observation area. As I was waiting for the next patients to arrive, another technician notified me that she had a reaction of vomiting. When asked patient stated after the injection she felt burning from the site to the nape of her neck and while waiting at the observation area she had nausea and went to one of our stations to vomit in the trash. Patient was escorted to our treatment room for vitals and was given a cold pack for the back of her neck. Our Allergist provider was called to assess patient. When I had arrived to the treatment room to observe her, patient stated this was the first time she had this type of reaction. The provider ordered for her to stay and be observed for 1 hour with 15 minute intervals of vitals. The patient had no other reactions and had no pain, vitals were within normal limits.

Fever; Cough; Fatigue; Congestion; Body aches; Nausea; Shortness of Breath; Acetaminophen (TYLENOL) tablet 650 mg Ondansetron ODT (ZOFRAN-ODT) disintegrating tablet 4 mg.

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

Pt started having nausea and then had difficulty breathing and hyperventilating. Pt was transported by EMS.

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.

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.

Isolated nausea about 8 minutes after her shot. No emesis. No other symptoms to suggest a vasovagal reaction. No SOB, CP, dizziness, or sense of asthma attack. No wheezing. Nausea spontaneous resolved within about 5 minutes. VSS throughout. No orthostasis. Initial BP- 110/81, Pulse - 68, O2 sat - 100%

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.

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

Within a minute of administration, patient became diaphoretic, pale, vomited. Chair reclined. After vomiting, she immediately felt better. She was given water and monitored for 30 minutes. Upon assessment, it appeared as though patient was having a significant amount of anxiety at the time of injection, possibly causing aforementioned events.

Date and time of vaccination: (list both if they received both shots): 1st dose 4/6/2021 at 1100. 2nd dose 4/27/2021 at 1100. Date and time adverse event started: ~4/8/2021 (2 days post-vaccination), time unknown. Pt's mother reports that a couple hour post 1st dose vaccination, pt vomited right after. Couple days after 1st dose, pt had a breakthrough symptoms of hallucinations and delusions. Approx. a week later these symptoms gotten better and pt seems to return back to her normal self. Pt reports several hours post 2nd dose, pt vomited off and on and developed chills. In addition, pt's breakthrough symptoms appeared once again but seems worse than from the 1st dose. Today, pt is getting better but symptoms appears to lessen. ***NOTE*** Recommend pt's mom to see MD per these are not a common ADEs of the vaccine. Pt's mom advised pt have a follow up with MD on 5/4/2021. 5/5-Pfizer lot#EP7533, #ER8730. Patient no longer has symptoms, diminished on 5/3/21. No treatment was used to alleviate symptoms. Provider wrote a script for Ativan PRN yesterday but patient has not taking medication as of yet, has used non-pharmalogical coping skills to help alleviate symptoms.

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

Throwing up, headaches, abdomen pain, soar throat, chills, fever, sleepy, coughing violently, sneezing constantly, mucus coming up well coughing, wheezing, painful coughs, 05/06/2021

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

one week after covid #2 vaccine developed fevers, neck pain, headaches and vomiting, treated for lymphadenitis with oral antibiotics with continued fevers now x 9 days

Pt felt dizzy after the 1st dose of Pfizer vaccination. As I was walking out to check on her, she fainted. She regained conscious immediately. I gave a small soda to drink and she threw up after but she didn't faint again. She felt better right after she threw up and stated that this never happened before. After about 45 minutes, pt stated that she felt much better and wanted to leave with her dad.

Client reported abdominal pain 7-8 out of 10 PSO2 99 Heart rate 112 b/p 122/72. A&O x3, skin pink warm and dry, respirations even and unlabored. Mother was gotten from car, reports her daughter gets anxiety and that causes stomach flare ups. States she is not concerned, not necessary for ER or further treatment. Client released to mother. Informed to go to ER for any further problems.

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

Patient was in recommended observation and was on the phone with her father and told him she began to feel nauseous. Shortly after she leaned forward from the chair and fell to the ground passed out. Her blood pressure was checked immediately and found to be 121/81. She was immediately responsive and said she still felt nauseous and light headed. EMT was called and they arrived within 10 minutes. Her father also arrived on scene. EMT determined that no serious medical treatment was required and patient left with her father to drive her home.

About 24 hours after shot: Nauseous, body ache, head ache About 42 hours after shot: head ache, stomach ache No treatment course taken

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

Appendicitis with hospitalization and surgery. Vaccine site. 2nd dose administered on 05/12/2021 at 3:00pm

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.

While sitting in class, suddenly passed out and vomited at the same time. Came to about 30 seconds later. No additional adverse affects after the episode.

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

Woke up sore with a mild fever with chills, slightly nauseous and improved as the day went on, mostly back to normal by the day after.

Fever - 24hrs Fatigue - 24hrs Vomiting - once around 7:00 PM on May 16 Headache - about 9 hours starting at 1 on May 16

Around 10-15 minutes after receiving 2nd dose of Covid vaccine, pt complained of feeling dizzy/nauseous and having lightheadedness. She had a brief moment of blackouts. 911 was called and she was transferred to the hospital.

Patient experienced syncope shortly after receiving vaccine while standing. Patient fell and remained on ground per advice of EMTs who arrived and escorted via ambulance for evaluation due to the patient experiencing nausea and vomiting upon rising back up.

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

Fever; chills; severe arm pain; nausea; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8736 and expiration date was not reported), via an unspecified route of administration in right arm, on 11May2021 at 19:15 (at the age of 17 years old) as second dose, single for COVID-19 immunization at a pharmacy or drug store. Medical history was reported as none. The patient had no known allergies. Concomitant medications included sertraline hydrochloride (ZOLOFT), loratadine (CLARITIN) and birth control (unspecified). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0170 and expiration date was not reported), via an unspecified route of administration in right arm, on 17Apr2021 at 13:00 (at the age of 17 years old) as first dose, single for COVID-19 immunization. The patient was not pregnant and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was never tested for COVID-19. The patient experienced fever, chills, severe arm pain and nausea on 12May2021 at 05:00. No treatment was given to the patient for these events. The outcome of these events was recovering at the time of report. No follow up attempts are needed. No further information is expected.

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

Patient received COVID19 vaccination and within 30 seconds experienced nausea and vomiting 2:03 PM Vital Signs: BP 104/62 HR 77 Resp 16 O2Sat 92% Skin Signs: Warm and dry Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally Initial Treatment: Patient monitored, Nausea resolved. Provided water 2:18 PM Vital Signs: BP 108/71 HR 71 Resp 16 O2Sat 97 Skin Signs: Warm and dry Circulation: Cap refill <1sec Respiratory: Breath sound clear bilaterally BP 120/84 HR 87 Resp 17 O2Sat 99 Skin Signs: Warm and dry Circulation: Cap refill <1sec Notes: Patient advised to follow up with medical provider if other symptoms occur. Patient released with parent. Patient and parent instructed to keep well hydrated and to re-introduce food initially as per a BRAT diet.

Developed nausea, vomitting, abdominal pain and early heavy menstral bleeding. Previously on oral contraceptive with normal periods. Got period a week earlier (while still taking oral contraceptives) and had a much heavier period. Had nausea and vomiting that awakened her from sleep the morning preceding the bleeding started.

Pt. Is a 17 y/o female with NKA, no past medical history. Second dose of Pfizer was given in L deltoid at 1536. Approx. 1543 pt. Began to c/o of nausea and dizziness. Pt. Was moved for privacy, she verbalized wanting to lay on the floor for comfort due to her history of fainting after injections. Pt. Was A&O x4 during event. VS were performed before patient departed. 1546: 100/70 HR:71 o2:91% RR 19 (Laying) 1550: 110/80 HR: 93 o2: 99% RR: 19(sitting) 1552: 120/90 HR:93 o2:99% RR:20 (standing)

Patient observed at 1647 stating she was nauseous and anxious. Patient given emesis bag and then vomited. Assisted patient in wheelchair and taken to observation private area with guardian. Obtained a full set of vitals at 1650 as follows: O2 sat 98% RA, HR 71, RR 32, and BP 110/80. Encouraged patient to slow breathe in and out of bag. Another set of vitals obtained at 1700 as follows: O2 sat 98% RA, HR 89, RR 20, BP 110/75. Pt stated she was starting to feel better. Observed patient for another 10 minutes at 1710 vitals as follows: O2 sat 98% RA, HR 83, RR 26, BP 111/79. Assisted patient to a sitting then standing position. Patient's mom stated she thinks everything is okay..and she would monitor her at home. Explained to her to seek EMS if symptoms progress. Patient's mother Verbalized good understanding. Left site at 1718.

Patient developed chest tightness during soccer tournament the day after receiving first dose of COVID vaccine and then subsequently developed abdominal pain with several episodes of hematochezia which self resolved. Upon arrival to the ED pt had elevated troponin which downtrended. EKG and ECHO were normal and symptoms resolved without intervention.

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.

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

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.

Fever of 103; chills; sweating; body ache; nausea; vomiting; diarrhea; headache; couch; chest pain; This is a spontaneous report from a contactable consumer for herself. A 17-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 07May2021 17:00 (Lot Number: EW0176) at single dose for COVID-19 immunisation. Medical history was none. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. The patient previously received first dose of BNT162B2 (lot number=EW0153) in left arm on 15Apr2021 04:00 PM for COVID-19 immunisation. The patient experienced fever of 103, chills, sweating, body aches, nausea, vomiting, diarrhea, headache, couch, chest pain on 08May2021 13:00 with outcome of not recovered. Events were resulted in doctor or other healthcare professional office/clinic visit. No treatment received. Patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19.

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.

passed out; vomited; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm left on 03May2021 15:30 (Batch/Lot Number: EW0153) as 2nd dose, single for COVID-19 immunisation. The patient had no relevant medical history. She had no allergies to medications, food, or other products. Concomitant medication included fluoxetine taken for an unspecified indication within 2 weeks of vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 12Apr2021, 03:30 PM (Batch/Lot Number: EW0153) as 1st dose, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination. On 04May2021 12:00, the patient passed out and vomited at the same time while in a sitting position. The were no additional side affects once the episode passed. The event resulted in doctor or other healthcare professional office/clinic visit. Events were reported as non-serious. No treatment was received. Outcome of the events was recovered in May2021. The patient had not been tested for COVID-19 since the vaccination. Information on Lot/Batch number was available. Additional information has been requested.

Patient was asymptomatic 4 hours after vaccination given at 10a, then in the evening started to develop chest pain, shortness of breath, nausea, and abdominal pain. Patient came to ED for evaluation. She received epinephrine IM 0.3 mg, Benadryl 25 mg, Pepcid 20 mg, 1 L NS bolus, Toradol and PO Tylenol for pain management. Patient is now feeling better.

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

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

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

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

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

Follow up report - The symptoms - severe headaches; shortness of breath; difficulty breathing; chest pain and throat pain with activities - even if he walked across the room he had this pain along with the shortness of breath; body aches and fatigue. He is an athlete and not able to do any of the sports - he starts breathing heavily when he walks across the room. He couldn't attend school for over a month. Has been to several physicians - a pulmonologist several times; cardiologist; gastroenterologist; his pediatrician. He got a steroid shot - 24th, given to him for the headaches. Last Monday, the 24th of May (the pulmonologist gave this to him). It (the headaches pain) was really bad on Tuesday, Wed, Thursday and he started feeling better with the headaches on Friday. He has been given an inhaler and Pepcid for acid reflux (gastroenterologist). These have given him a little relief - but he don't know if it's the steroid shot or the inhaler that is helping. Yesterday he tried to go to his Sports class and he couldn't do it - there was a problem with breathing; a lot of shortness of breath. The headaches and the breathing issues are still what are debilitating him the most.

Roughly 2 minutes after receiving her I am Pfizer vaccine, patient told mother that she was feeling slightly lightheaded. She proceeded to lose consciousness. Mother honk the horn and alerted staff to come to help. Patient was in the car on the passenger side, patient was fully sitting up. I reclined her all the way down in her passenger seat, she was slightly gasping for air, Ambulance was called for evaluation. She had loss of consciousness for approximately 30 seconds. She regained consciousness and said she was feeling confused as to what it happened. Denies any feelings of needing to vomit, Or post ictal symptoms. EMS and fire we?re on scene by then, report given to paramedics on site. Patient declined further medical treatment and Ian made with the ambulance. after this stating she was a little tired. She continue to wait for 30 minutes, she had 1 episode of emesis and felt better. At the site with no issues.

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

Swelling on the left hand (fingers) - a ring couldn't be taken off. The injection site was red and very itchy - that lasted for about three days. There was a lot of drowsiness; fatigue; upset stomach - lasted about a week. Went to Primary care doctor; he said it was a side affect. He told us to keep an eye on it. The swelling lasted three or four days.

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.

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

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

Patient developed a rash on both arms, became itchy, nauseous. Hydrocortisone cream was applied along with a dose of oral Benadryl.

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

Patient had nausea and dizziness after the vaccine ; patient vomit but after that felt better and left the pharmacy

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.

Woke up in morning around 8:00 with nausea and vomiting. Nausea most of the day. Headache, severe lower back pain

Patient reports that her 2 menstrual periods post vaccination over the last 2 months have been accompanied by severe cramps, lightheadedness and dizziness and nausea. Concerned that this is related to the Covid vaccine.

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.

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.

About 10 minutes after vaccination, patient felt lightheaded, nausea and appeared to be pale. She was nervous and felt scare at the time of vaccination. We found out patient didn't eat and wasn't hydrated. We provided water, orange juice and father approved for us to call paramedics. Paramedics didn't take her away. We were informed that patient had low blood pressure but did not go to the hospital. I followed up with patient and she said she was okay and she had food to eat. I informed patient to try to reach out to the family physician for follow up and discussion about the vaccine.

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 received the pfizer vaccine at 03:18 PM and at 03:22 PM as the patient was walking into the waiting room passed out on the floor. The mother of the patient caught the patient before she hit the floor and therefore the patient did not hit her head. Patient lost consciousness for about 30 seconds before regaining consciousness. Upon regaining consciousness the patient proceeded to vomit about 2 ounces of clear to yellowish emesis. Patient was given water and her vitals were taken. Her vitals are as follows: blood pressure 110/80 Heart rate 82 and oxygen level was 96. Patient is currently alert. The patient recovered well and is able to answer questions asked of her. The patient waited in the observation room from 03:22 PM-03:50 PM.

Mother of PT states her daughter experienced as diagnosed a sinus tachycardia, her heart rate elevated at 136bpm, it took awhile to come down at resting rate. Mother of PT experienced nausea, heart palpitations. Her daughter is now taking Metoprolol medication and is also now seeing a cardiologist. Mother of PT states her daughter's appetite is also gone since receiving the Pfizer vaccine.

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

Diarrhea; Pain in the lower right side of my back; This is a spontaneous report from a contactable consumer (patient, self-reported). A 17-year-old female patient (age at vaccination: 17 year) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0179 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 13May2021 at 12:30 PM, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included allergy to Biotin (big amounts of Biotin). Concomitant medications were not reported. 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 was not tested for COVID. The patient reported that on 13May2021 at 16:00, she had diarrhea and pain in the lower right side of her back, the first few days after the first dose. There was no prolonged hospitalization. The patient did not receive any treatment for the events. Outcome of the events was resolved on an unknown date in May2021. Follow-up attempts are needed. Further information is expected.

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

Pt. with some SOB, headache, stomachache, nausea , decrease appetite 5 hrs after receiving 2nd Covid-19 Vaccine (Pfizer). Epi (111000)She improved after giving 0.3 mg and giving Prednisone . She was sent home on tab Prednisone 20 mg bid x 3 days

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

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.

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.

Upon walking to recovery area patient went pale and fainted. Witnessed fall, fell and hit head on the floor. Vital signs taken: BP:110/60 HR:70 SpO2: 98% in RA. Pt initially did not recall receiving vaccine but when asked orientation questions, she answered all appropriately (A&Ox4). Within five minutes EMS on scene to assess pt. Pt could not recall last meal, BG checked and was 91. Upon sitting up pt was nauseated and dizzy. Pt transferred to ED for follow up care.

Severe abdominal and back pain starting at 7:20 May 25, 2021. No otc med worked to relieve pain. Could not get out of bed. Called pediatrician.

whole body ache; dizziness; chills overnight; bad headache; Nausea; This is a spontaneous report from a non-contactable consumer (patient). A 17-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248; expiration date: not reported) first dose via an unspecified route of administration, administered in arm left on 14Jan2021 at 15:30 as 1st dose, single and second dose via an unspecified route of administration, administered in arm left on 04Feb2021 at 15:30 (lot number: EN5318; expiration date: not reported) as 2nd dose, single (age at vaccination was 17 years) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccine in four weeks and had no COVID prior vaccination. On 05Feb2021 at 01:30, the patient experienced chills overnight, whole body ache, bad headache, dizziness, and nausea. No treatment for reported for the events. The patient had not COVID tested post vaccination. The outcome of the events was resolving. No follow up attempts are possible. information about lot/batch number cannot be obtained.

Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Abdominal Pain-Severe, Systemic: Confusion-Medium, Systemic: Fever-Medium

Patient fainted, she regained consciousness within 5 seconds, she vomited & she was lethargic. Paramedics arrived at the scene within 10 minutes and treated the patient off site.

Fever to 101.3 and malaise night of vaccine, "bad cough" on the following day with chest pain which resolved over a few days, then she developed bilateral ankle swelling and pain 80 hours later with a rash and swelling spreading up to her thighs and down through her feet. hands also swelled and turned white (sounds like Raynaud's). knee pain resulting in difficulty sleeping at night. tachycardic on exam. evaluated in clinic on 6/11 and follow up on 6/15. noted loss of appetite for a week and fatigue. Myalgias made ambulation painful. instructed to use NSAIDs and elevation and she improved over the next few days

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

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

The patient passed out about 12 minutes after receiving second dose of Pfizer covid vaccination. The patient's mother got the attention of the monitoring nursing staff at which time the patient was alert and staff elevated patients lower limbs, checked BP, HR, pulse ox, and provided cold compresses and water for patient. After about 5 minutes patient also vomited. The patient was monitored for an additional 20 minutes at which time patient felt better and was able to walk out without assistance.

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

Patient experienced vomiting/dizziness within minutes after administration. She felt better after drinking water and eating crackers.

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

low grade fever; severe diarrhea for 3 days; intermittent vomiting; headache; This is a spontaneous report received from a contactable consumer, the patient. A 17-Year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: FP7534) as a single dose via an unspecified route of administration in her left arm on 20Mar2021 at 10:30 (at the age of 17-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine. On 21Mar2021, the patient experienced severe diarrhea for 3 days with intermittent vomiting, low grade fever and headache. The patient did not receive treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes for the events severe diarrhea, intermittent vomiting, low grade fever and headache was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

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 received her shot and was told to sit and wait for 15 minutes- pt instead walked around the store and then felt lightheaded and fainted. pt was conscious and claimed to feel nauseous as well. we gave her water and some crackers and pt felt better and like she did not need any further medical attention. called pt this morning to check on her and pt father reported that she is fine and doing well.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: vomited-Mild, Systemic: Vomiting-Mild, Additional Details: pt passed out shortly after vaccine. turned white, gave some water and she strate trowing up. we called EMT WHO TOOK OVER. pt refused to go to hospital. went home, follow up with dad she was ok and was keeping her hydrated. had a call into md

nauseated & sweaty 10min after first dose. Stable vitals. No respiratory distress. Symptoms resolved.

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

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

Daily stomach discomfort; This is a spontaneous report from a contactable consumer (patient). A 17-years-old female patient received BNT162B2, via an unspecified route of administration on 15Jul2021, (at the age of 17-years old), (Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history and concomitant medications were reported as none. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The patient experienced daily stomach discomfort on 16Jul2021. Since the vaccination, the patient had not been tested for COVID. No treatment was given for the event. The outcome of the event was not recovered. Information on the lot/batch number has been requested.

PATIENT DID NTO EAT BEFORE THE VACCINATION AND WE GAVE HER A SNACK. SHE FAINTED AND THEN THREW UP. SHE WAS HYPOTENSIVE AND BARDYCARDIC. SHE REBOUNDED QUICKLY AND CLOTHES WERE CHANGED. pT OBSERVED FOR 10 MINUTE AND SENT HOME WITH MOM.

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

Got the vaccine about 12:30 and an hour later she said she felt she felt she was having difficulty swallowing, but she does have history if anxiety but was given 1 Benadryl by nurse Elissa and observed for her for 20 min then pt. claimed to felt fine and went to, nurse instructed her to call if she had any problem.

4 February 2021@0300-patint says she had body aches, Threw up, fever HA and SOB @ this time 1000-4 February 2021-she feels poopy/crappy I reminded her to go to the ER if she gets worse Motrin doesn't really help her feel better-she can sip some Gatorade to assist with the HA, BA & fever

Shortly after immunization, patient started to develop a rash around the injection site as well as nausea. Given Benadryl and transferred to the Emergency Department.

Throwing up; vomited 4 times; Chills; Headache; Fever; highest temperature was 101.4 degrees; low-grade temperature; Nausea; Stomach was not feeling right; upset stomach; This is a spontaneous report from a contactable consumer (patient's mother who is a caregiver). An 18-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), intramuscular in right arm, on 26Jan2021 at 07:30, at a single dose, for COVID-19 immunization. The patient's medical history included birth control pill. The patient's concomitant medication included ethinylestradiol/ norgestrel (CRYSELLE) from 26Jan2021 as birth control pill. The patient previously took the first dose of BNT162B2 on 05Jan2021 at 08:00 AM for COVID-19 immunization (in right arm). The vaccine was administered in a hospital facility. The patient was a certified nursing assistant (CNA) at a hospital. The patient and her mother both work at the same hospital that administered their COVID-19 vaccines, both received the first and second COVID-19 vaccines at the same date and time. The patient received her second COVID-19 vaccine dose yesterday (26Jan2021). Since 26Jan2021 around 09:00 PM, the patient was experiencing symptoms of chills, headache, fever, and nausea. The patient had a fever, clarifying that the highest temperature was 101.4 degrees, and also has chills and headache. Last night (26Jan2021 at 09:00 PM), the patient's stomach was not feeling right, had a low-grade temperature, and chills. On this morning (27Jan2021), the patient was throwing up. The patient didn't throw up until this morning and has vomited 4 times today. The patient has not sought medical treatment from an emergency room or doctor yet. The patient has been throwing up today. If the patient continues throwing up, and becomes dehydrated, she may need to go the emergency room. It was also reported that the patient started ethinylestradiol/ norgestrel last night. The patient's mother thought that the patient's initial stomach upset may have been caused by the ethinylestradiol/ norgestrel. Therapeutic measures were taken as a result of headache and fever including ibuprofen and acetaminophen; the patient isn't taking anything for nausea at this time. The patient's mother wanted to see if anyone else had been reporting these side effects the patient has been experiencing since receiving her second COVID-19 vaccine dose. The patient had not recovered from the events. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.

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

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

On Fri 3/5 one of the RPhs on duty administered the vaccine around 2:45 PM. RPh advised patient to wait in the waiting room for 15 minutes to make sure she felt fine. Around 3 PM patient told another patient sitting in the waiting room that she was feeling light headed and told her to call the pharmacy staff, which she did. One of the RPhs went out of the pharmacy into the waiting room to check up on her while the other pharmacist called 911. RPh who went to check up on her found her on the floor slouching. RPh tried to shake her awake and she appeared nodding off and on. Finally after a minute of two, she became more coherent and conscious. Team member grabbed orange juice to give to her. Other patient who grabbed our attention stated she was slowly sliding off her chair. RPh stayed by her side until paramedics arrived. Although she marked "No" on Section B #5 on the VAR form, she stated that she gets light headed and dizzy whenever she gets blood drawn or at the dentist. Paramedics checked on her vitals, was within normal range. Patient opted not to be taken to the hospital. RPh advised patient to call a family member to pick her up because although she felt ok to drive, she stated she felt a little nauseous and her head kind of hurts. Mother picked her up about an hour after the incident occurred.

Asthma; Syncope; Dizziness; Nausea; Vomiting; Severe headache; Fever; Muscle weakness; Muscle twitching; Fatigue; Chest tightness; This is a spontaneous report from a contactable consumer (patient). A 18-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: Em9810), on right arm via an unspecified route of administration on 23Feb2021 10:30 at single dose for covid-19 immunisation. The patient medical history was not reported. There was no known allergy. Concomitant medication included sertraline, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). Historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Feb2021 04:45PM on Arm Left for covid-19 immunisation. On 23Feb2021 10:30 patient experienced syncope (medically significant), dizziness, nausea, vomiting, severe headache, fever, muscle weakness, muscle twitching, fatigue, chest tightness, asthma. No treatment was received for the event. Patient not having COVID prior vaccination. Patient not tested COVID post vaccination. Outcome of the events was recovering.; Sender's Comments: Based on the strong temporal association, the association between the event syncope and the vaccine BNT162b2 administration cannot be completely ruled. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

At 1405, Patient was sitting in observation room after receiving first dose of Pfizer. Patient slide down from the chair to the floor and was assisted by her grandmother as well. I immediately went to the patient aide, and she awoke quickly to my voice. I asked the patient for her name and she stated her name. I asked her DOB and she identified her DOB. I asked her if she had any allergies and she denied. I asked the patient if she had any medical conditions, and she denied. I asked the patient if she has ever fainted before and she stated "yes", she has an extreme fear of needles. I also asked the patient if she had eaten anything and she stated, yes, we just had lunch. While I was asking the patient these questions, I assessed the Patient pulse and it was 110, and respiratory was 16. I then asked the patient to focus on her breathing and took the patient Vital Signs. 138/58, HR 78, Resp 16.Auscultated anterior fields, lungs were. clear, no advantageous sounds heard. The patient remained on the floor while asking the questions and assessing the patient. The charge nurse and the LVN, placed the patients feet up on the chair. I then asked the patient how she felt and she stated she was fine, I assisted the patient to a sitting position and asked her how she felt and she stated fine, and then we went to a standing position and she stated she was fine. I then assisted the patient to the chair, provided water and also a cool ice pack. Patient continued to have normal conversation with myself and her grandmother. A few minutes later, the patient appear to look like she was going to vomit, I then immediately provided the trash can to the patient. I also assisted the patient with cleaning the patients hands and right arm, where vomit was. Provided Clean hand wipes, and hand sanitizer. The patient remained stable, and 30 minutes later walked to the car with her grandmother and went home.

Pallor, vomiting, dizziness within 5 minutes of administration. Patient was given receptacle to vomit in, wet paper towels for head and neck, juice and snack to eat, and lowered to floor. Patient's color returned after snack/juice and rest for approximately 20 minutes. Was up and walking with her father after 30 minutes.

Developed appendicitis on Friday March 12th and had to have emergency surgery to have appendix removed

fever of 101.7 degrees, chills, aches, fatigue, nausea. have been happening since last night and have continued into today

BECAME NAUSEATED AND VOMITED IMMEDIATELY AFTER VACCINE DOSE. BECAME DIZZY WHILE WAITING IN OBSERVATION STATION. BLOOD PRESSURE WAS LOWER THAN USUAL. TREATED WITH ORAL REHYDRATION IN THE FORM OF WATER

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.

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

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

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

Patient stated she felt nauseous at the end of her 15 minute monitoring period. She was asked to stay for another 15 minutes while having a seat. At the end of the second 15 min monitoring period, she stated nausea had subsided and she felt okay to go home.

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

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

Patient vomited immediately after vaccination. She sat for approximately 7 minutes with an ice pack before asking to walk somewhere to lay down. About 100 feet in to the walk, she fainted. She was being supported on both sides by pharmacist and het boyfriend, so she went to the ground gently.

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

expected symptoms started at 24 hours: vague abdominal cramping, nausea, diarrhea, fatigue. and continued for 72 hours, then progressed to chills, sweats, intractable vomiting, severe abdominal pain and severe diarrhea. Visit to clinic required - IV fluids. Technical problem getting laboratory evaluation so return visit tomorrow if still symptomatic. Currently improved, but still with abdominal cramping and diarrhea.

Patient received dose at 11:30am, proceeded to obs area. Within minutes, she experienced c/o nausea, lightheaded feeling, and headache. Denies SOB, chest pain, or pain otherwise in body. Denies feeling of weakness. Patient reports exact symptoms with first dose, lasting all day. 11:45 BP 110/75, pulse 75 steady. Clinically stable, symptoms no worse. Patient mother agreed to transport patient home to recover, plans on calling provider re: mast cell activation and symptom management. Patient transported to personal vehicle via wheelchair without incident. NP

Immediately after injection, felt lightheaded, queasy, diaphoretic. BP- 70/34, p-70, repeat BP- 87/55, p-72 given juice, water, and laying down on gurney. After 30 minutes, reports feeling better, repeat BP- 96/60, p-73, O2sat- 98% Able to sit and stand without feeling dizzy or lightheaded. Discharged home with mother and ER precautions

Feeling nauseous at 7 pm, started to feel dizzy at 10 pm and passed out briefly, friend witnessed. Had 1/2 dinner at 7 pm and 3 water bottles between vaccination and 10 pm. Took shower next morning and felt dizzy getting out, tried to lay down and passed out briefly.

Two hrs after 2nd dose of pfizer on April 9, 2021, patient experienced the following for the next 48 hours: pain at injection site and redness; fever or 102; nausea; tiredness; chills (lasted 24 hours); headache; and muscle aches all over. All of this was handled through Sudafed Severe Cold tablets as if she had the flu.

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

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

Pt reports day 1 post vaccination fever, throat tightness; diffiuclty swallowing; difficulty breathing "a little"; dizziness; lightheadedness. Pt sent to ER

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

Patient sat in observation area and this RN noticed patient had head down between her legs. Patient reports feeling lightheaded and mother reports patient has a history of passing out with blood draws. This RN assisted patient in to wheelchair and wheeled her to the private observation area. Assisted patient on to stretcher. Patient removed mask and had patient recline. Patient also reports nausea. Gave patient apple juice and granola bar. VS as follows: 1002-BP 95/63, P 58, RR 20, 99% RA, no pain. 1007-BP 101/68, P 68, RR 20, 100% RA, no pain. 1013- BP 100/66, P 65, RR 16, 100% RA, no pain. After 30 minutes patient reports feeling back to baseline. Patient driven home by mother.

12 hours after receiving the second dose of Pfizer I felt fatigued and my injection site was red and swollen. 24 hours after the vaccine I was experiencing abdominal cramping, headache, and fatigue. 48 hours after I developed a severe full-body rash/hives/welts. It started as a small patch on my left arm and progressed to my hips, legs, arms, chest, back, and face - my whole body. The rash is extremely itchy and has caused me to bust blood vessels from scratching so hard and frequently. I began rotating Benadryl and Zyrtec, but it seemed to make it worse. I visited the ER in the middle of the night on 4/18 where I was given steroids and Benadryl IM along with Pepcid. The rash went away a few hours after, but has since then reappeared and I am currently running a low grade fever of 100.2. I am taking Prednisone 20mg 3x a day as prescribed by my doctor along with Benadryl 50mg every four hours and Pepcid twice a day. Despite these medications the rash continues to persist.

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

Pt became nauseous/sweaty/dizzy 10 minutes after 1st vaccine. Passed out w/ EMS for about 20 seconds then vomited. Pt fully recovered and hydrated. Released home.

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

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

Patient: Female, Per RN notes: "1610 vaccinated L deltoid, Reaction time: 1611 Fainted, Chin lift and head support, Patient recovered BP 82/55, HR 73 at 1614. Slight nausea. After vaccine administered, patient stated she "didn't feel good". Encouraged patient to deep breathe and wiggle toes. Noted pale in color and she lost consciousness. Noted breathing, still rapid response called. Patient awake, alert, transferred patient to gurney. Patient agreed to go/be transferred to the ER with security and ER nurse. "

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

Pt got vaccine and 10 min later started getting nausea and started puking. Was given water and gum to chew. Patient started feeling better

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

Patient came to vaccine clinic, immediately after vaccination, hypotensive 80/60, nauseated, but no other side effects

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

There was blood in the stool and coming alongside the stool; This is a spontaneous report from a contactable consumer (patient). An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 08Apr2021 at 18:15 (batch/lot number: EW0153) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient was not pregnant. The patient has no known allergies. Facility type vaccine was health clinic/facility. No other vaccine in four weeks. Concomitant medications included escitalopram oxalate (LEXAPRO), clarithromycin (CLARITIN) and melatonin; all taken for an unspecified indication, start and stop date were not reported. The patient experienced there was blood in the stool and coming alongside the stool on 09Apr2021 at 23:00 with outcome of not recovered. No treatment was received for the event. No Covid prior to vaccination and not Covid tested post vaccination.

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

Patient was sitting in a chair after the vaccine was administered, stated she was feeling well then fainted onto the floor. Assistance provided by nursing staff, noted to be pale, given water and stayed sitting on the floor (declined transfer to cot). She then felt intermittent nausea, had numerous emesis when attempting to stand 30" after initial fainting. Able to stand at 2015 and tolerated well. Able to ambulate to car, stated she felt better, accompanied by her father. Mother reported intermittent nausea and vomiting continued until 4/26 when seen in the ER, given IV fluids and antiemetics

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

Patient sat and waited she was feeling like she could not swallow - she was given 10 mgs of benadryl and was closely monitored. there were no breathing issues. After waiting, patient was feeling better and left with no issues.

About 24 hours after the vaccine, at 2 PM, I had body aches and mild nausea. The body aches and nausea increased over the course of the day and by about 7 PM I also had a mild fever of 99.7 F. I still felt sick and feverish when I went to sleep a little past midnight, but I was fine when I woke up at 9:15 AM.

Fever or Chills Cough Shortness of Breath Difficulty breathing Fatigue Muscle or body aches Headache Sore throat Congestion or running nose Nausea or vomiting Diarrhea

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.

Client explained she felt dizzy and then vomited 5 minutes after receiving vaccine. Vitals signs were: BP 110/72, 98% O2, HR 72, RR 16. Client status improved after some rest and water mouth rinse. Client explained she doesn't like needles and was feeling anxious before and after receiving the vaccine. Client educated on importance of eating a full meal and to call doctor if vomiting continues.

Had brain fog around 6 hours after injection. Felt nauseous around 11:30pm and vomited around 12:00pm

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

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

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

18 YOF had a brief syncopal episode after receiving the vaccine. She felt lightheaded associated with nausea prior to the syncopal episode. Pt has a fear of needles and reports that she did not eat much this morning. Denies CP, SOB, palpitations, difficulty breathing or any other complaints. There was no head injury.

waiting for the 15 minutes after getting the shot i felt my stomach bubble around 1:30-2 when i got home i had diarrhea and then around 2-3 i had bloody diarrhea and then again around 4

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

Redness at injection site (Wednesday-Thursday), swelling at injection site (Wednesday-Thursday), muscle pain (Wednesday-today), hives on left arm (Wednesday-Thursday), headache (Thursday-today), nausea (Thursday-today), vomiting (today) , diarrhea (today)

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

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

Client reported dizziness to nurse while in observation area. Client successfully made to trash can without incident where client threw up. Client was assessed by doctor. Client was encouraged to eat crackers and drink fluids when able. Client complied. Client denied discomfort, dizziness, light headedness or nausea at time information was gathered. Client is now stable.

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

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

Patient received the vaccine and shortly after became light headed and dizzy. We told her to remain seated and got her a water. She then vomited into the trashcan. She stayed in the pharmacy waiting area with her brother until 6 pm when she said she felt fine and left with him.

Patient received the vaccine at 4:15 pm. 4:27 staff notified of symptom onset. 4:30 BP 110/88 P 92 Patient reports feeling lightheaded and throat feels swollen 4:35 Lightheadedness comes in waves. Last ate around 12 noon. Feels like "lump in throat" slight pain with swallowing. Denes SOB, itching or N/V 4:57 No progression of symptoms, no new onset of symptoms. educated patient and Dad on signs and symptoms of severe reaction. Left with Dad at 4:57

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

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

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

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

Fainting (Syncope) patient Received the vaccine while she was sitted in a chair and within 3 min. she was not Responded a question. patient showed syncope symptoms patient said she Felt dizziness & a little nauseous However . she seemed not get better Called ER. 4:33pm Called patient she was at home & ok 5/30/2021 10:24AM Called PC pt is ok

Tachycardia; Lost 14 pounds; Ulcerative colitis flare up; Throat and glands swollen; Throat and glands swollen; vomiting a lot and couldnt hold food and water down; Diarrhea; This is a spontaneous report received from a contactable consumer (reporting on herself). A 18-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0150; Expiration Date: 31Jul2021) via an unspecified route of administration in Arm Left on 07Apr2021 13:30, as 1st dose, single dose and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0171; Expiration Date: was not reported ) via an unspecified route of administration in Arm Left on 28Apr2021 12:30, as 2nd dose, single dose for COVID-19 immunization. Medical history included colitis ulcerative from 2015 and ongoing. Additional Information for Other Conditions: states was in remission for 6 years prior to her second dose of the vaccine. The patient's concomitant medications were not reported. It was reported that she had a pretty severe reaction to her second dose of BNT162B2. States she has been in the hospital for 5 days last week and has now been in the hospital for 4 days this week because of side effects from vaccine that she received on 28Apr2021 which was her second dose. She thought the side effects would go away after the first hospitalization but was readmitted. First admitted to the hospital on 01May2021 for severe reaction to the shot for 5 days then was sent home because they thought the side effects would go away but the side effects have still been heavy. She was admitted again on Friday (14May2021) to the hospital from the side effects that are continuing. States she had lost 14 pounds from the time she was home from her first visit to the hospital. Patient vomiting a lot and couldnt hold food and water down: States that right after she got the second shot a couple of hours later she vomited a lot and couldn't hold food or water down which started 28Apr2021 and that she hasn't thrown up since Friday 14May2021, but has improved. She was starting to recover from it, it was just starting to get better. The really bad diarrhea started on the 28Apr2021 and was ongoing. The doctor thinks the second dose of the vaccine caused an ulcerative colitis flare up. She noticed the tachycardia on 29Apr2021. States her resting heart rate before the vaccine was 55 on average and now her resting rate was 105-115, and when she gets up to walk around it was 140-160. States that this was what was preventing her to be able to leave the hospital now. Tachycardia was the reason for admission for the first hospitalization. she was at urgent care she was tachycardic and her throat and glands were all swollen and they thought she needed to be admitted to the hospital. Swollen glands recovered last week, either 12 or 13May2021 and was completely recovered from that. Clarifies throat and swollen glands recovered 13May2021. Her dates of admission were 01May2021- 04May2021 for tachycardia. States she was currently at hospital and was admitted 14May2021 and was still there today for tachycardia and weight loss. States the tachycardia warranted both hospital admissions but the weight loss also contributed to the second admission as well. States her current weight was 116 after losing 14 pounds. She was weighed on the 4th when discharged from her first hospital admission and she weighed 130 pounds or 59 kilograms then had a follow up appointment with her cardiologist on the 14th for tachycardia and was weighed then and was 116 pounds at that time. They then sent her to the emergency room right after that follow up appointment to be admitted. States she hasn't been weighed again during this hospital admission so she thinks her weight was the same. She coughed and said sorry something got stuck in her throat, then continued her conversation. Ulcerative Colitis flare up- states she was unsure of when it transitioned from diarrhea to this flare up of ulcerative colitis. States she has just starting getting steroids and they increased her normal medications for her condition and was starting to improve. States she has a picture of her vaccine card and the events started after her 2nd dose. They did a procedure to confirm it was flare up at around 15:00 on 17May2021, performed a sigmoidoscopy and just found her left colon and rectum were inflamed as results which was similar to the ulcerative colitis flare up. The patient underwent lab tests and procedures which included heart rate: 55, heart rate: 105-115, heart rate: 140-160 on an unspecified date, sigmoidoscopy: found her left colon and rectum were inflamed as r on 17May2021. The outcome of the ulcerative colitis flare up was recovering, for event tachycardia, diarrhea and on 29Apr2021 with outcome of not recovered , lost 14 pounds was not recovered, and for vomiting a lot and couldnt hold food and water down was unknown and for events throat and glands swollen was recovered on 13May2021.

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

gastrointestinal issues mainly diarrhea and flatulence; gastrointestinal issues mainly diarrhea and flatulence; This is a spontaneous report from a contactable consumer (patient) reporting on herself. A 18-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: ER8734, Expiration date was unknown), via an unspecified route of administration on 03Apr2021 as 2nd dose, single dose (at the age of 18-years-old) for covid-19 immunisation. Patient had no medical history. Patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EP7534, Expiration date was unknown), via an unspecified route of administration on 13Mar2021 as 1st dose, single dose (at the age of 18-years-old) for covid-19 immunisation. Concomitant medications included cetirizine hydrochloride (ALLERTEC) at a dose of 5 mg, orally taken for hypersensitivity; sarecycline hydrochloride (SEYSARA) at a dose of 60 mg, orally (taking as antibiotic). Patient was also taking antibiotics, route of administration, they were just over the counter. So, the antibiotic was unrelated to this that was for the different health related issues (further clarification unknown). On unspecified date of 2021, patient experienced gastrointestinal issues mainly diarrhea and flatulence for the two months following because of the vaccine. Patient had done like Pro-biotic (TruNature Digestive Probiotic) recommended by her doctor, patient was not sure, it just said there were 10 billion TPCSE (Not clear and not further clarified) in one, she was not sure. It just said one tablet. On May-2021 (recently, last week), patient had blood test and stated that she does not had access to them right now and she do know that her doctor said that everything was negative, and she had them specifically for stomach issues. Patient had got a blood test and flu test and they both were negative, so she was seeing a gastroenterologist like tomorrow (01Jun2021). The outcome of the event was not recovered (still persisting). Information on the lot/batch number is available; further information is expected.

severe indigestion; vomiting; did not feel well; This is a spontaneous report from a contactable consumer or other non hcp. This is a split case of 1st dose. An 18-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number and expiration date were not reported), dose 1 via an unspecified route of administration, administered in left arm on 31Mar2021 given in the late afternoon as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included autoimmune thyroiditis (Hashimoto's disease) from Jan2020 and ongoing for which no medications were given for it though and family history of autoimmune disorder (autoimmune disease) from an unknown date and unknown if ongoing which run on both sides of the family. Sister also has Hashimoto's disease. Concomitant medication included ergocalciferol (VIT D) taken for vitamin d deficiency from Jan2021 and ongoing. No prior history of vaccination before the first dose of COVID-19 vaccine. However, reporter stated that, once when patient was a baby she was inconsolably crying after a set of shots, but nothing else as she knew of. After the first dose of Pfizer-BIONTECH COVID-19 Vaccine, the patient experienced severe indigestion, vomiting and did not feel well on 07Apr2021. Reporter mentioned that it just seems like the issues for the vaccine is much worse than COVID19. And that the Doctors/ CDC / Pfizer and all organizations would reconsider the possibility on the issue on the body attacking its own self. It was reported that patient was having strange side effects and reporter was trying to get more info on how to possibly treat it. The reporter stated that after the first dose, about 6 days later, patient had terrible indigestion and vomited. It was out of the blue and then patient felt better. Patient was very healthy without health problems, no GI issues, and has not thrown up since she was 8 years old. The reporter said that patient had no allergies, and this was strange for her. By about 07Apr2021, patient did not feel well in the evening, had terrible indigestion, and vomited. This eventually got better and seemed to go away after that. No investigation assessment and relevant tests were done. The outcome of the event vomiting was recovered on unspecified date and the other events were recovering at the time of this report. Information about Lot/Batch number is requested.

Patient responded well to first dose of COVID vaccination, but after second (administered 4/30/2021) developed persisting nausea x5.5 weeks, intermittent diarrhea and vomiting. She has been afebrile. One ED visit for IV fluids due to dehydration, but has been tolerating fluids since then, minimal food intake.

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

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.

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

Healthy 18 yo female presented with 4 days of fever, chills, vomiting, diarrhea, headache., as well as mid-sternal chest pressure. She had lab tests as indicated below that were consistent with a diagnosis of MIS-C. She was treated with IVIG and demonstrated significant improvement in symptoms following IVIG

She recieved the COVID19 vaccines that day and later in the day she started menses 3 weeks early, accompanied by continued abdominal/pelvic cramping and spotting which has continued

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.

Patient came in for first dose and told pharmacist of her existing conditions. The pharmacist had the patient stay for 30 minutes after the vaccine. about 20 minutes later the patient began to faint. Her mother, who was next to her, caught her in her chair and told us that this happens often when she is anxious. We immediately called 911. She was in and out for a few moments so we placed out a mat for her. When she came back to conciseness, she reported pain in her joints and acid reflux. We were able to give her fimotidine for the acid reflux.

fever; fresh blood in my stools; chills; headache; This is a spontaneous report received from a non contactable consumer (patient). A non-pregnant 18-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 18-year-old via an unspecified route of administration, administered in Arm Left on 28May2021 11:00 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history was none. The patient previously took lactose and experienced drug hypersensitivity. The patient received no other vaccines within 4 weeks prior to the COVID vaccine. No covid prior vaccination. No covid tested post vaccination. The concomitant medications included centrum multivitamins in two weeks. On 31May2021, patient experienced chills and a headache around noontime but had a fever at 11:30 PM. The fever and chills went away the next morning but still had a headache until the next morning. As of 03Jun2021, patient found herself experiencing, since 3 days ago, fresh blood in her stools which is to be identified by a doctor if the reaction is vaccine related. Adverse event resulted in [Doctor or other healthcare professional office/clinic visit]. Treatment included analgesic and bed rest. Seriousness reported as no. The outcome was reported as recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

4 days after receiving the initial vaccination she began to have nausea and vomiting. She had no signs of an infectious process. Weight prior to this was 123 lb. Current weight is 108 lb. She has persistent nausea, difficulty swallowing, constipation and urinary retention. Recent hospitalization with extensive work up could not identify and infectious, metabolic or anatomic cause.

At 1611 client's Mother alerted EMT daughter had headache and nausea. PHN responded. At 1611 client sitting upright in chair, alert and oriented x4. Client reports that she has been feeling headache since she sat down in observation 20 mins ago and did not inform anyone. At arrival to observation room client stated headache pain 5/10. EMT took vitals at 1614: blood pressure 122/78, pulse 90, oxygen sat 97%. Client denies blurred vision, dizziness, shortness of breath, no rash visible or swelling. Client reports medical history of migraines and high cholesterol, no medications and no known allergies. Per client tolerated 1st Pfizer Covid-19 vaccine well. At 1616 client reports headache resolved and nausea is improving. Vitals at 1620: blood pressure 116/84, pulse 83, oxygen sat 100%. Client reports new onset of "feeling head heavy". Client denies headache at this time or nausea. Per client this "heavy" feeling has happened in the past. PHN advises client to follow up with provider and client states she does not have insurance or provider at this time. PHN gave client healthcare resources: list of community clinics and Medi-cal resources. PHN gave ER precautions. Vitals at 1625: blood pressure 110/84, pulse 82, oxygen sat 99%. Client reports all previous symptoms have resolved. Last vitals at 1635: blood pressure 110/78, pulse 82, oxygen sat 99%. Client reports "feeling fine". Client left facility with steady gait at 1640.

passed out (head flew back)/her head went back to where she appeared to of lost consciousness for about 10 seconds and then they called EMS; HA/Headache; nausea; dizziness; elevated BP; This is a spontaneous report received from a contactable nurse from Pfizer sponsored program. This is first of three report. An 18-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: ER8727; Expiry Date: 31Jul2021), via an unspecified route of administration on 17Jun2021 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. Patient had previously received first dose of BNT162B2 on an unknown date for COVID-19 immunisation and had no reaction. On 17Jun2021, patient experienced passed out (head flew back)/ her head went back to where she appeared to of lost consciousness for about 10 seconds and then they called EMS and had HA/ headache, nausea, dizziness and elevated BP. About 10 minutes after the injection, patient started complaining of a headache, nausea and dizziness. She got to the point where she had appeared to pass out when she was sitting. The observation nurse was with her when she had complained of the headache, nausea and being dizzy and then her head went back to where she appeared to of lost consciousness for about 10 seconds. After that 10 seconds she was responsive again but she was still complaining of a headache, nausea and dizziness until the EMS arrived. Reporter stated that they have been administering this particular lot number at that location for about 2 weeks now without any incidents until today all of a sudden. 2 of the patient's reactions were kind of typical reactions that they have seen in the past. No further details provided about reactions in the past. The other one (reported in report 1 of 3) that had to be treated with an epinephrine (EPIPEN) was a pretty significant reaction and they have never had multiple reactions back to back like this. Reporter seriousness for events, her head went back to where she appeared to of lost consciousness for about 10 seconds and then they called EMS, complaining of a headache, nausea and dizziness were reported as not serious. Verbatim event relatedness: COVID vaccine: her head went back to where she appeared to of lost consciousness for about 10 seconds, complaining of a headache, nausea and dizziness were unrelated. Seriousness: She would even call it a mild to moderate reaction. She thinks that she would of been fine without medical intervention. She was okay during the time in observation without actual medical intervention other than helping to calm her down and that type of thing. Causality: She doesn't think the COVID vaccine caused the reaction necessarily. She thinks it may of been anxiety induced symptoms. The outcome for events headache was unknown and for other events was recovering. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on known drug safety profile and temporal relationship, there is reasonable possibility of causal association between the event Loss of consciousness, Headache, nausea, Dizziness, Elevated BP and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

PATIENT INITITALLY STATED FEELING NAUSEOUS. SHE ASKED FOR A BARRELL IN CASE SHE GOT SICK. WHEN ASKING, SHE SAID SHE WAS STARTING TO FEEL LIGHT HEADED. RPH CAME OUTSIDE TO ASSIST HER TO HER CHAIR. DURING TRANSPORT PATIENT SAID HER VISION WAS GONIG BLACK AND SHE COLLAPSED. I, THE RPH, CAUGHT HER BEFORE SHE WENT DOWN. 911 WAS CALLED AND I REMAINED WITH THE PATIENT UNTIL HELP ARRIVED. WE PROVIDED HER WITH WATER AND A SNACK AS SHE STATED SHE HAD NOT EATEN OR DRANK ANYHTHING THAT MORNING. BY THE TIME HELP ARRIVED SHE WAS FEELING BETTER, BUT WAS STILL CHECKED OUT. DECLINED TRANSPORT.

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

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

Since having my second shot I have felt severally nauseated constantly and cannot function due to debilitating nausea the nausea started the day after I got my second shot on April 13, 2021 taking Zofran has helped however it comes back as soon as the zofran wears off

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.

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

Patient received 1st dose of covid vaccine and instantly felt dizzy. Client's skin pale, patient eventually vomited. Patient stated they were very anxious over their 1st dose. Patient fully recovered. Symptoms no longer present.

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

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

Patient presented to the clinic for covid vaccine at approximately 2:20pm. She received her Pfizer #1 vaccine without incident. The patient was notified to wait 15 minutes in the waiting area for monitoring. While she was waiting she became pale, was heavily perspiring, and was vomiting. She was A+ O x3 during the event. She did not lose conciousness. Vitals were 100/60, HR 60, O2 99. She was moved to a lying position with her legs bent on the exam table. She began to feel better. Paitent was then sat up and monitored x 10 minutes. Patient was feeling better so she was moved to a chair in the waiting room and monitored for another 10 minutes. She left with her family without assistance. Patient verbalized she was feeling better.

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.

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

July 9th - chills, bad muscle pain throughout body July 10th at 12pm - vomiting, 5 times until 6:30 where it finally stopped

The first day was expected, queasy, headache, body aches, some light fever. However, at 5 in the morning on July 21, 2021, the second day after receiving my shot, I was not able to leave my toilet, or I was going there every ten minutes. With a trash can in front of me puking out anything I had ate the day before and earlier that morning, and having explosive diarrhea on the other end. This lasted all day to the point I couldn?t eat and was sore. The next morning still having diarrhea, but fortunately able to hold down a cracker because it went right through the other end. I had COVID-19 in February 2021, and there is nothing given for these side effects, and honestly, cannot make it away from home or the toilet to make it to the doctor. I have missed now three days of work instead of the expected 1 due to these side effects.

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

Nausea; Headache; Arm pain; Muscle aches; This is a spontaneous report from a non-contactable consumer (patient). An 18-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Not reported), via unspecified route, in right arm on 09Jul2021 as dose 1, single for COVID-19 immunization. Patient medical history included COVID-19. Concomitant medications included meningococcal vaccine for Meningitis. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included nasal swab: results unknown on an unknown date. The patient experienced nausea, headache, arm pain and muscle aches in Jul2021. No seriousness criteria reported. No treatment was taken for the events. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Four days after receiving her vaccine, pt. began experiencing a progression of symptoms. Starting with Nausea, then vomiting and constipation, extreme pressure in her chest, pain in her abdomen and difficulty swallowing / eating causing significant weight loss (123 lbs to 108 lbs). She has no or intermittent sensation to urinate and has had multiple catheters and is currently on a Foley catheter due to retetion. She has Gastroparesis and has not had a bowel movement since this all started. She began to experience Edema at the end of June and is currently experiencing tingling in her arms and legs since mid July.

So, Wednesday I felt a little tired and then the next day on Thursday I had a little headache and I had cramps in my stomach. Then on Saturday it hurt even worse and felt like my stomach was being knotted up. Then Sunday the pain was even worse still and I got a headache. I had to constantly go to the bathroom, and I started officially having diarrhea on Saturday. On Sunday I went to the hospital at 5:30PM when my temperature was 103. I was at the hospital for about four hours, and they gave me Tylenol, Motrin, Sodium Chloride, Diacylamine and Zithromax. Then yesterday, Monday 7/26/2021, I was feeling a little better. I was still weak yesterday and in pain, but the pain died down a little bit. I was also able to eat a couple of things. Today, 7/27/2021, the pain is bearable but still there.

Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Joint Pain-Medium, Additional Details: Patient claims to have had dizziness, stiff neck, nausea, and stomach irritability the following day after administration as well as up through today (7/26/21). Patient has not confirmed symptoms have not ceased as of yet (note: 3 days after administration).

Nausea; Abdominal pain; Very weak; This is a spontaneous report from a contactable consumer, the patient. An 18-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 29Apr2021 at 13:00 (at the age of 18-years-old), as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) for unknown indication from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on unknown date (at the age of 18-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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Apr2021 at 16:00, the patient experienced nausea paired with abdominal pain that will not let the patient sleep, body is very weak. The patient had eaten nothing out of the ordinary but on her period. The clinical outcome of the events nausea paired with abdominal pain and very weak were not recovered at the time of reporting. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

SHORTLY AFTER RECEIVING THE DOSE, THE PATIENT FELT NAUSEOUS AND ASKED TO GO TO THE RESTROOM. I BROOUGHT HER A GARBAGE CAN BECAUSE I DIDNT WANT HER OUT OF MY SITE. I GAVE HER A COLD BOTTLE OF WATER AND MINTS. SHE TOOK ABOUT 8 MINUTES UNTIL SHE STATED SHE WAS FEELING BETTER, BUT WEAK. HER MOTHER CAME TO SIT WITH HER FOR 20 MINUTES THEN TOOK HER HOME.

Patient left to front register to buy an orange juice and fainted at front end, her father sat her on a chair in the photo lab. I wa called to the front end and saw patient twitching and then she started vomiting. I administered an epi pen 0.15 mg on her right leg. She fainted a total of 3 times. EMS checked her blood pressure and it was 91/54 mmhg and her pulse was 103. Second reading on blood pressure was 90/66mmhg and her temperature was 96.7'F. Patient had not eaten before getting her vaccine,

Small red rash appeared next to the injection site, my arm was sore. I felt achey, had a headache and a slightly upset stomach. I felt better within 24 hours.

Day 1: pain/swelling at injection site with redness, muscle aches, joint pain Day 2: pain/swelling at injection site with redness, muscle aches, joint pain, headache; worked but with considerable discomfort/strain Day 3: pain at injection site, muscle aches, joint pain, headache, chills, fatigue, feeling unwell, insomnia; unable to work Day 4: extreme muscle aches, joint pain, headache, chills, fatigue, feeling unwell, insomnia, fever, sweating, sore throat, diarrhea; unable to work; attempted to see doctor but was refused care due to "CoVid-like symptoms" Day 5: extreme muscle aches, joint pain, headache, chills, fatigue, feeling unwell, insomnia, fever, sweating, sore throat, diarrhea; unable to work Day 6: extreme muscle aches, joint pain, headache, chills, fatigue, feeling unwell, insomnia, fever, sweating, sore throat, nausea; unable to work; attempted to see care at Urgent Care but was turned away for having "CoVid-like symptoms;" went to hospital per the recommendation of MD and urgent care Day 7: mild muscle aches, fatigue, feeling unwell, insomnia, sweating, sore throat; unable to work Day 8: sore throat, mild fatigue, sweating; unable to work

I have been experiencing intense nausea and vomiting the day after receiving the vaccine. Nothing has been able to treat the nausea.

30 minutes after injection, had sore arm, "hurting" while breathing, increased heart rate, increased blood pressure; after arriving at ER, more than 1 hour after injection, had vomiting x 3, hives/welts on chest and arms, fever and chills

19 year old female reaction to Covid 19 vac; she is alert and orientated; complaining of rash, difficulty breathing, dizzy, lump in throat, headache, nausea, cough. 1 dose of Benadryl 25 mg given at 1430. Patient states she is medical fragile and has a HX of epilepsy. EMS called at 1500 evaluation mild allergic rxn will transport to hospital for further evaluation.

Nausea/ Stomach cramps High fever (over 100) Both started night of injection and resolved over night with some help of Ibuprofen Patient had COVID-19 2 months prior to receiving vaccine.

Fever; headache; fatigue; nausea; muscle aches; This is a spontaneous report from a contactable nurse reported for herself. This 19-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 09Jan2021 15:30 at single dose (vaccine location=left arm) for COVID-19 immunization. Medical history included allergies: Iodine, shellfish. The patient had COVID prior vaccination. Patient was not pregnant, and did not receive other vaccine in four weeks. The patient's concomitant medications were not reported. On 10Jan2021 07:00 AM, the patient experienced fever, headache, fatigue, nausea, muscle aches. No treatment received for events. Patient had not tested COVID post vaccination. The outcome of events was not recovered. Information about lot/batch number has been requested.

On the day I took the vaccine, my whole left side became sore and numb. The soreness and numbness continued on through the next day. Friday evening, I had the same symptoms coupled with nausea, headache, and chills. Saturday, I continued to have slight soreness and nausea. Today (Sunday), I'm still having a bit of soreness on my left shoulder where I took the vaccine.

Soreness in left arm near injection site and slight nausea. Nausea persisted for 6 hours as with the pain in the injection site.

19 y.o. female who arrived to the emergency department for 19-year-old female with history of COVID infection several months ago was receiving her COVID vaccine this morning when she developed nausea and tightness in her throat about 15 minutes after the injection. Epinephrine was administered prior to transfer to the ED. She denies any rash. She does feel slight shortness of breath. She denies headache earache sore throat or rhinorrhea cough vomiting diarrhea fever chills or abdominal pain. She has had hives and tightness in her throat from several medications in the past including Prevacid Prilosec Zantac and iodinated contrast media. No new medications. Anaphylactic type reaction and patient advised to not receive the 2nd vaccine. PMH: Diabetes mellitus Initial Vital Signs Blood Pressure 01/25/21 0902 132/85 Heart Rate 01/25/21 0902 92 Respiratory Rate 01/25/21 0902 16 Temp 01/25/21 0925 36.6 °C (97.9 °F) Temp Source 01/25/21 0925 Oral SpO2 01/25/21 0902 99 %

Bad stomach pain; I had extreme abdominal pain for hours and diarrhea; I had extreme abdominal pain for hours and diarrhea; This is a spontaneous report from a non-contactable other Health Professional (patient). A 19-years-old female patient (not pregnant) started to receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176), via an unspecified route of administration at left arm on 12Jan2021 at single dose for COVID-19 immunization. Medical history included COVID-19 prior vaccination. The patient's concomitant medications were not reported. The patient historical vaccine included the first dose of BNT162B2 (lot number: EL1284) at left arm on 22Dec2020. The patient had extreme abdominal pain for hours and diarrhea. She ended up in the emergency room and nothing was found wrong with her ultrasound, bloodwork, or urine sample. She never had stomach issues so the doctor thinks this was a result of the second dose of the vaccine. She have had experienced such bad stomach pain. The adverse event (AE) start date was 13Jan2021. AE resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of events included intravenous fluid and pain relievers and zofran. The patient recovered from events in Jan2021. Since the vaccination the patient hadn't been tested for COVID-19. No follow up attempts are possible. No further information is expected.

About 8 hours after vaccine, sore arm began and has continued to the present time this next morning. About 20 hours after vaccine, this morning, woke up with a fever, chills, nausea, and dizziness. All of these symptoms I am still currently experiencing about 23 hours after the vaccine.

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.

Anaphylactic reaction; Throat was swollen shut, couldn't talk or breathe; Throat was swollen shut, couldn't talk or breathe; Throat was swollen shut, couldn't talk or breathe; loss of consciousness; brain fog; headache; fever; severe body aches and joint aches that make movement difficult; severe body aches and joint aches that make movement difficult; severe body aches and joint aches that make movement difficult; persistent chest pain/pressure; low blood pressure; some swollen and tender bilateral lymph nodes in my neck/trapezius/left (injection site) axillary region; fatigue; decreased appetite due to nausea; decreased appetite due to nausea; This is a spontaneous report from a contactable healthcare professional. A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the left arm on 25Jan2021 08:45 at a single dose for COVID-19 immunization at a hospital. Medical history included type 1 diabetes mellitus, Celiac disease, COVID-19, and heartburn. Concomitant medication included insulin lispro (HUMALOG), spironolactone, fluvoxamine, and alprazolam (XANAX XR). The patient previously took gluten, magnesium ,and iodine and experienced allergies. On 25Jan2021 09:00, patient had an anaphylactic reaction. Throat was swollen shut, couldn't talk or breathe, loss of consciousness, brain fog, headache, fever, severe body aches and joint aches that make movement difficult, persistent chest pain/pressure, low blood pressure, and some swollen and tender bilateral lymph nodes in my neck/trapezius/left (injection site) axillary region, fatigue, and decreased appetite due to nausea. Patient had a doctor or healthcare professional visit, went to emergency room/department or urgent care, and was considered life threatening illness (immediate risk of death from the event). Events was treated with epinephrine, diphenhydramine (BENADRYL), paracetamol (TYLENOL) and had oxygen. Patient was not tested post vaccination. The patient is not pregnant. The patient has not recovered from the events.; Sender's Comments: There is a plausible time relationship between vaccine administration and onset of the events in a subject with allergic diathesis. 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.

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.

Flu symptoms- 3 days and continuing, began about 5 hours post-2nd vaccine dose: 101-102 degree fever, chills/sweating, severe headache, stiffness in head/neck/shoulders/back, dizziness, extreme fatigue, nausea

low-grade fever; headache; nausea; This is a spontaneous report from a contactable consumer. A 19-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Jan2021 at single dose for covid-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for covid-19 immunisation. Yesterday (24Jan2021), the patient experienced a low-grade fever, headache, and nausea. Outcome of the events was unknown. Information about lot/batch number has been requested.

Fever; Nausea; Headache; Chills; Ache; she wasn't feeling well; This is a spontaneous report from a contactable consumer (patient's mother). A 19-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Batch/lot # EL8982) at single dose at right arm on 24Jan2021 15:00 for Covid-19 immunisation, administered at school/student health clinic. The patient medical history was none. There were no concomitant medications. The patient received the 1st dose of bnt162b2 (BNT162B2, Lot Number: EL1284 and Expiration Date: Apr2021) Intramuscular at single dose in her left arm on 03Jan2021 at around 4:00 PM for Covid-19 immunisation. No additional vaccines administered on same date of BNT162B2. No prior vaccinations (within 4 weeks). On 25Jan2021 the patient experienced fever, nausea, headache, chills, ache, she wasn't feeling well. The patient woke up on 25Jan2021 morning, and was kind of achy. The patient underwent lab tests and procedures which included body temperature: 99.8 on 24Jan2021. Reporter checked her daughter's temperature around on 25Jan2021 an hour before this report, and her daughter has a fever of 99.8, clarifying her daughter's temperature is running about 2 degrees higher than normal. Fever was treated drinking water, and patient uncovered herself to cool her body, and was using cold compresses. The patient was able to eat something, even though, she has some nausea and headache. The patient was feeling well enough to participate in remote learning from home, and she was resting her head on a pillow. The patient had chills on 25Jan2021 morning while in bed. The patient was a healthy, active, who exercises regularly, but and did not go to the gym on 25Jan2021morning because she was not feeling well. No event required a visit to Emergency Room or physician office. No relevant tests performed. The outcome of she wasn't feeling well was unknown, of all other events was not recovered.

atient received 2nd dose of Pfizer Covid19 vaccine today at approximately 9:35 AM. Patient received 1st dose on 1/15/21. Patient has history of anyphylaxis and was instructed to wait and be monitored for 30 minutes after vaccine. Patient alerted nurse responsible for monitoring that she was experiencing an itchy throat and difficulty swallowing. Nurse alerted nursing supervisor, and nursing supervisor brought patient into a clinic room immmediately. BP 178/110 O2 97% room air. Epi 0.5mg 0.5ml administered LD IM at 10:01 AM. Benadryl 100mg 2ml administered RD IM at 10:01 AM. EMS called. Patient reported some improvement of symptoms approximately 1 minute after EPI/Benadryl injections. EMS arrived at 10:10 AM and transported patient to hospital. Attempted to call patient on 2-10-21 and left message. No response.

1540 Pt complaint of feeling nauseous, states feels this was when anxious. Pt at POD with girlfriend. Squad was called for girlfriend earlier after girlfriend fell to ground. States anxious watching all that happen. Denies any other symptoms. Drank Capri sun. 1551 BP 118/60, RR 18, O2Sat 99%, HR 87. States feeling much better. States ready to go home. Advised pt to seek medical care if experiencing symptoms. Pt verbalized understanding. 1553 Pt left with girlfriend at his side.

Fever over 100 degrees; swollen lymph nodes; unable to swallow; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date unknown), via an unspecified route of administration in the left arm, on 30Jan2021 07:30, at single dose, for COVID-19 immunization, at the hospital. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Concomitant medication included an unspecified birth control medication. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. The patient experienced "fever over 100 degrees and swollen lymph nodes causing me to be unable to swallow" on 30Jan2021 at 22:00. No treatment was received for the events. The outcome of the events was not resolved. The reporter assessed the events as non-serious.

Patient states she feels nauseous after receiving vaccine and developed a headache. b/p 144/76,p-83, R 18, 02 sat 99% Temp 96.1. After observing patient for 20 minutes patient c/o sever left sided abd pain and was taken to ED for further evaluation

Bells Pals half of face, numbness, weakness, headache, fever, diarrhea, nausea, chills, body aches, fatigue., tics and then a few days later had a gran mal seizure, forgetfulness

Woke up the next morning with the most intense body aches to where I could not stand up. Vomiting continuously for 3 hours, eventually vomiting bile. Never had a fever. Took tylenol to help with the pain, as soon as it set in I fell asleep for about 3 hours. When I woke up I felt almost completely normal.

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.

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.

Less than one minute after injection into the right deltoid, an area of bright redness appeared superior to the injection site that quickly spread across right shoulder and across front of throat. No breathing difficulty was noted. Lungs were auscultated and were clear bilaterally all fields. However, it was noted that employee had an irreg/irreg heart sounds that was not known of ever before. Employee complained of vertigo and nausea, became pale and weak and was sent to the local ER across street for further evaluation. Lung sounds remained clear during monitoring of employee post vaccination. Mother reports that she had done this before during infant vaccinations but never since. Employee did not report this in pre-vaccination evaluation as she was unaware of it. Mother reports no prior cardiac history of any kind. Mother transported to ER located across street. Outcome is unknown at time of writing.

The night of the day I got the second dose of the Pfizer COVID vaccine, I felt like my stomach was on fire. I also felt really bloated. It felt like someone placed a sphere in my abdomen and then set it on fire. I tried eating, drinking water, and sleeping and nothing has helped. I have felt like this since then and it is currently 3/5 and I got the vaccine on 3/3.

Patient had received the pfizer covid vaccine, and approximately 10 minutes after dose, she felt light headed, headache, and nauseous. 12.5mg benadryl was given in the idea that she had an allergic reaction. over the next few minutes she had begun to talk about itchy, hot throat and immediately administered epinephrine and called 911. paramedics showed up briefly after, informed about her heart condition, afterwards paramedics took her out and under her care at this time. Epi administered into left

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.

Vomiting/diarrhea started at 2:00 PM. Took to urgent care around 5:00 PM. Treated with IV, ondansetron via IV. Rapid test for COVID came back negative. PA noted possible infection left ear. Prescribed ondansetron (nausea), Imodium AD (diarrhea), Claritin-D, Z-Pac. 7:00 PM - picked up meds. Took ondanestron (under tongue), Imodium AD. Vomiting/diarrhea continued until 9:30.

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

3/17/21-3/18/21: Nausea, vomiting, high fever (103F), diarrhea, muscle soreness & weakness, shakes, dehydration, migraine 3/19/21-3/21/21: chest tightness, muscle pain and weakness, low grade fever (100-101F), sore throat

Immediate reaction of nausea and question of mild throat soreness. No SOB/wheezing/hives/hypotension. Resolved within 30 min without intervention.

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

at 1pm EST on 3/19/21 patient reports onset of fatigue. then around 3pm 3/19/21 she developed nasal congestion, sore throat, increased fatigue, muscle aching generalized, backache generalized mid and lower back, chills, headaches, loss of appetite, swollen neck glands. She visited the Health Clinic on 3/20/21 at 3:40pm at which time she was noted to have temp of 100.6 and heart rate of 108. General exam indicated some tender anterior nodes, nasal mucous, and fatigued appearance.

Client states she developed severe headache and weakness about an hour after receiving vaccine. The following morning she awoke with nausea, vomiting, sore throat. She reports feeling better today, though not completely well. Client states she called and reported to CDC.

The next morning after I got the second dose of the vaccine, I felt incredibly ill. Stomach was aching to the point I thought I was going to throw up, my joints were aching to the point it hurt to move, my skin hurt so touch, and I had a slight quick fever. These symptoms lasted all day, but went away the day after (Wednesday 24, 2021).

3/28/2021 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: dizziness, FLUSHED, WARM AND SWEETY, NAUSEA WITH DRY HEAVES Assessment : Time of assessment 0841. Alert and oriented. Actions taken: VS taken at 0851- bp-131/92, p- 90, o2- 100%, VS RECHECKED - BP-112/78, P- 66, O2- 100%, 0855 SYMPTOMS RESOLVED, 0901 BP- 99/68, P- 67, O2-100% DISCHARGED HOME WITH FAMILY MEMBER. Medications administered: Famotidine (Pepcid) 10 mg by mouth. Time: 0851. Administered by RN. BENADRYL 25 MG po X 1 Disposition: Reports no further symptoms of adverse reaction after observation for 45 minutes. Discharged home. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/28/2021 8:36 AM 0.3 mL 12/11/2020 Intramuscular Manufacturer: Pfizer, Inc Lot: ER8730 NDC: 59267-1000-1 Electronically signed by RN at 3/28/2021 11:13 AM Immunization on 3/28/2021 Detailed Report Note shared with patient

Patient has syncope/nausea after vaccination and was transported to ED for further eval. Patient states that she typically faints/has syncope when giving blood. Patient received one dose of Zofran PO in ER and was discharged.

Shaking, chills, fever, severe muscle ache, headache, very painful swollen lymph node in armpit, nausea, apetite loss

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

Dizziness + nausea within 5 minutes of dose. Was given fruit cup and water, symptoms seemed to worsen. Was taken to ED where she developed chest tightness but no airway compromise. Subsequently self-resolved and was discharged home without further intervention.

Patient was receiving her first dose of the Pfizer COVID-19 vaccination and several minutes afterwards she developed dyspnea, intractable cough, nausea, sensation of her throat closing, difficulty breathing and sensation of facial swelling. In the ED, the patient was administered epinephrine 0.3 mg IM and was given albuterol inhaler, Zofran 4 mg IV, Solu-Medrol 125 mg IV, 1 L fluid bolus and milligram Pepcid IV and 50 mg of Benadryl IV. Pt received discharge instructions and stated understanding concerning medications, follow up care and when to seek emergent care. Pt PIV removed. Pt verbally acknowledged discharge instead of signing paperwork. Pt was ambulatory to discharge with all belongings and was escorted to the front of the bldg by staff.

" 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.

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Abdominal Pain-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Weakness-Medium, Additional Details: Temp 98.6 and BP normal

When I first got the vaccine, i got dizzy and sick to my stomach with a headache. I decided to leave after sitting for 20 minutes and go back to work because it got a little better. on tuesday. A few hours later, my chest started to ache and my throat started to hurt. thinking I had asthma due to the heat, i ignored it and used my inhaler. By the next day, I was coughing and it hurt worse. I was still dizzy but worse, felt neasious and had a headache. I used my inhaler twice with no help. My arm started to hurt to move, and my injection spot became a red lump. By Thursday, I could barely take a normal breath. It hurt to walk, talk, yawn, sneeze or anything that lifted my need to breathe above bare minimum. It hurt greatly and I couldn't take a full breath. I felt like my lungs were swollen and my throat hurt to swallow. I was very dizzy and had horrible nausea.

8:00pm-arm started to be sore 4:00am-chills and warm head 12:00pm-extremely tiredness when chills and a warm head 9:00am-feeling like i need to puke/extremely low energy

Experienced the following after 7 minutes of the vaccine: shortness of breath, lightheadedness, dizziness, chills, and fast heart beat. Symptoms began to subside after 5 minutes and nausea and chest pain began After another five minutes, another episode of shortness of breath, lightheadedness, dizziness, chills, and fast heart beat Symptoms slightly bettered and was taken to emergency room Fast heart rate still continues, along with lightheadedness, shortness of breath, and occasional dizziness

Pt. received first dose of the vaccine at 11:05. Pt. was instructed to sit for 30 minutes due to a nut allergy, after five minutes of sitting Pt. stated that he was started to get nauseous. Pt. was moved into the back room where he walked himself without difficulty. Initial set of vitals was obtained at 11:15, and pt. had stable vitals of 132/98, HR of 91, RR 16 and SpO2 of 98. Pt. was given a rubbing alcohol pad at 11:12, and after smelling it nausea was depleted. Pt. had stable vitals with a blood pressure of 132/98 at 11;15. Pt. had a second set of vitals after no complaints of nausea with stats of 113/76 PR of 88, RR of 16 and SpO2 of 98. Pt. had a patent self-maintained airway, and was speaking in full clear sentences without difficulty. Pt. had clear and equal lung sounds and was speaking in full clear sentences with no obvious difficulties. Patient had a regular and strong pulse with no signs of major bleeding. Pt. sat for five minutes after his original time and after Pt. walked out stated that he had no other signs or symptoms. Pt. was informed that after he left if he experienced any other difficulties or reactions to call. Pt. stated that he was feeling fine, and walked out of the clinic without difficulty.

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.

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

I had really bad abdominal cramps to the point where I couldn?t walk. I took Acetaminophen tablets and it didn?t come back after they wore off

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.

Worsening over 6 days: arm injection swelling and sharp pain (severe, 1st day on: ice pack), headache (severe: advil, tylenol, thera flu), muslce aches all over the body (medium: 2nd day on); tiredness (medium-severe: 1st day on), sore throat (severe: 3rd - 5th day: cough drops); congestion/nasal and chest with cough and yellow mucous and sneezing (severe: 4th day on: nyquil); difficulty breathing (medium: 5th day on); runny nose (medium: 4th day on); temperature (5th day on, highest of 102: tylenol); nausea/vomitting/diarrhea (5th day only: bland food, BRAT diet), swollen lymph nodes (medium: 4th day on). Possible loss of smell and taste but could be due to congestion. Doctor prescribed (and was carried out): antibiotic (Cefdinir, just in case) and steroid shot.

RN x 2 resonded to vehicle. Pt c/o feeling dizzy. Is wretching. Vomited small amoung of clear emesis. Epinephrine given @ 1055; Refused transport by ambulance. Dirver advised to take to ER for further observations. States they will o to ER. Nurse called facility and told that patiet is is still in ED and will be ofbserved for six hours. Someone attempted to reach. 4/12 @ 12 10. States they will give her the message. Called back and left message for Nurse @ facility. Nurse did not return call

Vomiting. Onset of symptoms under 1 hour from time of vaccination. No need for additional care or treatment.

A few Minutes after getting the vaccine, patient stood up, felt dizzy light headed and nauseas and then passed out. Patient was unconscious for approximately 5 seconds before waking up. Patient was then assisted to a supine position before getting a set of vital signs, all WNL except for a low blood pressure. Patient was then assisted to a cot where she explained how she felt before hand and another set of vital signs was taken, all WNL and an improved blood pressure. Patient was then asked to wait at least 30 minutes and until all symptoms had subsided before having someone assist her in getting home.

11:30 - 124/82, RR 22, HR 92. 11:56 - 126/82, RR 18, HR 86. Pt was vaccinated with Pfizer COVID-19 (Lot # EW0158) vaccine and went to post-vacc area. Pt told post-vacc nurses that she was feeling nauseous and anxious. Pt stated that she has Hx of anxiety and this episode felt "like my normal anxiety attack." Pt denied any chest pain, SOB, or other pain or discomfort. Pt was seated outside with post-vacc nurse and given a bottle of water because Pt stated that being outside helps her anxiety. Pt sat outside for approximately 30 minutes and then stated that she was feeling better. Pt left with her mother, who was also on-site for vaccination.

Upon discharge c/o nausea and headache. VS 118/76, OxSat 97%, HR 96. Verbalizes lightheaded dizziness. Appropriate to questions, sat additional 15 min. Symptoms relieved, medics monitored and ok to d/c home

2:00 am I woke up with diarrhea and vomiting. I vomited again at 4:00 am. I vomited again at 5:00 am. I had diarrhea again at 8:00 am. I was not able to eat anything all day. Very ache and weak all day. Slight headache. Slept most of the day. Hardly able to stand in shower. Woke up the next day (4/17/2021) feeling only a slight headache.

While talking to my parents I started to say things completely opposite of the conversation we were having. My speech began to slur and then I passed out/fainted and was unconscious for approx 1 minute. Once I came to I was disoriented and nauseated.

Patient presented to our primary care office 10 days after her Pfizer COVID booster shot was administered. She started with hives over her torso, arms and legs the day prior which was 9 days after her booster vaccine. Patient was placed on benadryl and pepcid for urticaira. Her symptoms progressed over that day with difficulty breathing, vomiting and syncope. She was taken to the emergency department. She was observed and placed on 5 days of oral prednisone. SHE DID NOT REQUIRE ANY EPINEPHRINE and was observed in the emergency department for hours prior to discharge. Symptoms resolved fully.

Night of vaccination: sweats, fever, headache, stomach ache, injection site pain Day after vaccination: sweats, fever, headache, injection site pain swelling and tenderness, nausea, diarrhea, muscle pain, chills, fatigue

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.

Upon crew arrival found 19 YO female in emotional distress. Patient was CAOx4 and stated she was going to pass out. Patient skin was cool, pale and dry. Patient was assisted to wheelchair where vital signs where obtained and monitored. EMS noted patient vomited. Patient told EMS personnel she felt extremely anxious coming into the facility to get the vaccine. Patient denies any SOB, chest pain, and abdominal pain. HR:66 RR: 16 non-labored BP:77/50 . Crew obtained 4 BPs with last know being : 88/58. Patient refused further evaluation at hospital. released after 30mins of observation.

Insomnia, malaise, soreness of entire body, nausea, vomiting (over the course of two hours), dizziness, fever, and chills

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.

9 days ago, got Pfizer vaccine #1. Immediately after vaccine, felt nausea, lightheaded. She was sitting in a chair and felt unable to sit in chair, needed support. "It was too much work to talk, knew answers, hard to speak." No LOC. BIBA to ED. Athol ED notes reviewed, found to be anemic (drew off IV), subsequently not confirmed. She has ongoing nausea (without vomiting), poor appetite (eating toast with avocado, pizza pockets), fatigue (slept 11 hours and felt tired on awakening, napping), shaky (whole body), weak (unable to break apart frozen bread loaf, but no focal weakness), high HR on ambulation (on apple watch, 170-180, even 200), vertigo (when turns head, feels tilting or rarely spinning, lasting a few seconds or minutes), gets cold very easily, throat felt and appeared to be jumping, maybe a little hard to swallow. Per mother (by text) she is "shell of her former self." Works front desk has missed work except yesterday when she was able to get through a 3 hour shift. Cognition is mostly intact. She and mom do not know what to attribute this to. She if feeling better than after she left the hospital, better for a while, some worse now but not as bad as immediately after. No CP, no cough, fever. She has felt a little SOB last week, maybe after standing or taking a few steps.

After injection the recipient felt dizzy, nauseated, and had a burning sensation at site of injection. Patient was transported to the emergency department for evaluation.

Flushing, sweating, dizziness, nausea. BP 98/58 (pulse 64), 100%. Crackers, juice, water given. F/u BP 108/95 (pulse 74).

Sweating/clammy, vomiting, felt faint, dizziness. Blood pressures 93/56 (pulse 71), 99/58 (pulse 92). O2 sats 100%.

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.

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.

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.

I noticed this weird bruise where I got my vaccine and I felt stomach pains and lack of an appetite afterwards.

Experienced life-threatening blood clots in both lungs (bilateral pulmonary embolism); chills; flu-like symptoms; difficulty breathing; chest pain; nerve pain in neck; severe rib pain; spitting up blood constantly; severe aches and pains all over my body; This is a spontaneous report from a contactable consumer. A 19-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 08Apr2021 15:45 (Batch/Lot Number: ER8737) (at age of 19-year-old) as single dose for COVID-19 immunisation. Medical history included Polycystic Ovarian Syndrome, and eczema. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE 1/20) and hydroxyzine, both taken for an unspecified indication, start and stop date were not reported. There was no other vaccine in four weeks. The patient previously took propylene glycol, scopolamine and experienced drug allergy. The patient previously took the first dose of BNT162B2, administered in Arm Left on 16Mar2021 12:00 PM (at age of 19-year-old) (Lot number: EN6207) for COVID-19 immunisation. It was reported on 09Apr2021 12:00, the patient experienced chills and flu-like symptoms that developed into difficulty breathing/chest pain. Nerve pain in neck, severe rib pain, and spitting up blood constantly. The patient started spitting up blood about two days after the vaccine. The patient experienced severe pain and difficulty breathing on12Apr2021. The patient received help from urgent care on 14Apr2021. On 14Apr2021, the patient was directed to receive a CT scan which revealed severe blood clotting in lungs. Rushed to ER where the patient was then admitted to the hospital overnight for observation and to receive blood thinners and pain medication. In the week since leaving the hospital the patient has experienced severe aches and pains all over her body and have continued to spit up blood. The events were reported resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event).The patient was hospitalized for the events for 2 days. Events treatment included: O2, Blood Thinners, Oxycodone, and Morphine. No COVID prior vaccination. COVID tested post vaccination on 14Apr2021, Nasal Swab, COVID-19 RNA - SARS Cov-2 test result was Negative . The outcome of events were recovering.

PATIENT REPORTED FEELING WARM, NAUSEATED, VOMITTING, LIGHT HEADED AND DIAPHOTRETIC. PATIENT STED SHE TOOK ZOLOF THIS MORNING AS HE HAS PANIC ATTACKS. PATIENT REPORTED TO FEEL BETTER AFTER VOMITTING AND KNEW THAT THE VOMITTING WAS DUE TO PANIC ATTACK AS THIS IS THE SYMPTOM THAT MANIFEST DURING THE EPISODE OF PANIC ATTACK. O PATIENT WAS INSTRUCTE TO WAIT OUT 15 MINUTES AND NOTIFY OBSERVER IF SYMPTOMS OCCUR OR WORSEN

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.

FELT LIGHTHEADED AND C/O NAUSEA POST VACCINE. REPORTS FEAR/ANXIETY WITH NEEDLES. IMPROVED UPON ARRIVING TO OBS, AMBULATED WITHOUT DIFFICULTY. GIVEN WATER AND SNACK PRIOR TO ARRIVING TO OBS, FELT BETTER. ORTHOSTATIC VSS. FELT SIMILAR S/S ALONG WITH FEELING HOT AND "WORKED UP" PTA. ONCE S/S RESOLVED, ESCORTED TO EXIT WITH NO FURTHER ISSUES AT 1545. 1528 INITIAL/LYING BP 143/82 HR 88 RR 18 SATS 100% RA 1532 SITTING BP 97/79 HR 99 RR 20 SATS 100% 1535 REPEAT SITTING BP 137/70 HR 91 RR 20 SATS 98% RA 1537 STANDING BP 115/77 HR 88 RR 20 SATS 99% RA

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.

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)

Fatigue, Nausea, dehydration, Headache (2-3 days), Vertigo (long lasting), swollen lymph nodes (long lasting) Given Meclizine, made patient numb, switched to Valium Lasting effects still stand

Severe Headache, nausea, fatigue, lightheadedness, muscle weakness in left arm and arm pain in left arm, chills Fatigue started in the morning and other symptoms started to emerge after a few hours. Severe headache started midday. Symptoms made it hard to focus and get work or anything else done. Took ibuprofen which helped headache, but it did not go away completely and lasted in to the next day

I got my vaccine Wednesday afternoon and woke up that night with a fever, muscle aches and spasms, a headache, and dizziness. My fever got up to 101.2 F by 3:00 Thursday morning, when I finally decided to take Tylenol. That eventually brought my fever down and kept it down. I was extremely tired throughout the day Thursday and had full body muscle aches, but I stopped taking Tylenol Thursday evening and my fever did not return. On Friday morning, I woke up extremely dizzy. I had trouble moving around and felt nauseous from the dizziness. It improved throughout the day and was nearly gone by the time I got up Saturday morning. By Sunday morning, my symptoms were pretty much resolved.

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.

Got the shot in the morning - no reaction other than sore arm which was normal. Later around 3pm, started becoming more tired so I took 6h nap. Woke up around 9, mostly just laying in bed. Started getting chills so I took a shower at 11, go out and started to feel nauseous. Went to restroom feeling like I was gonna vomit. I fainted instead.. for maybe 20-30 seconds I was out? Not sure since I was alone. Chills intensified to my whole body shaking pretty violently- I couldnt even point straight without looking like a Grimm Reaper! I was helped back into bed by my father and slowly fell asleep. This morning I still have some jitters but much less so - but my head is killing me.

The patient was minimally responsive when I arrived at her car consistent with a severe vasovagal episode with syncope. The patient rapidly regained consciousness with a supine position with legs elevated. The patient was given oral hydration but had large volume emesis. The patient was given SL 8mg Zofran. Emesis continued. The patient was transferred to EMS. The patient was given IV fluids and IV Zofran via EMS. A severe vasovagal episode with true syncope and significant emesis. Improved with IV fluids and antiemetics via EMS. Patient discharged home with father as the driver.

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.

The arm pain was right away and has not gone away after a couple days. A headache a d sweating started around 9 Pm, 5 hours after the shot. I woke up at 7 Am the next morning unable to stay warm, shivering for hours with a 101 fever and nausea that lasted most of the day.

Dizzy and nausea at 6 pm the day of the vaccination. Sore throat in morning next day; then fever for 4 days (102-103.5); cough; headache; body aches.

The day after I began to feel so dizzy that I could not walk properly. My skin all over my body was red and hot to the touch. I had nausea symptoms and a migraine.

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium

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.

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.

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.

Extreme nausea more then usual and vomiting Saturday morning. I am 6 weeks pregnant and due on December 28th.

Felt Nauseated, stomach cramps 10 to 12 minutes after shot. Pt Admits to eating very spicy Chinese chicken prior to shot.

I started having vaginal bleeding on April 14th. The first day, it was the same amount as a regular period. In the days following, the bleeding became very heavy, having me go through a super-sized tampon with a pad every 1 and a half to two hours along with several large blood clots each time changing. On the 15th, I called the on-call nurse for my gynocologist and she said that it might have been from the vaccine and taking birth control, since many patients of hers had called with the same problem. The bleeding continued at this rate all the way until my second dose on April 29th. I saw my primary doctor that day and she tested my hemoglobin, which came up at 10.7, which was slightly anemic. She prescribed an Iron supplement and told me to skip my "period" days and go straight to my next pack of birth control when the one I was using was finished. The next day, I experienced severe nausea, diarrhea, chills, fever-like symptoms, difficulty breathing, and extreme fatigue. I went to the Emergency Room, and they gave me about an IV and a half. They said I had extreme dehydration, and was slightly more anemic than when tested the day before. Following that day, the bleeding was significantly lighter and then stopped for a few days on the following Thursday when I started my new pack of birth control. I had little to no blood for.a couple days, followed by bloody discharge up until Tuesday night, the 11th of May, when the bleeding started again, being about the same amount as a regular period. I am still currently bleeding at this rate.

About 10 hours after my second dose, I began to have muscle pain. The muscle pain is different than body aches that I?ve gotten with a cold. My muscles hurt and my skin is sensitive to the touch. It feels like the pain goes from the skin to the bone. I don?t know how else to describe it other than feeling like a bad a sinus infection inside of my muscles. I know that?s a weird way to describe it but the pain is kind of indescribable and unique. The pain is worst in my neck and back. My joints also feel inflamed, it?s hard to close my hands into a fist. I spent most of the night freezing cold and shivering (I live without air conditioning). It has been about 35 hours since I received the vaccine. Cold and shivering has subsided but I have have the sweats for the past 8 or so hours. A bit of nausea and stomach pain started about 15 hours after the vaccine.

This is a spontaneous report from a contactable consumer. A 19-years-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3249), via an unspecified route of administration, administered in Left Arm on 27Jan2021 at 11:00, single for covid-19 immunisation. Medical history included tachycardia, irritable bowel syndrome, colitis, allergies to pineapple, dairy. Concomitant medication(s) included cobamamide (Vitamin B12 [cobamamide]), dicyclomine, escitalopram oxalate (lexapro). On 06Jan2021, the patient received first dose of bnt162b2 (Batch/Lot Number: EK5730) at Left arm. Facility type vaccine in Hospital. No other vaccine in four weeks. No COVID-19 tested post vaccination. No COVID-19 prior vaccination. On 27Jan2021 at 11:30 pm, the patient experienced dizziness, nausea, headache, chills, and diarrhea. The event assessed as non-serious. No treatment was received. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.

Fever (around 100 F), chills, arm soreness, fatigue, and severe headache for entire duration. I passed out/loss consciousness around 11:45 am and I threw up at around 4:30 pm.

COVID shot 4/30. Then the day after getting back pain mid back- constant in pain and headaches. Headaches are in the AM and sometimes at night. She takes Ibuprofen and it doesn't really help. Been nausea after she eats or before she eats. Started 2 weeks ago. With each meal. Not improving and not worsening. Has IUD. No sexual activity.

Systemic: Flushed / Sweating-Medium, Systemic: Vomiting-Medium, Additional Details: Patient said she got hot and then threw up. She said she was fine after throwing up.

Diarrhea; Throat constriction; Worsened breathing; Fatigue; Vertigo/Head spinning; This is a spontaneous report from a contactable consumer. A 19-year-old female non-pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in left arm on 16Mar2021 at 14:30 as 1ST DOSE, SINGLE for COVID-19 immunization. The patient was sometimes allergic for some types of fruit (edema of mouth, pustules in mouth). The patient did not receive any other vaccine in four weeks. The patient's medical history included phenylketonuria, thyroid gland disease, Crohn's disease. The patient's concomitant medication included zirtec, magnesium, acylpirin. The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. On the same day of COVID vaccination with in one minute, the patient felt throat constriction, worsened breathing, feeling of vertigo. The patient administered double dose of antiallergic drug Zyrtec and the symptoms re-solved. Only fatigue and mild vertigo were persisted. The next day after vaccination, the patient experienced diarrhea, and persisted till the day of reporting, and only mild form. The patient felt head spinning was still present. The patient received home treatment and patient was ready for possible adverse events, therefore the medication was available immediately. The outcome of the event diarrhea was not recovered and rest all other events was recovering. Follow-up attempts are completed. No further information is expected.

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.

She was diagnosed with appendicitis; This is a spontaneous report received from a contactable consumer (parent; patient's mother). A 19-year-old female patient (daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 24Apr2021 at 11:00 (at the age of 19 years old) (Lot Number: ER8736, unknown expiration) as 1st dose, single for COVID-19 immunization. Medical history and concomitant medication reported as none. One week after the vaccine dose, the patient went to the ED with pain and vomiting on 02May2021. She was diagnosed with appendicitis after running some tests on 02May2021 and had her appendix has been removed on the same day she was admitted. The reporter asked if there was any further information about more patients getting appendicitis after the Pfizer vaccine and if the patient should get the second shot. One of her daughter's friends knew someone else who got the shot and got appendicitis, so the reporter wanted to know if it was a common side effect or coincidence. The reporter has no identifying information about her daughter's friend who knew someone that got the shot and had appendicitis. No additional vaccines administered on same date of the Pfizer suspect. They knew from the blood test something was wrong, the patient's WBC results were too high on 02May2021. The regular range was between 4.31-10.16 but the result was 22.03 units per microliter, she was not sure what the units mean. The patient's urine test results (unknown results) were not explained to the reporter and the CAT scan confirmed positive for appendicitis on 02May2021. No prior vaccinations within 4 weeks. The patient was recuperating from it with no more complications. The events require emergency room visit. The patient was recovering from the events. The events were assessed as serious (hospitalization from 02May2021 to 03May2021) Information on lot/batch number was available. Additional information has been requested.

Nausea, light-headed, short of breath. Laid down, removed mask, gave water. Patient had not eaten since breakfast and had nausea prior to vaccine. Symptoms resolved very quickly, within 3 minutes.

Felt very hot/felt like heat rushed through her body; Very nauseous; Dizzy; Broke out in hives on her arms, chest and back; She still has some arm pain, left arm; Tired; very bad allergic reaction; This is a spontaneous report from the contactable consumers (patient's mother and patient). A 19-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in Arm Left on 04May2021 15:05 (time also reported as "15:00") [Batch/Lot Number: EW0167; Expiration Date: 30Aug2021 (expiration date also reported as "31Aug2021")] as 1st dose, single for covid-19 immunization. Medical history included ongoing ADHD which she had since she was little, 3rd grade, born with only one kidney, anxiety and whenever she has anxiety she does get some hives. Concomitant medications included ongoing methylphenidate hydrochloride (CONCERTA) since she was in grade school, probably 3rd grade for ADHD and birth control pill which the reporter was unsure of the name, she switched to this one about 2 months ago. The patient has no prior vaccinations within 4 weeks. The patient had a reaction with the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine. The patient felt very hot, very nauseous, dizzy, and broke out in hives on her arms, chest and back on 04May2021. She was given Benadryl, anti-nauseous medicine, Zofran, and some Pepcid. The patient felt fine afterwards. The patient's mother wanted to know if her daughter should still receive the 2nd dose on 25May2021. The patient was dizzy and felt like heat rushed through her body, she was nauseous and broke out in hives on her arms back and chest. The patient still has some arm pain, left arm which started on 04May2021, but everyone had that, and it has improved. The patient went to the hospital ER. The facility administering the vaccines had EMS and since she was having a reaction, they didn't give her a choice, they just took her to the ER and was glad they did. The patient was seen in the ER and released after she was observed for 4-5 hours. She doesn't know if it was from anxiety or if it was a reaction, she has concerns about whether or not her daughter should take the second dose. The patient stated that about 5 minutes into waiting her 15 minutes, she had a very bad allergic reaction to the vaccine on 04May2021. She ended up getting sent to the hospital. She explained that the vaccine facility had EMT and police at the site and they are the ones who suggested she be taken to the hospital. She clarified that as soon as she got the vaccine, she got hives on her chest, neck, arms and back. The hives are still going on at this time. She has some anxiety and whenever she has anxiety, she does get some hives, however these hives were different. She was anxious about getting the vaccine - she hates needles, but it was a different kind of hives/kind of feeling. She felt very nauseous, dizzy, and tired on 04May2021. She still feels very nauseous right now. The patient was seen in the ER and released at 8PM, she was never admitted into the hospital (the hospitalization was later verified as an ER visit only). She saw her doctor today. The events required a visit to emergency room on 04May2021 and physician office on 05May2021. The outcome of the events "felt very hot/felt like heat rushed through her body", dizzy, and hives was recovered on 05May2021, nauseous was not recovered, and arm pain was recovering. The outcome of the other events was unknown.

pt passed out 5 minutes after the shot was given. Then the pt started to shake a little for about 10 -15 seconds. When pt came back to she vomitted. Pt felt better about 5 minutes after event.

patient felt very light headed, sick to her stomach, face was very pale, vomited up some water she had just drank

Pt received second Pfizer COVID-19 vaccine on 5/10/2021. On 5/12, she saw her PCP c/o mid abdomen/esophageal pain after eating breakfast. Advised to go to the ED for more complete blood work. Pt was prescribed famotidine and pt sent home.

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.

Post vaccine (10:00am) pt experienced lightheadedness, dizziness and nausea. PT reported that she had not eaten; given juice and granola bar. 5 mins later pt reported nausea, but unable to vomit. PT continued to report dizziness. PT assisted to lay down on mat with legs up on chair. Cold compress to head and clothing loosened. Vitals remained stable, but symptoms would resolve only for a short period and would return. 911 called at 1037. EMT arrived at 1049. Following evaluation, PT transported to hospital for further evaluation and treatment if needed.

I got my first shot on 4/28. the week after my last period. My period was supposed to start on 5/17 and it hasn?t come. After my second dose on 5/19, I have no period but horrible cramps and abdominal pain/constipation.

- threw up at 5am morning after vaccine -rash on face since 05/23 -sore arm since 05/22 -clammy morning of 05/23

Client received 2nd COVID vaccine of Pfizer (Lot# EW0185 expiration date 06/24/2021). Client reported nausea and upset stomach at 1528. EMT and EMT responded to this event. RN was notified and responded at 1529. At 1529, vital signs are blood pressure 122/84, heart rate 88, oxygen saturation 97%. Client reports a history of anxiety and insomnia. Client reports current medication usage of Alprazolam, Ambien, Zoloft (sertraline) Sonata, and Zalephon. Client was offered supplemental nutrition and fluids. Client denied nutrition, but accepted fluids. RN educated Client about ED precautions and common adverse effects of the COVID vaccines. At 1540, vital signs are blood pressure 124/90, heart rate 84, oxygen saturation 99%. Client denies shortness of breath, no chest pain, no blurred vision, no headache, no lightheaded. Client reports "stomach feeling better" while drinking water. At 1550, vital signs are blood pressure 122/90, heart rate, 91, oxygen saturation 99%. Client reports "my stomach is improving", reports no nausea and continues to drink water. At 1600, vital signs are blood pressure 119/90, heart rate 86, oxygen saturation 98%. Client reports no new symptoms and that all past symptoms have resolved. At 1604, Client stood up with no complaints and states "I am ok to drive myself". Client walked out of facility with a steady gait.

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

Fever (over 101 degrees), chills, headache (severe), muscle pain, body aches, fatigue, nausea and vomiting starting 2 days after vaccination, lasting over 5 days.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild

Prolonged severe headache, fatigue, chills, muscle aches, nausea/vomiting for 5 days after injection.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Weakness-Mild, Additional Details: Patient received 1st dose of Pfizer vaccine on 5/29/21. 5 minutes post-vaccination, patient complained of feeling lightheaded, tingly in the hands/feet/legs, mildly nauseous, dizzy and sweaty. 1st BP (77/41 & HR 55) and 2nd BP taken 20 min later (86/53 & HR 56). Patient was given water and a cool towel and after 30 minutes of monitoring, patient confirmed feeling better and stated ok to leave (did not feel dizzy when standing up) with mother attending her.

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.

1st day of pain: Extreme Pain in Lower Extremities (Right Leg, Right abdomen, right lower back) Swelling of Right Leg 3rd day: Admitted into the hospital after visiting the ER Acute DVT in R Leg, multiple Pulmonary Embolisms 3rd-5th day in hospital: 2 Surgical Procedures to remove blood clot, on Blood thinners for a year to life

Flu like symptoms and arm soreness started the next day. Never really subsided. Transitioned to headache, stronger body aches to the point of hurting when touched. Started a fever on 5/27. Today is 6/1 and she still has intermittent fever, aches, nausea, congestion. Started on Zithormycin by doctor. Now on day 3 with no alleviation of the symptoms. Lyme, mono, covid - negative. Bloodwork all normal except for C reactive protein which was elevated at 20.

Client received the 1st COVID vaccine (Pfizer Lot #EW0187 and 06/28/2021) at 1848. At 1859, Office Assistant was walking past the client when she noticed that the client appeared unwell. Assistant asked the client if she was feeling ok, the client responded, ?I feel dizzy.? Assistant alerted PHN that the client was feeling dizzy. PHN responded. The client appeared drowsy but was oriented to person and place. The client?s eyelids were open halfway, and the client was mumbling answers to the questions. The client stated, ?I feel dizzy and hot under my skin.? Vital signs were taken by EMT at 1901 (Heart rate 92, Oxygen 99%, blood pressure 112/P?client was wearing a long-sleeved shirt). Client?s skin was warm and dry. At 1902 client appeared more alert, and PHN gave the client juice to drink, which she accepted and drank. Client stated that she has a history of vasal vagal reactions to needles and was anxious about receiving today?s vaccine. EMT and PHN transitioned client to zero gravity chair at 1904 and gave client chips and a granola bar to eat. The client accepted the snacks and started to eat them. At 1905 client stated, ?my head feels weird like I want to lay back.? PHN advised client to lay her head back onto the gravity chair head rest. Client laid her head back for less than 30 seconds than continued to eat. PHN offered the client Benadryl and she refused. Client stated that the last time that she ate was around 1100 or 1200. Client was wearing a beanie and long sleeves, we asked the client if she can remove her hat and outer layer, however, she refused. The client had a flat affect and was soft spoken. Vital signs taken at 1915 (oxygen 98%, heart rate 94, blood pressure 138/84). Client denied any shortness of breath. At 1919, client stated, ?I feel like I?m going to throw up.? The zero-gravity chair was positioned into a seating position and the client was given an emesis bag. Client did not vomit, and she sat with the emesis bag until 1923 and then stated that the feeling was gone. Client has a history of sickle cell anemia and stated that she receives blood transfusions every 2-3 weeks but had not received a transfusion in 8 weeks. Client is currently prescribed Metformin but has not taken the medication because ?she does not trust it.? Client stated that she was prescribed Lexapro 1 month ago and took her first dose the day before the vaccine but did not take it the day of the vaccine. She stated that she has anxiety but denied any other medical conditions. She is allergic to Toradol. Vital signs taken at 1924 (oxygen 98%, heart rate 91, blood pressure 146/102). At 1925 she sated ?my head hurts, it?s a sharp pain.? PHN called EMS at 1926. EMS arrived at 1928 and assumed care. EMS medic stated that her blood glucose levels were at 82 and advised her that they wanted to take her to the emergency room to be examined. The client refused transport to the hospital and stated, ?I don?t want to go to the hospital, it?s so expensive.? Client continued to refuse transport and stated that she will have her boyfriend take her to the hospital. Client?s boyfriend entered the building and client signed an AMA at 1953. PHN provided education to client and boyfriend on life threatening symptoms and to call EMS if any symptoms appear on their way to the hospital. PHN also advised client to follow up with her primary care provider and to follow up with an allergist before receiving her second vaccine. Client left the facility AMA at 1954 with her boyfriend, unassisted and with a steady gait. Client and her boyfriend stated that they would go to the hospital.

Patient had anxiety and nausea. Did vomit 1X. Patient was given water and crackers. 25 min later feel better

Pain in arm; Swollen; Itching; Headache; Nausea; My left nose clogged up; The left side of my throat burns, hurts to swallow and is swollen.; The left side of my throat burns, hurts to swallow and is swollen.; This is a spontaneous report from a contactable consumer (patient). A 19-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Lot number and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 25May2021 16:30 (at age of 19-year-old during vaccination) as a 1st dose, single dose for COVID-19 immunisation. The patient's medical history was reported as none. The patient had received birth control pills within 2 weeks of vaccination. The Patient had not received any other vaccines within 4 weeks prior to the Covid vaccine. The patient had not diagnosed with COVID-19 prior to vaccination. On 25May2021 12:00 AM, the patient experienced pain in arm, swollen, itching, headache, and nausea for the first few days in the night of. On 29May2021 (Saturday, four days later), her left nose clogged up and the left side of throat burns, hurts to swallow and was swollen. Since the vaccination the patient had not diagnosed with COVID-19. The outcome of the events were unknown. Information about lot/batch number has been requested.

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Mild

Patient experienced increased perspiration, chills, nausea, numbness in her fingertips, and syncope that lasted for about 30 seconds. This occurred about 15 minutes after receiving the vaccination. Paramedics were called per the request of the mother soon after she informed me that the patient was not feeling well. When the paramedics came, vitals were taken and she was escorted to the hospital.

After both shots, around 10 hours later I started to experience shivering but I was also sweating. I took my temperature and did not have a fever. I felt very nauseous during this time too but threw up only after the first dose. My whole body was sore and even the slightest touch was painful.

Patient has had a 2 day history of left sided chest pain, chest tightness, shortness of breath, dizziness, nausea and tightness in the left shoulder.

2nd COVID19 Pfizer vaccine 5/1/21 lot # EW0167. both vaccines received at pharmacy. 5/24/21 awoke at 0400 with headache and nausea and vomiting. Headache worsened throughout the day and went to ED where she had syncopal episode and was treated for migraine headache with migraine cocktail and sent home. Symptoms continued and progressed the next day and she went to Hospital ED in where a CTH revealed SDH near her sinuses. She was transferred to Medical Center in for higher level of care. On arrival she had a CTH/CTA which revealed and extensive central venous sinus thrombosis.

blood clots; she did get really sick / she was displaying a lot of symptoms; fever; whole body was aching; fatigue; nauseated; bruises on the legs / now she's getting more / she would say they have worsened; This is a spontaneous report received from a contactable consumer (patient's mother). A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0182), via an unspecified route of administration in arm left on 14May2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received flu shot and experienced nausea. The patient experienced blood clots on an unspecified date, bruises on the legs, she was getting more, she would say they have worsened in May2021, fever on 15May2021, whole body was aching on 15May2021, fatigue on 15May2021, nauseated on 15May2021, and she did get really sick, she was displaying a lot of symptoms on an unspecified date. Patient started having bruises on the legs and thought that it might be related to blood clots. She mentioned that she also experienced the common side effects but she was not concerned of that as people she knew also had those symptoms but was more concerned about the bruising. On patient's legs, she had a bunch of bruises. Reporter was just really nervous about her daughter's bruises. When patient was working, she was not noticing, but today patient noticed her legs and said reporter it was a lot of them. Patient did get really sick with her first shot, she had a fever, she couldn't go to work the next day. Reporter was not sure if the patient should get the second dose on 04Jun2021. Patient's whole body was aching, she was nauseated, she was displaying a lot of symptoms. Reporter checked online and they said it was a normal thing. Patient came down and showed reporter the bruises. Patient wasn't really paying attention to them. Patient had one or two bruises when she noticed and at the time of the report she was getting more. They had worsened. Patient took ibuprofen (ADVIL) for fever and she felt better. Outcome of events blood clots and she did get really sick, she was displaying a lot of symptoms was unknown, of event bruises on the legs, she was getting more, she would say they have worsened was not resolved, and of other events was resolved.

My daughter was fine on the first day. She woke up the next day with a weird headache that her scalp hurt. She went into work and started to feel poorly throughout the day. When she came home, she went to bed at 4:30 pm as she had aches & pains, continued headache, felt nauseous, tired, and noticed her left leg where she had surgery previously was bothering her with pins and needles. I told her to go to bed and she would be fine the next day. On 5/26, her leg was giving her increased problems where she could not flex her foot, nerve pain in her leg along with numbness, and she still had the headache. I told her to call her primary care physician and the nurse had her go the the ER. They ran no tests, but consulted with neuro on call and surgeon who performed surgery on her leg two years ago. She was instructed to follow-up with a neuro and start PT. We got her into a PT. The next day she continued to have same issues, but her leg pain increased. She followed up via phone twice to primary where the nurse told her to go back to the ER. She had blood work, ultra sound and x-ray. She saw neurologist on 6/2 and is scheduled for follow-up with an EMG on 6/14. She has seen physical therapist 6x since 5/26 and still has numbness, nerve pain, etc. The form from neuro office said left foot drop and parathesia. She has had headaches this week including a migraine on 6/8.

Hot flashes Red face Feeling like she was going to pass out or throw up if she didn't lie down Fatigue prodome Fast HR feeling episodes

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

patient was given pfizer 1st dose vaccine at 3:35pm and at 4:40pm reported feeling hot/nausea/neck pain (stiffness). BP 102/76 HR 81. Re took at 5:04 BP 96/62 HR 86. patient did report occasional anxiety but not with vaccines. called EMT at her request.

I have thrown up 3 times; had the chills; This is a spontaneous report from a contactable consumer (patient). A 19-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6207; Expiration date was not reported), via unspecified route of administration in the left arm on 13Mar2021 04:30 PM (at the age of 19-years-old) as first dose, single dose for COVID-19 immunization at an urgent care center/ doctor's office. Medical history included COVID-19 from an unknown date (prior vaccination) and unknown if ongoing. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. No other vaccine was received by the patient in four weeks. The patient was not tested for COVID post vaccination. The patient has no known allergies. On 14Mar2021 08:30 AM (reported to be the morning after getting the vaccine), the patient experienced to have thrown up three times and had the chills. No treatment was taken for the events. The patient underwent lab test and procedure which included COVID-19 test: Positive on an unspecified date prior to vaccination. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

Headache; Nausea; Vomiting; Injection site pain; Stiffness in injection limb; Mild fever (100.2 F); This is a spontaneous report from a contactable consumer, the patient. A 19-years-old non-pregnant female patient 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 17Mar2021 at 14:15 (at the age of 19-years-old), as a single dose for COVID-19 immunisation. Medical history included Idiopathic intracranial hypertension, Tourettes and fibromyalgia. Concomitant medications included naproxen (MANUFACTURER UNKNOWN), TOPAMAX, CYMBALTA, ATIVAN and trazodone (MANUFACTURER UNKNOWN) taken for unknown indications from unknown dates within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not tested for COVID-19. On 18Mar2021 at 12:00, the patient experienced headache, nausea, vomiting, injection site pain, stiffness in injection limb and mild fever (100.2 F). No therapeutic measures were taken for the adverse events. The clinical outcome of headache, nausea, vomiting, injection site pain, stiffness in injection limb, mild fever (100.2 F) was recovering/ resolving. Information about lot number cannot be obtained. No further information is expected.

Pt experienced vasovagal syncope within 1 minute of receiving her second dose of pfizer. She retained lucidity within seconds and immediately vomited. She regained color within two minutes of the event, was able to drink some fluids, and regained homeostasis thereafter. She stayed and was monitored for further reaction for 15 minutes but maintained equilibrium and her mom took her out to get breakfast and then head home.

Threw up shortly after second dose Extremely tired Unable to eat for days Lightheaded Lesions on vulva Pain, unable to walk Pain, unable to use bathroom Unable to leave bed

Dizzy, nauseated, felt hot. Brought to med screening via wheelchair for evaluation by medics. BP=114/76 Pulse=50 Left in stable condition at 17:13 p.m. Recorded by RN Medic

Threw up shortly after second dose, Extremely tired, Unable to eat for days, Lightheaded, Lesions on vulva. Pain, unable to walk. Pain, unable to use bathroom. Unable to leave bed.

This is a spontaneous report from a contactable consumer. A 19-years-old female patient received second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, Batch/Lot Number: EW0173, expiration date was not reported) via an unspecified route of administration, administered in arm right on Jun 11, 2021 16:00 (at the age of 19 years) as dose 2, single for COVID-19 immunization (reason: just to get it, everyone in my household got it, just to feel safe) at a medical facility. Medical history included depression (ongoing maybe 6 years ago), anxiety (ongoing maybe 6 years ago). The patient concomitant medications were not reported. No other products. No additional vaccines administered on same date of the Pfizer suspect. Family medical history relevant to adverse event was none. Patient previously received first dose of Pfizer-BioNTech COVID-19 vaccine (Batch/Lot Number: EW0179, expiration date: not reported) via an unspecified route of administration, administered in arm right on May 21, 2021 as dose 1, single for COVID-19 immunization. On Jun 11, 2021 16:00, the patient felt very dizzy and almost feels faint. On Jun 11, 2021 16:30 the patient got very nauseous. No emergency room and physician office visit. Relevant tests were none. The outcome for both events was not recovered. Clinical course was as follow: The patient just got the COVID-19 vaccine exactly 55 minutes before time of call and reported that she was not sure if it was a severe reaction, but she felt very dizzy and almost felt faint. The patient she was in her car and had to pull over. The patient reported that as soon as she got in the car, she felt very nauseous and started to feel dizzy. The patient she waited for 30 minutes after she got the COVID-19 vaccine. The patient began feeling dizzy when she stood up after receiving the COVID-19 vaccine and she had to sit right back down. The patient got some water and when she got the water she felt not as dizzy. The patient walked to her car after and sat there for a little. The patient was still feeling a little nauseous but wanted to get home to get settled. The patient was driving home, she felt herself drifting off, so she had to pull over. She was still feeling dizzy, and she was going to call her friend to pick her up. The patient was not sure what to do and inquired for any advice.

after receiving the shot, that night I started to have vaginal bleeding. My period ended well over a week ago and it?s strictly black blood. Also, The morning of Monday, June 28, 2021, one day after the vaccine from 6 AM until 10 AM I threw up 10 times. And today Tuesday, June 29 I am still bleeding black blood vaginally and now have cramps in my lower abdomen

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.

Severe arm pain at injection site, sudden onset dizziness about 2 hrs after injection; the next morning, fatigue, aches & pains, extreme nausea, dizziness, passing out upon standing up (lost consciousness twice, resulting in a fall and mild head injury). For several days afterward experienced unexplained depression, not sure if it was related.

Inflamed heart and chest wall pain. Went to dr. when breathing and drinking became painful, ekg and chest x-ray were normal. given steroids to reduce inflammation and sent home

Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Additional Details: Rph noticed pt didn't look well as she waited after the shot. pt said she was not feeling well and rested head on RPH shoulder & passsed out. Rph with assistance of another Rph lower pt to floor. pt regained consciousness but still seemed out of it. We called 911. kept her feet elevated, covered her with blanket since body temp dec to 93.2, she was able to answer questions. paramedics took bp & bs and said bs low. pt had had smoothie before shot . Went to hosp in ambulance

Pronounced weight loss began within two weeks of the first dose. Patient lost 30 pounds in 3 months. She was diagnosed as a Type 1 diabetic July 12, 2021. Her symptoms during those three months included weight loss, dizziness, fatigue, sensitivity to heat, racing heart, easily out of breath, nausea and vomiting.

Vomiting.; This is a spontaneous report from a contactable consumer, the parent. A 19-year-old non-pregnant female patient 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 25Mar2021 at 14:30 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history reported as asthma. Concomitant medication included LEXIPRO. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 26Mar2021 at 07:00, the patient experienced vomiting. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient had not received any treatment for the reported events. The clinical outcome of the event vomiting was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

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)

Soon after the shot she didn't feel "right" and her arm was very sore to the point where she didn't want to move it. The next morning she woke up with a stuffy nose and head and lethargy. Her symptoms progressed to fever, chills and body aches by the afternoon. She didn't feel well enough to eat through the evening and at midnight she became nauseas and had stomach cramps. She was then simultaneously vomiting and having diarrhea with moderate-to-severe stomach cramping for approximately an hour. After, the chills were even worse and the nausea continued. The second day after the vaccine she continued to have an upset stomach and lethargy. The lethargy and slightly upset stomach continued into the third day after being vaccinated. I cannot report further because this is the third day.

stomach cramping; Diarrhea; This is a spontaneous report from a contactable other healthcare professional, the patient. A 19-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 27Mar2021 at 13:30 (at the age of 19-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Concomitant medications included medroxyprogesterone acetate (DEPO PROVERA), hydroxyzine (MANUFACTURER UNKNOWN) and lithium carbonate (MANUFACTURER UNKNOWN), all for unknown indications from unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, the patient experienced diarrhea and stomach cramping. No therapeutic measures were taken as a result of the reported events. 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 the events of diarrhea and stomach cramps was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

Fever, chills, headache, body aches, nausea, and pain at injection site ( started at 8 pm lasted until 10 am)

Pt became nauseous and vomited minutes after receiving vaccine. Pt was given cold compress and water. VS were taken and WNL. Pt was allowed to rest until she felt better. No further adverse reaction was noted. Pt was advised to seek medical treatment if symptoms worsen over the course of time.

At 40 minutes post vaccination the patient experienced lightheadedness, nausea, and shaking. at 60 minutes the patient experienced a slight lump in her throat which did not progress. The patient was taken to the emergency room for observation.

tired; stomach pain; swelling at site; itching; body aches; headache; lightheaded; This is a Spontanoeus report from a contactable other HCP (patient) A 20 years old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 28Dec2020 at 11:00 AM, at single dose on left arm for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 28Dec2020 at 11:45 PM the patient experienced stomach pain, swelling at site, itching, body aches, headache, lightheaded, tired. At the time of the reporting the patient was recovering from reported events. No follow-up attempts are possible; information about lot/batch number cannot be obtained, No further information is expected.

Following you vaccination nausea, dizziness, and migraine. These persisted, and still happen occasionally. Started once a day and now is every few days.

I woke up with sever stomach pain and nausea. I could not lay down or else it would hurt worse. By the afternoon this turned into chest pain, shortness of breath, headache, sweating, back and muscle pain, and a fever of 101.4.

Fever, chills, malaise, body aches, nausea, headache, all lasting 24 hours. Treated with NSAIDs, resolved after 24 hours.

Chills within 8 hours of shot; fever, nausea, vomiting, chills, body aches started 12 hours after shot lasting for 24 hours

dizziness; Nausea; fast heart rate; This is a spontaneous report from a contactable other healthcare professional. A 20-year-old female patient received the first dose of bnt162b2 (lot number: EK9251), intramuscular in left arm on 04Jan2021 13:00 at single dose for covid-19 immunization. Medical history included COVID-19. Concomitant medication included ethinylestradiol, norgestimate (MONO LINYAH). The patient previously took ciprofloxacin (CIPRO) and experienced drug allergy. The patient is not pregnant at the time of vaccination. The most recent COVID-19 vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. The patient experienced dizziness, nausea, and fast heart rate on 05Jan2021. Since the vaccination, the patient has been tested for COVID-19 which included nasal swab test on 05Jan2021: negative. The outcome of the events was unknown. The events were reported as non-serious.

EE reports, started to be nauseous overnight, 1/12 into 1/13. 1/13 10 am, chest heaviness, SOB, anxiety, unable to function at work 1/13/2021, to Urgent Care, prescribed zofran for nausea. Was asked to contact her PCP regarding her HR 130, EE was on buprion and abruptly stopped taking it for 2 weeks without PCP recommendation, "I thought I didn't need it anymore". EE reported to OHN on 1/13, she restarted the med and took her first dose on 1/12 and her second one on 1/13. Covid results negative

I had pain in my arm when I received the vaccine. I also had nausea, a headache, joint pain, and body aches the day after and everyday since I received the vaccine. Today I vomited twice due to the headache and nausea.

I felt feverish and had joint and body aches the day following my vaccine. I was also nauseous, had a headache, and felt fatigued. Today, 01/18/2021 I had a migraine so bad I vomited twice. I had to go home from work because I was so sick.

Nausea, fatigue, headache, and body aches Treated with rest and Ibuprofen taken ever 4-6 hours Symptoms subsided within 24 hours of the start date

PATIENT REPORTED "SHAKY BREATHING," "PAIN ALL OVER BODY," AND FEELING NAUSEATED. SYMPTOMS WERE NOT RESOLVING UPON USING CONTROLLED BREATHING TECHNIQUES, AND RELAXATION. PATIENT WAS BECOMING DISTRESSED ALTHOUGH WAS NOT EXPERIENCING RESTRICTED AIRWAY.

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.

Pt reported to feel subjective fever, chills, diarrhea, nausea and vomit, fatigue since receiving COVID vaccine yesterday. She vomiting clear x5 since yesterday and is unable to hold food down. She had x6 episodes of mild diarrhea.

Approximately 30 second after injection patient reported feeling nauseated and then passed out. Patient regained consciousness a minute later. Her vision and pulse rate was back to normal within 5 minutes. She was given juice and was able to walk to observation where she remained for at least 30 minutes.

ice pick headache upon injection (3hr duration), nausea (36hr duration), fever 103F (8hr starting at 03:00 of day following injection), throbbing in arm of injection (36hr duration), chills (8hr starting at 03:00 of day following injection)

Beginning at 8:00 pm on 2/2/21 I had severely sore arm, chills, severe body aches, and fever until 8:00 am 2/4/21. Starting at 6:00am 2/3/21 I also had nausea and abdominal pain until 8:00am 2/4/21. Headache began 8:00 pm 2/2/21 and continues as of 11:15pm 2/4/21.

0925 AMThroat light swelling, feels something back of throat, dysphagia, dyspnea. Recent sinus infection, 0928 Benadryl po Last meal 1200am,Vital signs stable 0939am Feels better, still feels a lump in throat. 0955 Vital signs stable D/C

0300: woke up with widespread body pain/joint pain (7 out of 10), nausea (lasted about 20 hours) Treatment: took Advil and Tylenol according to manufacturers directions as continuously as possible, took 1 dose anti-nausea/motion sickness at 18:30 Symptom-free starting 02/04/2021 at 0915

I felt as if I head a fever; sweats; needed to vomit; felt pretty dizzy; 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, solution for injection), via an unspecified route of administration on 20Jan2021 18:45 at SINGLE DOSE at left arm for COVID-19 immunization. Medical history included ulcerative colitis. The patient was not pregnant at the time of vaccination. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. After my vaccine, on 20Jan2021 19:00, the patient felt as if I "head" a fever and sweats and needed to vomit I also felt pretty dizzy, I know this was in the side effects but just wanted to make sure I was going to be okay to receive my second dose. The patient did not receive treatment for the events. The patient recovered from the events on Jan2021. Information about lot/batch number has been requested.

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

Received the shot at 2:10. 2:15, she was feeling light headed and tingly sensation in her extremities. She didn't let anyone know at this time. The person observing her noticed she seemed zoned out and asked how she was doing at about 2:17 and learned that her tingliness was turning into numbness of extremities focused on her upper body. She started displaying other symptoms of a minor panic attack. We monitored her for the full 30 minutes, had her walk around, drink water, etc. She claimed that while her numbness wasn't getting better, it also wasn't getting worse. It was starting to itch though, so she was given some benedryl. She then went home for the evening where her roommate could monitor her. Next day, she called in to confirm that her numbness/itchiness had turned into a rash on her chest which has disappeared. But now is experiencing diarrhea, headache, weakness and dizziness. She was informed that these symptoms were within the normal range of immune responses, but that if she was too miserable, she could go in to urgent care for medical assistance. She declined to do so at that time (approximately 11:45 am).

ON 2/11/21, DEVELOPED PAIN ALL OVER THAT CAME AND WENT. FELT NAUSEOUS. BODY PAIN, JOINT PAIN, FATIGUE AND HEADACHE.

Immediately after injection, patient began to feel hot, nauseated, and anxious. She vomited x3. Upon arriving to the observation room, patient reports that all symptoms have resolved. Monitored for an additional 15 min with no complications. Pt ambulatory to private transportation.

My arm hurt about an hour after. I started to get a headache and feel nauseous. I woke up at 2am this morning getting sick, with a big migraine, and not being able to hardly move my arm

Rash is on my chest and on my upper back; Can barely breath; I can't really eat or swallow because my throat is swollen; I can't really eat or swallow because my throat is swollen; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 02Feb2021 at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization. Medical history included asthma, diabetes, autism and attention deficit hyperactivity disorder (ADHD). The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On 03Feb2021, the patient had rash on the chest and upper back; can barely breathe; and could not really eat or swallow because the throat was swollen. The patient did not receive any treatment for the reported events. The outcome of the events, 'rash on the chest and upper back', 'can barely breathe', 'could not really eat or swallow because the throat was swollen', was unknown. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination. Information on the lot/batch number has been requested.

4 hours post-vaccination: pain and soreness in the arm where the injection was given; soreness got progressively worse for 24 hours and then rapidly improved 12 hours post-vaccination: malaise, nausea, stomach pain, muscle aches, chills (no fever), fatigue, headache, and light-headedness onset; symptoms persisted for 24 hours following onset and improved overnight. 24 hours post-vaccination: axillary lymphadenopathy, currently persistent Overall, adverse effects felt like flu-like symptoms or a severe hangover

anaphylaxis; high blood pressure; elevated heart rate; her throat felt funny, like it was getting tight; very nauseous/sick of her stomach; rash on her chest; She could not swallow; This is a spontaneous report from a contactable consumer (parent of the patient). Information were received also from a Pfizer-sponsored program COVAX US Support. A 20-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL9261), via an unspecified route of administration in the left arm on 05Feb2021 09:30 at single dose for COVID-19 immunisation. Medical history included acne, allergy environmental cats dogs and latex. Adrenaline (EPIPEN) and Corticosteroid were used to treat these allergies. Due to these severe allergies, the patient had to take weekly allergy shots. Got allergy shot the day before the 2nd vaccine shot. Concomitant medication included isotretinoin (AMNESTEEM), buspirone (unknown manufacturer), calcium (unknown manufacturer), azelastine hydrochloride, fluticasone propionate (DYMISTA), gabapentin (unknown manufacturer), melatonin (unknown manufacturer), omeprazole (unknown manufacturer), estrogens conjugated, medroxyprogesterone acetate (PREMELLA), probiotics (PROBIOTICS), fluoxetine hydrochloride (PROZAC) , trazodone (unknown manufacturer), colecalciferol (VITAMIN D), cetirizine hydrochloride (ZYRTEC). The patient previously took clindamycin, bactrim and corticosteroids and experienced hypersensitivity. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3249) intramuscular in left arm on 15Jan2021 at 11:00AM. It was reported that 15 minutes after receiving her second COVID-19 vaccine dose the patient developed anaphylaxis, her throat started closing up, her throat felt funny, like it was getting tight. A nurse administered her anaphylactic shot (EPI-PEN shot) and was taken to the hospital by ambulance. The patient was monitored in the Emergency Room because her blood pressure and heart rate were up, but the Emergency Room didn't give her any further treatment. The patient was discharged home on 05Feb2021. On Saturday, 06Feb2021, at 4-5AM she developed anaphylaxis again, the patient had the same throat tightening happen again. The mother gave her an Epi-Pen shot (AUVI-Q) and brought her back to the Emergency Room. While in the Emergency Room, the patient was given steroids and Pepcid, and then sent back home. On Sunday, 07Feb2021, at approximately 1:00AM she had the same throat tightening so the mother gave her an Epi-Pen shot (AUVI-Q) again, and brought her back to the Emergency Room. The patient was admitted to hospital and discharged on 09Feb2021 evening (at 16:00). At hospital the patient received some steroid shots in the hospital. The patient was given 3-125mg steroid shots, and 3-40mg steroid shots, every night she spent in the hospital, she woke up with her throat closing and she was administered 125 steroids 50 mg Diphenhydramine (BENADRYL) and 4-5 hours later 40 mg of steroids 20 mg Famotidine (PEPCID) IV. They kept IV fluids. On 10Feb2021 at 7:50AM the patient experienced throat tightness again. The mother gave her some Diphenhydramine (BENADRYL) and steroids which were prescribed at hospital. The patient started a taper dose of Prednisone 10mg tablets. She was to take 2 Prednisone 10mg tablets twice a day for 3 days, then to take 2 Prednisone 10mg tablets in the morning and 1 Prednisone 10mg tablet in the evening for 3 days; then to take 1 Prednisone 10mg tablet twice a day for 2 days, and then 1 Prednisone 10mg tablet daily for 2 days. The patient was prescribed generic Famotidine (PEPCID), 40mg, one tablet, twice a day, and generic Diphenhydramine (BENADRYL) 25mg capsules. On unknown date in feb2021 the patient gets very nauseous when her throat starts to close. She could not swallow and was sick of her stomach. She experienced a rash on her chest. The outcome of the event heart rate increased and blood pressure high was recovered, for anaphylactic reaction and throat tightness was not recovered. For the other events was unknown. The events anaphylaxis, throat tightness, heart rate increased and blood pressure were serious due to hospitalization.

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.

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