Pfizer

Cardiovascular symptom reports

Female, 16 - 25 years

Age Reported Symptoms Notes
16 2021-01-07 chest discomfort Patient in clinic for chief complaint of possible side effect of the covid vaccine which she receive... Read more
Patient in clinic for chief complaint of possible side effect of the covid vaccine which she received yesterday. She states that she woke up at 0200 with chest tightness, achyness and headache. She rates the discomfort 7/10 last night and improved now to 5/10. She denies any worsening with any type of exertion and states that she can do simple things like take a shower, walk across the room, down the street or even stairs without any worsening. She denies any SOB or chest pain--just feels tight. Doesn't feel like she can't get a full breath or get the air out of her lungs either. She received her first of two doses of the Pfizer vaccine yesterday (4:23pm) and had no difficulty with the injection itself and then 9.5 hours later woke up from sleep with this chest tightness as well as achyness and headache.  She states that she had the exact same symptoms when she had positive covid test back in August of this year with the addition of fatigue which lasted for 5 days. At that time it was not felt necessary to do any further testing nor treat with steroids according to cardiology. She does have history of LV non-compaction cardiomyopathy and her last visit with cardiology was about 2 years ago and she had a normal EKG and echo only showed "mild LV non compaction at the apex" at that time. He did not need to see her again until she is 18 unless she has problems. She states that she generally does very well and other than this tightness she does not have any other significant symptoms.
16 2021-02-03 pallor, fainting Approximately 20 hours after vaccination patient felt faint, lost all color and fainted. She was in ... Read more
Approximately 20 hours after vaccination patient felt faint, lost all color and fainted. She was in and out of responsiveness. Patient was transported to the ER. Patient was treated with fluids and discharged after observation. According to patient's mom the EKG and lab work were unremarkable. Patient has fully recovered.
16 2021-02-04 fainting Systemic: Fainting-Severe
16 2021-02-07 fast heart rate Shortness of breath, fatigue, tachycardia - persisting since vaccination
16 2021-02-10 oxygen saturation decreased, heart rate increased Congestion, breathing abnormal, elevated heartrate , 02 lower then usual , tired , exhausted, fat... Read more
Congestion, breathing abnormal, elevated heartrate , 02 lower then usual , tired , exhausted, fatigue, not usual self , fussy , incosebale. Patient is a non verbal child
16 2021-02-16 chest discomfort, heart rate increased 1917 patient reported dizziness, tightness in chest , hyperventilating and pulse rate of 118 bpm.
16 2021-02-17 loss of consciousness A minute after receiving vaccine, client lost consciousness for approximately 30 seconds paired with... Read more
A minute after receiving vaccine, client lost consciousness for approximately 30 seconds paired with facial twitching. No history of seizures and history of syncope due to holding breath and anxiety with medical procedures and vaccinations in the past.EMS was called, client was evaluated by EMS upon arrival, parent was called and history verified. It was discussed with parent that PCP and client have a plan in place for these kinds of reactions to go home and continue monitoring, so client was driven home by friend.
16 2021-02-18 pallor, loss of consciousness Went to sit down and passed out; felt dizzy; nausious/nausia; sweaty; sick feeling; as she was ghost... Read more
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.
16 2021-03-03 pallor My daughter became very dizzy, pale, and hot (sweating through her clothing) almost passing out aft... Read more
My daughter became very dizzy, pale, and hot (sweating through her clothing) almost passing out after receiving her first dose . Paramedics were called, vitals taken, and she was taken to an observation area. She started to feel a bit better after about 15 minutes. She was observed by paramedics and a nurse for another 30 mins and we were able to leave and go home. At home she was exhausted the remainder of the night.
16 2021-03-05 fainting Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Severe
16 2021-03-12 lightheadedness Patient was sitting in the observation area. Patient stated that she was feeling "off" and we helped... Read more
Patient was sitting in the observation area. Patient stated that she was feeling "off" and we helped lower her to the ground into a sitting position. She stated that she felt dizzy and we lowered her onto her back and raised her legs onto a chair. 911 was contacted. Patient remained responsive and was able to answer questions throughout. Patient stated that her shoulder felt like it was burning where she received the injection. She also stated that her face felt numb and her lips felt funny (tingling). Patient was still able to breathe and respond appropriately to all questions. Care was taken over by Ambulance service. After speaking with patients mother later in the day, it was determined patient had a vasovagal episode.
16 2021-03-16 pallor Patient mother reported patient began to shake and she was unable to speak or respond. Upon observat... Read more
Patient mother reported patient began to shake and she was unable to speak or respond. Upon observation patient was pale, awake, and clammy, responding appropriately . Pulse ox placed on patient O2 sats 98-100, pulse 57, BP 87/45. Patient oriented to person, place, and time. Patient reported feeling weak, complains of headache and neck hurting. Patient reported tingling in her left hand and reported her tongue was tingling. . At this time ambulance was called to transport the patient to the ED.
16 2021-03-18 loss of consciousness PT RECEIVED 1ST DOSE OF PFIZER COVID VACCINE. SHE SAT ON A CHAIR FOR 15 MINUTES AND WAS FINE WHILE S... Read more
PT RECEIVED 1ST DOSE OF PFIZER COVID VACCINE. SHE SAT ON A CHAIR FOR 15 MINUTES AND WAS FINE WHILE SEATED. AFTER 15 MINUTES SHE STOOD UP TO LEAVE AND WALKED ABOUT 25 YARDS WHERE SHE SUDDENLY FELT DIZZY AND PASSED OUT. SHE FELL TO THE GROUND, HER FACE SLAMMING THE FLOOR. AFTER A FEW SECONDS SHE WAS CONSCIOUS AND BREATHING. WE KEPT HER LAYING ON THE GROUND AND TOLD HER TO KEEP BREATHING. SHE WAS CONSCIOUS AND RESPONDING TO OUR QUESTIONS. WE CALLED 911 AND EMT ARRIVED AND TOOK OVER HER TREATMENT
16 2021-03-18 fainting Patient is a 16 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 3... Read more
Patient is a 16 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot ER2613 on 3/19/2021. The patient experienced the following reaction(s) during the immediate of observation: Patient received vaccine at 4:21pm and proceeded to recovery area where she verbalized to her mother that "I don't feel good." 4:23pm Patient had a witnessed syncopal episode and fell to the ground where she was attended to. Patient was treated/managed as follows: 4:25pm VS BP 118/88, HR 57, RR 18, O2 sat 98% on room air. Patient alert and verbal. 4:35pm: VS BP 144/80, HR 85, RR 18, O2 sat 97% on room air. Patient alert and oriented. Denies shortness of breath, difficulty breathing, or pain. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. 4:37pm Paramedics arrived and care assumed by paramedics at this time. Patient mother present.
16 2021-03-21 chest discomfort Fever, chills, extreme fatigue, lightheadedness and very sore arm, but more importantly chest tightn... Read more
Fever, chills, extreme fatigue, lightheadedness and very sore arm, but more importantly chest tightness that became increasingly worse over 48 hours. My daughter dealt with the other symptoms but her asthma became less treatable over the two days since the second shot. I finally administered the nebulizer and inhaled steroid today after all other treatments failed to relieve her symptoms. She is doing better but I will follow up with the pediatrician.
16 2021-03-21 fainting Syncopal event after vaccine
16 2021-03-23 loss of consciousness Patient briefly lost consciousness immediately following vaccine administration. Had shaking, chill... Read more
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.
16 2021-03-25 pallor Patient was shaky and pale during post-vaccination observation following her second Pfizer dose. Jui... Read more
Patient was shaky and pale during post-vaccination observation following her second Pfizer dose. Juice was provided to the patient. Per Mom, client has a history of "vagal" reactions following blood draws or other needle encounters. Onsite EMS evaluated client, took vital signs (below). Client's condition improved. Client was cleared by EMS to discharge home with her mother, and she left the facility of her own volition.
16 2021-03-26 fainting Syncope, dizziness. BPs 92/54 (pulse 75), 105/60 (pulse 82). O2 sat 100%.
16 2021-03-28 chest pain Approximately 15 minutes following vaccination, the patient complained of headache, dizziness, chest... Read more
Approximately 15 minutes following vaccination, the patient complained of headache, dizziness, chest pain and throat burning. I asked that she wait an additional 15 minutes so that we could monitor her. Approximately 30 minutes after vaccination, patient appeared to experience syncope or absence seizure (prev. history). we called 911 and paramedics transported her to hospital
16 2021-03-29 fainting Felt dizzy about a minute after vaccine administration, patient described blurry vision and then she... Read more
Felt dizzy about a minute after vaccine administration, patient described blurry vision and then she fainted and fell to the floor. Patient described no prior history of reactions to prior vaccinations. After about a minute she regained consciousness and was able to walk, talk, and function normally. Mom did intend to follow up with primary care doctor regarding the fainting episode.
16 2021-03-29 fainting 16yo F with known history of syncopal episodes after injections who had a witnessed syncopal episode... Read more
16yo F with known history of syncopal episodes after injections who had a witnessed syncopal episode and LOC for 30s. Pt was evaluated by medical staff and EMS, provided with oral hydration and nutrition. Pt improved after 20min of observation and was released.
16 2021-03-30 fainting Patient waited 15 minutes after her vaccine and when she stood up to leave she fainted. Her mom aler... Read more
Patient waited 15 minutes after her vaccine and when she stood up to leave she fainted. Her mom alerted me right away and when I got out to the patien she was up and sitting in her chair. She was feeling fine at that point. She waited another 15 minutes and she was all better.
16 2021-03-31 cerebrovascular accident Patient had a CVA (stroke) to the R internal capsule and basal ganglia while therapeutic on warfarin... Read more
Patient had a CVA (stroke) to the R internal capsule and basal ganglia while therapeutic on warfarin. She has a history of Truncus Arteriosus s/p repair and has been anticoagulated for >10 years without issue. Stroke occurred 1 week after vaccine. She now has L sided motor deficits which are likely permanent. Left arm is flaccid. L leg with poor motor function.
16 2021-03-31 loss of consciousness patient passed out 10 minutes after receiving the Pfizer covid vaccination
16 2021-03-31 fainting Syncope
16 2021-03-31 fainting Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild
16 2021-04-01 chest pain, heart rate increased Pain in injection area, sharp pain in underarm area, shortness of breath, chest pain, rapid heart pa... Read more
Pain in injection area, sharp pain in underarm area, shortness of breath, chest pain, rapid heart palpitations, dizziness, tiredness,
16 2021-04-01 nosebleed Patient referred to clinic for increased bruising. Patient reports heavier menstrual flow, frequent ... Read more
Patient referred to clinic for increased bruising. Patient reports heavier menstrual flow, frequent bloody nose recently.
16 2021-04-01 loss of consciousness Immediate intense headache. Feeling faint. Lay down on floor, semi conscious. Ems staff moved her to... Read more
Immediate intense headache. Feeling faint. Lay down on floor, semi conscious. Ems staff moved her to sitting position where she completed blacked out. They struggled to hold her, so they lay her on the floor where she had convulsions similar to a seizure. Completely unconscious at this point.
16 2021-04-01 palpitations On Tuesday late morning, she texted from school - that her heart was racing. shaking, headache, tum... Read more
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.
16 2021-04-02 lightheadedness Dizziness and near syncope
16 2021-04-02 fainting Syncope, dizziness. BP 55/30 (pulse 56). Final BP 111/54, 100% O2 sat.
16 2021-04-03 fainting Patient received Pfizer vaccine at 2pm, went to coffee shop, and then went out to car to wait. Becam... Read more
Patient received Pfizer vaccine at 2pm, went to coffee shop, and then went out to car to wait. Became dizzy 5 minutes after coffee shop order. Patient fainted approximately 15 minutes after receiving pfizer vaccine on 4/4/21. Mom came into store to alert courtesy clerk, alerted pharmacy who brought E-kit out to car, brought patient into store to take blood pressure. Took patients blood pressure. ~83/63 mmHg pulse 109. EMTs were called and arrived within 5 minutes. EMTs arrived and stated vitals were normal but recommended mother take patient to be checked out by a doctor at a nearby hospital. Patient saw Dr who determined she can get the second dose, but must remain seated for 15 minutes after vaccination
16 2021-04-04 skin turning blue Patient became unresponsive within 15 minutes of getting vaccine. Her eyes were wide open, lips were... Read more
Patient became unresponsive within 15 minutes of getting vaccine. Her eyes were wide open, lips were turning blue, and had appeared to stop breathing.
16 2021-04-04 loss of consciousness Pfizer 1st dose administered at COVID-19 Clinic. Client reported being diagnosed with COVID-19 durin... Read more
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.
16 2021-04-04 pallor She almost fainted. BP dropped to 72/30. flushed pale skin. Pulse ox 96. Alert and felt dizzy throu... Read more
She almost fainted. BP dropped to 72/30. flushed pale skin. Pulse ox 96. Alert and felt dizzy throughout the stay. Paramedics arrived onsite and as requested by parents EMTs transported the client to the parents' vehicle.
16 2021-04-05 heart rate increased, fainting, pallor, loss of consciousness, heart rate abnormal Patient is a 16yo seen for her first dose of the COVID-19 vaccine. She was seated in the back seat o... Read more
Patient is a 16yo seen for her first dose of the COVID-19 vaccine. She was seated in the back seat of the car. Shortly after receiving her vaccine (within a few minutes), she chose to move to the front passenger seat of the car, and after sitting in the passenger seat she became lightheaded and lost consciousness. Syncopal event was witnessed and lasted a few seconds. She spontaneously regained consciousness, and complained of some lightheadedness and tunnel vision. No significant confusion was noted, her responses to questions were appropriate. Initial pulse was thready and heart rate initially difficult to auscultate. Pale color noted on the face. Initial pulse approximately 50bpm. Breath sounds clear with good air exchange. Patient was placed in a reclined position with feet on the dash. She quickly recovered and repeat heart rate was auscultated at approximately 70bpm, stronger pulse noted. She was noted to have improvement and she was then driven out of the vaccine site after obtaining consent from her mother (who was the driver) and parked beside EMS. BP was 100/50 and HR 68-72, SaO2 97%. Lightheadedness resolved and she was feeling well, at her baseline. She was monitored for 30 min then allowed to leave with her mother, she was at her baseline at last evaluation. Per history review with her mother, she has had 2 prior episodes of syncope with pin removal from hand after surgery and IV placement.
16 2021-04-05 loss of consciousness Patient passed out for about 2 minutes upon receiving immunization. The patient was caught by her fa... Read more
Patient passed out for about 2 minutes upon receiving immunization. The patient was caught by her father and placed in a seated position. As the pharmacist went to call for assistance, the patient's father realized that she was awake again. The whole incident occurred within a few minutes. We had the patient sit in observation for 30 minutes, and we gave her water.
16 2021-04-05 fainting, loss of consciousness Patient was accompanied by mother for her Pfizer COVID-19 vaccine. After recieving her vaccine, she ... Read more
Patient was accompanied by mother for her Pfizer COVID-19 vaccine. After recieving her vaccine, she told her mother that her hands were feeling 'different.' Mother attempted to walk patient over to nurse's vaccine bay. Patient then became faint and was lowered to the ground by mom and myself. She was brought up to the chair and reclined. She states that she does not remember this occurring. Her vitals signs were taken. BP was 103/61, pulse was 61. She admits that she did not eat anything today besides a couple of chips and admits that she was very nervous prior to the vaccine. She was given some Nutella, crackers, and water. After about 10 minutes she said she felt much better and she was allowed to leave with mom. Advised to eat prior to next vaccine appointment.
16 2021-04-05 fainting Patient fainted shortly after shot
16 2021-04-05 fainting Patient fainted within 5~10 seconds after the vaccine; not responding to conversations, not respondi... Read more
Patient fainted within 5~10 seconds after the vaccine; not responding to conversations, not responding to calling her name during the fainting. Patient woke up approximately 5 minutes after fainting, and reported that she started to feel much better. Patient was seated on chair under direct help of pharmacist at the time. No observable injury, did not fell to the floor. EMS was called and arrive, and patient care handed over to EMS.
16 2021-04-05 fainting Patient had syncopal event about 5-7 minutes after vaccination. She came to within a minute or two, ... Read more
Patient had syncopal event about 5-7 minutes after vaccination. She came to within a minute or two, but was very anxious and visibly upset. She stopped shaking within another minute or two and had calmed down enough to sit up upright. She drank a few sips of water and said she was feeling better. EMS as called as a precaution and arrived in about 15 minutes. Patient's BP was normal (120/80) and blood sugar within normal range.
16 2021-04-06 fainting, loss of consciousness, pallor, very slow heart rate Patient presented for her first COVID-19 vaccine. Approximately a minute after vaccine was given, sh... Read more
Patient presented for her first COVID-19 vaccine. Approximately a minute after vaccine was given, she was noted to be seated upright in the passenger seat of her car, with head bent forward and eyes open. She was unresponsive, stiff posture, and was placed into a reclined position. She then had some posturing with head turned to the left, no eye deviation or nystagmus, no tonic-clonic movement. Radial pulse was thready, bradycardia was noted, with normal respirations. She was noted to become diaphoretic and pale/ashen color noted to the face and arms. She became responsive within a few minutes, however initially was not able to answer questions clearly. She had no loss of bowel or bladder function. EMS assisted with evaluation. Initial blood pressure 78/31, HR 54, SpO2 100%. EMS then transferred her to the stretcher and she was transitioned from her car to the ambulance. She continued to improve spontaneously with BP 94/61 then 103/60 and HR 86 then 74. SpO2 remained stable at 100%. Skin color improved. She had normal responses to questions, no complaints of headache, dizziness, chest tightness, shortness of breath, numbness or tingling. She had some shaking/voluntary movement of the limbs and body noted, but she could control and stop this voluntarily, no myoclonic or tonic-clonic jerking noted. After syncopal event occurred, mom reported that the patient has a history of syncope routinely with blood draws and vaccines in the past, however this episode was slightly more prolonged and seizure-like activity was different. She has had some jerking movement previously with syncope which lasts 20-30 seconds, different from today's response. No known history of seizure disorder.
16 2021-04-06 fainting, fast heart rate Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Medium, Systemic: Tachycardia-Mild
16 2021-04-06 fainting POST VACCINATION SYNCOPE. DID NOT FALL, LOWERED TO GROUND. QUICKLY ALERT AND ORIENTED, ASSISTED TO W... Read more
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.
16 2021-04-07 pallor, chest discomfort Asthma Attack started at 1 pm while seated and attending virtual class. She was under no distress an... Read more
Asthma Attack started at 1 pm while seated and attending virtual class. She was under no distress and was not in any way exerting herself. She described the attack as a feeling of someone sitting on her chest and began to hyperventilate. The color drained from her face and her hands felt numb. Her asthma attacks are generally exercise-induced, so this was highly unusual. She took a dose of albuterol ( 2 puffs with a spacer) and followed her asthma action plan. She laid down and slowed her breathing. 20 minutes later her facial color returned to normal. Two hours later her hands returned to normal. She was disoriented for about 5 hours.
16 2021-04-07 pallor Patient showing symptoms (closing/opening of eyes. fall back on chair. pale face) of fainting tenden... Read more
Patient showing symptoms (closing/opening of eyes. fall back on chair. pale face) of fainting tendency within 5 minutes of vaccines. Pharmacist instructed patients to take slow, deep breaths and try to open eyes. Patients was able to stabilized.
16 2021-04-07 lightheadedness, pallor, loss of consciousness Patient felt lightheaded almost immediately after receiving vaccine. She was walking with her parent... Read more
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.
16 2021-04-07 fainting post vaccine syncope. did not fall. brought to observation tent. monitored for 25 minutes and sent h... Read more
post vaccine syncope. did not fall. brought to observation tent. monitored for 25 minutes and sent home.
16 2021-04-08 chest pain By 4:30 started having chest pains and could not take deep breaths, by 7:00 she was running a high f... Read more
By 4:30 started having chest pains and could not take deep breaths, by 7:00 she was running a high fever of 102, body aches and extreme fatigue. She had a fever all day on 8th and experienced severe fatigue. She is still weak, having body aches and a low grade fever on Friday the 9th. Her chest pains stopped on Thursday.
16 2021-04-08 loss of consciousness Pt received first dose pfizer covid vaccine. Approx 1-3 min later pt lost consciousness and experien... Read more
Pt received first dose pfizer covid vaccine. Approx 1-3 min later pt lost consciousness and experienced upper extremity myoclonic jerks for approx 5-7 seconds before regaining consciousness with fists clenched. Upon regaining consciousness, pt was A&Ox4, reported slight lightheadedness; denied CP, SOB, or cutaneous sx suggestive of anaphylaxis. Pt denies anything like this in the past, denies family hx of seizures, and denies needle phobia. Pt instructed to recline supine in car seat with legs elevated on dashboard, and soon reported feeling better, less lightheadedness.
16 2021-04-08 pallor Patient received first dose of Pfizer covid-19 vaccine on 4/9/2021 at 1800 with her mother in attend... Read more
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.
16 2021-04-08 fainting, pallor Pt was vaccinated. She said she felt fine. Pt walked 15 feet then fainted. Her mom was able to catch... Read more
Pt was vaccinated. She said she felt fine. Pt walked 15 feet then fainted. Her mom was able to catch her. We moved her to a cot. She slowly regained consciousness. She had no signs of anaphylaxis. She was breathing fine. Her mother states she has fainted during blood draws in the past and her daughter hadn't eaten this morning. We monitored pt for 30 minutes. Her color and smile came back. Pt was able to walk out on her own. Her mother will monitor her today.
16 2021-04-08 fainting, lightheadedness Pt syncopal episode post vaccination likely due to vaso vagal response. Diaphoretic and unresponsive... Read more
Pt syncopal episode post vaccination likely due to vaso vagal response. Diaphoretic and unresponsive slumped over at chair. Quickly regained consiousness was alert and oriented NAD, Given water allowed to lay down. Feeling much better. Discharged POV in NAD with father. Diaphoretic and unresponsive slumped over at chair Quickly regained consiousness was alert and oriented NAD
16 2021-04-09 loss of consciousness, fainting Systemic: Fainting / Unresponsive-Mild, Systemic: passed out for less than 1 minute immediately afte... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: passed out for less than 1 minute immediately after shot given-Mild, Additional Details: passed out immediately after shot given for less than 1 minute, after coming to, had her lay on floor with legs up, blood pressue and pulse normal 111/88 , 70bp, was okay. had her stay over 30 minutes for obeservation, her dad with her
16 2021-04-10 heart rate increased The patient started feeling anxious when she got out of her car to come up to the clinic. After she... Read more
The patient started feeling anxious when she got out of her car to come up to the clinic. After she received her vaccination, she started to feel anxious, felt like her heart was going fast, and sat down. We checked her blood pressure and HR which were normal.
16 2021-04-10 pallor, lightheadedness Immediately following administration of vaccine, patient was still in chair, became pale, diaphoreti... Read more
Immediately following administration of vaccine, patient was still in chair, became pale, diaphoretic, had pre-syncopal episode. Regained consciousness, did not fall. Placed in WC, transported to OBS area, completely alert and talking with parents and staff. Patient consumed gatorade, feels well. Finished 30 min obs period without incident. Left with parents feeling well.
16 2021-04-10 fainting After the patient got the vaccines she started to have the pre-verso symptoms related to cardioinhib... Read more
After the patient got the vaccines she started to have the pre-verso symptoms related to cardioinhibitory syncope
16 2021-04-11 loss of consciousness The patient received her first dose of the Pfizer vaccine and was waiting in observation when she mo... Read more
The patient received her first dose of the Pfizer vaccine and was waiting in observation when she momentarily loss consciousness. No other serious medical problem or injury occurred while on site.
16 2021-04-11 loss of consciousness Within 1 minute of receiving vaccine, patient started to shake and appear to loose consciousness for... Read more
Within 1 minute of receiving vaccine, patient started to shake and appear to loose consciousness for about 30 seconds. She then came to and was disoriented for just a minute then could answer all questions asked of her (name, dob, where are you) She stated she had an intense headache, had trouble hearing but hear a buzzing sound. Mom was in the room as well, we gave her water and sat with her for about 10 minutes and she seemed weak but okay. They remained in the waiting area for another 15 minutes, she was feeling better and mom was comfortable to take her home as Mom is a Doctor.
16 2021-04-11 loss of consciousness Patient felt dizzy and passed out for a minute. Patient also urinated while passed out
16 2021-04-11 fainting Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Hypotension-Medium
16 2021-04-11 fainting After patient received the shot she was sitting on a chair and she pass out and hit her head on the ... Read more
After patient received the shot she was sitting on a chair and she pass out and hit her head on the floor . As per mom she has history of passing out. So I called the 911 and they came check her blood pressure and she was ok. And mom took her home.
16 2021-04-11 fainting Pfizer-BioNTech COVID- 19 Vaccine EUA: Vaccine recipient experience vasovagal syncope post vaccinati... Read more
Pfizer-BioNTech COVID- 19 Vaccine EUA: Vaccine recipient experience vasovagal syncope post vaccination
16 2021-04-12 chest pain Dizziness, bad chest pain, headache
16 2021-04-12 fainting At approximately 6:00PM on 04/09/2021 patient during 15 minute observation has a syncopal episode an... Read more
At approximately 6:00PM on 04/09/2021 patient during 15 minute observation has a syncopal episode and fell to the floor. First aid staff came to her assistance as soon as she went to the floor. Patient trauma assessment conducted with no life threats, and was assisted to the wheel chair and moved to assessment area. Vitals take and recorded as 110/70, Pulse rate 76 regular at radial, Respirations 12 not labored, Pulse ox. on room air at 98%. Reassessment of the patient vitals, 76P, 108/68, 98%. Gave patient cold pack for the small hematoma on her left side of her head. Father of the patient did not want her taken to the hospital for evaluation. He stated he would take her to the hospital for additional evaluation.
16 2021-04-12 fainting Systemic: Fainting / Unresponsive-Mild, Additional Details: Sycope with twitch, fully awake and orie... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: Sycope with twitch, fully awake and oriented within a minute.
16 2021-04-13 blood glucose increased Patient received vaccine around 4:30pm. After 10 minutes patient reported that she was having a head... Read more
Patient received vaccine around 4:30pm. After 10 minutes patient reported that she was having a headache, felt like her breathing was a little bit heavy. Patient was brought to exam room with mother present. BP was 150s/100, O2: 99%, HR: 65, RR 20. No distress noted. Patient was slightly anxious, continued to complain about headache. Denied any blurred vision, changes in vision, nausea, vomiting. Around 4:45, patient was asked to lay down for a while to be observed further and to give her time to relax. Patient was given cold wash cloths for forehead. Patient suddenly became more increasing anxious at 4:49, complained of excruciating headache and bilateral arm pain. Oxygen remained at 100%. 911 called at 4:50pm. Paramedics arrived at 4:55pm. Paramedics checked patient's blood sugar: approximately 345. Patient reported last meal around 12:30pm. Patient was crying and continually stating that her head hurt. She was alert throughout the entire process and able to answer questions. Mother elected to have patient sent to ER for further evaluation. Followed up with family on 04/14/2021. Mother reported that patient was held at hospital for 5 hours, was given norco for headache. Diagnosed with panic attack. Mother reports that patient is doing better today.
16 2021-04-13 loss of consciousness, pallor Patient stated in evaluation form that she had passed out once before after giving blood for labwork... Read more
Patient stated in evaluation form that she had passed out once before after giving blood for labwork. She and her mother decided to continue with the vaccination as it had never occurred before after getting a vaccine. A few minutes after the vaccine the patient lost consciousness. Mom stated that her face tensed up right before hand. The patient remained in her chair for the duration of the event. She regained consciousness about 30 to 60 seconds later, and within a few minutes she was conscious but still very shaky, pale, and hot. She was able to sip some water and we put a cool, wet paper towel on the back of her neck. The patient and her mother remained seated and under observation for an additional 15 to 20 minutes with no further issues, at which point they left the store. I followed up with the patients mother the next day and she said her daughter was exhausted last night, but this morning she woke up feeling well and went to school like normal.
16 2021-04-13 fainting Patient had a syncopal episode after receiving vaccine. there is a history of anxiety over needles p... Read more
Patient had a syncopal episode after receiving vaccine. there is a history of anxiety over needles per family on scene.
16 2021-04-14 fainting Patient became clammy and fainted after vaccine administration. Episode lasted about 10-15 minutes.... Read more
Patient became clammy and fainted after vaccine administration. Episode lasted about 10-15 minutes. Patient became alert and oriented and felt fine.
16 2021-04-14 fainting Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild
16 2021-04-15 heart rate increased Dizziness and elevated heart rate of 133 resting for 48 hours.
16 2021-04-15 palpitations Patient presented to the ER following her first COVID immunization. Symptoms started an hour after t... Read more
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.
16 2021-04-16 loss of consciousness She had received COVID testing several times in the past. Each time, she feels tunnel vision, spinn... Read more
She had received COVID testing several times in the past. Each time, she feels tunnel vision, spinning, lightheadedness, and then she loses consciousness. This has happened in the past with each COVID test. When she received her vaccine today, she again had this same episode. She quickly regained consciousness after about 10 seconds. She continued to have lightheadedness afterwards.
16 2021-04-16 loss of consciousness Patient passed out shortly after getting shot--recovered fully after 10 minutes
16 2021-04-16 pallor, fainting, lightheadedness, hypotension Vasovagal syncope. She began to get very warm, then fainted and became very pale. She was better wit... Read more
Vasovagal syncope. She began to get very warm, then fainted and became very pale. She was better within 5 minutes.
16 2021-04-17 chest discomfort tingling in lips, hands, feet chest tightness
16 2021-04-17 pulmonary embolism, cardiac arrest Patient was a 16yr female who received Pfizer vaccine 3/19/21 at vaccine clinic and presented with o... Read more
Patient was a 16yr female who received Pfizer vaccine 3/19/21 at vaccine clinic and presented with ongoing CPR to the ED 3/28/21 after cardiac arrest at home. Patient placed on ECMO and imaging revealed bilateral large pulmonary embolism as likely etiology of arrest. Risk factors included oral contraceptive use. Labs have since confirmed absence of Factor V leiden or prothrombin gene mutation. Patient declared dead by neurologic criteria 3/30/21.
16 2021-04-18 hypotension lethary and altered mental status 2.5 weeks after COVID vaccine. Found to be septic (hypotension, hy... Read more
lethary and altered mental status 2.5 weeks after COVID vaccine. Found to be septic (hypotension, hypothermia, suspected infection). Admitted to ICU. Required 15L vapotherm for respiratory support and several fluid boluses for blood pressure. Urine culture resulted positive for a bacterial infection. Started on antibiotics and improved. Concern for vaccine adverse event is low.
16 2021-04-18 loss of consciousness pt informed mom that she was not feeling well. nurse in observation lane witness seizure. pt was u... Read more
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
16 2021-04-18 loss of consciousness Patient was given a Pfizer covid vaccine and then immediately passed out. She was completely unresp... Read more
Patient was given a Pfizer covid vaccine and then immediately passed out. She was completely unresponsive and given 1 dose of epi and she responded to the epi. Her dad was with her and said that she has anxiety issues and this is probably the reason she passed out. EMS was called and it was decided between EMS and Dad that there was no reason to transport her to the hopital as she was doing fine after being checked out by EMS; Dad signed a waiver with EMS declining transport to the hospital.
16 2021-04-18 loss of consciousness No immediate response, approx 4 hours after dose started not feeling well passed out 3 times with 5... Read more
No immediate response, approx 4 hours after dose started not feeling well passed out 3 times with 5 minute time frame, EMS called, became coherent while they were route, continue to improve and vitals were checked and advised to monitor. Currently experiencing dizziness when standing from a seated position consistently with no improvement, also fatigued as well. In touch with Primary Care Physician and am monitoring .
16 2021-04-18 lightheadedness, fainting Patient with near syncope, provided juice, ice pack and rest, continued to feel dizzy, moved to the ... Read more
Patient with near syncope, provided juice, ice pack and rest, continued to feel dizzy, moved to the cot to lay down, then a syncope episode occurred, Medics on site, transfer to local Emergency Department via squad. Vital Signs: B/P 120/73 P: 103 R: 18 Pulse ox: 100%
16 2021-04-18 fainting Syncope
16 2021-04-18 fainting Syncope, dizziness, flushing/sweating. BPs 92/52, 94/58 (pulse 77), O2 sat 98%.
16 2021-04-19 hypertension, hypertension Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypertension-Mild, System... Read more
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypertension-Mild, Systemic: Shakiness-Mild, Additional Details: pt complained of dizziness. lied down w/ feet elevated + used ice packs. stated this has not happened before. BP very high on 1 reading (233/108) and decided to call EMS out of precaution. begain shaking after a few minutes of ice packs but stopped after a few minutes of removal. EMS evaluated, sat pt up, and once pt was sitting up began shaking again and they decided to take to hospital to get checked out.
16 2021-04-19 loss of consciousness, heart rate decreased patient experienced lightheadness, followed by passing out for approximately 2-5 minutes, during whi... Read more
patient experienced lightheadness, followed by passing out for approximately 2-5 minutes, during which pulse was weak and patient difficult to arouse. pale color. ems and pharmacist contacted and watched patient. Patient fine after 15 minutes more of observatio
16 2021-04-19 loss of consciousness, hypotension The patient passed out completely while sitting after having her 1st covid vaccine. She was alert s... Read more
The patient passed out completely while sitting after having her 1st covid vaccine. She was alert shortly thereafter but had blurry vision and low blood pressure. She said she was very hot and was sweating somewhat. We gave her some water and gradually she started feeling better. In the meantime, we had call 911 and when they evaluated her, they felt it was somewhat of a panic attack since she did have anxiety before getting the vaccine.
16 2021-04-19 loss of consciousness It was reported that the guest felt nauseous and lightheaded and lost consciousness. EMS was called.... Read more
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.
16 2021-04-19 pallor About 5 minutes after receiving the vaccine, patient was sitting down, and started to feel nauseous,... Read more
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.
16 2021-04-19 pallor Customer was unresponsive, clammy, pale. Customer received 0.3 mg of Epi IM in right thigh, 911 call... Read more
Customer was unresponsive, clammy, pale. Customer received 0.3 mg of Epi IM in right thigh, 911 called and customer laid to floor with legs elevated. Customer became responsive after Epi. EMT arrived and vitals wnl. Customer and her mother declined hospital transfer.
16 2021-04-19 fainting, pallor Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy... Read more
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
16 2021-04-19 fainting Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting /... Read more
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
16 2021-04-19 blood clot, nosebleed After the first dose, mild dizziness and nausea followed by massive inflammation in joints and face,... Read more
After the first dose, mild dizziness and nausea followed by massive inflammation in joints and face, severe fatigue and loss of hearing in right ear. Hearing returned in 3 days, general malaise until a week before 2nd shot when she started having severe bloody noses and EXTREMELY heavy period. After the second dose, 45 minute nose bleed soaked through two wash cloths, so many blood clots it clogged the sink.
16 2021-04-20 chest discomfort 10 hours post vaccination, she felt tightness in chest and felt slightly wheezy. 16 hours post test ... Read more
10 hours post vaccination, she felt tightness in chest and felt slightly wheezy. 16 hours post test she was wheezing, taking shallow breaths, and felt like her throat was constricted. Shallow breaths only. Symptoms slowly dissipated. She returned to normal over the next two days post reaction.
16 2021-04-20 pallor It was reported by the safety officer that the guest was walking up the stairs to observation after ... Read more
It was reported by the safety officer that the guest was walking up the stairs to observation after receiving the vaccine and stated to her mother that she was feeling lightheaded and sat down on the stairs. Guest appeared pale, skin was cool and clammy. EMS was called. Guest remained sitting on the stairs when EMS arrived. Vital signs were taken and were WNL. Guest was transferred to a cot and monitoring continued. Guest was talkative. About 15 minutes later she sat up and began sipping juice. Denied lightheadedness and vertigo. Vital signs remained stable. She was released by the medics. Went home with her mother.
16 2021-04-20 fainting Patient received first dose of pfizer vaccine to the left deltoid. In observation the patient has a ... Read more
Patient received first dose of pfizer vaccine to the left deltoid. In observation the patient has a syncopal episode. She was guided to the cot and patient became responsive alert. Paramedics arrived on scene to intervene. No medical intervention was necessary.
16 2021-04-21 heart rate increased About 10:30 today, Meredith's teacher noticed she was breathing heavily after a trip to the restroom... Read more
About 10:30 today, Meredith's teacher noticed she was breathing heavily after a trip to the restroom. She was taken to the school clinic with a seat heart ate of around 110. She was seen by her pediatrician and came home. She slept much of the day with her heart rate while laying down reaching up to 136. She reports feeling hot at times, but does not have a fever. She also is very thirsty.
16 2021-04-21 loss of consciousness Patient became dizzy and nauseous after vaccine. pt was assisted to wheelchair and brought to hallwa... Read more
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.
16 2021-04-21 fainting, loss of consciousness, pallor Patient was on observation having a conversation with her father when suddenly she started passing o... Read more
Patient was on observation having a conversation with her father when suddenly she started passing out and exhibiting twitching like having Petit mal convulsions and not able to arouse, and later in 2 minutes she recovered eyes open appears pale in face and lips, not aware that she had passed out, and became responsive. Father claims that HR is always running on low side because she is an athlete. On around 4:40pm she was released under the care of her parent and recommended to get an appointment with her PCP for further evaluation Patient status was checked the following day 4/22 and Pediatrician said that it must be a vasovagal Syncope per Neurologist he consulted no further appointment will be needed at this time
16 2021-04-21 fainting Within a minute of receiving the vaccine, my daughter fainted and had a short seizure. She did not h... Read more
Within a minute of receiving the vaccine, my daughter fainted and had a short seizure. She did not hit her head because I was able to help her on her way down - it was a ver small room with 3 people in it. The pharmacist was there and he said it was a seizure, she just jerked her chin up, sharply 3 or 4 times. She laid on the ground for about five minutes, then sat on the ground, then sat in a chair for a total of about 20 minutes. She felt dizzy and nauseated for about 15 minutes after. She drank a juice and felt better so we drove home, no other symptoms since.
16 2021-04-21 fainting pt started feeling really dizzy and nauseated immediately after taking the vax. she started having ... Read more
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.
16 2021-04-22 chest discomfort Chest tightness, tingling in mouth. Vitals wnl. Resolved with deep breathing technique.
16 2021-04-22 loss of consciousness Patient stated that she sometimes gets a little lightheaded after a vaccine and would like to wait h... Read more
Patient stated that she sometimes gets a little lightheaded after a vaccine and would like to wait her 15 minutes after the vaccine in the room instead of the waiting area. After the administration of the vaccine she stated she was going to pass out and lost consciousness. She had a normal pulse and was breathing normally. Her mother stated that she has passed out after injections in the past. Once for close to an hour. Her mother indicated that she did not want an ambulance called. I watched her closely for about 30 to 40 minutes and made sure she was not disoriented until she felt steady enough to stand up and walk. Upon leaving the pharmacy the patient felt fine and ready to get on with her day.
16 2021-04-22 loss of consciousness patient verbalized and on consent form to no prior issues with vaccines, and no history of problems ... Read more
patient verbalized and on consent form to no prior issues with vaccines, and no history of problems when receiving, or allergies before vaccination. advised patient to wait in designated waiting area. As patient was sitting in chair, she immediately lost consciousness, and her mom was able to hold her up on the chair while i ran over within seconds. i gently shook the patients shoulders and put her feet up on a chair, and she regained consciousness. gave her water and crackers, and hard candy. sat with her for 5 minutes and told her to wait a full 30 before leaving. after the 5 minutes she was feeling normal. checked with me before leaving. patient then stated that this had happened before. i told the mother to advise us of this in the future before giving any vaccines.
16 2021-04-22 fainting Syncope
16 2021-04-22 fainting syncope
16 2021-04-22 fainting Patient felt weak and dizzy and had syncopal episode. Patient received vaccine, walked out to sit in... Read more
Patient felt weak and dizzy and had syncopal episode. Patient received vaccine, walked out to sit in observation area and had syncopal episode after sitting down. Lasted about 1-2 minutes. Mother provided water and held patient up to prevent from falling over. Declined requesting ambulance. Patient became responsive after 1-2 minutes and continued to feel weak and dizzy. The patient was instructed to stay for at least 30 minutes. Mother left with patient after 45 minutes and were instructed to go to urgent care or emergency room if condition of weakness/dizziness does not improve.
16 2021-04-23 blood glucose increased 16 year old female came to the triage to utilize the cot to lay down to get vaccinated. Patient had ... Read more
16 year old female came to the triage to utilize the cot to lay down to get vaccinated. Patient had no chief complaint at the time of arrival to the triage area. Patient lay down to get the vaccine due prior history of seizure after vaccine in 2018. Patient vaccinated at 4:50pm, at 5:12 pm patient wanted to stand up to see how she feels, prior to standing patient denies reporting any complaint. at 05:12 Per EMS, as soon as she stood up she went into Tonic-clonic seizure that last for one minute. Patient Stumped into EMS COT. Blood sugar 130. Bp at 17:10 136/96 Pulse 78, RR 24, )2 sat 100, PERLA, Normal sinus Rhythm. BP at 17:30 136/88 pulse 76 RR 20, O2sat at 100 %, PERLA, Normal sinus Rhythm. Patient has history of asthma, seizure after shot, NKDA. patient was postictal after seizure.no sob or any acute distress. This Nurse Practitioner was radio at 05:14 pm, i arrived at 05:17pm, Patient mental status was assessed, patient was awake and alert x 4, patient report history of seizure after shot and Asthma. Patient did not appear to be in any acute distress. Patient mother was present at bedside. Patient and patient mother was informed that patient will be transported to the hospital to be further evaluated, patient mother agree to the plan of care.
16 2021-04-23 loss of consciousness Dizzy, loss of consciousness
16 2021-04-23 pallor 1130 RN called. When this RN arrived patient was sitting up in a chair and was found to be pale, cla... Read more
1130 RN called. When this RN arrived patient was sitting up in a chair and was found to be pale, clammy, and non responsive verbally. Ammonia salts placed under nose and patient immediately aroused. Blood pressure at 1132 was 95/54 pulse-58, and 02 sat was 99% sitting. 1136 Blood pressure at 1136 was 76/44, pulse 66, 02 sat 99%, and Patient was still responding but somewhat dazed. Still alert and oriented. Ice pack applied. Sweatshirt removed. Patient was given water and a granola bar. Patient transferred to guerny and repeat blood pressure taken. 911 called by RN. Patient talking and awake.1138 blood pressure lying down was 113/62, pulse 67, and 02 sat was 98%. Transferred to nurse treatment room by RN RN. Patient's Mother present. 1147 Paramedics here and report given. 1158 Patient is awake and stable and transported to ER via ambulance.
16 2021-04-23 platelet count decreased Patient developed fatigue and headache within 24 hrs of receiving 1st vaccine, over the next several... Read more
Patient developed fatigue and headache within 24 hrs of receiving 1st vaccine, over the next several days she developed periorbital edema and cervical LAD. 6 days after vaccine she developed fever and chills and was febrile to 103. She went to the ER and labs revealed pancytopenia. She was admitted on the evening of 4/20 and was observed for 36 hrs. Symptoms improved without antibiotics
16 2021-04-23 fainting Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Det... Read more
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.
16 2021-04-23 fainting FAINTING, LIGHTHEADED
16 2021-04-24 hypotension After shot felt light headed, dizzy, Requested water. Sat down put head back started snoring loudly.... Read more
After shot felt light headed, dizzy, Requested water. Sat down put head back started snoring loudly. Stating seizing, eyes rolled back in head. Nurse had to wake up with smelling salts. Low blood pressure 60/40 All happened within 10 minutes.
16 2021-04-24 fainting Syncope, 102/62 (pulse 72), 98/64 (pulse 70). O2 sat 100%. Feeling dizzy post-vaccination and syncop... Read more
Syncope, 102/62 (pulse 72), 98/64 (pulse 70). O2 sat 100%. Feeling dizzy post-vaccination and syncope.
16 2021-04-24 fainting Syncope, flushing/sweating, vitals wnl. Given apple juice, graham crackers.
16 2021-04-25 blood pressure decreased, hypotension Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypotension-Mild, Additional Details: PATIENT BL... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypotension-Mild, Additional Details: PATIENT BLOOD PRESSURE DROPPED TO 103/67 BUT PT STATES BLOOD PRESSURE USUALLY AROUND 120/80 NORMALLY.
16 2021-04-25 hypotension, fainting Patient was with her mother and she fainted while walking down the aisle. We got her water and a cha... Read more
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.
16 2021-04-25 loss of consciousness, pallor Received first dose of Pfizer , within 1 minute fathe noted she "passed out". Called staff to car a... Read more
Received first dose of Pfizer , within 1 minute fathe noted she "passed out". Called staff to car ad observed pt with clonic/tonic movement of hands, eyes closed, respirations slowed but even pulse approx 58/min. Responded to verbal Stimuli. Said she felt failt, lips pale, skin clammy. 911 called had additional same incident 9 minutes later. Transferred pt to medical facility by ems after 2nd episode .
16 2021-04-25 loss of consciousness After RN administered vaccine she spoke to my daughter for some time afterwards 5-6 minutes and my d... Read more
After RN administered vaccine she spoke to my daughter for some time afterwards 5-6 minutes and my daughter was fine answering her questions and just visiting with her. She directed us to the table to schedule her second vaccine which was directly in front of us. We went to this table and spoke with two other ladies choosing a date and time and she was also fine talking with them and answering questions of eat time offered and then suddenly she went straight back with warning passed completely out and struck the back of her head on the concrete floor. EMS and RN?s who were there went to her aid immediately and she was unconscious for a little over a minute. They initially couldn?t get her to respond and finally she came to and had no idea what happened and no recollection of falling. She had blurred vision and bleeding a bit from the back of her head and they wanted her to have CT of her head after hitting it that hard. They took her by ambulance to hospital and they assessed her and ordered a CT. The CT thankfully came back clear and she has follow up appointment with concussion doctor first thing in the morning. On discharge she was describing her pain from hitting head a 7/10 It was very scary and everyone around us was visibly upset as well. She has never fainted or had a reaction to any other shot, vaccine or needle before today so that was a very unusual reaction.
16 2021-04-25 lightheadedness 11:40: Called to the car, witnessed vasovegal response with tonic / clonic activity. 11:45: BP 89/... Read more
11:40: Called to the car, witnessed vasovegal response with tonic / clonic activity. 11:45: BP 89/34 HR 48 sats99% Alert and oriented x3 CO L arm pain 5/10 @ injection site CO nausea. given 25mg Benedryl 11:48: Car pulled to the side 11:52: Ems called and charge nurse notified. 11:55 ems on scene and took over care.
16 2021-04-25 fainting, blood pressure decreased, loss of consciousness Patient had syncope (BP 85/52 -- > 106/68, RR 14 -- > 14), flushing/sweating, not alert for 9 minute... Read more
Patient had syncope (BP 85/52 -- > 106/68, RR 14 -- > 14), flushing/sweating, not alert for 9 minutes. BP dropped after passing out, put patient in Trendenburg position, gave orange juice. Patient alert & ate crackers. Advised to give second dose lying down. Patient stable, released from vaccination site.
16 2021-04-25 fainting Dizziness due to syncopal episode. Patient with previous reaction to "painful procedures." Last bein... Read more
Dizziness due to syncopal episode. Patient with previous reaction to "painful procedures." Last being her ears getting pierced. Spoke with mom who is a physician and states this happens to her frequently with procedures that can result in pain. VSS. Pt hydrated with PO fluids. Tolerated well, no nausea/vomiting. Observed for 25 minutes after event. Got up, ambulated steadily without discomfort/dizziness. VSS. Patient left clinic in stable condition, no acute distress. Left clinic ambulatory with dad.
16 2021-04-25 fast heart rate Nausea, tachycardia, dizziness, h/o anxiety. BPs 152/66 (pulse 121), 149/83 (pulse 105).
16 2021-04-26 chest discomfort Tightness in chest, extreme nausea, dizziness, headache, shortness of breath. After receiving the va... Read more
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 2021-04-26 chest pain After getting the 2nd dose of Pfizer, two days later, my daughter developed chest pain. She gets the... Read more
After getting the 2nd dose of Pfizer, two days later, my daughter developed chest pain. She gets the chest pain every day and it today's date is 4/27/2021. She went to urgent care on April 18, 2021. However, she kept having chest pain and Saturday, April 24th the chest pain was intense. Patient states she has daily chest pain. Chest pain tends to be intermittent but she has it several times throughout the day. Sometimes the chest pain can be intense. (patient has a history of Kawasaki Disease, she received IVIG as a toddler and was on aspirin for a few weeks after the treatment. We were concerned if the chest pain was related to her heart). Currently, still monitoring her chest pains daily.
16 2021-04-26 palpitations First experienced heart racing, fatigue, dizziness and heaviness in your legs followed by hives that... Read more
First experienced heart racing, fatigue, dizziness and heaviness in your legs followed by hives that moved throughout the body including face, hairline, ears, legs, arms for the next 2.5 days.
16 2021-04-26 lightheadedness Pt felt "near syncope" event, with a feeling like she was going to vomit. The sensations relived th... Read more
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.
16 2021-04-26 lightheadedness NEAR SYNCOPAL EVENT APPROX 2-3 MINS AFTER INJECTION. PT REPORTED MUFFLED HEARING AND BLURRED VISION... Read more
NEAR SYNCOPAL EVENT APPROX 2-3 MINS AFTER INJECTION. PT REPORTED MUFFLED HEARING AND BLURRED VISION DENIED CP, SOB, ITCHINESS, INITIAL VITALS UPON ENTERING OBSERVATION UNIT: BP-79/43 HR-46 RR-18 SPO2-100%--AOOX4 REPORTED A HEADACHE APPROXIMATELY 10 MINS INTO OBSERVATION PT DISCHARGED WITH CAREGIVER ASYMPTOMATIC WITH NEGATIVE ORTHOSTATICS. LAST SET OF VITALS: BP 109/76 HR 70 SPO2 99% RR18
16 2021-04-26 fainting Patient experienced a syncopal episode while in clinic. The episode was addressed while the patient ... Read more
Patient experienced a syncopal episode while in clinic. The episode was addressed while the patient was in our care.
16 2021-04-27 cerebrovascular accident Stroke; severe allergic reaction; This is a spontaneous report from a contactable consumer (the pati... Read more
Stroke; severe allergic reaction; This is a spontaneous report from a contactable consumer (the patient's father) from the Pfizer-sponsored program. A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the Right Arm (also reported as: right shoulder) on 23Mar2021 (Batch/Lot Number: ER8732; Expiration Date: 31Jul2021) at 16-years-old as a single dose for COVID-19 immunisation. Medical history included heart valve operation from an unknown date and unknown if ongoing (Mechanical heart valves). Concomitant medications included an unspecified medication, taken for an unspecified indication from an unspecified date to an unspecified date, which was reported as: "Yes she is taking other medication." On 29Mar2021, the patient experienced stroke and severe allergic reaction (medically significant). The clinical course was reported as follows: On behalf of his 16-year-old daughter, the patient's father reported that she had the first dose administer in the right shoulder on 23Mar2021. On 29Mar2021, the patient had a stroke. The patient's father stated, "our lives have changed, completely." The patient's father reported that his daughter was receiving medical care ever since then; and was also being treated by a physician. The patient's father was asking about compensation from Pfizer regarding his daughter's severe adverse event (AE) that occurred after the first dose of vaccine. The patient's father reported that the case had been submitted by the (Name) healthcare team "to the FDA and to Pfizer, and I haven't heard back from either." The patient's father mentioned in passing, that he "could call (Name) and have this all over the news" but that he "wants to be responsible" and doesn't want to do that. The patient's father stated the concern, "Well my concern I am not sure that medical profession is what I really need to do, my concern is that my daughter took the Pfizer COVID vaccine on 23Mar2021 in (Name) in vaccination location. On 29Mar2021, 6 days later, she had a stroke, and that she is receiving a medical care ever since then , now my question is like I said probably for maybe for correlated relation type of person define as well as for it there is a compensation for adverse reaction to COVID vaccination being that this was only thing that was introduce in her system as far as doing that time the vaccination shot." The patient underwent lab tests and procedures which included blood test: "that's for 4/2 out of normal" on an unknown date; also reported: "Yes that's been ongoing as far as giving blood. That's for 4/2 out of normal". Therapeutic measures were not taken and was reported as "no she isn't taking anything for it." The clinical outcome of the events, stroke and severe allergic reaction, was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021411875 Pfizer
16 2021-04-27 chest discomfort Arm soreness, tightness in chest, dizziness, nausea, difficulty breathing. Symptoms started pretty m... Read more
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.
16 2021-04-27 fainting Patient fainted while seated minutes after vaccine was given. Mother was next to her to prevent her ... Read more
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.
16 2021-04-28 loss of consciousness Patient was a client at a drive-through COVID-19 clinic. Patients Father was driving and the patient... Read more
Patient was a client at a drive-through COVID-19 clinic. Patients Father was driving and the patient was seated in the front passenger seat. After receiving vaccine, FOC drove forward and parked in an observation lot that was staffed by 3 RNs. FOC reported to an observation lot attendant that patient, Patient was losing vision (narrowing), shaking, and then stopped responding. The observation lot attendant noted loss of consciousness, reclined patient in the seat and elevated feet above the heart by placing them on the car dashboard. At 1535, 911 was notified by RN. When car door was opened by the attending observation lot worker, client began regaining consciousness. Client was given apple juice and crackers and vitals were taken. At 1540, Patient blood pressure measured 91/60, pulse oximeter reading of 96% saturation, and heart rate 72bpm. Paramedics arrived to the scene at 1545 and assessed the client; patient was not transported. Father was instructed by paramedics of warning signs and when to seek further care. FOC and patient were advised to inform PCP and to report this instance when receiving future vaccines. FOC and patient remained onsite for 15 minutes following Paramedic care and were dismissed when patient and FOC reported that they felt comfortable leaving.
16 2021-04-28 loss of consciousness Patient passed out during monitoring, observation period. She was alert and oriented and EMS was co... Read more
Patient passed out during monitoring, observation period. She was alert and oriented and EMS was contacted. She sat up and drank some water. EMS monitored her heart rate and blood pressure and she was released to her father.
16 2021-04-28 loss of consciousness Pt completed vaccination and was at check out station with mother scheduling her second appointment.... Read more
Pt completed vaccination and was at check out station with mother scheduling her second appointment. The patient suddenly fell backwards and landed on the concrete floor hitting her head. She was unconscious for about 30-60 secs.
16 2021-04-28 pallor, loss of consciousness Pt had finished getting her vaccine and was walking to observation area, when she fell to her knees ... Read more
Pt had finished getting her vaccine and was walking to observation area, when she fell to her knees as her mother caught her. Staff then helped her to her feet and started walking her over to medical area as pt went unconscious and Paramedic caught patient as she collapsed. Pt remained unconscious for approximately 10 seconds. Medic and one other staff member carried patient to cot in medical rehab area. Vitals were assessed at 1245PM: BP 102/78, HR 68, SPO2 98%, RR 22. Lungs clear and equal bilaterally skins: pale, cool, moist, pupils: PERRL. After patient regained consciousness she was alert and oriented answering all questions normally. Pt remained pale, cool and moist for another 20 minutes. PT stated she had not eaten anything all day and was given some snacks to eat while she was being observed. After about 45 minutes pt was stood up and checked to see if she was still feeling light headed and felt normal and was released to her mother to go home. Pt was advised to drink plenty of water and take the rest of the day to relax and recover, and to call 911 if any other serious issues occurred.
16 2021-04-28 fainting, hypotension, loss of consciousness, hypertension, fast heart rate Within 2-minutes of vaccination, the patient experienced a syncopal episode. EMS evaluated the patie... Read more
Within 2-minutes of vaccination, the patient experienced a syncopal episode. EMS evaluated the patient on-site. The patient was hypotensive (84/44) with a FSBG of 59mg/dL. EMS administered 15g PO Glucose. IV access was attempted but not obtained. Upon re-evaluation, the patient was hypertensive (147/116) and tachycardic (117bpm). EMS transported the patient to Hospital Emergency Department. In the ED, the patient stated they became dizzy and passed out after vaccination. The patient noted that they did not eat anything all day. The patient was hypotensive (99/56). The patient's labs/tests indicated dehydration and the physician administered 1L IV normal saline. The patient was discharged with dehydration and vasovagal syncope.
16 2021-04-28 fainting, loss of consciousness Patient fainted and unconscious less than 10 seconds. Patient flushed and admitted she had not eate... Read more
Patient fainted and unconscious less than 10 seconds. Patient flushed and admitted she had not eaten since the am. No further treatment required.
16 2021-04-28 fainting patient received vaccination at 9:29am. She was asked to sit down and wait for 15 minutes post vacc... Read more
patient received vaccination at 9:29am. She was asked to sit down and wait for 15 minutes post vaccination. Patient and grandmother left after 5 minutes. she had a brief fainting episode at the front door of store. She came back to pharmacy and was observed for 30 more minutes, she felt fine and then left the pharmacy
16 2021-04-29 hypotension Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Hypote... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Hypotension-Medium
16 2021-04-29 loss of consciousness, pallor Per EMT, patient became diaphoretic and pale suddenly approximately 5 minutes after receiving her fi... Read more
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.
16 2021-04-29 loss of consciousness Patient started seeing stars, fell up against silver anti-theft gates by front doors, then passed ou... Read more
Patient started seeing stars, fell up against silver anti-theft gates by front doors, then passed out. Did not hit head, and was awake and alert by the time I reached her.
16 2021-04-29 fainting, pallor Patient fainted post-vaccination. Observed patient beginning to lean forward and RN was able to pre... Read more
Patient fainted post-vaccination. Observed patient beginning to lean forward and RN was able to prevent her from falling. Patient's eyes observed to roll upward while patient became unresponsive to stimuli and diaphoretic. No incontinence. EMS called while patient assisted simultaneously to gurney by multiple staff. Upon lying down, patient awoke and become alert and oriented to person, place, time, and situation, though stayed pale and diaphoretic for several minutes. VS @ 12:55: BP 120/80, P 59, SAO2 99%, resp unlabored. VS @ 13:00: BP 138/83, P 62, R 20, SAO2 99% VS @ 13:04: BP 123/73, P 54, SAO2 99% VS @ 13:10: BP 100/69, P 78, SAO2 98% Sitting at edge of bed without symptoms at 13:05, alert and conversing with staff and mother. EMS arrived at 13:07 - their monitor showed NSR, random blood sugar = 93. Ate a snack and drank juice, symptoms completely resolved. Mother declined transport to ED. Discharged home with mother with post-vaccination instructions, will receive 2nd dose while lying down.
16 2021-04-29 fainting Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: shakes-Mild, Sy... Read more
Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: shakes-Mild, Systemic: Shakiness-Mild, Additional Details: pt fainted and had shakes/ convulsions for a few seconds. after 30 seconds pt awake and stated ok , after 30 min pt stated ok after 30 min observastion. mom n dad brought to hospital dad called and said pt was ok . no unusual findings
16 2021-04-29 fainting Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic:... Read more
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium
16 2021-04-30 fainting Patient Received her first dose Pfizer vaccine (LOT#: EW0173 EXP: 8/2021) at 1140 on 4/30/21. Mother... Read more
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.
16 2021-04-30 fainting Fainted 48 hours after shot, sweats, slumped over. Luckily I was there to catch her. Complete loss o... Read more
Fainted 48 hours after shot, sweats, slumped over. Luckily I was there to catch her. Complete loss of color. Came on very suddenly. Could have been catastrophic if she was driving.
16 2021-04-30 fainting fainted for a few seconds; I started seeing blurry; my ears were ringing; This is a spontaneous repo... Read more
fainted for a few seconds; I started seeing blurry; my ears were ringing; This is a spontaneous report from a contactable consumer (patient). A 16-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0161, expiry date not reported), via an unspecified route of administration, administered in the right arm on 16Apr2021 16:45 (age at vaccination was 16 years) as single dose for COVID-19 immunization. Medical history was none. The patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a pharmacy or drugstore. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications were not reported. The patient reported that on 16Apr2021 17:00, "I started seeing blurry. I stood still so my vision would clear. Then I fainted for a few seconds. When I came to my ears were ringing." The events resulted to emergency room/department or urgent care. Therapeutic measure was taken as a result of the events that was seen by a doctor. Clinical outcome of the events was unknown. No follow-up attempts are required. No further information is expected.
16 2021-04-30 fainting Patient received second dose of Pfizer vaccine and was waiting in the observation area when she fain... Read more
Patient received second dose of Pfizer vaccine and was waiting in the observation area when she fainted and was held to chair by Security Guard and mother. Patient reports that she had not eaten and that she has a history of fainting with other injections/blood draws. Patient was given orange juice and a snack and reported feeling better. RN remained with patient in observation until patient and mother left.
16 2021-04-30 fast heart rate, chest pain Five days following her first Pfizer COVID vaccine, she woke up from a dead sleep with sharp chest p... Read more
Five days following her first Pfizer COVID vaccine, she woke up from a dead sleep with sharp chest pain, shortness of breath, and feelings of her throat closing. She was given one dose of oral steroids by PCP, but continued to have the feeling that she couldn't breathe due to her throat closing throughout the day so she presented to the ED. There, she reported continued chest pain, worsening SOB, and the feeling that she could not breathe. She was tachycardic to 140 bpm, but otherwise vitals were stable. She was admitted and monitored on continuous telemetry and pulse oximetry overnight. By the following day on 4/29, her symptoms had largely resolved and she was discharged.
16 2021-05-01 loss of consciousness Patient passed out with associated convulsions within 2 minutes of vaccine being administered. No p... Read more
Patient passed out with associated convulsions within 2 minutes of vaccine being administered. No previous Hx of this post vaccination but did occur once after donating blood. Patient was lowered to flat position on floor.
16 2021-05-01 loss of consciousness 16 y/o female with NO PMH and no h/o similar prior experiences/syncope c/o "feeling tired" ~3 min af... Read more
16 y/o female with NO PMH and no h/o similar prior experiences/syncope c/o "feeling tired" ~3 min after receiving the 1st dose of pfizer vaccine. Pt LOC, "gently" falling onto the floor, landing on her face ~5 min after receiving the vaccine. Pt reported feeling tired before LOC, not associated with any other symptoms (dizziness, changes in vision/hearing). LOC lasted ~10 seconds, pt immediately returned to baseline. She was sat up with the help of her mother and nurse and the clinical lead was notified. Pt was laid down on a cot, VS were taken, ice was applied to her pressure points. Pt reported complete resolution of symptoms within ~5 min. Pt was progressively moved from lying down to sitting to standing. Pt denies eating or drinking anything today and was given fluids and snacks. Pt was monitored for a total duration of 45 min. Pt was driven home by parents. Pt was advised to eat and hydrate today and for the next dose. Pt and parents were advised to call PCP / 911 if symptoms return/persist/worsen or if pt develops concussive symptoms. Pt was instructed to inform the nurse that she fainted ater 1st dose and to prophylactically lay down prior to receiving prior to second dose vaccination.
16 2021-05-01 fainting, heart rate increased Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Mild, Systemic:... Read more
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.
16 2021-05-01 fainting Within about 5 minutes of receiving her first Pfizer Covid19 vaccine, the patient passed out and hit... Read more
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.
16 2021-05-02 fainting Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Severe, Systemic: Dizziness / L... Read more
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe
16 2021-05-02 fainting Vasovagal Syncope
16 2021-05-02 fainting Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Un... Read more
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Tingling at site of injection. Patient was seated after receiving the vaccine and suddenly collasped. Patient maintained consciousness throughout the episode and her symptoms have improved.
16 2021-05-03 chest pain Client c/o "chest hurting and hard to breathe" approx. 15 mins. after 2nd Pfizer dose. EMS was calle... Read more
Client c/o "chest hurting and hard to breathe" approx. 15 mins. after 2nd Pfizer dose. EMS was called for transport to local hospital. V/S @ 12:35: AOx3, BP 118/90, HR 72. At 12:42pm, client reported increased difficulty breathing and rated chest pain 7/10. V/S @ 12:42 BP 122/82, AOx3, HR 66, RR 22. At 12:50 medics arrived on scene and assumed care of client.
16 2021-05-03 pallor Patient reported feeling lightheaded status post first dose Pfizer COVID vaccine (Lot: EW0167, expir... Read more
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.
16 2021-05-03 pallor Pt complained of nausea and feeling dizzy immediately after vaccination. Patient became diaphoretic,... Read more
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%.
16 2021-05-04 loss of consciousness, palpitations pt recived 1st dose at 1:17pm. proceeded to observation area , no complications. 1:19- RN observer ... Read more
pt recived 1st dose at 1:17pm. proceeded to observation area , no complications. 1:19- RN observer rounds on pt who sts heart is racing. RN grabs bp tree and patient proceeds to pass out. Rapid response called patient A&O when response team arrives Pt passes out for second time pt taken to Trauma Room in ER
16 2021-05-04 pallor 16 yo female came into our injection site today 05/05/21 to receive her first pfizer vaccine. She wa... Read more
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.
16 2021-05-04 fainting Client received the Pfizer Covid-19 Vaccine (Lot #EW0167 Exp. 08/2021) at 1:51 PM. Approximately 10 ... Read more
Client received the Pfizer Covid-19 Vaccine (Lot #EW0167 Exp. 08/2021) at 1:51 PM. Approximately 10 minutes after receiving her first dose the patient fainted from her chair in the observation area. Patient did not strike her head. EMT and other nurses responded and sat the patient upright and began treatment. Patient was A&O X3, immediately after fainting. Patient was assisted to the gravity bed and vitals were taken, see below. Patient stated that she felt better almost immediately after laying in the gravity bed. Vital signs are as follows: 1400- BP: 100/80, O2: 98%, P: 80, Res: 18; 1405- BP: 106/74, O2: 98%, P:96, Res: 18; 1410- BP: 110/70, O2: 99%, P: 90, Res: 18; 1415- BP: 110/70, O2: 99%, P: 87, Res: 18; 1420- BP: 112/70, O2: 99%, P: 86, Res: 18; 1425- BP: 110/70, O2: 99%, P: 96, Res: 18.Patient's vitals improved over time after laying down. Patient was accompanied by her mother who was outside at the time of her fainting. Patient has a history of fainting after injections and getting blood drawn. Patient and Patient's mother felt comfortable after 30 minutes of observation to leave the vaccination site and return home. Client declined EMS transport. Patient and Patient's mother were instructed to seek medical attention if symptoms worsened or if symptoms returned. Patient left the facility in good condition with a steady gait.
16 2021-05-04 fast heart rate Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tachycard... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tachycardia-Mild, Additional Details: pt released to her father. spoke with father a few hours later. pt is fine.
16 2021-05-05 loss of consciousness, fainting At approximately 9 AM on the morning after receiving the second dose, the patient became dizzy at sc... Read more
At approximately 9 AM on the morning after receiving the second dose, the patient became dizzy at school. As she was walking to the teacher's desk, she lost consciousness and fainted, hitting her head on a desk, scraping her neck on a desk, and suffering several other minor injuries from the fall. She was immediately seen by school nurse and released to my care for the rest of the day. She rested at home and then was seen in at Walk-In Clinic to be evaluated for a concussion. On Day 2 after receiving the vaccine, the patient reported a sore throat, but no other symptoms. She was seen on the third day post-vaccine by our pediatrician's office for possible strep. She tested negative for strep and a concussion from her fainting episode was confirmed due to the lingering headache.
16 2021-05-05 pallor, fainting, loss of consciousness At approximately 1:04pm on 04/30/2021 patient during 10 minute observation had a syncopal episode an... Read more
At approximately 1:04pm on 04/30/2021 patient during 10 minute observation had a syncopal episode and fall from standing to floor with loss of consciousness. Trauma assessment found contusion to occipital region of skull. No bleeding, no other trauma findings. Pt moved to wheelchair, and then to cot without incident. Pt AA&Ox4, airway patent, breathing shallow and non-labored. Pulse strong and regular with delayed perfusion. Pt skin pale, cool and dry. Pt eyes PERRL bilaterally. Pt complains of pain 7/10, dull, localized, to the base of skull, and ringing of ears, as well as dizziness without nausea. Pt administered 650ml oral water with improvement to skin and respirations. Vitals and report continued on next page Pt however post oral hydration still stated no change to headache, and new onset tinnitus to left ear. Pt parent was consulted for transport to emergency department for assessment for potential injury post fall, and consented. EMS was contacted, who transported patient to hospital. Vital signs as follows 1312 108/68 93p 14r 98%RA 1323 106/62 82p 17r 98%RA 1335 104/60 74p 16r 97%RA
16 2021-05-05 pallor Accompany minor with dad received vaccine for first time. Pt complain of dizziness, diaphoretic, pa... Read more
Accompany minor with dad received vaccine for first time. Pt complain of dizziness, diaphoretic, pale to face, body stiffness and started jerking once on floor. Pt placed to floor for safety precautions. V/s obtained w/ b/p 80/54, HR 92 O2 98%. Jerking stopped with v/s obtained again w/ b/p 82/56 HR 95 O2 99%. EMS arrived and taken over care. Pt was more a/ox3. Taken to hospital via EMS.
16 2021-05-05 lightheadedness it seems like patient have vasovagal symptoms 5 minutes right after vaccinated. she was nauseated an... Read more
it seems like patient have vasovagal symptoms 5 minutes right after vaccinated. she was nauseated and sweat and almost faint. she said that she has hard time breathing. WE gave her 0.3mg epinephrine then she is ok and better. we called EMS over. and she is all fine after that. SHE did not need to go to hospital.
16 2021-05-05 lightheadedness Vasovagal episode for < 10 seconds, then vomited once and felt better. Didn?t eat anything earlier.... Read more
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.
16 2021-05-05 fainting Systemic: Fainting / Unresponsive-Mild, Systemic: Vomiting-Mild
16 2021-05-05 fainting Systemic: Fainting / Unresponsive-Mild, Additional Details: mom said she passes out after shots, fai... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: mom said she passes out after shots, fainted less than 1 min, had her lay down with feet up for 15 min, then sit up for 15min before leaving,
16 2021-05-05 troponin increased, chest pain Patient with chest pain 5/5. Elevated troponin, peak of 2.96 at time of report. Chest pain resolved ... Read more
Patient with chest pain 5/5. Elevated troponin, peak of 2.96 at time of report. Chest pain resolved at this time. ECHO by cardiology team completed and normal. Admitted to cardiology service for monitoring
16 2021-05-06 skin turning blue After counseling and giving the patient her vaccine, the patient walked to the waiting room and sat ... Read more
After counseling and giving the patient her vaccine, the patient walked to the waiting room and sat down. 2 minutes after receiving the vaccination the patient leaned back, tensed up, became unresponsive and had a vacant look in her eyes. We called 911. Her lips started turning blue. I administered 0.3mg epinephrine auto injector and the color in her lips came back. Paramedics arrived evaluated her and transported her to the hospital.
16 2021-05-06 heart rate decreased, chest pain Patient was seen at the urgent care clinic on 4/19/2021 having congestion for a couple of days as we... Read more
Patient was seen at the urgent care clinic on 4/19/2021 having congestion for a couple of days as well as cough, news throat the head and troubles breathing was noted to have normal oxygen saturation and was given an albuterol inhaler and told that she had a virus. She followed up in the PCP office on 4/21/2021 with worsening troubles breathing and was given Decadron in the office, 4days of prednisone, CXR and labwork. CXR showed possible reactive airway disease and was to do steroid and continue out albuterol every 4 hours. Had negative/normal lab work and positive Covid antibodies. History of Covid 10/2020. Felt almost completely back to normal by Sunday, her last day of steroids. On Monday had worsening of her breathing throughout the day, increased troubles breathing again after softball that night. Albuterol did seem to help up. Called the office as she woke up Tuesday morning with worsening and would started on Flovent. With no improvement return to PCP office on 4/29/2020 with marked inspiratory stridor. Was admitted to the hospital for work-up of return of stridor. Had a normal chest x-ray and neck/soft tissue x-ray. With continued troubles breathing and chest pains with decreased heart rate was elected to go to Hospital where she could have further work-up. When the ARNP came helicopter, was concerned about her airway and she intubated to fly to hospital. Was dx there with Sudden Acute Onset of Vocal Cord Dysfunction and is continuing with therapies.
16 2021-05-06 loss of consciousness 16yoF was accompanied with an adult who was present for the vaccination. The COVID-19 Vaccine Pfizer... Read more
16yoF was accompanied with an adult who was present for the vaccination. The COVID-19 Vaccine Pfizer-BioNTech 0.3mL administered IM in right deltoid while patient was sitting. Patient remained sitting for 10 minutes after administered dose. Patient reported feeling well after the injection. Patient stood up while we continued to talk, after 2 more minutes passed out while standing. Suddenly, patient begain to go limp and her eyes crossed and rolled back. Patient fell backwards into the privacy curtain and into aisle 13 of the store. Patient's head bounced off the floor. Immunizer knelt next to patient. Patient was unresponsive until immunizer placed cold hand on back of neck and front of chest to check if she was breathing, immunizer calmly guided patient to breath, slow deep breaths into the belly and patient's eyes fluttered open. She said her head hurt really bad. Immunizer offered to the accompanying adult to call EMS because patient should be evaluated after hitting her head so hard. The accompanying adult denyed EMS, then stating that patient had previously fainted while walking and said that she would be fine. Immunizer advised patient to remain laying down while immunizer got some ice. Ice was then placed on the back of the head. Patient slowly stood up after laying for 10 minutes and was walked over to a sitting area to put feet up and continue with ice for another 5 minutes before the accomanying adult wanted to leave.
16 2021-05-06 loss of consciousness Pt became dizzy and diaphoretic approximately 5 minutes after vaccination. She sat down and began to... Read more
Pt became dizzy and diaphoretic approximately 5 minutes after vaccination. She sat down and began to feel better. She reports fear of needles and not eating since 12pm that day. Approximately 10 minutes later she lost consciousness for approximately 30 seconds. Pt came to was given orange juice and left with her father around 20 minutes after vaccination.
16 2021-05-06 loss of consciousness Approximately after 1 minute from receiving her first pfizer vaccine the patient reported to her mot... Read more
Approximately after 1 minute from receiving her first pfizer vaccine the patient reported to her mother that she feels like she is going to pass out. This RN was alerted about the situation by the patients mother and when approaching the patient this RN noticed the patient losing consciousness and drawing her arms to chest and curling her hands with tremors throughout her body. This RN placed the patient on the floor for safety out of the chair and had other staff member contact 911. Tremors lasted approximately 30 seconds and patient regained consciousness however appeared tired and stated she is unware of what just happened. Vitals were taken which were within normal limits and continued to be taken frequently until EMS arrive to transport patient to Hospital
16 2021-05-06 inflammation of the heart muscle, ischemic chest pain, loss of consciousness, heart rate irregular My 16-year-old daughter, very healthy without any health conditions, got her first dose of the Pfize... Read more
My 16-year-old daughter, very healthy without any health conditions, got her first dose of the Pfizer vaccine on Saturday evening, April 10th, at around 5pm. On Wednesday, she started complaining of shortness of breath, chest pains, which she described as a feeling of someone stubbing her heart. By Thursday, she began blacking out repeatedly throughout the day, each blackout lasting about a minute. These progressed and whenever she blacked out, she would not remember what happened. At first, she and I brushed it off as maybe lack of calcium since she rarely drinks milk. But as they intensified, I began to become more concerned. I told her I cannot leave her by herself in the house as I prepared to go pick up her young siblings from school then schedule an appointment with her doctor. On our way back home, she blacked out again, however, it was for more than a minute. Straight away, I drove to the ER close by. The doctor came back to inform me that her heartbeat was irregular and concerning based on her age. In that same moment, she began complaining of excessive pain like someone punching her heart out, and then she passed out again. Still with my two other children, the whole ordeal began to frighten them and illicit some heavy tears. Being that this ER was general admission, the doctors insisted they call in the paramedics to transport her to another ER for children. However, after being transported to the other ER, her condition began to intensify rather quickly and the pediatric doctor at the second ER informed us we would have to be transferred to Childrens intensive care unit where the cardiologists could check her heart, find the ultimate cause, and monitor her closely. In that moment, as a mother, I was speechless and extremely terrified. Seeing my daughter being transferred from ER to ER, made it even tougher on me so much that I could no longer hold myself together. Here she was in terrible pain and being moved around with no clear diagnosis and treatment. From there on, we spent a couple days in the Cardiac ICU waiting and praying with friends for answers and the best treatment she could get to ease the pain. By about the third day of being in the ICU, the cardiologists informed me, she had Acute Myocarditis. This was so shocking in a sense that both sides of the family have no history of heart issues. Secondly, she is a very healthy child.
16 2021-05-06 pallor 12:12 Patient is in the Observation Area post VAccination on her LEft Arm 2nd dose, suddenly complai... Read more
12:12 Patient is in the Observation Area post VAccination on her LEft Arm 2nd dose, suddenly complaints of dizziness, lightheadedness, clammy, pale and cold skin. Vitals were taken as follows: 77/40, HR 68, Oxygen SAturation 93%, Temp 97. Kept attended, both parents are with this 16 years old lady. Patient remained alert and oriented. When Emergency TEam came and evaluate the patient, BP was 103/66, HR 84, O2 saturation 95% and felt better. Patient was advised to go to the emergency room for further evualtion but declined. EMS team left
16 2021-05-06 fainting Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-... Read more
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.
16 2021-05-06 fainting My daughter reported general achiness the night of the vaccine (May 4) and went to bed. The next mor... Read more
My daughter reported general achiness the night of the vaccine (May 4) and went to bed. The next morning (May 5) she passed out standing up from the toilet (about 5 minutes after getting out of bed).
16 2021-05-07 blood pressure decreased, fainting, hypotension 18 hours after administration, vasovagal syncope and low blood pressure for 11 hours after onset; pa... Read more
18 hours after administration, vasovagal syncope and low blood pressure for 11 hours after onset; patient fainted and could not sit up or stand -- blood pressure would drop; symptoms persisted for 11 hours
16 2021-05-07 loss of consciousness While in seated observation area, pt reported feeling faint. Brief loss of consciousness, while supp... Read more
While in seated observation area, pt reported feeling faint. Brief loss of consciousness, while supported by pharmacist, legs stiff, arm twitch then relax as regained consciousness, lasting few seconds. Feet elevated, called 911 for care. Evaluated by paramedics in parkinglot, returned back to pharmacy after recovery for checkout.
16 2021-05-07 pallor Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Medium, Systemic: Shakiness-Mild, Systemi... Read more
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.
16 2021-05-07 fainting Patient received Pfizer vaccination at 04:55 pm. Her father accompanied her. A few minutes after rec... Read more
Patient received Pfizer vaccination at 04:55 pm. Her father accompanied her. A few minutes after receiving the vaccination, she passed out. Her father shook her arm and she became cognizant again. She did not remember passing out and has never passed out in the past. I monitored her for 30 minutes and gave her bottled water to stay hydrated. After 30 minutes she was feeling well and I observed her as she stood up. She had no further problems.
16 2021-05-07 fainting Systemic: Fainting / Unresponsive-Mild
16 2021-05-08 loss of consciousness, fainting 20 hours after receiving the vaccine I felt very dizzy and nauseous for a moment and then fainted an... Read more
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.
16 2021-05-08 inflammation of the heart muscle, chest pain Myopericarditis with chest pain. currently improving
16 2021-05-09 nosebleed Nose bleed 2 hrs after vaccine. Occured on 4/18,4/23, 5/6 and 5/7. No history of nose bleeds prior... Read more
Nose bleed 2 hrs after vaccine. Occured on 4/18,4/23, 5/6 and 5/7. No history of nose bleeds prior.
16 2021-05-09 hypotension Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild, Add... Read more
Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild, Additional Details: Patient felt faint after void vaccine. She had some changes in vision and sat down to relax and drink an orange juice. Vitals were examined. (BP: 90/56 & 90/60; pulse: 62). Parents stated that patient has a history of feeling faint after vaccine administration. Patient was able to walk out under own power. A follow up call was placed and the parents stated that the patient was stable and doing well.
16 2021-05-09 lightheadedness vasovagal
16 2021-05-10 hypotension Patient felt dizzy. Became pale and diaphoretic. 1215 - 98/52 HR 54, repeat at 1220 110/64 HR 78, ... Read more
Patient felt dizzy. Became pale and diaphoretic. 1215 - 98/52 HR 54, repeat at 1220 110/64 HR 78, repeat. 12/25 patient feels better, able to ambulate, alert and oriented. 1234 symptoms completely resolved and able to resume normal activity.
16 2021-05-10 fainting Patient fainted
16 2021-05-10 fainting Patient had a syncopal episode after receiving vaccine. Apparently there is a history of anxiety ove... Read more
Patient had a syncopal episode after receiving vaccine. Apparently there is a history of anxiety over needles per family on scene.
16 2021-05-11 chest discomfort One day after the vaccine, feeling fatigued, feverish (99.5), headache Two days after the vaccine, f... Read more
One day after the vaccine, feeling fatigued, feverish (99.5), headache Two days after the vaccine, feeling some SOB w exertion, chest heaviness Mild chest heaviness 3 days after, resolved by end of day.
16 2021-05-11 lightheadedness vasovagal reaction right after shot
16 2021-05-12 loss of consciousness, hypotension PATIENT LOST CONSCIOUSNESS, FELL FORWARD OUT OF CHAIR (WAS CAUGHT AND ASSISTED TO THE FLOOR), PATIEN... Read more
PATIENT LOST CONSCIOUSNESS, FELL FORWARD OUT OF CHAIR (WAS CAUGHT AND ASSISTED TO THE FLOOR), PATIENT REGAINED CONSCIOUSNESS, EMERGENCY SERVICES WERE CALLED, PULSE, BLOOD SUGAR, OXYGEN, AND VISION WERE FINE, PATIENT VERY LIGHT HEADED, BLOOD PRESSURE EXTREMELY LOW, WASN'T RETURNING TO NORMAL
16 2021-05-12 loss of consciousness The patient felt tired and describes her eyes going dark, then passed out a few minutes after vaccin... Read more
The patient felt tired and describes her eyes going dark, then passed out a few minutes after vaccination. She was vaccinated and then left the immunization room to sit down for a 15 minute waiting period. When she went to sit down, she collapsed on the floor. Her mother assisted her into a chair. She continued to be incoherent and have her eyes rolling back into her head for a few minutes. We used a cool cloth on her forehead and the back of her neck. The parents requested that we call 911. EMS arrived shortly and evaluated her. Heart rate, blood pressure, pulse ox, blood sugar and chest sounds were all within normal range. The patient stated that her arm felt heavy and "funny". She then stated that her tongue felt funny. EMS evaluated her tongue and said it looked normal. To err on the side of caution, she was taken to the hospital to determine whether or not she was having a delayed onset anaphylactic reaction. This patient has no history of seizures.
16 2021-05-13 chest discomfort Heaviness in chest and mild shortness of breath within 2 hours of vaccine.
16 2021-05-13 chest pain, palpitations Pt developed chest pains and heart racing that night along with high fever 102 with very bad heada... Read more
Pt developed chest pains and heart racing that night along with high fever 102 with very bad headache. Chills and fever and weakness latest through Friday afternoon Fever started to go down Friday afternoon and weakness improved. Headache remains strong
16 2021-05-13 haemoglobin decreased, platelet count decreased 16-year-old medically complex female, JIA, bronchiectasis and chronic nighttime oxygen requirement w... Read more
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.
16 2021-05-13 hypotension LAYED PATIENT DOWN ON COT, ELEVATED HER LEGS, TOOK VITALS AND CONTINUED TO MONITOR HER . PATIENT WA... Read more
LAYED PATIENT DOWN ON COT, ELEVATED HER LEGS, TOOK VITALS AND CONTINUED TO MONITOR HER . PATIENT WAS RESPONSIVE AND AWARE OF THE SITUATION. VITAL SIGNS WERE STABLE , B/P- 131/71, HR: 104, RR- 20 , O2- 98% ON ROOM AIR. 911 WAS CALLED, ONCE THEY ARRIVED THEY RETOOK THE PATIENTS VITALS AND DECIDED THAT IT WAS NECESSARY TO TAKE HER TO THE LOCAL HOSPITAL DUE TO LOW BLOOD PRESSURE OF 78/42. AT THIS TIME, PATIENT WAS STILL RESPONDING TO COMMANDS AND ALERT AND ORIENTED X 4.
16 2021-05-13 loss of consciousness, fainting received vaccine and stood up. During walking out of room, fainted and potentially had seizure as s... Read more
received vaccine and stood up. During walking out of room, fainted and potentially had seizure as she fell. Head hit the ground. Stayed awake, alert after she fell. Generally knew who, what, when, where and that she just had vaccine. EMS called who arrived and transported to ER for evaluation.
16 2021-05-13 loss of consciousness Patient received vaccine, 1-2 minutes later stated she was feeling dizzy and passed out and began t... Read more
Patient received vaccine, 1-2 minutes later stated she was feeling dizzy and passed out and began to seize. 911 was called. patient was monitored and given water and an icepack upon regaining consciousness. Paramedics did a physical assessment, including checking blood pressure and blood sure. Patient's guardian refused going to hospital. After 30 minutes patient and guardian went home as patient stated she felt fine. Pharmacy planning to follow up with patient the next day.
16 2021-05-13 pallor, lightheadedness Adverse event: PT here for first dose of Pfizer COVID vaccine. PT reported feeling anxiety before va... Read more
Adverse event: PT here for first dose of Pfizer COVID vaccine. PT reported feeling anxiety before vaccination, but indicated that she was ready for her vaccination. Immediately post-vaccination, PT experienced an apparent vasovagal response, presenting with palor, slumped posture. PT's eyes were open, but PT was unresponsive and later reported no memory of events. PT became responsive within 2 minutes, but remained "shakey" and pale. RN was in attendance and provided initial assessment/response. RN also responded to PT. Aid was called at 1251 and EMTs arrived at 1253. Aid assessed PT, took vital signs (1256: BP 104/56 laying, HR 70, SPO2 98% on room air, 1303 BP 110/62 laying, HR 87, SPO2 99% RA, 1307: BP 96/58 sitting, SPO2 99%RA, 1311: BP 106/62 sitting, SPO2 99% RA). Treatment: PT was assisted to lay down on cot, water and juice were provided and consumed, cool compress were provided. Psychosocial support provided. Education to PT and mother to monitor for further s/s and to seek out urgent care if more were noted. Outcome: PT's color improved soon after laying down, PT reported "feeling better" after consuming juice and water. PT sat at edge of cot without difficulty, walked down hallway without difficulty. PT medically cleared by EMS at 1223, exited facility with mother in private vehicle.
16 2021-05-13 pallor Right after patient received the vaccine she turned very pale and told the technician she felt light... Read more
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.
16 2021-05-13 lightheadedness, fainting, pallor Within 5-10 mins post-injection pt became pallor, sweaty, dizzy and had a vasovagal episode while si... Read more
Within 5-10 mins post-injection pt became pallor, sweaty, dizzy and had a vasovagal episode while sitting in her chair. Pt exhibited jerking motions and then quickly had a syncope episode lasting <1 min. Pt was lowered to the ground during the episode. No trauma occurred. Pt mother beside pt entire time. During this time a pulse ox was put on pt and her legs were elevated. Pulse ox remained 96-98%. After waking, water and wet rag was given to pt and pt moved to reclined chair after 5 mins. Pt remained pallor and dizzy x15mins, after 40 mins pt was able to walk and leave the clinic. Mother stated in past that pt had a vasovagal episode after the Gardasil vaccine.
16 2021-05-13 fainting ADVERSE EVENT: DIZZINESS/ SYNCOPE AND NAUSEA, PATIENT ALS O TURNED PALE DURATION OF 15 MINUTES. TREA... Read more
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
16 2021-05-13 fainting she fainted; hit her head; This is a spontaneous report from a contactable consumer (patient's mothe... Read more
she fainted; hit her head; This is a spontaneous report from a contactable consumer (patient's mother) reported that a 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0171), via an unspecified route of administration, administered in arm left on 23Apr2021 (at the age of 16-years-old) as 1st dose, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 24Apr2021, she fainted and hit her head. Clinical course details was reported as the patient got her Pfizer COVID vaccine on Friday (23Apr2021), and she fainted on Saturday (24Apr2021), knocked her head on counter and was knocked out. The doctor was taking her to ER. The patient was not yet admitted to the hospital, since when the patient's mother called they were going there (hospital) now. The doctor had her blood drawn to find out what was going on. The patient underwent lab tests and procedures included weight: 58.97 (no unit), and height: 157 (no unit) both on an unspecified date. The patient was scheduled on 15May2021 for 2nd vaccine. The outcome of the events was unknown. No follow-up attempts possible. No further information expected.
16 2021-05-14 chest pain Child was complaining of pain and knot on the left side of her chest and her left shoulder and arm a... Read more
Child was complaining of pain and knot on the left side of her chest and her left shoulder and arm as well. Parent took child to the doctor on May 12, 2021 because the pain was unbearable. The doctor stated to the parent that she needs to consulted with the infections disease doctor to get his opinion on what it is and how to treat it. The infections disease doctor stated to the other doctor to treat it with antibiotics. The doctor wanted to do a follow-up with child in two to three days to see if the antibiotics is working. Childs follow-up is schedule for May 15, 2021. Child was saying that she cannot sleep on her left side because it hurts so much.
16 2021-05-14 loss of consciousness, fainting Syncope caused patient to lose consciousness and fall out of chair hitting her head. Paramedics were... Read more
Syncope caused patient to lose consciousness and fall out of chair hitting her head. Paramedics were called to the scene but patient did not require additional medical assistance at the time. Follow up with PCP recommended.
16 2021-05-14 fainting Patient fainted right after getting vaccinated - she has a history of fainting with needles
16 2021-05-14 fainting Patient fainted after vaccination. Patient was put into the wheel chair by the nurse and taken to ob... Read more
Patient fainted after vaccination. Patient was put into the wheel chair by the nurse and taken to observation area. Patient wake up and was alert and oriented. Patient was asked to sit for 30mins observation. Patient feels better.
16 2021-05-14 low platelet count Thrombocytopenia noted; Elevated temps to 104; Associated chills; headaches; This is a spontaneous r... Read more
Thrombocytopenia noted; Elevated temps to 104; Associated chills; headaches; This is a spontaneous report from a contactable healthcare professional. A 16-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 1 intramuscular on 25Apr2021 (Lot Number: EWO171) as 1st dose, single for covid-19 immunization. Medical history included eczema, Pyle disease, food allergies, short stature, seasonal allergies, peanuts allergies and nuts allergies. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The patient did not have other vaccine in four weeks. On 26Apr2021, the patient had elevated temperatures to 104 [unspecified unit], 4-5 days post vaccination (pending clarification) with associated chills and headaches. Thrombocytopenia noted. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment was provided for the adverse events. The patient was tested post vaccination with a nasal swab test on 28Apr2021 and the result of negative. The reporter did not consider the events was serious. The outcome of the event was recovering. No follow-up attempts are needed. No further information is expected.; Sender's Comments: The reported event thrombocytopenia was observed only 1 day after vaccination. It is unlikely that thrombocytopenia is related to BNT162B2. It's more likely intercurrent medical condition. 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.
16 2021-05-15 hypotension Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic:... Read more
Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Parademics/911 called, patient's parent refused transport to the hopsital. Patient waiting in recovery with NP and nurses, RPH to check
16 2021-05-15 loss of consciousness Patient passed out within a minute of vaccination. Mother and I moved patient to a laying down posit... Read more
Patient passed out within a minute of vaccination. Mother and I moved patient to a laying down position where she immediately woke up and knew where she was and what just happened. Declined any other symptoms. Mom said she passes out often after vaccinations. Patient was conscious carrying on a conversation like normal immediately after coming to. Over the next 30 minutes I tried to get patient to a sitting position to take her blood pressure but every time we tried she needed to lay back down because she felt like she was going to pass out. After trying this twice and being unsuccessful I had EMS called to check on patient to make sure nothing more serious going on. EMS came and took a couple blood pressures and pulses which were normal. Patient was starting to feel better. Walked out with EMS and planned on going home.
16 2021-05-15 palpitations Patient left vaccine site without waiting in observation with mother. Came back to site with report... Read more
Patient left vaccine site without waiting in observation with mother. Came back to site with reported palpitations and anxiety after going to Chik fila nearby. On arrival patient vitals 125/78 HR 85 regular O2 Sate 98% No signs of distress. Patient obviously anxious. Observed for 30 minutes and released with no treatment or transport. Released with Mother.
16 2021-05-15 fainting, loss of consciousness Syncope, loss of consciousness for approximately 10 minutes
16 2021-05-15 fainting Patient has a seizure history. Mother stated they have had numerous vaccines in the past without a ... Read more
Patient has a seizure history. Mother stated they have had numerous vaccines in the past without a problem though. Patient was waiting the period of time afterwards. Mother then stated she was having a reaction. Mother stated she is a nurse and said she believed the patient was having a seizure. Mother later was not sure if patient had fainted also since she was nervous about receiving the shot in the first place. After paramedics arrived, they took her glucose and was 77. Paramedics let mom then take patient home to get food.
16 2021-05-16 deep vein blood clot, pulmonary embolism, chest pain Presented with acute onset chest pain, found to have right lower extremity DVT and bilateral PEs. Re... Read more
Presented with acute onset chest pain, found to have right lower extremity DVT and bilateral PEs. Required short stay in ICU for close monitoring given clot burden in her lungs. Required heparin infusion and then transitioned to lovenox for home-going therapy.
16 2021-05-16 platelet count decreased, low platelet count Patient presented to the ED with dizziness, fever and heavy vaginal bleeding around 24 hours after r... Read more
Patient presented to the ED with dizziness, fever and heavy vaginal bleeding around 24 hours after receiving her first dose of the Pfizer-BioNTech COVID-19 vaccine. She was tested for active COVID-29 infection via nasal swab PCR and tested positive. Upon presentation labs were drawn and her platelet count was found to be 8 on 5/15. Repeat labs were drawn that day to confirm low platelet count and confirmed diagnosis and thrombocytopenia secondary to an immune reaction to the vaccine was suspected. She was admitted and was started on tranexamic acid, medroxyprogesterone, dexamethasone and IV immunoglobulin (Ig) to help treat low platelet count and vaginal bleeding. As of writing, she is still admitted and her most recent platelet count on 5/17 was 16.
16 2021-05-16 fainting Patient fainted about 30 seconds after the vaccination. She regained herself after about 5 seconds.
16 2021-05-16 fainting Pt passed out after fisrt dose of Pfizer vaccine. Pt was wheeled to the EMS station where she passe... Read more
Pt passed out after fisrt dose of Pfizer vaccine. Pt was wheeled to the EMS station where she passed out a second time. Pt VS at 11:08AM HR 54, BP 11/40. At 11:16AM HR 60, BP 90/60. At 11:32AM HR 66, BP 100/60. Pt was given cookies and water and appeared alright, she was released following last set of VS.
16 2021-05-16 fainting Very shortly after receiving the vaccine the patient's head dropped down and she momentarily fainted... Read more
Very shortly after receiving the vaccine the patient's head dropped down and she momentarily fainted. She was held in her seat so that she didn't fall out and was awakened only seconds later. She was kept in her seat for 15 minutes after the incident until she felt stabilized. She stood up slowly and assessed for balance and strength. She and her father felt she was stable enough to go home.
16 2021-05-17 loss of consciousness, fainting, pallor At approximately 1:04pm on 04/30/2021 patient during 10 minute observation had a syncopal episode an... Read more
At approximately 1:04pm on 04/30/2021 patient during 10 minute observation had a syncopal episode and fall from standing to floor with loss of consciousness. Trauma assessment found contusion to occipital region of skull. No bleeding, no other trauma findings. Pt moved to wheelchair, and then to cot without incident. Pt AA&Ox4, airway patent, breathing shallow and non-labored. Pulse strong and regular with delayed perfusion. Pt skin pale, cool and dry. Pt eyes PERRL bilaterally. Pt complains of pain 7/10, dull, localized, to the base of skull, and ringing of ears, as well as dizziness without nausea. Pt administered 650ml oral water with improvement to skin and respirations. Vitals and report continued on next page
16 2021-05-17 loss of consciousness Patient received vaccine in her left arm. It was made aware to the immunizing technician prior to va... Read more
Patient received vaccine in her left arm. It was made aware to the immunizing technician prior to vaccinating that the patient had a history of dizziness after vaccines. Patient was seated when receiving shot and after stayed seat. About 30 seconds after the shot patient lost consciousness and fell out of the seat hitting her head on the way down. The pharmacist and mother helped patient back to her seat. As she came to consciousness patient reports a little headache and dizziness. Pharmacist took blood pressure which read 84/52, temp 97.9 and gave patient some water and 911 was called. As EMS arrived patient reported still some dizziness but was feeling better.
16 2021-05-17 loss of consciousness Right after receiving Pfizer Covid-19 vaccine, patient began to feel queasy. I asked her whether sh... Read more
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.
16 2021-05-17 fainting, hypotension Mother states that 18 hours post-vaccination her daughter fainted. She was taken to receive medical ... Read more
Mother states that 18 hours post-vaccination her daughter fainted. She was taken to receive medical help and it was determined that her blood pressure was low and she was given IV fluids. Patient's blood pressure remained low for 11 hours.
16 2021-05-17 fainting fainting and lightheadedness starting day after receiving second dose
16 2021-05-18 chest discomfort Chest tightness
16 2021-05-18 pallor, fainting A few moments after receiving the vaccination, patient fainted and had some tremors afterwards. We p... Read more
A few moments after receiving the vaccination, patient fainted and had some tremors afterwards. We picked her up off of the floor and placed her in a chair. She was pale and had some discoloration around her nose area. She was able to speak to us. She felt cold and was sweating at the same time. Her body temp was 97 degrees F. According to her mom, she's had a previous reaction similar to this but not to this extreme with the HPV shot. We called 911 to have her assessed by the paramedics
16 2021-05-18 pallor Patient felt lightheaded and dizzy after 2nd dose of Pfzier, was pale and diaphoretic but alert and ... Read more
Patient felt lightheaded and dizzy after 2nd dose of Pfzier, was pale and diaphoretic but alert and oriented x4. Had pt lay done supine and observed for an extra 15 minutes. Pt felt fine and symptoms resolved. Left with father feeling better
16 2021-05-18 fainting At approximately 1825 a patient fainted over in her seat at the observation area. The EMS transporte... Read more
At approximately 1825 a patient fainted over in her seat at the observation area. The EMS transported her to the other side of the gymnasium wherea privacy screen is set up. She was fine to leave around 1835 per the EMT but stayed till 1848 and left on her own will. Patient was 16 years of age, female. Girl has a history of passing out, i.e. when she received novocaine and when she got her ears pierced. Her guardian declined to give a name for the report.
16 2021-05-18 fainting Pt was in 15 minute waiting period and suddenly collapse out of seat; she was immediately assisted ... Read more
Pt was in 15 minute waiting period and suddenly collapse out of seat; she was immediately assisted by pharmacy staff who also alerted EMT based on patient's rapid breathing; No Epi was needed. Cold pack put to pt's head and nape of neck & oximeter placed on finger until EMT arrived about 10 minutes after call. Pt was not taken by EMT; Left with mother and brother
16 2021-05-18 fainting PT HAD A SEIZURE APPROX. 30 MINS AFTER RECEIVING THE COVID VACCINE, PT FAINTED, STIFFENED UP, AND BE... Read more
PT HAD A SEIZURE APPROX. 30 MINS AFTER RECEIVING THE COVID VACCINE, PT FAINTED, STIFFENED UP, AND BEGAIN TO CONVULSE. PT WAS PLACED ON COTT IN THE RECOVERY POSITION, 911 WAS CALLED AND VS OBTAINED. P74, R22, BP118/80, O2SAT 98% ON RA. SEIZURE LASTED APPROX 10 SECONDS, AMBULANCE ARRIVED WITHIN 10 MINS, AND TOOK OVER PT'S CARE. PT'S COLOR REMAINED PINK THROUGHOUT, AND SHE WAS SLEEPY BUT ABLE TO ANSWER QUESTIONS APPROPRIATELY. VS: P83, R24,BP116/80, POX99% ON RA. PT TAKEN IN AMBULANCE TO HOSPITAL FOR FURTHER EVALUATION
16 2021-05-18 fainting Systemic: Fainting / Unresponsive-Severe
16 2021-05-18 fast heart rate, palpitations is a 16-year-old female patient admitted with tachycardia. Starting 1-1/2 weeks ago, mom notes that... Read more
is a 16-year-old female patient admitted with tachycardia. Starting 1-1/2 weeks ago, mom notes that she has had episodes where she feels her heart racing. It began 1-1/2 weeks ago with her crying and her watch that her heart rate was 208. They went to the ED, where she was given some fluids and her heart rate improved so she was sent home. She had had prior episodes of mild tachycardia up to the 140s in the past but which has always improved with fluids. Mom states that she used to have a lot of trouble maintaining her hydration and would not drink a lot of water. Since the last 1-1/2 weeks, she has been having these episodes 1-2 times a day that last about 1 to 2 minutes with a max of 5 minutes. When it comes on, she feels dizzy and lightheaded, and after the episode she feels a big rush of blood to her head. She also has some associated shortness of breath. She denies having any episodes of chest pain at all. She has never passed out, she has never felt like she was going to pass out, she has never felt like she was out of balance. She denies any nausea or vomiting during episodes. She denies any headaches during the episodes. She does have history of migraines, but has not had one in the last couple weeks. Her prior resting heart rate was in the 80s per her watch, and lately it has been in the 110s to 120s while awake in 80s while asleep. Along with the episodes, she also feels some pulsating sensation in her abdomen. She does not have any abdominal pain. Today, her heart rate was again in the 200s, but it was worse than before because it lasted about 30 minutes total. Lately they have been using an app that continuously monitors her heart rate. Since these episodes started, she has cut down on her caffeine intake and she has increased her water intake. Does not feel that this helped. She has never had syncope in the past and has never had seizures in the past. Patient was started on carvedilol which has helped control heart rate and was encouraged to drink fluids. Per primary care team, her current episode of tachycardia was not due to the vaccine.
16 2021-05-19 arrhythmia, chest pain, palpitations arrhythmia, heart palpitations, pain in left arm, pain in chest (particularly left side) radiating i... Read more
arrhythmia, heart palpitations, pain in left arm, pain in chest (particularly left side) radiating into shoulder blade, fatigue, muscle aches
16 2021-05-19 blood pressure decreased, lightheadedness The patient had a Vasovagal response. She had a 15 second seizure ,blood pressure dropped, was flus... Read more
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.
16 2021-05-19 chest pain, troponin increased Patient received first dose of Pfizer vaccine (lot EW0170) on 4/24/21 at University and received 2nd... Read more
Patient received first dose of Pfizer vaccine (lot EW0170) on 4/24/21 at University and received 2nd dose of Pfizer vaccine (lot EW0182) on 5/15/21 also at University. Came to hospital ED on 5/16 AM with diagnosis of acute chest pain, acute dehydration, and adverse reaction to vaccine administration. Was discharged to home and returned to ED on 5/17/21 for continued chest pain (central, throbbing, non-radiating chest pain). Medical tests and laboratory results revealed elevated troponin level (1.546 at peak, then declined to 0.585 prior to discharge home). Patient was admitted to PICU for close monitoring. CT angiogram of chest was negative, chest x-ray was negative, EKG showed normal sinus rhythm, echocardiogram was done and it was a normal study. Dr. discussed with the cardiology department at Hospital. Possible myocarditis due to vaccine. COVID-10 IgG IgM antibodies were positive for the patient which indicates good efficacy of the vaccine. Patient to have follow-up with outpatient pediatric cardiology Dr. Discussion with father on 5/20/21 indicates that patient's symptoms were improving.
16 2021-05-19 chest pain Within 15 minutes, pt complaining of chest pain, not radiating, in center of chest. Coughing, statin... Read more
Within 15 minutes, pt complaining of chest pain, not radiating, in center of chest. Coughing, stating sore throat. Given PO 50 mg Benadryl. Vital signs stable. No other s/s. Took private vehicle to hospital with RN.
16 2021-05-19 loss of consciousness Pt received her 2nd dose of the Pfizer COVID19 vaccine. While sitting in observation she proceeded t... Read more
Pt received her 2nd dose of the Pfizer COVID19 vaccine. While sitting in observation she proceeded to pass out. She was held up by the RN. Pt lost consciousness briefly. Pt was laid down on cot. Initial BP 91/70 JR 47, no pulse ox, Repeat BP while laying down 117/76 HR 70, pulse ox 99. EMS was called via 911. EMS arrived and evaluated the pt. BS 99. Pt did not want to go to the ED and a release was signed with EMS. BP 121/75 when leaving clinic. Pt reported feeling better. ED precautions were given.
16 2021-05-19 pallor Shortly after vaccination became warm, diaphoretic and pale BP 78/96
16 2021-05-19 fainting, hypotension Patient experienced fainting symptoms immediately after administration of vaccine. Further investiga... Read more
Patient experienced fainting symptoms immediately after administration of vaccine. Further investigation showed patient had low blood pressure 73/57 mm Hg.
16 2021-05-19 fainting Fainted; Didn't know if it was a convulsion or a seizure; Shaking; was very anxious; This is a spont... Read more
Fainted; Didn't know if it was a convulsion or a seizure; Shaking; was very anxious; This is a spontaneous report from two contactable pharmacists. A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0167, expiry date: Aug2021), via an unspecified route of administration, administered in the left deltoid, on 30Apr2021 15:30, as 1st dose, single, for COVID-19 immunisation, at a pharmacy/drug store. There were no medical history and concomitant medications. On 30Apr2021 15:30, the patient received the first dose of the COVID-19 vaccine and was very anxious. She wanted her mom to be present. On the same day, 30Apr2021 15:35, five minutes later, the patient was shaking, and she fainted. The reporter did not know if she was having a convulsion or a seizure. A few minutes later, the patient was sitting and becoming more alert. The patient was given water and one dose of Benadryl. The patient's vital signs were checked (unknown result). The reporter talked to the patient's mother and contacted the patient's pediatrician. The events resulted to emergency room and physician's office visits. Later in the evening, the reporter followed up with the mother and she confirmed that the patient was doing well and better. The mother asked the reporter if the patient should get the second dose of the COVID-19 vaccine. The outcome of the events fainted, shaking, "didn't know if it was a convulsion or a seizure" and "was very anxious" was recovering. The reporter assessed the events fainted, shaking, "didn't know if it was a convulsion or a seizure" as serious (medically significant). The reporter considered that BNT162B2 has a causal effect to the adverse events. Follow-up (18May2021: New information received from a contactable pharmacist includes: reporter information, lab data, suspect drug details (vaccination site and vaccination time), event details (onset time provided, outcome updated to recovering, causality and seriousness assessment provided). Follow up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information, and on a reportedly closed temporal association, the company assessed that a reasonable possibility could not be excluded that the reported events (fainted; didn't know if it was a convulsion or a seizure) were related to the suspect product BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
16 2021-05-19 fainting PATEINT WAS ANXIOUS BEFORE GETTING VACCINE, ABOUT 10 MINUTES AFTER GETTING VACCINE PATIENT FAINTED F... Read more
PATEINT WAS ANXIOUS BEFORE GETTING VACCINE, ABOUT 10 MINUTES AFTER GETTING VACCINE PATIENT FAINTED FOR A FEW SECONDS. PARAMEDICS WERE CALLED PATIENT WAS EVALUATED AND NOT SYMPTOMS WERE FOUND. PATIENT WAS NOT EXPERIENCING ANY OTHER SYMPTOMS AND WENT HOME WITH MOM.
16 2021-05-19 fainting Patient fainted approx. 1 minute after getting the vaccine. Layed down on the floor with feet elevat... Read more
Patient fainted approx. 1 minute after getting the vaccine. Layed down on the floor with feet elevated and head supported for 15 min after, given water and cold compress for forehead. No additional care needed
16 2021-05-20 fibrin d dimer increased 48hrs post-vaccine began with polyarthralgia, progressed to myalgias, arthritis, weight loss, abdomi... Read more
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.
16 2021-05-20 hypotension, pallor 6 days following vaccination, patient was exercising for the first time. started feeling dizzy. She... Read more
6 days following vaccination, patient was exercising for the first time. started feeling dizzy. She had some water and realized that her skin was red. She had a rash on face and puffy lips. Mom came to get her she stood up and was extremely dizzy. Mom did not notice that her lips were swollen but did notice that her skin was rashy and red. Mom, who is a nurse, also thought she appeared pale and diaphoretic. By the time they got the ED she was hypotensive. She got a cocktail of meds in the ED including a couple doses of EPI. She got IV fluids. She started to improve quickly after giving the medications.
16 2021-05-20 loss of consciousness Pt began to feel faint in observation area after vaccine. Transported via w/c to observation bay af... Read more
Pt began to feel faint in observation area after vaccine. Transported via w/c to observation bay after brief loss of consciousness. Mother present. BP 109/68, HR 58, RR 16 -- > 101/69, 64, 16. Pt reports feeling much better. Pt stable and released from the vaccination site.
16 2021-05-20 fainting, hypotension Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-S... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Severe
16 2021-05-21 loss of consciousness Pt received vaccine and was walking around the store and passed out. Pt was responsive, alert and o... Read more
Pt received vaccine and was walking around the store and passed out. Pt was responsive, alert and oriented. 911 was called. Pararmedics arrived and she was checked out. They released her to go home without addition followup.
16 2021-05-21 loss of consciousness Patient was fine after vaccine administration, but while sitting down patient passed out while sitt... Read more
Patient was fine after vaccine administration, but while sitting down patient passed out while sitting next to her mother. Patient was laid on the floor and regained consciousness while on the floor. Eventually with other help, got patient into wheel chair. Mom didn't want EMS called and just let patient sit for awhile until our store director in charge left with patient in wheel chair and Mom to make sure patient was alright.
16 2021-05-21 pallor, loss of consciousness PT SLUMPED OVER IN CHAIR UNCONCIOUS, PALE, DID NOT EAT PRIOR TO VACCINATION. PT WOKE UP, SX RESOLVED... Read more
PT SLUMPED OVER IN CHAIR UNCONCIOUS, PALE, DID NOT EAT PRIOR TO VACCINATION. PT WOKE UP, SX RESOLVED, DRINK AND SNACK PROVIDED. REFUSED TRANSPORT.
16 2021-05-21 fainting Systemic: Fainting / Unresponsive-Medium, Systemic: See statement below-Medium, Additional Details: ... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: See statement below-Medium, Additional Details: Minor patient with parents in attendance. After receiving immunization, patient stood up, took a few steps and fainted, falling backward and hitting head on the floor. Pharmacy staff immediately called 911 and provided supportive first aid. Patient quickly regained consciousness, RPh had her continue to lay in the floor, provided pillow for head, elevated feet and ice pack was applied to back of head. Paramedics arrived to evaluate patient's condition, patient was released home with parents.
16 2021-05-22 lightheadedness, pallor, hypotension Vasovagal response immediately after vaccination. Dizzy, pale, lightheaded, diaphoretic, hypotensive... Read more
Vasovagal response immediately after vaccination. Dizzy, pale, lightheaded, diaphoretic, hypotensive. B.P. 64/25 @10:25 and @10:35 B.P. 110/60. Laid down in medical screening with good rebound Blood pressure. Remains for 30 minutes observation. Left in stable condition at 10:53.
16 2021-05-23 chest pain Patient reporting worsening chest pain x 3 days, headache x 3 weeks, dizziness today
16 2021-05-23 loss of consciousness, pallor Patient was visibly nervous/anxious about the vaccination. Patient had reported syncope from a previ... Read more
Patient was visibly nervous/anxious about the vaccination. Patient had reported syncope from a previous vaccination on their consent/screening form. Vaccine was administered as prescribed and patient initially appeared fine but lost consciousness approximately 15 to 20 seconds after. The patient's mother, who was present as her legal guardian, helped me cushion the the patient to ensure she did not fall and injure herself. Patient regained consciousness in 10 to 15 seconds but then passed out again. I was then able to elevate the patient's legs and she regained consciousness. Provided patient with chilled bottled water and allowed her to rest in the vaccination booth for 15 minutes. I stayed with the patient during that time and observed her. Afterwards she said she was feeling better and the color in her face was returning. She felt comfortable standing up and moved to a different seat in front of the pharmacy where she waited another 15 minutes. I observed her from the bench during that time. When the patient and her mother felt comfortable they left the pharmacy together.
16 2021-05-23 fainting Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainti... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: 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.
16 2021-05-23 troponin increased, chest pain, inflammation of the heart muscle, lightheadedness Vaccine administered at outside facility. Patient is a 16 yo girl, admitted on 4/19 with myocarditis... Read more
Vaccine administered at outside facility. Patient is a 16 yo girl, admitted on 4/19 with myocarditis, s/p IVIG (4/19) after presenting with progressive new onset chest pain. She was in usual state of health up until 2 days ago when she started developing body aches, and chest pain. Patient received her 2nd Pfizer COVID vaccine last week (4/15). No known history of COVID infection. Parents brought her to the ED yesterday after she complained of dizziness, SOB, chest pain, and had a near syncopal event. EKG showed non-specific ST abnormalities with labs showing elevated troponin, mildly elevated CRP, normal CXR, negative COVID PCR. Denies fever, GI symptoms, GU symptoms, headache, rash. Once transferred to our PICU, she was worked up for myocarditis vs MIS-C. Troponin has been trended q6 and is trending up (now 11). Of note, there have been no fevers. Patient is a 16 yo girl, s/p admission (4/19-4/23/21) with myocarditis, s/p IVIG (4/19), has now been readmitted on 5/10 with myocarditis after presenting with headache and neck pain for 2 days. Following discharge from the PICU on 4/23, patient states that symptoms have lingered (low grade fevers, feeling tired, on and off chest pain). After developing a progressive headache and neck pain, she came back to the ER for re-evaluation. Upon readmission, her troponin was elevated (2.06 on 5/10). Her CBC and CMP were reassuring. Blood culture collected on 5/11 and urine culture collected on 5/10. ID consulted for workup.
16 2021-05-24 fainting, loss of consciousness Patient is a 16 yo female, experienced syncopal episode immediately after receiving first dose of pf... Read more
Patient is a 16 yo female, experienced syncopal episode immediately after receiving first dose of pfzier covid vaccine. Loss of conciousness noted for less than 60 seconds. Once patient regained consciousness, she presented Alert and oriented x4, verbal and able to make needs known. Respiration even and unlabored. Skin pink, warm dry and intact. No c/c of allergic reaction. No loss or altered level of consciousness noted. Patients mother reports patient has a history of anxiety, especially with medical procedures, reports prior near syncopal episodes but denies actual loss of concern, denies allergies or significant past medical HX. Patient reports feeling very nervous. Mother remained with patient and provided emotional support. Patient was assisted to ground, placed supine with lower extremities elevated, past medical HX obtained from patient and physical assessment completed simultaneously. VS 137/82 HR 75 O2 97% RR 20. Encouraged patient to relax and breathe. Within 60 seconds, patient reported feeling better, although emotional. Once pt was OK, patient was assisted from sitting position and provided oral fluids. Patient denied dizziness or lightheadedness while in sitting position. Patient was then assited to standing positions and escorted to observation area, patient sat in chair while being observed for 30 mins. After observation period, pt denied any symptoms, no acute distress noted, patient went home with mother.
16 2021-05-24 fainting Felt dizzy and like she would pass out Felt faint and nauseous and very sweaty. MOM noted she was ... Read more
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
16 2021-05-24 fainting 16yo female pt had syncope episode approx 15 min after vaccination. Parents said they had just come... Read more
16yo female pt had syncope episode approx 15 min after vaccination. Parents said they had just come off of a long international flight and that pt was very tired and had not had anything to eat or drink. After vaccination, the family walked around the store, and pt fainted on other side of store. Emergency services were called. Pt was helped to sitting upright in a chair, and had a scraped knee.
16 2021-05-24 fainting Patient fainted and vomited within 15 minutes of vaccination. No treatment needed. Patient release... Read more
Patient fainted and vomited within 15 minutes of vaccination. No treatment needed. Patient released to home with parent.
16 2021-05-25 chest pain, troponin increased Presented to ED on 5/13/21 with trouble breathing, chest pain, back pain and numbness. Had been exp... Read more
Presented to ED on 5/13/21 with trouble breathing, chest pain, back pain and numbness. Had been exposed to boyfriend with flu like symptoms 3 weeks prior and had had some symptoms around that time but had been improved. SARS-CoV-2 PCR negative in ED. patient afebrile but workup in ED revealed troponin of 0.71, no EKG changes. Symptoms resolved in ED but given troponin was admitted to the hospital for further evaluation. Echo performed and normal. Troponin trended in hospital and patient discharged without events.
16 2021-05-25 hypotension, heart rate decreased Patient went stiff/possible seizure 5 minutes after getting the vaccine. She came back after appro... Read more
Patient went stiff/possible seizure 5 minutes after getting the vaccine. She came back after approx. 30 seconds. EMS was immediately called and her blood pressure and pulse were both taken prior to EMS arrival. Blood pressure was 91/51 with a pulse of 48. PER EMS, the patients blood sugar was low.
16 2021-05-25 loss of consciousness, pallor This patient received the Pfizer vaccine on 5/24/21 at 4:30pm and was feeling fine until the next mo... Read more
This patient received the Pfizer vaccine on 5/24/21 at 4:30pm and was feeling fine until the next morning at 5:30am when she felt dizzy and passed out. She then was able to get back up and passed out again. Her guardian states that she was gray in color and was very weak. She was able to communicate but was very tired and stayed at home for 2 days. Today she is feeling fine and guardian was asking if she should get the 2nd dose. I said that she should contact her physician.
16 2021-05-25 loss of consciousness Pt has history of anorexia. When she arrived at 1:00pm stated she had only eaten 1/2 banana today. S... Read more
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.
16 2021-05-25 pallor Approximately 10 minutes after vaccination, patient's brother yelled out for help. The pharmacy cash... Read more
Approximately 10 minutes after vaccination, patient's brother yelled out for help. The pharmacy cashier then observed the patient convulsing. Her body was leaned back on the bench, with head tilted back a bit. When I came out, patient appeared very pale. I immediately ran back into the pharmacy, instructed a fellow employee to reach out for assistance from front end management, and I called 911. While on the phone with 911, I walked out to check on the patient. At that point, she appeared to be coherent and said she was okay, and doesn't need any medical help. At that time, her brother explained that a reaction like this had occurred in the past when she got other vaccinations/injections so they were familiar with the symptoms. We continued to monitor patient for further reactions. After about 30 minutes, patient appeared to have no further reactions and left.
16 2021-05-25 fainting, loss of consciousness, hypotension Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypo... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Medium
16 2021-05-25 fainting, pallor Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed ... Read more
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.
16 2021-05-25 fainting Patient sat about 2 minutes after getting vaccine and started to walk away to sit in our designate... Read more
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.
16 2021-05-26 chest pain, troponin increased arm pain, mild chest pain, mostly around the sternal area, more with on palpation, extremely elevat... Read more
arm pain, mild chest pain, mostly around the sternal area, more with on palpation, extremely elevated troponin levels (high normal is 0.04 for our labs, patient had 20) echocardiogram negative transferred to a more complex center, Hospital
16 2021-05-26 pallor PATIENT EXPERIENCED DIZZINESS, BLURRY VISION, HEARING LOSS AND BECAME SHAKY AND PALE ABOUT 2 MINUTES... Read more
PATIENT EXPERIENCED DIZZINESS, BLURRY VISION, HEARING LOSS AND BECAME SHAKY AND PALE ABOUT 2 MINUTES AFTER GETTING THE VACCINE. SHE WAS STILL SEATED IN THE IMMUNIZATION ROOM AT THE TIME THE ADVERSE EVENT OCCURED. SHE REMAINED SEATED IN THE ROOM FOR ABOUT 20 MINUTES BEFORE FEELING WELL ENOUGH TO LEAVE. SHE WAS GIVEN WATER AND AN ICE PACK.
16 2021-05-26 pallor PATIENT'S FATHER REPORTED AFTER PATIENT SAT DOWN IN OBSERVATION AREA, SHE REQUESTED A WATER. PATIENT... Read more
PATIENT'S FATHER REPORTED AFTER PATIENT SAT DOWN IN OBSERVATION AREA, SHE REQUESTED A WATER. PATIENT AND MOTHER WALKED TO RETRIEVE WATER AND AS SHE ENTERED THE TENT PATIENT REPORTED DIZZINESS AND VISION DISTURBANCE. PATIENT STATED SHE BEGAN TO SEE BLACK AS SHE WAS SEATED. NURSE WAS CALLED OVER. DAD STATED PATIENT'S BODY SLUMPED OVER AND HE SUPPORTED HER IN THE CHAIR. THE NURSE WITNESSED FULL BODY UNCONTROLLABLE SHAKING FOR LESS THAN 20 SECS. LOC ASSESSED AND PATIENT WAS AOx4 IMMEDIATELY FOLLOWING THE SHAKING. NURSE ALSO OBSERVED PALE LIPS. FLUIDS OFFERED AND CONSUMED. MD & EMS PAGED. DAD REPORTED TO MD, PATIENT HX OF FAINTING. PATIENT BECAME PALER. MD ADVISED AGAINST PLACING PATIENT ON GROUND. GURNEY PROVIDED. PATIENT FEET ELEVATED. VS OBTAINED #1 BP: 76/48; #2 83/52, p: 60, RR: 16; O2: 98%; #3 BP: 85/53, P: 81 at 1540. PATIENT OBSERVED WITH FEET ELEVATED FOR LESS THAN 10 MINS. MD RECOMMENDED PATIENT REMAIN IN OBSERVATION FOR 15 MINS PRIOR TO LEAVING. PATIENT MOVED TO CHAIR SEATED UPRIGHT POSITION WITHOUT ASSISTANCE FOR 15 MINS. 15 MINS ELAPSED, MD MADE AWARE AND DECLINED TO REEVALUATE PATIENT AT 1555. PATIENT EXITED OBSERVATION AREA ACCOMPANIED BY PARENTS AND BROTHER WITH FLUID IN HAND IN STABLE CONDITION.
16 2021-05-26 pallor patient became pale white ; lightheaded, had to lay her down to prevent full fainting episode
16 2021-05-26 pallor Shortly after receiving vaccine (about 5 minutes), pt complained about difficulty breathing. I went ... Read more
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.
16 2021-05-26 fainting Patient began to loose vision and fainted. after about 5 minutes she began to make jerking movements... Read more
Patient began to loose vision and fainted. after about 5 minutes she began to make jerking movements and fainted again 911 was called and they took over the situation
16 2021-05-27 chest pain shortness of breathe, chest pains
16 2021-05-27 loss of consciousness Patient received the Pfizer vaccine. Patient left to sit in out waiting room after vaccine. Patient'... Read more
Patient received the Pfizer vaccine. Patient left to sit in out waiting room after vaccine. Patient's mother informed in a few minutes that the patient was not feeling well. She stated that the patient felt hot. I grabbed an ice pack on my way out to her. I put the ice pack behind her neck. Patient passed out within a minute of me getting to the patient. She came back to quickly and stated that she was having a hard time seeing and hearing. She then again passes out. At this point I made the decision to call 911. I delegated to my tech to call 911. She called 911. I asked my other tech to come help me thinking the patient my have needed to be lower to the ground. The patient again regained consciousness. At this point I asked tech to call our Store Director and inform them. I also asked that she get me a water for the patient. The patient was feeling better and drank some water. She then again passes out. This time we were struggling to get her to regain consciousness. I used sternal rubs to help the patient regain consciousness. I was having a hard time finding her pulse. This lasted for a minute or two and then she stared responding. Right then EMS arrived and took over. I gave them the information I had and they took her vitals. EMS decided that she was stable and could go home to be monitored by mom. I did call the Mother the next morning to check on the patient. The patient did well last night and was feeling good this morning.
16 2021-05-27 pallor Shortly after receiving vaccination client became pale and diaphoretic, c/o blurry vision and fell f... Read more
Shortly after receiving vaccination client became pale and diaphoretic, c/o blurry vision and fell from chair. She received a minor injury to her right knee which was treated on the scene by EMS. BP 91/50, 02 99%, HR 46
16 2021-05-27 fainting Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium
16 2021-05-27 troponin increased, chest pain Patient developed left sided chest pain that lasted for approximately 12 hours. It then improved bu... Read more
Patient developed left sided chest pain that lasted for approximately 12 hours. It then improved but she still had it with lifting heavy objects. Was seen in clinic. Went home and has follow-up with Pediatric Cardiology tomorrow.
16 2021-05-27 troponin increased, inflammation of the heart muscle, chest pain, lightheadedness Myocarditis. Chest pain started 2 days after the 2nd shot. Elevated troponin and went upto 20. Near ... Read more
Myocarditis. Chest pain started 2 days after the 2nd shot. Elevated troponin and went upto 20. Near syncope and tiredness.
16 2021-05-28 blood pressure decreased, fainting Patient had an episode of vasovagal syncope right after receiving the vaccine. Her blood pressure dr... Read more
Patient had an episode of vasovagal syncope right after receiving the vaccine. Her blood pressure dropped to 92/50 at 11:15, but then it resolved to 102/60 within 5 mins. Gave 8 oz. of orange juice and patient reports feeling normal after 15 mins. Monitored for about 20 mins and no other symptoms were observed.
16 2021-05-28 chest pain, chest discomfort, heart rate increased Patient reports immediately after receiving the vaccine she developed chest tightness and pain that ... Read more
Patient reports immediately after receiving the vaccine she developed chest tightness and pain that has continued to wax and wane the past two weeks. Has some intermittent difficulty breathing and fast heart rate that each last about 20- 30 minutes. Also accompanied by dizziness or lightheadedness. Reports her whole right leg feels tingly and her joints hurt, but denies weakness, redness or swelling of the joints or right foot. Also has a continuous headache that started within an hour of receiving the vaccine and worsened over the next few days. This too has waxed and waned.
16 2021-05-28 loss of consciousness, blood pressure decreased passed out; BP was 70/44; could not sit or stand; EKG-Potential abnormal Twave; Calcium was low; Thi... Read more
passed out; BP was 70/44; could not sit or stand; EKG-Potential abnormal Twave; Calcium was low; This is a spontaneous report received from two contactable consumers reporting for her daughter. A 16-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), vaccinated at the age of 16 years old, via an unspecified route of administration, administered in Deltoid Left on 05May2021 15:00 (Batch/Lot Number: ER8735; Expiration Date: 31Jul2021) as single dose for covid-19 immunisation. Patient received the first dose on unknown date. Her daughter had no reaction from the first one that was three weeks prior. The patient medical history included Attention deficit hyperactivity disorder. Concomitant medications included lisdexamfetamine mesilate (VYVANSE) taken for attention deficit hyperactivity disorder, start and stop date were not reported. Last Wednesday, at 3 pm, caller's daughter received the second vaccine. Her daughter had no ill effects. Her daughter got up the next morning, 18 hours after administration, and passed out. Caller states that they called the squad and her daughter's BP was 70/44. They pushed an IV, transported her daughter, and they were in the ER for 10 hours. The local hospital gave her daughter 2 1/2 bags of fluid and transported her daughter to Hospital. Caller adds that there were 4 liters of fluid given, and her daughter could not sit or stand without her blood pressure dropping for about 8 hours after the incident. There were 2 transports and 2 ER's. Caller asks why were they not told that this is a symptom. She was grateful that she could catch her daughter before she hit her head, but what about parents who leave their kids alone. Last Wednesday, caller's daughter received the vaccine 05May2021 at 3 pm and passed out 06May2021 in the morning. It was the only time she passed out and caller states she saw her daughter's head drop and then was trying and caught her. She was trying to talk to her and her eyes were in the back of her head, and was trying to arouse her. She was out for over a minute. She went to Emergency Room in. They were there for 6 hours. Then, when she could not sit up and her blood pressure was dropping, they recommended Hospital. She was there, this all took place, on Thursday from 9 am or around 8:50 am when she passed out and then they were discharged after 9 pm. It was a 12 hour situation where they were transported and she spent 12 hours in 2 emergency rooms. The only one she had at time was vyvanse but she did not take this before passing out. The last time that she took this would have been nine hours before administration of the vaccine on 05May2021. She did not take it on 06May2021 when the incident happened. She was just getting up. She had only been on this for about a week. It is a stimulant drug but it is out of the system in the evening so people can sleep. She asked each doctors if this had any role in it and they said no. They told her to take it again which they have not started back yet. She has no other medical conditions. Investigations: caller does not provide dates or specific test results. The first ER did bloodwork, urine, chest x-ray. They wanted a CAT scan of her head but caller declined because she thought it was unnecessary. They did an EKG at first in the ER. Nothing was abnormal. She did have some things out of range in bloodwork which is not surprising because she was taking in fluids. Her calcium was low. Nothing was way out of range, nothing was abnormal. The second ER did a follow up EKG but no other tests or bloodwork. According to three physicians, the EKG was fine. A cardiologist reviewed the 2nd EKG and she got a phone call that they wanted her to follow up because of potential abnormal T waves which could have been a result of that much fluid intake and electrolytes being out of sync after that much fluid. They are following up on this. Her father has as vasovagal response hat he has experienced 4-5 times in his lifetime. He has never passed out following a vaccine. Caller had no idea that was even a response to vaccine. He has passed out after giving blood, with severe pain, coming out of anesthetic, and with severe stress. He has never had an extended period of time where his blood pressure was low. She, they could not get, her blood pressure up with fluid after fluid which is why she was transported to the second ER because they thought they did not know what was going on there. Caller states does she think that there may be some relationship and her daughter has this tendency to vasovagal - yes. Was it brought on by the vaccine? Yes. She has never fainted in her life. Caller adds she can see how some many say this may not be related to the vaccine but 18 hours after administration, they can not get her blood pressure up and were in the ER for 12 hours. Treatment included all the fluid, and 2 capsules of acetaminophen. No other treatment. Outcome of events was unknown. Information on Lot/Batch number was available. Additional information has been requested
16 2021-05-28 loss of consciousness About 18 hours after she got the shot, she started passing out. This happened 9 times over the 24 h... Read more
About 18 hours after she got the shot, she started passing out. This happened 9 times over the 24 hour period. She got a CT, MRI, 2 hour EEG and a 24 hour EEG. All of her test came back normal.
16 2021-05-28 pallor, lightheadedness I woke up not feeling well. I was pale in color and felt nauseous, light headed and my ears were rin... Read more
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.
16 2021-05-28 pallor Fever 37.5C, fatigue, headache, swollen lymph nodes, back of the neck pain, stomach ache, pale compl... Read more
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.
16 2021-05-29 loss of consciousness, fainting After leaving the immunization room the patient fainted and fell on the floor. Patient lost consciou... Read more
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.
16 2021-05-29 loss of consciousness Mother reported daughter fell in bathroom in the middle of the night- said she couldn't see then si... Read more
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.
16 2021-05-31 chest pain chest pain ER visit BNP was elevated
16 2021-05-31 hypotension, loss of consciousness Pt passed out. Experienced extremely low blood pressure. Pulse couldn't be detected for a couple o... Read more
Pt passed out. Experienced extremely low blood pressure. Pulse couldn't be detected for a couple of seconds. Pt woke and was clear and coherence. Paramedics saw pt and provided IV fluids. Pt left under own power.
16 2021-05-31 loss of consciousness, fainting Syncope x 3 in the early morning hours (around 3am) about 14-15 hours after vaccine. She had had hea... Read more
Syncope x 3 in the early morning hours (around 3am) about 14-15 hours after vaccine. She had had headaches that is intermittent, throbbing, phonophobia but no photophobia, from back of head to top of head and behind eyes, taking Advil or Excedrin intermittently with relief for a week prior to covid19 vaccine. Syncope, longest lapse was two minutes, her sister found her. She went to Medical Center ER at 0400, was assessed and scanned, neg CT scan of head, and was discharged home. Has felt some fatigue today due to not sleeping early the night before, has returned to school since concussion, with normal learning, and denies any exertional physical activity due to pre-existing torn ACL, torn medial meniscus L knee. After evaluation by ER, was given IV fluids, determined cause to be dehydration.
16 2021-05-31 loss of consciousness Patient appear to have seizure just after receiving the vaccination. After apparent seizure or loss... Read more
Patient appear to have seizure just after receiving the vaccination. After apparent seizure or loss of consciousness patient appear weak and had a hard time answering questions. 911 was called and patient transported for medical care.
16 2021-05-31 loss of consciousness My daughter had a mild seizure 5 minutes or less after receiving her first vaccine. She fell out of ... Read more
My daughter had a mild seizure 5 minutes or less after receiving her first vaccine. She fell out of her chair, her eyes fluttered and rolled in the back of her head, her teeth were clocking and chattering and her body was shaking mildly. She lost consciousness for approximately 2 minutes. At 8:33 pm she felt a second seizure begin, her step father grabbed her before she could fall and again, her eyes fluttered and rolled in back of her head, her teeth were clicking and chattering and her whole body was shaking. The second episode lasted approximately 2 minutes as well, with her losing consciousness again. She was taken to the emergency room and stayed overnight for observation.
16 2021-05-31 fainting After receiving the injection the patient fainted. Patient was offered juice and after taking a sip ... Read more
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.
16 2021-06-01 blood pressure decreased, heart rate increased Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lighthea... Read more
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: blurry vision-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Patient reported leg weakness and blurred vision and dizziness/slight difficulty breathing upon getting ready to leave observation area. Said she hadn't eaten in a while and felt cold due to A/C in the store as well. BP was low and HR high, so called 911 to get her emergency help as she didn't feel like she could walk out of store safely. Felt strange and that her legs might give way. EMS arrived, vitals looked good, pt refused ambulance.
16 2021-06-01 loss of consciousness, fainting Pt had loss of consciousness x 2 immediately after injection. , shaking of extremities described. La... Read more
Pt had loss of consciousness x 2 immediately after injection. , shaking of extremities described. Lasting appx 1 min each. return to baseline after . Differential was seizure vs. more likely vagal syncope
16 2021-06-01 fainting, chest discomfort, pallor Within minutes of receiving the 2nd dose of Pfizer vaccine the patient start to feel light headed, s... Read more
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.
16 2021-06-01 fainting syncope
16 2021-06-02 blood pressure decreased, lightheadedness Immediately following administration, patient walked out of room and sat down in waiting area. Pati... Read more
Immediately following administration, patient walked out of room and sat down in waiting area. Patient felt very dizzy and almost fainted. Complained of hearing loss then tinnitus. Initial BP was 82/31 then gradually increased back towards normal over 20-30 minute period. Hearing loss recovered after 1-2 minutes then complaint of tinnitus which then stopped after 5-6 minutes. Approx 30 min after admin, pt felt much closer to normal and parent felt comfortable bringing her home.
16 2021-06-02 chest pain, inflammation of the heart muscle Myocarditis (with chest pain, shortness of breath, dizziness) starting after first dose, worsening ... Read more
Myocarditis (with chest pain, shortness of breath, dizziness) starting after first dose, worsening after second
16 2021-06-02 loss of consciousness atient was in for 2nd covid-19 (Pfizer lot was EW0167, exp 8/31/2021): It was her and her brother r... Read more
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.
16 2021-06-02 lightheadedness vasovagal response lasted for approx. 10 minutes
16 2021-06-02 lightheadedness Vasovagal event. Pt fainted and immediately came to. Pt felt better after about 15 minutes and was a... Read more
Vasovagal event. Pt fainted and immediately came to. Pt felt better after about 15 minutes and was able to walk.
16 2021-06-02 fainting, chest pain At the time of the vaccine daughter dizzy and started to fade out 20 minutes after the vaccine. She ... Read more
At the time of the vaccine daughter dizzy and started to fade out 20 minutes after the vaccine. She couldn?t see and it seemed like it was a Vaso Vagal response which resolved quickly. At 5am the woke up with a fever of 102 and extreme left arm pain. The fever was controlled with Tylenol. Two days after the vaccine she woke up complaining of chest pain and a knot under her left arm. It felt like something was pressing on her chest. We went to the ER and all tests were negative. The feeling lasted until the end of the day. Three days after the shot the next morning she got a headache for half of the day and resolved with Tylenol. The next day all symptoms were gone. Emergency Room Dr.
16 2021-06-02 fainting patient fainted a few minutes after getting pfizer covid vaccine. She felt better 5 minutes later, H... Read more
patient fainted a few minutes after getting pfizer covid vaccine. She felt better 5 minutes later, Her blood pressure was 113/69 pulse 73. Her blood pressure was 98/64, pulse 80 30 minutes after. But she felt perfectly fine then.
16 2021-06-02 fainting Pfizer COVID-19 Vaccine Vaccine Lot Number: Ew0178 2nd dose; vagal faint. Pt got dizzy after immun... Read more
Pfizer COVID-19 Vaccine Vaccine Lot Number: Ew0178 2nd dose; vagal faint. Pt got dizzy after immunization, assisted to ground. Ambulating from vaccine site to chairs, slow faint to ground no LOC no sz no DOE VSS. glucose 93; weakness taken to ground, observation in EMS tent, home with parent. 5pm-94/60 p-93, r-20; 5:10 104/60 p-79, r-20, pox 99%
16 2021-06-02 fainting This young lady was at the school to receive her second dose of the Pfizer vaccine, she answered all... Read more
This young lady was at the school to receive her second dose of the Pfizer vaccine, she answered all the questions with a No answer, she stated she was feeling well and had minimal reaction to first vaccine. She appeared to be nervous as reported by the nurse. after recieving her second shot, as the nurse was finishing up paperwork and filling out card, the student felt like passing out, one of the other nurses that were at her side, caught her as she fainted out of chair, she was placed on the ground and EMS was called at 10:10 and Nursing Supervisor was notified at 10:15. EMS determined she had a Vasovagal Syncope. EMS attended to patient and it was unknown if she was released after observation or taken to ED for further evaluation. a field emergency record was recorded and return to the nursing supervisor at the health department.
16 2021-06-03 pallor Bleeding & bruising happened instantly as the injection was given. Within 2 minutes (walking to the... Read more
Bleeding & bruising happened instantly as the injection was given. Within 2 minutes (walking to the waiting area) she was feeling dizzy. By the time we sat down she said she felt like she was going to be sick. She began sweating - it was dripping off her head and neck and her eyes kept closing. She was extremely pale and her lips were white. She was like this for approximately 10 minutes.
16 2021-06-03 pallor approximately 5 minutes after vaccine, patient experienced paleness, nausea, tingling throughout bod... Read more
approximately 5 minutes after vaccine, patient experienced paleness, nausea, tingling throughout body, stomach tightness and sweaty
16 2021-06-03 lightheadedness Vasovagal episode following vaccination. Spontaneous resolution after being put in the supine positi... Read more
Vasovagal episode following vaccination. Spontaneous resolution after being put in the supine position. Paramedics on site. No treatment required.
16 2021-06-03 lightheadedness Vasovagal event following administration of vaccine. Spontaneous resolution after being placed in su... Read more
Vasovagal event following administration of vaccine. Spontaneous resolution after being placed in supine position. Paramedics on site. No treatment required
16 2021-06-03 fainting, loss of consciousness excessive bleeding immediately the needle was withdrawn. then 9 hrs later when the bandage was being... Read more
excessive bleeding immediately the needle was withdrawn. then 9 hrs later when the bandage was being removed patient fainted for 5 mins associated with LOC.
16 2021-06-03 fainting Pt w/ hx of allergy to penicillins (rash) & HPV vaccine (unknown reaction). Pt had syncope, flushin... Read more
Pt w/ hx of allergy to penicillins (rash) & HPV vaccine (unknown reaction). Pt had syncope, flushing/sweating and dizziness. BP 119/76, HR 78, RR 18 -- > 107/61, 72, 18. Recommended to the patient to take 2nd dose supine. Pt stable and released from the vaccination site.
16 2021-06-05 chest discomfort Patient's mom reported that patient had chest pressure and felt tired on Saturday 6/5/2021 (pt got 2... Read more
Patient's mom reported that patient had chest pressure and felt tired on Saturday 6/5/2021 (pt got 2nd pfizer covid 19 vaccine dose on 6/4/2021) per mom. Pt's mom was advised to contact PCP or visit urgent care or ER if symptoms get worse. Called pt's mom next day to follow up on pt's adverse reactions. Pt felt better and chest pressure went away per pt's mom.
16 2021-06-05 loss of consciousness, fainting Syncopal event. Np was doing routine rounds when mom of patient called for help. NP, Charge Nurse, a... Read more
Syncopal event. Np was doing routine rounds when mom of patient called for help. NP, Charge Nurse, and Paramedics went to aid patient. Patient was sitting in her chair, and recovered consciousness immediately. Pt's blood was assessed by NP, Charge nurse and Paramedics. Blood pressure was checked. Initial blood pressure was 60/32, O2 was 99% at room air, heart rate was 52 beats per minute. Once patient recovered consciousness she was alert and orient X4 , she stated she felt fine, blood pressure retaken was 99/62, O2 99% at room air, heart rate 68 beats per minute. Mother of patient stated this was the first time patient loss consciousness. Patient and mother of patient were given the option to be transferred to hospital and they refused. NP educated and advised mother of patient to make an appointment for patient to see primary provider. Patient stayed an additional 15 minutes for further observation and was able to leave home with mother.
16 2021-06-06 palpitations My daughter experienced fatigue, GI issues, heart racing, anxiety, jittery (these are signs that her... Read more
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.
16 2021-06-06 lightheadedness, loss of consciousness Pfizer COVID-19 Vaccine EUA Patient received 1st dose Pfizer at 1705. Patient stood up and had vaso... Read more
Pfizer COVID-19 Vaccine EUA Patient received 1st dose Pfizer at 1705. Patient stood up and had vasovagal reaction, passed out and seized for 15 seconds. Nurse performed sternal rub, patient was aroused. Patient A&Ox3. Physician arrived at 1708, vital signs obtained at 1711 (BP 113/68, O2 100%, HR 83 bpm. Patient right ear started to bleed at 1712. 1725 obtained another set of vital signs. BP 118/70, O2 96%HR 82 bpm. EMS/Fire arrived 1732.
16 2021-06-06 lightheadedness Fever and chills on the 8th and 9th; Over the last couple of weeks, several times that I've gone to... Read more
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.
16 2021-06-07 anaemia, fibrin d dimer increased Fever, urticarial rash to face, neck trunk, and extremities, arthralgias and swelling to hands, feet... Read more
Fever, urticarial rash to face, neck trunk, and extremities, arthralgias and swelling to hands, feet, ankles, left knee and left elbow occurring 4 weeks after vaccine lasting for 4 days in hospital after 2 days at home. still resolving slowly
16 2021-06-07 chest pain, inflammation of the heart muscle, fast heart rate, haemoglobin decreased, hypertension Patient admitted with myocarditis s/p dose #2 of the Pfizer COVID-19 vaccine. At the time of the re... Read more
Patient admitted with myocarditis s/p dose #2 of the Pfizer COVID-19 vaccine. At the time of the report, she is still hospitalized. From EHR note: Patient was in her usual state of health when she received her second dose of the Pfizer mRNA Covid vaccine on 6/3. She experienced mild myalgias in the day following the vaccine. However, on 6/5 she developed new severe substernal chest pain, dizziness, and dyspnea. Pain radiated to her throat. Given severity of pain, she presented to the emergency department. In the ED she was afebrile, tachycardic, and initially hypertensive. Labs demonstrated WBC 10.9 (N 49, L 27), Hb 11.7, PLT 315. ESR 25, CRP 7.61. Troponin T was mildly elevated at 0.08, consistent with mild cardiac inflammation. SARS-CoV-2 PCR and antibody testing were negative. An EKG was normal. However, an echo demonstrated low-normal LVEF (55%). Otherwise, patient denies nausea, vomiting, diarrhea, cough, runny nose, conjunctivitis, new rashes, arthralgias. Patient was admitted to the cardiology service for further monitoring. Following admission, she was started on ibuprofen. She notes that her substernal chest pain has improved somewhat since admission. Differential for patient's presentation includes infectious, post-infectious, and non-infectious causes of myocarditis. Although post-vaccination mild myocarditis seems likely, we agree with the infectious workup already undertaken, and recommend additional EBV and CMV PCR testing.
16 2021-06-07 chest pain Fever and chest Pain
16 2021-06-07 hypertension, chest discomfort, chest pain, fast heart rate Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat T... Read more
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.
16 2021-06-07 loss of consciousness Pt given vaccination in left deltoid at 10am today, approximately 5 minutes later, pt lot consciousn... Read more
Pt given vaccination in left deltoid at 10am today, approximately 5 minutes later, pt lot consciousness, and had seizure like activity for approximately one minute. Pt's primary provider and pharmacist told pt to come to ER to be assessed.
16 2021-06-07 loss of consciousness Patient received shot and left the room and then passed out in the waiting area, hit head on the gro... Read more
Patient received shot and left the room and then passed out in the waiting area, hit head on the ground.
16 2021-06-07 lightheadedness Pt was laying down for 2nd Covid vaccination as she fainted for 1st Covid vaccination. After 2nd vac... Read more
Pt was laying down for 2nd Covid vaccination as she fainted for 1st Covid vaccination. After 2nd vaccination was given- she had a vaso vagal reaction. BP 102/72 Pt has had 4 episodes of ears ringing & pressure both sides of head. Recommended to see her primary Dr. after leaving clinic.
16 2021-06-08 chest pain She experienced severe chest pains within the first 24 hours of the vaccine. The pains have lingered... Read more
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.
16 2021-06-08 pallor Patient had a headache this morning. At 11:30am she felt hot, so we took her temperature which was ... Read more
Patient had a headache this morning. At 11:30am she felt hot, so we took her temperature which was 100.0. She then walked into another room and had a febrile seizure lasting 30 seconds. Her face was pale white, her eyes were open and staring off, she moaned initially and then her jaw was stuck open with her tongue making a clicking sound. She urinated herself and then the seizure ended.
16 2021-06-08 lightheadedness, loss of consciousness Vasovagal Response. Passed out for 2 minutes and when awoken she could not see for 10 minutes.
16 2021-06-08 fainting, chest pain, troponin increased, inflammation of the heart muscle chest pain; body aches; dizziness; SOB; near syncopal event; an EKG showed non-specific ST abnormali... Read more
chest pain; body aches; dizziness; SOB; near syncopal event; an EKG showed non-specific ST abnormalities with labs showing elevated troponin,; mildly elevated CRP; Upon readmission, her troponin was elevated (2.06 on 5/10); myocarditis; This is a spontaneous report from a contactable nurse. A 16-year-old female patient (pregnant: No) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 16-year-old, via an unspecified route of administration on 15Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine, unknown if any other medications the patient received within 2 weeks of vaccination. Known Allergies: NSAIDs. On 19Apr2021, the patient experienced myocarditis, chest pain, body aches, dizziness, SOB, near syncopal event, an EKG showed non-specific ST abnormalities with labs showing elevated troponin, mildly elevated CRP, with outcome of recovering. Upon readmission, her troponin was elevated (2.06 on 5/10) on 19Apr2021 with outcome of recovering. Seriousness criteria-Caused/prolonged hospitalization. The patient was hospitalized for myocarditis from 19Apr2021 to 23Apr2021. The patient was hospitalized for other events for 6 days. The adverse event result in Doctor or other healthcare professional office/clinic visit. Emergency room/department or urgent care. Clinical course as follows: patient is a 16 yo girl, s/p admission (19Apr-23Apr2021) with myocarditis, s/p IVIG (19April) after presenting with progressive new onset chest pain. She was in usual state of health up until 2 days ago when she started developing body aches, and chest pain. Patient received her 2nd Pfizer COVID vaccine last week (15April). No known history of COVID infection. Parents brought her to the ED yesterday after she complained of dizziness, SOB, chest pain, and had a near syncopal event. An EKG showed non-specific ST abnormalities with labs showing elevated troponin, mildly elevated CRP, normal CXR, negative COVID PCR. Denies fever, GI symptoms, GU symptoms, headache, rash. Once transferred to our PICU, she was worked up for myocarditis vs MIS-C. Troponin has been trended q6 and is trending up (now 11). Of note, there have been no fevers. Upon readmission, her troponin was elevated (2.06 on 10May). It was unknown prior to vaccination the patient diagnosed with COVID-19. Since the vaccination, the patient tested for COVID-19. covid test type post vaccination: Blood test. covid test name post vaccination: SARS COV2 ANTIBODIES QUALITATIVE on 19Apr2021, covid test result: Positive. covid test type post vaccination: Nasal Swab, covid test name post vaccination: Respiratory Virus Panel by PCR on 19Apr2021, covid test result: Negative. Information on the Lot/batch number has been requested.; Sender's Comments: The reported myocarditis with chest pain, body aches, dizziness, SOB, near syncopal event and the abnormal lab data were possibly related to the bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), considering temporal relationship and the inflammation features. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
16 2021-06-08 fainting After given Covid19 vaccine Pfizer 2nd dose to patient on 6/8/21, patient feels dizziness, headache ... Read more
After given Covid19 vaccine Pfizer 2nd dose to patient on 6/8/21, patient feels dizziness, headache and start to faint. We called 911 and paramedic came very quickly. Patient was conscious and we continue monitored patient for about 30 more minutes and she was ok at the store. Advice her dad to continue monitor patient when at home and report if any side effects. We called patient to follow up in the evening and patient is doing fine.
16 2021-06-08 fainting Patient fainted immediately following her shot
16 2021-06-09 chest discomfort Patient came to college on 4/24/21 after she received her Pfizer COVID vaccine from hospital. She r... Read more
Patient came to college on 4/24/21 after she received her Pfizer COVID vaccine from hospital. She reported chest tightness and itchy throat. Her pulse ox was 98. Her lungs were clear. She accompanied her mother who was coming to college for her COVID vaccine. EMS spoke with patient as did Dr. Pt refused to go with EMS to the ED. She claimed if she had any problems she would go back to hospital.
16 2021-06-09 chest pain Patient has primary essential hypertension. Patient undergoes an annual echocardiogram to monitor fo... Read more
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.
16 2021-06-09 loss of consciousness patient passed out after being immunized
16 2021-06-09 pallor felt dizzy, became pale...was given water, VSS, school nurse aware and patient mother was called to ... Read more
felt dizzy, became pale...was given water, VSS, school nurse aware and patient mother was called to make aware she felt better after water and color returned, she left the clinic on own within a hour
16 2021-06-09 fainting Systemic: Dizziness / Lightheadness-Mild, Additional Details: Pt fainted after receiving the shot. ... Read more
Systemic: Dizziness / Lightheadness-Mild, Additional Details: Pt fainted after receiving the shot. BP was stable. Pt was conscious and responsive and rested on the floor for a while and then went home with father.
16 2021-06-10 fibrin d dimer increased, deep vein blood clot, chest pain, pulmonary embolism, increased heart rate, coughing up blood Patient vaccinated on 5/28. She reported having pleuritic chest pain and hemoptysis 3 days after tha... Read more
Patient vaccinated on 5/28. She reported having pleuritic chest pain and hemoptysis 3 days after that lasted about a week. Then after she developed right leg pain and swelling x 3 days. Seen at our ER 6/11- studies show DVT of the common femoral vein and other veins of the right lower extremity. Also had b/l pulmonary emboli. Started on lovenox treatment and pending thrombectomy by vascular surgeons in 2 days. (In addition she also had admitted to OCP use for a month prior to this event; no reported FH of clotting disorders)
16 2021-06-10 loss of consciousness, fainting Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt did not have breakfast before her sho... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt did not have breakfast before her shot at 11am. She got the shot and sit down. Mom came over and said her daughter passed out. Rph and techs rushed over. We laid her down to the floor and call emergency number. After a few minutes, she wake up and feel better. Mom said thank you and took her to eat.
16 2021-06-10 pallor, heart rate increased Patient Had Bilateral Tingling In Hands And Was Pale With Slow Cap Refill
16 2021-06-10 fainting, loss of consciousness anxiety, fainting was able to drink water, was not unconscious
16 2021-06-10 fainting Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Naus... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium
16 2021-06-11 palpitations Attendee received first dose Pfizer vaccine at 10:03 in the Left arm. Lot# ER8737. Attendee was dir... Read more
Attendee received first dose Pfizer vaccine at 10:03 in the Left arm. Lot# ER8737. Attendee was directed to observation area. At 10:10 the observation RN noticed redness in the attendee's left arm. Upon palpation the arm was firm not just directly at the injection site but above and below the site as well. The observation RN did an assessment and noticed that the attendee's tongue seemed to be swelling. Attendee did not complain anything; she was very stoic, did grimace x 1 with palpation of the arm. Attendee's skin was warm and dry. Attendee's respirations were not tachypneic or dyspneic. No difficulty with swallowing or speech. HR: Not done BP: 110/70 RR: Not done Temp: 98.3 10:12 – Benadryl 50 mg was administered orally. 10:15 - 911 was called. The mother seemed upset about 911 being called and so the EOA had the mother feel how firm the attendee's arm was and then the mother seemed to understand why the site team was so concerned about the attendee. The EOA was then informed that the attendee was a current participant in a medical study and received an injection of an unknown medication in the same arm, in the past 24 hours. Medical Group is where she is doing the clinical trial. Neither the parents or the attendee were able to tell the site staff what the study is about or what injection she might have been given in the same arm as the Pfizer vaccine site. 10:20 –EMS arrived and took over care of the attendee. Unsure of time – EMS left as the attendee was having no trouble breathing, swallowing, or speaking and the parents refused transport of the attendee to the emergency room. 10:45 - Care Practitioner educated on home discharge/adverse reaction instructions and attendee. Advised to check on her every 30 minutes and if she developed any other or further symptoms to take her to the emergency room. They were also advised that if she develops any difficulty in breathing to call 911 instead of attempting to transport the attendee to the emergency room. She was then discharged to home with her parents, were she will be monitored by the parents.
16 2021-06-12 chest discomfort pt felt slight tightening of chest and throat- injected epinephrine- pt felt better after about 15 m... Read more
pt felt slight tightening of chest and throat- injected epinephrine- pt felt better after about 15 minutes and was released to her mother. After phone discussion on 6/13/21, mother said symptoms returned later in the day and she went to ER and received a steroid injection. Per mother on 6/13/21. pt was feeling fine
16 2021-06-12 chest pain, palpitations Fatigue - rapid heart rate when standing up, exceeds 120bpm when walking or standing and then goes d... Read more
Fatigue - rapid heart rate when standing up, exceeds 120bpm when walking or standing and then goes down when lying, chest pain, severe headache, shortness of breath. All tests to rule out other causes negative
16 2021-06-12 chest pain Patient returned after 15 minute observation with complaints of "chest pain"; denies pain radiating ... Read more
Patient returned after 15 minute observation with complaints of "chest pain"; denies pain radiating towards arm or having difficulty breathing; pain rated 3/10 on p.ain scale. RN and LPN assess vitals, provide water, extend observation time to 30 minutes, and assure pt sits upright. Vitals: B/P: 102/64; HR: 68; O2 Sats: 97% on room air; RR: 16; anterior lungs clear bilaterally. Pt spoke in full complete sentences without difficulty RN and LPN educated parent on high alert symptoms and when to call 911 or pediatrician. Pt vitals after 30 minute observation: BP: 110/72; HR: 72; O2 Sats: 98% on room air; RR: 16. Pt spoke clearly without difficulty and was alert and oriented to person, place, and time.
16 2021-06-12 fainting Patient received her 1st dose on 6/1, 9 hours later she fainted. She has no medical conditions and n... Read more
Patient received her 1st dose on 6/1, 9 hours later she fainted. She has no medical conditions and no history of fainting.
16 2021-06-12 fainting Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Medium
16 2021-06-13 chest discomfort Patient experienced fever to 103 and seizure about 28 hours after vaccine administration. Also had s... Read more
Patient experienced fever to 103 and seizure about 28 hours after vaccine administration. Also had some fatigue. Since vaccine notes ongoing fatigue and weakness. Having some chest discomfort without wheezing that has been responsive to albuterol.
16 2021-06-13 hypotension, fainting Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsiv... Read more
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
16 2021-06-13 fainting PATIENT CAME TO PHARMACY TO RECEIVE FIRST DOSE OF PFIZER VACCINE. PATIENT CLAIMS TO NOT HAVE EATEN T... Read more
PATIENT CAME TO PHARMACY TO RECEIVE FIRST DOSE OF PFIZER VACCINE. PATIENT CLAIMS TO NOT HAVE EATEN THAT MORNING AND WAS ANXIOUS OF RECEIVEING THE VACCINE. AFTER SHE RECEIVED THE VACCINE SHE SAT IN THE WAITING AREA AND IMMEDIATELY TOLD HER MOTHER AND FRIEND (WHO'S MOTHER WAS ALSO THERE) THAT SHE FELT NAUSEOUS. PATIENT BECAME CLAMMY AND FAINTED, THUS FALLING OUT OF THE CHAIR. SHE HIT HER HEAD AND HER MOTHER REPORTS "SEIZING LIKE MOVEMENTS FOR A BRIEF SECOND." THEY CALLED FOR HELP AND PATIENT DID NOT HAVE LABORED BREATHING AND WAS CONSCIOUS. WE WERE ABLE TO SIT HER UP, PUT A COLD TOWEL ON THE BACK OF HER NECK AND FOREHEAD AND SHE WAS ABLE TO DRINK SOME WATER AND A COKE. ADDITIONALLY, AFTER A FEW MINUTES SHE GOT BACK UP IN THE CHAIR AND ATE SOME GOLDFISH TO TRY AND CALM HER STOMACH. PATIENT THEN WAITED AROUND FOR 30 MINUTES BEFORE FEELING BETTER AND WAITING THE ALLOTTED TIME AFTER RECEIVING AN IMMUNIZATION. I CALLED MY DISTRICT MANAGER TO EXPLAIN THE SITUATION AND IT WILL BE REPORTED AS VASOVAGAL SYNCOPE. COUNSELED PATIENT AND MOTHER THEN THEY FELT COMFORTABLE LEAVING. STATED I WOULD FILL OUT INCIDENT REPORTS.
16 2021-06-14 chest discomfort, chest pain Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Aller... Read more
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
16 2021-06-14 loss of consciousness Onset of diaphoresis, dizziness, and visual changes shortly after shot given. Dark vision described ... Read more
Onset of diaphoresis, dizziness, and visual changes shortly after shot given. Dark vision described without tunnel vision. No nausea or LOC. Initial BP 95/60, Pulse 74, O2 sat 96%. BP consistently 103-112 systolic thereafter without orthostasis. Returned to feeling normal. Patient dismissed with father feeling well. She stood while father made off-site 2nd vaccination arrangements at exit desk. Walking out the door she had sudden classic tunnel vision, and brief LOC. She was eased to the ground by her brother and had no injury. Second stay in Observation was for 40 minutes with resolution of symptoms and consistently normal vital signs. No orthostasis.
16 2021-06-14 palpitations I experienced fatigue upon waking up along with frequent heart palpitations. Heart was racing and t... Read more
I experienced fatigue upon waking up along with frequent heart palpitations. Heart was racing and then would come and go in fits.
16 2021-06-15 loss of consciousness patient passed out in the store about 5 minutes after the vaccine was given
16 2021-06-15 pallor patient received covid -19 vaccine at 1552 . patient stood and went with guardian to registration de... Read more
patient received covid -19 vaccine at 1552 . patient stood and went with guardian to registration desk to schedule second dose appointment. shortly after mother and registration clerk called out for help. patient c/o dizziness and pale. mother assisting pt to floor and supporting her. patient assisted to chair. still responsive answering questions. reports not eating at all that day. pt provided with juice and snack. assisted to bed and observed for 30 mins.
16 2021-06-15 palpitations, chest pain Chest pain, heart racing, extreme vomiting , extreme fatigue
16 2021-06-15 fainting After receiving first COVID vaccine, patient walked out of the immunization room and up towards the ... Read more
After receiving first COVID vaccine, patient walked out of the immunization room and up towards the photo department where she reported tunnel vision then fainted into her mother's arms. Patient instantaneously recovered and sat on the floor. Technician was told about the incident where she gave her a bottle of water and a granola bar. Patient reported not having anything to eat or drink prior to the vaccine. Pharmacy manager called 911 for EMS to tend to patient. Patient did not go with ambulance.
16 2021-06-16 heart rate increased, chest pain shortness of breath; Chest pain; increased heart rate; This is a spontaneous report from a contactab... Read more
shortness of breath; Chest pain; increased heart rate; This is a spontaneous report from a contactable consumer (patient). A 16-year-old female (not pregnant) patient received the second dose of BNT162B2 via an unspecified route of administration on the left arm on 06May2021 at 11:00 (Lot Number: Ew0153) at 16-year-old as single dose for COVID-19 immunization. Medical history was not reported. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medication was not reported. The patient previously took the first dose of BNT162B2 via an unspecified route of administration on the left arm on 15Apr2021 at 11:00 (Lot Number: Er8731) at 16-year-old as single dose for COVID-19 immunization. On 09May2021 at 06:00, the patient experienced chest pain, increased heart rate, shortness of breath. The events result in emergency room visit. The test and medication were received as treatment. The outcome of events was recovered in 2021. No follow-up attempts are possible; no further information is expected.
16 2021-06-16 loss of consciousness, blood pressure decreased, pallor felt exhausted; Blood pressure low, after the seizure: 73/49 and 68/42; skin pale and sweating, afte... Read more
felt exhausted; Blood pressure low, after the seizure: 73/49 and 68/42; skin pale and sweating, after the first vaccine; skin pale and sweating, after the first vaccine; Tired and weak, with some lightheadedness, after the first vaccine; Tired and weak, with some lightheadedness, after the first vaccine; Seizure: described as staring, passing out, stiffening of arms, talking like a toddler and giddy, after the first vaccine.; Seizure: described as staring, passing out, stiffening of arms, talking like a toddler and giddy, after the first vaccine.; Seizure: described as staring, passing out, stiffening of arms, talking like a toddler and giddy, after the first vaccine.; Seizure: described as staring, passing out, stiffening of arms, talking like a toddler and giddy, after the first vaccine.; Seizure: described as staring, passing out, stiffening of arms, talking like a toddler and giddy, after the first vaccine.; felt funny; This is a spontaneous report from a contactable consumer(mother, a nursing assistant, years ago) reported for a patient(daughter). The 16-year-old female patient received bnt162b2 (BNT162B2, Pfizer vaccination, Covid vaccine) at the age of 16-year-old, dose 1 via an unspecified route of administration, administered in Arm Left on 28May2021 11:52 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history included seizure from 28May2021 to an unknown date (doctor wants to schedule an EEG, for further evaluation of the seizure ,because they did not do that test in the hospital.), ongoing Feels down at times (Consumer states the doctor originally prescribed her daughter another medication. Because all the appointments were by video, Consumer felt the doctor was not understanding her daughter's issue. Consumer states the original medication for ADHD was helping her daughter, but it made her daughter uncomfortable, as her daughter had no problems with attention, or school. Caller states then the doctor changed the medication to Zoloft. Name of previous medication was Zenzedi.). No family Medical History. Concomitant medication included sertraline hydrochloride (ZOLOFT) taken for depressed mood from 19May2021 and ongoing. Consumer states that her daughter is not depressed, but just feels down at times, and it is not severe. Consumer states the doctor had her daughter on another medication before Zoloft, that is used for ADHD. Consumer states that her daughter has not been diagnosed with ADHD, and the doctor switched the medication once her issues were further understood, as clarified in later part of report. The patient experienced seizure: described as staring, passing out, stiffening of arms, talking like a toddler and giddy, after the first vaccine on 28May2021 with outcome of recovered, felt funny on 28May2021 with outcome of recovered , blood pressure low, after the seizure: 73/49 and 68/42 on 28May2021 11:52 with outcome of recovered , skin pale and sweating, after the first vaccine on 28May2021 with outcome of recovered , skin pale and sweating, after the first vaccine on 28May2021 with outcome of recovered, tired and weak, with some lightheadedness, after the first vaccine on 28May2021 with outcome of unknown, tired and weak, with some lightheadedness, after the first vaccine on 28May2021 with outcome of unknown, felt exhausted on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included blood pressure measurement: 73/49 on 28May2021 low , blood pressure measurement: 68/42 on 28May2021 low , blood pressure measurement: normal on 28May2021, heart rate: 55 on 28May2021, heart rate: 70 on 28May2021. The clinical course was reported as follows: Consumer states she took her daughter Friday, to have her first Pfizer vaccination, later reclarified as the Covid vaccine. Consumer states her daughter had a seizure after the vaccine. Consumer states Height maybe 5'8" or 5'9". Consumer states her daughter was weighed at the hospital. Consumer states that the experience was terrifying for her, to watch her daughter have the seizure. Consumer states her husband got the vaccine, and was fine. Consumer reports that her daughter got the vaccine at 11:52 am and within 30 seconds, her daughter said she felt funny, and then rolled her eyes and passed out. Consumer states after a minute, her daughter was conscious and the staff was rushing to her aid, as the Consumer called 911. Consumer states that for the next 25 to 30 minutes, her daughter was talking like a toddler, and was pale and sweating. Consumer states that the paramedics, told her daughter that she had a seizure, as they took her to the hospital. Consumer reports her daughters blood pressure, around the time of the event. Consumer states the first blood pressure, when her daughter awakened, after the seizure about 2 minutes later was 73/49, pulse 55, and a few minutes after that it was 68/42 and her pulse was 70. Seizure: Time: 11:52 am, almost immediately after the vaccine. Outcome: caller answers as she is monitoring her daughter closely. Consumer states that during her seizure, her daughter started to stare, and then passed out. Consumer states her daughter did have some stiffening of the arms with the seizure. Blood pressure low: Consumer states he daughter's blood pressure, began to elevate, before they transported her to the emergency room. Time: 11:52 am, almost immediately after the vaccine. Outcome: Consumer answers as her daughter's blood pressure was stabilized enough by the time she was transferred to the hospital, where it normalized. Consumer reports later that her daughter's skin was pale and she was sweating, at this time. Reclarified, Consumer states that when her daughter was talking to the medical staff, she was talking like a toddler, and giddy. Consumer states she was trying to tell the staff that this is not normal for her daughter. Consumer reports her daughter feels tired and weak after all the events. Consumer states she signed up for VSafe. Time: Consumer states sometime, after the vaccine. End: Consumer answers as her daughter is not as tired and weak, as she was the first day the event happened. Caller states that the next day, her daughter relaxed all day, and the day after that, her daughter went to work and felt exhausted, but felt that she could still go to work. Consumer states that yesterday at work, her daughter said she felt weak, and lightheaded. Consumer states that after having a snack and a break, her daughter felt better and worked the rest of her shift. Outcome: Unknown. Reclarified, Caller states she does not want to assume anything, and is monitoring her daughter, and that this event may be due to another reason, as well. Consumer clarifies her daughter went to the emergency room and then was released. Vaccination Facility Type was pharmacy. No Vaccine Administered at Military Facility. No History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available).No additional Vaccines Administered on Same Date of the Pfizer Suspect. The event Seizure required a visit to Emergency Room, not Physician Office. Prior Vaccinations (within 4 weeks), list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was none. No AE(s) following prior vaccinations. Caller reports some prior vaccinations that her daughter had without any events. Consumer states that her daughter is not going to get the second vaccination. Consumer states that she does not know the potential risk, if her daughter gets another vaccination. Information about lot/batch number has been requested.
16 2021-06-16 pallor Patient became nauseated and pale after receiving her first vaccine. Patients vital signs were evalu... Read more
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.
16 2021-06-17 chest pain, heart rate increased, hypertension Chest pain, upset stomach, elevated heart rate and blood pressure Performed tests, gave them water ... Read more
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.
16 2021-06-17 chest pain, pulmonary embolism Admitted to hospital 2 days after second Pfizer covid vaccine. Presented with abdominal/chest pain, ... Read more
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.
16 2021-06-17 hypotension, oxygen saturation decreased Patient received first dose Pfizer Vaccine and developed a reaction about 5 minutes later. patient c... Read more
Patient received first dose Pfizer Vaccine and developed a reaction about 5 minutes later. patient complained of "dizziness" and "weakness" . Vitals checked: BP 90/50, HR 72, O2 sat 88%. EMS was called. Five minutes later BP 90/60, HR 72, O2 Sat 98%. Patient was alert and oriented to time, place and person. Ten minutes later, BP 110/70, HR 80, O2 Sat 99%. Fully alert, oriented and stable. Patient said she had not eaten since morning. EMS arrived, checked Patient and declared patient ok. Patient was asked to go home in a very stable condition
16 2021-06-17 fainting Patient got her pfizer vaccine 1st dose and was fine. She went to sit on a chair for observation an... Read more
Patient got her pfizer vaccine 1st dose and was fine. She went to sit on a chair for observation and was fainted a few minutes after. After that, the mother called 911 and ambulance came. By the time the ambulance came, patient already regained her consciousness.
16 2021-06-18 pallor Pt began to feel dizzy, warm and faint within 10 minutes of her second pfizer vaccine. Pt did not l... Read more
Pt began to feel dizzy, warm and faint within 10 minutes of her second pfizer vaccine. Pt did not lose consciousness but was dizzy, clammy, sweaty, pale, faint feeling. Pt responded to commands but felt faint.
16 2021-06-18 fainting, pallor 1604: 1st dose Pfizer vaccine administered 1609: Syncope episode- Client appeared limp and sliding o... Read more
1604: 1st dose Pfizer vaccine administered 1609: Syncope episode- Client appeared limp and sliding out of chair. Pallor appearance. NP and MA witnessed event and placed client on floor before she fell out of chair. Did not hit head. Feet were immediately raised. Client was vocal but disorientated. ice packs used. Client A&Ox4 within seconds. Gatorade and water offered. 1611: BP: 122/ 68 HR: 94 RR: 18. After syncope episode, mother stated that client has history of vasovagal syncope with needles. Client still laying on floor with feet raised. NP sitting on floor with client and her mother for observation. 1645-Instructed mother to follow up with pediatrician. Complexion returned to normal. Client stated that she feels fine. Mother and client left site without no further incidents.
16 2021-06-19 loss of consciousness, pallor Approximately 20 minutes after vaccine patient passed out, became pale and sweaty. She lost consciou... Read more
Approximately 20 minutes after vaccine patient passed out, became pale and sweaty. She lost consciousness briefly. I put her in a supine position on some chairs in waiting area. A technician called 911 while cool towels were applied and water was administered. She regained consciousness before EMTs arrived. She relayed while her that she disliked needles and did not eat breakfast that day.
16 2021-06-20 chest pain Arm pain, chest pain, shortness of breath, earache, headache, and swollen nodes.
16 2021-06-20 heart rate increased, chest pain 16 y/o F with hx of autoimmune disorder and Tourette's syndrome BIB mom for dizziness s/p Pfizer COV... Read more
16 y/o F with hx of autoimmune disorder and Tourette's syndrome BIB mom for dizziness s/p Pfizer COVID-19 vaccine received yesterday. Pt endorses muscle pain, nausea, sinus pain, throat pain, and HA. Pt with fever (Tmax 100.2F) onset this AM. Denies chest pain and difficulty breathing. Pt reports she feels a little out of breath. Mom has a heart rate monitor at home and states pt's HR has been in the 140s. No medications taken. NKDA. Differential Diagnosis: vaccine reactions, myocarditis, pericarditis. After physical assessment and management, pt is well appearing, explained to mom on reassessment symptoms have improved, no longer dizzy or having trouble breathing. Pt still feels a little myalgia. Explained symptoms likely from vaccine reaction, explained normal heart enzymes and normal EKG, strict return precautions given including chest pain and persistent fever.
16 2021-06-20 fainting, hypotension Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypo... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Additional Details: Within 5 minutes of received 2nd dose of Pfizer Covid-19 vaccine, patient became very dizzy and fainted. We layed her down and elevated her feet and she immediately regained consciousness. The patient was assessed by paramedics and they did not transport her to the emergency room and instructed her to drink lots of water over the next 24 hours.
16 2021-06-20 fainting The patient has a history of fainting after shots. She became warm and faint after receiving the in... Read more
The patient has a history of fainting after shots. She became warm and faint after receiving the injection. She was very weak and put her head on the table for about 10-15 minutes until she was feeling better.
16 2021-06-21 chest pain woke with heart attack like pains in chest. Went to ER. had an EKG, chest x-rays and blood drawn and... Read more
woke with heart attack like pains in chest. Went to ER. had an EKG, chest x-rays and blood drawn and urine sample. Was told "slight" inflammation around heart.
16 2021-06-21 fainting Previously healthy 16-year-old female presents with syncope after COVID-19 vaccine. In vaccine clin... Read more
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.
16 2021-06-22 chest pain Chest Pain started within 24 hours intesity of 4/10 with increases to 8/10 and lasted for 6 days. Ha... Read more
Chest Pain started within 24 hours intesity of 4/10 with increases to 8/10 and lasted for 6 days. Had normal Troponin, crp and ECK on 6/16/2021
16 2021-06-22 chest pain Sharp chest pain and left shoulder blade/back pain with difficulty taking deep breaths. Did not repo... Read more
Sharp chest pain and left shoulder blade/back pain with difficulty taking deep breaths. Did not report initially because it went away after a few days, but after reading the studies wondering if she had the myocarditis/pericarditis side effects.
16 2021-06-22 loss of consciousness Passed out 12 hours after receiving the vaccine.; This is a spontaneous report from a contactable co... Read more
Passed out 12 hours after receiving the vaccine.; This is a spontaneous report from a contactable consumer(patient). This 16-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0175) at single dose via an unknown route in left arm on 04Jun2021 08:30 at 16-year-old for Covid-19 immunization. Medical history included Paramyotonia-congenita. Prior to vaccination, was the patient diagnosed with COVID-19. Patient had no known allergies. Concomitant drug included fluticasone propionate (FLONASE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Jun2021 08:00 PM, patient passed out "12 hours" (as reported) after receiving the vaccine. No treatment was received. Outcome of the event was resolved. Since the vaccination, the had not patient been tested for COVID-19. The report was assessed as non-serious.
16 2021-06-22 fluid around the heart, chest pain ~4 weeks after the 2nd dose of Pfizer, patient presented to the hospital with chest pain; had perica... Read more
~4 weeks after the 2nd dose of Pfizer, patient presented to the hospital with chest pain; had pericardial effusion. Initially improved but then had decompensation, prolonged hospitalization. Diagnosed with hemophagocytic lymphohistocytosis (HLH) and ultimately died.
16 2021-06-22 fainting My daughter fainted immediately after receiving the vaccine. I was not there so I do not know all th... Read more
My daughter fainted immediately after receiving the vaccine. I was not there so I do not know all the details. My daughter does not have needle anxiety and has never had problems with vaccines before.
16 2021-06-23 chest discomfort Patient became lethargic within 5 minutes. Within 10 minutes she developed tightness in the chest, ... Read more
Patient became lethargic within 5 minutes. Within 10 minutes she developed tightness in the chest, difficulty breathing, and numbness in both hands. We administered an Epi-pen and symptoms began to improve in 10-15 seconds. She then was evaluated by emergency medical personnel and taken to a local hospital for follow up.
16 2021-06-23 chest pain Patient reports having felt chest pain and shortness of breath the night she was vaccinated. She was... Read more
Patient reports having felt chest pain and shortness of breath the night she was vaccinated. She was taken to the hospital and had lab work done. Patient was discharged and had follow up visit the next day (6/4/21) with primary care physician, who ordered additional labs and EKG. D-dimer, troponin and EKG also came back unremarkable.
16 2021-06-23 pallor DIZZINESS, PALE, DIAPHORETIC, BLURRED VISION, LAUGHING AND CRYING AT SAME TIME. ICE PACK APPLIED AND... Read more
DIZZINESS, PALE, DIAPHORETIC, BLURRED VISION, LAUGHING AND CRYING AT SAME TIME. ICE PACK APPLIED AND PT WAS FEELING FINE AFTER SOMETIME.
16 2021-06-23 fainting Patient got the 1st dose of pfizer and was fine at the time of administration. However, as she sat ... Read more
Patient got the 1st dose of pfizer and was fine at the time of administration. However, as she sat down on the chair for observation, that was when she fainted and fell off but someone was there to catch her. After a minute, she regained her consciousness back. We took her BLOOD PRESSURE and it was normal. Ambulance came and took her to hospital. Yesterday, her sister came to pharmacy and asked if it was normal for her to keep having runny nose. We told her she might feel like flu-like symptom but to be safe, it's better she goes to see her primary doctor/urgent care.
16 2021-06-24 pallor Patient was fine when receiving vaccine,(350 pm) patient and parents were instructed to wait 30 and ... Read more
Patient was fine when receiving vaccine,(350 pm) patient and parents were instructed to wait 30 and to stay close in case there was a reaction. after a few minutes parent and patient started to walk to a nearby park bench and when she was sitting she "Looked like something was wrong" per parents, they (Parents walked her back over to mobile unit and the Nurse immediately called 911 at 3:56pm. Patient was talking at this time, she stated she lost hearing, appeared pale and Diaphoretic, patient was sat down and given water, her color started to return to her lips and face, patient stated after a few minutes she started to feel better. the emergency squad arrived at roughly 4:05 pm. Patent walked to squad car and they took her vitals. Patient and family refused to go the hospital. After squad left patient stated that "She only had coffee all day"
16 2021-06-24 fainting patient was seated in waiting area when fainted and fell out of chair and hit head - was responsiv... Read more
patient was seated in waiting area when fainted and fell out of chair and hit head - was responsive - ems came and took to hospital to be checked out - Mom reported Doctor said normal reaction to teen receiving shot - mild concussion from hitting head
16 2021-06-24 fainting Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Det... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Approxiamately 5 minutes after the vaccine the patient felt light headed and dizzy. She then fainted forward and her mom lifted her back and at that point she appeared to shake (2 jerking motions) and then became alert. The patient was instructed to lay down. Her blood pressure was taken and was normal. The ambulance was called due to the shaking motion which appeared to be a possible seizure. The patient and her mom did not wish to be taken to the hospital. Follow-up call not answered
16 2021-06-25 anaemia Sore throat; Vomiting; Diarrhea; Anemia; This is a spontaneous report from non-contactable consumer ... Read more
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.
16 2021-06-25 chest pain takes my breath away; Sharp pains in chest that come and go; This is a spontaneous report from a con... Read more
takes my breath away; Sharp pains in chest that come and go; This is a spontaneous report from a contactable consumer (patient). This 16-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0176) via an unspecified route of administration on 01May2021 at 17:00 (at the age of 16-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included asthma, migraines, lactose intolerant, and eczema. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included stool softener and nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine (VITAMIN B-COMPLEX) from unknown dates for unknown indications. The patient did not have any known allergies. On 03May2021 the patient experienced sharp pains in chest that came and went. "Took her breath away." The patient did not receive any treatment for the events. The outcomes of sharp chest pains and took her breath away were not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19. The patient received dose 2 of BNT162B2 (lot number EW0180) on 22May2021 at 17:00 as a single dose in the right arm for COVID-19 immunization. No follow-up attempts are needed. No further information is expected.
16 2021-06-25 nosebleed 2d post receiving the second dose developed a nose bleed - lasted 10 minutes 2d post had headache al... Read more
2d post receiving the second dose developed a nose bleed - lasted 10 minutes 2d post had headache all day 3d post started her menses (would not have been typically due at that time)
16 2021-06-25 hypotension Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Me... Read more
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Severe
16 2021-06-25 loss of consciousness, pallor, skin turning blue, blood pressure increased Patient lost consciousness leaning against mother slowly rolling to the ground. Patient had slight c... Read more
Patient lost consciousness leaning against mother slowly rolling to the ground. Patient had slight convulsions for 3-5 seconds. Patient then regained consciousness after about 5 seconds looking pale with blue lips and eyes. Upon regaining consciousness patient was told to slightly elevate head and legs for increased blood flow. Upon arrival of paramedics patient had improvement in color. Patient vitals were within normal limits aside from reported hypotension per paramedics. Handed off patient to paramedics for transport to ER for further inspection at around 11:30 am.
16 2021-06-25 loss of consciousness PT WAS GIVEN FIRST DOSE OF PFIZER IM LEFT ARM. APPROXIMATELY 3-5 MIN AFTER ADMINISTRATION PATIENT P... Read more
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
16 2021-06-25 pallor 1455: Pt c/o of dizziness, diaphoresis with hx: of anxiety, NKA. Laid pt down to floor and elevated ... Read more
1455: Pt c/o of dizziness, diaphoresis with hx: of anxiety, NKA. Laid pt down to floor and elevated legs on chair. 1500 called EMS. 1st vitals: 102/60 02 99 HR 84. 1500 NP assess pt, she stated her face was pale. NP instructed her to deep breath and increase oral fluids. Pt states she was dizziness. Sat patient up 2nd vital 85/56 O2 97 HR92. 3 vital patient sitting on chair 101/66, O2 90, HR 92. NP assessed patient. Patient denies dizziness was able to stand and walk to car.
16 2021-06-26 blood clot in the brain Blood clots on brain. Needed to be hospitalized for 5 days on blood thinners. Will Continues to se... Read more
Blood clots on brain. Needed to be hospitalized for 5 days on blood thinners. Will Continues to self administer blood thinners for 3 more months
16 2021-06-26 lightheadedness Vaccine administered without issue to pt (behavior & appearance normal, engaged in conversation). Pt... Read more
Vaccine administered without issue to pt (behavior & appearance normal, engaged in conversation). Pt agreed to wait 15 min. for observation and left vaccination area for monitoring area. Shortly thereafter, RPh heard what sounded like pt falling. RPh observed pt lying supine on tile floor of monitoring area. RPh assumed occurance of vasovagal syncope and went to aid pt; however, pt seemed to immediately (<1 sec.) regain consciousness, was breathing without difficulty and was able to shift to chair under own power. Tech who had been monitoring remarked pt had opted to stand rather than sit after exiting vaccination area and that she'd "hit her head" upon falling. RPh provided ice pack while pt's mother retrieved water bottle. Pt seemed alert and cognizant of situation (denied pain, was overheard saying to assumed male relative, "You didn't help me."). RPh strongly encouraged pt to wait 30 min. instead of 15 min. but family left after original time; mother remarked pt had vasovagal rxn after an unspecified vaccine in past (RX had not been previously made aware). About 1.5 hours later, RPh called mother to follow-up & advise on signs/symptoms of concussion. At the time, mother said she would monitor pt. Perhaps another half hour later, mother called RX to ask for advice: pt complaint of pain (took Tylenol) and tiredness (despite getting enough sleep the previous night & not usually tired around that time). RPh recommended taking pt to ER as soon as reasonably possible (mother denied any other S/S like uneven pupils, confusion or being difficult to rouse). Mother seemed receptive to that suggestion as well as warning staff of vasovagal syncope for all future vaccinations, though she could not be reached for confirmation of action the next morning.
16 2021-06-26 fainting, loss of consciousness 18 hours after the 1st vaccine shot... healthy female while in the shower....blacked out, couldn't ... Read more
18 hours after the 1st vaccine shot... healthy female while in the shower....blacked out, couldn't see, called for mother who she knew was not home, passed out, and was not coherent, felt dizzy, had a bad headache, and face was swollen, Called her doctor's office, told them about the vaccine and the incident, they said to go to the emergency room. Went to emergency room. She had a full list of tests. Was given a saline drip, hydration unit. Level V emergency code. Name vasovagal syncope, reaction to vaccine, electrolyte abnormalities, dehydration, dysthymia
16 2021-06-26 fainting Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive... Read more
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hyperventilation-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Vomiting-Mild, Additional Details: Approximately 5 minutes after administration, patient fainted while seated in chair. After awakening, patient reported feeling faint and tingling in her extremities. Patient was breathing heavily. After breathing normalized, patient reported severe menstral cramps. Patient was given Midol, water, and pretzles. Shortly after, patient stated that she was still light headed so she laid on the ground. Patient eventually recovered and left pharamcy.
16 2021-06-27 fainting patient fainted
16 2021-06-28 loss of consciousness 15 seconds after given vaccine, patient lost consciousness and then woke up 3 times in a row, having... Read more
15 seconds after given vaccine, patient lost consciousness and then woke up 3 times in a row, having maintained consciousness less that 30 seconds. Respirations were 16 and unlabored. Heart Rate 72. EMS called and responded within 5 minutes. Pt awake and alert when ambulance arrived. Pt stated that she had not eaten all day and had only drank 2 bottles of water. Heart rate 70's, B/P 111/73, Resp 16, and FSBS 80 per EMS. Ambulance personnel waited at scene for 10 minutes and family made decision to bring the patient home.
16 2021-06-28 pallor PATIENT RECEVIED VACCINES AT 1050 IN OUR OFFICE, PATIENT WAITED 30 MINUTES AFTER VACCINES WITH NO S/... Read more
PATIENT RECEVIED VACCINES AT 1050 IN OUR OFFICE, PATIENT WAITED 30 MINUTES AFTER VACCINES WITH NO S/SX OF REACTIONS. AT 1220 DAD CAME IN WITH PATIENT WHO WAS REPORTING FEELING DIZZY, HEADACHE, FEELING LIGHT HEADED. PATIENT WAS HAVING A HARD TIME KEEPING EYES OPEN. CLOSE TO PASSING OUT. PATIENT WAS SHAKING AND PALE. ALSO C/O ARM PAIN
16 2021-06-28 fainting Patient was originally nervous about the vaccine to begin with. Patient was given the vaccination an... Read more
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.
16 2021-06-29 loss of consciousness, pallor Attendee became pale and momentarily lost consciousness - did not initially respond to verbal of tac... Read more
Attendee became pale and momentarily lost consciousness - did not initially respond to verbal of tactile stimuli - required sternal rub, awakened after 1 minute. Vital signs normal. EMS were called. Glucose 86. No transport - mother of Attendee refused this.
16 2021-06-29 pulmonary embolism, inflammation of the heart muscle, troponin increased Myocarditis diagnosed on 6/17. Patient then also diagnosed with a pulmonary embolism on 6/30.
16 2021-06-30 fainting 16 yo F received vaccination had a syncopal event in observation. She recovered immediately. She has... Read more
16 yo F received vaccination had a syncopal event in observation. She recovered immediately. She has had a history of similar reactions in the past.
16 2021-06-30 blood clot L distal internal jugular venous thrombus found on 6/29 after pt had three days of squeezing sensati... Read more
L distal internal jugular venous thrombus found on 6/29 after pt had three days of squeezing sensation on upper arm followed by acute pain on day of presentation to ED. In ED upper extremity Doppler demonstrated clot. Pt transferred to our hospital where she started on anticoagulation therapy for treatment.
16 2021-07-01 very slow heart rate, pallor Bradycardia, Pale Skin Color, Clammy, Dizziness.
16 2021-07-01 chest discomfort extreme discomfort in her chest; liver enzyme that normal is 40 and it was 110; Dose Number : 1; Dat... Read more
extreme discomfort in her chest; liver enzyme that normal is 40 and it was 110; Dose Number : 1; Date of start of drug: 16Apr2021; Dose Number : 2; Date of start of drug: 28May2021; This is a spontaneous report from a contactable consumer (patient's mother). This is the second of two reported. This report concerns events occurred after the second dose. A 16-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0180), administered in left arm, on 28May2021 at 18:00 (at the age of 16-years-old) at dose 2, single for COVID-19 immunization. The patient was not pregnant. Medical history included ichthyosis vulgaris. No COVID prior vaccination and no COVID tested post vaccination. The patient had not known allergies. Concomitant medications were not reported. No other vaccines were received in four weeks and no other medications in two weeks. The patient received the first dose of BNT162b2 (lot number: EW0164) on 16Apr2021 at 13:30, at the age of 16-years-old, administered in right arm for COVID-19 immunization and experienced extreme radiating nerve pain in her arm to her fingertips. The reporter purposely waited 6 weeks for her second vaccine because she had adverse reactions to her first. The patient suffered extreme discomfort in her chest on 01Jun2021 at 03:00 AM. She described it as something sitting on her chest not allowing air in at a level 7 w 10 being dead. She had been taken to emergency room (ER) immediately. There she received an EKG, heart and lung scan and bloodwork on 01Jun2021. All that showed up was a liver enzyme that normal was 40 and it was 110, on 01Jun2021 at 03:00 AM. No treatment was administered in response to the events. The events were reported as non-serious and they required emergency room/department or urgent care visit. The patient had recovered from the events extreme discomfort in her chest and liver enzyme that normal is 40 and it was 110 in Jun2021, the outcome of the other event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021669577 same patient/drug, different doses/events
16 2021-07-01 fainting, pallor patient returned to the lobby area and begin to turn pale and fainted briefly but came back to consc... Read more
patient returned to the lobby area and begin to turn pale and fainted briefly but came back to consciousness quickly and complained of blurred vision in the left eye and ringing in ears. patient was given cold water while awaiting service from EMS that was called by the pharmacy department. patients' color came back and EMS checked the patient vitals.
16 2021-07-01 fainting Systemic: Fainting / Unresponsive-Mild, Additional Details: After vaccination patient and mom were d... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: After vaccination patient and mom were directed to the waiting area and asked to wait for 15 minutes. Mom and Pt decided to leave the waiting area and walk around. Shortly after pt fainted and hit her arm. She had mild scrapes on her arm. We had her lay on the pharmacy bench with her feet up for 30 minutes. We gave her apple juice to drink. After that she was fine
16 2021-07-02 loss of consciousness, fainting Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient was well during the 15 minute ob... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient was well during the 15 minute observation period and has no comorbidities according to health questionnaire. As she was exiting the store she felt faint and lost consciousness for 30 seconds and recovered consciousness. She fell backwards and bumped her head against the ground. Paramedics were called and patient BP and blood glucose was within normal limits. Patient was alert and sitting upright when paramedics arrived.
16 2021-07-02 inflammation of the heart muscle Received at ER at 2 am on June 6, 2021, then transferred to another ER at 9 am on June 6, 2021. Rele... Read more
Received at ER at 2 am on June 6, 2021, then transferred to another ER at 9 am on June 6, 2021. Released from hospital at 4 pm that day with diagnosis of myocarditis.
16 2021-07-03 chest pain Chest pain - went away and came back in the same area of the chest. Patient went to an urgent care f... Read more
Chest pain - went away and came back in the same area of the chest. Patient went to an urgent care facility were they refereed them to a nearby hospital. 2 EKGs were preformed, one at the urgent care and the other at the hospital.
16 2021-07-03 fainting After receiving vaccine, patient fainted. She recovered after about 10 seconds and immediately beca... Read more
After receiving vaccine, patient fainted. She recovered after about 10 seconds and immediately became sick to her stomach, shaky, and clammy.
16 2021-07-04 loss of consciousness Patient lost consciousness for about 1 minute, she was able to wake up with smell of alcohol swabs a... Read more
Patient lost consciousness for about 1 minute, she was able to wake up with smell of alcohol swabs and water. Patient stayed in the store for 30 minutes following incident to monitor.
16 2021-07-04 fainting Fainting after administration, within minutes of receiving vaccine. Short episode, only fainted for ... Read more
Fainting after administration, within minutes of receiving vaccine. Short episode, only fainted for a second.
16 2021-07-05 chest pain, heart rate increased On July 1, 2021, I felt chest pain around 6pm. 10 times, each lasting 1 second. My heart rate was 9... Read more
On July 1, 2021, I felt chest pain around 6pm. 10 times, each lasting 1 second. My heart rate was 95, higher than my normal 75. On July 2, 2021, I felt chest pain 3 times around midnight, 2 times around 2am, 2 times around 7am, 1 time around 9:30am. The above chest pain each lasting 1 second. But at 6:10pm I felt chest pain once, lasting 2 seconds and more dull than previous ones. I have never had any chest pain before the Pfizer covid vaccine. I called my pediatrician's office in the evening of July 1 and was told to rest and observe. I saw my pediatrician at 10:30am on July 2. My blood pressure is normal and heart rate is above 90. My doctor told me it was obvious the side effects of covid vaccine.
16 2021-07-06 anaemia Patients Mom states that after completing the COVID-19 series she has had a very irregular menstrual... Read more
Patients Mom states that after completing the COVID-19 series she has had a very irregular menstrual cycle, irregular hormone levels, and anemia. The patient has been hospitalized due to these issues
16 2021-07-06 palpitations, heart flutter, chest discomfort Feelings of having a fast-beating, fluttering, or pounding heart. And tightness in the chest.
16 2021-07-07 chest pain Patient's mother reports patient c/o of chest pain with inhalation, swollen/sore throat, weakness, a... Read more
Patient's mother reports patient c/o of chest pain with inhalation, swollen/sore throat, weakness, and dizziness with change of position. Pt's mom was advised to take pt to ED or urgent care for evaluation.
16 2021-07-07 increased heart rate, ventricular tachycardia Patient went to urgent care 1 day after vaccine for feeling tremors and pains in her lower extremiti... Read more
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.
16 2021-07-08 blood clot She started her menstrual 10 days late with heavy clots and cramps which is abnormal. When she went ... Read more
She started her menstrual 10 days late with heavy clots and cramps which is abnormal. When she went to her 16 yr old well visit on 7/17 we informed her PCP of the concerns.
16 2021-07-09 chest pain Chest pain, Shortness of Breath, high fever
16 2021-07-09 fainting 16 y/o patient fainted after receiving first COVID vaccine. Pt was in waiting area in front of pharm... Read more
16 y/o patient fainted after receiving first COVID vaccine. Pt was in waiting area in front of pharmacy and all aid was managed there. Guardian helped me get pt on the ground, rolled to side w/ head supported, and tech helped provide icepack and fan to cool pt. Pt had strong pulse and breaths entire time. She came back around after about 10 min - was able to sit back in chair for another 10 min before ambulating out of store. Pt reported no hx of fainting or allergic reaction after a vaccine.
16 2021-07-09 fainting PATIENT FAINTED
16 2021-07-10 chest pain Chest pain, fatigue, sore arm
16 2021-07-11 loss of consciousness PT HAD BLACK OUT AFTER 10 MIN OF RECEIVING THE VACCIE FOR 1-2 SEC. PT LAID DOWN AND FEET UP. SHE WA... Read more
PT HAD BLACK OUT AFTER 10 MIN OF RECEIVING THE VACCIE FOR 1-2 SEC. PT LAID DOWN AND FEET UP. SHE WAS OKAY AFTER 5 MIN. CHECK THE BLOOD PRESSURE , WAS 130/68 AND PULSE 78. PARENTS WANTED TO CALL 911. PARAMEDIC CAME AND CHECK THE VITAL. PATINET LEFT AT 3:00 PM 7/9/21
16 2021-07-11 palpitations Fatigue 6 days Fever about 12 hours after 2nd dose, then again 6 days later (chills, sweating, shaki... Read more
Fatigue 6 days Fever about 12 hours after 2nd dose, then again 6 days later (chills, sweating, shaking) Racing heart, 6 days after 2nd dose. Shortness of breath, 6 days after 2nd dose. Acetaminophen and ibuprofen.
16 2021-07-11 fainting Patient felt ill and had syncope
16 2021-07-12 palpitations Complains of heart palpitations , pulse 120 when checked. Please went down to 105.
16 2021-07-12 fainting Patient fainted in her chair about 10 mins after vaccine was administered. Patient did not hit her h... Read more
Patient fainted in her chair about 10 mins after vaccine was administered. Patient did not hit her head. Patient was given water, asked to lie down, and monitored for an additional 15 minutes until she felt better
16 2021-07-13 chest pain light headed, chest pain. Evaluated by EMS- Refusal to transport.
16 2021-07-13 chest pain Having a stabbing pain in the center of her chest, went on for a few days. Was taken to the dr whom ... Read more
Having a stabbing pain in the center of her chest, went on for a few days. Was taken to the dr whom advised them to take her to the ER.
16 2021-07-13 loss of consciousness, fainting Patient had syncope episode, brief (less than 10 second) loss of consciousness.
16 2021-07-13 loss of consciousness While completing paperwork in immunization room, patient's mother stated she thought her daughter wa... Read more
While completing paperwork in immunization room, patient's mother stated she thought her daughter was starting to react to the vaccine. It appeared patient was starting to pass out so pharmacist and mother lowered her down from the chair to the floor to prevent injury. Patient's pulse was very faint to the touch and patient was difficult to arouse. Pharmacist delegated pharmacy technician to obtain AED. Patient's mother stated patient was beginning to shake and was becoming very hot and sweaty. 911 was dialed. No health conditions or medications were noted that would cause this reaction. Pharmacist was beginning to take BP when EMS arrived. EMS continued taking vitals. BP 100/65, HR 84, SPO2 96%. Patient started to become alert again as vitals were being taken.
16 2021-07-13 fainting Systemic: Fainting / Unresponsive-Mild
16 2021-07-14 chest pain Major reaction. Field vaccination by Strike Teams of Department of Public Health. At ~13:01, patie... Read more
Major reaction. Field vaccination by Strike Teams of Department of Public Health. At ~13:01, patient vaccinated with Pfizer COVID-19 vaccine. Within a few minutes of vaccination with Pfizer COVID-19 vaccine, patient showed urticaria + generalized chest pain (6/10) + postural weakness + convulsions. Field RN assessed an immediate, severe clinical deterioration. Epinephrine 0.3mg given by auto-injector to same left arm. Field RN summoned EMS. Field LVN provided postural support and second-eye VS measurement. EMS arrived at ~13:22. Taken by EMS to ED. VS: BP 90/40; HR 70; Pain 6/10 general chest. ? BP 110/60; HR 90. S/S: Physical weakness; ALOC. ? AOx4 upon EMS arrival. Current disposition unknown at time of this report. Department to attempt contact with family or admitting facility.
16 2021-07-14 fainting Patient experienced fainting, syncopal episode.
16 2021-07-14 fainting Systemic: Fainting / Unresponsive-Severe, Systemic: PT FELL AND HAD 2 LACERATION TO HEAD-Severe, Add... Read more
Systemic: Fainting / Unresponsive-Severe, Systemic: PT FELL AND HAD 2 LACERATION TO HEAD-Severe, Additional Details: PT WAS STILL IN IMMUNZATION CHAIR WITH FATHER AND IMMUNIZER PRESENT AND SUDDENLY FAINTED AND FELL OFF THE CHAIR AND HIT HER HEAD ON THE DR SCHOLLS FOOT SOLE END CAP BEHIND THE IMMUNIZATION SCREEN
16 2021-07-15 platelet count decreased, low platelet count, fainting, haemoglobin decreased Patient presented after syncopal episode and abdominal pain, was found to have profound thrombocytop... Read more
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
16 2021-07-16 heart rate irregular Patient felt light-headed, said she lost some sense of hearing, stomach was upset. Her blood pressur... Read more
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.
16 2021-07-16 fainting, loss of consciousness Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Naus... Read more
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.
16 2021-07-17 nosebleed Migraine with aura; Burning pain along her right side; prolonged nosebleed; bruise developed under r... Read more
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.
16 2021-07-17 loss of consciousness About 1 minute, or so, after her daughter received her COVID-19 Vaccine injection, her daughter pass... Read more
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.
16 2021-07-17 fainting Fainted; Mom thought maybe dehydration; This is a spontaneous report from a contactable consumer (pa... Read more
Fainted; Mom thought maybe dehydration; This is a spontaneous report from a contactable consumer (patient). A 16-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Leg Right on 06Jun2021 10:30 (at the age of 16 years old, not pregnant) (Lot Number: Ew0191) as single dose for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. No any other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (Lot number: Ew0185) in Right arm on 16May2021 10:30 (at the age of 15 years old) for Covid-19 immunization and no events reported. Facility where the most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. On 08Jun2021 at 18:30, the patient fainted in kitchen at night on day 3 after second dose, over 48 hrs after shot. Mom and dad caught her and put her on floor until she came back. Mom thought maybe dehydration so gave pedialyte but didn't know if that was reason. She slowly felt better. No treatment for fainted. The reporter considered the report as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Outcome of the events was recovering. No follow-up attempts are needed. No further information is expected.
16 2021-07-18 chest pain Received her 2nd shot at 16:00 yesterday (7/10/2021) *first shot was June 18, 2021 She started expe... Read more
Received her 2nd shot at 16:00 yesterday (7/10/2021) *first shot was June 18, 2021 She started experiencing chest pain last night, also complained of shortness of breath when going up stairs She took 1/2 apap tab (strength not specified) for injection site pain (After first shot, she had anxious at the time of the shot; her BP was checked and was within normal limits. Only issue beyond that was redness of her arm). Follow Up call to parent on July 11, 2021: Spoke with mom. She took daughter to the emergency room last night. EKG and chest x ray were both normal, She was given a muscle relaxer in ER with improvement of pain. Child is sleeping but when mom checked on her she said her pain was minimal this morning.
16 2021-07-19 very slow heart rate, fainting, pallor Bradycardia, Syncope, diaphoresis, dizziness, pale skin
16 2021-07-19 chest pain on 7/16/21 3 days after the COVID vaccine patient started experiencing chest pain.
16 2021-07-19 fainting Systemic: Fainting / Unresponsive-Medium
16 2021-07-20 loss of consciousness Patient was given her second covid19 vaccine at approximately 1045. She stood up and walked to a ch... Read more
Patient was given her second covid19 vaccine at approximately 1045. She stood up and walked to a chair in the waiting room. At 1048 she passed out and had a small seizure. Mom said she normally passes out after a shot for a short period of time but this was the first time she had a seizure. She was moved to the floor. She was sweating, eyes glossed over, said she felt like she couldn't breathe and couldn't feel her extremities. She stayed on the floor until EMS arrived approximately 10 minutes later. She was moved to a chair and once she tried to stand up she was moved back to the floor. She left in a wheelchair and was taken to her moms car.
16 2021-07-21 chest discomfort, chest pain 16 yo F with no PMHx presents with mother to receieve 2nd dose of Pfizer vaccine. Pt denies no adver... Read more
16 yo F with no PMHx presents with mother to receieve 2nd dose of Pfizer vaccine. Pt denies no adverse reaction to 1st dose. 15 minutes after receiving 2nd dose, pt reports feeling dizzy, chest tightness and pain, rated 7/10 non radiating. Pt states chest tightness is constant with no relieving factors and feels as if "her throat is closing". Pt denies difficulty breathing, HA, dizziness, palpitations, diaphoresis, blurry vision, n/v, history of anxiety. Pt states she has experienced a similar feeling of chest tightness in the past but never to this extent and it resolved on its own. Initial vitals: BP 137/94, HR: 75, RR: 16, O2 sat: 100%. Repeat vitals 10 minutes later: BP 139/96, HR 99, RR 18, 02 sat 100%. PE: HEENT: AT/NC. Throat clear, no swelling. Lips no cyanosis, palor or swelling. Cardiac: r/r/r. no murmurs. Lungs: CTABL. non-labored breathing. no wheezing. Abd: No tenderness. Neuro: A & O x3. Patient had EKG performed : NSR. Given 100% O2. Transported via EMS to ED.
16 2021-07-21 loss of consciousness Patient received the dose at 5:15pm. I was alerted by father at 5:25 that she was not feeling well. ... Read more
Patient received the dose at 5:15pm. I was alerted by father at 5:25 that she was not feeling well. I went to check on her and she had lost consciousness in her father's arms. I told the technician to call 911 at retrieved and epipen. I opened the epipen and checked the patient for response. She woke up and appeared very weak and confused. She responded that she could breathe. The epipen was not administered. EMS arrived and checked for vitals. Vitals were within normal range. The father decline transportation for further care. She remained sitting until 5:50 pm and she left on her own power with her family.
16 2021-07-21 lightheadedness Three days after vaccine,case reported blurry vision, hands and legs numbness and tingling, near syn... Read more
Three days after vaccine,case reported blurry vision, hands and legs numbness and tingling, near syncope. Ten days after vaccine case reported near syncope while riding bike.
16 2021-07-23 loss of consciousness She passed out for few seconds. Called 911 and paramedic. BP and glucose was normal. drank some wate... Read more
She passed out for few seconds. Called 911 and paramedic. BP and glucose was normal. drank some water and laid down for 20 minutes till paramedic came.
16 2021-07-23 pallor PATIENT WAS PALE, CLAMMY, FELT HOT, NAUSEA, VISUAL AND AUDITORY DISTURBANCES--- PATIENT GIVEN COLD C... Read more
PATIENT WAS PALE, CLAMMY, FELT HOT, NAUSEA, VISUAL AND AUDITORY DISTURBANCES--- PATIENT GIVEN COLD COMPRESS TO NECK, BP CHECKED TWICE AND INCREASED ON 2ND READING, PATIENT LAID ON BACK/FEET UP--- OVER 10 MINUTE PERIOD, PATIENT FELT BETTER AND WAS ABLE TO LEAVE ON OWN.
16 2021-07-23 fainting Pt reported hx of fainting to vaccines. Made sure she was comfortable sitting in her car. I attempte... Read more
Pt reported hx of fainting to vaccines. Made sure she was comfortable sitting in her car. I attempted to distract her, but she still fainted. She was out for approximately 3 seconds before recovering spontaneously. I applied ammonia inhalants as she was awaking, and she immediately came to. Afterwards, she complained of HA, lightheadedness, + fatigue. On exam, lungs: CTA B/L; Cardio: normal RRR, no murmurs, gallops, rubs; HEENT: no erythema or edema of face or throat. Denied CP, palp, SOB, pruritis, dizzy Ammonia inhalant used. Post-vaccination wait for 30 mins. HA, lightheadedness, and fatigue resolved w/in 30 min wait. Pt went home.
16 2021-07-23 fainting Pt was fine for approximately one minute following vaccination. She then experienced syncope. She w... Read more
Pt was fine for approximately one minute following vaccination. She then experienced syncope. She was examined by EMS and determined to not need additional care.
16 2021-07-24 fainting Patient felt uneasy and fainted shortly after dose. Her mother caught her from falling. She remained... Read more
Patient felt uneasy and fainted shortly after dose. Her mother caught her from falling. She remained unresponsive for 1 hour. She was breathing, 911 was called. Blood pressure, breathing, pulse normal.
16 2021-07-25 fainting, hypotension, heart rate decreased Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / ... Read more
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: IMMEDIATELY AFTER VACCINE ADMINISTRATION, PT FAINTED FOR A FEW SECONDS, STARTED JERKY MOVEMENT. WHEN CAME BACK SHE DID NOT REMEMBER ANYTHING. THEN AGAIN SHE FAINTED TURNED EXTREMELY PAIL WITH EXCESSIVE SWEATING AND FEELING HOT, SHE SEEMED STUNNED GAZING TO ONE POINT NOT ABLE TO TALK OR MOVE. RPH ASKED TO CALL 911 IMM. PT TURNED BLUE WITH VERY LOW PULSE AND SHALLOW BREATHING. RPH ADMINISTERED EPIPEN TO THE UPPER OUTER RIGHT THIGH TO HELP RAISE BP AND PULSE. PUT PT IN SUPINE POS W/ ELEVATED FEET
16 2021-07-25 fainting Patient fainted after receiving dose 2 in Pfizer covid-19 series. According to father, patient turne... Read more
Patient fainted after receiving dose 2 in Pfizer covid-19 series. According to father, patient turned slightly green, then slid down to the floor from a standing position.
16 2021-07-25 fast heart rate, fainting Fainted, flushed colored skin, breathing limited, tachycardic. EMS called and recommended a doctor ... Read more
Fainted, flushed colored skin, breathing limited, tachycardic. EMS called and recommended a doctor visit for the day of. Was not transported to the hospital by EMS personnel.
16 2021-07-26 loss of consciousness Vaccinated on 05/22/21. On 06/10 patient woke up with unusually painful menstruated cramps. She pr... Read more
Vaccinated on 05/22/21. On 06/10 patient woke up with unusually painful menstruated cramps. She proceeded to stand up and passed out hitting her head on wall. She went to er required stitches. Had full blood workout, ct scan , ekg, and chest X-ray. No abnormalities noted. Likely she passed out due to the pain reaction. Subsequent first day of. On July 27. Woke up with severe cramps and felt like passing out. Previous to first vaccination she had never had cramps this severe. Nor had never passed out her second vaccination was on June 16, 2021.
16 2021-07-26 pallor, fainting Approximately 15 minutes after vaccine administration, patient became nauseated and pale in the wait... Read more
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".
16 2021-07-27 chest pain difficulty breathing; strong internal chest pain that gradually subsided; chills; fever; body pain; ... Read more
difficulty breathing; strong internal chest pain that gradually subsided; chills; fever; body pain; exhaustion; This is a spontaneous report from a contactable health care professional (patient's mother). A 16-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number and expiration date were not reported) via intramuscular in the right arm on 14Jun2021 03:45 PM (at the age of 16-years-old) at single dose for covid-19 immunization. The patient medical history included that prior to vaccination, the patient was diagnosed with COVID-19. The patient was not pregnant. The patient was not pregnant at time of vaccination. There was no concomitant medication. 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 experienced approximately 24 hours of difficulty breathing and strong internal chest pain that gradually subsided, along with chills fever, body pain, and exhaustion on 15Jun2021 06:00 AM. No treatment was received for the events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovered in Jun2021. The report was reported as non-serious. Information on the lot/batch number has been requested.
16 2021-07-27 fast heart rate Very high heart rate over 120 for 8 hours; Fever.; Chills; Sore muscles; Headache; Dizzy; Very high ... Read more
Very high heart rate over 120 for 8 hours; Fever.; Chills; Sore muscles; Headache; Dizzy; Very high heart rate over 120 for 8 hours. Fever, chills, sore muscles, headache, dizzy, and tired.; This is a spontaneous report from a contactable consumer (patient). A 16-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left (at the age of 16 years old) on 12May2021 at 18:30 (Batch/Lot Number: EW0186) as DOSE 2, SINGLE for covid-19 immunization. Also reported 'Device Date:19May2021' no additional details provided. Facility where the most recent COVID-19 vaccine was administered was health facility. No other vaccines were given within 4 weeks. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Medical history included attention deficit hyperactivity disorder. Concomitant medication(s) included methylphenidate hydrochloride (CONCERTA) 54mg. Historical Vaccine includes BNT162B2 Dose 1 (at the age of 16 years old) on 21Apr2021 at 18:30 Batch/lot number ER8736, Left arm Covid-19 immunization and not events were reported. The patient previously took amoxicillin and experienced drug hypersensitivity. On 13May2021 at 02:00 The patient experienced Very high heart rate over 120 for 8 hours, Fever, chills, sore muscles, headache, dizzy, and tired. The event Very high heart rate over 120 for 8 hours was considered medically significant. The patient underwent lab tests and procedures which included heart rate: high on 13May2021 (Very high heart rate over 120 for 8 hours). No Treatment was given and No hospitalization was involved. The clinical outcome of the events was recovered May2021. Follow-up attempts completed. No further information expected.
16 2021-07-28 blood pressure increased patient experienced what appeared to be an anaphylactic reaction immediately after receiving the va... Read more
patient experienced what appeared to be an anaphylactic reaction immediately after receiving the vaccine. Patient's chest became extremely red and splotchy. Patient's blood pressure was slightly elevated. Patient reported no difficulty breathing and no wheezing was witnessed. The doctor remained in the room with this patient and monitored her until emergency services arrived. Patient refused hospital transfer. Patient was alert and vocal during entire incident. Patients mother was shown how to enroll herself and her daughter in V-safe. Patient will remain in clinic for monitoring and will be followed-up with later this evening and tomorrow morning.
16 2021-07-28 palpitations sweating and racing heart noted on 09May21 Diagnosis of hyperthyroidism on 18Jun21
16 2021-07-28 lightheadedness, pallor Per witness, patient was sitting in the waiting room post vaccination w/ Pfizer vaccine. Patient's m... Read more
Per witness, patient was sitting in the waiting room post vaccination w/ Pfizer vaccine. Patient's mother got up and walked to counter to make 2nd dose appt. Patient started leaning over in chair and fell to the floor (witness reports patient bumped head). Per witness, mother ran to patient's side. This writer heard someone call for help. This writer was in the back assisting with immunization clinic. Patient was observed lying on the floor w/ mother at her side. Patient appeared confused and was actively trying to sit upright. This writer and patient's mother explained that she had experienced a vasovagal reaction after her COVID-19 vaccine. Patient was instructed to stay in lying position while vital signs were obtained. Patient was able to verbalize name, DOB, and place. Vital signs at 1040 (BP 98/55, HR 61, O2 98% on room air). Patient was diaphoretic and pale. Patient reported eating breakfast this morning. Patient was observed crying stating "I feel like I can't breathe." This writer continued to monitor vital signs (BP 120/72, HR 77, O2 99% on room air). Staff placed several ice packs on patient. She complained of headache and told staff that her head hurt. Mother of patient requested EMS to be called. Staff called EMS. Vital signs at 1050 (BP 101/64, HR 92, O2 98% on room air). Patient reported feeling better and was able to move to sitting upright position on the floor. Patient appeared less diaphoretic and color was returning to normal. Patient was moved to wheelchair w/ assistance from staff. Patient was provided with water and crackers. EMS arrived to the facility at 1050. EMS evaluated patient, but patient declined to be transported. V/S stable. Patient reports history of passing out unrelated to vaccine administration. Staff explained that mother/patient need to inform staff w/ the 2nd dose of vasovagal hx, so patient can receive vaccine lying down. Staff provided mother w/ concussion education and explained what S/S would indicate a need to go to the ER. Patient was also encouraged to f/u with pediatrician. Patient was taken out to car via wheelchair by staff at 1100.
17 2021-01-04 low blood oxigenation Administered first dose of COVID19 vaccine at 1:29pm on 1/4/21. At approximately 11:00pm resident ex... Read more
Administered first dose of COVID19 vaccine at 1:29pm on 1/4/21. At approximately 11:00pm resident exhibited acute respiratory decompensation with very limited air entry and hypoxemia. Patient received Benadryl, steroids, epinephrine, and Duoneb without improvement. Resident was referred to the emergency room and found to be COVID positive. No fever or rash were reported.
17 2021-02-04 loss of consciousness She passed out.; This is a spontaneous report from a contactable consumer (parent). A 17-year-old fe... Read more
She passed out.; This is a spontaneous report from a contactable consumer (parent). A 17-year-old female patient (daughter) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL1284) on 22Jan2021 11:45 AM at left arm at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. No known allergies. Patient was not pregnant. Patient did not have COVID prior vaccination, and did not have other vaccine in four weeks, did not other medications in two weeks. The patient experienced passed out on 22Jan2021 12:00 PM. Treatment included they had her lay on the ground with her knees up and cold compresses. Patient did not test COVID post vaccination. The outcome of event was recovering.
17 2021-03-02 loss of consciousness Per paramedic, "Pt's mother told staff "my daughter's not feeling well." Paramedic was notified and ... Read more
Per paramedic, "Pt's mother told staff "my daughter's not feeling well." Paramedic was notified and pt was unc when he arrived. Pt was taken to the medical tent via w/c. Pt regained consciousness and was placed supine with legs elevated." RN was present when pt transferred to cot without assist. Pt was talking, accompanied by mother who states this happens every time she gets blood drawn or has a vaccine. B/P at time of incident 119/77 HR 91, 98% O2 Sat, at 5min 114/76 HR 77 100% O2 sat, at 10min. standing B/P 110/73, HR 76, O2 sat 99%. A/O speaking in full sentences, sitting up drinking water. Skin color pink. Pt monitored for 45 min. Stable at d/c by paramedic. Post vaccination instructions given.
17 2021-03-09 fainting Syncope, BP 104/61 (pulse 100), O2 sat 100%. Given water and rested 45 minutes. Final BP 129/86.
17 2021-03-10 loss of consciousness PATIENT BECAME DIZZY AND PASSED OUT ABOUT 10 MINUTES AFTER RECEIVING HER VACCINE. WHEN SHE REGAINED ... Read more
PATIENT BECAME DIZZY AND PASSED OUT ABOUT 10 MINUTES AFTER RECEIVING HER VACCINE. WHEN SHE REGAINED CONSCIOUSNESS, SHE SAID THAT SHE COULDN'T HEAR OR SEE ANYTHING AND SHE ALSO WANTED TO VOMIT. WE CALLED EMERGENCY SERVICES. EMERGENCY SERVICES CAME WITHIN 10 MINUTES AND SHE SAID THAT SHE WAS FEELING BETTER; BOTH SIGHT AND HEARING IS NORMAL AGAIN. THEY RECOMMENDED SHE REMAINED SEATED FOR A LITTLE BIT MORE BEFORE LEAVING, BUT DECLARED THAT SHE WAS OK.
17 2021-03-10 fainting, loss of consciousness, pallor Written by the patient and guardian: " 8-10 minutes after shot, complaints of light head an throat ... Read more
Written by the patient and guardian: " 8-10 minutes after shot, complaints of light head an throat closing up. Removed mask for fresh air, no relief. Went to get up for water, immediately for light headed, pale face, checked-out look in eyes. Body went limp, set 17yo in chair, still was light headed and lethargic. Laid 17yo down on floor, administered water. Vision came back dizziness went away. remained seated for another 15minutes. Continued hydrating w/ water, other symptoms diminished." From Dr.: "Witnessed patient pass out in chair, within 10-20s was helping caregiver lower patient to the floor and patient had come to. Increasingly alert. Endorses above narrative, as well as not having eaten or drinking much today, "maybe an apple". She does not have a history of vasovagal syncope. Patient Pulse at 65, normal breathing, no distress, no signs of injury. Overall episode appears to be vasovagal syncope. Patient asked to drink water and remain at the vaccine center an additional 15-20 minutes for observation. After 15 min patient feeling back at baseline. No further medical intervention.
17 2021-03-12 blood glucose increased Fever of 103 F, received Tylenol, then developed tonic-clonic seizure activity for about 20 minutes ... Read more
Fever of 103 F, received Tylenol, then developed tonic-clonic seizure activity for about 20 minutes (received 10mg intranasal midazolam and 0.5mg buccal clonazepam while awaiting EMS)
17 2021-03-12 pallor 5 minutes after administration of vaccine, Patient had visual white-out of vision, diminished hearin... Read more
5 minutes after administration of vaccine, Patient had visual white-out of vision, diminished hearing, disoriented, severe pallor and then vomitted.
17 2021-03-14 chest discomfort Within 2 minutes of vaccine developed dizziness, nausea, within 5 minutes developed mild tingling in... Read more
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
17 2021-03-14 heart rate increased, fainting Hard heart rate, sweating, nausea, fainting
17 2021-03-19 fainting Patient fainted roughly 5 minutes after receiving the vaccine. She was sitting down on a chair rest... Read more
Patient fainted roughly 5 minutes after receiving the vaccine. She was sitting down on a chair resting her head on a table in the waiting room. She felt lightheaded and then fell down to the ground. Her mom was with her at the time. We made sure she was not having an allergic reaction. Patient responded seconds after she was on the floor but was not coherent. EMS was called and arrived within minutes. Patient was accessed and transported to the hospital.
17 2021-03-21 loss of consciousness At 5AM a 17 year old female accompanied by her sister which is her legal guardian, received first do... Read more
At 5AM a 17 year old female accompanied by her sister which is her legal guardian, received first dose of Pfizer. While patient was in observation she became dizzy, passed out, and fell on the floor and hit her forehead. Patient was immediately attended to by clinical staff. Within less then a minute patient was alert and oriented X3 but could not recall what happened. Ambulance was called, and site lead was made aware. Vital signs at the time were BP: 90/45, O2 100%, HR: 55. Ambulance arrived on scene and assessed patient. Vital signs upon transfer to hospital 111/56 HR78. Patient was transfer to hospital.
17 2021-03-22 hypotension Patient felt dizzy after receiving vaccine. BP initially low but recovered within 30 minutes.
17 2021-03-24 chest pain The day after the vaccine- chills and headaches-lasted for 3 days The symptoms worsened slowly & on ... Read more
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.
17 2021-03-24 lightheadedness, fainting EUA Pfizer-BioNtech vaccine reaction Patient was hesitant about vaccination because she is afraid of... Read more
EUA Pfizer-BioNtech vaccine reaction Patient was hesitant about vaccination because she is afraid of the needels. in observation room she had a syncopal episode lasting 10 min. she had a vaso-vagal reaction , she has history of similar episodes.
17 2021-03-25 chest discomfort After first dose of Pfizer patient indicated bronchial spasm/tightness. Patient left her Albuterol ... Read more
After first dose of Pfizer patient indicated bronchial spasm/tightness. Patient left her Albuterol inhaler at home. BP= 121/83, HR= 99, O2 sat= 98%. Patient's dad indicated home was "5 min" away, EMS declined. Dad indicated severity was 3-4 on a scale of 10. No medication provided. Patient walked out with both parents and one EMT unassisted.
17 2021-03-25 pallor, loss of consciousness after recieving the vaccine, patient turned very pale and appeared to lose conciousness as well as h... Read more
after recieving the vaccine, patient turned very pale and appeared to lose conciousness as well as have convulsions. 911 was called. nurse had patient lie on the floor. o2 was measured to be 96 and bp was 103/74
17 2021-03-25 pulse abnormal Called to Pod 3 green chair 5 at 8:45. Pt awake leaning over feeling shaky and dizzy. pt cool and c... Read more
Called to Pod 3 green chair 5 at 8:45. Pt awake leaning over feeling shaky and dizzy. pt cool and clamy to touch weak pulse. given water to drink. Denies eating breakfast. wheel chair transport to observation to stretcher. :Apple juice po. 8:55 BP 111/67 Pulse 67 Pulse Ox 86 Resp 24. Head of bed elevated. Apple juice po. 9:05 BP 109/76 Pulse 67 Pulse Ox 87 RR 20. 9:20 99/64 Pulse 83 Pulse ox 100 RR 22. Apple juice po. Pt sat on edge of bed and remains shaky and layed back for further observation. 9:30 pt reported feeling better sat on side of bed BP 103/68 Pulse 79 Pulse Ox 100 RR 24. feeling well enough to walk accompanied to exit with Nurse and mom. Discharge to home in care of mom
17 2021-03-26 lightheadedness Anxious with injections, felt lightheaded, then near syncope, placed to floor by staff with recovery... Read more
Anxious with injections, felt lightheaded, then near syncope, placed to floor by staff with recovery, BP 80/50 in OBS- felt better, BP 84/54 at time of discharge and normal condition
17 2021-03-27 loss of consciousness Patient received second dose of pfizer covid19 vaccine. Then while she was sitting during the 15 min... Read more
Patient received second dose of pfizer covid19 vaccine. Then while she was sitting during the 15 minutes after receiving the vaccine, she was found slipped out of her chair unconscious. 911 was called and her parents were called. After several minutes, she regained consciousness. When asked how she felt, she stated that she was hot and dizzy. Patient remained sitting on the floor, leaning against the wall. An ice pack and water was brought to her to help cool her down. Paramedics came and assessed her. Patient then left with her mother who said she was taking her to the doctor.
17 2021-03-27 pallor Almost immediately after receiving the vaccine the patient started feeling nauseous. Patient's mothe... Read more
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.
17 2021-03-28 fainting Patient fell on her face and fainted for a couple of minutes.
17 2021-03-29 loss of consciousness The patient received her COVID-vaccine and then told the immunizer she felt dizzy seconds afterward.... Read more
The patient received her COVID-vaccine and then told the immunizer she felt dizzy seconds afterward. She passed out for a few minutes and we were unable to wake her. We called 911 and she came back to consciousness after what felt to be several minutes.
17 2021-03-29 lightheadedness Immediate vasovagal reaction. Recovered with supine positiion. Vital signs were monitored. Was able... Read more
Immediate vasovagal reaction. Recovered with supine positiion. Vital signs were monitored. Was able to sit after 15 minutes, then stand and walk after 15 more minutes of observation
17 2021-03-30 fainting, hypotension Dizziness. Fainting. Low blood pressure
17 2021-03-30 fainting Patient had initial dizziness and syncopal episode. Patient reported "vision went dark and felt hea... Read more
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.
17 2021-03-31 fainting, hypotension Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotens... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Systemic: Weakness-Mild
17 2021-04-01 fainting Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Additional Detai... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient felt some lightheadness and felt she was having a panic attack. sje slumped but patient was responsive
17 2021-04-04 nosebleed Patient woke up in the middle of the night because her nose was spontaneously bleeding She had a sl... Read more
Patient woke up in the middle of the night because her nose was spontaneously bleeding She had a slight headache the next day. She has never had a nosebleed before.
17 2021-04-04 loss of consciousness, pallor Pt had reaction in the waiting room. Pt became pale, diaphoretic, passed out and had brief seizure ... Read more
Pt had reaction in the waiting room. Pt became pale, diaphoretic, passed out and had brief seizure x 3-5 seconds. She suddenly became aware again with no recollection of what happened. She continued to be pale and diaphoretic and c/o confusion and blurry vision. Pulse ox 98-100, HR dropped to 40's and BP 90/60. Squad was called, they assumed care and transported pt to ER with her mother present.
17 2021-04-04 loss of consciousness 5-10 minutes post vaccinating while waiting 30 minutes pt began hyperventilating with fluctuating LO... Read more
5-10 minutes post vaccinating while waiting 30 minutes pt began hyperventilating with fluctuating LOC. Family member reported hx of allergies so she was waiting 30 minutes, EMS onsite, pt began drooling so EMS took her to local hospital. Nurse reports v/s remained stable. I have not heard back from pt or family as I attempted follow up calls and emails.
17 2021-04-04 loss of consciousness Following the vaccine admin patient felt a wave coming over her and passed out she experienced tunne... Read more
Following the vaccine admin patient felt a wave coming over her and passed out she experienced tunnel vision and was clammy. She was placed on the floor and was then placed on a back board and taken to medical observation, patient wears a continuous glucose monitor and her mom reported that her bld glucose was 129, patients vital signs upon arrival was 120/65, P 71, Ox 98% on room air @ 10:35, at 10:40 her blood presure was 120/78. she was then placed in a sitting position and bp was 119/79 and then standing after 1 minute was 121/74- patient was released from observation via wheelchair she was taken to the exit with her mom and she exited the building.
17 2021-04-04 fainting, pallor Fainted for 2 seconds. Sweating. Pale lips but the color got back on after few minutes. Tingling. Co... Read more
Fainted for 2 seconds. Sweating. Pale lips but the color got back on after few minutes. Tingling. Could not lift up her arm (but could feel squeezing thumb). Shaken hands and feet. Lied down on the ground around for 10 minutes and elevated feet. Had her to keep breathing in/out. Kept drinking water and gave orange juice. Called 911. EME arrived and took care of patent. Pt didn?t want to ride on the ambulance and said fine. Was able to walk in the end. Left the scene with her mom.
17 2021-04-05 loss of consciousness patient lost consciousness approximately 3 minutes after receiving vaccine, appeared to be fine imme... Read more
patient lost consciousness approximately 3 minutes after receiving vaccine, appeared to be fine immediately following vaccine, was speaking coherently to nurse, stood up under own power, became dizzy and lost consciousness
17 2021-04-05 lightheadedness, pallor Presented at 0905 for vaccine. 0912: Staff were called to the patient vaccine area. Patient did see... Read more
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.
17 2021-04-05 lightheadedness Within 5 minutes of receiving vaccine, patient became lightheaded and diaphoretic. Patient vasovaga... Read more
Within 5 minutes of receiving vaccine, patient became lightheaded and diaphoretic. Patient vasovagal. Feet were propped up, patient returned to baseline with 5 minutes of episode. Was released into the care of her boyfriend.
17 2021-04-05 fainting Syncopal episode within 1 minute of injection, seizure like active posturing, unresponsive. Alert a... Read more
Syncopal episode within 1 minute of injection, seizure like active posturing, unresponsive. Alert and oriented by the time she was transferred to ER.
17 2021-04-05 fainting 6 am following day (4/6) after injection on 4/5/21, my 17-year-old daughter complained of sore right... Read more
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.
17 2021-04-06 chest pain, loss of consciousness Patient passed out. tingling in finger. light headedness. chest pain related to anxiety. occurred a... Read more
Patient passed out. tingling in finger. light headedness. chest pain related to anxiety. occurred after about 15 minutes
17 2021-04-06 loss of consciousness, pallor At 1137am, 5 minutes after receiving Pfizer vaccine, pt c/o dizziness and lightheadedness. At 1139 p... Read more
At 1137am, 5 minutes after receiving Pfizer vaccine, pt c/o dizziness and lightheadedness. At 1139 pt became pale and diaphoretic, so EMT lifted her from chair, she then lost consciousness for approximately 30 seconds. Pt was placed on floor in trendelenburg position with her feet elevated on a chair. When she regained consciousness she did not recall being placed on the floor and stated she "blacked out" and was still dizzy. At 1138 EMT called 911. At 1145 EMT recorded the following vitals: BP 68/44, HR 58, and RR 16. At 1145 paramedics arrived and assumed care of pt. At 1150 paramedics took the following vitals: BP 70/50, HR 54, and blood glucose 95, and from these indications decided to start and IV and admininster a 500cc bolus. Pt O2 sat was 100% but she was placed on 2L O2 NC for comfort. At 1205 paramedics transported pt to Hospital for further evaluation.
17 2021-04-06 loss of consciousness Patient passed out, fell out of her chair and hit her head hard after receiving her shot. Once she w... Read more
Patient passed out, fell out of her chair and hit her head hard after receiving her shot. Once she went down, two nurses ran to her assistance where they propped the patient's feet up on a chair and got her some water. Patient reported blurred vision, had a goose egg on the back of her head but did not appear to be mentally foggy.
17 2021-04-06 pallor, hypotension PER PT, FEELING DIZZY AND AS IF SHE WAS FAINTING - PT WAS RESPONSIVE TO QUESTIONS AND HAD NORMAL BRE... Read more
PER PT, FEELING DIZZY AND AS IF SHE WAS FAINTING - PT WAS RESPONSIVE TO QUESTIONS AND HAD NORMAL BREATHING. PT GIVEN 1 DOSE OF ADULT EPI (LOT 0FM501, EXP 05/22). PER EMT (ARRIVED WITHIN 10 MIN OF CALL), PT HAD NORMAL FAINTING SYMPTOMS OF HYPOTENSION AND LOOKING PALE
17 2021-04-06 fainting Patient experienced an episode of syncope almost immediately after her first dose of Pfizer covid va... Read more
Patient experienced an episode of syncope almost immediately after her first dose of Pfizer covid vaccine. She was unresponsive for approximately 20-30 seconds. Her vaccinator held the patient steady until help was available. When the patient came to, her pupils were not of equal size, left being larger than right. Cap refill was about 5 seconds. She felt hazy/dizzy and was clammy. First pulse readings were 39-45 bpm. Vitals recorded 1545 BP 73/40, P 48, O sat 99 1558 BP 91/55, P 58, O sat 96 1607 BP 106/62, P 68, O sat 98 BP 111/70, P 57, O sat 100 At the time of dismissal, patient reported that she felt fully recovered. She was accompanied by her father who was her mode of transportation. It was recommended that she be scheduled for an appointment with her PCP for baseline/well visit as she had not been in some time.
17 2021-04-07 loss of consciousness Events happened about 5 mins after shot was given. Patient experienced lightheadedness, loss of cons... Read more
Events happened about 5 mins after shot was given. Patient experienced lightheadedness, loss of consciousness for a couple seconds, uncontrolled urination, hot flashes, headache. Patient was given water and a snack to consume. After about 10 minutes of resting and consuming food, she feeling better afterwards, said it could have been to fear of getting injections, and was able to go home with her family.
17 2021-04-07 pallor Patient received dose 1 of Pfizer vaccine LOT ER8733 on 4/6/21 at 0955. Patient had witnessed seizu... Read more
Patient received dose 1 of Pfizer vaccine LOT ER8733 on 4/6/21 at 0955. Patient had witnessed seizure at 0957. EMS called at 1000. Seizure lasted 15 seconds. Patient alert after seizure. Appeared very pale. Advised patient mother that she needed to be seen at the ED for further evaluation. 1004 attempt made to call ED Lead but unable to reach. 1005 called House Supervisor to confirm correct number for ED Lead. 1007 EMS arrives. Pt mother declines transport to ED. EMS assists patient to car. Patient and mother sat in car for long period of time prior to leaving lot. Further follow up documents there is no documentation of visit to ED.
17 2021-04-07 pallor Patient had a reaction to the Pfizer Covid-19 vaccine. While waiting for 15 minutes after the shot, ... Read more
Patient had a reaction to the Pfizer Covid-19 vaccine. While waiting for 15 minutes after the shot, patient had a 'seizure' according to patient's mom. She was flapping her hands, staring, and sliding down the chair. 911 was called. Patient was pale and calm but responding to the immunizer (technician) and pharmacist. Patient said she was fine. EMS came and checked the patient and said patient is fine. Patient said she was fine again. EMS left without the patient since she was fine.
17 2021-04-07 fainting Patient fainted. She faints after all immunizations according to her and her father. She was fine, ... Read more
Patient fainted. She faints after all immunizations according to her and her father. She was fine, laid down, raised feet, ice pack on forehead/neck. She rested and left after 15 minutes
17 2021-04-07 fainting A few minutes after receiving the vaccine, the patient fainted in the pharmacy wait area. She woke u... Read more
A few minutes after receiving the vaccine, the patient fainted in the pharmacy wait area. She woke up a few seconds later and was alert. She was able to answer questions like "what is your name?" "where are your?" " etc. She denied a history of fainting but did say she fainted once about 8 years ago. She remained seated in the pharmacy waiting area for another 30 minutes and said she felt fine. She denied feeling dizzy, short of breath, and any allergic reaction symptoms.
17 2021-04-07 fast heart rate Per ER HPI on 3/19/2021: 03/19 21:19 This 17 yrs old - Female presents to ER via Private Vehicle wit... Read more
Per ER HPI on 3/19/2021: 03/19 21:19 This 17 yrs old - Female presents to ER via Private Vehicle with complaints of Allergic Reaction. 21:19 Patient is a 17-year-old female she presents to the clinic with mom, the concern is that the patient wonders if she is having an allergic reaction, she says she received a Covid vaccine on Wednesday and then today earlier received an HPV vaccine and another vaccine that she cannot remember the name of. She feels like there is a tight sensation in her throat. She denies any chest pain or shortness of breath. Patient denies any abdominal pain. Denies any swelling of her lips, tongue or cheek. Patient denies any other associated signs and symptoms.
17 2021-04-08 loss of consciousness, fainting The patient experienced the following reaction(s) during the immediate of observation: 1240- pt re... Read more
The patient experienced the following reaction(s) during the immediate of observation: 1240- pt received first dose of Prizer vaccine at 1220. Pt was ready to leave and had a syncopal episode in her chair. Pt was lowered to the ground and was not alert or oriented. Mother was at the patient side. Pt was able to open her eyes and state her name. At this time the patient was placed into a wheelchair and during movement to post vac area, pt lost consciousness and had generalized muscle twitching resembling seizure like activity. At no time did patient have airway compromise. Pt was placed on the floor with feet up on the wheelchair. Vitals are as follows BP: 92/52 P: 72 R:18 99% sp02. Pt continued to answer questions appropriately with mother at her side. 1246: repeat vital signs BP: 118/64 P: 85 R:18 98% sp02 on RA Pt A&Ox4. Mother stated pt had same type episode 4 years ago while they were out of the country. EMS Was called to assess pt with possible transport to a higher level of care. 1259: BP: 110/72 P: 83 R:18 99% Sp02 Fire Department on scene speaking with mother and pt. All pt care given released at this time to FD. Mother spoke with FD and decided against transport to the hospital. Pt was observed 10 minutes longer and final set of vital signs done prior to pt leaving the facility. BP: 102/82 P: 75 R: 18 99% Sp02. Pt A&O x4, placed in a wheelchair and helped to vehicle. All questions answered prior to leaving the facility.
17 2021-04-08 fainting, loss of consciousness Systemic: Abdominal Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresp... Read more
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.
17 2021-04-09 loss of consciousness patient stated feeling dizzy and seeing darks spots. patient passed out for about 30 seconds.
17 2021-04-09 fainting Patient fainted within 5 minutes of administration. She came to very quickly and felt nauseous. We m... Read more
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
17 2021-04-10 hypotension Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, Additional Details: After ... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, Additional Details: After getting the shot in the 15 minutes of monitoring patient started to feel dizzy. Nurses from the minuteclinic monitored vitals and initial vitals were blood pressure 80/50 heart rate 48. After 5 minutes the vitals rose to blood pressure 92/60 and heart rate 72. Patient and parents said they were fine and no issues and were comfortable leaving.
17 2021-04-10 pallor, fainting PATIENT WAS SEATED AFTER VACCINATION FOR OBSERVATION PERIOD. PATIENT FAINTED IN HER CHAIR ABOUT 10 M... Read more
PATIENT WAS SEATED AFTER VACCINATION FOR OBSERVATION PERIOD. PATIENT FAINTED IN HER CHAIR ABOUT 10 MINUTES AFTER VACCINE. SHE CAME TO AFTER ABOUT A MINUTE OR LESS. SHE LOOKED PALE, SHE WAS GIVEN ICE PACKS, WATER, AND ORANGE JUICE. 911 WAS CALLED, PATIENT WAS TAKEN AWAY VIA AMBULANCE ON A STRETCHER.
17 2021-04-11 chest pain, cardiac arrest Patient reported difficulty breathing and chest pain; suffered cardiac arrest and death
17 2021-04-11 loss of consciousness, fainting Systemic: Fainting / Unresponsive-Mild, Additional Details: pt passed out several minutes after reci... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: pt passed out several minutes after recieving vaccine. BP was measured at 144/82 and the patients father stated she had passed out in the past when giving blood or seeing needles after a vaccine. no allergic response or history of allergy reported prior to administration outside of mild shellfish allergy. pt was monitored for 30 minutes before being allowed to leave with her father
17 2021-04-11 pallor less than 10 minutes after vaccine administration patient was kneeled over on floor bent over on cha... Read more
less than 10 minutes after vaccine administration patient was kneeled over on floor bent over on chair . extremely pale, feeling lightheaded, head pounding, ears with sudden onset of lots of pressure. mother said never reacted to vaccine like this before. called EMTs they said her blood pressure was fairly low and wanted to take her to the ambulance for further evaluation.
17 2021-04-11 pallor At 12:20 p.m, patient began to experience dizziness and the eyes began to roll back into the head. I... Read more
At 12:20 p.m, patient began to experience dizziness and the eyes began to roll back into the head. Initial blood pressure reading was 80/160 with a heart rate of 60 and an O2 saturation of 100%. This patient has a history with passing out with shots. Patient was given juice and multiple blood pressure screenings were recorded with results being 100/80, 112/78 and 104/75. At 1300, patient's heart rate was 68 bpm while sitting. Once the patient stood, blood pressure went to 90/60 and heart rate went up to 115 bpm. Patient was pale. Over next 15 minutes blood pressure and heart rate were routinely taken until patient felt better. Patient entered the vehicle safely and left with parents at 1:15
17 2021-04-11 lightheadedness, fast heart rate Reportedly had some redness and blotchiness at the time but currently no signs of anaphylaxis with n... Read more
Reportedly had some redness and blotchiness at the time but currently no signs of anaphylaxis with no urticaria, no respiratory involvement, no intraoral swelling or voice changes, no GI symptoms. He is warm and well-perfused although is slightly tachycardic but appears anxious. His reported inability to move her arms and legs does not seem consistent with a neurologic etiology of this complaint and more likely consistent with anxiety/conversion reaction in the setting of a vasovagal episode. Will give zyrtec at mother and patient's request, PO challenge and reassess.
17 2021-04-12 nosebleed, chest discomfort, chest pain Heavy sleeping, sore and stiffness in arm that was injected, chest pains and tightness of chest, ... Read more
Heavy sleeping, sore and stiffness in arm that was injected, chest pains and tightness of chest, nose bleeds and severe headaches
17 2021-04-12 pallor, fainting, loss of consciousness While waiting during the 15 minute monitoring period patient (17 year old female) fainted in her cha... Read more
While waiting during the 15 minute monitoring period patient (17 year old female) fainted in her chair. Mom noticed that patient's arms went rigid right before she passed out. Patient was still breathing and was laid on the ground to her side and 911 was called immediately. Mom was massaging her thighs and arms to increase blood flow and she regained consciousness within a few minutes. She was very pale and felt weak. She was given water and remained laying on the ground for another 10 minutes before EMS arrived. She explained she gets anxiety about any medical procedure, has had history of fainting after shots/blood draw/blood pressure reading. EMS took fingerstick reading and gave her oxygen to ensure she doesn't faint again from blood glucose fingerstick. Vitals came out to be normal. Mom explained this is very normal and she doesn't see the need to take her to the hospital. EMS offered to have patient with them in the ambulance for another 15-20 minutes before she's free to leave.
17 2021-04-12 pallor, fainting Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: she was sitting for 15 minutes observation she fainted and fell from the chair. She wa unconsious for about few seconds. called 911 for her. she looked paled. paramedics took her in. checked all her vital sign she was fine , her dad took her home. Spoke to dad at 6 pm in the afternoon. she is home resting and having dinner.
17 2021-04-12 fainting patient fainted after receiving vaccine - her dad was with her here in the pharmacy and stated that ... Read more
patient fainted after receiving vaccine - her dad was with her here in the pharmacy and stated that this was typical of her when getting blood drawn/needles
17 2021-04-13 chest discomfort She had COVID-19 infection on January 5. She received Pfizer vaccine 3.28.2021 - er8733 lot. she was... Read more
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.
17 2021-04-13 chest discomfort Pt with a history of asthma and anxiety started to c/o dizziness, tightness in the chest. VS were a... Read more
Pt with a history of asthma and anxiety started to c/o dizziness, tightness in the chest. VS were as follows: 1750 HR 79, O2 sat 97% on RA, BP 109/62 - 50mg of Benadryl given 1755 HR 74, O2 sat 99% on RA, BP 110/67 1800 HR 76, O2 sat 99% on RA, BP 115/72. At 1800 Patient reported that she was feeling much better, tightness in the chest had resolved and was not dizzy. Through out she was able to hold a conversation, no wheezing, and no SOB noted. Pt discharged home with father. Spoke to father to call PCP to advise on second dose.
17 2021-04-13 chest pain, chest discomfort Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat T... Read more
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
17 2021-04-13 loss of consciousness Patient arrived with mom for Covid vaccine at 12:48 pm. Mom reports a history of fainting so nurse d... Read more
Patient arrived with mom for Covid vaccine at 12:48 pm. Mom reports a history of fainting so nurse decided to administer vaccine with client lying down. Vaccine was administered and client immediately stiffened arms and appeared to seize while her eyes rolled back. Nurse reported she turned the client onto her side and she "came to within 20-30 seconds." She reported blurry vision but could read when asked to do so. She quickly became alert and oriented. Her mother reported that she had a previous episode one time in the past year with painful menses. Her vitals remained stable but each time she attempted to stand up, she reported feeling "sick." She developed a headache within minutes of the vaccine and took 2 Tylenol while still there. Client left with parent to follow up at hospital.
17 2021-04-13 loss of consciousness Pt LOC. Patient denies thinners. No deformities /head trauma noted. VSS. Patient a&ox4 upon discharg... Read more
Pt LOC. Patient denies thinners. No deformities /head trauma noted. VSS. Patient a&ox4 upon discharge. Pt received pfizer vaccine at 1:50 hours and discharged at 2:15. Patient stable and no complaints at discharge. Guardian- Father was present.
17 2021-04-13 fainting, palpitations The shot was given on Friday around 1 pm. Blurry Vision immediately after vaccination, then felt fi... Read more
The shot was given on Friday around 1 pm. Blurry Vision immediately after vaccination, then felt fine until 7 pm. At 7 pm she fainted at Lacrosse practice. The following day, Saturday, she fainted at work and was sent home. Sunday, she slept most of the day. Monday, she fainted at school and was sent home. Symptoms have been feeling of her heart racing, blurry vision, fainting, weakness, and major fatigue. No fever.
17 2021-04-13 fainting, lightheadedness, loss of consciousness Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patie... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient fainted in waiting are 5 minutes after shot. Patient's muscles stiffened up and she hit back of head on shelf. Pharmacists lowered patient to recovery position on floor, where pt recovered consciousness and relaxed. Patient's mother said that patient has vaso-vagal responses to shots and that she was having one of those. Patient was well and was able to leave without further assistance.
17 2021-04-13 fainting Immediately after receiving the vaccination, patient presented to be lightheaded and rested her head... Read more
Immediately after receiving the vaccination, patient presented to be lightheaded and rested her head on the table. Upon assessment, patient states that she felt lightheaded, seeing orbs, dilated pupils. Upon arrival from EMS, patient did faint for no longer than 10 seconds and regain consciousness.
17 2021-04-13 fainting Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unrespons... Read more
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.
17 2021-04-14 chest pain abdominal pain, tingling, chest pain. Evaluated by EMS-Refusal to transport.
17 2021-04-14 loss of consciousness, pallor Patient is a 17 year old female who has completed a 30-minute observation period with the following ... Read more
Patient is a 17 year old female who has completed a 30-minute observation period with the following signs and symptoms of an adverse reaction: loss of consiousness. Pfizer-BioNTech COVID-19 vaccine # 1 in series administered. Parents states that patient become pale and dizzy 1 minute after she received covid vaccination , Patient had a syncopal episode in the hallway, unknown if patient hit her head against the floor, no bruises, soreness or redness notice Patient become alert and oriented x 4, pale, diaphoretic, Patient states that she didn't breakfast.Also Patient mentioned that she is afraid to needles. Action(s) taken: Vital sign at 0814: blood pressure ; 75/34, heart rate: 65, respiration ; 16, Spo2: 99 % Repeat Vital sign at 08:28: blood pressure ; 85/44, heart rate: 65, respiration ; 16, Spo2: 99 % Repeat Vital sign at 08:31: blood pressure ; 97/58, heart rate: 66, respiration ; 16, Spo2: 99 % - Patient denies chest pain ,shortness of breath, nausea vomiting, diarrhea, abdominal pain, difficulty swallow, headache, dizziness, or vision changes - Patient was able to tolerated fluids intake well. Action(s) taken: Transferred to higher level of care, ER Patient and parents advised to discuss second dose considerations with a clinician
17 2021-04-14 loss of consciousness Dizziness, mild sweating, and a temporary loss of hearing a few minutes after the shot before brief ... Read more
Dizziness, mild sweating, and a temporary loss of hearing a few minutes after the shot before brief LOC. Mother reported "eyes rolling up" and a respiratory gasp. Rapid recovery with fully orientation on the floor. VS stable in observation. No nausea or visual changes reported by the patient. No orthostasis.
17 2021-04-14 loss of consciousness 1705- Pt passed out right after vaccine. Pt regained consciousness about 3-5 seconds later, stated t... Read more
1705- Pt passed out right after vaccine. Pt regained consciousness about 3-5 seconds later, stated that she couldn't hear anything. Pt moved to the observation area in a wheel chair. 1715- Pt passed out again, ammonia inhalants used. Regained consciousness 3 seconds later. Pt sweaty. Ice placed to back of neck. Pt moved to cart. First set of vitals @ 1717: Spo2: 100% HR: 53 BP: 83/42 Water and snack given to pt. Second set of vitals @ 1720: Spo2: 95% HR: 54 BP: 88/48 Third set of vitals @ 1726: Spo2: 97% HR: 64 BP: 102/64 Pt sitting up and talking with staff an mother, color in face improving. Pt states she is starting to feel better. Fourth set of vitals @1732: Spo2: 99% HR: 67 BP: 103/66 Pt sitting at 90 degrees, eating and drinking. States she does not feel nauseous. Last set of vitals @ 1537: Spo2: 100% HR: 62 BP: 94/63 Per mother she normally faints with vaccines. Pt states she is feeling much better. Reminded pt and mother to keep up with fluids.
17 2021-04-14 pallor pt looked pale 10 minutes after vaccine went out to check on him he was getting faint and lips looke... Read more
pt looked pale 10 minutes after vaccine went out to check on him he was getting faint and lips looked purple, was NOT having breathing problems and BP was normal at 104/54, called 911 patient was very clammy and sweaty, stayed with patient until paramedics arrived, patient was feeling much better a little before paramedics arrived, but they decided to take him to hospital
17 2021-04-14 pallor 1325- Pt presented to observation room, mom was supporting her as she walked. I got to the patient a... Read more
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
17 2021-04-14 pallor immediately after vaccine patient asked if she "could sit for a minute"; became pale, diaphoretic an... Read more
immediately after vaccine patient asked if she "could sit for a minute"; became pale, diaphoretic and limp in the chair; responded immediately to spirits of ammonia and position change; patient given oral fluids and responded well; patient observed for 45 minutes before being allowed to leave vaccine clinic
17 2021-04-14 lightheadedness Client had vasovagel response immediately after she stood up from getting the vaccine.
17 2021-04-14 fainting 3 episodes of vasovagal syncope this morning, clustered over approximately 1 hour, on the day follow... Read more
3 episodes of vasovagal syncope this morning, clustered over approximately 1 hour, on the day following her second dose of Pfizer Covid-19 vaccine.
17 2021-04-15 fainting syncopal. Evaluated by EMS-Refusal to transport.
17 2021-04-16 chest discomfort wheezing, chest tightness. Hx of asthma. Epi-pen, albuterol inhalers. Pt sent to Urgent Care, the... Read more
wheezing, chest tightness. Hx of asthma. Epi-pen, albuterol inhalers. Pt sent to Urgent Care, then ER
17 2021-04-16 chest discomfort General fatigue, feeling slightly unable to speak or text in clear sentences (i.e., patient said she... Read more
General fatigue, feeling slightly unable to speak or text in clear sentences (i.e., patient said she feels "loopy"), coughing for a little while, chest (lungs) feels heavy
17 2021-04-16 heart rate abnormal After receiving the vaccination, patient was advised to sit for 15 minutes in the designated waiting... Read more
After receiving the vaccination, patient was advised to sit for 15 minutes in the designated waiting area. Approximately 5 minutes while sitting in the waiting area, patient's father noticed his daughter was about to fall over but caught her without her falling to the floor. The patient was conscious, has a pulse and was breathing the whole time. Pharmacist on duty called 911 and within 10 minutes the paramedic arrived. They checked her BP, heart rate and blood sugar. Both her BP and blood sugar were within normal range, while her heart rate was out of range. The paramedics suggested to the parents that their daughter needs further monitoring. The parents agreed and left wit the Paramedics.
17 2021-04-16 hypotension Light headed, low BP
17 2021-04-16 pallor 17 Y/O FEMALE UNRESPONSIVE POST VACCINATION. PT APPEARED COOK, PALE, PUPILS DILATED, NON REACTIVE P... Read more
17 Y/O FEMALE UNRESPONSIVE POST VACCINATION. PT APPEARED COOK, PALE, PUPILS DILATED, NON REACTIVE PT ASSESSED BY EMS PLACE ON STRETCHER IN TRENDELENBURG POSITION. PT C/O VISION LOSS AND UNABLE TO HEAR. 02 SAT UNDETECTED THEN 98%. PT PLACED ON OXYGEN. BOTH PARENTS PRESENT AT TIME OF INCIDENT. PARENTS ALSO STATED PT HAD MENINGITIS VACCINE APPROX 2 WEEKS AGO. NO OTHER HX. PT REGAINED CONCIOUSNESS, HEARING AND VISION. TRANSPORTATION T(JFRD) ARRIVED. PATIENT DECLINED TRANSPORTATION TO ER. CLEARED BY EMS APPROX 9:50 A.M.
17 2021-04-16 fainting Nausea, dizziness and fainted for some few minutes. Paramedics were called, patient did not need any... Read more
Nausea, dizziness and fainted for some few minutes. Paramedics were called, patient did not need any treatment and was able to go home.. Mom was counseled on signs and symptoms to watch out and if needed to seek medical care
17 2021-04-16 fainting Dizziness, Syncope; Cough abd pain, sweathing. BP 101/53, HR 60; RR 24 -- > 119/59, 67,20 -- > 94/6... Read more
Dizziness, Syncope; Cough abd pain, sweathing. BP 101/53, HR 60; RR 24 -- > 119/59, 67,20 -- > 94/67, 57. Given OJ and water, pt felt fine after drinking water and OJ. Patient stable and released from vaccination site.
17 2021-04-17 loss of consciousness Patient passed out, no injuries
17 2021-04-17 fainting Patient received vaccine at approx 7:38pm, immediately experienced a syncopal episode. She was place... Read more
Patient received vaccine at approx 7:38pm, immediately experienced a syncopal episode. She was placed in a wheel chair, brought to an observation area, placed on a cot with feet elevated. Patients color began to return, and she was answering all questions appropriately. Initial BP 90/52, HR 47. Patient began to feel better, sat up and drank 1 bottle of water, repeat BP 92/64 HR 67 then 115/72, HR 63. Patient stood and walked feeling back to baseline released home with father in stable condition.
17 2021-04-18 chest discomfort Pt complained of Shortness of breath and chest tightness that started just a few minutes after vacci... Read more
Pt complained of Shortness of breath and chest tightness that started just a few minutes after vaccine administration. Pt has history of asthma. Exam done within normal limits. Pt given 2 puffs of albuterol. Symptoms remain mild after 45 min of observation. Pt discharged home with precautions.
17 2021-04-18 loss of consciousness I gave the patient the immunization. She seemed fine after getting the shot. I asked her to go outsi... Read more
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.
17 2021-04-18 palpitations, heart rate increased Dizziness Vomit Shortness of breath Palpitations Accelerated pulse
17 2021-04-18 palpitations Heart racing Dizziness Weakness Numbness at injection site
17 2021-04-18 fainting Syncope episode. EMS monitored, blood sugar taken resulted 97 after juice, declined transport after... Read more
Syncope episode. EMS monitored, blood sugar taken resulted 97 after juice, declined transport after all s/s resolved (45 minutes)
17 2021-04-18 fainting The patient had her second Pfizer covid 19 vaccination at 1835. During sitting in observation area ... Read more
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.
17 2021-04-18 fainting Patient experienced severe syncope episode. Monitored by onsite EMS - 45 minutes until symptoms res... Read more
Patient experienced severe syncope episode. Monitored by onsite EMS - 45 minutes until symptoms resolved. Patient waited additional 45 minutes. Patient declined transport to ED.
17 2021-04-18 fainting FAINTED AND FELT LIGHT ENDED POST VACCINE, ALSO FELT NAUSOUS
17 2021-04-19 chest discomfort Rashes all over the body with medium to large size blots, redness and raised. The skin has a rough t... Read more
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.
17 2021-04-19 chest discomfort One hour after returning home.Heaviness in limbs, unable to walk, shortness of breath, nausea, heav... Read more
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
17 2021-04-19 chest pain Chills, nausea, fatigue, right side chest pain, hard to breathe, excessive seizure like shaking.
17 2021-04-19 loss of consciousness Felt dizzy at work the next day after the second shot. Passed out and then was sitting down and I fe... Read more
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.
17 2021-04-19 inflammation of the heart muscle, troponin increased, chest pain On 4/17/21 (ie within 48 hours of receiving COVID 19 Pfizer Shot #2 (4/15/21), my daughter began exp... Read more
On 4/17/21 (ie within 48 hours of receiving COVID 19 Pfizer Shot #2 (4/15/21), my daughter began experiencing chest pain in the PM (PM of 4/17). It was initially mild so we did a watch and wait overnight but when it did not go away by morning of 4/18/21 we went to Urgent Care . Upon presentation at urgent care, she had an irregular EKG, we were advised to immediately do to a Hospital ER , upon arrival she presented with same EKG findings from urgent care, BW was run and her troponin level was a 7, this hospital recommended (after consultation with their cardiologist) that based on her age and urgency of the heart condition, we should be transported to a pediatric hospital with cardiology expertise. She was transported by ambulance to another Hospital, Cardiology Unit. . After a scary 24 hour overnight stay at the hospital she was released on 4/19/21.
17 2021-04-19 lightheadedness Vasovagal episode
17 2021-04-19 fainting Transient lightheadedness with brief syncope. Subsequent NV controlled with position of comfort. ... Read more
Transient lightheadedness with brief syncope. Subsequent NV controlled with position of comfort. Patient had not eaten anything today and had only coffee so far. Pt was given fruit, muffin and water and was monitored for an additional 45 minutes with continued improvement and no other symptoms.
17 2021-04-20 hypotension, pallor, very slow heart rate emale client received her first dose of Covid Vaccine (Pfizer, Lot # ER8729, Expiration date: 07/31/... Read more
emale client received her first dose of Covid Vaccine (Pfizer, Lot # ER8729, Expiration date: 07/31/2021) at 1132. This minor client, accompanied by her mother proceeded to the observation room for her 15 minute wait period. Co-lead RN, was present in the observation room assessing another client. At 1137 this client's mother loudly voiced from the back of the room, "she's feeling dizzy" and co-lead observed client was hanging her head. Co-lead and EMT1 hurried to her side, and client stated she was feeling lightheaded and dizzy and was suddenly pale and diaphoretic. EMT1 immediately transferred her from chair to floor with full assistance to prevent a fall/injury. Client was placed in trendenlenburg position by elevating feet and placing them on the chair. Client was unresponsive for about 15 seconds until she regained consciousness and returned to baseline mentation. Client verbalized she "blacked out" and did not remember being placed on the floor. Client denied pain and respiratory distress. EMT1 called 911 at 1138. Client and her mother deny she has any medical issues, allergies, medications, or previous incidence of syncope. At 1145, first set of vitals taken by EMT1 indicate hypotension and bradycardia as follows: BP 68/44, HR 58, and RR 16. At 1145 paramedics arrived and assumed care after receiving report from EMT2. At 1150 medics took VS with BP 70/50, HR 54, and blood glucose 95, and determined they would start an IV to administer a 500cc bolus for dehydration and to improve BP. Client was also placed on 2L O2 for comfort, no desat noted. At 1200, medics advised client's mother and co-lead they would transport client to the Hospital for further evaluation. Medics departed at 1205 to transport client to the hospital.
17 2021-04-20 loss of consciousness, pallor Patient became dizzy and passed out after returning to her car. Guardian beeped horn and nurses eva... Read more
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.
17 2021-04-20 loss of consciousness Per recovery RN notes: "At approximately 0841, patient stated feeling dizzy. Mother noted with patie... Read more
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.".
17 2021-04-20 loss of consciousness Lost consciousness approximately 3 minutes after receiving first dose of vaccine. was feeling fine a... Read more
Lost consciousness approximately 3 minutes after receiving first dose of vaccine. was feeling fine after vaccine until they stood up.; This is a spontaneous report received from a contactable consumer (patient). A 17-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0153, expiration date unknown), via unspecified route of administration in left arm on 05Apr2021 at 11:30 AM at a single dose for COVID-19 immunization. The medical history was not reported. Patient did not receive any other vaccine in four weeks. No allergies to medications, food, or other products No known allergies. Concomitant medications included birth control pills (other medications in two weeks). On 05Apr2021 at 11:30 AM, the patient lost consciousness approximately 3 minutes after receiving first dose of vaccine and was feeling fine after vaccine until they stood up. Treatment included the emergency room/department or urgent care, treatment was EKG, concussion test. No covid prior vaccination. There was no covid test performed post vaccination. The patient considered the event as non-serious. The patient recovered from the event on 05Apr2021. Information on Lot/Batch number was available. Additional information has been requested.
17 2021-04-20 pallor Patient became pale and unresponsive in post vaccine waiting area within 3 or 4 minutes while waitin... Read more
Patient became pale and unresponsive in post vaccine waiting area within 3 or 4 minutes while waiting 15 minutes with mother. When assessed patient was breathing and had pulse but was only responding partially to verbal stimuli. Placed cold compress on neck and once alert and fully responsive gave glucose tablets. EMS responded and checked vitals but did not share results. Patient fully recovered and left with mother after we verified contact info.
17 2021-04-20 palpitations Less than 24 hours after receiving first shot, my 17 year old daughter started experiencing heart pa... Read more
Less than 24 hours after receiving first shot, my 17 year old daughter started experiencing heart palpitations. Her resting heart rate is 63. She has an Apple Watch and was able to track her rate. Highest was 123, then fluctuated between high 100s and low 110s. It lasted until Tuesday (and slowly lowered). By Wednesday morning it returned to normal. It frightened her and kept her awake at night.
17 2021-04-20 lightheadedness 04/21/2021 11:48 AM Patient says she was lighted headed and dizziness. wasnt speaking dropped her ph... Read more
04/21/2021 11:48 AM Patient says she was lighted headed and dizziness. wasnt speaking dropped her phone and was not aware. BP WAS 79/37 Pupils were fixed with some movement.. mother was outside, called in. mother had stated earlier that she was afraid of needles. felt clamy and sweaty. patient taken to ER in wheelchair with mother for evaluation
17 2021-04-20 lightheadedness Fell to floor from chair in observation area. OC related to vaccine administration. Pain in right ch... Read more
Fell to floor from chair in observation area. OC related to vaccine administration. Pain in right cheek. Pain level 2.5/10. Vaso-vagal response post vaccine injection. Vital Signs: BP 100/60 HR 85 Resp 20 O2Sat 98 , Skin Signs: Cool and dry, Clammy, Circulation: Cap refill <2sec, Respiratory: Breath sound clear bilaterally, Initial Treatment: Water/observation/elevated les bilateral. Assessed/evaluation by Dr. 10:25 AM, Vital Signs: BP 100/72 HR 85 Resp 20 O2Sat 72, Skin Signs: Cool and dry, clammy, Circulation: Cap refill <2sec, Respiratory: Breath sound clear bilaterally Follow up Treatment: Mask Oxygen administration for 10 min. 10:25-10:35 AM. Ice pack to right cheek, approx. 4 L and reduced to 2 L/min\, 10:35 AM\, Vital Signs: HR 98 Resp 20 O2sat 99, Skin Signs: Cool and dry, clammy, diaphoretic Circulation: Cap refill <2sec, Respiratory: Breath sound clear bilaterally 10:45 AM, Vital Signs: BP 120/82 HR 76 Resp 20 O2Sat 97, Follow up Treatment: 10:45 skin warm and dry, alert and oriented x3. Cap refill <2sec ,Notes: Recommended parent to contact peds office for injury to right cheek. Continue to maintain good hydration at home the rest of the day. Home with father at 10:55 AM
17 2021-04-20 fainting Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild
17 2021-04-20 fainting Patient received her 2nd dose of COVID (Pfizer). She walked out of the immunization room to wait in... Read more
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.
17 2021-04-20 transient ischaemic attack patient woke up with aphasia. per ER note, differential TIA vs focal seizure vs stress.
17 2021-04-21 loss of consciousness Moments after receiving vaccine patient passed out. Mom and Dad were with her. Pharmacist had dad la... Read more
Moments after receiving vaccine patient passed out. Mom and Dad were with her. Pharmacist had dad lay her on the floor, pharmacist lifted legs and patient immediately regained consciousness. Pharmacist asked patient to stay in the waiting area until she felt better. Patient was given frozen water bottle wrapped in paper towel (store was out of immediately cold ice packs). When patient indicated she was ready to leave, pharmacist instructed parents to walk near in case she felt faint again. Pharmacist called patient a few hours later to check but no answer. Left message but no return call.
17 2021-04-21 pallor, loss of consciousness about 5 minutes after administration, patient became unresponsive and was going in and out of consci... Read more
about 5 minutes after administration, patient became unresponsive and was going in and out of consciousness. Her pupils became dilated and she would not respond to stimuli. Her respiratory status was unclear. No hives or rash could be observed. Patient became pale in the face. An allergic reaction could not be ruled out and the patient became less responsive so an EpiPen 0.3mg was administered in the left thigh. Patient was placed on her back on the ground. She became more alert and seemed to have normal breathing. EMS arrived and took vitals. Blood pressure was 138/77 with a heart rate of 88 bpm. Patient's father is taking her to her PCP for follow up this afternoon.
17 2021-04-21 fainting, chest discomfort, fast heart rate, chest pain Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, ... Read more
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
17 2021-04-22 blood glucose increased Dizziness, BS 255
17 2021-04-22 hypotension COLD SWEATS, DIZZINESS, DROWSINESS, BP WAS TAKEN 74/44, THEN 5 MINS LATER 99/60, PT WAS LAID DOWN TO... Read more
COLD SWEATS, DIZZINESS, DROWSINESS, BP WAS TAKEN 74/44, THEN 5 MINS LATER 99/60, PT WAS LAID DOWN TO PREVENT FALLING, PT WAS NERVOUS AND ANXIOUS
17 2021-04-22 loss of consciousness After receiving vaccine, patient became light headed and passed out sitting in chair. diaphoretic an... Read more
After receiving vaccine, patient became light headed and passed out sitting in chair. diaphoretic and clammy. Heartrate 60, BP 60/29,SPO2 100%. Medical response called, patient taken to ER, accompanied by mother
17 2021-04-22 pallor At 1143 - 17 year old female was sitting with her mom, pt advised staff that she was feeling dizzy. ... Read more
At 1143 - 17 year old female was sitting with her mom, pt advised staff that she was feeling dizzy. Pt states the room was spinning. Pt was assisted to wheelchair and escorted to designated private patient area. Pt was pale and diaphoretic but was alert and talking to staff, pt was assisted to remove her sweatshirt and assisted to lay down. Pt instantly stated she felt better after laying down. Pt provided wet cloth for comfort and skin color return to WNL . Pt had small sip of water and stated she felt much better. Pt advised she had only eaten two small donut holes and did not drink water prior to arrival at the clinic. Pt skin returned to normal warm and dry, VSS, AOx4 and pt stated she felt much better and was ready to go home. Pt mother will continue to monitor pt and ensure she continues to hydrate and eat after leaving the site. 1145 VS Bp 94/60 HR 51, 16RR 100% 1150 VS Bp 102/64 HR 60, 16RR 98% 1155 VS Bp 102/68 HR 69, 16RR 98% 1200 VS Bp 104/68 HR 73, 16RR 99% sitting
17 2021-04-22 fainting Fainted, BP 89/59, O2 sat 99%. Patient fell and hit her head under the chin. Patient has a history o... Read more
Fainted, BP 89/59, O2 sat 99%. Patient fell and hit her head under the chin. Patient has a history of low BP with shots. Sent to ED.
17 2021-04-23 loss of consciousness Patient felt lightheaded and dizzy after receiving the vaccine, and then passed out.
17 2021-04-23 pallor c/o feeling faint, pale and diaphoretic, seen by paramedic
17 2021-04-23 pallor slightly pale, c/o feeling lightheaded upon standing, ate banana this AM
17 2021-04-24 hypotension She became very red; Dizziness; Vomiting; Diarrhea; Hypotension; This is a spontaneous report from a... Read more
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.
17 2021-04-24 fainting Fainted; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female pa... Read more
Fainted; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 15:30 (at the age of 17years) as single dose for Covid-19 immunization. The patient is not pregnant at the time of vaccination. Medical history included asthma, pediatric Kawasaki disease from 2006 to an unknown date, known allergies: Sulfa drugs, and Covid-19 from an unknown date and unknown if ongoing (Covid prior vaccination: Yes). Concomitant medications included sertraline hydrochloride (ZOLOFT) and ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE 1/20), both taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient fainted the following morning on 08Apr2021 10:00. There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of event was recovering. Information on the lot/batch number has been requested.
17 2021-04-24 fainting C/O dizzy, syncope x1, less than 5 seconds, patient reports similar problem with all other vaccinat... Read more
C/O dizzy, syncope x1, less than 5 seconds, patient reports similar problem with all other vaccinations and injections. Father reports daughter ate dinner last night . Did not eat breakfast before coming to site. Patient alert and oriented x4 after incident.
17 2021-04-25 heart rate increased, heart rate irregular Mild SOB, fever, aches, rapid HR 130 and slightly irregular.
17 2021-04-25 hypotension Patient had flushing/sweating, dizziness, anxious, sweating. Low BP 84/46 -- > 116/75 -- > 121/82. P... Read more
Patient had flushing/sweating, dizziness, anxious, sweating. Low BP 84/46 -- > 116/75 -- > 121/82. Patient stated did not eat since 4/24/21 6PM. Patient stable, released from vaccination site.
17 2021-04-25 fainting FAINTED D/T FEAR OF NEEDLES, RESOLVED, NO TRANSPORT
17 2021-04-25 fainting pt has a history of fainting almost every time she has a needle stick , she did again. Patient was... Read more
pt has a history of fainting almost every time she has a needle stick , she did again. Patient was faint and light headed for 20-30 minutes at 30 minutes her bp was 96/69 63 pulse. she left on her own feet with mother at her side.
17 2021-04-26 chest pain, enlargement of the heart, chest discomfort ON 4/21/21, SHE BEGAN TO EXPERIENCE SHORTNESS OF BREATH, COUGHING, CONGESTION, SEVERE BACK ACHE, WEA... Read more
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.
17 2021-04-26 chest pain, heart rate increased Reported sudden "fast heartbeats with mild chest pain" lasted less than 2 mins with tingling of L ar... Read more
Reported sudden "fast heartbeats with mild chest pain" lasted less than 2 mins with tingling of L arm where she received the injection. Stable, released from vaccination site.
17 2021-04-26 nosebleed Nosebleeds at random times
17 2021-04-26 fainting, blood pressure decreased, loss of consciousness At 2am 4/22 patient started to feel sick and sent a text that I didn't read until 630 as I was aslee... Read more
At 2am 4/22 patient started to feel sick and sent a text that I didn't read until 630 as I was asleep. She had severe muscle aches, hurt to move, hurt to breathe and felt like she was having a heart attack. She felt like she might pass out and had some blurred vision. At 630am, I saw her texts and immediately brought her 2 tylenol and a large glass of water. She went back to bed. She woke up around 10:45 and was feeling decent except for a headache but no fever or anything so we went to try on some Prom dresses. At the dress shop, she collapsed and had a seizure lasting around a minute. She lost her bladder and was completely confused and incoherent. She's never had a seizure before. I scooped her up, brought her to the ER where they ran every test and scan imagineable. Full blood work up and cultures, a chest xray, a CT scan of her brain and lungs. Her temp was high 103-104 and she had full body chills and a pounding headache. Her BP kept dropping and got as low as 81/36. They threw 2 bags of IV fluids into her and admitted her to the hospital. She had also developed a heart murmur. Over the course of the night, her BP stabilized but her temp continued to spike and come back down with Tylenol/Ibuprofen. She also had IV Tordahl for the headache. Her inflammatory markers were high at 15.3 which we were told should be less than 1. They reran labs in the morning but everything can back really low which they felt was a dilution effect from all the fluids so wanted us to follow up with her primary care on Monday. On Saturday night, he lymph nodes were swollen to the size of ping pong balls but have since slowly reduced in size although still there. Her labs were better from discharge and her white blood cell count was within range and her inflammatory marker was down to 1.7. Her blood sugar was a little low. She did pass out and have seizure like response to giving blood in the doctors office, lost bladder control again, shot pupils, etc. She is still stuttering over words, has some short term memory retention and has some motor function issues which they think is a result of the initial seizure and should resolve itself over time. Her liver function tests were totally normal in the hospital but are a high now so they will be checking her out again next week.
17 2021-04-27 blood pressure decreased, fainting Pt had an episode of syncope for 10 seconds after getting vaccinated . Blood pressure dropped to 90/... Read more
Pt had an episode of syncope for 10 seconds after getting vaccinated . Blood pressure dropped to 90/50, Hr 48. After repositioning the pt and giving some fluid Blood pressure raised to 113/96 Hr 72.
17 2021-04-27 chest pain She had chest pain and dizziness and local swelling left arm 15 min after injection.
17 2021-04-27 hypotension, loss of consciousness patient became very diaphoretic in the observation area, her head went back, eyes closed, extremitie... Read more
patient became very diaphoretic in the observation area, her head went back, eyes closed, extremities became very rigid and patient appeared to have lost consciousness for a brief moment. RN was present at side of patient, patient was hypotensive, vitals checked BP 71/48 and pulse 54. Patient states she felt like she went to sleep, started to feel better several minutes later. EMS was contacted to evaluate and transport patient to ED.
17 2021-04-27 loss of consciousness passing out; Vomiting; diarrhea; This is a spontaneous report from a contactable consumer (patient).... Read more
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.
17 2021-04-27 lightheadedness, pallor Pt received Pfizer COVID vaccine, was walking with father next to her, felt faint, and father eased ... Read more
Pt received Pfizer COVID vaccine, was walking with father next to her, felt faint, and father eased her to the floor, no head or body injury. Positive pallor and diaphoresis noted, legs elevated and pt color improved with pt now alert and oriented. Assisted to upright position, onto stretcher, given 1 small bottle water po, BP: 108/68, HR: 87, RR: 16 nonlabored, SaO2: 100% on RA. Pt currently has menses. 1023: drank 1 apple juice, feeling better. 1038: BP: 94/53, HR: 64, RR: 16 nonlabored, Sa02: 100% on RA. Sat upright on stretcher, legs dangling. 1044: BP 91/58, HR: 70, RR: 16 nonlabored, SaO2: 100% on RA, feeling well, drank 2 apple juice cups, standing up. 1049: standing up BP: 84/46, HR: 62, RR: 16 nonlabored, SaO2: 100% on RA. 1100: Pt feeling well, no c/o, escorted to front door of hospital, father at side. Pt aware to drink fluids today and especially during menses. Pt is also a dancer and practices every day. Discussed hydration needs prior to discharge from vaccine clinic. Pt aware to discuss vasovagal response from this injection at next visit so pt can lay down.
17 2021-04-27 fainting Patient fainted after vaccine, had patient lay down, called 911, Fire and Rescue responded, patient ... Read more
Patient fainted after vaccine, had patient lay down, called 911, Fire and Rescue responded, patient left with father.
17 2021-04-27 fainting Pt. had first vaccine at 14:55. Pt. walked to observation one where she fainted upon arrival. Pt. ... Read more
Pt. had first vaccine at 14:55. Pt. walked to observation one where she fainted upon arrival. Pt. was CAOx3 after she was laid down. Pt. was transferred to the back via wheelchair where she was observed for 15 minutes without any further complications. After 15 minutes patient walked out without any obvious difficulties.
17 2021-04-27 fainting Patient fainted after vaccine administration.
17 2021-04-28 hypertension, loss of consciousness, fainting, fast heart rate Recipient is a 17yo who presented for second dose of COVID-19 vaccine. She reported some anxiety rel... Read more
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.
17 2021-04-28 loss of consciousness Passed out right after vaccine; muscle aches; tired; chills; migraine; This is a spontaneous report ... Read more
Passed out right after vaccine; muscle aches; tired; chills; migraine; This is a spontaneous report from a non-contactable consumer (patient). A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 14Apr2021 at 14:15 (Batch/Lot number was not reported) as single dose for covid-19 immunization, administered at the Pharmacy or Drug store. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Mar2021 at 14:15 in the left arm for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient was not pregnant at the time of report and vaccination. The patient did not receive other vaccines in four weeks. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. The patient passed out right after vaccine, also experienced muscle aches, tired, chills, and migraine; all on 14Apr2021 with outcome of unknown. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
17 2021-04-28 fainting Patient fainted
17 2021-04-28 fainting Syncope. BPs 85/43 (pulse 43), 95/57 (pulse 86). Found slumped in chair and placed in Trend. Positio... Read more
Syncope. BPs 85/43 (pulse 43), 95/57 (pulse 86). Found slumped in chair and placed in Trend. Position. Given water, juice.
17 2021-04-28 fainting Arm pain, slight swelling in injection site area. Swollen lymph nodes on both sides of neck, overall... Read more
Arm pain, slight swelling in injection site area. Swollen lymph nodes on both sides of neck, overall malaise/body aches, fatigue, light-headedness resulting in fainting episode, headache
17 2021-04-29 chest pain, fibrin d dimer increased After receiving the vaccine on 4/26, she developed headache and temperature to max 99-100 as well as... Read more
After receiving the vaccine on 4/26, she developed headache and temperature to max 99-100 as well as muscle pain in the arm where she received the vaccine. Progressed to diffuse myalgias on 4/27 and 4/28. Was having a slight cough that is typical for her during this time of year due to allergies, no other respiratory symptoms. Then acutely developed severe jaw pain that radiated to the throat and into her chest when she woke up on 4/29 in the morning. She had 10 out of 10 crushing chest pain.
17 2021-04-29 chest pain patient felt dizzy, lightheaded, nauseous after receiving pfizer covid-19 vaccine. I checked her blo... Read more
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.
17 2021-04-29 loss of consciousness Fainted- Started feeling sick and other common side effects after 7 hours continuing throughout the ... Read more
Fainted- Started feeling sick and other common side effects after 7 hours continuing throughout the next day, and passed out at 8pm about 30 hours after the shot. And continuing to feel common side effects throughout night 2 and next day (aprox. 48 hours after shot)
17 2021-04-29 lightheadedness Near syncopal episode, revived with smelling salt. Water and snacks offered. Patient has history of ... Read more
Near syncopal episode, revived with smelling salt. Water and snacks offered. Patient has history of fainting with needles. After laying down for several minutes she was able to sit up to eat and drink. Patient able to walk out, father at her side for assistance.
17 2021-04-29 fast heart rate on the same day as first dose of covid vaccine, several hours later, patient had first episode of su... Read more
on the same day as first dose of covid vaccine, several hours later, patient had first episode of supraventricular tachycardia. Required vagal maneuvers in ambulance to resolve. No longterm sequelae.
17 2021-04-30 chest discomfort Not sleeping well at night due to pressure feeling in her chest up; Not sleeping well at night due t... Read more
Not sleeping well at night due to pressure feeling in her chest up; Not sleeping well at night due to pressure feeling in her chest up; shivers; jaw got paralyzed; she got shaky; feeling bad/ brain fog; burning sensation in her body; She couldn't talk; slight elevated temp (99.7F max); She has been off balance this week since getting her vaccine; This is a spontaneous report from a contactable physician. A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Apr2021 (batch/lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome, panic attacks, migraines and acne. The patient was not pregnant at the time of vaccination. It was unknown if there were other vaccines in four weeks. The patient did not have Covid prior to vaccination and was not Covid tested post vaccination. Concomitant medications in two weeks included ondansetron hydrochloride (ZOFRAN) taken for anti-nausea, start and stop date were not reported; doxycycline taken for acne, start and stop date were not reported. The patient previously took glycerol (GLYCERIN) and experienced allergies. The patient got her vaccine on 12Apr2021. Two nights after her vaccine (14Apr2021), she got shaky and feeling bad and burning sensation in her body. No fever at that time, but slight elevated temp (99.7F max) the day after the vaccine (13Apr2021). Mother gave her anti-nausea medication (ondansetron hydrochloride 2 mg) and within 5 minutes her jaw got paralyzed. She couldn't talk. It lasted about 30 min. Mother called ambulance and patient was brought to ER. ER didn't do bloodwork or any evaluation. ER didn't know what happened per mother. She has been off balance this week since getting her vaccine (Apr2021). She feels better this morning but she still feels off balance. Not sleeping well at night due to pressure feeling in her chest up and she shivers to get the feeling away per patient (unspecified date). Slept better last night as of 17Apr2021. No facial drooping. She can smile and lift her eyebrows. Patient had "brain fog" this week as well after the vaccine. The adverse events "she got shaky", "feeling bad", "burning sensation in her body", "jaw got paralyzed" and "she couldn't talk" resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. There was no treatment received for the adverse events. The outcome was recovered on an unspecified date for the events "jaw got paralyzed" and "she couldn't talk"; recovering for the event "not sleeping well at night"; not recovered for the event "off balance"; and unknown for the rest of the events. Information on the lot/batch number has been requested.; Sender's Comments: Based from temporal relation of event and vaccine administration, Trismus as an event in relation to suspected drug BNT162B2 cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
17 2021-04-30 heart rate increased fever 100.9; nausea; back pain; sleepiness; chills; fast heartbeat; This is a spontaneous report fro... Read more
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.
17 2021-04-30 pallor, fainting Immediately after administration of vaccine, patient fainted. Patient assisted in to wheelchair and ... Read more
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.
17 2021-04-30 palpitations Within a couple of minutes of receiving the shot, my daughter felt hotness running down the length o... Read more
Within a couple of minutes of receiving the shot, my daughter felt hotness running down the length of her vaccinated arm and into her hand. Started feeling hot and started to produce a small patch of hives on the outside of the throat and chest. Did vigorous windmill motions with vaccinated arm. She had a feeling of slight unwellness that was followed by a rush of energy. As we leave the store and start to drive home her hives are a little bit worse and she says she feels a little lightheaded and has some heart palpations. But is still reporting a rush of energy. By the time we get home 10 minutes later hives, lightheadedness, and heart palpations have resolved. She feels great the rest of the day. Next day slight redness around the injection site and arm a bit sore. The following day redness is gone but a slight rash is starting to show up around the neck. 5 days later, the rash becomes inflamed, sore, hot and itchy, hives are full upper-body flareups. She takes Allegra 24 for hives control. Rash comes and goes daily. Acts more like hives. Allegra 24 controls hives mostly along with icing. After a few days, the effectiveness of the Allegra 24 is not as efficient with the neck rash. Switches to Zyrtec 24 which seems to provide better relief from both hives and rash around the neck. Sees Dr. April 29th. He advises not to take a second dose of Pfizer at this time and prescribes her an EpiPen.
17 2021-05-02 hypotension, heart rate increased, fainting Fainting; syncope Emergency room visit: low blood pressure, high heart rate, administered a bag of f... Read more
Fainting; syncope Emergency room visit: low blood pressure, high heart rate, administered a bag of fluids to hydrate High fever, chills and lightheadedness
17 2021-05-02 lightheadedness, loss of consciousness Sudden sweatiness, nausea and tunnel vision. Very brief LOC. Immediately better when placed supine... Read more
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.
17 2021-05-02 fainting, loss of consciousness Patient become unresponsive and faint approximately 5-10 minutes after receiving dose 2 of the covid... Read more
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.
17 2021-05-02 fainting Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemi... Read more
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Seizure-Medium, Systemic: Vomiting-Mild
17 2021-05-02 troponin increased, inflammation of the heart muscle, chest pain acute myocarditis; acute onset chest pain; admitted to the pediatric intensive care unit; about to r... Read more
acute myocarditis; acute onset chest pain; admitted to the pediatric intensive care unit; about to receive IVIG. Chest pain started 5/1/20 about 2 days after her 2nd Pfizer COVID-19 vaccination
17 2021-05-03 cerebrovascular accident left-side facial drop with left mouth corner; stroke symptoms; transient mild headache; blurry visio... Read more
left-side facial drop with left mouth corner; stroke symptoms; transient mild headache; blurry vision; left side of tongue affected; slurring speech; felt confused; drowsy; This is a spontaneous report from a contactable consumer (patient). This 17-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8734), via an unspecified route of administration in the right arm at 17 years old on 30Mar2021 at single dose for COVID-19 immunization. Medical history included acquired brain injury (C-PVL) from pneumococcal strep infection, hypoxic ischemic encephalopathy, premature birth, quadriplegic dyskinetic cerebral palsy. Concomitant medications were none. The patient was not pregnant at time of vaccination. The patient previously received T-Dap vaccine at 10 years old and had prolonged migraine reaction. 12 days after, the patient developed stroke symptoms with transient mild headache, blurry vision, and left-side facial drop with left mouth corner and left side of tongue affected causing slurring speech also felt confused and drowsy which lasted for 8 hours. Events were started on 11Apr2021 at 03:30 PM. Events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient went to ER, they did stroke work-up. No evidence of stroke. The patient received treatment including CT scan, MRI, EKG, labs. The patient had no covid prior vaccination, no covid tested post vaccination. Outcome of the events was recovering.
17 2021-05-03 chest pain chest pain and chills 2 days after vaccination. seen in ED 2 days after for chest pain. normal lab... Read more
chest pain and chills 2 days after vaccination. seen in ED 2 days after for chest pain. normal labs and EKG. seen 6 days later in this office for continued chest pain and chills. no previous history of chest pain
17 2021-05-03 troponin increased, chest pain This is a spontaneous report from a contactable pharmacist. A 17-years-old female patient received s... Read more
This is a spontaneous report from a contactable pharmacist. A 17-years-old female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID VACCINE, Solution for injection, Lot number was ER8731), via an unspecified route of administration on 15Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant was not reported. Historical vaccine included BNT162B2 for COVID-19 immunization. It was reported that 48 hours after receiving the 2nd Pfizer Biontech COVID vaccine she woke up with chest pains and the next morning went to urgent care where she had an irregular EKG. The sent her to the local hospital where her troponin was 7. The patient underwent lab tests and procedures which included electrocardiogram irregular on 18Apr2021, troponin was 7. Event took place after use of product. The outcome of the events was unknown.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Chest pain.The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
17 2021-05-04 lightheadedness, pallor Pt experienced full vaso vagal reaction post COVID vaccine. Cold packs were administered to back of... Read more
Pt experienced full vaso vagal reaction post COVID vaccine. Cold packs were administered to back of neck and forehead. Pt sweating resolved and color came back. Aided pt to stand until feeling came back in legs/feet. Called Dad into room. He stated he was a nurse and understood the situation. Everyone was calm. Had pt stay for additional time and offered snack once feeling better. Pt was not thirsty so allowed sip on water and gave reese cup. Dad walked around store for a bit before getting into the car.
17 2021-05-04 fainting, loss of consciousness Site: Pain at Injection Site-Mild, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Mild, Sy... Read more
Site: Pain at Injection Site-Mild, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Fever-Medium, Systemic: Headache-Severe, Systemic: Unable to Sleep-Mild, Additional Details: mom called to report adverse reaction to 2nd dose of pfizer vaccine. pt had chills on monday, fever on tuesday, wed morning child passed out in the kitchen mom heard her fall, she did call 911. child was transported via ambulance to strong ER. pt was diagnosied with syncope. pt is now home with mild headache/lethargy and recovering. mom has called pcp waiting to talk to her.
17 2021-05-04 fainting, loss of consciousness Systemic: Fainting / Unresponsive-Mild
17 2021-05-04 fast heart rate Systemic: Dizziness / Lightheadness-Medium, Systemic: Tachycardia-Mild
17 2021-05-05 loss of consciousness Patient describes feeling nauseated, lightheaded, and dizzy about 20 minutes after vaccine while in ... Read more
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.
17 2021-05-05 pallor Client was lightheaded post vaccine--breathing was not in distress. Client was diaphoretic and pale.... Read more
Client was lightheaded post vaccine--breathing was not in distress. Client was diaphoretic and pale. Raised clients legs , propped her head up and applied ice packs to her neck. Client recovered in 10 minutes. No 911 call or meds received. Client walked out of clinic feeling "normal".
17 2021-05-05 lightheadedness Pre-syncope while at restraint approximately 45 minutes after vaccine. She slumped to the ground an... Read more
Pre-syncope while at restraint approximately 45 minutes after vaccine. She slumped to the ground and lost muscle tone before being caught by her grandparents.
17 2021-05-05 fainting Client received her second dose of the Pfizer COVID-19 vaccine (Lot #EW0179 Exp. 8/2021) at 10:03 AM... Read more
Client received her second dose of the Pfizer COVID-19 vaccine (Lot #EW0179 Exp. 8/2021) at 10:03 AM. EMT saw client stand in observation area. Client appeared "unsteady on her feet". EMT rushed to patient and guided her slowly to the ground while protecting her head. Patient then fainted. EMTs assisted patient to gravity bed where patient regained consciousness. Patient was alert and oriented to person, place, time, and event (AAO x 4) immediately following the incident. Client's vitals were assessed every 5 minutes. They were recorded as follows 10:19- Blood Pressure (BP) 100/74, Heart Rate (HR) 86, Oxygen Saturation (SPO2) 99%, and Respiratory Rate (RR) 18; 10:24- BP 100/72, HR 81, SPO2 99% RR 18; 10:29- BP 100/76, HR 82, SPO2 99% RR 16; 10:34- BP 102/74, HR 84, SPO2 99% RR 18; 10:39- BP 100/72, HR 82, SPO2 99% RR 18; 10:44- BP 110/76, HR 86, SPO2 99% RR 18. Client was given a bottle of water and instructed to remain in a semi-fowler's (45 degree) position until vitals stabilized. Patient remained on vaccination site for 30 minutes following the episode of fainting. EMT obtained orthostatic vital signs (vital trend from lying down, to sitting, to standing). Patient was negative for orthostatic hypotension. Symptoms resolved as indicated above in vital signs. Patient stated she was "feeling better" and declined EMS transport. Patient and father were educated by RN on home care (rest and fluids) and to seek emergency medical attention if symptoms persisted or worsened. Patient left the vaccination site at 10:45 with father and sister with steady gait and in no change in status.
17 2021-05-06 pallor, fainting Immediately after giving the injection, patient felt lightheaded, nauseated, had a decrease in her h... Read more
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.
17 2021-05-06 pallor Within a minute of administration, patient became diaphoretic, pale, vomited. Chair reclined. After ... Read more
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.
17 2021-05-06 platelet count decreased The day after vaccine patient developed fever, myalgias, sore throat. Fever persisted 4-5 days. She ... Read more
The day after vaccine patient developed fever, myalgias, sore throat. Fever persisted 4-5 days. She developed rash on 4/30. Labs done showed low platelets (64k), low WBC with neutropenia. Fever resolved by 4/30 and rash resolved by 5/1/21. Platelets and WBC are recovering.
17 2021-05-07 fainting Patient had syncope event following first shot. Father was in room with pharmacist. She also stated ... Read more
Patient had syncope event following first shot. Father was in room with pharmacist. She also stated she had no eaten anything prior. After event, she claimed this had happened prior BUT SHE DID NOT make aware that this previously occurred on form.
17 2021-05-07 fainting PATIENT HAD A SYNCOPE EPISODE AROUND 5- 10 MINUTES AFTER GETTING THE INJECTION
17 2021-05-08 loss of consciousness This writer received the following report: Adverse Event: Guest reports that she passed out and thi... Read more
This writer received the following report: Adverse Event: Guest reports that she passed out and this was her first time. (Vital Signs: SPO2-99%, P-60) Treatment: AID called - Juice and water provided - EMT's arrived and assessed. (Vital Signs: SPO2-100%, P-60, B/P-90/54). No further treatment indicated. Outcomes: EMT's assessed no further treatment indicated and they released guest to the care of her mother. Guest and her mother were informed if this event occurs to go to the nearest emergency room and report to her PCP.
17 2021-05-08 fainting Syncope following vaccination. Patient reported blurry vision, dizziness. Had patient rest with fe... Read more
Syncope following vaccination. Patient reported blurry vision, dizziness. Had patient rest with feet elevated and gave patient bottle of water. Observed patient for 30 minutes. After 30 minutes patient reported feeling back to normal.
17 2021-05-08 fainting Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Shak... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Shakiness-Severe
17 2021-05-09 loss of consciousness Patient presented for second dose of Pfizer COVID vaccine. Per mom, patient had anxiety attack after... Read more
Patient presented for second dose of Pfizer COVID vaccine. Per mom, patient had anxiety attack after first dose last approximately 45-60 minutes. Patient transferred from vaccine clinic to private room with stretcher prior to vaccine administration. Post vaccine administration, patient exhibiting typical symptoms of panic attack per mom (seizure-like activity, unable to respond to verbal stimuli, sternal rub or fingernail pressure). EMS arrived at 0925. Patient regained consciousness after EMS arrived, back to baseline at 0940. Patient and mother declined EMS transfer to ED for further evaluation. Patient and mother informed to seek medical attention immediately for any worsening/concerning symptoms. Patient discharged via wheelchair with mother.
17 2021-05-09 pallor, fainting Dizziness, followed by brief syncope, all resolved within 2 minutes. She fell out of chair on to gro... Read more
Dizziness, followed by brief syncope, all resolved within 2 minutes. She fell out of chair on to ground and immediately woke. Sweaty and pale, placed cool compress on back of neck and gave her a cold water to drink. She remained upright on the floor for approximately 5 minutes until she felt like she was fully recovered. Her father was present the entire time. She stated that she had no injuries or pain from falling out of chair. No rashes, bruising or bleeding observed. Mgr came over and patient's father declined to file a report for injury.
17 2021-05-09 fainting syncope in observation area after vaccination, was sent to hospital for further evaluation
17 2021-05-09 fainting Pt felt like she was going to vomit 2 mins after administration, then fainted as being assisted to g... Read more
Pt felt like she was going to vomit 2 mins after administration, then fainted as being assisted to gurney to lie down.
17 2021-05-09 fainting Pt felt dizzy after the 1st dose of Pfizer vaccination. As I was walking out to check on her, she fa... Read more
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.
17 2021-05-10 heart rate increased Immediate sever pain at injection site, immediately followed by flushed face, racing heartbeat, ting... Read more
Immediate sever pain at injection site, immediately followed by flushed face, racing heartbeat, tingling and inching of face, watering eyes, itchy throat that felt like it was closing in, lump in throat, difficulty breathing, unable to speak. Was able to speak after a couple minutes and the other symptoms started to gradually improve at that point. Most of the above symptoms subsided within around forty minutes. The lump in the throat remained for weeks eventually coming and going.
17 2021-05-10 hypertension Patient complained of tingling/numbness in her hands. She became dizzy and needed to sit down. Sympt... Read more
Patient complained of tingling/numbness in her hands. She became dizzy and needed to sit down. Symptoms progressed to what the nurse practitioner called "strokelike symptoms". She was conscious but could not respond to requests such as smile or say your name. Her blood pressure was high when taken. It was probably 30 minutes before the EMTs took her to the hospital.
17 2021-05-10 pallor While in observation, patient reports being lightheaded and hot. Patient became diaphoretic and pale... Read more
While in observation, patient reports being lightheaded and hot. Patient became diaphoretic and pale. Mother and patient state she does this after every injection. Ice pack, cold water, and snack provided. Pt feet propped on chair. Pt. waited additional 15 minutes and states she was feeling better and ready to go. ER/UC precautions given.
17 2021-05-10 pallor Pt rec'd Pfizer vaccine, completed 15 minute observation period without complaint, then returned to ... Read more
Pt rec'd Pfizer vaccine, completed 15 minute observation period without complaint, then returned to clinic around 10:30am reporting numbness in entire left arm. Pt states she was not able to move fingers in left arm. Upon initial evaluation by nurse left arm was pale and cold to the touch. Paleness and coldness resolved within a few minutes. There was slight weakness in left hand when patient was asked to squeeze nurses hands. Right Arm- b/p: 112/82, O2: 99%, heart rate: 91 BPM. Left Arm- b/p: 98/77, O2: 98%, BPM: 87. Pt was asked again to squeeze nurses hands, pt was able to squeeze slightly harder, however slight weakness compared to right arm was still noted. Pt verbalized improvement in feeling and movement, however states still did not have full feeling or movement back. Advised to stay with school nurse for 1 hour and re-evaluate weakness. If weakness persisted, advised to call physician. Upon f/up from school RN, pt remained in clinic until 11:40am when student stated she felt "much better" and strength of left hand was almost that of the right. School nurse states "vitals remained good".
17 2021-05-10 lightheadedness vasovagal reACTION
17 2021-05-10 fainting Few minutes after Pfizer 1st dose injection, patient felt lightheaded and fainted.
17 2021-05-11 chest pain Per parent report: Friday 4-30-21. Vaccine was given at 1500, at 1730 client displayed a rash on fa... Read more
Per parent report: Friday 4-30-21. Vaccine was given at 1500, at 1730 client displayed a rash on face and chest with extreme fatigue and chills. client took Benadryl. Saturday 5-1-21. Rash gone, but extreme fatigue, crushing pain on chest and pain in arm. continued to take Benadryl. Sunday 5-2-21. Extreme fatigue. continued to take Benadryl. Monday 5-3-21. Still extremely fatigue, DC'd Benadryl. Tuesday 5-4-21. some improvement in fatigue, but experienced some brain fog. Wednesday 5-5-21. attended school where she presented to the health office with medical concerns, see quote taken from an email with the school nurse: "She missed school on Monday and Tuesday due to the reaction. On Wednesday, she presented to the health office with extreme redness to the face and chest. Emergency services was called and she was transported to the hospital. Benadryl was given in the rig to which she responded to well." parent reported that ER doctor ran many tests but did not determine cause. Tuesday 5-11-21. saw Primary Care provider. client is still having significant "brain fog". she is very confused more than half the day, not remembering things or events, and will zone out or fall asleep in inappropriate places with out realizing it.
17 2021-05-11 loss of consciousness Patient was in recommended observation and was on the phone with her father and told him she began t... Read more
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.
17 2021-05-11 pallor, hypotension lIght headed, tingling of fingers, pale, diaphoretic, c/o tingling of the throat briefly. sips of g... Read more
lIght headed, tingling of fingers, pale, diaphoretic, c/o tingling of the throat briefly. sips of gatorade. hypotensive: 80/40, 88; placed on stretcher semi-trendelenberg . BP: 120/P, No LOC.
17 2021-05-11 platelet count decreased, low platelet count Hematomas on the body from the thrombocytopenia
17 2021-05-12 anaemia, chest discomfort, fast heart rate Approximately 5 minutes after receiving vaccine client became quiet, clenching fists, and started cr... Read more
Approximately 5 minutes after receiving vaccine client became quiet, clenching fists, and started crying. RN asked if she was okay, stated she was scared and that her arms felt weird and her chest was tight. RN asked some questions about her health history, she then offered a granola bar and water. Client drank some water, declined snack. Clients hand began to shake, RN offered to lay client on a cot but client declined. Her dad came to check on her, she broke down saying that her arms were numb and chest was tight. The 15 vaccine minute timer went off, client stood but legs were week. She sat down and then slid herself onto the floor. She at first went into a fetal position then laid out flat on the floor. Client began acting more panicked and frantic with short quick breaths and her hands appeared to be contracting some. Clinic team made the decision to call 911 and administer 0.50 mg epinephrine. Ambulance arrived quickly and client was taken to the Medical Center via ambulance.
17 2021-05-12 fainting school nurse filled out incident report per their policies. Incident highlights: "Pt got her mom?s... Read more
school nurse filled out incident report per their policies. Incident highlights: "Pt got her mom?s attention and started to slump down, Mom and volunteer? Were able to assist her to the floor. No injuries during the episode, did not hit her head. She has twitching of her extremities which appeared to be a seizure. Mom stated there was no seizure history. EMS was called. Pt was alert when EMS arrived, they assessed her and it was determined that she should get an evaluation but EMS gave the option to transport themselves for follow up as she appeared stable." unable to contact mother, no additional information available.
17 2021-05-13 pallor Patient was sitting in observation for about 10 minutes and complained of feeling dizzy and fuzzy. P... Read more
Patient was sitting in observation for about 10 minutes and complained of feeling dizzy and fuzzy. Pt was pale and sweating. This RN assisted patient to wheelchair and escorted patient to EMS room. Pt was lying on the cot; ice pack was applied to Pt forehead and neck. BP 102/60, P 80. Pt refused drink and snacks when RN offered. Pt reported of feeling better after 15 minutes. Patient's mother was with Pt at all times. Pt and her mother left at 15:30 without any complications.
17 2021-05-13 fainting Episode of syncope in observation area. No s/sx of distress. AOx3. Given water, assisted to stretche... Read more
Episode of syncope in observation area. No s/sx of distress. AOx3. Given water, assisted to stretcher & sx resolved (BP 118/75; HR 71; RR 16; O2 sat 100%). No health hx or medications. Released from vaccine site with mother
17 2021-05-13 fainting Patient given dose @ 6:00 pm, mother stated prior that she had passed out with HPV vaccine in past.... Read more
Patient given dose @ 6:00 pm, mother stated prior that she had passed out with HPV vaccine in past. Had patient lay back while giving vaccine and after 5 minutes she stated she felt fine and proceeded to waiting area. After sitting in chair in waiting room, patient fainted, return to previous state by 6:20.
17 2021-05-14 loss of consciousness, increased heart rate Patient got vaccinated at 4:03 p.m. At 4:10 p.m., patient had involuntary muscle movements and lost ... Read more
Patient got vaccinated at 4:03 p.m. At 4:10 p.m., patient had involuntary muscle movements and lost consciousness. Per parent, patient has history of panic attacks presenting like same symptoms observed., vital signs taken: BP 154/89 and 120/77, PR: 138; blood glucose: 124, EKG: sinus tachycardia; oxygen given at 4:26 p.m. and discontinued at 4:37p.m.; patient transported to hospital at 4:45 p.m.
17 2021-05-14 loss of consciousness pt was very scared before vaccine, after vaccine passed out, i suspect syncope , came back fast sat ... Read more
pt was very scared before vaccine, after vaccine passed out, i suspect syncope , came back fast sat and was fine
17 2021-05-14 loss of consciousness Approx 2 minutes after receiving dose, patient became dizzy. Per pt's father, patient became stiff ... Read more
Approx 2 minutes after receiving dose, patient became dizzy. Per pt's father, patient became stiff and tremored some. He lowered patient to the floor at which time there was LOC. Reaction clinician used smelling salts which brought patient to (pt was out for approx 1 min per staff) No loss of bowel/bladder. Pt was brought to med obs 1 via stretcher. Vitals taken, water and crackers given Pt feeling well and discharged to home with father and sister Vitals: 11:46 HR 82, Resp 16, BP 109/70, O2 100 12:02 HR 86, Rep 16 BP 102/70, O2 100
17 2021-05-14 fainting faint; Fever; chills; body ache; diahhrhea; nausea; light headed ness; unable to move cause in so mu... Read more
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.
17 2021-05-15 loss of consciousness While sitting in class, suddenly passed out and vomited at the same time. Came to about 30 seconds l... Read more
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.
17 2021-05-15 fainting Patient felt light headed and fainted. Patient was alert and aware immediately and did not sustain ... Read more
Patient felt light headed and fainted. Patient was alert and aware immediately and did not sustain injury. Ambulance was called but patient did not end up needing.
17 2021-05-16 chest discomfort Patient received first COVID19 Pfizer vaccine on 4/18. At that time, had about 3 days of cough and ... Read more
Patient received first COVID19 Pfizer vaccine on 4/18. At that time, had about 3 days of cough and chest tightness. Subsequently began having neck pain on 5/8 and received second Pfizer vaccine on 5/9. Then began having fevers (Tmax 103F), cough. Admitted to Hospital on 5/15 with respiratory failure and shock. Unclear etiology of pneumonia vs multisystem inflammatory syndrome in children (MIS-C). Did not initially respond to antibiotics so treatment for MIS-C was initiated. Now slowly improving but still hospitalized.
17 2021-05-16 chest discomfort chest and throat tightness
17 2021-05-16 loss of consciousness PATIENT PASSED OUT IN DAD'S ARMS, CAME TO WHEN WE LAID HER DOWN SWEATINESS AND DIZZINESS RESOLVED ON... Read more
PATIENT PASSED OUT IN DAD'S ARMS, CAME TO WHEN WE LAID HER DOWN SWEATINESS AND DIZZINESS RESOLVED ON ITS OWN
17 2021-05-16 loss of consciousness THE PATIENT, AFTER RECEIVING ONE DOSE OF VACCINE, PASSED OUT AND WAS HAVING DIFFICULTY BREATHING, SH... Read more
THE PATIENT, AFTER RECEIVING ONE DOSE OF VACCINE, PASSED OUT AND WAS HAVING DIFFICULTY BREATHING, SHORTNESS OF BREATH, SWEATING. SHE WAS CONSCIOUS AT THE TIME THE EMS ARRIVED.
17 2021-05-16 fainting, chest discomfort, chest pain Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chest Tightness / Heavin... Read more
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.
17 2021-05-16 fainting, hypotension Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: sync... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: syncope/seizure like activity-Medium, Systemic: Hypotension-Medium, Additional Details: Patient experienced a syncope/fainting/hypotensive event immediately post vaccination that had characteristics of possible seizure activity. Patient regained consciousness after a few minutes and seemed disoriented but stable (still hypotensive). Transported to reading hospital (tower health) emergency room for evaluation
17 2021-05-16 fainting Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient was administered the Pfizer Covi... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient was administered the Pfizer Covid Vaccine. A few minutes later, while watching her mom receive the vaccine she fainted. Patient was unresponsive for less than a minute. Upon regaining consciousness patient seemed to recover fully after resting and drinking some water.
17 2021-05-17 blood pressure decreased, fainting about 5 minutes after receiving injection, patient's BP dropped. She was sitting when it happened an... Read more
about 5 minutes after receiving injection, patient's BP dropped. She was sitting when it happened and we rushed over to put feet up. She was non-responsive for about a minute and then started to come back for syncope episode. Water was provided until ambulance arrived to check on patient.
17 2021-05-17 loss of consciousness Patient passed out as soon as she got to the waiting area post-vaccination. She was unresponsive for... Read more
Patient passed out as soon as she got to the waiting area post-vaccination. She was unresponsive for less than 15 seconds before waking up. She was breathing the whole time. We moved her to the ground to avoid any injury if she was to pass out again. We called paramedics who were at the pharmacy within 5 minutes. They checked vital signs and deemed she was ok. Patient walked out of the store on her own with her mother.
17 2021-05-17 pulmonary embolism, cardiac arrest, heart failure, fibrin d dimer increased on 5/14 developed severe bilateral pulmonary embolism with severe right ventricular hypertension and... Read more
on 5/14 developed severe bilateral pulmonary embolism with severe right ventricular hypertension and heart failure. Progressed to cardiac arrest requiring mechanical circulatory support (ECMO) in PICU. Managed in the Cardiac ICU
17 2021-05-17 fainting patient fainted five minutes after receiving vaccine. regained consciousness and emts evaluated but... Read more
patient fainted five minutes after receiving vaccine. regained consciousness and emts evaluated but did not have to go to hospital
17 2021-05-17 fainting Fainting/syncope; high fever; lightheadedness; This is a spontaneous report from a contactable consu... Read more
Fainting/syncope; high fever; lightheadedness; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 29Apr2021 at 14:30 (at the age of 17 years old) (Lot Number: EW0171, unknown expiration) as 2nd dose, single for COVID-19 immunization. Medical history reported as none. No known allergies. The patient's concomitant medications were not reported. The patient also received first dose of BNT162B2 on 08Apr2021 at 16:30 in the left arm (at the age of 16 years old; Lot number: EW0150, unknown expiration) for COVID-19 immunization. The patient experienced fainting/syncope, high fever, and lightheadedness on 30Apr2021 at 06:45 AM. The events resulted in emergency room/department or urgent care visit. The patient received IV fluids as treatment for the events. No COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient is recovering from the events. Information on lot/batch number was available. Additional information has been requested.
17 2021-05-18 very slow heart rate 17 year old patient with no known allergies who was given 1st dose of Pfizer vaccine at 1655. At 170... Read more
17 year old patient with no known allergies who was given 1st dose of Pfizer vaccine at 1655. At 1700 during observation patient mentioned to the mother that she was not feeling well, was slumped over. The RN on observation noticed that she was apneic, whole body was rigid. Vital signs at 1701: BP 153/88, HR: 64. Oxygen saturation 99%. After 5 minutes a recheck of the vital signs: BP 115/74, HR: 64. Oxygen 97%. Patient did state that she gets anxious when she gets shots.The paramedics were called. Vital signs on arrival: 117/83, HR: 58, Oxygen saturation 100%. Blood sugar 70. After a few minutes patient stated that she was feeling a little better. Patient was able to walk to the ambulance for them to perform an EKG: Results were normal sinus bradycardia.(Patient is an athlete). Patient's mother declined further treated and signed AMA form.
17 2021-05-18 loss of consciousness, fainting patient experience dizziness after receiving immunization and later fainted . Patient sat on ground ... Read more
patient experience dizziness after receiving immunization and later fainted . Patient sat on ground before completely fainting to floor with help of mother and regained consciousness about 1 minute later. patient complained of muffled voices and trouble hearing for about 4 minutes, sweating , dizziness and shakiness. patient received water and Gatorade and cool cloth behind neck area. patient able to leave after approximately 20minutes in care of mother feeling better.
17 2021-05-18 loss of consciousness About 5 minutes after shot, the patient's mother alerted us to her daughter being unconscious. She ... Read more
About 5 minutes after shot, the patient's mother alerted us to her daughter being unconscious. She was sitting in a chair slumped forward, we pushed her back in the chair. The patient was tensed up, sweaty, with labored breathing. She was assessed to not to be in respiratory distress and held so she wouldn't slide out of the chair she was sitting in. She began to return to consciousness and pulse seemed relatively normal with breathing returning to normal after 3 minutes. Local EMS was activated. The patient was given cold water to hold on her neck and was alert. Local EMS assessed she was ok and the patient's mother refused transport to the ED. The patient left on her own.
17 2021-05-18 pallor Patient began to feel faint within 2 minutes after receiving vaccine. Became pale and diaphoretic. ... Read more
Patient began to feel faint within 2 minutes after receiving vaccine. Became pale and diaphoretic. Patient was brought to floor and began to show improvement immediately. Patient remained in observation until 9:05 AM (25 minutes after vaccine administration) and was cleared to discharge home with father at that time.
17 2021-05-18 pallor Client received 1st COVID vaccine of Pfizer (Lot# EW0185 expiration 05/23/2021). At 1347, RN assiste... Read more
Client received 1st COVID vaccine of Pfizer (Lot# EW0185 expiration 05/23/2021). At 1347, RN assisted Client to stand up from vaccination chair. Client began to have unsteady gate. Both RN and RN assisted Client back to the gravity chair. At 1348, RN and PHN responded to the event. At 1348, vital signs are blood pressure 116/72, heart rate 64, oxygen saturation 100%. Client reported no blurry vision no headache, appearance is pale. Client is accompanied by mother. Per client's mother, Client has no medical history, allergies to dogs, and a history of syncope and lightheaded with needles/vaccines. At 1352, vital signs are blood pressure 118/82, heart rate 62, oxygen saturation 100%. Client reports lightheaded, feels tired, no shortness of breath, no headache. Supplemental nutrition and fluids provided to Client . Client accepted. At 1357, vital signs are blood pressure 116/76, heart rate 63, oxygen saturation 100%. Client reports no headache, no blurred vision, lightheaded improving, feels "sleepy", and skin tone returning to appropriate ethnicity. PHN educated client and mother ED precautions, common adverse effects of COVID vaccine, and emphasize a follow up with primary care provider. At 1400, vital signs are blood pressure 118/72, heart rate 63, oxygen saturation 100%. At 1402 Client stood up with no complains. At 1403 Client walked out of vaccination facility with a steady gait accompanied by mother.
17 2021-05-18 fainting 2nd dose Pfizer vaccine administered patient was in Observation Area and c/o of sweating and dizzine... Read more
2nd dose Pfizer vaccine administered patient was in Observation Area and c/o of sweating and dizziness. Patient fainted for about 2 seconds. Patient arousable and VS were within normal ranges, blood sugar was 68 when being cared for by EMS. Pt states she has had this history of reaction before to vaccines. She had not eaten or drank anything since around 8pm the night before. Patient given water and a food and stated she felt better. Patient remined in Obs area for an additional 40 minutes with EMT, RN and Physician oversight.
17 2021-05-18 fainting Patient experienced syncope shortly after receiving vaccine while standing. Patient fell and remain... Read more
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.
17 2021-05-19 blood glucose increased Patient's sister came over to get RN and said patients throat was closing up. RN Grabbed doctor on ... Read more
Patient's sister came over to get RN and said patients throat was closing up. RN Grabbed doctor on site to assess. MD and RN auscultated with stethoscope; good air movement and color. Alert, oriented, speaking full sentences. The patient had a potential reaction to COVID-19 vaccine. Many co-morbidities and previous reaction noted. Rn and MD evaluated. Despite good air flow, patient reports throat closing up. Patient self-dosed Benadryl (50mg) with no improvement. 911 called. Mom Called. RN gave report to EMS, EMS took over care and consulted mom who denied transport and with patient. Patient's blood glucose also read "high" on meter x2 times.
17 2021-05-19 pallor, loss of consciousness, lightheadedness Passed out; Vasovagal reaction; Dizzy; Skin was sweaty; Pale; This is a spontaneous report from cont... Read more
Passed out; Vasovagal reaction; Dizzy; Skin was sweaty; Pale; This is a spontaneous report from contactable Pharmacist. A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 06May2021 10:15 am (Lot Number: EW0171) at the age of 17-year-old as single dose for covid-19 immunisation. Medical history reported as none. No known allergies. The patient was not pregnant. The patient's concomitant medications were not reported. Vaccine was given, patient was sitting with her mother. Approximately 10 minutes after vaccine, she slumped to the side and passed out. When the reporter got to her she was just waking up. She still felt dizzy, skin was sweaty and pale. Paramedics arrived within 5-10 minutes to evaluate. They said they had seen this vasovagal reaction with the covid vaccine. Patient left on gurney with the paramedics. Adverse events start date was 06May2021. Events resulted in Emergency room/department or urgent care. The outcome of the events was unknown. The patient had no covid prior vaccination, no Covid tested post vaccination.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event of Loss of consciousness. 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.
17 2021-05-19 lightheadedness Blurry vision, near syncope after receiving vaccine. Onset of symptoms was 3-4mins after vaccine adm... Read more
Blurry vision, near syncope after receiving vaccine. Onset of symptoms was 3-4mins after vaccine administration. Did not eat breakfast this morning Given juice and crackers Exam was normal Discharged to home
17 2021-05-19 fast heart rate Patient a 17 year old female developed supraventricular tachycardia post-immunization reaction.
17 2021-05-19 fainting, hypotension, heart rate increased While waiting for 15 mins monitoring after getting Pfizer covid vaccine, she fainted and fell off th... Read more
While waiting for 15 mins monitoring after getting Pfizer covid vaccine, she fainted and fell off the chair. She fell on the ground and hit her head. Nurse and pharmacy staff rushed to her aid. She appeared to have convulsions for about a couple seconds but regained conciousness right away. We checked vital signs : low blood pressure but high heart rate, oxygen level was good. We placed ice pack on her head where said was hurting. She and her mother refused to call 911. She felt better, however we recommended her mom to take her to urgent care for further evaluations
17 2021-05-20 loss of consciousness, palpitations, fainting 17 y/o female received 1st dose of Pfizer and was sitting in the observation area. She had a witness... Read more
17 y/o female received 1st dose of Pfizer and was sitting in the observation area. She had a witnessed syncopal episode, lasting approx. 45-60 secs. When pt. regained consciousness she was placed in a wheelchair and moved to a private area. VSS at that time. Pt. was given some water to sip on and stated she was feeling better. Pt. denied any other complaints at that time. Pt. denied any PMH/ Meds./Allergies. Pt?s grandmother is with her and states pt. appears to be back to baseline. Approx. 30mins. after syncopal episode, pt. stated ?my heart is racing and my throat feels dry?. VS reevaulated, pt?s HR was 122, BP 130/66. Pt. stated she wanted to go to the ER. She was t/p BLS to ER. See PCR for further.
17 2021-05-20 loss of consciousness Patient lost conscious and fell to the ground. hit back of head. Patient is alert and oriented. Brou... Read more
Patient lost conscious and fell to the ground. hit back of head. Patient is alert and oriented. Brought to ED.
17 2021-05-20 loss of consciousness Pt received vaccine and was walking around the store and passed out. Pt was responsive , alert and ... Read more
Pt received vaccine and was walking around the store and passed out. Pt was responsive , alert and oriented. 911 was called. Paramedics arrived and was checked out. They released her to go home without additional followup.
17 2021-05-20 inflammation of the heart muscle, troponin increased, chest pain Chest pains, difficulty breathing, outcome: diagnosed with myopericarditis and costochondritis as we... Read more
Chest pains, difficulty breathing, outcome: diagnosed with myopericarditis and costochondritis as well as inflammation in joints. Was in the hospital for 7 days and was on IV, morphine and then switched to hydro-morph for severe pain. Was given ketorlax via Iv for inflammation as well and steroids. Has been put on steroids for 1 month, Colchicine for 3 months, naproxen for inflammation.
17 2021-05-20 pallor dizzy, pale, fullness in ears. Increased monitoring. VSS and symptoms resolved
17 2021-05-20 lightheadedness (Vasovagal Response) Felt tired and ?felt like fainting? immediately after shot. Pt laid down and e... Read more
(Vasovagal Response) Felt tired and ?felt like fainting? immediately after shot. Pt laid down and elevated feet. No additional treatment needed. (Initial BP 87/58)
17 2021-05-20 fainting, excessive bleeding Systemic: Fainting / Unresponsive-Medium, Additional Details: Pt fainted after vaccine, hit head on ... Read more
Systemic: Fainting / Unresponsive-Medium, Additional Details: Pt fainted after vaccine, hit head on nearby object. sustained approx 2 cm laceration to scalp with moderate bleeding. applied saline wound wash and gauze. bleeding stopped. VS normal BP110/72, P90,RR14,O297%RA. Pt revived after1-2 min. She sat up and was able to walk. Mom at work. Mom called neighbor to pick up pt. Mom agreed to have FM take pt to ER/urgent care.
17 2021-05-21 fainting Immediately after the receiving dose #1 of Pfizer COVID-19 immunization the patient fainted. Patient... Read more
Immediately after the receiving dose #1 of Pfizer COVID-19 immunization the patient fainted. Patient remained seated until she came back to after 2 mins. Patient's mother was in the room, and stated this happens every-time she gets a shot. VAR stated no history of fainting or reaction after any vaccinations. Patient remained seated for 15 minutes while being monitored. After she stated she felt normal and left in her mothers care. No medication was administered.
17 2021-05-21 fast heart rate, heart rate increased Tachycardia began at 27 hours after vaccine with hear rate up to the 160s . Fever developed after th... Read more
Tachycardia began at 27 hours after vaccine with hear rate up to the 160s . Fever developed after the tachycardia 31 hours after vaccine. Patient was monitored in the hospital on propranolol and was sent home on propranolol.
17 2021-05-22 nosebleed Nosebleeds Bruising
17 2021-05-23 chest discomfort, chest pain Received dose #1 on the 17th, about 3-4 days later noticed having chest pain, described as a "pressu... Read more
Received dose #1 on the 17th, about 3-4 days later noticed having chest pain, described as a "pressure" that is worse with deep breathing and lying down. This was a telemedicine visit. She was well appearing, but sent her to urgent care for further eval.
17 2021-05-23 chest discomfort, fast heart rate, heart rate increased Systemic: Chills-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Numbness (specify: facial ar... Read more
Systemic: Chills-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: patient was feeling cold, hot, shaky, weak, a heavy chest feeling, numbness in extremities a few minutes after her vaccine. Her pulse went from 80, 99, to 110 after 3 readings. Her BP was normal. Her brother said she just had a unspecified chest procedure. It wans't noted on her intake. She wasn't feeling after lying down for 30 minutes with legs propped up and wanted to paramedics to come. They sent her home after another 30 min. She doing well before she left.She went to school day after.
17 2021-05-23 chest discomfort Patient developed chest tightness during soccer tournament the day after receiving first dose of COV... Read more
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.
17 2021-05-23 loss of consciousness, fainting Syncopal episode resulting in 911 response. Pt became lightheaded then lost consciousness for approx... Read more
Syncopal episode resulting in 911 response. Pt became lightheaded then lost consciousness for approximately 30 seconds. Pt did not fall and no trauma was sustained. She was taken to a private recovery area where she was placed in trendellenburg?s. Vitals signs monitored every 5 minutes. Upon EMS arrival, pt was assessed with findings unremarkable. Pt refused transport by EMS and was released from the clinic after she displayed no symptoms for 10 minutes.
17 2021-05-23 loss of consciousness Patient was extremely nervous prior to vaccine. Got shot, walked out of room to waiting area. about ... Read more
Patient was extremely nervous prior to vaccine. Got shot, walked out of room to waiting area. about 2-3 minutes post vaccine, realized did not feel well. Passed out. Mom said patient felt a touch rigid and twitched a couple times, then came too. Did hit head when patient fell to floor, although was not a major hit. Patient was worked up after coming to.
17 2021-05-23 inflammation of the pericardium, chest pain Patient developed substernal chest pain that began about 3 days after her first Pfizer Covid shot. ... Read more
Patient developed substernal chest pain that began about 3 days after her first Pfizer Covid shot. It was worsened by laying flat and relieved somewhat by sitting upright or forward. NSAIDS were slightly effective at improving the pain. It took about a week to totally resolve. The patient went to a walk-in clinic initially and they noticed right-axis deviation on an EKG and sent her to the Hospital for further workup. She was discharged from the ER several hours later with no clear diagnosis but a suggestion that it sounded clinically like a viral pericarditis.
17 2021-05-23 lightheadedness, chest discomfort After receiving dose, pt experienced Vasovagal response which she never had before when receiving a ... Read more
After receiving dose, pt experienced Vasovagal response which she never had before when receiving a shot. When they woke her she had a lot of jerky arm movement. About half an hour to 1hr after injection she said she had an odd taste in her mouth and her tongue was numb. Her chest felt tight but was not wheezing. About an hour later when she was home (~6pm) gave her "click it albuterol" and it relieved the tightness in the chest. She had pain in her left breast area. Around 6:30pm she continued to comment about her tongue being numb and pain in her breasts. She fell asleep right away and the next afternoon around 1pm she had a temperature of 99F. After motrin the temperature went back to normal and she felt better. No further chest tightness after that and she is feeling normal.
17 2021-05-23 fainting The day after the vaccine, she had an episode of syncope while in the bathroom. She does not remembe... Read more
The day after the vaccine, she had an episode of syncope while in the bathroom. She does not remember the event, but was at a friend's house and was found in the bathroom after they heard a bang and was noted to be shaking. She then passed out again and continued shaking. She texted her mom and was given a cold rag on her forehead but has no recollection of any of that. Afterwards, she returned to normal.
17 2021-05-23 fainting Systemic: Allergic: Anaphylaxis-Severe, Systemic: Fainting / Unresponsive-Severe
17 2021-05-23 fainting Patient became light headed and fainted from a seated position about 10 minutes after her first Pfiz... Read more
Patient became light headed and fainted from a seated position about 10 minutes after her first Pfizer COVID-19 vaccination. She doesn't think she lost consciousness. Her skin was quite warm and sweaty after this event. I had her remain laying down on the ground while she recovered and I assessed her symptoms. She felt better almost immediately so I had her move to the pharmacy office for observation for an additional 15-20 minutes. She then reported that she has fainted with shots before and she hadn't eaten anything today. Her mother said this has happened before and drove her home once she felt well again.
17 2021-05-23 fainting Fainted for 5 sec, HR 75 bpm, oxygen saturation 99%, recovered w water and oreos
17 2021-05-23 fainting Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Mild
17 2021-05-24 chest discomfort My 17 year old daughter had her second Pfizer shot on Sunday, May 16 at 10AM. On Wednesday, May 19th... Read more
My 17 year old daughter had her second Pfizer shot on Sunday, May 16 at 10AM. On Wednesday, May 19the she woke up and said that she had a terrible time in the middle of the night with a tight chest and she couldn't catch her breath. She wouldn't go to Urgent Care with me so I told her that we had to call the 24 hour nurse line (on the back of the insurance card). I called and she spoke with a nurse, then spoke with a doctor on the phone who told her to go the doctor if her symptoms got any worse.
17 2021-05-24 loss of consciousness, fainting Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Shakines... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild
17 2021-05-24 loss of consciousness, fainting Pt was swimming and started to cough (felt swallowed water) and upon getting out of water - collapse... Read more
Pt was swimming and started to cough (felt swallowed water) and upon getting out of water - collapsed and lost consciousness for a few seconds
17 2021-05-24 loss of consciousness Patient passed out after receiving her 2nd dose of the Pfizer COVID19 vaccine. Patient was sitting i... Read more
Patient passed out after receiving her 2nd dose of the Pfizer COVID19 vaccine. Patient was sitting in waiting area after receiving the dose when she passed out and her mother was holding on to her. Patient came back after a few seconds and was laid to the ground. Her BP read at 107/68 and then later at 101/71. Mom stated that patient has history of passing out before. She stayed with us until she felt better until her mom took her home.
17 2021-05-24 palpitations PATIENT FELT FAINT, HAD PALPITATIONS. EVENTUALLY FELT BETTER AND RETURNED HOME.
17 2021-05-24 fainting PATEINT RECEIVED INJECTION AND ABOUT 6 MIN LATER SHE FAINTED AND HAD A 5 SEC SEIZURE. WOKE UP ON HE... Read more
PATEINT RECEIVED INJECTION AND ABOUT 6 MIN LATER SHE FAINTED AND HAD A 5 SEC SEIZURE. WOKE UP ON HER OWN
17 2021-05-24 fainting Patient fainted within 15 minutes of vaccination. She had not eaten that day. Given some food; no ... Read more
Patient fainted within 15 minutes of vaccination. She had not eaten that day. Given some food; no treatment needed and she was released to home with a parent.
17 2021-05-25 blood pressure decreased, heart rate decreased Pt felt lightheaded and sweaty and heart rate dropped to 50 and blood pressure dropped to 70/30. Pa... Read more
Pt felt lightheaded and sweaty and heart rate dropped to 50 and blood pressure dropped to 70/30. Paramedics were called 911 and arrived at 12:32 the episode happened at 12:30 by the time the paramedics arrived she was feeling better she had been put on the floor with her legs elevated on a chair and her blood pressure has come up since then she had refused to go to the hospital because she fell back to her normal.
17 2021-05-25 chest pain Fever of 103; chills; sweating; body ache; nausea; vomiting; diarrhea; headache; couch; chest pain; ... Read more
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.
17 2021-05-25 hypotension, chest discomfort On 5/19 she got her first Covid Vacc (Pfizer). The following day she had mild fatigue and chills, bu... Read more
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.
17 2021-05-25 loss of consciousness, fainting Pt fainted several minutes following vaccination. Pt's mother was vaccinated, then patient, then pat... Read more
Pt fainted several minutes following vaccination. Pt's mother was vaccinated, then patient, then patient's sister. Pt left vaccination chair following vaccination to allow her younger sister to sit. She stood for several minutes, leaning against wall/counter but immediately after her sister's vaccine she fainted. She slid down the counter but her mother and the vaccination caught her before she landed on the floor. She lost consciousness for approx. 30 seconds, regaining it slowly. While no health conditions were reported on the VAR form the pt appeared to possess traits of a developmental difficult such as Down's syndrome. While she awoke she didn't want to speak and appeared nervous. After approx. 2 min the patient spoke voluntarily. After several more minutes of deep breaths, patient sat up and answer questions regarding the time and place and personal history. She moved to another area to sit, was given water, and after approx. 25 min, left with her family.
17 2021-05-25 loss of consciousness Passing out POT syndrome has occurred 10 times since initial vaccine; Passing out POT syndrome has o... Read more
Passing out POT syndrome has occurred 10 times since initial vaccine; Passing out POT syndrome has occurred 10 times since initial vaccine; 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 on 07Apr2021 15:15 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunization. Medical history included history of migraines from an unknown date and unknown if ongoing. Concomitant medication included vitamin d3 taken for an unspecified indication, start and stop date were not reported. Passing out POT syndrome has occurred 10 times since initial vaccine worsening post second vaccine on 13Apr2021 12:00. The patient experienced "passing out POT syndrome has occurred 10 times since initial vaccine" and was reported as worsening post second vaccine. 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 hasn't been tested for COVID-19. Therapeutic measures taken as a result of the event included a Heart monitor (as reported). Outcome of events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
17 2021-05-25 pallor Pt diaphoretic, pale, nauseas, blurred vision, difficulty hearing, lightheaded, SOB, 10 minutes afte... Read more
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.
17 2021-05-25 fainting Two days after receiving the vaccine, the patient fainted at the home. Has had intermittent shortne... Read more
Two days after receiving the vaccine, the patient fainted at the home. Has had intermittent shortness of breath, and dizziness
17 2021-05-25 fainting Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild
17 2021-05-26 blood pressure increased, pallor Less than 1 minute after received the shot, patient became clammy and pale while sitting in chair. H... Read more
Less than 1 minute after received the shot, patient became clammy and pale while sitting in chair. Her eyes rolled back in her head and her body went slack. Myself (parent) and the nurse who had given the shot braced her on either side while she appeared to fade in and out of consciousness for several minutes (she seemed to occasionally interact with us, mumbling responses to 'yes' or 'no' questions). The nurse did not want to lower her to the floor, but wanted to keep her propped on the chair. Her head kept rolling to the side. At one point, she began to jerk rhythmically. Just as I was about to bring this to the attention of the nurse, the patient returned to consciousness. Patient was moved to a rolling recliner chair and taken to a recovery area where I (parent) did not see her for another 30 minutes as I was receiving my own shot. The chair she had sat in was wet, but it was assumed this was due to sweat (patient had sweated profusely). On the way out of the clinic, noticing a wet stain on the back side of patient's pants, I asked if she had wet her pants (quietly) two separate times. Patient denied it both times. However, upon returning home, patient confirmed that she had wet her pants. Patient was monitored during the evening for similar adverse events ; none noted. Patient ate lunch approximately 1 hour before receiving shot and was given crackers while at clinic. Patient is a well-hydrated individual, and also drank water while on-site. No fever either before or after shot. A slightly elevated BP the next day (135/83). However, patient complained of headache, fatigue, and pain at injection location; elevated BP may be related to headache and/or ordeal from day of the shot.
17 2021-05-26 hypotension Site: Pain at Injection Site-Medium, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-M... Read more
Site: Pain at Injection Site-Medium, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: BP 103/65 Pulse 62-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Additional Details: EMS was called but she went home with her mother and slept the rest of the day, she had a sore arm on Tuesday but was otherwise fine per mom.
17 2021-05-26 pallor, fainting Patient upon seated for the 15 minutes post-vaccination fainted. When she was coming through, she st... Read more
Patient upon seated for the 15 minutes post-vaccination fainted. When she was coming through, she started shaking as if she was having a seizure. When I reached the patient, she was shaking and then came through and stopped shaking. Patient was still pale, sweating, and didn't feel okay. 911 was already called once the patient was shaking. As I am checking in on the patient, the mom discloses that she has fainted at least twice before and when she comes through she shakes but it is not seizures. However, during the screening process, patient and mom stated the patient never had any problems when getting vaccinated. I got her BP checked and it was 102/61 and HR of 92. We had the patient sit still and drink water. When EMS arrived within 5-10 mins, they took her vitals and it was 112/70s and HR of 84 with 98% O2 sat. Patient and mom decided to be taken to the ED to make sure she is okay.
17 2021-05-26 pallor, fast heart rate Patient began to sweat, complained of blurred vision, and turned very pale in the face. We called 91... Read more
Patient began to sweat, complained of blurred vision, and turned very pale in the face. We called 911 and I stayed with the patient monitoring heart rate and symptoms. Patient was slightly tachycardic upon initial assessment. Once EMS arrived, patient had had resolution of blurred vision and the sweating. Her vitals were normal. Her mom refused further treatment to the hospital. I recommended to follow up with pediatrician.
17 2021-05-26 fainting, hypotension Site: Pain at Injection Site-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Me... Read more
Site: Pain at Injection Site-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Fever-Medium, Systemic: JAW AND THROAT PAIN-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium
17 2021-05-26 fainting Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Det... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient recovered in about 20 to 25 minutes.
17 2021-05-26 fainting Fainted shortly after vaccination, patient was seated and assisted
17 2021-05-26 fainting An attendee fainted after receiving vaccine Pfizer 1st dose. She didn?t lose her airway. The busines... Read more
An attendee fainted after receiving vaccine Pfizer 1st dose. She didn?t lose her airway. The business called 911 they assessed the situation and said she was ok. Patient up walking around.
17 2021-05-26 fainting Patient fainted in a chair in the waiting area during observation period (~10 minutes after vaccinat... Read more
Patient fainted in a chair in the waiting area during observation period (~10 minutes after vaccination). Patients guardian said the patient has a history of vasovagal syncope in medical environments. Patient recovered in a few minutes. Patient remained in the chair for 15 minutes until her guardian and her were able to leave the store on their own accord.
17 2021-05-26 fainting Patient fainted and felt hot. Patient fainted within 10 seconds of receiving vaccine. Once patient c... Read more
Patient fainted and felt hot. Patient fainted within 10 seconds of receiving vaccine. Once patient came to, she sat down for about 15 minutes and felt better. Patient stated she did not eat anything before.
17 2021-05-27 chest discomfort Patient felt like she was having trouble breathing, stated it felt like someone was sitting on her c... Read more
Patient felt like she was having trouble breathing, stated it felt like someone was sitting on her chest. didn't feel like throat was closing, but felt anxious. asked patient if she would like benadryl, she stated yes. sat for 20 minutes after receiving benadryl and felt okay, felt like her trouble breathing went away.
17 2021-05-27 loss of consciousness, fainting at 2:30pm pt had temporary loss of consciousness for approx. 15 seconds pt. was safely assisted to g... Read more
at 2:30pm pt had temporary loss of consciousness for approx. 15 seconds pt. was safely assisted to gurney and placed in supine position with BLE elevated. vitals monitored VS BP 97/67 P-65 RR-17 o2SAT 97% RA pt offered fluids and snacks pt refused snacks pt had water. 230pm pt denies dizziness no headache no SOB no lightheadness vitals BP80-/50 17,69, 98%RA 245pm pt bp still cont. to be below normal. bp 87/57 P-63 RR-18 o2SAT 97% RA pt was recommended to sent to hospital for further eval. 255pm 911 came and elaluated pt per paramedics based in theri eval. pt. &mother was made to choose to go to the hospital or go home pt. and mom choose to go home. #23 Syncope #21 went home against med advice
17 2021-05-27 loss of consciousness Passed out/ got chills and sweats after receiving vaccine at the Pharmacy. Proceeding the vaccine sh... Read more
Passed out/ got chills and sweats after receiving vaccine at the Pharmacy. Proceeding the vaccine she had headaches and still gets them and it?s currently 05/27/2021 which it?s been 9 days since also for 3 days after vaccine was extremely exhausted.
17 2021-05-27 fainting, loss of consciousness She had been bleeding since May 2. We took her to Hospital Pediatric ER on Thursday, the ambulance t... Read more
She had been bleeding since May 2. We took her to Hospital Pediatric ER on Thursday, the ambulance took her in because she had a seizure on Wednesday (the Ambulance - they stabilized her that day and took her vitals and was sure she was okay - they knew we had an appt to go in the next day at 10:00 am for tests (previously scheduled); Thursday morning she had another seizure - we gave her seizure meds and she came out that - she ate breakfast after and then took her regular meds and the next thing we know ,50 minutes later, her head drop forward and her arms go completely limp and there was no response. She was breathing but she was out. I called the ambulance. And they took her in to ER. What they put in the paperwork was that she had a seizure and they wrote that she had had syncope episode - it took 20 minutes to come out of it. Which she has never had anything like that. We were in the ER for 7 hours. Was admitted to Hospital -from 24th -28th.
17 2021-05-28 chest discomfort, troponin increased, inflammation of the heart muscle I saw and evaluated the patient. I agree with the findings and the plan of care as documented in the... Read more
I saw and evaluated the patient. I agree with the findings and the plan of care as documented in the Fellow note. Of note patient is a 17yo male with no significant past medical history who received the second dose of his Pfizer COVID19 vaccine on 5/25/21. This morning he woke up with chest pressure and eventually was seen at an outside hospital ED. EKG was concerning for possible myocarditis and he was transferred further work-up of myocarditis. On arrival, echocardiogram was performed demonstrating grossly normal LV function with some suggestion of apex hypokinesis. EKG was repeated and showed ST elevation in lead I and V1. Troponin was elevated at 1.11. On exam, no murmurs rubs or gallops. No known family history cardiomyopathy. I personally reviewed the echocardiogram. Overall, patient is a 17yo male with what appears to be myocarditis that is temporally associated with the second dose of the MRNA Pfizer COVID19 vaccine. We have seen several of these patients with similar presentations over the past few weeks and most seem to respond well to treatment with IVIG and steroids. We will confer with our Rheumatology and ID colleagues. Plan will be to obtain cardiac MRI in the next 24 hrs. Ibuprofen PRN for pain. Will trend troponin and EKG.
17 2021-05-28 loss of consciousness passed out; vomited; This is a spontaneous report from a contactable consumer (patient). A 17-year-o... Read more
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.
17 2021-05-28 low blood pressure, lightheadedness Dizziness, presyncope with exertion, nausea, occurring daily
17 2021-05-28 fainting, chest discomfort Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Confusion-Medium, Systemic: Dizziness... Read more
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Medium
17 2021-05-28 fainting She fainted and collapsed about 18 hours after receiving the second dose (6:30 am). She was confused... Read more
She fainted and collapsed about 18 hours after receiving the second dose (6:30 am). She was confused for about an hour after she fainted. She was on ibuprofen (400 mg taken at 5:30 am). Other than weakness, headache, and fever, she has had no other adverse reactions so far besides the single fainting episode.
17 2021-05-28 fainting Syncapal event. Patient was found lying on the ground after being vaccinated with Pfizer first does.... Read more
Syncapal event. Patient was found lying on the ground after being vaccinated with Pfizer first does. Pt had prior history of fainting, and was vaccinated in a supine possition. Pt stayed in a supine possition for about 7 minutes and walked to the observation area with her mom. Patient was assed by parametics and myself. She regained consiousness approximately 10 seconds after even or less. Initial BP 121/83, HR 64, O2 100% room air. Pt vitals retaken at 10:37 BP 110/74, HR 72, O2 100% room air. Pt was advised to stay for an aditional 15 minutes and reassessed. Patient left in stable condition with mom.
17 2021-05-28 fainting Syncope approximately 3 minutes after shot with resulting head injury. Pt conscious on paramedic ev... Read more
Syncope approximately 3 minutes after shot with resulting head injury. Pt conscious on paramedic evaluation with hematoma on forehead. Unable to walk without assistance. Pt's mother chose to drive her for follow up at ED against recommendations of reporter. Fire Department wheeled pt to personal vehicle. Unknown dispositions/outcome.
17 2021-05-28 fainting Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Head... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Headache-Mild, Systemic: Shakiness-Medium, Systemic: Weakness-Severe, Additional Details: Patient was given Pfizer vaccine, told to remain in waiting area for 15 minutes. Immediately after shot she seemed and and was conversing with me normally. 2-3 minutes later her dad noticed that she was tipping over and called for help. When I rushed over, pt was moved to the floor, close to passing out, very weak and shaky. We called 911 - she was responsive. she laid on the floor until ems arrived at which point they took over and took patient to get further checked out.
17 2021-05-29 chest pain Patient was asymptomatic 4 hours after vaccination given at 10a, then in the evening started to deve... Read more
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.
17 2021-05-29 fainting PATIENT FAINTED IMMEDIATELY AFTER VACCINE ADMINISTRATION. PATIENT DID NOT INJURE HERSELF, WAS CAUGH... Read more
PATIENT FAINTED IMMEDIATELY AFTER VACCINE ADMINISTRATION. PATIENT DID NOT INJURE HERSELF, WAS CAUGHT IN MOM'S ARMS. PATIENT WAS EXTREMELY WARM AND CLAMMY AND SHAKY. SHE KEPT SEATED, FAN BLOWING, PROVIDED WITH GATORADE AND FELT NORMAL AFTER 10 MINUTES. PATIENT ADMITTED TO NOT EATING PRIOR TO VACCINE.
17 2021-05-30 chest pain Chest Pains Shortness of Breath Costochondritis - Per the Doctor These conditions were present after... Read more
Chest Pains Shortness of Breath Costochondritis - Per the Doctor These conditions were present after the first vaccine shot on April 6th and then again after the second shot on April 27th. Doctor initially thought it could be a simple case of Acid Reflux and gave her Nexium. Once that didn't work, she had her Chest X Ray done that came back all clear. She then had her blood tests done and that too came all clear except for Vitamin D3 that came in at 15 so doctor gave her a 50,000 unit Vitamin D3 dose. That also didn't do much to relieve the chest pains and shortness of breath so he had her EKG and Echo done and those were all clear as well. Finally, he gave her a day steroid course of Prednisone at 40 mg/day which is where she is currently. It is helping her a bit but she is still complaining of original two issues - chest pain and shortness of breath. She is also doing cold and warm compressions throughout the day that helps her temporarily.
17 2021-05-30 hypotension, fainting The patient felt dizzy and weak then fainted while her mom was holding her . Her mom gradually led h... Read more
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
17 2021-05-31 loss of consciousness received the Covid 19 Pfizer vaccine and passed out approximately 2 minutes after the vaccine. Was s... Read more
received the Covid 19 Pfizer vaccine and passed out approximately 2 minutes after the vaccine. Was seated at the time. Physical support until patient regained consciousness approximately 30 seconds after. Assisted via wheelchair to cot to lay down and water provided. Mother with. Instructed to lay down for second dose of vaccine when receiving it. Left with mother ambulatory in stable condition approximately 30 minutes after dose administered.
17 2021-05-31 fainting, pallor FELT DIZZY AND HAD A WITNESSED SYNCOPAL EPISODE, TRANSPORTED TO COT, APPEARED DIAPHORETIC AND PALE. ... Read more
FELT DIZZY AND HAD A WITNESSED SYNCOPAL EPISODE, TRANSPORTED TO COT, APPEARED DIAPHORETIC AND PALE. PARAMEDIC CAME, BP 86/51, HR 49, OFFERED HYDRATION, SX RESOLVED, NO TRANSPORT, AMA SIGNED.
17 2021-05-31 fainting Patient was very anxious and breathing heavy. About 5 minutes after the vaccination they started to ... Read more
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.
17 2021-06-01 chest pain, heart rate increased First on Saturday May 22 had sore arm, then pain that thought was possibly heartburn/indigestion, fe... Read more
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.
17 2021-06-01 chest pain Follow up report - The symptoms - severe headaches; shortness of breath; difficulty breathing; chest... Read more
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.
17 2021-06-01 loss of consciousness passing out episodes, seizures, hospitalized
17 2021-06-01 loss of consciousness Roughly 2 minutes after receiving her I am Pfizer vaccine, patient told mother that she was feeling ... Read more
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.
17 2021-06-02 lightheadedness Patient developed warmth, clamminess, nausea and lightheadedness shortly after her shot. She admitte... Read more
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.
17 2021-06-03 chest discomfort, chest pain My daughter has had a full body rash, that nobody can identify, since the shot. They start as littl... Read more
My daughter has had a full body rash, that nobody can identify, since the shot. They start as little dots and change into circles after a while. She had had chest pains and pressure and is very uncomfortable
17 2021-06-03 chest pain Patient presented for second vocid-19 vaccine. after receiving vaccine, mother reported that patient... Read more
Patient presented for second vocid-19 vaccine. after receiving vaccine, mother reported that patient had chest pain and grabbed chest and was experiencing leg numbness. Patient's parent reports that prior to receiving vaccine, aptietn has had history of one sided flank pain and tardive dsykinesia induced by medication. After vaccine mother reports patient is experiencing flank pain on opposite side. Mother wanting patient to be seen by provider so patient taken to hospital ED
17 2021-06-03 loss of consciousness, fainting, pallor Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed ... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: Patient received 1st dose of pfizer vaccine. Less than 1 minute later patients mother alerted us that the patient had lost consciousness. She was immediately laid down and gained consciousness within 10 seconds. She stated feeling lightheaded, sweaty, looked pale and felt like she was in a trance. 1st BP reading (111/67), 2nd BP reading done 15 min later (106/59 & HR 65). After 30 min of monitoring patient was able to leave.
17 2021-06-03 pallor Patient experiences blurred vision, hot, dizziness at the observation area after the vaccination. H... Read more
Patient experiences blurred vision, hot, dizziness at the observation area after the vaccination. Her pupils were dilated and her lip was pale. She felt better after zip of water and felt normal after few minutes.
17 2021-06-03 fainting, pallor Syncope; 911 called; patient woke up promptly, was pale, but responsive
17 2021-06-03 fainting Patient had syncopal episode within 15 minutes of vaccination. Patient felt better after resting an... Read more
Patient had syncopal episode within 15 minutes of vaccination. Patient felt better after resting and drinking some juice and was released to home.
17 2021-06-03 fainting Pt w/ Syncope and dizziness. BP 115/71, HR 65, RR 12 -- > 115/68, 73. Pt stable and released from t... Read more
Pt w/ Syncope and dizziness. BP 115/71, HR 65, RR 12 -- > 115/68, 73. Pt stable and released from the vaccination site.
17 2021-06-03 fainting PT FAINTED AFTER COVID VACCINE. PT WAS FINE AFTER A FEW MINUTES AND DRINKING GATORADE. MOTHER WAS PR... Read more
PT FAINTED AFTER COVID VACCINE. PT WAS FINE AFTER A FEW MINUTES AND DRINKING GATORADE. MOTHER WAS PRESENT.
17 2021-06-05 loss of consciousness Patient was waiting for her family members to get vaccinated after she received hers. She was standi... Read more
Patient was waiting for her family members to get vaccinated after she received hers. She was standing by her father and passed out.
17 2021-06-05 inflammation of the heart muscle, troponin increased, chest pain 8 hours post vaccination, developed subjective fever, chills, headache, malaise 6/2: Around 32 hours... Read more
8 hours post vaccination, developed subjective fever, chills, headache, malaise 6/2: Around 32 hours post vaccination, developed acute chest pain, shortness of breath, difficulty breathing when laying flat. Required ibuprofen. 6/3: felt better, required ibuprofen. Presented to ED on 6/4 with continued symptoms (chest pain, shortness of breath), noted to have elevated troponins. Transferred to Hospital on 6/4 to ICU for monitoring. To the floor on 6/5. Clinically doing well just on NSAIDs with slowly decreasing troponins. Dx: probable acute myocarditis per cardiology based on clinical symptoms and troponin leak
17 2021-06-06 chest pain, inflammation of the heart muscle myocarditis with ekg changes and severe chest pain requiring pediatric ICU stay. Treated with schedu... Read more
myocarditis with ekg changes and severe chest pain requiring pediatric ICU stay. Treated with scheduled Motrin and cardiology follow up
17 2021-06-06 pallor, loss of consciousness patient was nervous/anxious about the shot. Sat in chair and received shot in the left deltoid with ... Read more
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
17 2021-06-06 pallor, loss of consciousness After receiving the vaccine we moved to waiting area. Within minutes she told me she was not feelin... Read more
After receiving the vaccine we moved to waiting area. Within minutes she told me she was not feeling well she began sweating profusely, her skin became pale and clammy, her eyes rolled back she lost consciousness and began convulsing. She came to and said she could not hear well. She was taken to ED for observation and testing.
17 2021-06-06 fainting, hypotension, pallor Systemic: Abdominal Pain-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Un... Read more
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.
17 2021-06-06 fainting Patient told us that she has passed out and vomited after receiving vaccines in the past. After gett... Read more
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.
17 2021-06-07 chest discomfort, inflammation of the heart muscle, chest pain Patient having pain 7am 6/8 upon awakening. Sharp, heavy 10/10 left sided chest pain radiated to L a... Read more
Patient having pain 7am 6/8 upon awakening. Sharp, heavy 10/10 left sided chest pain radiated to L arm. Shortness of breath. pain worse with inspiration, no positional changes. Similar to previous myocarditis episode in 2019 (thought to be 2/2 virus as had fevers, fully resolved). No recent URI, last sick 1 year ago, no covid per knowledge. Had COVID vaccine week prior without side effects. Presented to hospital. Initial troponin 0.819> 4.43. CK-MB 42.8, CK 471. BMP, CBC, CRP within normal limits. ECG non ischemic however mild j-point elevation in anterior leads consistent with myocarditis. POCT echo normal. Patient admitted for IVIG, steroids, viral panel and monitoring.
17 2021-06-07 chest pain The day after the second dose of the vaccine she started to have pains in all of her joints. Her che... Read more
The day after the second dose of the vaccine she started to have pains in all of her joints. Her chest felt painful and even her finger joints. It was a constant pain that got worse with movement. The pain scale without the medication was an 8 but with the medication a 5 on the scale of 1-10. Ibuprofen and Hydrocodone helped control the pain but it did not make it totally go away. The joint pain lasted for three weeks to date but the chest pain has improved. Heat pads also help. She has never experienced these symptoms before. There were similar symptoms after the first vaccine but it is much more intense after the second dose. It has been consistent since the second dose of the vaccine but the medication and heat application does seem to help. Hospital after the first dose for chest pain.
17 2021-06-07 heart rate increased Dose 1, headache. DOSE 2 Five hours later severe headache, extensive heat being generated from hea... Read more
Dose 1, headache. DOSE 2 Five hours later severe headache, extensive heat being generated from head, body not, then followed by high fever 101.8 with heart rate going up to 155, followed by twelve hour later breaking fever. Extensive headache continues. At 24 hour mark hives on face under eyes, big welts and red. Continued migraine. This is not safe!!!!!! I will sue the agency for this product, emergence use yet mandate by colleges and employers. SOMEONE NEEDS TO PAY FOR THIS!!!!! I WILL CONTACT A LAWYER.
17 2021-06-07 hypotension see prior
17 2021-06-07 loss of consciousness, pallor Patient exhibited a seizure like episode that lasted approximately 15 seconds. Patient was placed o... Read more
Patient exhibited a seizure like episode that lasted approximately 15 seconds. Patient was placed on the ground in a supine position where she regained consciousness. 911 was notified at 1401. Patient with clammy and pale skin. At 1405 BP was 122/69, HR 100, RR 18. Attempted to put patient in chair, once in chair she began to feel dizzy and was placed back on the ground in a supine position.. At 1410 BP was 122/58, RR 20. Blood sugar at 1413 was 92. Patient was able to sit up on the ground and was given juice and crackers. Patient continued to have pale and clammy skin. Alert and oriented x 3. EMS arrived and patient transported to hospital.
17 2021-06-07 increased heart rate Sinus Tachycardia and lightheadedness that has not gone away since
17 2021-06-08 chest pain Day after vaccination, patient reports intermittent fevers (Tmax 104F), neck pain that radiates down... Read more
Day after vaccination, patient reports intermittent fevers (Tmax 104F), neck pain that radiates down her back, and is interacting a lot less than usual, The following day, she was unable to walk at all and required being carried to use the bathroom. Patient denies and fevers, cough, gi distress. She does states that she is not feeling short of breath at this time, but is having weakness in her hands as well as her legs. Additionally patient states that she has been having chest pain today that comes and goes. On neuro exam Mental status: Appears to be distressed due to photophobia. Lethargy, however easily arousable, able to have a conversation, attention intact to spelling "globe" backwards, intact to high and low frequency words. Able to name and repeat. Speech: Mild dysphonia Cranial Nerves: II: Pupils equal, round reactive III/IV/VI: EOMI. Pupils move in all four cardinal directions VII: Face symmetric when talking, however limited effort to excursion on command VIII: Responds to voice IX/X: Voice normal XI: Turns head side-to-side XII: Tongue midline Motor: Normal bulk and tone. Resistance met to passive motion of BLE RUE/LUE: shoulder abduction 4/5, elbow flexion/extension 5/5, wrist flexion/extension with give-way weakness up to 4+/5, finger flexor 4/4 RLE/LLE: On command, 0/5 -however able to support her legs in a flexed position bilaterally, with encouragement 5/5 on dorsiflexion. Able to support her weight on her legs, however does not walk slowly sits back on the bed. Sensory: Intact to light touch, proprioception intact Coordination: No obvious dysmetria on FNF testing DTR: 2+ brachioradialis, bicep, patellar, ankle b/l. Plantars mute. Absent pathological reflexes: Hoffman, cross adductor
17 2021-06-08 heart rate abnormal Client Received the 2nd dose of Pfizer COVID vaccine lot #ER8735 and expiration date 07/04/21 at 1:... Read more
Client Received the 2nd dose of Pfizer COVID vaccine lot #ER8735 and expiration date 07/04/21 at 1:34pm. At 1:34pm, client reports to vaccinator that she feels dizzy. Vaccinator offer client water and client starts drinking it. PHN 1 & PHN 2 arrive client reports she "feels weird" PHN asks client to explain and client is unable to describe. Client is alert and oriented X 4 and is already seated in zero gravity chair due to reporting history of syncope. Vaccinator offered client water and client starts drinking it. Client reports no headache, no shortness of breath, no blurred vision, no chest pain, just dizziness. At 1:34PM vitals heart rate taken manually by PHN :72 and blood pressure: 128/74, unable to get oxygenation due to long acrylic nails. PHN gets report from mother that client reports with the first dose something similar happened that she experienced dizziness after vaccine. Client was kept in observation and symptoms resolved prior to client going home. Clients mother reports no medical history, no medications and no history of allergies. At 1:36PM PHN gets called away for another adverse reaction and PHN stays with client. At 1:39pm client reports dizziness is resolving but still "feels weird", PHN asks client to clarify what weird means and she says "it feels like my heart is slower." At 1:40pm client reports she is feeling sleepy, PHN attempts to call 911 and gets disconnected. At 1:41pm vitals: blood pressure: 130/82 and pulse:134. At 1:42pm PHN calls 911 again to reconnect and observes clients lips look purple, closed eyes but able to answer questions and speak in complete sentences. Ask RN to get AED as instructed by 911 dispatcher. At 1:45pm, client reports having trouble breathing and RN placed zero gravity chair to laying position and assist client with coaching her to take slow deep breaths. Fire department paramedics arrived at 1:47pm and assumed care. Client was wheeled out on a gurney at 1:50pm.
17 2021-06-08 loss of consciousness Patient had immunization was given at 3:15pm, about 2 minutes later patient began to loose consciou... Read more
Patient had immunization was given at 3:15pm, about 2 minutes later patient began to loose consciousness. She appeared semi-alert but not fully conscious. After3 minutes, patient was alert enough to speak and drink water. Local EMS was activated and arrived at 3:35pm. EMS did vitals as said the patient had no immediate emergency. The patient's mother refused transport but said she would take her daughter to the local emergency department. The patient left on her own power. The same reaction/situation happened when the patient got her first shot on 5/19-2021.
17 2021-06-08 pallor, fainting, loss of consciousness Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainti... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-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.
17 2021-06-08 blood clot received the first dose of the Pfizer COVID-19 vaccine and also recently started taking Depo-Provera... Read more
received the first dose of the Pfizer COVID-19 vaccine and also recently started taking Depo-Provera. After receiving the first dose of the Pfizer COVID-19 vaccine her daughter developed a blood clot; tired and frail; feels lost and light headed; cramping pain; This is a spontaneous report from a contactable consumer (Patient's mother). A 17-year-old female patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Right on 03May2021 15:00 (Batch/Lot number was not reported) as 1ST DOSE SINGLE for covid-19 immunization and medroxyprogesterone acetate (DEPO-PROVERA), route of administration, start and stop date, batch/lot number and dose were not reported for contraception. The patient's medical history and concomitant medications were not reported. The patient experienced received the first dose of the pfizer covid-19 vaccine and also recently started taking depo-provera. after receiving the first dose of the pfizer covid-19 vaccine her daughter developed a blood clot, tired and frail, feels lost and light headed and had cramping pain all on unspecified dates. It was reported that after receiving the first dose of the Pfizer COVID-19 vaccine her daughter developed a blood clot. Her daughter, who is currently on Depo Provera got her first dose of the Covid 19 vaccine. The daughter has been experiencing blood clotting and would like to further document this experience. Is also seeking medical advice to inform her daughter. Her daughter Has been on Depo Provera for 4 to 5 months. Since she had the Covid vaccine, she has been having bad blood clotting and has been having a continuous period. When she got the shot, she has been getting blood clots straight for three weeks. Patient is Tired and frail: She is a waitress, so all of this has made it hard. It started right when she got the shot and has pretty much stayed the same. She will feel like she is lost when she wakes up and is light headed from the loss of blood. It occurs when she is doing activities, like working. Patient took some Midol one day for cramping pain but it barely did anything. The action taken for medroxyprogesterone acetate was unknown. Outcome of tired and frail was not recovered. Outcome of all the other events was unknown. Information on Lot/Batch number was not available. Additional information has been requested.
17 2021-06-09 stroke Patient had massive acute intracranial hemorrhage. Was found down in bathroom. In ED CT scan showed ... Read more
Patient had massive acute intracranial hemorrhage. Was found down in bathroom. In ED CT scan showed large intraventricular hemorrhage, EVD placed, patient progressed to massive brain swelling and infarctions, decompressive craniectomy, unable to control intracranial pressure, parents agreed to DNR status and patient is not expected to survive.
17 2021-06-09 chest pain J40 - Bronchitis, not specified as acute or chronic HEADACHE SHORTNESS OF BREATH CHEST PAIN
17 2021-06-09 nosebleed Patient has NOT been seen in the office for side effects, but reports nose bleeds starting a few hou... Read more
Patient has NOT been seen in the office for side effects, but reports nose bleeds starting a few hours after receiving her first dose.
17 2021-06-09 fainting Syncope with possible seizure-like activity immediately following vaccine administration. Patient wa... Read more
Syncope with possible seizure-like activity immediately following vaccine administration. Patient was observed, and transported to the ED by EMS.
17 2021-06-09 fainting Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainti... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: PT fainted and fell out of the chair several minutes after administration of vaccine. Pt regained conciousness immediately after fall. Suffered minor injuries to the face and knee (rug burn) and felt dizzy, lightheaded, and nauseas for at least 15 minutes before regaining complexion. PT discloses after incident that she has issues fainting with blood draw and some injections. PT rested for 45 minutes in the store before leaving. Vitals reviewed are normal before leaving the store
17 2021-06-10 deep vein blood clot Patient with significant right leg DVT requiring thrombolysis by vascular surgery. She will need to ... Read more
Patient with significant right leg DVT requiring thrombolysis by vascular surgery. She will need to continue on anticoaggulants outpatient.
17 2021-06-10 pallor, loss of consciousness Within seconds of receiving the 2nd PFizer covid vaccine, the patient slumped over sideways in her ... Read more
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.
17 2021-06-10 pallor Patient became dizzy, had heaviness in her limbs, was pale,had blurred vision - none of these sympto... Read more
Patient became dizzy, had heaviness in her limbs, was pale,had blurred vision - none of these symptoms improved, so 911 was called.
17 2021-06-10 pallor PT WAS SITTING IN WAITING AREA, WAITING THE REQUIRED 15 MIN POST-VAX, JUST A FEW MIN AFTER ADMIN, PT... Read more
PT WAS SITTING IN WAITING AREA, WAITING THE REQUIRED 15 MIN POST-VAX, JUST A FEW MIN AFTER ADMIN, PT STARTED TO FEEL FAINT, LOOSE COLOR IN FACE AND BREAK OUT IN SWEAT. NO S/SX OF ANAPHYLAXIS. LOWERED PT TO THE FLOOR AND ELEVATED FEET. COLOR IMMEDIATELY RETURNED TO FACE AND PT REPORTED FEELING BETTER IMMEDIATELY. PT REMAINED CONSCIOUS THROUGHOUT. CHECKED BP 113/79 PULSE 69. HAD PT WAIT ANOTHER 15 MIN THEN LEFT WITH NO FURTHER COMPLAINTS.
17 2021-06-11 loss of consciousness Passing out; Feeling very faint; high fever (103 degrees Fahrenheit); Body aches; This is a spontane... Read more
Passing out; Feeling very faint; high fever (103 degrees Fahrenheit); Body aches; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 27May2021 16:00 (at the age of 17years) (Batch/Lot number was not reported) as unknown, single for Covid-19 immunization. Medical history included ADHD (attention deficit hyperactivity disorder) and known allergies to Sulfate. Concomitant medication included tilactase (LACTAID) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28May2021 12:00, the patient experienced very high fever (103 degrees Fahrenheit) for at least more than 2 days, body aches, feeling very faint, passing out whenever she stands up for more than a couple of minutes. There was no treatment received for the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered. Information on the lot/batch number has been requested.
17 2021-06-11 fainting, loss of consciousness She has fainted and pass out; She has fainted and pass out; She fell down and hit her head and all o... Read more
She has fainted and pass out; She has fainted and pass out; She fell down and hit her head and all of her left eye; She fell down and hit her head and all of her left eye; she was like in pain; she needs help with her balance, walking; This is a spontaneous report from a contactable consumer (patient's grandfather). A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 17 years of age), dose 1 via an unspecified route of administration, administered in arm right on 27May2021 17:15 (Batch/Lot Number: EW0187) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history was none. Family history included her grandmother had diabetes. The patient's concomitant medications were not reported. It was unknown if the patient was pregnant. The patient did not have any prior vaccines. It was reported that the patient received Pfizer vaccine. She was under 18, she was 17 and she had a very bad side effect from it. She got her first dose yesterday (27May2021) and she had a bad reaction and was rushed to the emergency room. She fainted and passed out and she was like in pain and she was out like about four minutes. Just all of a sudden and then after she got out of it and then they needed to rush into the emergency room. She fell down and hit her head and all of her left eye. They took her to the emergency room. They did every test, they checked everything, and they said it was a bad side effect from the vaccine. She got her vaccine around, it was like about 5:15 pm in the afternoon and the incident happened like about 7:20, 7:30. She was trying to recover, she needed help with her balance, walking. She was trying to rest. The doctor in emergency room said that she had to rest, if side effects continue or happen again then she had to go back to the emergency room. Not really. They did some lab tests yesterday (27May2021) in the hospital. They don't know what they did. There was complete blood, there was CBC done. They did CT scan of her head, X-rays for her arm. They have here PMP, the reporter was not sure as they have different kind of blood test. They have calcium level 1, glucose level, there are so many different test names such as WBC and RBC. When asked about treatment it was reported that 'No, they did not prescribe her any medicine'. They told her for any pain, from the fall she found hit her head she could take Tylenol regular'. The events occurred on 27May2021. The outcome of 'fainted and pass out' was recovered on 27May2021 (she was out like about four minutes); 'she needs help with her balance, walking' was not recovered; while outcome of other events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
17 2021-06-13 chest discomfort Trouble breathing and heavy feeling on chest 4 days after first dose of Pfizer vaccine
17 2021-06-13 loss of consciousness, fainting Patient had syncopal episode within 4 minutes of vaccination and felt to floor. Hit head. Regained... Read more
Patient had syncopal episode within 4 minutes of vaccination and felt to floor. Hit head. Regained consciousness and was transported to ER by EMS.
17 2021-06-13 loss of consciousness Patient received the pfizer vaccine at 03:18 PM and at 03:22 PM as the patient was walking into the ... Read more
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.
17 2021-06-13 loss of consciousness Approximately a minute and a half after the show was administered my daughter passed out and started... Read more
Approximately a minute and a half after the show was administered my daughter passed out and started convulsing for approximately 2 minutes.
17 2021-06-13 pallor, blood pressure decreased About 10 minutes after vaccination, patient felt lightheaded, nausea and appeared to be pale. She wa... Read more
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.
17 2021-06-14 heart rate irregular, palpitations, fast heart rate, heart rate increased Systemic: Tachycardia-Mild, Additional Details: patient reported having rapid heart beat as she was ... Read more
Systemic: Tachycardia-Mild, Additional Details: patient reported having rapid heart beat as she was checking out. Had her sit, checked pulse, it was 73 but could feel full pressure of beat. She said she was feeling pouding. Had her sit another 15 min, she was feeling a little 'out of it', rechecked pulse and rhythem felt irregular. NO other symptoms. Mom was going to call PCP right away or go to Urgent Care. Did not want us to call an ambulance
17 2021-06-14 pallor DIZZINESS, LIGHTHEADED, PALE, ICE PACK, WATER
17 2021-06-15 chest pain PT with chest pain and SOB since the day of vaccination; this was the 2nd COVID vaccine. First dose ... Read more
PT with chest pain and SOB since the day of vaccination; this was the 2nd COVID vaccine. First dose 22May2021 with no reactions.
17 2021-06-15 heart rate increased, increased heart rate Mother of PT states her daughter experienced as diagnosed a sinus tachycardia, her heart rate elevat... Read more
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.
17 2021-06-15 fainting Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unrespo... Read more
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
17 2021-06-16 loss of consciousness, chest pain At around 9:25 am on Thursday, June 17th, 2021, seventeen-year-old patient walked into the vaccinati... Read more
At around 9:25 am on Thursday, June 17th, 2021, seventeen-year-old patient walked into the vaccination site. She was accompanied by two guardians, along with 14 other minors. The minors came in for their 2nd shot of Pfizer Covid-19 vaccines. Patient signed all necessary consent forms and pre-vaccination checklist requirements with guardian and entered the vaccination section at around 9:35 am. The Pfizer vaccine was administered at 9:39 am. Observation nurse reported that around 10:06 am the patient complained about having a severe headache, ?seeing stars?, feeling very dizzy, and not feeling well. Nurse assisted patient to lay down on the mat in case the patient may faint. Charge nurse obtained a pulse oximetry reading of 95% and a pulse of 96. Charge nurse checked if the patient experienced any symptoms of hives/redness, shortness of breath, or any difficulty breathing or swallowing. The patient complained to observation nurse that she was having a hard time breathing, severe headache, and chest pain. Observation nurse instructed patient to be calm and to relax. Charge nurse instructed the patient to take deep slow breaths to help increase O2 levels but the patient complained to the observation nurse that she cannot breathe through her nose. At 10:15 am charge nurse continuously monitored the patient?s B/P, pulse, and O2 level readings. The BP reading was 117/64 with a pulse of 78 and an O2 level of 100%. At approximately 10:16 am, patient started showing signs of change in LOC and lost consciousness for a few seconds. First responder paramedics from the first minor incident were still at the scene waiting for the 2nd ambulance to arrive. The first responder paramedic did a sternum rub using his knuckles with a closed fist to the center of the patient?s chest and immediately after the patient gasped for air and regained consciousness. The patient remained in a sitting position on the floor to be able to breathe easier. At approximately, 10:18 am charge nurse took another BP reading of 121/76, a pulse of 96, and O2 level of 99%. At approximately 10:20 am, patient started exhibiting a change in LOC and was very disoriented again. Observation nurse kept calling the patient?s name but did not get a response. This lasted for around 30 seconds while the patient gasped for air before becoming responsive again. At this time observation nurse observed that patient could not recall her name and did not know how she got there. At approximately 10:22 am, charge nurse took another BP reading of 165/133, a pulse of 122, and an O2 level of 96%. At around 10:24 am, the charge nurse took another BP reading of 112/78 and pulse of 112 with an O2 level of 96%. The second ambulance arrived at approximately 10:26 am and took over. The second ambulance?s first responder paramedics left with patient at approx. 10:29 am and took her to hospital for further observation.
17 2021-06-16 lightheadedness At around 9:25 am on Thursday, June 17th, 2021, a seventeen-year-old Foreign-speaking patient walked... Read more
At around 9:25 am on Thursday, June 17th, 2021, a seventeen-year-old Foreign-speaking patient walked into the vaccination site. She was accompanied by two guardians, along with 14 other minors. The minors came in for their 2nd shot of Pfizer Covid-19 vaccines. Patient signed all necessary consent forms and pre-vaccination checklist requirements with guardian and entered the vaccination section at around 9:30 am. The Pfizer vaccine was administered at 9:37 am. Observation nurse reported that around 10:04 am the patient complained about having a severe headache. The observation nurse notified charge nurse that she needs assistance. The charge nurse immediately obtained a pulse oximetry reading of 99% and a pulse of 88. The charge nurse assessed if the patient is experiencing any symptoms of hives or redness, shortness of breath, or any difficulty breathing or swallowing. The patient stated to the observation nurse that she was having difficulty breathing. At 10:06 am the charge nurse called 911. While the charge nurse was standing and speaking with the 911 operator, the patient started to faint and laid her head on charge nurse's stomach while she was sitting. The patient looked like she was sleeping and making some whimpering sounds for about 2 minutes. At the same time, these events were taking place, observation nurse reported that another 17-year-old minor started complaining of a severe headache and ?seeing stars?. First responder paramedics came on the scene at around 10:09 am and took over care of the patient. At that point charge nurse attended to another patient, 17-year-old minor. Patient was also exhibiting a reaction to the Pfizer Covid-19 vaccine. First responder paramedics left with patient at around 10:15 am and she was taken to hospital for further observation.
17 2021-06-16 troponin increased, chest pain chest pain, shortness of breath
17 2021-06-17 lightheadedness, fainting Within minutes of receiving first dose of Pfizer vaccine, pt had a vasovagal episode and fainted. Vi... Read more
Within minutes of receiving first dose of Pfizer vaccine, pt had a vasovagal episode and fainted. Vital signs were obtained; pulse was 40. Pt's lower extremities were elevated and pt was given juice and crackers. Within several minutes, pt verbalized feeling good and left facility with her attendant/grandfather.
17 2021-06-17 fainting, loss of consciousness Patient was given the second dose of Pfizer brand Covid-19 vaccine by our immunizing tech. and said ... Read more
Patient was given the second dose of Pfizer brand Covid-19 vaccine by our immunizing tech. and said patient was ok until she stood up to leave the immunization room and that is when she immediately fainted and slumped back into the chair. Within a few seconds she regained consciousness. Mom said she had not eaten anything before coming and has fainted before when having blood drawn. (patient does have a fear of needles) We had the patient sit the immunization room for around 20 minutes. We got her some juice and a wet cloth upon moms request as she was sweating and shaky feeling. After sitting for a while she said she was feeling better and mom declined further care and we advised she follow up with her PCP
17 2021-06-18 fainting around 7:00 pm in the evening, she had a syncope episode. Video footage shows she is standing in lin... Read more
around 7:00 pm in the evening, she had a syncope episode. Video footage shows she is standing in line with other children, and just faints and falls to the floor. Initially she was not responding much to EMS and to FNP that received her, EKG was completed, and VS were within normal limits. She received lab work, UA, and CT of Head as she appeared to have hurt her head at time of fall. Few hours later, when FNP checked on her again, about 9:50 pm, she was more responsive, answering his questions and doing much better than when she initially arrived to hospital around 8 pm. She was verbal, and VS were within normal limits during my time with her at the hospital
17 2021-06-20 hypotension, loss of consciousness, fast heart rate, fainting Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypote... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Mild, Systemic: Tachycardia-Mild, Additional Details: EVENT OCCURED WITHIN 5 MINUTES OF ADMINISTRATION. DURATION OF LOSS OF CONCIOUSNESS LESS THAN 10-15 SECONDS. PULSE PRESENT AT WRIST IMMEDIATELY FOLLOWING REGAIN OF CONCIOUSNESS. PER PATIENT AND CAREGIVER, PATIENT HAS HISTORY OF SYNCOPE WITH IMMUNIZATION/BLOOD DRAWS. PATIENT ABLE TO WALK OUT OF BUILDING FOLLOWING 30 MINUTES OF OBSERVATION INCLUDING ELEVATION OF FEET, EVALUATION OF BP/PULSE (104/60 MMHG/87 BPM), AND INGESTION OF WATER AND CRACKERS.
17 2021-06-20 hypotension, fainting, pallor 17 year old female received Pfizer COVID vaccine and was told to sit and wait 15 minutes for monitor... Read more
17 year old female received Pfizer COVID vaccine and was told to sit and wait 15 minutes for monitoring after the shot. Patient attempted to leave before the time elapsed with her father and collapsed in the aisle. She was able to be assisted to a nearby chair and 911 was called. I was told she did not hit her head or any other part of her body when she fell. I attempted to take her blood pressure, but it was too low. Patient appeared very pale and was responsive but stated she was seeing black and couldn't hear properly. She did not eat anything that morning. Patient continued to talk and answer questions updating me on her improvements but still appeared very lethargic and eyes were not focused. EMTs arrived and her BP was 81/46. EMTs, store management and health care ambassador remained with patient. Patient began to feel better and did not go to the hospital. EMTs left and management and associate remained with patient. Once patient felt better, she walked out of the pharmacy/store with her father.
17 2021-06-20 platelet count decreased Bilateral knee swelling and pain (severely limiting mobility to the point of being unable to walk du... Read more
Bilateral knee swelling and pain (severely limiting mobility to the point of being unable to walk due to pain/swelling), rash (c/f erythema nodosum) for 2-3 weeks (presented on 6/18/21). Concerning for flare of JIA vs other autoimmune etiology (infectious studies mostly negative, though some studies pending). Diagnostics ongoing.
17 2021-06-20 fainting Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient nervous/anxiety about shot, pa... Read more
Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient nervous/anxiety about shot, patient received shot. Approximately 5 min after vaccine, during patient's 15 min, patient became lightheaded, then fainted. Patient then became responsive less than a minute after fainting. 911 was called at 6:58pm. EMT arrived, took over and patient/mother declined to hospital transportation. Patient left pharmacy on own.
17 2021-06-21 loss of consciousness She felt dizziness immediately and passed out as we were leaving the store.
17 2021-06-21 fainting Immediately after receiving the last vaccine patient had an episode of syncope. She regained conscio... Read more
Immediately after receiving the last vaccine patient had an episode of syncope. She regained consciousness quickly and was moved to our Trendelenburg chair. Vitals were checked within a few minutes (BP 108/62 P 70) and she was given water as well. She was accompanied by her mother and was able to leave after about 15 minutes.
17 2021-06-22 cardiac arrest Cardiac arrest without resuscitation. Unknown cause of cardiac arrest. Awaiting autopsy report.
17 2021-06-22 chest discomfort, chest pain Patient received her first COVID Vaccine on 6/4/2021 and on 6/5/2021, 6/6/2021, 6/7/2021, and 6/8/20... Read more
Patient received her first COVID Vaccine on 6/4/2021 and on 6/5/2021, 6/6/2021, 6/7/2021, and 6/8/2021, she experienced chest pain and shortness of breath. She experienced shortness of breath even when ascending the staircase in our home. She felt chest pain and tightness in her chest for 4 days after receiving her vaccine.
17 2021-06-22 chest discomfort Client received the Pfizer COVID vaccine (lot #EW0187 and expiration date 7/15/21) at approximately ... Read more
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.
17 2021-06-22 chest pain Chest pain, shortness of breath, fatigue, unable to take a deep breath
17 2021-06-22 pallor About 5 minutes after shot, pt felt extremely unwell, really hot, pale, blurry vision, confusion, a... Read more
About 5 minutes after shot, pt felt extremely unwell, really hot, pale, blurry vision, confusion, and feeling of fainting. After an ice pack , and Gatorade pt felt well enough to go home approx. 30 minutes after shot
17 2021-06-22 platelet count decreased Developed pin dot rash on arms that was noticeable on 06/06/2021. Sought medical treatment with doc... Read more
Developed pin dot rash on arms that was noticeable on 06/06/2021. Sought medical treatment with doctor on 06/10/2021. Labs drawn and rash identified as Petechiae. Labs showed very low platelets and WBC. Spent day in ED on 06/11/2021 based on lab results. Labs were redrawn evening of 06/10/2021 to confirm initial lab results. Labs repeated on 06/11/2021 in ED. Another set of labs drawn on 06/14/2021. Appt with Outpatient Hematology on 06/16/2021 and more labs drawn. This is an ongoing issue and I am not sure if related to vaccine, but timing seems concerning. New labs drawn today and awaiting those results. She is still under medical care.
17 2021-06-22 fainting, loss of consciousness Patient developed syncope about 10 minutes after receiving the Pfizer vaccine. She had normal breat... Read more
Patient developed syncope about 10 minutes after receiving the Pfizer vaccine. She had normal breathing and mild sweating and lost consciousness for a brief moment. Patient was evaluated by EMT.
17 2021-06-22 fainting, pallor About 5 minutes after receiving the Covid vaccine patient fainted, she was pale and reported feeling... Read more
About 5 minutes after receiving the Covid vaccine patient fainted, she was pale and reported feeling very tired and had tingling in her hands. After drinking water. Patient was feeling better but still felt tired. After 10 minutes paramedics arrived and took her vitals. Her blood pressure and pulse were normal.
17 2021-06-22 fast heart rate, heart rate increased Within 13 hours of the second dose of the covid 19 vaccine, patient started to have tachycardia. She... Read more
Within 13 hours of the second dose of the covid 19 vaccine, patient started to have tachycardia. She got a notification from her watch that her heart rate was elevated for an extended period of time. Patient states it has gotten over 200 at times. Heart rate can increase with walking or going up stairs. Patient unable to do normal activities due to this. This does seem to be improving, but still present four weeks after the second vaccine.
17 2021-06-23 chest pain Patient's maternal aunt reports that about 2 weeks after her second covid vaccine she began having s... Read more
Patient's maternal aunt reports that about 2 weeks after her second covid vaccine she began having shortness of breath and chest pain. Patient went to local ED and was seen to have a left sided pleural effusion (same side she has a ventriculoplueral shunt). Patient continues to struggle with shortness of breath and chest pain and left sided pleural effusion since and has visited multiple emergency rooms. Most recently patient was admitted to hospital on 6/23 and was seen to have a worsened pleural effusion and lab work that were positive for Lupus.
17 2021-06-23 chest pain Chest pain, sinking feeling, shortness of breath,. It lasted for 1/2 a day
17 2021-06-23 pallor, fainting Upon walking to recovery area patient went pale and fainted. Witnessed fall, fell and hit head on th... Read more
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.
17 2021-06-23 fast heart rate Patient was observed post Covid-19 immunization for 15 minutes after her vaccination at 11:20am. Rep... Read more
Patient was observed post Covid-19 immunization for 15 minutes after her vaccination at 11:20am. Reports to us at 1:38pm after experiencing tachycardia at 1:30pm. No complaints of SOB, rash or throat swelling. History of eating disorder and soda 2 hrs prior to episode. Initial V/S 122/67, 144, 20, O2 sat 98%. PE: Skin with no rash. Alert, cooperative and calm appearing. Lungs sounds clear A&P, heart rate regular. Actions taken: Repeat V/S @155pm- P-124, B/P 121/69. EMS called and she will be further evaluated in ER. Medications administered: No medication administered. Disposition: Patient evaluated and transferred to the hospital for further evaluation and care. Time of transport: 1:55pm.
17 2021-06-24 chest discomfort, chest pain Shortness of breath Chest tightness/pain - thought to be costochondritis
17 2021-06-25 atrial fibrillation Presented to the Medical Center with concern for seizure activity, found to have atrial fibrillation... Read more
Presented to the Medical Center with concern for seizure activity, found to have atrial fibrillation in emergency department. Echocardiogram performed, and found to have moderately dilated left atrium and moderate mitral valve insufficiency. Initiated metoprolol for heart rate control, levetiracetam for possible seizure, and rivaroxaban to prevent cardiac thrombosis.
17 2021-06-27 pallor This was the patient's second dose of the Pfizer COVID19 vaccine. The patient came with her mother. ... Read more
This was the patient's second dose of the Pfizer COVID19 vaccine. The patient came with her mother. She was slightly nervous before getting the vaccine. The vaccine was given to her; she was pleasantly surprised that it barely hurt and even said "wow that was nothing!". Her mother did mention that the patient got her first dose at a clinic where the pharmacist who gave it to her gave the vaccine very roughly and the patient and her mother were in tears after the FIRST shot at clinic so they were so thankful that it barely hurt for her SECOND dose. Then we started talked about traveling and everyone was engaged in a pleasant conversation for about 5 minutes. Then suddenly the patient almost fell to the side but thankfully the chair that the patient was in had armrests and her mother caught her. We gave the patient a bottle of Sprit soda for her to drink. The patient was still in her chair and resting against her mother and said "I'm fine" but her mother insisted that we call 911. So 911 was called while a pharmacy team member stayed in the room to help keep and eye on the patient. After 911 was called that patient didn't need to rest against her mother anymore but she looked very pale and looked like she wanted to throw up. Shortly after the fire department and EMS came and took over the situation. When EMS came they said it probably sounded like a vasovagal reaction. Afterwards they cleared the situation and the patient and mother were fine afterwards (patient regained color in her face and looked and sounded normal).
17 2021-06-29 chest pain, fibrin d dimer increased She had the vaccine on 5/16 around 10:00am. The symptoms started at 5:00pm on 5/16 exp extreme sharp... Read more
She had the vaccine on 5/16 around 10:00am. The symptoms started at 5:00pm on 5/16 exp extreme sharp chest pains with difficulty breathing. We did give her Tylenol for pain for sharp pain around 7 pm started to come back. She was taken to ER to make sure it was not related to the vaccine. At the ER she had Chest X-rays, EKG, Bloodwork and her D-Dimer test was elevated she had a CT scan done showed swollen lymph nodes on (left arm)no problems with her heart.We was told to follow up with pcp told to continue to watch her for myocarditis. She has a follow up Sonogram scheduled on 7/16 to ensure the swelling of the lymph nodes has went down.
17 2021-06-29 heart rate decreased, fainting The patient came in for her first dose of vaccine. I verbally asked if she had any health conditions... Read more
The patient came in for her first dose of vaccine. I verbally asked if she had any health conditions, allergies, andy reactions to previous vaccines. The mother answered for her and declined all. Once the patient filled out the paperwork and received the vaccine she stated she felt light headed. I noticed quickly she was about to faint. We put a chair under her and sat her down. She became unresponsive, but was breathing fine. She began to sweat and her pulse decreased. I asked for someone to call 911 and find her mom. I attempted to check her blood pressure but was unable because of her positioning. She was breathing fine and was answering short sentences but was speaking slow. Right after we called the ambulance she asked what happened and said she was feeling better. Shortly after the ambulance arrived and checked her out. Her mother declined transport to the hospital.
17 2021-06-29 platelet count decreased, haemoglobin decreased Patient initially contacted her PMD on 5/13/2021 that she "felt anemic" (which she has struggled wit... Read more
Patient initially contacted her PMD on 5/13/2021 that she "felt anemic" (which she has struggled with in the past), we got a CBC on 5/17/2021 which showed severe pancytopenia: WBC 1.7, hgb 5.0, plt 10. Referred that night to Hospital. Bone marrow aspiration on 5/19/2021 confirmed severe aplastic anemia. Since then she has had an on-going work up including a genetics evaluation that was non-contributory. She has had a second opinion at another hospital that confirmed the diagnosis, and treatment plan, which was Bone Marrow Transplant if donor available, or immune therapy if no donor found.
17 2021-06-29 fainting, pallor Fainted and had a slight seizure. Left hand seized up. Lasted for about 45 seconds. Lost color in... Read more
Fainted and had a slight seizure. Left hand seized up. Lasted for about 45 seconds. Lost color in face and sweating all over.
17 2021-06-29 fainting Patient fainted, she regained consciousness within 5 seconds, she vomited & she was lethargic. Par... Read more
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.
17 2021-06-30 fibrin d dimer increased, fast heart rate, chest pain Fever to 101.3 and malaise night of vaccine, "bad cough" on the following day with chest pain which ... Read more
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
17 2021-07-02 ischemic chest pain This is a spontaneous report from a contactable consumer (patient). A 17-years-old female patient re... Read more
This is a spontaneous report from a contactable consumer (patient). A 17-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 20May2021 at 08:30 (Batch/Lot number was not reported), at the age of 17-years-old, as dose 2, single for Covid-19 immunisation. The patient has no medical history, no concomitant medications and no past drug history. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. The patient previously took the first dose of bnt162b2 on an unspecified date for Covid-19 immunisation with no reaction. On 20May2021 at 15:00, the patient experienced heart pain for 17 hrs. She got the injection at 08:30. Heart started hurting around 3pm and hurt for 17 hrs until next evening. Outcome of the event was recovered on 21May2021. Since the vaccination, the patient has not been tested for COVID-19. Information on lot number/batch number has been requested.
17 2021-07-03 fainting Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional D... Read more
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.
17 2021-07-04 loss of consciousness Immediately afterwards she passed out and peed her pants. Her mom was sitting next to her and was ab... Read more
Immediately afterwards she passed out and peed her pants. Her mom was sitting next to her and was able to catch her and support her.
17 2021-07-04 fainting Systemic: Fainting / Unresponsive-Mild, Additional Details: PATIENT WAS GIVEN COVID VACCINE AT 9:13A... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: PATIENT WAS GIVEN COVID VACCINE AT 9:13AM. Patient was slightly nervous, covid vaccine was adminstered as normal routine. Patient was tense, slight blood at adminstration site. Left arm was wiped with pad, and given band-aid. After 30 seconds patient passed out on chair with faint response. I IMMEDIATELTY called 911 and ambulance came to observe patient. Ptaient became response, mother assured she had "Anxiety" and she left pharmacy.
17 2021-07-06 very slow heart rate Bradycardia
17 2021-07-06 chest pain 3 days after receiving Pfizer vaccine. pt developed chest pain and shortness of breath. Seen at ER d... Read more
3 days after receiving Pfizer vaccine. pt developed chest pain and shortness of breath. Seen at ER diagnosed as Pericarditis/Chest Wall Pain. Sent home on ibuprofen . Still having chest pain and shortness of breath. It has been 5 weeks per mom.
17 2021-07-06 loss of consciousness The patient passed out about 12 minutes after receiving second dose of Pfizer covid vaccination. Th... Read more
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.
17 2021-07-07 increased heart rate Postural orthostatic sinus tachycardia; This is a spontaneous report from a contactable consumer (pa... Read more
Postural orthostatic sinus tachycardia; This is a spontaneous report from a contactable consumer (patient). A 17-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0183), via an unspecified route on 25May2021 at 14:30 (at the age of 17-years) as dose 1, single in the right arm for covid-19 immunisation. The patient medical history included migraines and known allergies to cetirizine hydrochloride (ZYRTEC). The patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 25May2021 at 14:45, the patient experienced postural orthostatic sinus tachycardia. The patient visited to emergency room and physician office. The patient did not received treatment for events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not resolved. Information on Lot/Batch number was available. Additional information has been requested Follow-up (28Jun2021): Follow-up attempts are completed. No further information is expected.
17 2021-07-08 heart rate increased Blurred Vision; Rapid Heart Rate; Tingling in extremities; This is a spontaneous report from a conta... Read more
Blurred Vision; Rapid Heart Rate; Tingling in extremities; This is a spontaneous report from a contactable healthcare professional. A 17-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8734), via intramuscular route in the right arm on 26Mar2021 at 09:45 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient had been tested for COVID-19 since the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via intramuscular route in the right arm on 05Mar2021 at 12:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 26Mar2021 at 09:45, the patient experienced tingling in extremities, blurred vision, and rapid heart rate. The adverse events resulted in emergency room/department or urgent care. It was unknown if the patient had received any treatment for the events tingling in extremities, blurred vision, and rapid heart rate. The clinical outcomes of the events tingling in extremities, blurred vision, and rapid heart rate were unknown at the time of the report. No follow-up attempts are needed. No further information is expected.
17 2021-07-09 fainting Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Seizur... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Pt fainted/blacked out while sitting down on her mothers shoulders. She blacked out for a few seconds may have had a mild seizure or could have been shaking. Laid patent flat and used moms soft backpack to put under her head. Had bystander call 911 when onset of shaking/seizure that lasted for a couple seconds 2-3 minutes. Fire department came to evaluate pt. All vitals were normal. They think it was sycopy and pt was scared and nervous of needles and only had a protein bar for lunch.
17 2021-07-11 fainting Patient developed syncope very soon after injection. We helped her lay flat and provided wet cloth... Read more
Patient developed syncope very soon after injection. We helped her lay flat and provided wet cloths and ice to keep her comfortable. We monitored her blood pressure and she walked out of store with help from parents about 1-1/2 hours later.
17 2021-07-11 blood clot, chest pain, deep vein blood clot, coughing up blood, pulmonary embolism First vaccine 3/24/21 Second vaccine 4/14/21 In early may, mom can't remember date, patient c/o left... Read more
First vaccine 3/24/21 Second vaccine 4/14/21 In early may, mom can't remember date, patient c/o left leg and foot pain. Went to podiatrist - no diagnosis made - was told to monitor. Mid to late May developed dry cough. Not seen for this. On June 10 taken to ED lower left leg extremely painful and swollen and mom reported discoloration to back of leg. Diagnosed with DVT and put on blood thinner Xeralto and discharged. A week later went to hematologist who said to continue Xeralto and monitor. A week after seeing Dr. and two weeks after initial ED visit, on a Wednesday, patient started to cough up blood. Went back to Dr. and patient was taken off of Xeralto. PE scan ordered. The next day patient developed chest pain and went to ED. PE scan done and diagnosed with two PE's on right lung. Was informed had six blood clots in lower left leg. Admitted to ICU. Was an inpatient for 5 days then discharged. Now patient is taking Lovenox injections twice daily.
17 2021-07-12 chest pain Pt states she has burning in her chest substernal about 24 hrs after getting the vaccine. Pt states ... Read more
Pt states she has burning in her chest substernal about 24 hrs after getting the vaccine. Pt states the pain was about 7/10 and subsides about an hour or so later. Pt denies sob, radiating pain, n/v, fever, chills, GI upset, vision change, skin reaction, h/a, acid taste in mouth. Pt says she has been fine ever since without any residual symptoms. Symptoms: CHEST PAIN, UNSPECIFIED(R079).
17 2021-07-12 pallor, pulse abnormal, lightheadedness Patient stated she was nervous and received the vaccine without incidence. After receiving the vacc... Read more
Patient stated she was nervous and received the vaccine without incidence. After receiving the vaccine while sitting the patient had what appeared to be a vasovagal response. She became pail and her eyes rolled back in her head. Patient appeared to have a seizure stuck both arms straight out and was incontinent. Patients was moved to the floor where her color returned and her pulse improved. Patient was taken to hospital via ambulance.
17 2021-07-12 fainting Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild
17 2021-07-13 skin turning blue, pallor After we left pharmacy and was in the car at a stoplight, my daughter starting feeling very uncomfor... Read more
After we left pharmacy and was in the car at a stoplight, my daughter starting feeling very uncomfortable. She complained that she did not feel well, she could not see and that her ears were "foggy". When I looked over at her, her face was pale as can be and her lips had bluish tinge to them and she looked limp laying in the passenger seat of the car. It came on very quickly and lasted about a minute or so and was extremely scary. It took close to 30 minutes for her to regain her color. We sat in a parking lot for thirty minutes to make sure she was stable and gave her water. Went home and gave her benadryl. She slept through the night fine and this morning so far is ok.
17 2021-07-13 fainting, loss of consciousness Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient passed out in waiting area 5 m... Read more
Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient passed out in waiting area 5 minutes after being given vaccination. 911 was called, NP assisted, patient came to and was given water and something to eat. Paramedics checked vitals and patient was okay to leave on her own.
17 2021-07-14 loss of consciousness Patient came to the RX to get the vaccine as 17 years with her mom. We gave patient the vaccine afte... Read more
Patient came to the RX to get the vaccine as 17 years with her mom. We gave patient the vaccine after confirming her information and her form with allergies, medications history. Pt was ok and not allergic to anything per mom. After got the vaccine, she was sitting 15 mins to see if pt is having the reaction to covid and she passed out 5 mins later. pt was unconscious for 10 second, after I lay her on a flat surface, elevated her feet and get her blood flow, she was ok with her bp is 85/65. paramedic came to take her.
17 2021-07-14 pulmonary embolism Patient Develop a Pulmonary Embolism
17 2021-07-16 loss of consciousness PT WAS SEATED IN CHAIR WAITING FOR 15 MINS AFTER THE VACCINE AND HER MOM CAME TO GET ME JUST A FEW M... Read more
PT WAS SEATED IN CHAIR WAITING FOR 15 MINS AFTER THE VACCINE AND HER MOM CAME TO GET ME JUST A FEW MINS AFTER SHE SAT DOWN AND SAID SHE PASSED OUT FOR A FEW SECONDS AND WOKE BACK UP. I PUT HER BACK IN THE IMZ ROOM, ASSESED HER AND ASKED FOR 911. SHE STATED SHE WAS FEELING BETTER AND DIDNT WANT 911 CALLED. I GAVE HER SOME WATER AND A COLD RAG AND FAN AND CALLED MANAGEMENT. SHE SAT IN THE ROOM FOR AN ADDITIONAL 30 MINS AND SAID SHE FELT FINE BEFORE SHE LEFT. I WILL FOLLOW UP WITH PT TOMORROW TO MAKE SURE SHE IS STILL DOING WELL.
17 2021-07-16 fast heart rate, heart rate increased Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-M... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tachycardia-Severe, Additional Details: pt was very complusive and her eyes rolled back. Started sweating, pulse rate going up, light headed
17 2021-07-17 fainting, pallor Fainting; slight seizure of the left hand; Loss color in face; sweating all over the body; This is a... Read more
Fainting; slight seizure of the left hand; Loss color in face; sweating all over the body; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female patient received BNT162B2, via an unspecified route of administration, administered in left arm on 29Jun2021 12:15 (Batch/Lot number was not reported) at the age of 17 years old as dose 1, single for COVID-19 immunization. Medical history was none. Patient was not pregnancy at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. On 29Jun2021 12:15, the patient experienced fainting with a slight seizure of the left hand. Lasted about 45 seconds. Loss color in face and sweating all over the body. No treatment was provided for the events. Outcome of events fainting and slight seizure of the left hand was recovered on 29Jun2021, while other events were recovered on unspecified date on Jun2021. The report was assessed as not serious. Information on the lot/batch number has been requested.
17 2021-07-18 chest discomfort Client reported chest pressure from her neck to her chest to the EMT's at 4:47 PM. The client was al... Read more
Client reported chest pressure from her neck to her chest to the EMT's at 4:47 PM. The client was alert and oriented to person, place, time, and event. The client stated her current symptoms were less intense than her initial reaction. Vitals obtained at 4:49 PM were as follows: BP 126/78, HR 64, and O2 98%. The client denied any other s/s of anaphylaxis. At 4:52 PM the client stated the chest pressure was still present but mild. The client reported less chest pressure at 4:54PM. At 4:58 PM the client reported mild neck pain and chest pressure. At 4:59PM activated EMS. The client denied feeling cold or clammy. Vitals obtained at 5:03PM were as follows: BP 130/70, HR 64, and O2 96%. Felt similar chest pressure after she received the four doses of vaccines at her medical provider in the beginning of July but did not report the chest pressure to her mother. Fire Dept assumed care at 5:09PM. Client and mother refused medical transport at 5:16PM. At 5:20PM the client denied any chest tightness or pain in her neck. The client ambulated unassisted with a steady gait out of the observation area at 5:23PM.
17 2021-07-18 chest pain, inflammation of the heart muscle Perimyocarditis requiring hospitalization. Treatment with colchicine and ibuprofen. Hemodynamically ... Read more
Perimyocarditis requiring hospitalization. Treatment with colchicine and ibuprofen. Hemodynamically stable and discharged after a day of monitoring. Presented due to refractory chest pain originally.
17 2021-07-19 chest discomfort, ischemic chest pain Heart pain,Pounding heart ( Like someone hit the heart and the heart had ~ one minute big pain. This... Read more
Heart pain,Pounding heart ( Like someone hit the heart and the heart had ~ one minute big pain. This happened around twice a day since ~ Jun. 14th), feel tired.
17 2021-07-19 chest pain, fainting fainted and complained of chest pain. EMS called and took pt in ambulance
17 2021-07-19 loss of consciousness Patient was given vaccine. She then stood with mother and left booth. She then returned with mothe... Read more
Patient was given vaccine. She then stood with mother and left booth. She then returned with mother to sit down and passed out before getting to the chair. Patient was helped up to chair by mother and pharmacist. She was given an ice pack and remained sitting for about 30 minutes. Patient felt better and was walked to car with mother and pharmacist. Patient admitted to not eating and to being very anxious about getting vaccine. Mother was taing her to eat and home to rest.
17 2021-07-19 fainting The morning of the day after of getting the second Covid shot my daughter fainted. (Same thing happe... Read more
The morning of the day after of getting the second Covid shot my daughter fainted. (Same thing happened to my other daughter) neither daughter has ever fainted before and neither daughter has anxiety from shots
17 2021-07-19 fainting pt received her shot and was told to sit and wait for 15 minutes- pt instead walked around the store... Read more
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.
17 2021-07-20 heart rate irregular pt was nervous about getting covid 19 vaccine before entering store and after vaccine she said her h... Read more
pt was nervous about getting covid 19 vaccine before entering store and after vaccine she said her heart felt like it was beating strongly and her vision was blurred she got extremely warm to touch and clamie skin she was "tingeling" felt weird
17 2021-07-20 fainting Fainting with seizure-like appearance not before experienced.; Fainting with seizure-like appearance... Read more
Fainting with seizure-like appearance not before experienced.; Fainting with seizure-like appearance not before experienced.; This is a spontaneous report from a contactable consumer (patient) reported for herself. This 17-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 26May2021 09:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. Patient was not pregnancy at time of vaccination. Medical history was none. No known allergies. Concomitant medication included sertraline hydrochloride (ZOLOFT). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fainting with seizure-like appearance not before experienced on 26May2021 09:00 with outcome of unknown. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received. Patient received second dose on 16Jun2021 09:00 AM in left arm. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on lot/batch number has been requested.
17 2021-07-21 very slow heart rate Bradycardia; This is a spontaneous report from a contactable consumer. A 17-years-old female patient... Read more
Bradycardia; This is a spontaneous report from a contactable consumer. A 17-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14May2021 16:00 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation in public health clinic/facility. Medical history included cerebral palsy. The patient's concomitant medications were none. The patient experienced bradycardia (hospitalization, disability, life threatening) on 15May2021 08:00 with outcome of recovering. The patient was hospitalized for bradycardia (bradycardia) for 3 days. The patient underwent lab tests and procedures which included sars-cov-2 test negative: negative. Therapeutic measures were taken as a result of bradycardia as Fluid and enema. Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care visit required. Information on the lot/batch number has been requested.
17 2021-07-21 chest pain PCP received records related to patient ER visit for chest pain after COVID-19 vaccine. Was seen in ... Read more
PCP received records related to patient ER visit for chest pain after COVID-19 vaccine. Was seen in the local ER.
17 2021-07-21 loss of consciousness, pallor, fainting Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: vomited-... Read more
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
17 2021-07-21 fainting Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Shakines... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Additional Details: Patient fainted immediately after vaccine administration, she remained seated upright and came to within seconds of fainting episode. She state she was nervous before hand and mentioned in the car that she felt like she was going to pass out, and has passed out while receiving other vaccines in the past. RPh was not made aware of this by mother prior to administration. She was monitored for over 25 minutes, ate a small snack her mother had and drank some water, we gave her an ice pack/fan.
17 2021-07-22 inflammation of the heart muscle, chest pain, palpitations, fast heart rate Pt.initially had acute onset left arm pain with left sided chest pain worsened with deep breathing w... Read more
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.
17 2021-07-22 fainting, pallor On the day after vaccination, patient was pale, dizzy, tired, and fainted. Mother called and went to... Read more
On the day after vaccination, patient was pale, dizzy, tired, and fainted. Mother called and went to ED. Vitals and tests were normal and she was discharged home. Patient is feeling better, but remains tired.
17 2021-07-23 pallor, fainting, loss of consciousness syncope type reaction, briefly blacked out. hands became cold and patient looked pale. Also stated t... Read more
syncope type reaction, briefly blacked out. hands became cold and patient looked pale. Also stated that throat felt slightly tingly starting about 20 minutes after vaccine. Checked blood pressure and it was normal. Called 911. Paramedics arrived within 10 minutes. Patient was some better but parents decided to let her be taken to ER to be checked out since she had recently been diagnoses with an autoimmune disorder.
17 2021-07-23 fainting Patient got the vaccine and was fine and talking. Pt got up off the chair and walked to the door an... Read more
Patient got the vaccine and was fine and talking. Pt got up off the chair and walked to the door and she fainted. We got her lying on the floor and she was breathing and talking.. We sat her up once she felt better and gave her water. We monitored her for 30 plus minutes.
17 2021-07-25 blood pressure decreased Approximately 3 minutes after injection, pt. reported that her vision had gone black, her ears were ... Read more
Approximately 3 minutes after injection, pt. reported that her vision had gone black, her ears were ringing, and she felt faint. I notified the nurse immediately. Within another minute her breathing became rapid and faint. She was given water and coached to breath slowly and deeply. The nurse checked her blood pressure with a result of 67/22. A second BP check resulted in 70/27. The nurses transferred her to the ER. In the ER, a third BP check 20 minutes after injection resulted in a normal reading of approximately 110/70. She continued to take oral fluids for approximately one hour before being released. The medical staff reported to us that this is a completely normal reaction for many people to all vaccinations, and suggested that she should get the second dose of Pfizer vaccine in 3-4 weeks. However, when we check the CDC website we find that these are anaphylactic symptoms and should not get the 2nd dose of Pfizer, so we are greatly concerned and decided to report the event.
17 2021-07-25 blood pressure increased Fatigue, enlarged left breast and lymph nodes. Dizziness, had the feeling of blacking out, headache,... Read more
Fatigue, enlarged left breast and lymph nodes. Dizziness, had the feeling of blacking out, headache, muscle weakness, BP was stable 58-60 when patient sitting, spikes to 100 when she stands.
17 2021-07-27 loss of consciousness patient passed out after walking to the waiting area, then threw up when she came to
17 2021-07-27 fainting Patient received vaccine at roughly 2:40 pm on 7/28/21. Was advised to stay at location for 15 minut... Read more
Patient received vaccine at roughly 2:40 pm on 7/28/21. Was advised to stay at location for 15 minutes prior to leaving . Patient was shopping in store and fainted . Found patient lying on floor with her mother by her side . Patient was alert but shaken . Patient said she had hit her head and scraped her leg. patient was put into a chair and given some juice and an ice pack for back of neck . After about 10 to 15 minutes patient said she felt well enough to walk and was taken home by her mother .
17 2021-07-27 fainting Patient seemed to faint / look like they had a seizure, no seizure history, color recovered to face ... Read more
Patient seemed to faint / look like they had a seizure, no seizure history, color recovered to face once we laid her down and lifted legs up. EMS was called and assessed patient.
17 2021-07-28 very slow heart rate, fainting, hypotension PATIENT DID NTO EAT BEFORE THE VACCINATION AND WE GAVE HER A SNACK. SHE FAINTED AND THEN THREW UP. S... Read more
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.
18 2021-01-03 chest discomfort Covid 19, Fever, Chills, Body Aches, Headache, Left arm numbness, chest tightness
18 2021-01-05 palpitations Time course: Received Pfizer COVID vaccine 1515. Had immediate reaction. See next page.
18 2021-01-15 chest pain 100.1 fever at 630pm , swelling of face, chest pain , trouble with breathing , redness of face , and... Read more
100.1 fever at 630pm , swelling of face, chest pain , trouble with breathing , redness of face , and body pain at 8pm ,
18 2021-01-17 chest pain, palpitations Patient felt dizzy and short of breath. Complained of feeling like her heart was racing and chest p... Read more
Patient felt dizzy and short of breath. Complained of feeling like her heart was racing and chest pain. Was seen in the ED and received antihistamines and was monitored. Continued to complain of symptoms 7 days after receiving the vaccine and called in to work that day as well.
18 2021-01-20 chest discomfort Systemic: cramping fingers, tightness in the chest, trouble breathing, dizziness-Severe; symptoms la... Read more
Systemic: cramping fingers, tightness in the chest, trouble breathing, dizziness-Severe; symptoms lasted 1 day
18 2021-01-20 loss of consciousness, lightheadedness Vasovagal episode. pt briefly passed out after reported blurred vision, dizziness and tingling arms.... Read more
Vasovagal episode. pt briefly passed out after reported blurred vision, dizziness and tingling arms. Staff supported patient by moving pt to ground and elevated pt feet. pt did not lose consciousness and reported feeling better after laying down for a few minutes. We moved her to a sitting position on the ground, then to the chair. continued to monitor and pt reported feeling fine. Patient recovered within 10 minutes of episode.
18 2021-01-24 fainting Immediately after vaccination patient reported feeling lightheaded, diaphoretic. Witnessed syncopal... Read more
Immediately after vaccination patient reported feeling lightheaded, diaphoretic. Witnessed syncopal episode in bay (no head trauma), assisted to recliner by vaccinator. BP 90/80 at start of event. Given Gatorade and crackers with minimal effect. 15 minutes after treatment BP 80/70 and administered O2 via nasal canula. Transported via wheelchair at 12:06pm.
18 2021-02-06 lightheadedness 1 min post inj cc/lightheaded, dizzy, blurry vision, ringing in ears. Pt reported vasovagal effect... Read more
1 min post inj cc/lightheaded, dizzy, blurry vision, ringing in ears. Pt reported vasovagal effects with needles. Subsided after 5 mins.
18 2021-02-22 hypotension Dizziness, hypotension. resolved quickly.
18 2021-02-23 loss of consciousness Pt came up to the EMS table and stated she did not feel well. Pt lost conciousness from a standing p... Read more
Pt came up to the EMS table and stated she did not feel well. Pt lost conciousness from a standing position and was caught and lowered to the ground. Pt was unconcious for approx 5 minutes. Pt regained conciousness. Pt was placed in a wheelchair and wheeled to the examination room. Pt was monitored for 30 minutes. Pt states she is feeling better and would like to leave. Pt was walked out to her car. Pt was driven home by her mother. Pt did not require transport.
18 2021-02-25 chest pain Nausea, Vomiting, Diarrhea, Stomach Ache, Chest Pain
18 2021-02-26 loss of consciousness Staff at facility informed staff that a staff member had passed out. RN from drug store found clie... Read more
Staff at facility informed staff that a staff member had passed out. RN from drug store found client sitting in a chair, awake and alert, no signs of injury. Had client lay down and elevated legs. BP at 1:50 PM is 122/86, HR is 100, regular and strong, color is good, mentation is good, no signs of injury, client state she feels "weird and tingling". Patinet monitored for over 30 minutes with multiple BP and HR checks and mentation checks. One dose of Bendaryl 25 mg given at 1:57 PM. Orthostatics completed at 2:00 PM. Both HR and BP remain WNL and client continjues to be awake and alert,. Ambulated to bathroom with RN at side. Patient declines need for EMT and went home with her boyfriend at 2:20 PM, BP at 132/88, HR at 80.
18 2021-02-28 heart attack, troponin increased, hypotension Pt presented by EMS for acute epigastric pain radiating to the back. While waiting for lab results, ... Read more
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
18 2021-03-03 chest discomfort After receiving first mRNA COVID vaccine, patient experienced flushing, headache, chest tightness, s... Read more
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.
18 2021-03-04 chest discomfort, fainting Asthma; Syncope; Dizziness; Nausea; Vomiting; Severe headache; Fever; Muscle weakness; Muscle twitch... Read more
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.
18 2021-03-04 loss of consciousness On Fri 3/5 one of the RPhs on duty administered the vaccine around 2:45 PM. RPh advised patient to w... Read more
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.
18 2021-03-09 fainting At 1405, Patient was sitting in observation room after receiving first dose of Pfizer. Patient slide... Read more
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.
18 2021-03-11 pallor Pallor, vomiting, dizziness within 5 minutes of administration. Patient was given receptacle to vom... Read more
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.
18 2021-03-15 fast heart rate Patient explained tachycardia in the early morning that came and went following the vaccination. She... Read more
Patient explained tachycardia in the early morning that came and went following the vaccination. She stated she was going to urgent care for treatment.
18 2021-03-17 loss of consciousness, fainting Pt. stated she started feeling dizziness 5 mins. after getting vaccinated. Seconds later she had a ... Read more
Pt. stated she started feeling dizziness 5 mins. after getting vaccinated. Seconds later she had a syncope episode for around 10 seconds. At. 5:10 pm she was conscious and dizziness went away. Vital signs were done BP101/60, R 19, O2 sat 100%, HR 62. Pt stated, "I always have episodes of syncope when I get medical procedures, This is not the first time." At 5:25 pm pt stated she is feeling ok, pt is alert and oriented x4. At 5:38 pm pt stated she wants to go home. Pt. went home at 5:40 pm.
18 2021-03-21 blood pressure decreased BECAME NAUSEATED AND VOMITED IMMEDIATELY AFTER VACCINE DOSE. BECAME DIZZY WHILE WAITING IN OBSERVAT... Read more
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
18 2021-03-22 pallor, loss of consciousness Loss of consciousness, vomiting, turned pale and unresponsive at times.
18 2021-03-23 pallor Immediately following vaccination, patient "saw black", became diaphoretic and pale. Patient was lai... Read more
Immediately following vaccination, patient "saw black", became diaphoretic and pale. Patient was laid on floor with feet up on chair. Vitals: 1600 BP 87/52 HR 52 98% (laying 1602 102/68, 57, 98% (laying) 1604 103/74, 66, 100% (laying) 1605 111/69 73 100% (sitting on floor) 1609 106/69, 64, 100% (sitting in chair) Pt was eating, talking and drinking water. Symptoms resolved. No further treatment needed.
18 2021-03-24 blood pressure decreased Patient felt like she was going to pass out so laid down on floor. Staff responded assessed and help... Read more
Patient felt like she was going to pass out so laid down on floor. Staff responded assessed and helped into wheelchair and took her to observation area. Vital signs were stable. Gave patient juice, water and granola bar. Patient stated that she has had episodes like this in the past when getting injections. Also stated she had not had lunch or fluids prior to COVID injection. At 2:17 pm sat patient up and dangled her legs. Patient became dizzy and laid her back down. Rechecked vitals and blood pressure had dropped. Kept her for another 15 minutes and set her up, reviewed blood pressure and nurse assisted her to observation area. Patient was fine and left to go home with mother.
18 2021-03-24 loss of consciousness 6:45AM- blurred vision and chills upon getting out of bed followed by loss of consciousness for ~30 ... Read more
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.
18 2021-03-24 fainting She had recieved her dose, she fainted while she was seated, vitals were normal incident occured at ... Read more
She had recieved her dose, she fainted while she was seated, vitals were normal incident occured at around 8:37 am.
18 2021-03-26 blood pressure increased Patient received the 1st dose of the Pfizer Covid Vaccine (Lot: ER8732, EXP: 7/21) on 3/27/21. Short... Read more
Patient received the 1st dose of the Pfizer Covid Vaccine (Lot: ER8732, EXP: 7/21) on 3/27/21. Shortly after the injection the patient's arm started itching and a rash developed. Patient was dizzy, hot, and had an elevated blood pressure. Patient was transported to Emergency Department by EMS.
18 2021-03-26 fainting About two hours after getting vaccinated, Patient had her first ever migraine and the pain was so in... Read more
About two hours after getting vaccinated, Patient had her first ever migraine and the pain was so intense she passed out. Paramedics transported her to ED where she had altered consciousness for about another 4 hours.
18 2021-03-29 heart rate increased migraine at rhe base of my Head; My heart rate rose to around 133 just laying down; extremely nauseo... Read more
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.
18 2021-03-29 loss of consciousness patient lost consciousness, possible seizure following vaccination
18 2021-03-30 chest discomfort, pallor Client became light headed and dizzy after injection. Pale skin and some chest tightness. Denied any... Read more
Client became light headed and dizzy after injection. Pale skin and some chest tightness. Denied any difficulty breathing.
18 2021-04-01 fainting Syncopal episode following vaccination 106/58 14 62
18 2021-04-04 blood clot, deep vein blood clot Acute DVT in left LE. Patient presented to ED on 3/22/21. She had 2 day h/o leg discomfort and leg w... Read more
Acute DVT in left LE. Patient presented to ED on 3/22/21. She had 2 day h/o leg discomfort and leg was taught and painful on the day she went to the ED. Study was limited due to pt lack of cooperation. Lovenox started.
18 2021-04-05 loss of consciousness PT RECEIVED SHOT, SAT ON CHAIR FOR 5 MINUTES. PT STATES SHE DOESN'T FEEL GOOD AND SLOWLY FELL OUT OF... Read more
PT RECEIVED SHOT, SAT ON CHAIR FOR 5 MINUTES. PT STATES SHE DOESN'T FEEL GOOD AND SLOWLY FELL OUT OF HER CHAIR. I WAS ABLED TO CATCH HER IN TIME AND LAY HER DOWN ON THE GROUND. PT LOST CONSCIOUSNESS AND STOPPED BREATHING. WAS ABOUT TO PERFORM CPR BUT PT WOKE UP BY HERSELF AND ACTED NORMAL AGAIN.
18 2021-04-05 fainting PT STATED NOT FEELING WELL AND SHE SAID SHE IS NOT ABLE TO SEE. PT FELT DIZZY AND FAINTED. SHE FELT ... Read more
PT STATED NOT FEELING WELL AND SHE SAID SHE IS NOT ABLE TO SEE. PT FELT DIZZY AND FAINTED. SHE FELT BETTER AFTER ELEVATING FEET AND WAITED 30 MIN FOR OBERVATION.
18 2021-04-05 fainting Immediately after receiving vaccine patient fainted. Before administering vaccine, patient instructe... Read more
Immediately after receiving vaccine patient fainted. Before administering vaccine, patient instructed us that she faints with every vaccine she receives
18 2021-04-06 pallor, fainting 17 y/o female, 5 minutes post vaccination c/o lightheaded ness, pt. Fainted for <15secs, upon assess... Read more
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.
18 2021-04-06 pallor client received covid vaccine approx 5-10 min later c/o feeling sick to stomach and light headed. cl... Read more
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.
18 2021-04-06 fainting, hypotension Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Additional Details: Patient fell out of chair #7 in pharmacy. This author caught patient and brought to floor. EMS called at 12:44. Nurse on site took patients BP 108/66. Could not get HR. EMS arrived at 12:52. EMS evaluated patient. Gave patient cold water. Patient declined hospital transfer. Patient was over 18 and EMS gave her paper that stated she declined hospital care. EMS left 12:57.
18 2021-04-06 fainting Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium
18 2021-04-06 fainting Pt received vaccine and approximately 5 minutes later pt got light headed fainted and hit head on th... Read more
Pt received vaccine and approximately 5 minutes later pt got light headed fainted and hit head on the floor of the waiting room. Pt begun to seize for approximately 30 seconds then regained consciousness. Pt was stabilized and monitored. 9-1-1 contacted immediately and handled pt care once they arrived.
18 2021-04-07 loss of consciousness Within 5 mins of receiving the vaccine, patient collapsed, skin turned red, had difficulty breathing... Read more
Within 5 mins of receiving the vaccine, patient collapsed, skin turned red, had difficulty breathing and "strange feeling in throat" on her way to the 15 minute observation room. 911 was called and 2 Pharmacists rushed to her and one administered an epinephrine pen. Patient could breathe more deeply after the epi pen administered. One pharmacist stayed with her in case another dose of epinephrine needed to be administered, once the paramedics arrived the pharmacist left the room so they could care for the patient.
18 2021-04-07 lightheadedness 3:35PM NEAR SYNCOPY - PLACED IN WHEEL CHAIR AND MOVED TO COT. MOM AAT SIDE. 'FEELING BETTER'. BP 100... Read more
3:35PM NEAR SYNCOPY - PLACED IN WHEEL CHAIR AND MOVED TO COT. MOM AAT SIDE. 'FEELING BETTER'. BP 100/60, HR 81, R 20, 02 SAT 99%. A/O, PINK, W/D, RESP REG WITH EASE. 3:42PM SITTING UPRIGHT - WATER AND PEANUT BUTTER CRACKERS GIVEN. 3:51PM 'FEELS FINE NOW'. AMBULATORY TO EXIT MOM TO DRIVE PT HOME, GIAT STEADY. NO ACUTE OR OBVIOUS DISTRESS NOTED. 4-8-21 11AM TC: MOM STATES 'SHE IS FINE NOW; WENT TO SCHOOL TODAY'.
18 2021-04-07 fainting About 5 min after vaccine given, patient had a syncopal episode. BP 59/35. Taken to ED. Noted wit... Read more
About 5 min after vaccine given, patient had a syncopal episode. BP 59/35. Taken to ED. Noted with a fear of needles and had not eaten that morning. In ED, BP 125/82, respirations 20, HR 84. Remained stable with no further hypotension.
18 2021-04-07 fainting Patient vomited immediately after vaccination. She sat for approximately 7 minutes with an ice pack ... Read more
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.
18 2021-04-08 loss of consciousness Took Benadryl before getting the shot at 2:30pm Allergic reaction resulting in facial and throat swe... Read more
Took Benadryl before getting the shot at 2:30pm Allergic reaction resulting in facial and throat swelling, red welts at the back of the throat, wheezing, going unconscious and shaking all within 2 hours of receiving the vaccine Took second Benadryl to try and calm down the reaction (no effect) Epipen was given at the advice of my physician at 6:30pm Was directed to the ER Given medication in the ER Released after 4 hours
18 2021-04-08 pallor, hypotension, loss of consciousness, fainting The Pfizer shot was given at 1:30. We shopped at the store for 15 minutes (they didn't have a waitin... Read more
The Pfizer shot was given at 1:30. We shopped at the store for 15 minutes (they didn't have a waiting area to sit down). We left the store. As I (her mother) was driving home she passed out and her head almost hit the dashboard. I grabbed her head and pulled into a parking spot. She was white as a ghost. I called 911. The ambulance arrived 6-8 minutes later. She was speaking incoherently to the paramedics and her blood pressure was extremely low. They transported her to the Medical Center. Her blood pressure was monitored and she was given a bag of fluids. We were there over 2 hours before she was released. They said it was Vasovagal Syncope and the paramedic said he had a few similar calls shortly after the Covid-19 shot had been administered (I hope they are all reporting it). A friend of ours called us and told us his daughter passed out after the Pfizer shot just last week. She was at (college in out of state) and got her shot there. They didn't report it or anything. I think this needs to be looked into. Especially in regards to younger people.
18 2021-04-08 fainting Patient was reported to have fainted in an aisle about 10 minutes after administration of the vaccin... Read more
Patient was reported to have fainted in an aisle about 10 minutes after administration of the vaccine. Upon arriving the patient was conscious but appeared to be disoriented, sitting in a chair. 911 was called and a police officer responded; patient was evaluated and EMT services were called in afterwards.
18 2021-04-09 loss of consciousness, fainting fainting, followed by seizure like involuntary movement for 15 secs. patient regained consciousnees ... Read more
fainting, followed by seizure like involuntary movement for 15 secs. patient regained consciousnees and left with family to healthcare providers.
18 2021-04-11 fainting, heart rate decreased Patient appeared to be faint, moderate dizziness, and low heart rate. Was assisted by pharmacist and... Read more
Patient appeared to be faint, moderate dizziness, and low heart rate. Was assisted by pharmacist and paramedic, declined to be admitted. Patient was alerted to place, person, time, and situation.
18 2021-04-11 fainting, loss of consciousness Fainted and lost consciousness, came back quickly (30 seconds) but did not remember anything. Was ta... Read more
Fainted and lost consciousness, came back quickly (30 seconds) but did not remember anything. Was taken S/V, blood sugar test (DXT). All normal values
18 2021-04-11 fainting Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe
18 2021-04-11 fainting fainted/fell, BP 117/71, pulse 80. Resolved within minutes following monitoring
18 2021-04-11 fainting Patient begun to faint shortly after receiving the COVID vaccine.
18 2021-04-12 loss of consciousness, lightheadedness, blood pressure increased Pt had vagel response. Due to high anxiety about the shoot pt , passed out after shot for 2 to 3 s ,... Read more
Pt had vagel response. Due to high anxiety about the shoot pt , passed out after shot for 2 to 3 s ,and was helped to get down on floor with her legs elevated. Patient was in shock, this her BP was high, but was alter and oriented, helped to get stable. with in five minutes of the response pt was at her base line but we kept her at vaccine site for 30 minutes to monitor her response.
18 2021-04-12 loss of consciousness Patient loss consciousness immediately after receiving the vaccine. EMS arrived immediately and the ... Read more
Patient loss consciousness immediately after receiving the vaccine. EMS arrived immediately and the patient regained consciousness. The mother believes that the loss of consciousness may be due to the patient's medications and not the vaccine. Patient stated she felt tired and refused EMS treatment. No further issues.
18 2021-04-12 loss of consciousness Feeling nauseous at 7 pm, started to feel dizzy at 10 pm and passed out briefly, friend witnessed. H... Read more
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.
18 2021-04-12 fainting Systemic: Fainting / Unresponsive-Mild
18 2021-04-12 fainting Patient fainted about 10 minutes after shot. Laid patient down got her to raise legs, drink water, i... Read more
Patient fainted about 10 minutes after shot. Laid patient down got her to raise legs, drink water, ice pack after about 10 minutes patient felt well was coherent. Left pharmacy with mom.
18 2021-04-12 fainting acute sinus infection; bilateral cerumen impaction; Bilateral otitis media; Had a syncopal episode; ... Read more
acute sinus infection; bilateral cerumen impaction; Bilateral otitis media; Had a syncopal episode; Dizzy; This is a spontaneous report from a contactable physician. A 18-years-old female non-pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8730), dose 1 intramuscular, administered in right arm on 24Mar2021 as single dose for covid-19 immunisation. Medical history included dysmenorrhoea, menometrorrhagia, obesity, guillain-barre syndrome. Concomitant medication's included ethinylestradiol, levonorgestrel (LUTERA) taken for an unspecified indication, start and stop date were not reported. The patient previously took fluconazole (known allergies). Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was tested for Covid test post vaccination on 25Mar2021 show the negative result. Patient claimed she became dizzy within 15 minutes of the vaccine and had a syncopal episode. She stated that it occurred twice since the vaccine. This MD conducted physical exam on 30Mar2021 and found bilateral cerumen impaction that was cleared. She reported that this revealed bilateral otitis media and she was diagnosed with acute sinus infection and treated. Although her symptoms can be explained by these findings, this MD was continuing work up for Guillain-Barre. The adverse event result in Emergency room/department or urgent care. Treatment received for the adverse event are supportive care, antibiotic for sinus infection and clearance of impacted cerumen. The outcome of the events were recovered with lasting effects. No follow-up attempts are needed. No further information is expected.; Sender's Comments: The event syncope is assessed as possibly related to the suspect vaccine BNT162B2 based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications. 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.
18 2021-04-13 lightheadedness approximately 2 minutes after vaccination patient began to have light headed sensation- near syncope... Read more
approximately 2 minutes after vaccination patient began to have light headed sensation- near syncope without long term disability or injusy
18 2021-04-13 fainting Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild
18 2021-04-15 blood pressure increased immediately after vaccine pt states feeling sweaty, spots in vision, muffled hearing, brought to OB... Read more
immediately after vaccine pt states feeling sweaty, spots in vision, muffled hearing, brought to OBS via wheelchair by reaction nurse. given water and transferred self to stretcher, placed in tredelenburg, vs monitored as noted. pt feeling better once laying down, pt slowly positioned to sitting up to dangle and then to standing. feeling better with position changes pt states normally has lower BP no further symtpoms. ok to discharge home pt ambulated to exit at 0935 vs 0913 bp 97/60 hr 73 rr 18 o2 96, 0919 bp 109/65 hr 77 rr 18 o2 98, 0924 bp 108/76 hr 91, rr 18 o2 97 low fowlers, 0926 bp 98/64 hr 92 rr 18 o2 98 dangle 0932 bp 110/64 hr 86 rr 18 o2 98 0933 bp 111/72 hr 92 rr 20 o2 98 standing
18 2021-04-15 chest discomfort Chest discomfort when breathing and Shortness of breath upon mild exertion.
18 2021-04-15 chest pain, heart rate increased Shortness of breath, chest pain, rapid heart beat. Called triage nurse, was advised to go to ER her... Read more
Shortness of breath, chest pain, rapid heart beat. Called triage nurse, was advised to go to ER her symptoms weren?t normal for the vaccine side effects. At ER they gave her Tylenol to lower her her heart beat.
18 2021-04-15 pallor Patient came to clinic with mother to get COVID 10 Vaccine. Patient received vaccine at 1515 and sta... Read more
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.
18 2021-04-16 lightheadedness vasovagal reaction
18 2021-04-17 loss of consciousness, pallor Patient was given vaccine. A couple of minutes after the vaccine, during observation period, patient... Read more
Patient was given vaccine. A couple of minutes after the vaccine, during observation period, patient was in and out of consciousness, feeling faint, and was very pale. Fire rescue was called and all vitals were fine. Patient opted out of leaving with fire rescue and decided to go home.
18 2021-04-17 fainting Patient fainted (syncope) within 2 minutes. Fell off her chair and hit her front tooth which broke o... Read more
Patient fainted (syncope) within 2 minutes. Fell off her chair and hit her front tooth which broke off. 911 was called, her vitals were taken. Cleared by medical staff. Patient and mother refused to be taken to the Hospital. Both signed waivers of fact. Patient walked off without assistance.
18 2021-04-18 loss of consciousness Pt became nauseous/sweaty/dizzy 10 minutes after 1st vaccine. Passed out w/ EMS for about 20 seconds... Read more
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.
18 2021-04-18 loss of consciousness pt told her dad that she was not feeling well and lost consciousness and had seizure for about 5 sec... Read more
pt told her dad that she was not feeling well and lost consciousness and had seizure for about 5 seconds. vitals monitored, WNL. Pt A&Ox4, observed for additional 30 minutes while constantly monitoring vitals, stated she felt better and was driven home by her dad.
18 2021-04-18 loss of consciousness [April 10; Evening]: Headache with small pounding feeling, a slight fever. [April 11, Morning]: Slig... Read more
[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.
18 2021-04-18 palpitations, hypotension Nausea, Low HR, Low BP, Diaphoresis
18 2021-04-18 fainting 1328 - Father stated daughter didn't feel well - walked to stretcher and fainted. 1330 - Patient a... Read more
1328 - Father stated daughter didn't feel well - walked to stretcher and fainted. 1330 - Patient awake, VS taken, on stretcher, color improved, talking. BP = 98/53, HR = 74, RR = 22, O2 Sat = 100% 1335 - Patient sitting up. 1340 - Patient talking, drinking soda. BP = 117/76, HR = 80, RR = 22, O2 Sat = 100% 1350 - Patient's color pink, in no apparent distress. BP = 129/71, Hr = 83, RR = 16, O2 Sat = 98% 1351 - Patient ambulated out of clinic with father.
18 2021-04-18 fainting Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainti... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe
18 2021-04-19 blood pressure decreased Event described to me by RN who administered the vaccine, the patient was nervous prior to receiving... Read more
Event described to me by RN who administered the vaccine, the patient was nervous prior to receiving vaccine and experiences anxiety regularly. After receiving vaccine, patient became increasingly anxious and began sweating. Blood pressure reportedly dropped to 90/70 at which time RN administered an epipen 0.3mg. 911 was subsequently called to further care for the patient.
18 2021-04-19 fainting Patient reports she felt dizzy two hours after the shot. She went to a quiet area and had a witnesse... Read more
Patient reports she felt dizzy two hours after the shot. She went to a quiet area and had a witnessed syncopal episode and seizure like activity for 10 seconds with urine incontinence. She said she woke up on the ground. She did not go to the ER or call 911. She didnt report the episode until April 20, 2021, when she showed up for her second vaccination. She was declined the second vaccination.
18 2021-04-20 chest discomfort PATIENT HAD TIGHTNESS IN CHEST, BUT WAS ANXIOUS BEFORE GETTING THE VACCINE AND FORGOT HER INHALER. ... Read more
PATIENT HAD TIGHTNESS IN CHEST, BUT WAS ANXIOUS BEFORE GETTING THE VACCINE AND FORGOT HER INHALER. IT WENT AWAY AFTER 20 MINUTES.
18 2021-04-20 excessive bleeding bleeding; less soreness at the injection site; This is a spontaneous report from a contactable consu... Read more
bleeding; less soreness at the injection site; This is a spontaneous report from a contactable consumer. An 18-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8735, expiration date: unknown), via an unspecified route of administration administrated on left arm on 05Apr2021 at 16:00 at the age of 18-year-old at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. No other medications in two weeks. The patient did not have any known allergies. She received first dose of BNT162B2 (Pfizer Covid-19 vaccine, Lot number: EN6204, Expiry date: unknown) via an unspecified route of administration, administrated on left arm on 14Mar2021 at 15:00 (03:00 PM) at the age of 18-year-old at a single dose for COVID-19 immunization. On 05Apr2021 04:00 PM, reported that the 2nd dose of vaccine caused unusual amount of bleeding after needle was removed. The patient had to clean excess blood after the shot. The band aid was soaked with blood. The patient experienced less soreness at the injection site compared to the first vaccine shot. The concern is whether the vaccine was bled out due improper injection. She did not have any other vaccine in four weeks before the covid-19 vaccine dose. The patient did not receive any treatment for the events. She was not having COVID prior to the vaccination, neither was tested for Covid-19 post vaccination. The patient recovered from the events on an unspecified date in 2021.
18 2021-04-20 heart rate increased, chest discomfort, pallor 1:50 Called into observation room by RN. for assistance with this patient. Pt had Dose 2 of Phizer a... Read more
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.
18 2021-04-20 pallor, fainting, loss of consciousness Patient: Female, Per RN notes: "1610 vaccinated L deltoid, Reaction time: 1611 Fainted, Chin lift an... Read more
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. "
18 2021-04-20 fainting Within minutes of pt receiving covid vaccine, verbalized to 'not feel well' and fainted. A friend an... Read more
Within minutes of pt receiving covid vaccine, verbalized to 'not feel well' and fainted. A friend and staff members gently assisted pt to the floor. Immediate assessment of vital signs and pt taken to private area for monitoring. Pt may have had vasovagal response due to anxiety.
18 2021-04-21 chest discomfort The first time I had the vaccine my throat started burning and chest tightness I stayed with the nur... Read more
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
18 2021-04-21 heart rate increased Fast heartbeat, shortness of breath, dizziness. Started 1-2 hours after shot administered. Intensi... Read more
Fast heartbeat, shortness of breath, dizziness. Started 1-2 hours after shot administered. Intensity increased around 5PM. Had to seek emergency medical help. Admitted to ER at Medical Center at 6PM, discharged about 9PM.
18 2021-04-21 loss of consciousness, pallor Approximately 5 minutes after vaccine administered, patient started feeling nauseous and dizzy. She ... Read more
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.
18 2021-04-21 fainting near syncope, fatigue
18 2021-04-21 fainting Patient had vasovagal syncope starting about 5 minutes after vaccination that resolved within 10 min... Read more
Patient had vasovagal syncope starting about 5 minutes after vaccination that resolved within 10 minutes. She stayed in pharmacy area for an additional 15 minutes for monitoring
18 2021-04-22 heart rate increased Dizziness and rapid hearbeat within 15 minutes of getting the shot. Symptoms persisted for 7 days af... Read more
Dizziness and rapid hearbeat within 15 minutes of getting the shot. Symptoms persisted for 7 days after the shot.
18 2021-04-22 hypotension Patient came to vaccine clinic, immediately after vaccination, hypotensive 80/60, nauseated, but no ... Read more
Patient came to vaccine clinic, immediately after vaccination, hypotensive 80/60, nauseated, but no other side effects
18 2021-04-22 loss of consciousness She received the shot walked a couple steps had a blank stare on face sat her in a chair where she s... Read more
She received the shot walked a couple steps had a blank stare on face sat her in a chair where she sat for a couple seconds and just stared at me then head jerked and right hand curled and eyes rolled back into head. tried shaking her to respond she passed out .She came to opened eyes wasn't speaking but followed my command to spit out gum then again went limp with head shaking and hands twitching. Got her to the ground with help and called 911. She laid on ground then came to . She did not remember incident but was responding appropriately to questions. drank orange juice and placed ice bag under neck while laying. By the time paramedics arrived she was awake and appropriate. Pulse ox, blood sugar and EKG normal. Blood pressure was low but not unusual for her. Prior to shot she was well hydrated and had eaten. After being checked out by paramedics we denied need to go to hospital and she did walk out on her own. Observed her closely over night and had no further symptoms.
18 2021-04-23 hypotension Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-M... Read more
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
18 2021-04-23 pallor, loss of consciousness, skin turning blue, pulse abnormal Patient is a 18-year-old, female. No known medical history. No known allergies. At 3:18 pm, the pati... Read more
Patient is a 18-year-old, female. No known medical history. No known allergies. At 3:18 pm, the patient received her first dose of Pfizer vaccine (lot number EW0179, expires on 08/2021) on left deltoid, given by RN. Patient informed RN that she has a history of fainting after vaccines. RN recommended the patient wait in the zero-gravity chair. Patient continued to be A&Ox3, walked herself over to the EMT waiting area with a steady, balanced, and sat down in zero-gravity chair. At 3:20 pm, patient checked in with EMT and stated she feels "fine". At 3:27 pm, while waiting in observation area, patient stated "I don't feel good" and went unconscious. EMT reclined patient into supine position. Patient remained unconscious for approximately 10 seconds. RN called 9-1-1 at 3:28 pm. Patient regained consciousness at 3:28 pm and stated "I need something sweet". At 3:30 pm, the patient's BP 69/44, RR 8/min, HR 63 bpm and weak, skin dry and cold to touch, lips pale and cyanotic. At 3:33 pm, the patient's BP was 87/60. Fire Department arrived on site at 3:34 pm. Patient was transferred to gurney by FD. Patient left facility at 3:34 pm .
18 2021-04-24 loss of consciousness losing vision; almost passing out; After second dose: fever; chills; headache; body ache; pain at in... Read more
losing vision; almost passing out; After second dose: fever; chills; headache; body ache; pain at injection site; dizziness; This is a spontaneous report from a non-contactable consumer (patient). An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, at 18 years old. The patient medical history was not reported. There were no concomitant medications. No other vaccines if four weeks. Patient received the first dose of bnt162b2 at 12Mar2021 16:30, arm left for covid-19 immunisation, at 18 years old. Patient is not pregnant. The patient experienced after second dose: losing vision, almost passing out, dizziness, fever, chills, headache, body ache, pain at injection site on 10Apr2021 00:00 (12AM). Treatment was not given. Outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
18 2021-04-24 fainting Immediately following pt receiving Pfizer vaccine, she fainted in chair. Symptoms lasted approx 3-4 ... Read more
Immediately following pt receiving Pfizer vaccine, she fainted in chair. Symptoms lasted approx 3-4 mins. Medic placed on stretcher and observed for over 30minutes. VS WNLs. Pt diaphoretic and provided juice, water and peanut butter crackers. Pt's mother reported no PMH.
18 2021-04-25 hypotension Systemic: Dizziness / Lightheadness-Medium, Additional Details: Patient said they felt light headed.... Read more
Systemic: Dizziness / Lightheadness-Medium, Additional Details: Patient said they felt light headed. We had her lay down. First blood pressure was low 80/64, then 99/64, after sitting went to 110/69 with pulse of 55 which patient and parent said was normal. Patient was feeling good upon leaving. Note, patient said they had a very light breakfast and might have been a factor.
18 2021-04-25 pallor, lightheadedness, fast heart rate After vaccination, patient became lightheaded as she left the room. Mother lowered patient to ground... Read more
After vaccination, patient became lightheaded as she left the room. Mother lowered patient to ground with feet resting on chair in hallway. Pulse was mildy tachy and patient had severe pallor at that point per Dr. Patient was taken to urgent care via wheelchair. Blood pressure 92/61 at 1646, pulse 76 BPM. Patient felt improvement lying on bed. Patient had been hiking that morning and admitted to not drinking enough water that day. Dr. suspected dehydration and vasovagal reaction.
18 2021-04-26 heart rate increased Heart rate steadily above 115. Has gotten as high as 167.
18 2021-04-26 fainting, pallor Patient was sitting in a chair after the vaccine was administered, stated she was feeling well then ... Read more
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
18 2021-04-26 fainting syncope
18 2021-04-26 fainting After receiving the vaccine the patient became clammy and fainted. Patient faints every time she get... Read more
After receiving the vaccine the patient became clammy and fainted. Patient faints every time she gets a vaccine. We let the patient lay down to regain consciousness and she did after about 30 seconds. After patient sat for a few minutes she was feeling well again
18 2021-04-27 loss of consciousness patient blacked out and passed out after receiving her first dose within the 15 min wait time. 911 w... Read more
patient blacked out and passed out after receiving her first dose within the 15 min wait time. 911 was called and vitals were normal. patient refused admission to hospital
18 2021-04-27 increased heart rate symptom started 4/21, with pain and tightness in the left arm, progressively spreading up the arm ov... Read more
symptom started 4/21, with pain and tightness in the left arm, progressively spreading up the arm over the following 48 hours, and then to the distal right arm, and legs. The leg symptom were present when seen 5 days ago, though were not discussed as Patient wasnt sure if thats what was really starting. This is associated with a feeling of "not being able to feel muc" and "doesn't feel right", as if it "feels foreign... body says this is weird," and feels heavy. Also notes that different extremities feel different - left is worse than right. Seen 5 days ago, and noted to have been advised by hematology to stop eliquis approximately 2 weeks prior to onset of symptom after PE/Renal artery embolism 1/2021. At that visit was referred to ER, where workup for repeat clot was normal (CTA, b/l upper extremities dopplers, head/neck CT, CXR). EKG was notable for Sinus tach and nonspecific T wave abnormalities. Discharged home with close follow up. Since then the intensity of the symptom as worsened and the leg symptoms have gotten more pronounced and consistent with the upper extremities symptom. Today notes new difficulty getting dressedon because clothes were getting stuck/he couldnt pull them down. Also notes when his left arm is touched it causes burning pain that shoots up the arm. Reports headache. 2-4/day, last 30 minutes, 5/10 in severity. Worse with movement of head. Frequent nausea, no emesis. but not specifically associated with headache. No waking from sleep. Since PE, has complains of intermittent left sided squeezing chest pain, which he wonders may be due to his anxiety. Lasts a few minutes Received Pfizer COVID vaccine 3/29, hasnt received 2nd dose yet ROS: general: no fevers or weight loss. CHRONICALLY C/O FATIGUE AND TROUBLE FOCUSING. has had evaluation for executive function difficulty in the past (interdynamics), now purusing evaluation at Neurology and awaiting EEG with this. HEENT: no sore throat. + VISION CHANGES - TROUBLE FOCUSING, but not specifically blurry vision. CV: LEFT SIDED CP, NONSPECIFIC T WAVE CHANGES ON LAST EKG W/SINUS TACH. Pulm: SOB, with walking up and down stairs, since PE. not worsening. No Cough. GI: +NAUSEA, no vomitting, no abdominal pain. No current diarrhea. Neuro: + HEADACHES. + SENSORY CHANGES. + family h/o MS
18 2021-04-27 fainting Patient received her first Pfizer Covid vaccine, sat down for the waiting period and fainted 1-2 min... Read more
Patient received her first Pfizer Covid vaccine, sat down for the waiting period and fainted 1-2 minutes afterwards. She states she thinks she was only out for about a minute. Came to on her own. Pulse checked by personnel at the vaccine clinic. Patient then called her PCP's office (me) to report the event.
18 2021-04-28 hypotension, loss of consciousness, pallor I passed out in the car.; My blood pressure was extremely low; I was pale and incoherent; I was pale... Read more
I passed out in the car.; My blood pressure was extremely low; I was pale and incoherent; I was pale and incoherent; This is a spontaneous report from a contactable consumer. An 18-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 08Apr2021 13:30 (Batch/Lot Number: ER8734) as SINGLE DOSE for covid-19 immunisation. The patient's medical history was reported as none. Pfizer shot was administered at 1:30 pm. The patient's mother decided to drive her car home. 10 minutes later the patient passed out in the car. The patient's mom called (Number) and paramedics transported her to the ER. The patient's blood pressure was extremely low, She was pale and incoherent. The patient underwent lab tests and procedures which included electrocardiogram: unknown result on an unspecified date. Therapeutic measures were taken as a result of i passed out in the car, my blood pressure was extremely low, i was pale and incoherent, i was pale and incoherent: EKG, a bag of fluids and monitoring. The outcome of the events was recovered in Apr2021. The event passed out was assessed as serious (medically significant).
18 2021-04-28 fainting Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Medium
18 2021-04-29 heart rate increased Low grade fever 100.4 approximately 8.5 hours after vaccine administered. Severe body aches - compla... Read more
Low grade fever 100.4 approximately 8.5 hours after vaccine administered. Severe body aches - complained that bones hurt, especially ribs and legs. Rapid heart beat on. and off for 24 hours. Injection site pain for 30+ hours.
18 2021-05-01 fainting Slight fever 100.3F One fainting episode
18 2021-05-01 fainting writer was called by family member, patient observed sitting in chair with episode of unresponsivene... Read more
writer was called by family member, patient observed sitting in chair with episode of unresponsiveness. No head trauma, No SOB, No respiratory distress. Paramedic notified. Patient had episode of fainting lasting about 30secs then returned to baseline mental status post covid vaccination. MD notified. Family member present stated that she history of fainting. Patient discharged home, in stable condition.
18 2021-05-01 fainting Patient; writer was called by family member, patient observed sitting in chair with episode of unres... Read more
Patient; writer was called by family member, patient observed sitting in chair with episode of unresponsiveness. No head trauma, No SOB, No respiratory distress. Paramedic notified. Patient had episode of fainting lasting about 30secs then returned to baseline mental status post covid vaccination. MD notified. Family member present stated that she history of fainting. Patient discharged home, in stable condition.
18 2021-05-02 chest discomfort CHEST PRESSURE
18 2021-05-02 loss of consciousness CLIENT PASSED OUT OR FAINTED AFTER RECEIVING THE VACCINE WHILE VACCINATOR WAS PROVIDING HER WITH INS... Read more
CLIENT PASSED OUT OR FAINTED AFTER RECEIVING THE VACCINE WHILE VACCINATOR WAS PROVIDING HER WITH INSTRUCTIONS. CLIENT WAS ASSISTED TO THE FLOOR. NO INJURIES OBTAINED. CLIENT CAME TO IN SECONDS AND EXPLAINED SHE OFTEN FAINTS AFTER VACCINATION. CLIENT REMAINED UPRIGHT FOR 10 MINUTES AND DRANK WATER. WHEN ABLE TO WALK, CLIENT WAS ESCORTED TO A COT IN THE MONITORING AREA AND LAID DOWN. CLIENT WAS STABLE AND REMAINED AT FACILITY FOR 30 MINUTES UNTIL ABLE TO WALK AND WAS NO LONGER LIGHT HEADED.
18 2021-05-02 loss of consciousness The patient received the shot, and after a few minutes the patient passed out on the chair. After n... Read more
The patient received the shot, and after a few minutes the patient passed out on the chair. After noticing the patient slumped over we made sure the patient was still breathing. We got the emergency equipment and contacted the emergency protocol, and the patient woke back up promptly and communicated that they felt dizzy. We allowed the patient to lay down and waited for the emergency services. She felt better as time passed and by the time her dad made, they refused to go to the hospital and made it home on their own accord
18 2021-05-02 fast heart rate She is mildly tachycardic and oxygen saturation is mildly decreased at 95%.
18 2021-05-03 chest pain Adverse events: Extreme chest pain, couldn?t move arms very much, hands went numb and tingly, throat... Read more
Adverse events: Extreme chest pain, couldn?t move arms very much, hands went numb and tingly, throat pain Treatment: went to the doctors and the hospital and have tried over the counter pain medicine which didn?t work, prescribed prednisone which didn?t work, prescribed naproxen 500 which didn?t work, prescribed famotidine which didn?t work, all blood and heart and lung tests came back fine Outcome: still in a lot of pain and nothing is helping and nobody can figure out what is wrong
18 2021-05-03 loss of consciousness Patient received the shot. They felt dizzy and passed out after receiving the shot during the monit... Read more
Patient received the shot. They felt dizzy and passed out after receiving the shot during the monitoring period. After establishing that the patient was conscious and breathing. We initiated the emergency protocol. The EMTs came and checked blood pressure and blood sugar. The patients dad also came in and after concluding that the patient was okay they decided to forgo going to the hospital. They went home on their own accord. I called them again after 3 hours to verify that they were still okay.
18 2021-05-03 pulmonary embolism Pulmonary Embolism of left lower lung
18 2021-05-03 fainting The patient was very nervous of the vaccine and of needles & informed the certified technician of th... Read more
The patient was very nervous of the vaccine and of needles & informed the certified technician of this. She talked to her to calm her prior to administering the vaccine. Said patient was shaking during the administration. The technician informed her we would have her sit & wait for 15 minutes & when she got up she was shaking and said she was going to pass out. The technician called for assistance & told the patient to sit back down. Pharmacist came and patient did faint in the chair. We tapped her a few times and held her up in the chair for a short time until patient came to. Patient called her mom & we gave her crackers, orange juice and held ice packs on her and talked with her until her mother came.
18 2021-05-04 blood pressure decreased Felt Dizzy , cold/hot sweats , blurry vision/Hearing , nausea at first. BP low (per paramedics)
18 2021-05-04 lightheadedness Who: What: Vasovagel Where: Observation When: 5/5/2021 @ 1700 How: Response to second vaccine Pt was... Read more
Who: What: Vasovagel Where: Observation When: 5/5/2021 @ 1700 How: Response to second vaccine Pt was taken by EMS and was only able to get mothers information which is listed above. Pt is 18, email and phone number are posted. 911 called by medic, taken to ER on request of mother. Pt stable at time of transfer.
18 2021-05-04 pulmonary embolism pulmonary embolism
18 2021-05-05 heart rate increased Every time I work out or my heart rate goes up, I get incredibly dizzy, lightheaded, and I feel like... Read more
Every time I work out or my heart rate goes up, I get incredibly dizzy, lightheaded, and I feel like I?m going to pass out.
18 2021-05-05 pallor Patient became very pale and whole body sweating. Patient reported ears ringing and black spot in vi... Read more
Patient became very pale and whole body sweating. Patient reported ears ringing and black spot in vision. Also, said arms were tingling. lasted approximately 15 minutes
18 2021-05-07 heart rate increased, heart rate decreased vomited; nauseous; visibly distressed; hyperventilating; began seizing/visibly having tonic clonic s... Read more
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.
18 2021-05-07 lightheadedness Patient was near syncope. After receiving the vaccine about 2 minutes she started getting light head... Read more
Patient was near syncope. After receiving the vaccine about 2 minutes she started getting light headed. Patient was given water and animal crackers to get. She was feeling a little better but when she turned her head she still felt lightheaded. I had her eat and drink some more water. I asked how she was feeling. She stated that she was feeling better so i had her sit the rest of the way up with her feet hanging over the bed. I asked how she was feeling. She stated that she was feeling good. I then had her stand up with me standing in front of her and asked how she was feeling. She stated that she was feeling light headed in the middle of her forehead. I had her sit back down and gave her an ice pack to put on her neck. I then asked how she was feeling and she stated that she was feeling better and while she had the ice pack on her forehead she kept eating and drinking. I then had her stand up and she stated that she was better. i took her vitals at 11:24 am heart rate 75, o2 99 and BP 115/81, again at 11:30 am heart rate 79, o2 97 and BP 117/82. I released her to go home with her mom and dad at 11:41.
18 2021-05-08 loss of consciousness Patient passed out after receiving second Pfizer vaccine
18 2021-05-08 fainting Systemic: Confusion-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsiv... Read more
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
18 2021-05-10 chest discomfort - Chills - Sweating - Headache - Full body ache - Tightness in chest - Queasy stomach
18 2021-05-10 chest pain 5/5/21 Wednesday - got 2nd Pfizer Shot. 5/6/21 Thursday - 2am awoke with shakes/chills and through... Read more
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 2021-05-10 fainting 18 YOF had a brief syncopal episode after receiving the vaccine. She felt lightheaded associated wi... Read more
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.
18 2021-05-11 chest pain immediately after the dose she developed chest pain that radiates to the upper back, lower back and ... Read more
immediately after the dose she developed chest pain that radiates to the upper back, lower back and hips
18 2021-05-11 pallor, lightheadedness Came to location for Pfizer vaccine on 5/4/21. She had a vasovagal reaction immediately after the v... Read more
Came to location for Pfizer vaccine on 5/4/21. She had a vasovagal reaction immediately after the vaccine. Her B/P was 122/62. She was pale and diaphoretic. She was seen by Dr. She recovered after a brief period and went home.
18 2021-05-11 lightheadedness Patient came to location with her twin sister to get her first Pfizer COVID vaccine. She had a vaso... Read more
Patient came to location with her twin sister to get her first Pfizer COVID vaccine. She had a vasovagal response at the same time as her sister. She was laid down and recovered in 20 minutes.
18 2021-05-11 fainting Patient arrived for second dose of Pfizer vaccine. Made provider aware that she has a history of syn... Read more
Patient arrived for second dose of Pfizer vaccine. Made provider aware that she has a history of syncopal episodes. Vaccine given. Patient sat in waiting area and began to faint. Provider alerted. Ammonia was broken and cold towel was placed on forehead. Patient came to and was given water and snacks. Mother was present. Observed patient for thirty minutes and she left with mother.
18 2021-05-12 fainting Pt received vaccine soon after began to c/o syncope episodes. Pt able to walk to cot and lay down. N... Read more
Pt received vaccine soon after began to c/o syncope episodes. Pt able to walk to cot and lay down. No sob noted. Pt cold and clammy. 911 called paramedics out to assess pt refused to go to hospital. after 30 minutes pt began to feel better. 1st set V/S 530 pm p-88, 02 sat 97, BP 104/80 waited 1.5 hrs for husband to pick pt up. Pt stable no c/o no distress able to ambulate on own home with husband.
18 2021-05-13 nosebleed Nosebleed, flushing, dizziness
18 2021-05-13 inflammation of the heart muscle, inflammation of the heart muscle Post Vaccine Myocarditis
18 2021-05-14 chest pain Nauseous, fever, bodyaches, diffculty breathng, chest pain
18 2021-05-14 loss of consciousness per pt's dad, about 1 minute after vaccination, client stated she was not feeling well. She was the... Read more
per pt's dad, about 1 minute after vaccination, client stated she was not feeling well. She was then observed unconscious for about 60 seconds.
18 2021-05-14 fainting 18 y/o F with no known prior medical conditions or NKDA presented for her first dose of Pfizer vacci... Read more
18 y/o F with no known prior medical conditions or NKDA presented for her first dose of Pfizer vaccine. 7-min post vaccination the patient began to feel dizzy and light-headed. The patient experienced a syncopal event resulting in an assisted fall from chair. The fall was atraumatic and the patient instantly regained consciousness. Patient was alert and oriented x3, and rapidly improved back to her baseline. Patient denied any SOB, difficulty breathing, throat swelling, itching, or HA. Parental guardian was advised to keep patient hydrated and educated on any signs or symptoms that would warrant urgent care.
18 2021-05-15 fainting, pallor PATIENT FAINTED WITHIN 5 MINUTES OF VACCINE, BUT REGAINED CONSCIOUSNESS QUICKLY. PATIENT APPEARED PA... Read more
PATIENT FAINTED WITHIN 5 MINUTES OF VACCINE, BUT REGAINED CONSCIOUSNESS QUICKLY. PATIENT APPEARED PALE. PATIENT REMAINED SEATED FOR 30 MINUTES AND PARAMEDICS ARRIVED TO CONDUCT EVALUATION OF PATIENT.
18 2021-05-16 fainting Patient experienced a syncope episode post vaccination. Patient laid down on the floor for about ten... Read more
Patient experienced a syncope episode post vaccination. Patient laid down on the floor for about ten minutes, she drank water and was able to recover on her own. She also stated that this happens when she doesn't have anything to eat or drink. She refused us to call 911. She then waited for about 20 minutes in the observation area and was able to leave on her own
18 2021-05-17 pallor Prior to vaccination, the patient reported a history of feeling light headed during and immediately ... Read more
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.
18 2021-05-18 chest pain 5 minutes after receiving the vaccine, she reported headache, nausea, shaking, and some chest pain. ... Read more
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.
18 2021-05-18 chest pain 5 minutes after administration, she started having a headache and then nausea. Afterwards she felt ... Read more
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.
18 2021-05-18 fainting Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild
18 2021-05-19 fainting Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild
18 2021-05-20 fainting Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Mild, Additional Details: got emotional... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Mild, Additional Details: got emotionally excited after shot fainted for 25 seconds, patient was tired bur responsive
18 2021-05-20 fainting weakness, nausea, headache, faintness all lasting all day the day after
18 2021-05-21 loss of consciousness During her observational 15 minutes, patient was having dizziness and blurred vision. Patient had a ... Read more
During her observational 15 minutes, patient was having dizziness and blurred vision. Patient had a loss of consciousness for 30 seconds. After regaining, patient was alert and oriented. Patient was given water and asked to sit for 15 minutes.
18 2021-05-21 fainting, pallor PT BECAME PALE AND FAINTED, FALLING FOrward OUT OF CHAIR AND HITTING HEAD ON FLOOR. SCRATHES AND BUM... Read more
PT BECAME PALE AND FAINTED, FALLING FOrward OUT OF CHAIR AND HITTING HEAD ON FLOOR. SCRATHES AND BUMP Appeared on forehead. ice packs were applied to back of neck after sitting patient on floor , leaning against chair. pt sat for several minutes and felt better so she left.
18 2021-05-23 chest pain, palpitations This is a 18 Years old Female presenting with chest pain for [a couple hours last night]. Pain st... Read more
This is a 18 Years old Female presenting with chest pain for [a couple hours last night]. Pain started [gradually]. It is described as [dull and aching], radiating into [nowhere]. Pain is described as [moderate] upon onset and is currently [mild]. [No] history of the same. Pain [is not] worse with exercise. Patient [has no] decrease in exercise tolerance recently. Patient states that she received her second dose of her Pfizer vaccination 3 days ago, and last night she started to experience chest pain, headache, palpitations, and shortness of breath, and feeling dehydrated.
18 2021-05-23 fainting, heart rate decreased, loss of consciousness, blood pressure decreased, oxygen saturation decreased Patient had syncopal episode approximately 1-2 minutes after receiving injection of vaccine. Slumpe... Read more
Patient had syncopal episode approximately 1-2 minutes after receiving injection of vaccine. Slumped over in her chair, lost consciousness for approx 30-60 seconds. Regained consciousness, diaphoretic, slow to respond. Heart rate dropped to 44 bpm. Blood pressure 80/58. Sp02 90%. Nursing staff assisted pt to reclining position, called EMS for assistance. Monitored vital signs until arrival of EMS. Pulse and BP gradually returned to normal range. LOC assessed, pt remained in clinic until recovered. No transport needed.
18 2021-05-23 fainting Patient frequently faints following vaccinations. About 2-3 minutes after receiving vaccination, pat... Read more
Patient frequently faints following vaccinations. About 2-3 minutes after receiving vaccination, patient fainted while sitting in a chair. Once patient began to come to, she convulsed. Pharmacist and nearby customers helped lay her on the ground. Patient came to and was given water and a glucose tablet. EMS was called at the start of the incident. Patient remained lying down until she felt ok to sit up. EMS checked her blood pressure, which was normal and she was ok to go home.
18 2021-05-24 chest discomfort Tightness in chest for about 2 days. Resolved All over body tingling for about 2 days Resolved
18 2021-05-24 chest pain, heart rate increased rapid heart rate and chest pain
18 2021-05-24 fainting syncope for 10 seconds, dizzy and weakness. patient given water and rest. Symptoms resolved
18 2021-05-25 fainting Immediately after vaccination was administered the patient fainted but stayed in the chair. After sh... Read more
Immediately after vaccination was administered the patient fainted but stayed in the chair. After she came to in about 10 seconds I offered her a cold compress for her head. After a couple of minutes the patient felt good enough to move to observation area. I started getting a vaccine ready for another patient and this patient saw the needle and fainted again. I rushed over to her chair and kept her from falling. After she came to in about 10 seconds I offered to call 911 but the patient refused. Her brother came over from shopping and after a couple more minutes they decided to leave together.
18 2021-05-25 fainting On May 5th and May 24th, my daughter syncope'd randomly and this has never happened before. I took h... Read more
On May 5th and May 24th, my daughter syncope'd randomly and this has never happened before. I took her to her general practitioner and her EKG is now abnormal. It never was in the past. We will be taking her to a cardiologist and neurologist for further testing.
18 2021-05-25 fainting Syncopal event ~ 5 minutes after injection, fell from chair and hit forehead on ground
18 2021-05-26 ischemic chest pain, chest pain The first dose of the vaccine went fairly well aside from fever, muscle aches, and pain in the left ... Read more
The first dose of the vaccine went fairly well aside from fever, muscle aches, and pain in the left arm at the injection site. The second dose was reportedly worse. The fever ranged from 104.8 degrees Fahrenheit as a high and 102 degrees Fahrenheit being low, which receded after 3 days of care. In addition, chest pains and heart pain started at 8:00pm the day of the vaccination which was completed at 11:15am. Pain at the injection site and overall body muscle aches lasted for 3 days. The heart/chest pains have yet to recede. Instead it is occurring more frequently in ?bursts? of pain with a constant aching sensation.
18 2021-05-26 chest discomfort, chest pain First dose on 4/27/21. The day following first dose, pt developed chest pain (dull/tightness, 3/10)... Read more
First dose on 4/27/21. The day following first dose, pt developed chest pain (dull/tightness, 3/10). Worsened after the second dose on 5/18/21.
18 2021-05-26 inflammation of the heart muscle, troponin increased, palpitations Presenting symptom palpitations. Elevated troponin, diagnosed with myocarditis
18 2021-05-26 fainting, nosebleed -Bleeding from vagina (I don?t start my period for another two weeks) -Nose bleeds -Heat flashes (fe... Read more
-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
18 2021-05-26 fainting Systemic: Fainting / Unresponsive-Mild, Systemic: Weakness-Mild
18 2021-05-26 fainting Patient was administered Pfizer COVID-19 vaccine and fainted during her 15 minute observation time. ... Read more
Patient was administered Pfizer COVID-19 vaccine and fainted during her 15 minute observation time. Mother alerted pharmacy staff. Pharmacist observed patient regain consciousness. Patient reported feeling warm, was sweating, and saw spots of light. Patient was given a bottle of water and and instant cold ice pack. Patient observation time was continued. After fifteen minutes patient was feeling better and left pharmacy with mother.
18 2021-05-26 troponin increased, chest pain Chest pain, vomiting, and elelvated troponin 15 days after vaccine
18 2021-05-27 pallor, loss of consciousness After about 2 minutes of getting her shot she passed out and fell onto the floor. She became conscio... Read more
After about 2 minutes of getting her shot she passed out and fell onto the floor. She became conscious again within a minute we gave her some water. I had somebody call 911 and an ambulance came. While the ambulance was here she seemed to be turning pale in the face. The ambulance ended up taking her to the hospital for further evaluation
18 2021-05-27 palpitations Patient's mother called us on 5/28 to inform us that her daughter received the Pfizer vaccine on 5/1... Read more
Patient's mother called us on 5/28 to inform us that her daughter received the Pfizer vaccine on 5/16 and started having symptoms on 5/22: Swelling of lymph nodes, breasts, and what felt like her throat, a fever of 102F and felt like her heart was pounding. Patient's mother states that her heart is no longer pounding but is still having swelling and fever.
18 2021-05-28 chest pain, ischemic chest pain, loss of consciousness, inflammation of the heart muscle, hypotension Problems with her heart; Shortness of breath; Pain the chest; Low blood pressure; Passed out; Starte... Read more
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.
18 2021-05-28 fainting Patient passed out and fell on a cardboard display box, fortunately her dad who was standing next to... Read more
Patient passed out and fell on a cardboard display box, fortunately her dad who was standing next to her picked her up immediately, and said that she had anxiety and she was ok. I spoke to the patient and when she said she was ok I had her sit down on the chair. After about 15 minutes patient and father left and confirmed that she was doing ok. Next morning patients dad called and said she was doing fine, that we might need to fill out paper work regarding the incident to submit it at patients school so she would not have to take the second dose.
18 2021-05-29 heart attack, inflammation of the pericardium 18 year old female suffered a heart attack/swelling of the sack around the heart die to the second P... Read more
18 year old female suffered a heart attack/swelling of the sack around the heart die to the second Pfizer vaccine. Spent two days in the hospital/cardiac wing. She is still being monitored by doctor to this day.
18 2021-05-29 fainting Fainting (Syncope) patient Received the vaccine while she was sitted in a chair and within 3 min. s... Read more
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
18 2021-05-30 hypotension, fainting Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient got the pfizer vaccin 11:00am and after 2-3 min after din't answer back my question like you have to stay 15 min then i'll give your immunization card which will be 11:15am but was mummering and showed syncope symptomes soI make th patient kind of lie down and check patient in 2 min. but she was still said feld so dizzy so I had to call 911 and 911 came check bp & Temp. BP was low so 911 team took her ER. About 4:33 pm patient came home checked 5-30-21 she was fine
18 2021-05-30 loss of consciousness, fainting Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Additional Details: patient said s... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Additional Details: patient said she felt dizzy, and the pasted out. Her boyfriend was with her, and helped me lay her on the floor. She Shook or seized for a few seconds and then came to. She was confusion at first, but then recognized her boyfriend. She asked him to call her Mom. I talked to her Mom on the phone while she was starting to feel better. We got her some water and a fan. I had her wait an extra 30 minutes after she come to.
18 2021-05-31 chest discomfort, chest pain Pt c/o chest pain and chest tightness
18 2021-05-31 heart rate irregular, chest pain Within 2 hours of getting the second COVID vaccine I started to have frequent sharp shooting pains i... Read more
Within 2 hours of getting the second COVID vaccine I started to have frequent sharp shooting pains in my heart making it hard to breathe as well as having erratic heart beats and blurry vision. The symptoms worsened approximately 24 hours after to where it has and continues to be sharp shooting and constant pain in my heart that travels into my left arm. Simple things like walking and breathing make it extremely painful.
18 2021-05-31 fainting SYNCOPE IS WHAT PATIENT EXPERIENCED. PATIENT LOST CONSCIOUS COUPLE MINUTES AFTER RECEIVING THE VACCI... Read more
SYNCOPE IS WHAT PATIENT EXPERIENCED. PATIENT LOST CONSCIOUS COUPLE MINUTES AFTER RECEIVING THE VACCINE. SHE FALL OFF THE CHAIRE SHE WAS SITTING AT , BUT WOKE UP DIRECTLY AFTER. PATIENT DID NOT HIT HER HEAD AGAINST THE FLOOR, NOR DID SHE HAVE ANY INJURY OTHER THAN A SCRATCH ON HER ARM. SHE WAS ALLERT, ORIENTED AND HAVE PROVIDED ME WITH EVERY SINGLE INFORMATION I NEEDED TO COMPLETE THIS REPORT. SHE LEFT THE PHARMACY WITH HER FATHER.
18 2021-05-31 fainting While we were observing patient for 15 minutes after the vaccination, patient fainted and hit her he... Read more
While we were observing patient for 15 minutes after the vaccination, patient fainted and hit her head on the floor on 6/1/21.
18 2021-05-31 fast heart rate Tachycardia; Lost 14 pounds; Ulcerative colitis flare up; Throat and glands swollen; Throat and glan... Read more
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.
18 2021-06-01 chest pain Headache; Fever; strong pain in the chest; This is a spontaneous report from a contactable consumer ... Read more
Headache; Fever; strong pain in the chest; This is a spontaneous report from a contactable consumer (patient's mother). An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number unknown) via an unspecified route of administration on 24May2021 as 2nd dose, single (at the age of 18-years-old) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had no effects, but patient went to bed early at 20:00 last night and did not mention anything. On 24May2021, patient experienced headache, fever, strong pain in the chest. Patient still felt pain in chest. Outcome of the events was unknown. Information on the lot/batch number has been requested.
18 2021-06-01 heart rate increased, palpitations, chest pain, chest discomfort Chest pain/heart palpitations with onset approximately 10 hours after second COVID-19 shot. Heavines... Read more
Chest pain/heart palpitations with onset approximately 10 hours after second COVID-19 shot. Heaviness in chest, harder to breath, tightness in throat. Blood pressure normal, but heart rate increased. No fever or other symptomology. Symptoms worse reclining and trying to rest rather than upright.
18 2021-06-01 heart rate increased Approximately 10 minutes after the shot, patient reports not feeling well, rapid heart beat, shakine... Read more
Approximately 10 minutes after the shot, patient reports not feeling well, rapid heart beat, shakiness, and has difficulty breathing (feels like her throating is closing up). Gave one dose of 0.3 mg Epi-Pen 15 minutes after the vaccine. Called paramedics and arrived at 5:35 pm when patient was taken to the hospital. Patient was alert when she was picked up by the paramedics.
18 2021-06-01 loss of consciousness minutes after receiving the 2nd dose, patient felt dizzy and passed out on the floor. she regained c... Read more
minutes after receiving the 2nd dose, patient felt dizzy and passed out on the floor. she regained consciousness within a few seconds, and was responsive, she waited about 20 minutes before leaving the store, EMS was not called, she reported no other adverse effects
18 2021-06-02 fainting Fever and syncope followed by chronic headaches since
18 2021-06-02 troponin increased, palpitations, inflammation of the heart muscle She presented with symptoms of palpitations and was diagnosed with myocarditis. She was hospitalize... Read more
She presented with symptoms of palpitations and was diagnosed with myocarditis. She was hospitalized 5/27-5/28/21 and discharged in stable condition.
18 2021-06-03 pallor Patient felt dizzy about 10 minutes after receiving the vaccine. Patient was alert, oriented, and re... Read more
Patient felt dizzy about 10 minutes after receiving the vaccine. Patient was alert, oriented, and responsive but her skin looked pale in color. Patient was assisted to lay down on the exam table. No fainting or near syncopal episode noted. Vital signs were taken and were stable. Patient was offered a water bottle to drink. Patient laid down on the exam table for a bout 10 minutes and left in a stable condition.
18 2021-06-03 fainting Patient had syncopal episode within a couple of minutes following vaccination. Patient felt better ... Read more
Patient had syncopal episode within a couple of minutes following vaccination. Patient felt better after resting and drinking some juice, and was released to home.
18 2021-06-05 lightheadedness The patient had a vasovagal episode after administration for Pfizer Dose 1. She had a previous histo... Read more
The patient had a vasovagal episode after administration for Pfizer Dose 1. She had a previous history of vasovagal episodes with flu and possibly HPV shots
18 2021-06-06 loss of consciousness patient got light headed and passed out in aisle
18 2021-06-06 fainting patient received vaccine and fainted about 5 minutes later. She hadn't eaten prior and believe event... Read more
patient received vaccine and fainted about 5 minutes later. She hadn't eaten prior and believe event actually due to low blood sugar. Called patient later, she was fine
18 2021-06-07 pallor, loss of consciousness Passed out, dizzy, lightheaded, sweating, pale/clammy
18 2021-06-07 fainting Patient fainted about 5 minutes after being administered vaccine. Patient recovered within 2 minute... Read more
Patient fainted about 5 minutes after being administered vaccine. Patient recovered within 2 minutes.
18 2021-06-07 superficial blood clot Superficial thrombophlebitis
18 2021-06-08 fainting Client was waiting in line for Covid shot, client fainted. She caught herself on a tale with her fa... Read more
Client was waiting in line for Covid shot, client fainted. She caught herself on a tale with her father's assistance. Event was not witnessed by any staff at POD site but client moved to cot after reporting what happened. Patient denied hitting head and it was confirmed b father. BP 102/81, P 85, oxygen 99%. Vaccination given without further incident.
18 2021-06-08 fainting Patient fainted approximately 5 minutes after receiving vaccine. She was walking around the store an... Read more
Patient fainted approximately 5 minutes after receiving vaccine. She was walking around the store and fell onto the ground. The patient sat in a chair and drank water for approximately 15 minutes until she felt better and was able to leave the store with her mom.
18 2021-06-10 chest discomfort, troponin increased Healthy 18 yo female presented with 4 days of fever, chills, vomiting, diarrhea, headache., as well ... Read more
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
18 2021-06-10 loss of consciousness she fell on the floor and become unconscious; she fell on the floor and become unconscious; She got ... Read more
she fell on the floor and become unconscious; she fell on the floor and become unconscious; She got sick; she lost all energy; She hurt her throat its like she can read but she has very heavy under her neck; She hurt her throat its like she can read but she has very heavy under her neck; This is a spontaneous report from a contactable consumer (Father). An 18-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot Number: EW0185), dose 1 via an unspecified route of administration, administered in Arm Left on 28May2021 16:00 as 1ST DOSE, SINGLE for covid-19 immunisation. Patient Medical history and concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. It was reported that, On 28May2021 caller stated that we took our daughter to get vaccinated on 28th and she loss of conscious and she got sick, and it took almost 24 hours to recover so we need to get the forms, so she does not get her second shot and we do not want to have a second shot for her because of the lot reaction on her body. In the 22nd day later she fell on the floor and become unconscious, and she lost energy and you know it takes time to come up and it take 2-3 minute to come up and she lost all energy and she hurt her throat it's like she can read but she has very heavy under her neck. The event loss of consciousness, fall and illness was recovered on unspecified date in 2021.The event musculoskeletal discomfort oropharyngeal pain and asthenia was unknown. Therapeutic measures were taken Tylenol and green juice as a result of she fell on the floor and become unconscious (loss of consciousness), she fell on the floor and become unconscious, she got sick, she lost all energy, she hurt her throat it's like she can read but she has very heavy under her neck, she hurt her throat it's like she can read but she has very heavy under her neck (oropharyngeal pain). No follow-up attempts are possible. No further information is expected.
18 2021-06-13 blood glucose increased, chest pain Patient received second pfizer vaccination at 13:01 and ambulated to the observation area unassisted... Read more
Patient received second pfizer vaccination at 13:01 and ambulated to the observation area unassisted. At 13:14 she stated she was feeling dizzy. VS: 89 bpm, 98%RA, 112/89, RR 14 non labored. Patient has (DM1, Graves Disease, Asthma, Autism) per mother. Patient has electronic glucose monitor and pump, Mother insists this is functioning as site was changed and inspected yesterday. BS per monitor reading 331. EMS with patient and she was moved to inversion chair via wheel chair. When asked how she felt patient shook her head no in response. Per mother patient most likely would not give more information because of her Autism. Patient given a water and demonstrated the ability to drink. When asked more specifically the patient denied nausea but admitted to still feeling dizzy and tired. Patient is awake, pink, warm and dry, alert but mother states this is not her baseline cognitively. A brief period intermittent audible grunting noticed but then resolved on its own, breathing non labored and even. Patient holding and checking her phone periodically. Two episodes of patient closing her eye observed not lasting more than 2 seconds. Mother states patient has "uncontrolled epilepsy". Denies any itching or throat discomfort but is now stating she has chest pain. Patient unable to describe the pain to the RN. HR manually 98 bpm. Skin remains warm, pink and dry, Alert. VS: 99%, RR 16 non labored, 100 bpm, 108/65, Mom states she would feel more comfortable if patient went to hospital "to be checked out and given fluids". At 1342 patient transported to Medical Center via ambulance with Grandmother.
18 2021-06-13 hypotension Symptoms included tightness of the throat and trouble breathing. They took my blood pressure and it ... Read more
Symptoms included tightness of the throat and trouble breathing. They took my blood pressure and it was also very low. I took benadryl and they gave me some water and a shot of epinefrin. I got to the hospital probably around 6:45. They gave me more benadryl, and started giving me prednisone and another steroid. It took a few hours for it to improve, and there wasn't any immediate relief. I was released at around noon and took 2 more days of steroids before feeling better.
18 2021-06-13 inflammation of the heart muscle, fluid around the heart, fibrin d dimer increased, chest discomfort, troponin increased The evening after receiving the vaccine, pt began having headache, lightheadedness, shortness of bre... Read more
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.
18 2021-06-13 fainting After vaccination, patient was sitting in a chair and got up to say she was feeling lightheaded then... Read more
After vaccination, patient was sitting in a chair and got up to say she was feeling lightheaded then fainted. Patient regained consciousness within seconds. Patient was helped up in a seated position in a chair and was instructed to take deep breaths and keep head between knees. Patient was also given water and fruit snacks. An ice pack was also placed on the back of patient's neck because patient complained she was feeling hot. Patient was able to communicate and remember details. Patient did not complain of any pain anywhere on the body. Pharmacy technician was at the patient's side the entire time after she regained consciousness. Patient was able to call her mother to pick her up and drive her home.
18 2021-06-13 fainting Patient received vaccine dose #1. 15 minutes later she fainted. She passed out for no more than 2-... Read more
Patient received vaccine dose #1. 15 minutes later she fainted. She passed out for no more than 2-4 minutes with no injuries. When she awoke, it took her about 1-2 minutes to become fully coherent. There were no other adverse reactions or side effects. EMT was called and upon arriving asked her some basic questions. Turns out she had not eaten all day so they determined the fainting was for this reason and had nothing to do with the vaccine.
18 2021-06-15 loss of consciousness, fainting, pallor 6/16/21 patient had an episode of syncope within 5 minutes of vaccine administration - fell and hit ... Read more
6/16/21 patient had an episode of syncope within 5 minutes of vaccine administration - fell and hit tailbone first, then hit head against the ground and had brief seizure witnessed by mother (full body shaking), LOC, unresponsive, pale and cold/clammy. lasted for several seconds. no PMH of syncope, seizures. no medical problems
18 2021-06-15 fainting Patient came in for first dose and told pharmacist of her existing conditions. The pharmacist had th... Read more
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.
18 2021-06-16 chest pain chest pain, shortness of breath, wheezing, abdominal pain, anaphylaxis
18 2021-06-16 blood clot I started experiencing pain in my calf on 4/21 that same night of the vaccination. There was a tigh... Read more
I started experiencing pain in my calf on 4/21 that same night of the vaccination. There was a tight feeling in my knee and every time I took a step with my right leg there was pain that radiated down my calf. It almost felt like a muscle pain so I ignored it for a few days. By 4/24 the pain had gotten so bad that I didn't want to walk anywhere and cried when I walked. My mom came and picked me up and took me to the urgent care center. They asked me a few questions and told me that I needed to go to the ER to get checked for a blood clot. I went to hospital on 4/24, and an ultrasound of my knee was done. The doctor diagnosed me with a blood clot and told me to stop taking the Xulane which was my birth control at the time. They told me to follow up with my OBGYN and a hematologist. (I had been on my birth control for about 6 months and I have never had any issues with blood clots and they do not run in my family. The NP is who told me to report my blood clot to the CDC because she is a little suspicious that the shot is where it come from.)
18 2021-06-19 heart rate decreased, pallor AFTER VACCINATION, PATIENT SAT AT THE WAITING ROOM. WITHIN A FEW MINUTES HE BECAME PALE WITH COLD CL... Read more
AFTER VACCINATION, PATIENT SAT AT THE WAITING ROOM. WITHIN A FEW MINUTES HE BECAME PALE WITH COLD CLAMMY SKIN, THROAT SWELLING, SLOW THREADY PULSE, SEIZURE LIKE SYMPTOM, BARELY RESPONDING WHEN WE TRIED TALK TO HIM. 911 WAS CALLED IMMEDIATELY AND EPIPEN WAS GIVEN WITH DADS PERMISSION. AFTER A FEW SECONDS, PT BECAME ALERT AND CAN RESPOND WITH US. I MONITORED HIS RESPIRATION AND PULSE RATE WHILE WAITING FOR EMS. EMS TOOK OVER APPROX. WITHIN 10 MINUTES AND TOOK THE PATIENT TO THE EMERGENCY ROOM.
18 2021-06-19 hypotension, fainting Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy... Read more
Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Shakiness-Severe, Systemic: Weakness-Severe
18 2021-06-19 pallor Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tingling ... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: After vaccine, pt bled slightly at injection site. She saw the blood and started to feel faint, tingly lips, flushed and then lost color in her face. I instructed her to deep breath and elevated her feet since she felt she couldn't move to be laid down. Finally she was able to stand up, I assisted her to the floor the pharmacy, elevated her feet, and she improved immediately in the supine position w/ feet elevated. She recovered 100 percent without fainting or losing consciousness.
18 2021-06-20 fainting patient was sitting in waiting area and fainted a few minutes after receiving vaccine
18 2021-06-21 fainting After receiving vaccination while walking with father to observation area, patient had a syncopial e... Read more
After receiving vaccination while walking with father to observation area, patient had a syncopial episode and collapsed in father's arms. He sat in chair with patient in his arms until RN reached patient. Patient sent in wheelchair to room with gurney. Patient non-responsive for approximately 4 minutes. Alert was made overhead at hospital for a assistance. Vital signs were stable. Patient did awake and was able to move all extremities. Was taken to ED.
18 2021-06-22 chest pain, inflammation of the heart muscle Myocarditis The right side of my chest began feeling sore with sharp burning pain 2-3 hours after g... Read more
Myocarditis The right side of my chest began feeling sore with sharp burning pain 2-3 hours after getting home and resting at my kitchen table. I was out of breath and would feel excruciating pain whenever I would move around. I thought I was dying or going to die because of the pain I felt and spent the next 3 days resting in bed.
18 2021-06-22 nosebleed 12 days after vaccine experienced closing of throat; difficulty breathing; vocal chord dysfunction; ... Read more
12 days after vaccine experienced closing of throat; difficulty breathing; vocal chord dysfunction; excessive congestions; sore throat; cough; bloody noses; fatigue. Went to urgent care and confirmed negative Covid-19 and negative strep test. Saw campus clinician on May-24 and determined "just allergies." Saw primary physician on May-17 . Also confirmed allergies but severity of symptoms not typical for patient who has been on immunotherapy for years for seasonal allergies.. Initiated aggressive allergy treatment with medications and when symptoms got worse instead of better wad finally put on oral steroids. And then also required a course of antibiotics. Illness lasted almost 3 weeks.
18 2021-06-22 loss of consciousness, blood pressure increased passed out (head flew back)/her head went back to where she appeared to of lost consciousness for ab... Read more
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.
18 2021-06-22 fainting looks like fainting but she begin to convulse in her legs in her arms; seizure event; looks like fai... Read more
looks like fainting but she begin to convulse in her legs in her arms; seizure event; looks like fainting but she begin to convulse in her legs in her arms; seizure event; She couldn't see that her vision was blurry and she was seeing spots in front of her eyes; Dizzy; She couldn't see that her vision was blurry and she was seeing spots in front of her eyes; This is a spontaneous report received from a contactable pharmacist. An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0185 and expiration date 31Aug2021), on 07Jun2021 (at the age of 18-year-old) as 1st dose, single dose (reported as first COVID vaccine) for COVID-19 immunization. The patient's medical history was reported as no appointment history. The patient's concomitant medications were not reported. It was unknown if patient was taking concomitant medications, reporter believed they said like birth control pills. The pharmacist stated that he/she did not believe that patient received other vaccine within 4 weeks, he/she did not know, they did not report that. Pharmacist stated that he/she administered the vaccine to the patient, about he/she would say less than 5 minutes later she said she had been having the reaction to the vaccine she said that she could not see that her vision was blurry and she was seeing spots in front of her eyes. Pharmacist saw, wanted step down and he/she asked her if she was having any signs of the anaphylactic reactions like swelling of the face or top of the lip or tongue if she could swallow correctly, If she felt that she could breath and all of those things were normal however she said that she felt very dizzy so he/she suggested to lay her on the floor because he/she assumed that she was like she was going to faint and then started to, like her eyes sort of curl she looks like fainting. Pharmacist also stated that so, he/she would asking for questions about how she felt and then she said she felt dizzy and he/she suggested that they potentially put her on the floor in case she might faint and then she started to looks like fainting but she began to convulse in her legs in her arms and he/she would say that it happened for roughly he/she did not know 5 seconds only the mom and his/herself the mom really pulled her on the floor urgently and once she was on floor all of all of it stopped and she regained consciousness and the mom was not it was just normal thought she was fainted or she had a seizure event. The mom said that this was not something that ever happened to her daughter before with the vaccination. Pharmacist stated that the event was resolved but she was going to the hospital for a neurological (as reported). Pharmacist did not know if lab data were performed. Pharmacist stated that as he/she know of no treatment due to the event was administered. Reporter's seriousness was not specified. The outcome of the events was resolved.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Seizure and Fainting cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
18 2021-06-23 loss of consciousness, blood pressure decreased pt had nausea vomiting and passed out BP dropped
18 2021-06-23 platelet count decreased, low platelet count Flare of underlying Evans Syndrome, with onset of severe thrombocytopenia occurred 2 weeks and 6 day... Read more
Flare of underlying Evans Syndrome, with onset of severe thrombocytopenia occurred 2 weeks and 6 days after the first injection.
18 2021-06-23 fainting Syncope, vomiting. Resolved after PO hydration and trendelenberg
18 2021-06-24 hypotension, loss of consciousness, pallor, fainting About 5-10 minutes after patient received first dose of COVID-19 Pfizer vaccine she lost consciousne... Read more
About 5-10 minutes after patient received first dose of COVID-19 Pfizer vaccine she lost consciousness for a few seconds. When pharmacist got back out to patient she had already come back to (eyes opening and trying to talk), but was clearly having labored breathing and became pale, began sweating, and her pulse was very faint. Father did not mention any history of fainting at the time, but turns out patient had a similar reaction when getting blood drawn not long ago. Patient appeared to be wheezing and stated she could not breath so 911 was called. EMS took over from there. After speaking with them, patient was okay after her blood pressure returned to normal (had decreased significantly according to EMS) and was able to lie flat for some time.
18 2021-06-24 loss of consciousness, hypotension, fainting Pt arrived for first dose of Pfizer vaccine, no history of reactions to vaccines and no known allerg... Read more
Pt arrived for first dose of Pfizer vaccine, no history of reactions to vaccines and no known allergies. Patient did fine initially after her shot, dad denies patient feeling anxious and nurses noted patient seemed calm before and after her vaccine. Pt was sitting/leaning on dad towards the end of her 15 mins, he then felt her become heavy on his arm and noticed she had passed out. Observation nurse and another nurse working the clinic got the patient on her side (she was on a bench seat) and took vitals, put a cold water bottle behind her neck. Initially her bp was low (88/62) and progressively became higher, getting up to 146/98 at one point. Pulse/Respirations were WNL. Patient was in and out of consciousness so EMS was called and transported to Hospital emergency department. Patient evaluated with EKG, labs, and neurology consult. Urinalysis consistent with urinary tract infection. Patient discharged from emergency department with antibiotics and follow-up with primary care provider.
18 2021-06-24 fainting Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Det... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient was seated at the post vaccination area on a bar stool provided by the store when she felt light headed and fainted. Upon falling off the bar stool she hit her head on a water fountain located next to her. Her ankle was also tangled within the constructs of the chair and was broken upon falling. 911 had to called for assistance and she was taken away.
18 2021-06-25 blood clot A doctors office visit on 4/28. Discussed the symptoms (minimal change disease-like symptoms, possib... Read more
A doctors office visit on 4/28. Discussed the symptoms (minimal change disease-like symptoms, possible nephrotic syndrome, possible acute kidney injury, possible blood clots).; A doctors office visit on 4/28. Discussed the symptoms (minimal change disease-like symptoms, possible nephrotic syndrome, possible acute kidney injury, possible blood clots).; A doctor's office visit on 4/28. Discussed the symptoms (minimal change disease-like symptoms, possible nephrotic syndrome, possible acute kidney injury, possible blood clots).; no facilitated urination; Severe swelling on both legs with sudden body weight increase (over 10 lbs) after about a week of second dose; Severe swelling on both legs with sudden body weight increase (over 10 lbs) after about a week of second dose; This is a spontaneous report form a contactable consumer (patient) reported for herself. A 18-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection Batch/Lot Number: EW0158) via an unspecified route of administration in arm right on 18Apr2021 as dose 2, single for covid-19 immunisation. Medical history included none history. Concomitant medications include levocetirizine (LEVOCETIRIZINE Batch/Lot number was not reported) via an unspecified route of administration from an unspecified date, at 5 mg for an unspecified indication. Historical vaccine includes bnt162b2 (Dose 1 lot number=EP7534 vaccine location=Right arm) on 26Mar2021 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 23Apr2021, the patient experienced a doctors office visit on 28Apr. Discussed the symptoms (minimal change disease-like symptoms, possible nephrotic syndrome, possible acute kidney injury, possible blood clots). Started to take 20mg furosemide for 7 days from 28Apr and 20mg prednisone for 10 days and 20mg furosemide on 04May. Even after finishing medication, there were no changes in symptoms. Continued leg swelling and no facilitated urination. There was severe swelling on both legs with sudden body weight increase (over 10 lbs) after about a week of second dose. After finishing both, the swelling in legs subsided and weight returned to normal. About 10 days later, moderate swelling in legs returned and body weight increased by about 5 lbs. The patient visited nephrologist visit on 02Jun and was prescribed 20mg prednisone, 3 tablets every other am for 20 days. Currently, patient have been taking the medicine since 03Jun. As of now 12Jun2021, the leg swelling partially decreased and the body weight decreased by 1-1.5 lbs. The clinical outcome of all the events was not resolved.
18 2021-06-27 inflammation of the heart muscle, chest pain Myocarditis, Chest pain
18 2021-06-28 fainting Patient fainted after seeing brother in distress. Brother fainted after receiving his covid shot
18 2021-06-29 loss of consciousness PATIENT CAME TO RECEIVE VACCINE AT THE PHARMACY, AFTER GETTING THE VACCINE PATIENT PASSED OUT WHITE ... Read more
PATIENT CAME TO RECEIVE VACCINE AT THE PHARMACY, AFTER GETTING THE VACCINE PATIENT PASSED OUT WHITE SITTING ON THE CHAIR FOR OBSERVATION
18 2021-06-30 cerebrovascular accident, stroke Acute right posterior cerebral artery stroke, symptoms (headache, vision change) started 06/26/2021,... Read more
Acute right posterior cerebral artery stroke, symptoms (headache, vision change) started 06/26/2021, patient sought medical attention and diagnosed 06/28/2021
18 2021-07-01 fast heart rate Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Chills-Mild, Systemic: ... Read more
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.
18 2021-07-04 fainting Roughly 10 minutes after vaccination patient had fainted in their chair, patient's mother helped dau... Read more
Roughly 10 minutes after vaccination patient had fainted in their chair, patient's mother helped daughter remain in char. Patient was given water and an ice pack and felt fully recovered after about 15 more minutes. Patient did not want 911 called and was ready to leave.
18 2021-07-05 fainting Fainted & blacked out Dizziness nausea headache
18 2021-07-05 fainting Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Det... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient fainted after several minutes of the vaccine administration. She hit her head and twisted her ankle when she fainted according to witnesses/mother.
18 2021-07-06 chest pain, fast heart rate, heart rate increased, fibrin d dimer increased Covid vaccine on the late afternoon of 7-5-21. At 11pm, general body aches turned into horrific pain... Read more
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
18 2021-07-06 fainting Systemic: Fainting / Unresponsive-Medium, Systemic: vomitting-Mild, Systemic: Vomiting-Mild
18 2021-07-07 chest discomfort, excessive bleeding Extreme bleeding; Cramping; Tightness in chest; This is a spontaneous report from a contactable cons... Read more
Extreme bleeding; Cramping; Tightness in chest; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 18-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 23Jun2021 (at the age of 18-year-old) at dose 1, single for covid-19 immunisation. Medical history included acne. Family medical history relevant to adverse event was none. Patient did not administer additional vaccines on same date of the Pfizer Suspect. History of all previous immunization with the Pfizer vaccine was not considered as suspect. Patient did not have adverse event following prior vaccinations. Patient did not have prior vaccinations within 4 weeks. Concomitant medication included trimethoprim (TRIMETHOPRIM) at 100mg taken for acne from an unspecified date in Dec2019 and ongoing (Trimethoprim: Patient has been taking this medication for over a year and never had any issues with it. She started it and stopped it and then they had her start it again. It has been sporadic based on her acne). The patient experienced extreme bleeding, cramping, tightness in chest on 24Jun2021 08:00. Patient had an adverse reaction. Patient stated that she had extreme bleeding, cramping and tightness in her chest. Another person came on the line and stated that patient had these symptoms last night and was on the way to the doctor now. Clarified with patient that she was on the way to the hospital. Did not think patient will be receiving the second shot. That person stated that the date of onset of the adverse events was last night, but patient clarified onset date for each event as 24Jun2021. Relevant tests were none. Outcome of the events was not resolved. Information about lot/batch number has been requested.
18 2021-07-07 pallor Patient received 1st dose of covid vaccine and instantly felt dizzy. Client's skin pale, patient ev... Read more
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.
18 2021-07-08 hypotension, fainting Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Swe... Read more
Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium
18 2021-07-08 fainting, loss of consciousness Client was observed dizziness and fainting in the observations area, and lost consciousness for 1 se... Read more
Client was observed dizziness and fainting in the observations area, and lost consciousness for 1 second, client was accompanied by mother and didn't fall or hurt, EMT and NP assessed clients, VS stable, client stated that she didn't eat lunch today, provided client with water and snacks, client recovered and went home with mom.
18 2021-07-09 fainting PT FAINTED SHORTLY AFTER RECEIVING COVID VACCINE. BP 92/66, HR 64. NO INJURIES REPORTED, NOT AMBULAN... Read more
PT FAINTED SHORTLY AFTER RECEIVING COVID VACCINE. BP 92/66, HR 64. NO INJURIES REPORTED, NOT AMBULANCE/MEDICAL CARE REQUIRED. PT WAS ABLE TO WALK TO CAR AFTER FULL RECOVERY.
18 2021-07-10 chest pain Patient notes having chest pain 2/10 after getting vaccination. Vitals were stable, no other symptom... Read more
Patient notes having chest pain 2/10 after getting vaccination. Vitals were stable, no other symptoms noted. She was observed for 30 minutes and during this time pain completely resolved.
18 2021-07-10 fast heart rate, palpitations, chest pain Following SARS-CoV-2 vaccination on 7/8 the patient then developed a subjective fever and chills, af... Read more
Following SARS-CoV-2 vaccination on 7/8 the patient then developed a subjective fever and chills, after which she took Advil. On 7/9 she then developed waxing/waning shortness of breath and tachycardia with palpitations. On 7/10 the patient then developed chest pain which lead to ED presentation and admission.
18 2021-07-11 chest pain Patient reported chest pain and shortness of breath 2-3 days following her vaccination. She did not ... Read more
Patient reported chest pain and shortness of breath 2-3 days following her vaccination. She did not present until one month later.
18 2021-07-12 chest pain Pain in chest, shortness of breath on 2nd day
18 2021-07-12 loss of consciousness, pallor Patient received vaccine at seemed ok initially. No history of adverse reaction to vaccines previous... Read more
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.
18 2021-07-12 fainting, hypotension Patient with syncope event 5 minutes post vaccination. Patient falling forward out of chair and hit ... Read more
Patient with syncope event 5 minutes post vaccination. Patient falling forward out of chair and hit forehead. Immediately aroused and neurologically appropriate. Placed in recumbent position, given juice and water. Sat up about 10 minutes later and hypotensive requiring being placed in recumbent position for another 10 minutes. Escorted to ED.
18 2021-07-13 fainting Systemic: Fainting / Unresponsive-Mild
18 2021-07-13 troponin increased, chest pain chest pain and elevated troponin
18 2021-07-14 fainting Pt fainted shortly after getting the pfizer covid vaccine, she fell and hit her head. no loss of co... Read more
Pt fainted shortly after getting the pfizer covid vaccine, she fell and hit her head. no loss of conscientiousness. Called 911, obtained VS, and kept pt immobile until cleared by EMTs. EMTs cleared C-SPINE, and wanted to take pt to the hospital, but pt refused. Pt left with her friend who drove her home. Pt was fully awake without deficit when she left, driven by her friend. I called pt approximately 1 hour after the event and she said she was doing fine. Instructed pt to go to the ED should she have headache for N/V. And to call 911 for any difficulty breathing or any other concerns.
18 2021-07-17 chest pain Neck, left arm and chest pain; Neck, left arm and chest pain; Neck, left arm and chest pain; Unable ... Read more
Neck, left arm and chest pain; Neck, left arm and chest pain; Neck, left arm and chest pain; Unable to work; discomfort; Pain; This is a spontaneous report from a contactable consumer or other non-Health care professional (patient). A 19-year-old female (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on 19May2021 13:00 (age at vaccination 18-years-old) as dose 2, single for covid-19 immunisation. The patient medical history reported as none and concomitant medications were not reported. The patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 28Apr2021 13:00 as dose 1, single for covid-19 immunisation with no reaction on previous exposure to vaccine. Prior vaccination, the patient had no Covid. It was unknown if patient tested covid, post vaccination. On 24May2021 12:00, the patient experienced neck, left arm and chest pain. Patient was unable to work because of the pain and discomfort. The events resulted in doctor or other healthcare professional office/clinic visit. Events considered as serious with disability or permanent damage. The patient received treatment and doctors are still working this up for the events. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
18 2021-07-17 hypertension, heart rate increased pulse over 140, no temp; Woke up at 2 am. Uncontrollable shaking; Teeth were chattering so much tho... Read more
pulse over 140, no temp; Woke up at 2 am. Uncontrollable shaking; Teeth were chattering so much thought my teeth would crack; blood pressure was high; This is a spontaneous report from a contactable consumer (patient). A 18-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration, in the right arm on 28Mar2021 at 16:00 (at the age of 18-year-old) as dose 1, single for COVID-19 immunization. Medical history included obesity from an unknown date and unknown if ongoing. No allergies to medications, food, or other products. Concomitant medications and other medications the patient received within 2 weeks of vaccination were not reported. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. The patient did not receive any vaccines within four weeks prior to the vaccination. On 29Mar2021 at 02:00, the patient woke up at 2 am. Uncontrollable shaking, pulse over 140, no temp. Teeth were chattering so much thought her teeth would crack. Patient was taken to local emergency room. Vitals where a high pulse, 143, blood pressure was high. The shaking continued in the ER until 3:30 ish. Therapeutic measures were taken as a result of events. They administered 1000 mg of Tylonol. Events were considered serious nut seriousness criteria not reported. Adverse events resulted emergency room/department or urgent care. The patient underwent lab tests and procedures which included blood pressure measurement was 143 mmhg on 29Mar2021, heart rate increased was 140 on 29Mar2021, negative rapid, nasal swab, sars-cov-2 test on 17Mar2021, negative PCR nasal swab sars-cov-2 test on 17Mar2021. Outcome of the events was not resolved. Information of the Batch/lot number has been requested.
18 2021-07-18 pallor Patient presented to the clinic for covid vaccine at approximately 2:20pm. She received her Pfizer #... Read more
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.
18 2021-07-18 fainting About 10 minutes after receiving vaccine the patient approached the pharmacy counter and fainted.
18 2021-07-21 chest discomfort Presented dizziness; tight chest; blurry vision; This is a spontaneous report received from a non-co... Read more
Presented dizziness; tight chest; blurry vision; This is a spontaneous report received from a non-contactable consumer. An 18-year-old female patient (unknown if pregnant at time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jul2021 at 12:00 PM (Lot number: EW0172) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. Unknown if covid prior vaccination; unknown if covid tested post vaccination. On 06Jul2021 at 12:00 PM, patient presented dizziness, tight chest, blurry vision; refused EMS. Treatment received for events including first aid, vitals. Outcome of events was unknown. No follow-up attempts are possible. No further information is expected.
18 2021-07-21 chest pain, chest discomfort Chest tightening; Chills; Heat all over the injected arm; Sweating; Hand shaking (on injected arm); ... Read more
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.
18 2021-07-21 fainting The patient was instructed to wait 15 minutes after the vaccine . after about 10 minutes , while the... Read more
The patient was instructed to wait 15 minutes after the vaccine . after about 10 minutes , while the patient and her mother was waiting in the waiting area , the mother shouted loudly saying " she fainted " . The pharmacist went directly to the waiting area , the mother said "she's back" . The patient probably fainted for about a minute or so . When the patient gain her concious , she was sweating badly , pharmacist went and got her some gatorade . she was fine , responsive and alert , she had few sips of the drink and felt fine completly . The mother had mentioned before the vaccine the was very nervious about the vaccine and also the face that she didn't eat any thing all morning . The mother took her to the pediatrician office right after she felt fine , to check her vitals , the pediatrician suggested it could be the vaccine .
18 2021-07-23 chest discomfort She got her 2nd Pfizer dose around 12pm on 7/10/21 (1 st dose given on 6/19/21 at our pharmacy) . A... Read more
She got her 2nd Pfizer dose around 12pm on 7/10/21 (1 st dose given on 6/19/21 at our pharmacy) . Around 11pm on the night, she started having an intermittent chest pressure. She took ibuprofen and was able to sleep through the night. She took a total of 4 doses of ibuprofen. By the morning of 7/12/21, the symptoms went away and she has been feeling fine since then. She did not seek a medical treatment.
18 2021-07-23 loss of consciousness, pallor Patient passed out in the waiting area about 5 minutes after getting vaccinated. She regained consci... Read more
Patient passed out in the waiting area about 5 minutes after getting vaccinated. She regained consciousness after a minute or two but her skin was pale and gray. EMT was called and she was taken to the ER.
18 2021-07-23 loss of consciousness, pallor At approximately 1132, following a 2nd dose Pfizer COVID (LOT# EW0183, exp: 08/31/2021) Co-Lead RN, ... Read more
At approximately 1132, following a 2nd dose Pfizer COVID (LOT# EW0183, exp: 08/31/2021) Co-Lead RN, noted client 18 y/o female sitting in observation area stating to her father " I am not feeling well". Co-Lead RN, Lead RN, and EMT responded. A few seconds later, client turned pale and lost consciousness while seated. Client assisted to a supine position on the floor by Lead RN , EMT and Co-Lead RN. Client regained consciousness within 10 seconds of being placed supine on the floor. Client's skins were pale, clammy and cool. At 1134 vital signs were taken in supine position: BP: 108/81, HR: 70, RR26, Spo2 98% RA. Client's father reports there is a family history of syncope with injections. Furthermore, the client's father states that the last time the client ate was last night. Client denies hydrating this morning prior to vaccination. Client's father denies allergies foods/medications/environment, medical history, or use of medications. At 1141, client was assisted to a seated positions on floor and monitored for about 1 minute before transferring client to wheelchair at 11:43. Vital signs were taken at 11:43 in seated position: BP 116/75, HR: 100, RR:16, Spo2: 99% RA, and skins were pink, warm and dry. At 1214 another set of vital signs were taken: BP 101/74, HR: 94, and RR 14. Pt states "I am feeling better" and symptoms have completely resolved at 1156. Client's father provided with ER precautions and advised to follow up with PCP. At 1215 client left observation site with her father and with a steady gait.
18 2021-07-23 fainting Patient fainted and fell down from the chair in the vaccination waiting area following first dose of... Read more
Patient fainted and fell down from the chair in the vaccination waiting area following first dose of Covid-19 vaccine . Syncope(fainting) , Fall from chair, : Paged "Code White", called store management over, Cleaned wound and blood with alcohol, have her drink water, have patient rest until she felt normal. Advised patient to take Tylenol or Advil for pain. Called to verify if patient was ok next day . Called Supervisor and spoke to pharmacy manager regarding the event . Reported the event into center System.
18 2021-07-24 chest discomfort Four days after receiving her vaccine, pt. began experiencing a progression of symptoms. Starting w... Read more
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.
18 2021-07-25 chest discomfort 2 hours later after vaccination, patient started feeling uncomfortable. She felt better the next da... Read more
2 hours later after vaccination, patient started feeling uncomfortable. She felt better the next day, but started having persistent symptoms on 06/30/21 with difficulty to take deep breath and felt uncomfortable in the throat as well. Patient also felt dizziness on 07/01/21 - not anymore on 07/03/21. Provider scheduled a F/U visit on 07/05/21. On 07/05/21 televisit, patient chest discomfort persistent but stable; prev episodes of shortness of breath, throat discomfort, and dizziness still recurring intermittently. Provider recommended immediate evaluation; patient declined. Provider scheduled a F/U visit on 07/06/21. On 07/12/21 televisit, chest discomfort persistent but stable. Patient was no show on 07/06/21 and self reported to ER. Patient stated that easily fatigued and needing to take deep breaths; denied palpitations, LOC, MS change, or other neuro/cardio/pulmonary symptoms. Provider referred patient to F/U with cardiologist.
18 2021-07-27 chest pain Chest pain; Breathing difficulty; Part of my body is like burning now; side of my body, my back is b... Read more
Chest pain; Breathing difficulty; Part of my body is like burning now; side of my body, my back is burning; This is a spontaneous report from a contactable consumer. A 18-year-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 24May2021 (Batch/Lot Number: EW0183) as DOSE:1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date patient experienced chest pain , breathing difficulty, part of my body is like burning now; side of my body, my back is burning. Consumer stated, I am having some side effects from my vaccine, chest pain and difficulty breathing and then a part of my body is like burning now. Do you know if it's an allergy? I don't know what it is? Consumer stated, Yeah, really bad chest pain like the first day I took it which goes away but today I am experiencing the back of my body really some it should I don't know, something wrong in my body. Consumer stated, the breathing that has gotten better but reactions today, side of my body, my back is burning. Consumer stated, I have just received the first shot. The date that was I believe that was 24MAY at, I believe that 2:05. Expiration Date of first dose of COVID Vaccine: Consumer stated, No, I don't see it expiration date, I only see the date I took the Vaccine. Consumer stated, I would say the first day I experience like chest pain and little difficulty to breathe and then that went away. That was the first day yes and the second day no symptoms and then the third day I have been just happen initially today just like the back of my body is like burning. Consumer stated, I believe on the right side, I got the shot on my right arm I believe. Consumer stated, all medical condition I have just allergies that is it. (Further not clarified. Hence, not captured in tab). Consumer stated, I have not taken any treatment. Consumer was informed about the for the concern and was provided with the number as ## and requested to dial the option 3 and informed about timings as 8AM to 8PM Monday to Friday and 9AM to 3PM Saturday and Sunday as per EST. The outcome for the events was unknown. Follow-up attempts completed. No further information expected.
18 2021-07-27 hypertension It was like the first 5 mins my temperature went up by four degrees, my blood pressure go really hig... Read more
It was like the first 5 mins my temperature went up by four degrees, my blood pressure go really high, I felt dizziness, lightheaded like I was going to pass out. I had to go to the ER, said my body reacting so quickly because I had COVID a month prior.
18 2021-07-27 inflammation of the heart muscle, chest pain, increased heart rate Presented to ER with tachycardia, chest pain. Evaluation most c/w a myocarditis.
18 2021-07-27 fainting Patient left to front register to buy an orange juice and fainted at front end, her father sat her o... Read more
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,
18 2021-07-28 chest discomfort, chest pain, ischemic chest pain chest and heart pain; Short of breath; chest and heart pain; sore arm; tremendous pain; The chest pa... Read more
chest and heart pain; Short of breath; chest and heart pain; sore arm; tremendous pain; The chest pain is pinching and tightening like a poking of a needle or tightening of the chest; This is a spontaneous report from a contactable consumer. This consumer reported for an 18-year-old female patient (reporter's daughter). An 18-year-old female patient received BNT162b2 (BNT162B2), first dose, intramuscularly, administered in arm left on 11Jul2021 15:30 at the age of 18 years old, at 0.3 ml single dose for covid-19 immunisation. Medical history was none. History of all previous immunization with the Pfizer vaccine considered as suspect was none. The patient's Mother in law has a heart problem, the patient's brother was born with a hole in his heart. There were no concomitant medications. There was no other vaccine in four weeks. The patient experienced chest and heart pain on 12Jul2021, short of breath on 12Jul2021, sore arm on 11Jul2021, tremendous pain in Jul2021, the chest pain is pinching and tightening like a poking of a needle or tightening of the chest in Jul2021. The reporter was calling on behalf of his daughter. The vaccine didn't sit right with the patient. The patient had chest and heart pain and was short of breath. The patient went to her primary care provider and they checked her out and gave them a cardiologist's name to go see tomorrow. The doctor prescribed some ointment to rub on the chest. The doctor recommend that the patient not get her second shot because there was a heart condition that runs in the reporter 's wife's side of the family. The cardiologist was going to do an ultrasound on the patient. The patient was going through tremendous pain and colleges are requiring the vaccine, which was why she got it. The chest pain started Monday (12Jul2021) night at midnight. First came the chest pain and then the shortness of breath. The patient had arm pain and they recommended that she take Tylenol. Tuesday (13Jul2021) the patient had chest pain and took Tylenol and recommended that she see a cardiologist. The patient took Tylenol for her sore arm. The chest pain was pinching and tightening like a poking of a needle or tightening of the chest. The patient is going to be getting an MRI and sonogram tomorrow at the Cardiologist. The doctor is not advising the patient to take the second shot because the symptoms are worse with the second shot. The outcome of the events chest and heart pain, short of breath was not recovered, of the event sore arm was recovering, of the other events was unknown. The lot number for the vaccine, [BNT162b2], was not provided and will be requested during follow up.
18 2021-07-28 chest pain, chest discomfort Headache, ringing loss of hearing in one eat, chest pain tightness, breathing inhibited, fatigue
18 2021-07-28 fainting Vasovagal syncope after first Pfizer COVID-19 vaccine 0.3 mL IM in left arm.
19 2021-01-03 heart rate increased Patient was feeling some numbness in her arm, dizziness and heart rate increased.
19 2021-01-05 hypotension Hypotensive - 106/62, 98/57; Lightheadedness; Flushed Monitored for 35 minutes total Placed in Tren... Read more
Hypotensive - 106/62, 98/57; Lightheadedness; Flushed Monitored for 35 minutes total Placed in Trendelenberg position. BP 121/74. HR 85 Released from clinic.
19 2021-01-07 blood pressure increased, heart rate increased 30 minutes after injection, had sore arm, "hurting" while breathing, increased heart rate, increased... Read more
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 2021-01-07 heart rate increased, chest pain Patient reported no adverse event or allergies at pre-screening so received vaccine around 1:55pm an... Read more
Patient reported no adverse event or allergies at pre-screening so received vaccine around 1:55pm and around 3.25pm patient reported of headache, SOB, faster heart rate, having to stop in middle of sentence, chest hurting breathing in . Emergency services was called and patient was assessed while waiting for emergency services to arrive. At 3.39pm BP 125/80 mmHg, 84 bpm and oxygen stat. 97%, again at 3.42pm oxygen stat. 98% and pulse 81bpm
19 2021-01-09 pallor, skin turning blue, loss of consciousness I woke up this morning (approx 18 hrs post injection of my 2nd dose) feeling some myalgia, joint pai... Read more
I woke up this morning (approx 18 hrs post injection of my 2nd dose) feeling some myalgia, joint pain (perhaps 7/10 on a pain scale) and fatigue. I was able to work out (exercise bike 30 mins) and shower despite the pain. Then, around noon today (nearly 24 hrs post injection) I began feeling increasingly dizzy and warm. I stood to go to my bed and lost consciousness and collapsed. I was only unconscious for perhaps 15 seconds. I woke up feeling very shaky and cold and breathing rapidly. I was able to slow my respirations. My skin on my face and hands was very pale (lips were whitish blue). My housemate had called 911 for me: FD showed up and took a couple sets of orthostatic vitals. My BP when seated on the floor was around 110/80, pulse 80, and my BP when standing was around 90/70, pulse 100. I was able to walk to the bed without help so I decided to stay home and just hydrate, sleep, and keep a close eye on things. Now (1620, around 4 hrs after passing out). I still feel lots of soreness, but only very minor dizziness.
19 2021-01-19 hypertension Lightheaded, dizziness, high blood pressure, nausea
19 2021-01-20 chest pain, chest discomfort A few hours after the shot I felt fatigued and my arm was very sore. Later in the day around 3:00pm ... Read more
A few hours after the shot I felt fatigued and my arm was very sore. Later in the day around 3:00pm I got chills and muscle soreness throughout my whole body. I then started to develop pain in my chest while breathing and I was having to gasp for air(this was around 5:30pm). My skin (mostly on my back) felt like it was burning and itchy. That lasted the entire night. 24 hours after the injection and I am still feeling tightness in my chest when I breathe, sore throat, and sore muscles.
19 2021-01-27 chest discomfort 19 y/o female had appointment for a Covid 19 vaccination. The vaccine was administered ~9:40 AM, im... Read more
19 y/o female had appointment for a Covid 19 vaccination. The vaccine was administered ~9:40 AM, immediately client began to complaint of her left arm hurting (opposite arm that the vaccine was administered) and that her chest was feeling tight. EMS and nurse was with client. Vitals were BP 150/84, P 78. Client was smiling and constantly on her cell phone during the assessment. Client did not appear to be in distress. Client stated that she had a migraine and chest tight. Vitals retaken about 15 minutes later BP 139/86 and P72. EMT asked how she was and she said that she thought she needed to go to ER via ambulance. Ambulance was called and taken to Hospital.
19 2021-02-01 hypotension, loss of consciousness, chest discomfort, chest pain Anaphylactic reaction; Throat was swollen shut, couldn't talk or breathe; Throat was swollen shut, c... Read more
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.
19 2021-02-03 chest discomfort Patient felt dizziness and chest tightness. EMS was called
19 2021-02-03 loss of consciousness rashes on arm getting worse and had one on chest and then on legs; I felt like I was gonna pass out ... Read more
rashes on arm getting worse and had one on chest and then on legs; I felt like I was gonna pass out and I did it right when I got to my house; I felt like I was gonna pass out and I did it right when I got to my house; She was lightheaded and extremely dizzy; huge headache; arm didn't hurt when she got the shot but 30 minutes later it hurt so bad; throat hurt extremely bad; This is a spontaneous report from a contactable health professional, the patient. A 19-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the left arm on 11Jan2021 at 15:00 (at the age of 19-years-old) as a single dose for COVID-19 immunization. Medical history included allergies to latex, oranges, and adhesive. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL), hydroxyzine and celecoxib (CELEXA). The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Her arm didn't hurt when she got the shot but 30 minutes later, on 11Jan2021 at 15:30, it hurt so bad. On 18Jan2021 at 15:00 (also reported as the Monday of the vaccination), the patient experienced a feeling like she was going to pass out, at cheer practice, and did it right when she got to her house. She was lightheaded and extremely dizzy the whole time at practice and had a huge headache. Also, when she got to practice at on 18Jan2021 at 15:15, she noticed the rashes on her arm getting worse, and on her chest and then on her legs. Then, on an unknown date in Jan2021, her throat hurt extremely bad, so she gargled with salt water and it felt a little better. The patient was not treated for the events "I felt like I was gonna pass out and I did it right when I got to my house", "She was lightheaded and extremely dizzy", "huge headache", "rashes on arm getting worse and had one on chest and then on legs" and "arm didn't hurt when she got the shot but 30 minutes later it hurt so bad"; and was treated for "throat hurt extremely bad" as the patient gargled with salt water. Since the vaccination, the patient had been tested for COVID-19 via rapid nasal swab on 18Jan2021 with a negative result. The clinical outcome of "I felt like I was gonna pass out and I did it right when I got to my house" and "arm didn't hurt when she got the shot but 30 minutes later it hurt so bad" was unknown; of "She was lightheaded and extremely dizzy", "huge headache", "rashes on arm getting worse and had one on chest and then on legs", "throat hurt extremely bad" was resolving. Information on the lot/batch number has been requested.; Sender's Comments: Considering the temporal association, a causal association between administration of BNT162B2 and the onset of pass out cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. 40.~
19 2021-02-04 chest discomfort Systemic: Other- Chest tightness and anxiety
19 2021-02-17 fainting Patient fainted; This is a spontaneous report from a contactable pharmacist. A 19-years-old female ... Read more
Patient fainted; This is a spontaneous report from a contactable pharmacist. A 19-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL8982), intramuscular in the left arm on 04Feb2021 12:00 at single dose for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient medical history and concomitant medications were not reported. The patient fainted on 04Feb2021 12:00 with outcome of recovered in Feb2021. No treatment was performed due to the event. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.; Sender's Comments: Based on vaccine-event chronological association, a causal relationship between event syncope and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
19 2021-02-21 lightheadedness Dizziness, near syncope that resolved immediately when put in supine position
19 2021-02-25 chest discomfort 1530: Approximately 10 minutes after receiving vaccine patient reported having itching to throat, an... Read more
1530: Approximately 10 minutes after receiving vaccine patient reported having itching to throat, and hands. Patient stated she did have a Depo-Provera Injection after 1st vaccine approximately 3 weeks ago. Pt did state she pre-medicated herself with Benadryl 50mg orally at approximately 1300hrs today. Mom was present with patient while covering physicians and EMS on duty assessed patient. VS:112/82-B/P, 123-HR, 18-RR, SaO2 98% on RA. Allergies: Steroids, fish FMHx: Sports induced asthma and gallstones. 1550: Patient had notable facial swelling eye redness and flushing. 0.15 Epinephrine IM via home Epi-Pen self delivered by patient's mother for increase SOB, and tightness in chest. EMS transport called to transport patient to location. VS:118/86-B/P, 100-HR, 18-RR, Sa02 96% on RA. 1600:Transfer of care to EMS staff assisting in transfer of the patient.
19 2021-02-26 chest discomfort Chest heaviness in center of the chest, cant take a deep breath, evaluated by EMS-cleared
19 2021-03-01 chest discomfort Patient received 1st dose of vaccine a approximately 1435. 1500 approximately 25 minutes post vaccin... Read more
Patient received 1st dose of vaccine a approximately 1435. 1500 approximately 25 minutes post vaccination patient started feeling upper midsternal chest pressure, worsened with swallowing. Patient's skin with redness to upper chest and neck.
19 2021-03-02 heart rate irregular, pallor Less than one minute after injection into the right deltoid, an area of bright redness appeared supe... Read more
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.
19 2021-03-06 loss of consciousness Pt stated that she had become light headed and dizzy just after getting her shot. Pt stated that she... Read more
Pt stated that she had become light headed and dizzy just after getting her shot. Pt stated that she also started to feel like her vision was starting to narrow. Staff stated that she had passed out for a couple of seconds and had become alert after laying her down.
19 2021-03-09 palpitations, chest pain I was tired that night and slept until 11:00 am or 12 pm and muscle aches and body aches were notice... Read more
I was tired that night and slept until 11:00 am or 12 pm and muscle aches and body aches were noticed when I woke up. Thursday night, My heart started racing very quickly and it lasted for 30 minutes - my whole chest was hurting really bad and my heart was beating hard. I had a monitor - 207 beats per minutes. Blood pressure was normal. ER - monitored my heart. I think they gave me some medication. They gave me a heart monitor to check my heart for next 14 days. There was not another occurrence.
19 2021-03-11 fainting, loss of consciousness, heart rate increased Got second dose of vaccine the morning of March 10th. Had the "expected" symptoms of fatigue, heada... Read more
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.
19 2021-03-14 heart rate increased Swelling of the face and eyes, high fever, loss of appetite, rapid heart rate. The swelling of the e... Read more
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
19 2021-03-15 fainting Approximately 5 mins after vaccine administration, patient became lightheaded and fainted. Patient r... Read more
Approximately 5 mins after vaccine administration, patient became lightheaded and fainted. Patient regained consciousness and recovered quickly.
19 2021-03-17 chest discomfort Patient received vaccine on 03/16/21 at 440pm, woke up on 03/17/21 with bumps on her left arm where ... Read more
Patient received vaccine on 03/16/21 at 440pm, woke up on 03/17/21 with bumps on her left arm where the vaccine was given. She then woke up on 03/18/21 having chest tightness and shortness of breath.
19 2021-03-17 pallor Approx. 3min after administration pt became pale and light-headed. Pt reports feeling weak, blurred... Read more
Approx. 3min after administration pt became pale and light-headed. Pt reports feeling weak, blurred vision, and difficulty speaking. Denies SOB or LOC.
19 2021-03-18 lightheadedness chills, body aches, near-syncope the following day, and tinnitus
19 2021-03-20 chest discomfort 3/17/21-3/18/21: Nausea, vomiting, high fever (103F), diarrhea, muscle soreness & weakness, shakes, ... Read more
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
19 2021-03-20 loss of consciousness Patient passed out shortly after receiving first dose of pfizer covid 19 vaccine. Pt stated that she... Read more
Patient passed out shortly after receiving first dose of pfizer covid 19 vaccine. Pt stated that she has fainted before after reveiving IM injection, but failed to mention on consent form
19 2021-03-21 palpitations, chest pain Immediate dizziness and heart race. Constant chest pain and occasional dizzy spells to this day.
19 2021-03-21 fast heart rate, heart rate increased 3/22/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination ... Read more
3/22/2021 Patient 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: rapid heart rate, tachycardic Assessment : Time of assessment 1700. Alert and oriented. Actions taken: VS taken at 1700, BP- 132/79, P- 66, Gave water and crackers Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for . minutes. Discharged home. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/22/2021 4:52 PM
19 2021-03-22 loss of consciousness Patient was observed post COVID-19 immunization for 30 minutes based on pre-vaccination screening. D... Read more
Patient 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: loss of consciousness. Assessment: Time of assessment 1915. Alert and oriented. Actions taken: placed in wheelchair, given water and crackers, VS BP-102/61, P-69, O2-100%, VS BP-124/89, P=87, O2=100. Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for minutes. Discharged home. Immunizations Administered: Name, Date, Dose, VIS Date, Route - Pfizer COVID-19 Vaccine 3/22/2021, 7:07 PM, 0.3 mL, 12/11/2020, Intramuscular, Manufacturer: Pfizer, Inc.
19 2021-03-23 chest discomfort Temporary loss of taste started on 3/21 that lasted 12 hours. Fatigue and chest tightness from 3/20-... Read more
Temporary loss of taste started on 3/21 that lasted 12 hours. Fatigue and chest tightness from 3/20-3/23. Occasional nausea
19 2021-03-23 loss of consciousness patient received vaccination at 9:43 am , at 9:45 am she passed out briefly. We called 911, paramed... Read more
patient received vaccination at 9:43 am , at 9:45 am she passed out briefly. We called 911, paramedics came and checked her out ,gave her the ok to leave
19 2021-03-23 fainting Syncope with seizure like activity lasting 20 seconds; occurred twice within 2-3 minutes while seate... Read more
Syncope with seizure like activity lasting 20 seconds; occurred twice within 2-3 minutes while seated in car
19 2021-03-24 fainting pt was having fainting spelling
19 2021-03-24 fainting syncope after injection, VSS, no emergency transport needed
19 2021-03-25 fainting Dizzy, light headed, chills, faint, weak, exhaustion
19 2021-03-28 chest discomfort Chest tightness/ discomfort, wheezing.
19 2021-03-28 loss of consciousness Client was in observation post vaccination. Had seizure and lost consciousness. Not responsive for ... Read more
Client was in observation post vaccination. Had seizure and lost consciousness. Not responsive for a few seconds. Regain consciousness and was transported to Hospital via ambulance.
19 2021-03-28 fainting Patient has syncope/nausea after vaccination and was transported to ED for further eval. Patient sta... Read more
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.
19 2021-03-28 fainting Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient received first dose of Pfizer CO... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient received first dose of Pfizer COVID vaccine. Several minutes later, patient felt faint, got up to inform family to inform pharmacist, and fell to the ground
19 2021-03-28 fainting Syncopal episode lasting 10 seconds. Patient reported not eating or drinking before. Blood pressure ... Read more
Syncopal episode lasting 10 seconds. Patient reported not eating or drinking before. Blood pressure 78/54, O2 saturation 100%. Patient drank water and apple juice. Blood pressure 117/70. Blood sugar 142. Patient evaluated by MD. Repeat blood pressure 116/66. Patient released home with mother.
19 2021-03-29 fainting Two minutes after receiving her vaccination, she experienced lightheadedness and the syncopized for... Read more
Two minutes after receiving her vaccination, she experienced lightheadedness and the syncopized for approximately 5 to 10 seconds. She was taken to a private section of the arena and monitored. Her blood pressure? was initially low with systolics in the 70s,, then increased to the 90s. Her heart rate range from 50 to 70s.
19 2021-03-30 skin turning blue, fainting, pallor, hypotension Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Blue lips, white face, blurry vision-Severe, Systemic: Hypotension-Severe
19 2021-04-01 chest pain Sore throat 2 days after vaccine for 2 days, headache after vaccine for 2 days for 1 day, chest pain... Read more
Sore throat 2 days after vaccine for 2 days, headache after vaccine for 2 days for 1 day, chest pain for a few hours 4 days after vaccine, joint pain for 4 days, body aches for 5 days, blue feet and grey nails for 30 seconds 3 days after vaccine, couldn't walk for 5 days after vaccine, a lot of weakness everyday for 5 days, bruises on both feet 4 days after vaccine for 3 days.
19 2021-04-01 heart rate increased Patient received first dose of COVID-19 vaccine. Within a few minutes after vaccination, patient rep... Read more
Patient received first dose of COVID-19 vaccine. Within a few minutes after vaccination, patient reported feeling lightheaded with blurred vision and rapid heart rate. Patient drank some juice and sat for an additional 10 minutes; patient reported she felt better and opted to leave. Suspected vasovagal reaction.
19 2021-04-01 pallor, fainting fainted briefly, pallor - happened within a couple minutes of receiving vaccine. patient recovered ... Read more
fainted briefly, pallor - happened within a couple minutes of receiving vaccine. patient recovered within 10-15 minutes, sat with ice packs, had a glass of water, and a granola bar.
19 2021-04-01 fainting 4:10PM SYNCOPE -EASED TO FLOOR BECAME RESPONSIVE. MOVED TO COT PER WHEEL CHAIR. A/O, PINK, W/D, RESP... Read more
4:10PM SYNCOPE -EASED TO FLOOR BECAME RESPONSIVE. MOVED TO COT PER WHEEL CHAIR. A/O, PINK, W/D, RESP WITH EASE. NO PAIN, NO SOB. FAMILY X 3 AT SIDE. 4:20PM 'FEELS BETTER'. CRACKERS AND WATER GIVEN. 4:31TO EXIT PER WHEEL CHAIR, MOM TO DRIVE PT HOME. NO ACUTE DISTRESS NOTED. 4-2-21 12N TC: 'FEELS FINE TODAY'.
19 2021-04-02 fainting Systemic: Abdominal Pain-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Un... Read more
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
19 2021-04-04 chest discomfort Dizziness + nausea within 5 minutes of dose. Was given fruit cup and water, symptoms seemed to worse... Read more
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.
19 2021-04-04 lightheadedness patient with vasovagal response following vaccine vital signs obtained, lying BP 127/80 HR 78, R 16 ... Read more
patient with vasovagal response following vaccine vital signs obtained, lying BP 127/80 HR 78, R 16 Pulse ox 100% on room air, sitting patient was 111/77 and standing patient bp was 109/73- patient was released to the exit via wheelchair with no additional intervention other than additional monitoring
19 2021-04-04 fainting " Called to vaccine table for pt feeling faint. Pt reports similar response to vaccinations in the p... Read more
" 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."
19 2021-04-04 fainting Patient didn't think she fainted. Thought she fell asleep. However, a customer saw her phone and pe... Read more
Patient didn't think she fainted. Thought she fell asleep. However, a customer saw her phone and personal items fall. She did state she has a history of fainting from taking blood, so it's possible she fainted. She was feeling light headed and woozy and her ears were ringing just before the episode. I asked her if she wanted me to call 911 and she said no because when it had happened in the past, she had been fine. I took her blood pressure and it was 95/52. She waited in the area till 12:25 and I took her blood pressure again and it was 115/60. She did not have any other incindent. She left with her companion. I called her at 1:27p. She had arrived home and was still doing ok.
19 2021-04-05 chest discomfort 19 y/o female had appointment for COVID 19 vaccination. The vaccine was administered ~9:40AM, Immedi... Read more
19 y/o female had appointment for COVID 19 vaccination. The vaccine was administered ~9:40AM, Immediately client began to complaint of her left arm hurting (opposite arm that the vaccine was administered) and that her chest was feeling tight. EMS and nurse was with client. Vitals were BP 150/84, P 78. Nurse states that she was smiling and constantly on her cell phone. Client did not appear to be in distress. Client stated that she had a migraine. Vital retaken about 15 minutes later BP 139/86 and P72. EMT asked how she was and she said that she thought she needed to go to ERT via ambulance. Ambulance was called and taken to Hospital.
19 2021-04-05 chest discomfort SOB; pulse oximetry 93%; chest tightness; tingling hands; warm
19 2021-04-05 loss of consciousness Following the injection, I made my way to the observation room to wait for 10 minutes. After about t... Read more
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.
19 2021-04-05 fainting syncope, eye twitching
19 2021-04-06 loss of consciousness, pallor Received COVID-19 vaccine (Pfizer dose 1) at 6:05PM. She was then instructed to wait in the waiting ... Read more
Received COVID-19 vaccine (Pfizer dose 1) at 6:05PM. She was then instructed to wait in the waiting room for 15 minutes. Notified by PCT that patient had ask for an ice pack stating that "she felt like she was going to pass out." PCT retrieved water for pt and informed NP of situation. Upon entering waiting room patient appeared to be passed out in chair. Patient unable to speak, pale in color, and limp in chair. Placed cool paper towels on pts forehead - continually ask patient to speak or respond - patient was unable to. Call placed to 911 at 6:11PM. Patients vital signs BP 86/58, pulse 79, 02sat 97%. Sternal rub performed. Patient regained consciousness while PCT was on the phone with EMS. Patient then stated that this happens to her with medical procedures such as drawing blood. Assisted patient into exam room. Upon assessment lung sounds clear throughout, heart sounds normal. EMS arrived and discussed situation with NP and pt. Decision was made by pt to decline further workup at this time stating that she "feels fine now." Repeat vital signs at 6:39 BP 92/70 Pulse 115, and o2sat 97%.
19 2021-04-06 fainting Patient was standing in line and started to feel light-headed and fainted. Patient fell to the groun... Read more
Patient was standing in line and started to feel light-headed and fainted. Patient fell to the ground that caused a cut above her eye. Patient was still conscious and aware. Ambulance was called for assistance. Patient received stitches and taken by ambulance to hospital.
19 2021-04-07 loss of consciousness pt loss conscious briefly but is fine.
19 2021-04-07 pallor Patient was ambulating to waiting area chair and became weak. Patient was assisted to floor with nur... Read more
Patient was ambulating to waiting area chair and became weak. Patient was assisted to floor with nurses help. Eyes closed and was responsive with sternal rub to upper chest wall. Respiratory rate even, unlabored. Patient opened eyes and started talking. Alert and oriented x 3. Skin color grayish white with lips white. Water was given. Vitals obtained with BP 92/58, HR 64, 100% O2 on RA. Placed in wheelchair and pushed to private area. Patient refused for EMS to assist. Denies pain. No acute distress noted. Patient left vaccine site with no further incident.
19 2021-04-08 chest pain When I first got the vaccine, i got dizzy and sick to my stomach with a headache. I decided to leave... Read more
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.
19 2021-04-08 fainting, hypertension patient was sitting in waiting area and felt dizzy and fainted. was on ground for 30-40 seconds and ... Read more
patient was sitting in waiting area and felt dizzy and fainted. was on ground for 30-40 seconds and had nurses and paramedics attend to her. blood pressure was high at first and then she felt fine after 30 minutes and denied ambulance and went home
19 2021-04-09 heart rate increased, hypertension, chest pain Experienced the following after 7 minutes of the vaccine: shortness of breath, lightheadedness, dizz... Read more
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
19 2021-04-10 hypotension, lightheadedness 19-year-old with no significant past medical history presenting to ED after experiencing lightheaded... Read more
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
19 2021-04-10 pallor 4/11/2021 Pt was observed post Covid-19 immunization for 15 minutes . During the observation peri... Read more
4/11/2021 Pt was observed post Covid-19 immunization for 15 minutes . During the observation period, she experienced an adverse reaction with the following symptoms: dizziness, weakness and jittery, loss of vision. Assessment : Time of assessment ** 415pm*. Alert and oriented and Pallor. Actions taken: Vs taken at 510pm BP- 69/45, P-59, O2- 100%, juice, water, cookies and potato chips given, patient is consuming, feet elevated in chair, recheck of VS at 525pm- BP- 89/57. P- 58, O2-100%, she is alert , answering questions appropriately, continues to drink and eat, recheck of VS at 540pm, BP- 104/72, P- 57, final BP at 543pm 101/67. Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. The Patient was provided with Vaccine Information Sheet and instruction to access the system. Patient left with friend. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 4/11/2021 5:06 PM 0.3 mL 12/11/2020 Intramuscular Manufacturer: Pfizer, Inc Lot: EP7533 NDC: 59267-1000-2 Electronically signed by RN at 4/11/2021 5:58 PM Immunization on 4/11/2021 Detailed Report Note shared with patient
19 2021-04-10 pallor Patient began feeling dizzy immediately after administration. She said she could not open her eyes/... Read more
Patient began feeling dizzy immediately after administration. She said she could not open her eyes/ see. She became extremely sweating and pale. She never lost consciousness but could not regain her strength/ color.
19 2021-04-11 hypotension, fainting Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypo... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Visual Changes/Disturbances-Medium
19 2021-04-11 palpitations The night I got the vaccine I was studying and all of a sudden I couldn?t finish my sentence and fel... Read more
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.
19 2021-04-12 nosebleed Started VERY heavy menstrual period after not bleeding for nearly a year. Also had several bloody no... Read more
Started VERY heavy menstrual period after not bleeding for nearly a year. Also had several bloody noses.
19 2021-04-12 hypotension, loss of consciousness A few Minutes after getting the vaccine, patient stood up, felt dizzy light headed and nauseas and ... Read more
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.
19 2021-04-12 palpitations, fainting, hypotension, heart rate decreased low blood pressure (99/71), low heart rate (40-70 bpm), fainting, palpitations
19 2021-04-12 fainting Syncopal episode followed by 15 seconds of seizure activity.
19 2021-04-12 fainting Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Med... Read more
Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Additional Details: a few minutes after the patient took the vaacine she started getting lightheaded and she came to the pharmacy counter and passed out there. i carried the patient and sat her straight in a chair. i gave her water and orange juice. patient was confused and not aware of her surrounding and said she barely could hear. once she drank the OJ she felt better. took her vitals everything was fine. pt said she felt all good
19 2021-04-13 chest pain, hypertension high blood pressure, fatigue, anxiety, chest pain
19 2021-04-13 fainting, pallor Patient was walking to observation room when she began to feel dizziness, vision changes and tinniti... Read more
Patient was walking to observation room when she began to feel dizziness, vision changes and tinnitis resulting in syncope 1-2 minutes. Patient was on floor in sitting position supported by staff member. Diaphoretic. Pale. Unresponsive <1 minute. No head or face injury noted. No bleeding, swelling or ecchymosis noted. Full ROM to neck, LE and UE. Denies pain, CP, SOB, HA, palpitation or vision changes. BP 94/53 HR 99 O2 99% Patient was assisted to chair. A&O x 4. Reports that she was fasting x 1 month, reports eating small amount of granola bar and small amount of water. Patient was observed for 30 minutes. d/c home in stable condition w/ dad. ED warning s/s discussed. Patient and father repeated instructions w/ good understanding.
19 2021-04-14 fainting Syncopal episode resolved without intervention. Pt vitals within limits and stable. Pt refused trans... Read more
Syncopal episode resolved without intervention. Pt vitals within limits and stable. Pt refused transport to ED.
19 2021-04-14 fainting Parient fainted after receiving Pfizer vaccine.
19 2021-04-15 chest discomfort Patient taken to designated area to be assessed and observed. Vital signs obtained and blood pressu... Read more
Patient taken to designated area to be assessed and observed. Vital signs obtained and blood pressure noted to be 80/50 and patient lowered to floor at this time and feet elevated. Blood pressure retaken after 5 minutes and noted to be 120/80 and showing improvement. HR 88 and oxygen noted to be 99% on RA. 10: 17 Vital signs 140/82 HR 100 oxygen 99%. Patient consumed water as requested and tolerating well. 11:09: 140/90 oxygen 99% HR 88 and RR 18. Patient having c/o chest tightness that is not improving at this time. Patient states that he feels a lot better but no improvement with chest tightness. Observation reviewed with staff and decision made to call out to 911 at 11:28. Prior to rescue team arriving vital signs set to be monitored every 15 minutes starting at 1132. 1st set noted to be 110/88 HR 81 oxygen at 100% RA RR 18. 11:44 Rescue team arrived on scene and report provided and patient care given to them at this time. Patient's mother arrived at scene and made aware of condition and rescue decision.
19 2021-04-15 fainting, loss of consciousness Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Det... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient got really cold and passed out in chair. Immunizers laid her down on the ground. Patient told paramedics that this is a hereditary issue and that this happens every time she gets a vaccine/blood work done . She came back around immediately after passing out. Ambulance service was refused but mother drove her to hospital just in case.
19 2021-04-15 fainting RIGHT AFTER PATIENT RECEIVED HER VACCINE AT 9:45 AM, SHE REPORTED HERSELF DIZZY. WE IMMEDIATELY WENT... Read more
RIGHT AFTER PATIENT RECEIVED HER VACCINE AT 9:45 AM, SHE REPORTED HERSELF DIZZY. WE IMMEDIATELY WENT OUT THE PHARMACY TO ASSIST HER. WE WERE ABLE TO BREAK HER FALL WHEN SHE STARTS FAINTING AND SLOWLY LIE HER DOWN THE FLOOR. I IMMEDIATELY ASK MY OTHER TECHNICIAN TO CALL 911. PATIENT STARTED SITTING UP AND REQUESTED SONE COLD WATER WHICH WE GAVE. WE WAITED FOR HER TO FEEL BETTER BEFORE WE ASKED HER TO STAND UP SO SHE CAN SIT PROPERLY WHILE WE WAIT FOR THE PARAMEDIC.
19 2021-04-15 cardiac arrhythmia, heart rate irregular Received COVID shot #2 in the morning. Went to a GI specialist appointment and noted irregular hear... Read more
Received COVID shot #2 in the morning. Went to a GI specialist appointment and noted irregular heart beat on exam. Referred to see PCP that same day Saw pediatrician, did EKG and PVCs noted and heard. Referred to cardiologist
19 2021-04-16 palpitations, fast heart rate During 15 min waiting period patient developed lightheadedness and dizziness with heart racing. No ... Read more
During 15 min waiting period patient developed lightheadedness and dizziness with heart racing. No chest pain or chest tightness. She felt weak and unable to walk. At first was thought to be a vasovagal reaction and she was given po fluids and monitored. Vitals were stable. HR was in the 70s with a baseline of 50s. She began to feel somewhat better in terms of the lightheadedness and dizziness and was able to walk to "clinic" area at the vaccination event. Her heart rate was fluctuating between 50 and 107 and otherwise vitals remained normal. Blood pressure up a bit more than likely due to anxiety. BP 132/90; HR 50 - 107; Rep 20; P.O. 98%; denied pain. She was given 25mg diphenhydramine IM. No complaint of throat closing, no anaphylaxis. She continued to feels waves of tachycardia. Rescue squad dispatched for further management and observation to make sure no delayed anaphylactic reaction. Her course at the ED was benign. No further management other than fluids. Urine pregnancy test was negative. No bloodwork completed. Patient observed four hours with no adverse event and left ED feeling her normal self. At no time had anaphylactic reaction.
19 2021-04-16 platelet count decreased, low platelet count Thrombocytopenia, bruising within a week of vaccine. Patient was admitted for 48 hours and discharg... Read more
Thrombocytopenia, bruising within a week of vaccine. Patient was admitted for 48 hours and discharged. Plan is for her to follow up with PCP and have a CBC rechecked.
19 2021-04-16 lightheadedness vasovagal reaction
19 2021-04-16 fainting, hypotension, pallor patient turned white and fainted, hyperventilation and low BP 79/69
19 2021-04-16 fainting Pt became light headed and dizzy prior to a syncopal episode
19 2021-04-17 loss of consciousness, fainting While talking to my parents I started to say things completely opposite of the conversation we were ... Read more
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.
19 2021-04-17 fainting, blood glucose increased Patient presented to our primary care office 10 days after her Pfizer COVID booster shot was adminis... Read more
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.
19 2021-04-17 blood clot strange pain on her left collar bone; going to see someone just in case it's a blood clot; lump on h... Read more
strange pain on her left collar bone; going to see someone just in case it's a blood clot; lump on her collar bone, left collar bone; does hurt a little bit; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 19-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 1 intramuscularly administered in Arm Left (like the shoulder area) on 28Mar2021 09:00 (Lot Number: ER8734 and Expiry date: unknown) as single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. No additional Vaccines administered on same date of the Pfizer suspect. On 30Mar2021, the patient experienced going to see someone just in case it's a blood clot, lump on her collar bone, left collar bone, does hurt a little bit and on unspecified date strange pain on her left collar bone. 19-year-old female got the first Pfizer Covid vaccine at 9 am on Sunday, March 28 and this morning, she woke up with a strange pain on her left collar bone and there was a lump there, states when she woke up, she noticed a pain, checked in the mirror, she saw on the left side she saw a bump and checked on the right side and didn't see anything and that's when she got worried. Caller states she was just calling to report it, she's worried that it's a blood clot or something else. Why was the patient taking Pfizer BioNTech COVID Vaccine (Verbatim): she wanted to be vaccinated to protect herself and her community. Caller states she would not like to provide her last name at this time. However, provided her last name initial. She also reports she would not like to provide her address, height, or weight right now. She states she used to volunteer at a hospital. She does not see expiration or NDC number on card she received when she got her vaccine. Caller states she does know that one of her family members has the Factor 5. She is not sure if she has it but would like to be tested for it. The outcome of the event going to see someone just in case it's a blood clot was recovered, lump on her collar bone, left collar bone and does hurt a little bit was not recovered and strange pain on her left collar bone was unknown. Information on batch/Lot number has been requested.
19 2021-04-18 chest discomfort, chest pain, fainting Patient received 1st dose of Pfizer COVID-19 vaccine and was placed in Observation area for monitori... Read more
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.
19 2021-04-18 loss of consciousness Patient is an employee at this store. She passed out immediately after receiving injection. She wa... Read more
Patient is an employee at this store. She passed out immediately after receiving injection. She was unconscious for no more than 5 seconds then regained consciousness and remained in the vaccination room for 15 minutes. She stated numerous times that she was ok and eventually went back to work on her own volition.
19 2021-04-18 pulmonary embolism This is a spontaneous report from a contactable consumer (patient). An 19-year-old female patient (n... Read more
This is a spontaneous report from a contactable consumer (patient). An 19-year-old female patient (not pregnant at event onset and time of vaccination) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm on 11Feb2021 at 00:00 (19-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included Ewing Sarcoma which was not ongoing (Diagnosed at 5 years old, treated with chemotherapy for 1 year, cancer free for 13 years). There were no known allergies. Concomitant medications included low dose ethinylestradiol, norgestimate (TRI-SPRINTEC) and montelukast sodium (SINGULAIR). No other vaccine in four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm on 20Jan2021 at 00:00 (19-year-old at time of vaccination), at single dose, for COVID-19 immunization. Starting 15Feb2021 at 12:00, the patient began to have shortness of breath that got progressively worse throughout the week. On 22Feb2021, she woke up with severe shortness of breath and her O2 saturation was 82%. She went to the hospital emergency department and was given a chest CT, and diagnosed with large bilateral pulmonary embolisms. She also had severe right ventricular strain due to the PEs. She was rushed into an EKOS procedure and a IVC filter was also put in. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (4 days), and Life threatening illness (immediate risk of death from the event). COVID test (test type: Nasal Swab, test name: Novel Coronavirus PCR) post vaccination was Negative on 22Feb2021, and Negative on 29Mar2021. Therapeutic measures were taken as a result of the events and included Heparin drip, EKOS and IVC filter procedure. The outcome of the events was recovering. Information on the lot/batch number has been requested.
19 2021-04-18 fainting Syncope - two episodes after vaccine administration. Transported to local hospital for evaluation.
19 2021-04-19 pallor Upon crew arrival found 19 YO female in emotional distress. Patient was CAOx4 and stated she was goi... Read more
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.
19 2021-04-20 heart rate decreased The patient is a 19-year-old female who presents for an allergic reaction s/p receiving her 1st COVI... Read more
The patient is a 19-year-old female who presents for an allergic reaction s/p receiving her 1st COVID vaccination at 1640 today. About 15 minutes later, the patient developed a tingling sensation in her tongue, tight scratchy throat, and swelling in her upper lip. She denies any rash or shortness of breath. She denies having any drug allergies, but does note an allergy to macadamia nut in the past. She denies taking any anti-histamines or epinephrine prior to arrival. She reports a history of ADHD and took 30 mg of Vyvanse, which typically causes her heart rate to elevate in the low 100s. LNMP: 3-4 weeks ago. She denies any chance of pregnancy.
19 2021-04-20 hypotension Patient experienced hypotension post vaccination; transported to hospital via ambulance.
19 2021-04-20 loss of consciousness Nausea; Passed out; Felt a little dizzy; Mumbling, slurred speech; Developed a "static" feeling in h... Read more
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.
19 2021-04-20 lightheadedness vasovagal episode; patient fell from chair 5 min after receiving vaccine, denied any SOB; left asymp... Read more
vasovagal episode; patient fell from chair 5 min after receiving vaccine, denied any SOB; left asymptomatic after 30 min
19 2021-04-20 fainting, pallor Syncope, pale, dizziness, Pass out when receives vaccines. Went out for fresh air, felt better. Giv... Read more
Syncope, pale, dizziness, Pass out when receives vaccines. Went out for fresh air, felt better. Given water and snacks.
19 2021-04-21 anaemia, heart rate increased 9 days ago, got Pfizer vaccine #1. Immediately after vaccine, felt nausea, lightheaded. She was sitt... Read more
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.
19 2021-04-21 chest pain (4/19/2021-present(less severe now)): -leg spasms (mainly in left leg/thigh and hip area) (4/18/202... Read more
(4/19/2021-present(less severe now)): -leg spasms (mainly in left leg/thigh and hip area) (4/18/2021-4/20/2021): -chills -chest pain -fever -severe headache Present: -leg spasms -mild headache
19 2021-04-21 pallor She has been ill from day of and remains sick with no relief in that time. Developed a 102 degree fe... Read more
She has been ill from day of and remains sick with no relief in that time. Developed a 102 degree fever and delirium day of and the following day. Bones hurt, chills, joints swollen. Headache, dizziness, fatigue. The fever remained for 36 hours and she's had mild fevers off and on since. Tylenol would temporarily reduce the 102 fever before it went back up. The other symptoms have remained, predominantly bone and joint pain and stiffness, fatigue, and general feeling if being unwell. Her coloring is very pale, gray-looking. She's missed work and school due to pain and fatigue. She was completely healthy pre-vaccine.
19 2021-04-21 fainting Pt waited 5 min out of required 15 minutes. She stated she felt fine and decided to leave. As she w... Read more
Pt waited 5 min out of required 15 minutes. She stated she felt fine and decided to leave. As she was leaving, she had dizziness and fainting spell. Her brother caught her and prevented her from hitting head. She was incoherent for 5 minutes not knowing where she was. After she regain her senses, she stated she did not eat anything the whole day. She had blood pressure of 114/84. Paramedics came, evaluated and discharged her.
19 2021-04-22 chest pain, pulmonary embolism, fast heart rate, coughing up blood Patient transferred from medical group practice for b/l PE. Patient reports chest pain and SOB x 4 d... Read more
Patient transferred from medical group practice for b/l PE. Patient reports chest pain and SOB x 4 days ago. Patient has also been having hemoptysis for the past couple days as well. Physical exam is remarkable for tachycardic heart rate and rhythm is regular. Patient given heparin bolus and infusion and admitted to hospital for acute large main vessel pulmonary embolism. 2D echocardiogram showing no signs of right heart strain. Patient was transitioned to oral Eliquis and given a 1 month supply on discharge. Patient told to stop birth control and avoid NSAIDS. Patient instructed to F/U with PCP and hematology.
19 2021-04-22 loss of consciousness On 4/18/21, it was reported that the patient had a seizure following the 2nd dose of Pfizer vaccine.... Read more
On 4/18/21, it was reported that the patient had a seizure following the 2nd dose of Pfizer vaccine. This is a 19 year old female patient with a known history of a seizure disorder. She has been under the care of a neurologist x 6 years, is not on any seizure medications, and no diagnosis made. She reports she has a seizure every two weeks, which are triggered by anxiety/stressful events. On this day, 3 minutes after received the 2nd dose in the supine position, she fell unconscious and developed eyelid and arm twitching. Vitals signs remained stable. MD described seizure as 'starting as a sleep state, moving to slight twitching, then tonic clonic. Duration of seizure symptoms was 12 minutes. ' The patient regained consciousness, symptoms resolved, and patient was discharged home with family following increased observation. No medication treatment needed. Upon chart review, it was identified that she has a similar reaction following her 1st Pfizer dose. On 3/28/21, the patient received Pfizer (Lot ER8730 in the left deltoid). Following her 15 minute observation period, she rose from her chair and fell to the ground unconscious. She was taken to the treatment tent and observed to have 'seizure like jerking of upper and lower extremities, fluttering eyelids, unarousable.' Vitals stable (BP=103/68, HR =111, SpO2=98%). Patient and family described this seizure as similar to the ones she experiences due to stress/anxiety. Symptoms resolved, no medication treatment needed. She was advised to follow-up with PCP regarding 2nd dose, and if proceeds, recommended to lie down in treatment tent for 2nd dose (which was then done on 2nd dose). Patient reported that she has not had seizures with other vaccine administrations.
19 2021-04-22 fainting Syncope, flushing, sweating, dizziness. Water given. BPs 90/38 (pulse 78), 120/64 (pulse 82).
19 2021-04-23 chest pain, heart rate increased, palpitations Within 5 minutes of receiving vaccine daughter felt something was not right as we sat in 15 minute h... Read more
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.
19 2021-04-23 pallor On 04/24/2021, 2 minutes after the Pfizer immunization given to patient, complained of not feeling w... Read more
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.
19 2021-04-24 loss of consciousness After receiving her dose of the Pfizer vaccine the pt seemed to be doing well conversing and reporte... Read more
After receiving her dose of the Pfizer vaccine the pt seemed to be doing well conversing and reported she was feeling fine. The pt then stood up to leave the vaccination area and slouched to the ground. She went unconscious for about 4 seconds. When she came to she was awake, alert, and oriented. Paramedics were called to ensure the pt didn't suffer injury. After an evaluation by the paramedics the pt was released and her friends picked her up.
19 2021-04-25 loss of consciousness Patient stood to approach her father, when she slumped over and lost consciousness and was unarousab... Read more
Patient stood to approach her father, when she slumped over and lost consciousness and was unarousable. She had normal breathing and pulse. The clinical team transferred patient to the Assessment Tent, where she was observed to have seizure-like jerking of her upper & lower extremities and fluttering of the eyelids while she remained unconscious. She had normal pulse and respiration during this time, no tongue biting or urinary or stool incontinence. Within approximately 10 minutes her seizure-like movements resolved, and she gradually regained consciousness. I spoke with the patient afterwards: she recalls having stood to meet with her father, and then she has no recollection of the event.
19 2021-04-25 fainting Fainting
19 2021-04-26 chest discomfort Roughly an hour after vaccination, experienced light-headedness and dizziness. During the night, a m... Read more
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.
19 2021-04-26 chest pain, pulmonary embolism Experienced life-threatening blood clots in both lungs (bilateral pulmonary embolism); chills; flu-l... Read more
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.
19 2021-04-26 hypotension, pallor Patient became pale, diaphoretic, feeling of passing out and had 1 episode of vomiting.
19 2021-04-26 loss of consciousness Dizziness for 5 minutes after vaccination. Passed out for less than 30 seconds. Patient stable, rele... Read more
Dizziness for 5 minutes after vaccination. Passed out for less than 30 seconds. Patient stable, released from vaccination site.
19 2021-04-26 palpitations, chest discomfort approximately 10 minutes after receiving her first COVID vaccine, the pt developed dizziness, palpit... Read more
approximately 10 minutes after receiving her first COVID vaccine, the pt developed dizziness, palpitations and feeling "out of it". heart rate regular at106 bpm, bp 131/69. the pt drank 8 oz of , her vitals were monitored every 5 minutes. she developed tremors to bilateral upper extremities, chills, and chest pressure substernally that was worse with deep inspiration the pt has a history of anxiety however she states that the symptoms were not her "typical anxiety. the pt was feeing worse and ER was recommended, the pt accepted and 911 activated. bp was 134/66, hear rate 96, pulse ox 99%, resp rate 20
19 2021-04-27 loss of consciousness Shot given 4/23/2021 at 1pm. 4/25/2021 around 1pm started losing vision in both eyes while at work, ... Read more
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.
19 2021-04-27 fainting Patient said she feels dizzy after vaccines sometimes. After administration she was walked to a chai... Read more
Patient said she feels dizzy after vaccines sometimes. After administration she was walked to a chair in our waiting are and at that time was fine. After about 5 minutes she fainted in the chair and appeared to have a seizure. We called 911 and we were able to get her to talk to us but she appeared to go in and out of it. After the paramedics arrived she became better and better. She was able to walk out of the store with her mom and appeared fine. We spoke with her dad later that evening and she was doing well.
19 2021-04-28 chest discomfort At 7:40 pm on 04/27 I received my second Pfizer COVID19 shot. I felt okay for the rest of the night ... Read more
At 7:40 pm on 04/27 I received my second Pfizer COVID19 shot. I felt okay for the rest of the night and went to bed around 2am that night. The next day, I woke up around 10:30am and was sore until about 12pm when I began to feel completely awful. I was tired and no pain reliever helped with the muscle aches in my shoulders and back. I felt like my chest was being weighed down and it felt like a horrible chore to even breathe. About 24 hours after the shot, under my jaws began to hurt terribly and ice didn't do much to help it. I finally fell asleep on 04/28 around 2am and woke up on 04/29 without any pain.
19 2021-04-28 pallor Shortly after injection patient was light headed, had blurry vision, was pale, and was having troubl... Read more
Shortly after injection patient was light headed, had blurry vision, was pale, and was having trouble hearing.
19 2021-04-28 fainting A FEW MOMENTS AFTER ADMINISTERING THE COVID VACCINE PATIENT APPEARED TO HAVE FAINTED. THE EPISODE LA... Read more
A FEW MOMENTS AFTER ADMINISTERING THE COVID VACCINE PATIENT APPEARED TO HAVE FAINTED. THE EPISODE LASTED A FEW SECONDS AND RESCUE WAS CALLED RIGHT AWAY. PATIENT CAME TO CONCISOUNESS AND STATED SHE WAS STARTING TO FEEL BETTER AND DID NOT WANT TO GO TO THE HOSPITAL. SHE DENIED RESCUE AND A FRIEND DROVE HER HOME AFTER SITTING IN THE PHARMACY FOR ABOUT 1 HR UNDER OBSERVANCE.
19 2021-04-28 fainting Hot and cold flashes 14 hours after Fainting/ Passing Out 20 hrs after Lightheadedness Starting 8am ... Read more
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)
19 2021-04-30 loss of consciousness, fainting Patient began to feel light headed about 5 minutes afterward. She came up to the counter to tell us... Read more
Patient began to feel light headed about 5 minutes afterward. She came up to the counter to tell us and by the time we got to her with a chair she fainted into the technicians arms. We sat her down and she was only unconscious for about 3 seconds. We called 911. She asked for some water and we also gave her some OJ. By the time the paramedics got here she was pretty much back to normal and said she knew it was because she was anxious. She signed a refusal for the paramedics and sat for a few more minutes before she said she felt fine to leave.
19 2021-04-30 fainting syncope, self-resolved with supportive care, pt released.
19 2021-04-30 fainting This took place in Pod 3 purple chair 3. The vaccinator saw the patient roll out of her chair. Patie... Read more
This took place in Pod 3 purple chair 3. The vaccinator saw the patient roll out of her chair. Patient states that she got dizzy after the vaccine, that she came through right away. I asked if the patient ever fainted before and she stated that she fainted in the past from vertigo. Patient stated that she was feeling better and we sent her home with family members that were here with her today.
19 2021-05-02 lightheadedness, fainting, loss of consciousness The patient was minimally responsive when I arrived at her car consistent with a severe vasovagal ep... Read more
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.
19 2021-05-02 fainting Got the shot in the morning - no reaction other than sore arm which was normal. Later around 3pm, st... Read more
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.
19 2021-05-03 deep vein blood clot She developed pain a week after date of injection, this seemed to get better but then returned again... Read more
She developed pain a week after date of injection, this seemed to get better but then returned again about 2 weeks later. Her L arm pain got progressively worse. She then received the 2nd dose of pfeizer vaccine on 4/19/2021 this time she got it in her R arm because of the pain in her L arm. Her L arm pain got worse to the point she was not able to feel her entire L arm. So she decided to go the ER
19 2021-05-03 pallor, fainting post vaccination approximately 1 minute in observation patient began to slide off chair, eyes closed... Read more
post vaccination approximately 1 minute in observation patient began to slide off chair, eyes closed, pale vitals 121/66, 89, 22, 98.9 02. 98% 911 called patient assessed responding well was not transported to hospital remained in observation
19 2021-05-06 hypotension, lightheadedness Suspected vasovagal episode, blurry vision, sweaty, hypotension, eval by EMS, transported to ER via ... Read more
Suspected vasovagal episode, blurry vision, sweaty, hypotension, eval by EMS, transported to ER via ambulance.
19 2021-05-06 loss of consciousness, pallor About two minutes after being vaccinated patient states she felt nauseous, lightheaded, weakness, bl... Read more
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.
19 2021-05-07 heart rate increased Dizzy Lightheaded Brain zaps Fast heart rate/pain Increased anxiety and panic attacks
19 2021-05-07 loss of consciousness, enlargement of the heart nausea; passed out; seizure; enlarged heart; hurt knee; sore mouth; This is a spontaneous report fro... Read more
nausea; passed out; seizure; enlarged heart; hurt knee; sore mouth; This is a spontaneous report from a contactable other HCP (patient). A 19-year-old female non-pregnant patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration, in the left arm on 20Apr2021 at 11:00 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient has no history of COVID-19 prior to vaccination. The patient had received other vaccines within 4 weeks prior to the COVID-19 vaccine: 2nd dose of Human papilloma virus (HPV) vaccine on 06Apr2021 in the right arm. On 20Apr2021 22:30, the patient experienced passed out, seizure, hurt knee, sore mouth, enlarged heart, and nausea. The patient reported, "I was fine all day until around 10:30 pm I went into my mothers room and she was asking me how my arm feels I told her it was fine and right after saying that she said I passed out in front of her and then I began to have a seizure for about 50 seconds and then I woke up. After waking up from the event I had a hurt knee and sore mouth as well as an enlarged heart. I have no history of seizures in the past so it was definitely scary." The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 20Apr2021. Therapeutic measures taken included anti seizure meds, fentanyl, and paracetamol (TYLENOL). The patient recovered with sequelae from the events, passed out, seizure, hurt knee, sore mouth, and enlarged heart. Outcome of nausea was unknown.; Sender's Comments: A contributory role of BNT162B2 to the reported events cannot be fully excluded based on close temporal relationship and lack of alternate explanation at this time. However, the information provided is very limited and does not allow for a complete medical assessment. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
19 2021-05-07 loss of consciousness The patient passed out in her chair while being observed in front of the pharmacy about 5 minutes af... Read more
The patient passed out in her chair while being observed in front of the pharmacy about 5 minutes after receiving the Covid vaccine. She was laid down from her chair and became fully responsive about 10 seconds after being laid down. 911 was called and the pt was checked by EMTs and escorted to her car with the patient's mother
19 2021-05-07 platelet count decreased I can't be standing for more than a few minutes; My legs begin to cramp up; Muscle aches; Sore throa... Read more
I can't be standing for more than a few minutes; My legs begin to cramp up; Muscle aches; Sore throat; Couldn't get out of bed all weekend; White blood and platelets count abnormally low; White blood and platelets count abnormally low; Mononucleosis; Cough; Dizziness; Muscle weakness; Fever; Headache; 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, Batch/Lot Number: EW0158), via an unspecified route of administration, administered in left arm on 15Apr2021 10:00 as single dose for Covid-19 immunization. Medical history included gastritis and sensitive stomach from an unknown date and unknown if ongoing. The patient has no history of COVID prior vaccination. Concomitant medications included drospirenone, ethinylestradiol (NIKKI); pantoprazole sodium sesquihydrate (PROTONIX); and an unspecified vitamin, all taken for an unspecified indication. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, for Covid-19 immunization. The patient received her second dose on 15Apr2021, Thursday, and on 16Apr2021, Friday night, she got a mild headache. Beginning 17Apr2021 09:00, Saturday, she got severe headache, dizziness, muscle weakness, and a fever. Symptoms worsened throughout the days. On 19Apr2021, Monday, she also got a sore throat. She couldn't get out of bed all weekend. She went to the hospital and they found that her white blood and platelets count were abnormally low, among other low things (white blood at 1.8). She was hospitalized until 20Apr2021, Tuesday, and was found to have mononucleosis. Cough developed and ended Tuesday, 20Apr2021. Beginning 20Apr2021 onward, the muscle aches were the biggest complaint, she can't be standing for more than a few minutes or her legs begin to cramp up. Headaches and dizziness continued. Sore throat stopped, and fever began to subside. On 19Apr2021, the patient underwent lab tests and procedures which included platelet count: abnormally low, Nasal Swab/PCR: negative, and white blood cell count: 1.8. The events resulted in Doctor or healthcare professional office/clinic visit, Emergency room/department or urgent care, and events from 19Apr2021 caused hospitalization until 20Apr2021. Treatment for the events included Tylenol and IV fluids. The outcome of sore throat recovered in Apr2021, cough resolved on 20Apr2021, fever was recovering and for other events was not recovered.
19 2021-05-07 fainting I almost fainted; Nausea; Feeling sick and throw up; Feeling sick and throw up; felt very light head... Read more
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.
19 2021-05-08 nosebleed Random heavy period a week before the injection, about 2 after the first dose. Excessive nose bleed ... Read more
Random heavy period a week before the injection, about 2 after the first dose. Excessive nose bleed approximately 17 hours after the second dose.
19 2021-05-09 chest discomfort SOB, difficult to speak, chest tightness
19 2021-05-10 chest pain, troponin increased 19 year old female with a history of tachycardia syndrome (on carvedilol) presented to ER with acute... Read more
19 year old female with a history of tachycardia syndrome (on carvedilol) presented to ER with acute chest pain radiating to jaw and bilateral arms. Episode occurred 3 days after second shot of Pfizer COVID vaccine.
19 2021-05-10 chest pain Dizziness, fatigue, muscle spasms, chills, chest pain, vomiting, insomnia
19 2021-05-10 fainting, pallor, lightheadedness presents with a potential reaction to the COVID19 vaccine. I was summoned to the patient's vehicle. ... Read more
presents with a potential reaction to the COVID19 vaccine. I was summoned to the patient's vehicle. She was responsive, by pale and diaphoretic slumped in the back seat. Given the nature of the vehicle, her position could not be changed. EMS was summoned so the patient could be repositioned on a gurney properly with legs elevated. The patient was responsive and relayed a history of POTS. Documentation was reviewed in detail, she does use a Clonidine patch. VS were WNL via EMS. The patient had not had anything to eat or drink today. Given this, 1L of IV fluids was started via EMS. This was a vasovagal episode with syncope in the setting of known POTS currently under treatment. With close monitoring, hydration, and repositioning, the patient returned to baseline and was returned home with her parents.
19 2021-05-10 fainting, lightheadedness Vasovagal syncope, has a history with needles/shots No injuries No treatment needed Vitals checked M... Read more
Vasovagal syncope, has a history with needles/shots No injuries No treatment needed Vitals checked Monitored and left without problem after monitoring
19 2021-05-11 chest discomfort Very swollen arm immediately after vaccine and worsened throughout the day, inflamed and painful joi... Read more
Very swollen arm immediately after vaccine and worsened throughout the day, inflamed and painful joints, tightness in chest
19 2021-05-11 chest pain Chest pain, Headache
19 2021-05-12 chest discomfort 1:15 Patient left the building after 15 minute wait ,went to eat. Felt chest and throat tightness... Read more
1:15 Patient left the building after 15 minute wait ,went to eat. Felt chest and throat tightness and burning. Came back to COVID vaccine clinic. Also reported a headache. PSO2 100 %Pulse 72 b/p 128/82, crying ,face red. Skin pink warm and dry. Respirations even and unlabored. Informed her that her vital signs are stable , she can be taken to ER. Wanted to wait and be monitored here. 1:25 PSO2 99% pulse70 calming down called mother to talk. 1:37 PSO2 97% pulse 78 reports chest and throat tightness 1:42 Still reports throat and chest tightness. B/P 132/84 Pulse 76 PSO2 98 does not want to go the ER wants to go home. Informed to go to ER for any shortness of breath or further problems.
19 2021-05-12 fainting Vasovagal Syncope on the 11th, severe hives to follow and fever resulting in emergency treatment via... Read more
Vasovagal Syncope on the 11th, severe hives to follow and fever resulting in emergency treatment via steroids, anti-inflammatories, and allergy medication.
19 2021-05-12 low platelet count Thrombocytopenia discovered at routine office visit for travel clearance.
19 2021-05-14 anaemia, haemoglobin decreased I started having vaginal bleeding on April 14th. The first day, it was the same amount as a regular ... Read more
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.
19 2021-05-14 loss of consciousness Fever (around 100 F), chills, arm soreness, fatigue, and severe headache for entire duration. I pass... Read more
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.
19 2021-05-14 loss of consciousness Called and asked to assist in the vaccine clinic. Patient vaccinated at approximately 1620, reactio... Read more
Called and asked to assist in the vaccine clinic. Patient vaccinated at approximately 1620, reaction at 1630 Patient sitting on the floor complaining of being light headed. Patient reports feeling better and is able to converse without difficulty. Patient moved to a chair on her own accord and after approximately one minute patient began to lose consciousness. BP taken and was reported at 56/35 and was placed on 4L of O2. Patient did not respond well and was transitioned to O2 per facemask at 10 L and paramedics called. Patient transferred to stretcher and patient regained consciousness. Patient able to speak. VS taken by team and BS taken and was WNL. Patient declined ER visit, but remained in vaccine clinic for additional 30 minutes until 1715. Patient left clinic ambulatory in stable condition without incident.
19 2021-05-15 heart rate increased Rapid heartbeat and allergic reaction/angioedema and new psoriasis flare. Treatment- corticosteroid... Read more
Rapid heartbeat and allergic reaction/angioedema and new psoriasis flare. Treatment- corticosteroids, antihistamines.
19 2021-05-15 lightheadedness PT EXPRIENCED VASOVAGAL RESPONSE/SYNCOPE AND VOMITING 20 MINUTES AFTER ADMINISTRATION
19 2021-05-16 lightheadedness After receiving the vaccine the patient reported feeling light headed. I (the pharmacy manager) was ... Read more
After receiving the vaccine the patient reported feeling light headed. I (the pharmacy manager) was called over. I witnessed the patient have a near fainting episode (diagnosis). The patient shook, and was guided from the chair to the ground. she did not hit her head. someone remained with patient the entire time. Patient was given water while waiting for EMT to arrive. EMT evaluated patient, diagnosed with near-fainting episode related to anxiety. EMTs do not believe response was vaccine related. BP, sugars, and all other tests within normal limits. Mom arrived and patient left pharmacy once she calmed down.
19 2021-05-16 fainting 19 y/o female fainted following Pfizer vaccine. VS: BP=108/64, RR=24, HR=45, 100% RA, BGL=90. Pt m... Read more
19 y/o female fainted following Pfizer vaccine. VS: BP=108/64, RR=24, HR=45, 100% RA, BGL=90. Pt monitored for over 30 minutes and felt better. Repeat VS: BP=117/75, RR=18, HR=74, 100% RA. Pt cleared by medical provider and went home with family.
19 2021-05-17 pallor At approximately 4:15 PM, a pt stated feeling light-headed and clammy. Pt was assisted to a wheelch... Read more
At approximately 4:15 PM, a pt stated feeling light-headed and clammy. Pt was assisted to a wheelchair and moved to a cot. Pt's vital were assessed. HR:120, RR:20, SaO2: 98. Ot appeared flushing and pale. Lung sound were clear and equal bilaterally. Pt sat for 30 minutes and stated she wanted to go to the hospital POV. Pt's VS were reassessed. HR: 106, BP: 136/86, RR: 20, SaO2: 98%. Pt signed form. Pt was assisted out of the clinic by wheelchair.
19 2021-05-17 fainting When the patient was given the Pfizer Covid vaccine she felt dizziness at first. Immediately afterwa... Read more
When the patient was given the Pfizer Covid vaccine she felt dizziness at first. Immediately afterwards she fainted and urinated within a few seconds apart. The patient sat in the chair for the remaining 15 minutes and was given water to drink. She had not eaten anything since the night before and this was her first vaccine. After 15 minutes, her head was clear and she was not dizzy anymore and her father came to pick her up.
19 2021-05-18 hypotension, loss of consciousness lost vision in both eyes; passed out; dizzy; severe nausea set in with severe body pain; severe naus... Read more
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.
19 2021-05-18 lightheadedness Patient received Pfizer COVID vaccine #1 on 5/17/21, and during the post vaccination 15 minute obser... Read more
Patient received Pfizer COVID vaccine #1 on 5/17/21, and during the post vaccination 15 minute observation period, the patient had a pre-syncopal episode where she felt a warm sensation in the arm where she received vaccine. HR was in the 40s in the ER, increased on exertion.
19 2021-05-18 fainting Systemic: Fainting / Unresponsive-Mild, Systemic: FAINTED RESPONSIVE-Mild, Additional Details: PATIE... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: FAINTED RESPONSIVE-Mild, Additional Details: PATIENT FAINTED
19 2021-05-19 palpitations Pt felt heart racing, shaking hands, dizziness Hx of POTS at 15:04pm BP 118/74 HR 106 o2 97 at 15... Read more
Pt felt heart racing, shaking hands, dizziness Hx of POTS at 15:04pm BP 118/74 HR 106 o2 97 at 15:09pm BP 116/64 HR 80 o2 97
19 2021-05-19 palpitations Dizziness and fatigue in head developed and lasted for two weeks after the shot that was administere... Read more
Dizziness and fatigue in head developed and lasted for two weeks after the shot that was administered on April 25th.. About 5 days after the shot in the evening, I experienced hot, shooting pain in left leg that felt like a band around my thigh but would sometimes shoot down into my calf and feet. My feet would feel tingly and sore. I experienced shooting pain on and off again in my left and right arms as well as my right leg, but the pain in my left thigh stayed for over a week. The feeling in my legs made it difficult to sleep. Two weeks after the shot on Wednesday May 12th at 11am, the dizziness and fatigue made me lightheaded and I could not keep my eyes open. My head got really hot and my vision blurred and I could feel my heart beating in my head loudly and all over my body. I tried to walk to my thermometer to take my temperature but struggled to hold things in my hands or walk properly. My sister called my mother who took me to the Emergency Room around 11:50. The doctors took urine and blood samples, X-rayed my chest and did an EKG but could not figure out what was wrong with me and discharged me at 3pm.
19 2021-05-19 fainting pt passed out 5 minutes after the shot was given. Then the pt started to shake a little for about 10... Read more
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.
19 2021-05-19 fainting Vasovagal syncope, the patient had waited approx. 12 minutes after her injection at 8:30 am and star... Read more
Vasovagal syncope, the patient had waited approx. 12 minutes after her injection at 8:30 am and started feeling dizzy. She slumped over and rolled onto the ground. She was assisted to a gurney from the floor. She was given snacks water and juice and was observed for approx. 45 minutes. V.S remained stable and the patient was sent home.
19 2021-05-19 fainting Anaphylaxis reactions: fainting, flushing, epipen was administered and emergency response took patie... Read more
Anaphylaxis reactions: fainting, flushing, epipen was administered and emergency response took patient for further evaluation.
19 2021-05-20 pallor, hypotension, fainting Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypo... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient was vaccinated at about 4:45pm, felt dizziness & lightheadedness shortly after. Following that patient states that her field of vision became black and foggy, she then was witness dropping to a knee. Pharmacist helped her to a chair and father got her some water. Patients skin appeared pale and felt clammy at this point. Her blood pressure was check at 3:57pm (81/50) and then again at 4:05pm (113/67). She felt and looked better, so the pharmacist walked both her and father to vehicle.
19 2021-05-20 pallor patient felt very light headed, sick to her stomach, face was very pale, vomited up some water she h... Read more
patient felt very light headed, sick to her stomach, face was very pale, vomited up some water she had just drank
19 2021-05-20 fainting Patient got fainted after getting 2nd dose of vaccine that lasted for 1-2 seconds and after that pat... Read more
Patient got fainted after getting 2nd dose of vaccine that lasted for 1-2 seconds and after that patient was fine.
19 2021-05-21 chest discomfort Patient stated that she was having tingling in her arms, chest was tight and legs were feeling heavy... Read more
Patient stated that she was having tingling in her arms, chest was tight and legs were feeling heavy. The feeling started with her arms and then went to legs but didnt notice this until she pulled her phone out and that she was having tightness in her chest. We took the patients vitals at 11:24 am heart rate 92, Blood pressure 132/80, o2 100, and then again at 11:30 am heart rate 69, Blood pressure 112/73, o2 99. I asked the patient how she was doing. Patient stated that legs still feel heavy and that the chest tightness is better. After the second blood pressure the patient stated that her chest tightness was completely gone. Patient also stated that her arms and legs were better. I released the patient home with mom and dad. She was released at 11:40 am.
19 2021-05-21 fainting vasovagal syncope
19 2021-05-23 loss of consciousness Patient received shot and after about 30 seconds got up to leave immunization room and lost consciou... Read more
Patient received shot and after about 30 seconds got up to leave immunization room and lost consciousness. Was examined immediately upon falling and was alert with no allergic reaction signs.
19 2021-05-23 fainting At 10:52 am patient stood up to schedule her second dose appointment because she stated she did not ... Read more
At 10:52 am patient stood up to schedule her second dose appointment because she stated she did not have the appointment yet. She was up front with the PCT, when this NP was called to come to the front because the patient had passed out and hit her head. EMS was called. Upon coming up to the patient, the patient was conscious. Examined patient for head or neck injuries. She denied any neck pain but stated the back of her head hurt. patient placed into chair with assistance, and given a bottle of water and an icepack. Upon inspection, patient had no lacerations or bleeding from the head. A 4 cm "goose egg" was noted to the back of the head. Neuro exam was normal. Patient alert and oriented times 4. Stated vision got blurry prior to passing out, however it was normal at the time of the exam. noted. Patient refused EMS transport at time of arrival 11:08 am. patient refused to go to ER. AMA form signed. Patient educated on signs and symptoms that mean she should seek immediate medical attention. Patient verbalized understanding of these teachings.
19 2021-05-23 fainting Site: Pain at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Fainting / Unre... Read more
Site: Pain at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe
19 2021-05-24 chest discomfort had the Pfizer vaccine LOT WE0169 clinic she had in less 48 h generalized hives + swollen joints a... Read more
had the Pfizer vaccine LOT WE0169 clinic she had in less 48 h generalized hives + swollen joints and fingers as well SOB + chest tightness she was prescribed Benadryl but still after 10 days she is still w same symptoms and hives getting more uncontrolled
19 2021-05-24 loss of consciousness nausea and vomiting, loss of consciousness, symptoms resolved with rest and water
19 2021-05-24 loss of consciousness Client 2-5 minutes after vaccine fell out of her chair and hit her head on the ground. Client attend... Read more
Client 2-5 minutes after vaccine fell out of her chair and hit her head on the ground. Client attended to immediately, when she was rolled over she was unconscious. Epi 0.3 mg im given, feet elevated as she laid on the ground. Client awoke. 911 called and client sent to ED.
19 2021-05-25 loss of consciousness ended up passing out right there; feeling hands and legs num; feeling very week; having hard time ea... Read more
ended up passing out right there; feeling hands and legs num; feeling very week; having hard time eating or drinking anything; This is a spontaneous report from a contactable consumer(patient). A 19-year-old female patient(not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 07May2021 03:30 (Lot Number: EW0158) as 2nd dose, single for covid-19 immunization. Medical history and concomitant medications were none. There was no other vaccines within 4 weeks prior to the COVID vaccine, no other medications the patient received within 2 weeks of vaccination. There was no known allergy. She was not diagnosed with COVID-19. Historical vaccine included first dose of BNT162B2 on 15Apr2021 at 03:00(Lot No.: EWO173) in arm left for COVID-19 immunisation. It was stated that 2 days after the second dose, on 09May2021 she was at work and start feeling hands and legs num . She was at the cashier and ended up passing out right there. She was rushed to ER(Emergency room) and she could feel or move her last for at least 30 minutes. She was afraid she would not be able to walk again. She was treated and after 3-4 hours they discharged herself saying it was a reaction to the vaccine. She had been home since then and still (4 days after the shot ) having a hard time eating, or drinking anything in May2021. She was still feeling very week in May2021. Treatment for ended up passing out right there, feeling hands and legs num included just a bunch of exams were done and everything see in May2021. Outcome of ended up passing out right there, feeling hands and legs num was recovering, of other events was not recovered.
19 2021-05-25 fainting Pt brought to ED w/concerns for allergic rxn immediately following COVID-19 vaccine at PCP office (5... Read more
Pt brought to ED w/concerns for allergic rxn immediately following COVID-19 vaccine at PCP office (5/19) where w/in 15 mins, experienced significant lightheadedness, dizziness & throat swelling & itch w/wheezing. In ED, developed brief episodes of syncope and was administered EpiPen, IV fluids, solu-medrol and famotidine w/improvement. After multi doses of epi IM for recurrent symptoms throughout observation, was started on epi drip. Ultimately discharged, however, returned same night with recurrent anaphylactic rxn and was again started on an epinephrine drip and claritin. Of note, pt had previously had COVID on 1/22/2021. Pt discharged w/plans to f/u w/ allergy and immunology at Hospital.
19 2021-05-25 fainting Patient had presumed fainting episode post. Blood pressure checked (117/78) pulse 77. once determine... Read more
Patient had presumed fainting episode post. Blood pressure checked (117/78) pulse 77. once determine glucose was run and ended up 77 after some lemonade. Patient Denied EMS later and signed AMA. Patient stable, with friend at end and was told s/s to re call ems if needed.
19 2021-05-25 fainting Patient fainted after approximately 5 minutes after first dose.
19 2021-05-26 chest discomfort, chest pain 8:30 am - Sudden chest pains, pressure and shortness of breath. Came on suddenly and worsened as tim... Read more
8:30 am - Sudden chest pains, pressure and shortness of breath. Came on suddenly and worsened as time went on. Shortly after 9am placed call to family Dr and was directed to go to ER. Arrived at ER around or shortly after 10am. ER immediately did a EKG then followed by all of the tests listed below. Blood work showed elevated heart enzyme which signaled there was an issue. As day progressed the heart enzyme continued to elevate. 2pm-2:30pm we had a diagnosis and were told she would need to stay overnight for observation while they started her on drugs to get her heart stabilized. She was hooked to a heart monitor throughout the night. Discharged with treatment plan the next day 5/22.
19 2021-05-26 pallor Headache; Episode of stiffness, going pale; Episode of stiffness, going pale; 15 seconds of memory l... Read more
Headache; Episode of stiffness, going pale; Episode of stiffness, going pale; 15 seconds of memory loss; This is a spontaneous report from a non-contactable female other HCP reported for herself. A 19-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via intramuscular route of administration on 19May2021 16:45 (at the age of 19-year-old) as single dose for COVID-19 immunization. Medical history was none, and no allergies were reported. Concomitant medication included sarecycline(SARECYCLINE) contraceptive pill via oral route of administration. On 20May2021 11:00 AM, the patient experienced headache, episode of stiffness, going pale, 15 seconds of memory loss. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment medications for events. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine, diagnosed with COVID-19 prior to vaccination and has been tested for COVID-19 since the vaccination. The events were reported as non-serious. Outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained
19 2021-05-26 fainting Patient fainted after receiving covid19 Pfizer 1st dose vaccination
19 2021-05-27 hypotension, fainting Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Headache... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild
19 2021-05-28 inflammation of the heart muscle Three days after patient took the vaccine she felt light head and dizzy. She went to the doctors an... Read more
Three days after patient took the vaccine she felt light head and dizzy. She went to the doctors and they did a number of test and eventually referred her to a cardiologist. The cardiologist saw swelling or enlargement of her heart. Patient took a stress test and afterward felt fine. However, the swelling of the heart was concerning. She never had any issues before taking the vaccine. More tests scans are planned, to see what is going on.
19 2021-05-29 hypotension Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-M... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: 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.
19 2021-05-30 fainting Patient start having nausea and vomiting symptoms about 10 min after administration. She also mentio... Read more
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.
19 2021-05-31 deep vein blood clot, pulmonary embolism 1st day of pain: Extreme Pain in Lower Extremities (Right Leg, Right abdomen, right lower back) Swel... Read more
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
19 2021-05-31 loss of consciousness PATIENT PASSED OUT. SHE LOST CONSCIOUSNESS. THOUGH HAD NORMAL PULSE AND BREATHING. BUT WE GAVE SOME ... Read more
PATIENT PASSED OUT. SHE LOST CONSCIOUSNESS. THOUGH HAD NORMAL PULSE AND BREATHING. BUT WE GAVE SOME COLD WATER AND JUICE FROM THE MOM, USED COLD ICE PACK ON THE FACE AND NECK AND WE LAY THE PATIENT DOWN IN A SUPINE POSITION, MAINTAINED AIRWAYS AND RAISED HER LEGS. WE CONTINUED TO CHECK PULSE AND BREATHING WHICH WAS NORMAL AND WE FANNED THE PATIENT SO SHE CAN GET SOME VENTILATION. SHE GOT REVIVED IN ABOUT 20-25MINUTES
19 2021-05-31 pallor We left the store and got a bite to eat at the drive through. After driving about 7 minutes she grab... Read more
We left the store and got a bite to eat at the drive through. After driving about 7 minutes she grabbed her throat and started acting like she was not able to swallow. I asked her was she ok? She stated no in a raspy voice. She shook her head and said she felt like molasses was in her throat. She seemed pale and began to sweat. I am a former EMT-Parmamedic. I remembered there was a store about 2 miles away. I called and got the Pharmacist on the phone. I ran into the after driving 92 miles an hour and she converted children's Benadryl for me and stayed on the phone. I gave her 1/2 a bottle. began to be more responsive. I had a medical bag with me with airways and other medical devices I use for work but no Epi Pen. After giving her all the Benadryl she said she felt better but she stayed hoarse for the remainder of the day and was sleepy. I kept an eye on her an Called her physician on Monday morning as this was a Saturday and they called in Epi pens in case this happens again. The first shot she felt like she swallowed a potato chip wrong and started acting the same way then through up but never got this bad. We just thought she ate something and it went down the wrong way. Never giving it a second thought. Then after the second shot it was much worse. Had I not the pharmacist on the phone, Benadryl liquid and a medical bag, I would have called an ambulance. In the county we live in though we do not have enough ambulances and I am afraid she would have went into full anaphylaxis and died. I did what I thought was the best for my only child.
19 2021-06-02 loss of consciousness Patient cam to Walgreens with her mother for a Covid 19 shot. We administered the Pfizer shot in the... Read more
Patient cam to Walgreens with her mother for a Covid 19 shot. We administered the Pfizer shot in the left arm and was asked to stay in the store for 15 to 20 minutes to make sure she di not have an adverse reaction. She walked to the front of the store and and started felling dizzy, therefore, mom had patient sit down on the floor. Our store manager noticed she was on floor and cam over to offer assistance. Pt's mom said she pass out and was not feeling good. I was paged and upon going to front of the store saw the patient on the floor. I came up to and ask how she's feeling and noticed she was flushed and warm. An associate got her some water and a chair. Our store manager offered to call 911 and mom did not want an ambulance called and after 15 to 20 minutes of sitting in the chair drinking water, patient was able to leave the store with no assistance. I called to check on Pt at 5:30pm and she was feeling good with no other issues.
19 2021-06-05 loss of consciousness, fainting, fainting Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium
19 2021-06-05 fainting Patient experienced increased perspiration, chills, nausea, numbness in her fingertips, and syncope ... Read more
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.
19 2021-06-06 chest pain, chest discomfort Patient has had a 2 day history of left sided chest pain, chest tightness, shortness of breath, dizz... Read more
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.
19 2021-06-06 fainting, haemoglobin decreased, sinus rhythm difficulty breathing, syncope, headache
19 2021-06-07 brain sinus blood clot, fainting 2nd COVID19 Pfizer vaccine 5/1/21 lot # EW0167. both vaccines received at pharmacy. 5/24/21 awoke at... Read more
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.
19 2021-06-07 chest pain Swollen lymph nodes under left arm , Arm of injection is L arm. In addition Rib pain across chest wi... Read more
Swollen lymph nodes under left arm , Arm of injection is L arm. In addition Rib pain across chest with pain while taking a deep breath
19 2021-06-07 blood clot blood clots; she did get really sick / she was displaying a lot of symptoms; fever; whole body was a... Read more
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.
19 2021-06-09 chest pain Very Bad Chills; She is Shaking Right Now; Her Chest Hurt; Jaw Hurt; arm pain; This is a spontaneous... Read more
Very Bad Chills; She is Shaking Right Now; Her Chest Hurt; Jaw Hurt; arm pain; This is a spontaneous report from a contactable consumer (patient mother). A 19-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24May2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. On 24May2021, the patient was experiencing the very bad chills right now and her chest hurt, and her jaw also hurts. The patient received ibuprofen (MOTRIN) at 800 mg for the arm pain (noted in 2021). Outcome of the event of arm pain was unknown while not recovered on the remaining events. Information regarding the lot/batch has been requested.
19 2021-06-09 heart rate increased, lightheadedness Hot flashes Red face Feeling like she was going to pass out or throw up if she didn't lie down Fatig... Read more
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
19 2021-06-09 pallor, fainting As soon as patient exited the vaccination room and sat in the waiting room chair she started to feel... Read more
As soon as patient exited the vaccination room and sat in the waiting room chair she started to feel lightheaded and slumped over and fainted. She lost consciousness for less than a minute. She lost color in her skin and was confused when she woke up. Her mother and brother were with her and called for help. The pharmacist and a technician also went out to assist. Patient was seated in the chair and assisted the whole time not to fall out or get up and walk after waking back up. She was given a cold compress and water. Her blood pressure was taken and was WNL. We asked them to stay in the pharmacy an additional 15-30 minutes after to watch over her. Her mother and brother were able to stay with her in the waiting room. After resting for an additional 20 minutes patient was able to walk out on her own and color returned to her body. Her mother felt comfortable taking her home at this point. Patient is very nervous about shots and had little to eat today.
19 2021-06-10 inflammation of the heart muscle, chest pain myocarditis. chest pain, elevated troponin
19 2021-06-11 loss of consciousness PATIENT LOST CONSCIOUSNESS WITHIN A FEW MINUTES OF RECEIVING HER COVID-19 VACCINE (PFIZER- 1ST DOSE... Read more
PATIENT LOST CONSCIOUSNESS WITHIN A FEW MINUTES OF RECEIVING HER COVID-19 VACCINE (PFIZER- 1ST DOSE). HEART RATE TAKEN BY NURSE REPORTED TO BE IN THE 40S. PT WAS DIAPHORETIC. PT REGAINED CONSCIOUSNESS WITHIN 2-3 MINUTES. UPON REGAINING CONSCIOUSNESS- PATIENT REPORTED BLURRED VISION.
19 2021-06-13 chest discomfort, inflammation of the heart muscle Patient developed myopericarditis two days following second dose administration. Patient had two day... Read more
Patient developed myopericarditis two days following second dose administration. Patient had two days of chest pressure in the substernal chest
19 2021-06-14 hypotension, pallor, loss of consciousness Routine covid 19 vaccination using Pfizer requested by patient. All screening questions were answer... Read more
Routine covid 19 vaccination using Pfizer requested by patient. All screening questions were answered by patient and received the vaccination without incident. Approximately 3 minutes after she received vaccination she came back in the professional services room with her father, as he received his vaccination she complained of becoming dizzy and was told to go have a seat in the waiting area. She was sitting with her mother for another moment and her mom became concerned because the patient urinated on the floor while she was sitting there and seemed to lose consciousness. We responded to the patient who was awake but was extremely pale. Warehouse management was called over and they observed the patient and made the decision to call 911 based on the mother's concern. Paramedics arrived within 10 minutes and recorded very low blood pressure and were concerned she may have had a seizure. The decision was made to take the patient to the hospital because her blood pressure was still remaining low after approximately another 10 minutes. I called the phone number on her immunization consent form the next morning (6/15/21) and again in the evening but was able only to leave a voice mail.
19 2021-06-14 loss of consciousness pt passed out right after getting vaccine for 10 seconds. Father stated this has happened before an... Read more
pt passed out right after getting vaccine for 10 seconds. Father stated this has happened before and they had hoped it wouldn't happen again. The family did not disclose this information until after vaccine given. Patient was monitored for 30 minutes with no additional reaction.
19 2021-06-15 chest discomfort, palpitations When I got the shot I immediately got extremely tired witch us normal I belive but a few hours later... Read more
When I got the shot I immediately got extremely tired witch us normal I belive but a few hours later at 4:30 ish I was swimming bc I felt okay and my heart started pounding more then normal when I'm swimming so we leave and go home my heart was still pounding 2 hours later and now my chest is tight and I'll randomly gasp for air its been I belive 2 days after the vaccine and my heart is still pounding and the gasping for air has not stopped the gasping is a random thing so uts not a continuous cooking feeling just every now and then the heart pounding though has been continuous qnd the night after the shot I had gotten worked up on top of the heart pounding qnd thought I was about to have a heart attack I calmed down and have yet to go to a hospital bc its only really bad when I'm walking or getting worked up if it does not pass by Thursday I will be seeing a doctor
19 2021-06-15 chest pain Patient is a 19-year-old female with no significant past medical history BIBself with report of mids... Read more
Patient is a 19-year-old female with no significant past medical history BIBself with report of midsternal chest pain (described as soreness) that started around 8:20 AM when she woke up with associated jaw pain and L>R upper extremity pain. She reports pain is worse with deep breaths and has improved significantly since it started (currently rated 2/10). She took three ibuprofen tabs (presumably a total of 600 mg) prior to presentation but took no other pain medications. Denies abdominal pain, nausea, vomiting, fever, chills, leg pain or swelling. Denies cigarette, alcohol, or drug use. Patient received her 2nd Pfizer COVID vaccine 4 days ago, with initial side effects of chills, body aches, and intermittent headaches resolving yesterday. Emergency Department to Inpatient.
19 2021-06-15 lightheadedness Near Syncope
19 2021-06-16 loss of consciousness fell on the floor and she lose all the conscious; she got a kind of choke; fell on the floor and she... Read more
fell on the floor and she lose all the conscious; she got a kind of choke; fell on the floor and she lose all the conscious; lose all the energy; cannot breathe; This is a spontaneous report from a contactable consumer (patient's mother). A 19-year-old female patient received bnt162b2 (Pfizer product, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on May2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Last Friday (unspecified May2021) she was vaccinated with the Pfizer and she got a lot of symptoms of the vaccine, after 20 seconds she fell on the floor and she lose all the conscious and took that it was minute and half to come up and she got a kind of choke, cannot breathe and lose all the energy, it took almost 2 days to become normal again. The patient's mother did not want her to get another shot. The outcome of events was recovered. Information about lot/batch number has been requested.
19 2021-06-16 lightheadedness, fainting Pt experienced vasovagal syncope within 1 minute of receiving her second dose of pfizer. She retaine... Read more
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.
19 2021-06-16 fainting Patient had fainted roughly 2-5 minutes after vaccination. Patient had been told to wait for 15 minu... Read more
Patient had fainted roughly 2-5 minutes after vaccination. Patient had been told to wait for 15 minutes after vaccination but was thirsty and went to her car to grab some water. When outside, patient felt dizzy and fainted, falling and hurting her head and leg. Ambulance was called but patient refused any care and wanted to go home. We had the patient call a friend/family to pick her up. When asked, patient reported not having eaten today and vaccination was given approximately at 2:30 pm.
19 2021-06-17 palpitations, ischemic chest pain Sharp heart pain and palpitations.
19 2021-06-18 fainting, hypotension Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Det... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient fainted after vaccine was given. Ambulance was called. Patient was taken to Hospital. I spoke to mom, after patient was seen at hospital. Hospital believes fainting occured due to patient having low blood sugar.
19 2021-06-21 chest pain, anaemia So I had some on and off chest pain for the week after I got the vaccine, I didn't think it was beca... Read more
So I had some on and off chest pain for the week after I got the vaccine, I didn't think it was because of the vaccine initially. It started to get consistent and then 2 weeks after the vaccine it became very intense pain to where I could not carry anything or sit or stand comfortably. About three weeks after my vaccine I was able to get in with a PCD and she did not attribute it to the vaccine, she put me on 600MG of Motrin every 8 hours and that managed the pain pretty well. She wanted me to take the meds for a week but the pain continued so I am now still taking the medicine. I saw my own PCD a week later and she ran a lot of tests, still no definitive answers.
19 2021-06-21 pallor during pt's observation period reported signs of tunnel vision, pale and clammy skin, and chills. Pt... Read more
during pt's observation period reported signs of tunnel vision, pale and clammy skin, and chills. Pt vitals were taken and Dr. called for pt vasovagal. Pt was given snacks and water then observed for an hour with vitals taken every 15 min. released after an hour after Dr. final evaluation.
19 2021-06-22 pallor 97/47, HR 70, c/o lightheadedness. Pt. received vaccine via RD started getting pale and stated felt... Read more
97/47, HR 70, c/o lightheadedness. Pt. received vaccine via RD started getting pale and stated felt faint. Pt. lowered in passenger front seat. Fire Rescue called, checked vitals. Pt. stated feeling better. Sat back up in seat, sipped water. Pt. stable. No acute distress noted.
19 2021-06-23 loss of consciousness pt got vaccine at 11:30, went to the waiting area to wait out 15 mins. got light headed, slid out of... Read more
pt got vaccine at 11:30, went to the waiting area to wait out 15 mins. got light headed, slid out of chair into floor. pharmacist seen her draw up like she was about to seize. pt straightened out and came to. when pt woke up she did not know how she got into the floor. 911 was called. pt was stabilized before 911 arrived. Pt states she had not ate before vaccine was given. Pt was gave a bottle of water and crackers. ems checked B/P, blood sugar, pulse, listened to lungs. all was normal. Pt was slightly light headed but remained instore for monitoring and until resolved. family was called to pick pt up.
19 2021-06-27 chest pain Patient experienced shortness of breath and chest pain resulting in a visit to the ER (02/07/2021) w... Read more
Patient experienced shortness of breath and chest pain resulting in a visit to the ER (02/07/2021) where doctors found multiple blood clots in lungs as well as decreased heart function due to stress on cardiac system. Patient was hospitalized for 3 days and had to have an INR procedure to remove the blood clots (Patient is now on blood thinner and diagnosed with Antiphospholipid Syndrome after event.)
19 2021-06-29 heart rate increased Dizziness; Hungry; Tingling lips; Shakiness/ trembling; Fast heartbeat; Easily irritated; Confusion;... Read more
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.
19 2021-06-29 loss of consciousness Severe arm pain at injection site, sudden onset dizziness about 2 hrs after injection; the next morn... Read more
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.
19 2021-06-29 fainting Pt was ok during vaccination. Pt fainted in chair while sitting after during observation.
19 2021-06-30 fainting, pallor Patient in Clinic to for services and review vaccines and request COVID vaccine, Trumenba and Hep A.... Read more
Patient in Clinic to for services and review vaccines and request COVID vaccine, Trumenba and Hep A. Gave Pfizer and grandmother requested to wait 15 mins before giving other vaccines. Patient was sitting on table, fainted after about 8-10 mins.Granmother caught her and placed back on table in supine position. Patient very pale, legs stiffened and feet turned inward. Feet were elevated and fan turned on patient. Patient aroused within 1 min. B/P 110/60. Denied difficulty breathing. Dr was present. Patient was cold and clammy. Heart rate 100. Ambulance was called. Ambulance arrived within 10 mins. Patient ambulated to stretcher. Ambulance transported to Hospital.
19 2021-07-02 fainting Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsi... Read more
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
19 2021-07-03 heart failure, chest pain Patient received her second COVID 19 shot on April 26, 2021. She began to feel general fatigue tow... Read more
Patient received her second COVID 19 shot on April 26, 2021. She began to feel general fatigue toward middle/end of May. Also at end of May she began to experience chest pain when working out. On June 14th she felt chest pain just walking and developed a cough. I took her to ER on June 15th around 1am. Her chest X-ray showed some abnormality. Around 3am she had significant difficulty breathing. She was admitted and a cardiologist and pulmonary physicians determined she was in heart failure with an ejection fraction of 10%. She was life flighted to another hospital where she spent 3 weeks on Echmo and Impella, received a heart transplant on week 4 and is still in ICU recovering. We are not sure if the vaccine is related to her illness. We just know that patient was a healthy 19 year old, former high school athlete, current straight A student having completed her freshman year of college, and no health issues prior to this event.
19 2021-07-03 chest discomfort Patient's mom reported her having dizziness. Patient later said she's having blurry vision and ches... Read more
Patient's mom reported her having dizziness. Patient later said she's having blurry vision and chest tightness. Pharmacy staff called 911 and personnel from the fire department came, awaiting the ambulance. When patient's vitals were checked they were normal. Patient's mom said, patient has a history of anxiety and she had told patient not get the vaccine; so she thinks patient got anxious after having blurry vision. Patient later reports of feeling fine, paramedics arrived and patient and mom went with them. Patient said she had Hep A and Meningitis vaccine about 3 weeks ago and was ok.
19 2021-07-06 chest discomfort, ischemic chest pain, heart rate decreased, palpitations, chest pain within 24 hours of 2nd dose patient experienced intense pain in her heart. Her pain was described ... Read more
within 24 hours of 2nd dose patient experienced intense pain in her heart. Her pain was described as intense, sharp and dull at times. She also described a sensation of her heart skipping beats or even slowing way down "stopping" a "hollow" feeling. She also felt pain that traveled across her chest to right side.
19 2021-07-06 pallor Systemic: Dizziness / Lightheadness-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Pale and slight pain on left cheek/gave water. Patient stated she didn't eat anything all day except Chexmix.
19 2021-07-07 fainting Patient received their vaccine and waited in the store for 10 mins. Upon exiting the building they f... Read more
Patient received their vaccine and waited in the store for 10 mins. Upon exiting the building they felt dizzy and fainted for a few seconds, which was witnessed by patient's mother. Patient quickly came to and was brought into the store and monitored for 30+ minutes. No harm noted.
19 2021-07-08 chest discomfort A few minutes after receiving the pfizer vaccine, patient noted some chest tightness and a weird fee... Read more
A few minutes after receiving the pfizer vaccine, patient noted some chest tightness and a weird feeling in her throat. Blood pressure was 111/79 with a pulse of 79. The feeling of chest tightness did not get worse or better. No difficulty breathing. No change in color. Second BP reading taken 5 minutes apart was same.
19 2021-07-08 fibrin d dimer increased 3rd visit to ACC secondary to persistently high fevers and diffuse skin rash, swelling over the past... Read more
3rd visit to ACC secondary to persistently high fevers and diffuse skin rash, swelling over the past 5 days. Patient states symptoms began the day after receiving her 1st covid vaccine. Has been taking steroids, benadryl, and pepcid 2 days prior. Returned to ACC yesterday with fever up to 104.5 and then broke out into a diffuse rash. had swelling around the eyes.
19 2021-07-08 loss of consciousness Pt (adult age 19) was administered her first dose of the Pfizer Covid 19 vaccine at approx 8:30 AM o... Read more
Pt (adult age 19) was administered her first dose of the Pfizer Covid 19 vaccine at approx 8:30 AM on Friday 7/9/21. Pt did not appear to be in any distress. Upon completion of the vaccine administration, the pt sat in recovery chair with mother. After about 2 min, pt was talking to mother and passed out. Mother revived her by toughing her. She did not fall. the administering pharmacist was notiied and went out to the pt. Pt put head between knees to get blood flow to head and took deep slow breaths. She was given water. CSM, also came over and they both calmed her down and had her move her arms to help with her circulation due to complaint of arms feeling funny. Pt said she had worked the night shift the previous night & had not slept or ate so she got her a bottle of orange juice to sip on. Once pt sat for about 30 mins, she felt better and her mother escorted her out.
19 2021-07-08 fainting Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Mild
19 2021-07-10 loss of consciousness Patient was found lying on the floor in front of pharmacy having passed out. She had received the i... Read more
Patient was found lying on the floor in front of pharmacy having passed out. She had received the immunization minutes earlier. She was assessed for head injury or extremities. None were found. She was alert in seconds and reported no unusual discomfort aside from menstrual cramping which began earlier in day. She rested here for about 45 minutes before leaving with her boyfriend stating she was fine. Only reason she rested so long was actually the cramps.
19 2021-07-11 loss of consciousness, fast heart rate I was diagnosed with Postural orthostatic tachycardia syndrome. I was given medication. Currently on... Read more
I was diagnosed with Postural orthostatic tachycardia syndrome. I was given medication. Currently on treatment. I passed out and had tachycardia. That would cause shortness of breath and dizziness. I was diagnosed in March and I am currently on medication treatment.
19 2021-07-11 fainting About 5 minutes after receiving the vaccine the patient felt light headed and fainted into her dads ... Read more
About 5 minutes after receiving the vaccine the patient felt light headed and fainted into her dads arms while scheduling her second appointment. Dad sat her into a chair and by the time the pharmacist reached her she was already coming to. She did report some trouble hearing and focusing her eyes. She drank some water and sat for about 15 more minutes before she felt back to normal. She then left with her father.
19 2021-07-12 haemoglobin decreased ASYMPTOMATIC Admission Discharged 7/5/2021 - 7/7/2021 (2 days) Last attending ? Treatment team 3... Read more
ASYMPTOMATIC Admission Discharged 7/5/2021 - 7/7/2021 (2 days) Last attending ? Treatment team 39 weeks gestation of pregnancy Principal problem Discharge Summary (Resident) ? ? Family Medicine Cosigned by: MD at 7/7/2021 10:24 PM Attestation signed at 7/7/2021 10:24 PM I was present on the 3rd floor and saw this patient prior to her discharge. I agree with the key elements of the discharge note as written by Dr. Routine anticipatory guidance given including need for follow-up, daily vitamin, and pelvic rest. Discussed birth control options, post-partum depression issues, and other issues that would warrant a call to the office. Obstetric Discharge Summary BRIEF OVERVIEW Admitting Provider: DO Discharge Provider: DO;Nic* Primary Care Physician at Discharge: N/A Admission Date: 7/5/2021 Discharge Date: 7/7/2021 Primary Discharge Diagnosis 1-Postpartum day #2 post vaginal delivery 39 weeks gestation of pregnancy 2-Postpartum hemorrhage Secondary Discharge Diagnosis 1-Iron deficiency anemia 2-Asymptomatic COVID-19 positive test Hospital Course PT is a 19-year-old G1P0 at 39w4d admitted on labor. Patient was GBS negative. Patient completed COVI-19 vaccine schedule and tested positive on admission to the unit. No evidence of respiratory symptoms during hospital stay. Following unit policy isolation measures were placed. Patient had spontaneous vaginal delivery of viable female infant. Labor course was uncomplicated. However, persistent bleeding was noted after delivery. Fundal tone was adequate following active management of the 3rd stage with oxytocin and then use of misoprostol 1000 mcg were given following delivery of the placenta. Due to the persistence of bleeding examination was remarkable for bilateral sulcal laceration with brisk bleeding that were controled with repair (suture). Total blood loss during delivery: 1400 ml. Postpartum course in the hospital was uncomplicated. Her hemoglobin at the time of discharge was 9.6 g/dL and she was discharged with ferrous sulfate 325 mg p.o. twice daily. Patient was stable for discharge to home with appropriate follow-up.
19 2021-07-12 fainting, hypotension Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension... Read more
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe
19 2021-07-13 palpitations, fast heart rate 1. My period, which I got on April 20th (18 days after dose 2), resulted in extreme and debilitating... Read more
1. My period, which I got on April 20th (18 days after dose 2), resulted in extreme and debilitating cramps, which are lasting to this day. They're so bad I can't get out of bed for the first two days of my period - then I have infrequent occasional pangs of pain on day 3, and I'm okay days 4 and 5. I have never had cramps during my cycle before April 2021. 2. On April 16th, I was driving my car and I noticed that when I had my foot on the the brake, it was shaking uncontrollably in almost every position I put my leg in. The frequency of this leg tremor during driving became more frequent, and I started noticing heightened anxiety, trouble focusing, weight loss of 7 pounds thus far (my weight has not fluctuated more then 3 pounds in the last 4 years so this was a surprise to me), lightened period, increased heat intolerance, heart palpitations that keep me awake at night and tachychardia, muscle weakness, and fatigue. I had a really stressful semester in school so I chalked these symptoms up to anxiety. Then, in the first week of June, I went to the gynecologist to get the cramps situation checked out. She told me she wanted me to check out my thyroid for the rest of the symptoms. When my blood test came back, my Thyroid Stimulating Hormone (TSH) result came back as 0.03 (lowest acceptable range is 0.4). My primary care provider ran T3 and T4 tests, which came back as 15 and 5, respectively - which are both quite elevated for their range. So, I went to an endocrinologist at my primary care provider's referral, who ran more tests. This time, they found TSH to be 0.006 (got lower), T3 and T4 were elevated, very slightly lower than they were before. My endocrinologist then ran a test for Thyroglobulin antibody, which came back as 53.3, when the highest reference value was 0.9. Thus, my endocrinologist determined hyperthyroidism, but wanted to figure out the what I had so she sent me for a thyroid uptake scan. In the scan, they found my thyroid to be working at 51%, when the highest value after 24 hours of receiving the radioactive iodine was 33%, and my endocrinologist determined that I had Graves' Disease, an autoimmune hyperthyroid disease. I am now on Methimazole and Propranolol for Graves' Disease. I don't know if the vaccine caused my horrendously painful cramps and the onset of the autoimmune disease, but I just wanted the CDC to know! I am curious to know if there is a correlation. Please let me know if you have any questions.
19 2021-07-13 palpitations Pronounced weight loss began within two weeks of the first dose. Patient lost 30 pounds in 3 months.... Read more
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.
19 2021-07-13 lightheadedness, chest discomfort Pt is a 19 y/o F who suddenly endorsed feeling dizzy, hot, short of breathe, and peri-oral itchiness... Read more
Pt is a 19 y/o F who suddenly endorsed feeling dizzy, hot, short of breathe, and peri-oral itchiness ~ 10min after receiving first dose of Pfizer vaccine (done at 1357). PMHx pertinent for hx of anaphylaxis to bee stings, currently being treated with allergy shots, last injections given 12JUL21. Pt was immediately evaluated, with initial VS done at 1415 with BP 110/70, SPO2 99%, HR of 94, RR >20. Endorse chest tightness. Lungs CTA B/L, pt noted to be diaphoretic. Patient had a near syncopal episode and was placed in supine position and given an epi-pen 0.3mg at 1418. EMS was called. Repeat VS at 1420 found BP of 115/60, SpO2 100%, HR 100, RR >20. Lungs still CTA b/l. Patient endorsed improved SOB and less peri-oral itching. Chest tightness improved, Pt was AOX3. EMS arrived at 1435, pt stable. Transferred pt to EMS.
19 2021-07-13 lightheadedness, heart rate increased shakiness; increased heart rate; horrible headache; i have almost passed out multiple times; slurred... Read more
shakiness; increased heart rate; horrible headache; i have almost passed out multiple times; slurred speech; This is a spontaneous report from a contactable other HCP. A 19-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EL3247) via an unspecified route of administration, administered in arm left on 04Mar2021 at 11:00 for COVID-19 immunisation. The patient medical history not reported. The patient concomitant medications included alprazolam (XANAX), ascorbic acid, beta vulgaris root, iron amino acid chelate, rosa canina fruit, rubus idaeus leaf (IRON SUPPLEMENT). The patient historical vaccine included first dose on 09Feb2021 at 07:00 PM (lot number: EL3241) as 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 4 weeks prior to the COVID vaccine. The patient received birth control, xanax, iron supplement medications within 2 weeks of vaccination. On 04Mar2021 at 11:00 AM, the patient experienced the same reaction that get anemic, shakiness, increased heart rate, horrible headache and patient had almost passed out multiple times, had slurred speech. These happened directing after the vaccine. No treatment was received. The outcome of the event was resolving. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
19 2021-07-17 chest discomfort PT USUALLY HAS A SWOLLEN ARM AT THE INJECTION SITE WHEN SHE DOES GET INJECTIONS. AND HER MOM SAID SH... Read more
PT USUALLY HAS A SWOLLEN ARM AT THE INJECTION SITE WHEN SHE DOES GET INJECTIONS. AND HER MOM SAID SHE GETS ANXIETY KINDA FEELING WHEN SHE GETS INJECTIONS BC OF THAT. WAS TOLD AFTER THE SHOT THAT INFO. PT INITIALLY EXPERIENCED , WHILE CRYING VERY LITTLE SHORTNESS OF BREATH. BUT WHEN SHE PUT HER MASKED DOWN, SHE FELT A LOT BETTER. SHE THEN FELT A LITTLE DIZZY THEN AFTER PUTTING HER AGAINST THE WALL AND RAISING HER LEGS , FELT BETTER AND DIZZINESS WAS GOING AWAY. AFTER 5 MINUTES, SHE FELT SLIGHT CHEST TIGHTNESS. KEPT MONITORING HER. CALLED THE AMBULANCE.. THEY CAME AFTER 1O MINUTES..
19 2021-07-20 excessive bleeding I have a horrible sinus infection; Painful sore throat (puss in throat red it's gross); Painful sore... Read more
I have a horrible sinus infection; Painful sore throat (puss in throat red it's gross); Painful sore throat (puss in throat red it's gross); This is a spontaneous report from a contactable consumer (patient) reported for herself. A 19-year-old female patient received bnt162b2 (PFIZER BIONTIC COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 02Jul2021 at 10:30AM (at age of 19-year-old) (Batch/Lot number was not reported) as single dose for covid-19 immunisation. There was no medical history, no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ethinylestradiol / norgestrel (ELINEST). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of bnt162b2 on 02Jun2021 at 10:30AM (at age of 19-year-old) for covid-19 immunisation. The patient had been dealing with a painful sore throat (puss in throat red it's gross) and she had a horrible sinus infection on 05Jul2021 at 01:15 PM. No treatment was received for the event. The outcome of the events was not recovered. Since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch cannot be obtained.
19 2021-07-20 fainting Patient was given her first covid 19 shot of pfizer. She was told to sit for 15 minutes after the s... Read more
Patient was given her first covid 19 shot of pfizer. She was told to sit for 15 minutes after the shot which she did. After her 15 minutes of post shot she stood up not feeling well and fell to the floor feeling dizzy and fainting. She rested on the floor for a few minutes then in a chair for at least an hour until somebody could take her home.
19 2021-07-25 fainting Patient fainted 5 minutes after receiving the vaccine. Laid down with her legs up. She drank a bot... Read more
Patient fainted 5 minutes after receiving the vaccine. Laid down with her legs up. She drank a bottle of water and felt better.
19 2021-07-25 fainting Admitted to hospital after syncopal episode and diagnosis of covid
19 2021-07-27 ischemic chest pain Experiencing Myocarditis symptoms. sharp pains on back shoulder blade when leaning back, or to sid... Read more
Experiencing Myocarditis symptoms. sharp pains on back shoulder blade when leaning back, or to side. pain in heart region in chest area. Relief from pain when crouching forward.
19 2021-07-27 fainting Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed ... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild
19 2021-07-28 chest pain Aching chest pain and headache
19 2021-07-28 pallor After receiving a 1st dose of Pfizer vaccine, patient fell to the ground within a minute. A pharmaci... Read more
After receiving a 1st dose of Pfizer vaccine, patient fell to the ground within a minute. A pharmacist rushed back to check her heart rate and consciousness. She was quickly alert and breathing normal. She did not recall what happened. Her face was still pale and she felt dizzy. 911 was called. After 5 minutes, she had new seizure episode last for 10 seconds then stopped. 911 came and checked her blood pressure, heart rate and oxygen level. They were all normal. Patient was advised to see doctor for follow up. Her mother took her to seek medical care.
20 2021-01-04 haemoglobin decreased Following you vaccination nausea, dizziness, and migraine. These persisted, and still happen occasi... Read more
Following you vaccination nausea, dizziness, and migraine. These persisted, and still happen occasionally. Started once a day and now is every few days.
20 2021-01-06 chest discomfort, chest pain, fast heart rate 15 minutes after inoculation she developed obvious cutaneous flushing, pruritus, and hives with no o... Read more
15 minutes after inoculation she developed obvious cutaneous flushing, pruritus, and hives with no other symptoms. She was initially given 50mg diphenhydramine PO. Approximately 45 minutes later she reported chest pain and her vital signs were checked and she was tachycardia at 102 BPM. Her BP was 128/74. EMS was activated and she was given 0.3mg of epinephrine IM after which her flushing and pruritus immediately resolved. She described continued mild chest tightness but over stated that she felt much better.
20 2021-01-06 chest pain I woke up with sever stomach pain and nausea. I could not lay down or else it would hurt worse. By t... Read more
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.
20 2021-01-06 heart rate increased Stayed fir Observation for 15 minutes then left. 25 minutes after injection, developed rash and swe... Read more
Stayed fir Observation for 15 minutes then left. 25 minutes after injection, developed rash and swelling on arm, chest, face with rapid heart rate and shallow/rapid breathing. Called number on vaccine sheet and was sent to ER but was turned away due to over crowding (COVID) and told to go to PCP, which was two hours away. Went to urgent care instead and was immediately treated with steroids and antihistamine.
20 2021-01-07 palpitations palpitations; 3 days straight skin rash with itching on her left leg; muscle soreness on arm of inje... Read more
palpitations; 3 days straight skin rash with itching on her left leg; muscle soreness on arm of injection site; muscle soreness on arm of injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 20-year-old female patient received the first dose of bnt162b2 (Covid 19 vaccine, brand: Pfizer) via an unspecified route of administration in right arm on 31Dec2020 10:00 at a single dose for COVID-19 immunization in a hospital. Medical history included GERD and Strep throat, both from unknown dates. Concomitant medication included benzylpenicillin (PENICILLIN). The patient did not receive other vaccine in four weeks. The patient experienced palpitations - 3 days straight skin rash with itching on her left leg, muscle soreness on arm of injection site, all on 31Dec2020 11:00. The events were reported as non-serious. The patient did not receive treatment for the events. The patient had not recovered from the events. Information on the lot number/Batch number was requested.
20 2021-01-10 chest discomfort Shot was given at 11:45 am. Patient started to feel numb both arms. Tingling of left arm and left ha... Read more
Shot was given at 11:45 am. Patient started to feel numb both arms. Tingling of left arm and left hand, tingling chest and both legs within 10 min of shot. She saw black/white spots at 12:45pm. Called EMT and they took her to the hospital.
20 2021-01-11 heart rate increased dizziness; Nausea; fast heart rate; This is a spontaneous report from a contactable other healthcare... Read more
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.
20 2021-01-13 chest discomfort EE reports, started to be nauseous overnight, 1/12 into 1/13. 1/13 10 am, chest heaviness, SOB, an... Read more
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
20 2021-01-15 heart rate increased, chest pain I feel pain on my left arm, and my chest and I feel like my heart is going to pump out. Sometimes I ... Read more
I feel pain on my left arm, and my chest and I feel like my heart is going to pump out. Sometimes I feel the heartbeats on my hand and neck, and this cause me headache.
20 2021-01-16 chest discomfort Symptoms: hives, chest tightness, felt dizzy Blood pressure taken at 2:05 p.m.- 150/110, 50 mg Ben... Read more
Symptoms: hives, chest tightness, felt dizzy Blood pressure taken at 2:05 p.m.- 150/110, 50 mg Benadryl administered BP recheck at 2:10p.m.- 140/90 Symptom improvement at 2:20p.m. Patient remaining in observation for about 30 additional minutes, symptoms subsided, had boyfriend drive her home
20 2021-01-18 fainting Syncopal episodes 2-4x daily Hot flashes 2-3x daily
20 2021-01-18 fast heart rate After receiving second dose on 1/16 I experienced a fever of 102 F, headache, and tachycardia. I too... Read more
After receiving second dose on 1/16 I experienced a fever of 102 F, headache, and tachycardia. I took acetaminophen after 12 hours of symptoms and every 6 hours after that for 24 hours and the symptoms have not returned.
20 2021-01-19 chest pain HEADACHE, SHORTNESS OF BREATH, CHEST PAIN
20 2021-01-26 chest discomfort Chills; chest tightness; minor fatigue; joint and muscle pain throughout the body (injection site in... Read more
Chills; chest tightness; minor fatigue; joint and muscle pain throughout the body (injection site in upper left arm; shoulder; back; ankles). Injection site soreness began immediately after the vaccine, but is normal for me. Everything else began at time listed on this form (1/25/2021 afternoon) and ended by the following morning. I took one Tylenol to help with the chills and pain about 5 hours after symptoms started and it seemed to help a little.
20 2021-01-28 fast heart rate Tachycardia and sensation in throat 15-30 minutes after vaccination. HR-140 BP-180/120 HR went back... Read more
Tachycardia and sensation in throat 15-30 minutes after vaccination. HR-140 BP-180/120 HR went back down to 115 and BP 136/67. Received Solu Medrol for reaction. Advised not to received 2nd dose per CDC guidelines.
20 2021-02-01 loss of consciousness Approximately 30 second after injection patient reported feeling nauseated and then passed out. Pati... Read more
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.
20 2021-02-04 chest pain, chest discomfort Arm was sore; Chest feels tight and very ache; Chest feels tight and very ache; Terrible headache; T... Read more
Arm was sore; Chest feels tight and very ache; Chest feels tight and very ache; Terrible headache; This is a spontaneous report from a contactable consumer, the patient. This 20 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1 , single dose via an unspecified route of administration in the right arm on 21Jan2021 at 09:15 AM (at the age of 20 years-old) for COVID-19 vaccination. There was no relevant medical history reported. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included sertraline and buspirone. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 21Jan2021, the patient did a workout and "my arm was sore." About 4 hours after the injection "my chest feels tight" and very ache and had a terrible headache. The events, arm was sore, chest feels tight and very ache and headache were reported as non-serious. There was no treatment received for the events. The clinical outcome of arm was sore, chest feels tight and very ache and headache was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
20 2021-02-05 chest pain 15 min after vaccine, pt started complaining of chest pain and shortness of breath. EMS called and t... Read more
15 min after vaccine, pt started complaining of chest pain and shortness of breath. EMS called and transferred to local hospital
20 2021-02-07 chest discomfort Client developed chest tightness and pain after vaccination. Vital signs normal, and lungs clear to... Read more
Client developed chest tightness and pain after vaccination. Vital signs normal, and lungs clear to auscultation. No other local or systemic allergic type signs or symptoms noted. Client appeared anxious and admitted to same. Responding well to reassurance. She normally takes hydroxyzine PRN for anxiety, and we offered diphenhydramine which she accepted (50mg po x 1). Feeling improved prior to discharge, this is NOT suspected to be a severe adverse reaction to the vaccine (suspect panic/anxiety).
20 2021-02-08 fast heart rate Rash covering face, neck, and chest. Also had tachycardia. Treated with Benadryl and a steroid inje... Read more
Rash covering face, neck, and chest. Also had tachycardia. Treated with Benadryl and a steroid injection 30-45 after reaction
20 2021-02-11 heart rate increased This patient was given the COVD vaccine and then had an adverse reaction. She experienced a racing h... Read more
This patient was given the COVD vaccine and then had an adverse reaction. She experienced a racing heartbeat, couldn't feel her tongue, and she had difficulty breathing. One of the pharmacists who was monitoring the patient administered an epi-pen and after 20 minutes or so the patients symptoms subsided.
20 2021-02-13 fainting Severe hot flashes Syncope episodes
20 2021-02-15 chest discomfort I sat down in the observation area and went home. I was fine until the 2nd day. I was sore, couldn't... Read more
I sat down in the observation area and went home. I was fine until the 2nd day. I was sore, couldn't move, super heavy chest and felt like my body was shutting down. Went to ER and was told that it was possibly the vaccine since I had COVID in August. I went home, got rest and took Tylenol as directed. After 2 or 3 days, I felt better.
20 2021-02-15 fainting, loss of consciousness Pt. fainted roughly 30 seconds after vaccine administration - had some jerky motions in chair, but d... Read more
Pt. fainted roughly 30 seconds after vaccine administration - had some jerky motions in chair, but did not fall. Pt. loss of consciousness less 2 minutes.
20 2021-02-25 cardiac arrest Guillian Barre Syndrome with asystole for 20 seconds
20 2021-02-25 chest discomfort, chest discomfort, fast heart rate, fast heart rate Patient reported symptoms of: tachycardia, shakiness, vision changes, tongue numbness and shortness ... Read more
Patient reported symptoms of: tachycardia, shakiness, vision changes, tongue numbness and shortness of breath following the first dose of the COVID19 Pfizer-BioNTech Vaccine on 2/5/2021. Patient said that historically has experienced tachycardia and shakiness after getting a flu shot or booster a few years ago. Symptoms reported by patient were enough to suspect potential anaphylaxis, and patient consented pharmacist to administer epinephrine. Patient was then advised by the pharmacist to follow-up with her primary care doctor as soon as possible to report the incident and to discuss the risk versus benefit of the vaccine, whether recieving the second dose would be appropriate for her. Patient returned to assisted living facility for her second dose of the COVID19 Pfizer-BioNTech vaccine on 2/26/2021. Patient said that she discussed the incident with her doctor, was told it would be appropriate to get the second dose despite her reaction and was advised to take "cautious measures". Pharmacist reviewed the patient information and screening questions, discussed the potential side effects and reiterated her risk of experiencing the same reaction with the second dose. Patient stated that she decided on getting the second dose because "her boyfriend is high risk and I'm doing this for him". Patient stated that she decided on getting the second dose because "her boyfriend is high risk and I'm doing this for him". Pharmacist asked patient if she had any questions/concerns or additional information to add prior to getting her vaccine, and patient denied having any at that time. After administering her second dose, pharmacist instructed patient to stay in the observation area for at least 30 minutes and to ask the staff for water given her experience with the first dose. Patient asked pharmacist how common it was for someone to get a reaction from the vaccine, and then mentioned that her family memeber had to drive her to the emergency room after her first dose becuase her throat was "burning", and was told that her throat was "a little swollen" and recieved a second dose of epinephrine at the emergency room. Patient included this information after the fact her second dose was already administered. Approximately 5 minutes after receving her vaccine, the patient reported similar symptoms that she experienced on 2/5/2021: tachycardia, vision changes, shortness of breath and chest tightness. After monitoring patient with no resolvement of her symptoms, patient was then given a dose of epinephrine by the pharmacist, and the paramedics were called in to assess patient and take her to the emergency room.
20 2021-02-25 hypertension, heart rate increased anaphylaxis; high blood pressure; elevated heart rate; her throat felt funny, like it was getting ti... Read more
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.
20 2021-03-01 heart rate irregular barely able to stand; swollen lymph nodes; irregular heartbeat; severe upper back and neck pain; sev... Read more
barely able to stand; swollen lymph nodes; irregular heartbeat; severe upper back and neck pain; severe upper back and neck pain; She has barely been able to move for several weeks; dizzy; vertigo; headache; This is a spontaneous report from a contactable consumer, the patient's parent. A 20-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 on 25Jan2021 at 10:30 AM (at the age of 20-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included allergy to eggs. Historical vaccination included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ), via an unspecified route of administration on 04Jan2021 at 10:30 AM (at the age of 20-years-old) in the left arm for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The vaccine was administered in a hospital. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The reporter explained that the patient's adverse events "started as expected" with a headache side effect (date not specified), however two days after the vaccine, while working as an EMT the patient became very dizzy and had to stop work. She remained dizzy, like vertigo, the next day but attempted to go to work. Her co-worker could see she wasn't right and took her to the hospital. The patient spent two days in the hospital, barely able to stand, getting a head MRI with contrast, evaluated for vertigo, blood tests, and they did not find anything and gave her vertigo medicine and sent her home. She has since had shifting symptoms, swollen lymph nodes, irregular heartbeat, severe upper back and neck pain. She has barely been able to move for several weeks and has seen an ENT doctor, another emergency doctor, and her regular doctor. None have found any other cause and have tried treating her with steroids. The events were treated with Meklazine and unspecified steroids. Lab data included SARS-CoV-2 test COVID 19 testing on 28Jan2021 which was negative. The clinical outcomes of headache, dizziness, vertigo, difficulty standing, swollen glands, irregular heart rate, back pain, neck pain and unable to more for several weeks were reported as not recovered. The patient was tested for COIVD-19 after the vaccination, on 28Jan2021, and was found to be negative.
20 2021-03-01 fainting My arm was numb after the shot and i began to feel faint a few minutes after, my ears were ringing a... Read more
My arm was numb after the shot and i began to feel faint a few minutes after, my ears were ringing and thought i was going to pass out. I became very flushed and sweaty and my bangs were tingling
20 2021-03-03 chest discomfort After receiving first mRNA Covid vaccine, patient experienced flushing, headache, chest tightness, s... Read more
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.
20 2021-03-03 lightheadedness Vasovagal reaction.
20 2021-03-03 fainting Fainted within five minutes of receiving and sitting after the vaccine. Experienced a complex migrai... Read more
Fainted within five minutes of receiving and sitting after the vaccine. Experienced a complex migraine with aura for the entire day after, no relief until having slept through the night.
20 2021-03-04 skin turning blue Pfizer-BioNTech COVID- 19 Vaccine EUA: During the post-vaccination observation period, vaccine recip... Read more
Pfizer-BioNTech COVID- 19 Vaccine EUA: During the post-vaccination observation period, vaccine recipient experience an allergic reaction. They developed throat closing, angioedema, and perioral cyanosis. They were treated by EMS on site with epinephrine, diphenhydramine, methylprednisolone, ondansetron, and normal saline fluids. They were transported to emergency department. During reexamination, the patient?s symptoms improved and they were discharged to home.
20 2021-03-05 chest discomfort Patient stated after vaccination that she has difficulty swallowing, "lump in throat," chest tightne... Read more
Patient stated after vaccination that she has difficulty swallowing, "lump in throat," chest tightness, and dizziness. Vitals stable. MD at bedside. An RN gave Benadryl 50mg IM. Patient no longer having chest tightness or feeling of lump in throat.
20 2021-03-06 fainting Fainted x 10 seconds. Given juice, vitals stable. History of fainting during medical procedures.
20 2021-03-07 loss of consciousness, fainting Pt states after receiving the vaccine she started feeling faint. Pt fainted and fell from a standing... Read more
Pt states after receiving the vaccine she started feeling faint. Pt fainted and fell from a standing position. Pt was unconscious for approx. 30 seconds. Pt was seated in a wheelchair and moved to the observation area. Pt denies any head, neck, or back pain. Pt states she is feeling better and would like to leave. Pt didn't require transport to the hospital.
20 2021-03-08 chest discomfort 15 minutes post injection, pt. c/o "rash & tightness in chest". Evaluated by APN & assisted by POD ... Read more
15 minutes post injection, pt. c/o "rash & tightness in chest". Evaluated by APN & assisted by POD supervisor RN & assistant pod supervisor RN. Vital signs at 10:52am: 120/80 blood pressure taken manually, heart rate 79 bpm with no irregularity. Benadryl 100 mg administered IM in right VL by APN at 10:56am. Within 15 minutes, patient reported symptoms resolved & rash observed to be improving. Pt. called family member to drive her home. Pt. instructed to call 911 immediately for any worsening of symptoms or difficulty in breathing.
20 2021-03-10 ejection fraction decreased, fast heart rate, hypotension, chest pain, troponin increased 20 yo female with recent hospitalization for myocarditis. Pt initially Dx with Covid 19 on 31 Dec 20... Read more
20 yo female with recent hospitalization for myocarditis. Pt initially Dx with Covid 19 on 31 Dec 2020 and received Pfizer COVID Vaccines on 19 and 09 Feb. Pt reports on 21 Feb developing fevers of 107 and stomach upset, by 25 Feb she developed chest pain, SOB, weakness, continued fevers and diarrhea. She was seen at ER on 25 Feb where she was tachycardic, hypotensive, and hyponatremic with an elevate lactate. She was transferred to another hospital and found to have a Troponin of 0.629. she was admitted from 25 Feb to 04 March. During that time she had an ECHO with an EF of 35-45% with global hypokinesis and peak BNP of 1389. Pt is currently felling well with no chest pain or shortness of breath.
20 2021-03-13 chest discomfort Chest heavy, throat swelling. Evaluated by EMS-Refusal to transport.
20 2021-03-13 chest discomfort chest heavy, throat swelling. Evaluated by EMS- Transported to Emergency room/department or urgent c... Read more
chest heavy, throat swelling. Evaluated by EMS- Transported to Emergency room/department or urgent care.
20 2021-03-16 loss of consciousness, pallor Vaccine was administered. Within approximately 1 to 2 minutes after administration patient got very ... Read more
Vaccine was administered. Within approximately 1 to 2 minutes after administration patient got very clammy, lost color in her face and passed out while sitting in the chair. Patient regained consciousness within a matter of seconds. Patient remained seated and was observed for another 30 minutes before she was allowed to leave facility. Patient did state that she has a history of fainting with vaccinations.
20 2021-03-17 chest discomfort Patient reports to clinic with vaccine related illness. Patient received the 2nd Pfizer COVID Vacci... Read more
Patient reports to clinic with vaccine related illness. Patient received the 2nd Pfizer COVID Vaccine on 3/14/21. She reports having developed symptoms on 3/15/21 including fever, chills, headache, myalgia, chest tightness, runny nose, and productive cough. She reports coughing up purulent sputum. She reports having congestion and ear pain for 2 weeks prior to receiving vaccination, related to seasonal allergies. She denies sick contacts and has not been taking any OTC medications at this point. Vaccine Reaction Patient presents with: body aches, fever and fatigue Presenting symptoms: cough, fatigue, fever, headaches, myalgias, rhinorrhea, shortness of breath and sore throat Severity: Moderate Onset quality: Gradual Duration of current symptoms: 2 days Timing: Gradually worsening Chronicity: New Treatments tried: Rest Worsened by: Activity Response to treatment: Mild improvement Associated symptoms: arthralgias, chills and nasal congestion Associated symptoms: no abdominal pain, no chest pain, no decreased appetite, no dizziness, no ear pain, no neck stiffness and no lethargy Zika exposure risk: None Covid-19 Vaccine #1 Date: 1/21/2021 Covid-19 Vaccine #2 Date: 3/14/2021 Vaccine Manufacturer: Moderna Covid-19 Administration Site: Left Arm Patient prescribed: Bromfed, Ventolin, Flonase,Doxyxyline, and encouraged to take Tylenol and rest. She was educated on when to go to the ER if worse.
20 2021-03-17 heart rate increased, loss of consciousness Patient felt flushed after vaccine, then started to have increased heart rate and dizziness. patient... Read more
Patient felt flushed after vaccine, then started to have increased heart rate and dizziness. patient passed out for an estimate of 15-20 seconds. Patient was sweating. Patient came to and started to feel better. Gave water, after a few minutes patient denied shortness of breath, dizziness, or racing heart. Had patient walk hallways and denied any symptoms after and during walk. No dizziness. Patient did not fall and was assisted to chair by RN before patient passed out for 15-20 seconds.
20 2021-03-18 lightheadedness Delayed vasovagal response with possible seizure. 911 called and arrived minutes later. Pt was sit... Read more
Delayed vasovagal response with possible seizure. 911 called and arrived minutes later. Pt was sitting in chair and was lowered to the floor when she slumped and started to have a seizure. As soon as she was on the floor she snapped awake. She was disoriented for a moment but was aware. After a few minutes she sat back down in chair and her blood pressure was taken. it was 139/81 with HR of about 79. The fire department came in at this point. Eventually, the fire dept released her as she was with her mother.
20 2021-03-20 pallor Patient received the Pfizer Vaccine around 4:00 PM. Patient proceeded to sit at the observation ar... Read more
Patient received the Pfizer Vaccine around 4:00 PM. Patient proceeded to sit at the observation area for monitoring then patient flagged down staff with c/o dizziness, blurred vision, hearing loss, slight pallor noted. Patient was noted sitting at the observation area with LVN next to her side. Patient was offered to lay down. Ice pack was placed on the back of patients neck, patient ate a candy bar, Nurse encouraged fluids. VS were taken and noted to be stable. Patient was monitored for 30 mins before departure. Patient stated having needle anxiety in the past. Nurse instructed patient and patient mother on signs, Symptoms of Severe Adverse Reactions to report to health care provider or to go to the emergency room. Patient/Family verbalized understanding.
20 2021-03-21 heart rate increased, chest pain I had an extremely high heart rate. BPM was 118-156 for about three hours. For three days after that... Read more
I had an extremely high heart rate. BPM was 118-156 for about three hours. For three days after that, I had severe chest pain and a burning sensation in my chest.
20 2021-03-22 fainting Syncope
20 2021-03-22 fainting Syncope - 15 seconds, person sates always faints-scared of needles
20 2021-03-23 fainting, loss of consciousness Patient lost consciousness for a minute while waiting in the pharmacy after her vaccination. She sli... Read more
Patient lost consciousness for a minute while waiting in the pharmacy after her vaccination. She slid down from the chair she was sitting on and recovered consciousness soon after laying down on the floor. She mentioned she was dizzy but otherwise alright. No signs of allergy, had cold hands. Symptoms indicated syncope but witnesses mentioned they saw her having a small seizure, where she threw her hands and head back before sliding down. 911 was called, they checked her and walked her to her car and let her go with a friend.
20 2021-03-24 pallor Pt recieved vaccination, in monitoring area felt faint Pale/ diaphoretic, lowered to floor with feet... Read more
Pt recieved vaccination, in monitoring area felt faint Pale/ diaphoretic, lowered to floor with feet up Vitals: 1105 HR 48, 109/66 (laying) 1108 HR 67, 113/72 1110 HR 69, 128/89 (sitting on floor) 1113 HR 73, 134/80 1117 HR 72, 110/70 (sitting in chair) 1124 HR 58, 120/78 Heart regular, rate and rhythm on auscultation Eating and drinking, conversing easily Ambulated independently, mother to drive home
20 2021-03-24 fast heart rate, chest pain chest pain; tachycardia; cold sweats; shakes; This is a spontaneous report from a contactable other ... Read more
chest pain; tachycardia; cold sweats; shakes; This is a spontaneous report from a contactable other health professional. A 20-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on an unspecified date (at the age of 20-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (Batch/Lot number was not reported) administered in arm left on an unspecified date for COVID-19 immunisation. The patient ended up in the hospital with chest pain, tachycardia, shakes and cold sweats, 5 hours after receiving second dose. The patient underwent lab tests and procedures which included SARS-COV-2 test: unknown results on an unspecified date. The outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of chest pain, tachycardia, shakes and cold sweats due to temporal relationship. Case will be re-assessed upon the additional information provided. 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.
20 2021-03-25 pallor Pt in observation area, felt lightheaded Pale/ diaphoretic Laid to floor with feet elevated, cool r... Read more
Pt in observation area, felt lightheaded Pale/ diaphoretic Laid to floor with feet elevated, cool rag to forehead Vitals: 104/58, HR 58, 99% (laying on floor) 1345 Pt states feeling much better Vitals: 101/68, HR 84, 99% SpO2 1350 Pt sitting on floor, eating granola bar and drinking water Vitals: 110/72, HR 79, 99% 1400 Pt sitting up in chair, states feeling well BP 107/75, HR 91, 98%
20 2021-03-25 fainting About 2 or 3 hours after dose 1 got on legs and arms. NO SOB angioedema, faintness, cardiac sx, N o... Read more
About 2 or 3 hours after dose 1 got on legs and arms. NO SOB angioedema, faintness, cardiac sx, N or V. Supervisor called EMS and she was taken to the ER, diagnosed with hives and give an antihistamine only. Did well though some hives lasted for 4 days. After much discussion decided on dose 2. Told to return if any hives or sx. and to check in around 5 pm. When she did had a hivey area covering most of posterior L lower leg. (flat red rash) None elsewhere. Is itchy. No SOB, etc. Lungs clear Pulse about 76. Give Benadryl at 5 pm and less itchy by 6 pm. Plan : Observe at POD until mother picks her up. If any other symptoms will call 911. Take Benadryl every 4 to 6 hours today and switch to a non-sedating antihistamine such as loratadine tomorrow when she works.
20 2021-03-26 heart rate decreased One minute after receiving her vaccination, she started feeling itchy nose and her throat, then subs... Read more
One minute after receiving her vaccination, she started feeling itchy nose and her throat, then subsequently started feeling swelling in her town. Evaluation by physician so no swelling of the tongue. Her lungs were clear auscultation bilaterally. Her heart rate initially was in the 130s. She was taken to a private section of the arena and monitored. Her heart rate gradually decrease to the 110s. She remains normotensive. One minute after receiving her vaccination, she started feeling itchyness in her throat, then subsequently started feeling swelling in her tongue. Evaluation by a physician showed no swelling of the tongue. Her lungs were clear auscultation bilaterally. Her heart rate initially was in the 130s. She was taken to a private section of the arena and monitored. Her heart rate gradually decrease to the 110s, then to normocardia. She remains normal tensive. Prior to monitoring, she already taken a 50 mg dose of oral diphenhydramine (which she brought herself). Recommended she switch to J&J vaccination instead of getting the 2nd dose of Pfizer.
20 2021-03-26 hypertension Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Rash (specif... Read more
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Hypertension-Medium
20 2021-03-27 fainting Patient received her Pfizer vaccine around 12:13pm. While sitting in the observation area she report... Read more
Patient received her Pfizer vaccine around 12:13pm. While sitting in the observation area she reports dizziness within 10 minutes of receiving her vaccine. She denied SOB, itching, nausea and pain. No swelling or erythema at the injection site. As the patient walked with EMS over to the stretcher, she had a syncopal episode. EMS was able to help her to the stretcher without falling to the floor. Her symptoms lasted only a few minutes. Her vital signs were all within normal range. She was given water and rested for about 30 minutes and symptoms resolved.
20 2021-03-27 fainting immediately felt dizziness and syncope, observed for 30 minutes and recovered, no issues
20 2021-03-28 hypotension Patient was feeling nervous after receiving vaccine. Patient said she didnot want EMS, just needed t... Read more
Patient was feeling nervous after receiving vaccine. Patient said she didnot want EMS, just needed to sit down. Patient blood pressure is dangerously low and might need some fluids. patient refused and said she was fine. Patient signed refusal form and walked away.
20 2021-03-29 pallor Pt felt faint, diaphoretic/ pale 1645: BP 110/72, HR 60, O2 95% Laid to floor, feet up, cool rag to ... Read more
Pt felt faint, diaphoretic/ pale 1645: BP 110/72, HR 60, O2 95% Laid to floor, feet up, cool rag to head 1655 125/78, HR 91, O2 99% 1700 Up to sitting against wall: 119/97, HR 97, O2 97% 1710 Up to sitting in chair 134/81, HR 83, O2 97% Pt eating nuts, drinking water, no distress
20 2021-03-29 fainting Roughly 12 hours after I recieved my second dose of the vaccine (around 11:00 PM on 3/26) I started ... Read more
Roughly 12 hours after I recieved my second dose of the vaccine (around 11:00 PM on 3/26) I started to develop a fever, headache, and chills. These symptoms lasted throughout the night into the morning. In the morning on Saturday (3/27), and for most of the day I felt fatigued and slightly nauseous. At 5:00 PM that night, I was walking in the hall of my residence when I experienced a syncopal episode, which has never happened to me before. I fainted several times and my roommate brought me to the ER. Other than low BP, my EKG and other vitals looked fine, and the doctor sent me home with the conclusion it was likley related to the vaccine. The next day, Sunday 3/28, I felt naseua and dizziness all day.
20 2021-03-30 hypotension Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemi... Read more
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: WAS CLOSE TO FAINTING BUT DID NOT.-Mild, Systemic: Hypotension-Severe, Systemic: Shakiness-Severe, Additional Details: COMPLAINED OF DIZZINESS, VISION DISTURBANCES. STORE CALLED EMS BUT BY THE TIME THEY GOT TO STORE THE PATIENT WAS ALERT AND RESPONSIVE. PATIENT ALSO COMPLAINED OF THURST AND WE GAVE HER WATER TO DRINK. THEY DID A FULL WORKUP ON HER BUT DID NOT TRANSPORT HER TO HOSPITAL. SHE LEFT WITH HER MOTHER , EVENT LASTED ABOUT 45 MINUTES .
20 2021-03-30 fainting fainted two times; felt very tired after the vaccine for several days; This is a spontaneous report ... Read more
fainted two times; felt very tired after the vaccine for several days; 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) via an unspecified route of administration, administered in left arm on 07Mar2021 11:45 (Lot Number: EN6206) as single dose for Covid-19 immunisation at age 20 years old. Medical history included allergies to penicillin. The patient is not pregnant. The patient had no covid prior to vaccination. There were no concomitant medications. The patient did not receive other vaccine in four weeks and no other medications in two weeks. The patient previously received amoxicillin and experienced allergies. The patient reported that she felt very tired after the vaccine for several days. Four days after she received the vaccine, she took a bath and when she got out of the bath, she fainted two times. She stated that she has never fainted before and she has taken several baths. Onset of the events was on 11Mar2021 21:00. No treatment given for the events. The patient had a covid test (saliva) post vaccination on 15Mar2021 with negative result. The patient recovered from the events.
20 2021-03-31 lightheadedness, pallor Patient's family called staff approximately 10 minutes after vaccine administration due to her becom... Read more
Patient's family called staff approximately 10 minutes after vaccine administration due to her becoming pale and feeling lightheaded. EMS was called to the scene and the patient was evaluated after having a near syncopal episode just prior to their arrival. EMS stayed on scene for approximately 30 minutes and evaluated the patient in the ambulance. Staff was advised that the patient ended up feeling better after evaluation and refused care from EMS, leaving with her family. No further information was obtained.
20 2021-03-31 fainting Patient received vaccine and experienced syncope shortly after causing her to fall. 911 was called a... Read more
Patient received vaccine and experienced syncope shortly after causing her to fall. 911 was called and patient was taken to the emergency room.
20 2021-03-31 fainting Systemic: Fainting / Unresponsive-Medium
20 2021-04-01 fainting Individual fainted while walking to the medical area. Patient was brought by wheelchair to medical a... Read more
Individual fainted while walking to the medical area. Patient was brought by wheelchair to medical area. Loss of consciousness was approximately 1 minute. Patient laid on cot, vital signs all within normal limits. Patient recovered quickly and signed off on further medical assistance.
20 2021-04-01 fainting Patient received 1st dose of Pfizer COVID vaccine. Upon administration, patient reported she felt as... Read more
Patient received 1st dose of Pfizer COVID vaccine. Upon administration, patient reported she felt as though she was having an anxiety attack. She then fainted and started falling forward in her chair. The pharmacist and technician caught the patient as she fell forward and as they were leaning her back in the chair she began seizing in their arms for approximately 5-10 seconds (no more than 20-30 seconds). At this point, the patient spoke and stated that was weird and said she felt lethargic. Another technician was on the phone with 911 at this time. We gave her a bottle of water and kept the patient seated in the immunization room until EMS arrived. She was complaining of being very hot and lethargic. EMS arrived and checked her vitals and recommended the patient go with them to the hospital due to B/P and pulse being very low (exact vitals were not communicated to us). She agreed to go to the hospital and we will be following up with the patient tomorrow.
20 2021-04-02 pallor, cardio-respiratory arrest 20 y/o female, s/p 1st vaccine. C/o blurred vision, pale, diaphoretic. Code green called by clinic ... Read more
20 y/o female, s/p 1st vaccine. C/o blurred vision, pale, diaphoretic. Code green called by clinic staff, med consult, and medic with patient, laid down onto cot. Cold water bottle applied to neck, ice to head by staff. Speech clear, he of allergies to MMR per mother. Symptoms resolving, pt signed out AMA with medic. Cleared by med consult Dr to go home. Requested pt to remain on site for additional 15 minutes. Head of cot raised, eating Cliff Bar and drinking Gatorade. C/o feeling tired. Escorted to car via wheelchair with mother. Denies any symptoms.
20 2021-04-04 loss of consciousness, fainting Patient appeared to faint. She said everything became black and then she came to. She apparently pas... Read more
Patient appeared to faint. She said everything became black and then she came to. She apparently passed out but recovered extremely quickly. This occurred within 5 minutes of receiving the immunization. We provided her orange juice and observed her for another 20 minutes.
20 2021-04-06 loss of consciousness Patient complained of feeling dizzy and possibly passing out. Patient diaphoretic with brief moment ... Read more
Patient complained of feeling dizzy and possibly passing out. Patient diaphoretic with brief moment of loss of consciousness and the woke on her own. Patient alert and oriented. BP 104/70, HR 71, O2 sat 98%. Patient assess by physician.
20 2021-04-06 fainting Syncope.
20 2021-04-06 blood clot experiencing passing a ton of clots; I washed my face, it got extremely red; This is a spontaneous r... Read more
experiencing passing a ton of clots; I washed my face, it got extremely red; 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 not reported) at the age of 20-year-old, via an unspecified route of administration, administered in the left arm on 19Jan2021 13:00 as single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included lupus and idiopathic thrombocytopenic purpura (ITP). Concomitant medications included mycophenolate mofetil (CELLCEPT), esomeprazole magnesium (NEXIUM), medroxyprogesterone acetate (DEPOPROVERA), and propranolol; all taken for an unspecified indication, start and stop date were not reported. The patient has known allergies to rituximab and amoxicillin. As a woman, the patient was having a lot of blood clots being passed. The patient doesn't get a period because of depo, but for some reason, she was experiencing passing a ton of clots on an unspecified date. Also, after the first dose, when she washed her face, it got extremely red on an unspecified date in 2021 (She did the same in the days before and that didn't happen). The patient underwent lab tests and procedures which included Covid test: negative on an unspecified date. The outcome of the events was unknown. No treatment was received for the events. The patient received the second dose of BNT162B2 on 11Feb2021 for COVID-19 immunisation administered at the left arm. Information on the lot/batch number has been requested.
20 2021-04-07 loss of consciousness Immediately after the vaccine was injected, I felt like I got slugged in the arm. I also had a momen... Read more
Immediately after the vaccine was injected, I felt like I got slugged in the arm. I also had a momentary hot flash. Then, I went to go sit in the waiting area, and I continued to get warmer and warmer. After 5 minutes, I went up to the front desk, and told them I didn?t feel well and that I felt like I was overheating. They put me in a wheelchair, and I immediately passed out and hallucinated for a minute or two. I felt incredibly weak, and I had sweat completely through my shirt. A paramedic came and put me in a stretcher in a cornered off area of the clinic. After 30 minutes or so, I started feeling better, but I got several spirts of cold flashes. All of my vitals came back normal.
20 2021-04-08 chest pain Pt. states she received her vaccination on 04/06/2021. She states she was experience soreness at the... Read more
Pt. states she received her vaccination on 04/06/2021. She states she was experience soreness at the vaccination site and fatigue for 2 days. Today she is experiencing chest pain on inspiration and was unsure if this could be related to the vaccine. Advised patient to go to urgent care/ED or contact primary care physician
20 2021-04-08 loss of consciousness, fainting Patient was sitting down for about 10 minutes after receiving 1st dose of COVID vaccine. She stood u... Read more
Patient was sitting down for about 10 minutes after receiving 1st dose of COVID vaccine. She stood up to ask for some water and a few seconds later she fainted. She was on the floor for a few seconds unconscious but then quickly regained consciousness. We called 911 to get an ambulance to arrive. EMT's tended to her and checked her vitals upon arriving. Patient was able to leave on her own power and have a friend take her home.
20 2021-04-08 palpitations, heart rate increased Fast heart rate/feeling like I was going to pass out; dizzy/heart palpitating/skin sensitivity (my s... Read more
Fast heart rate/feeling like I was going to pass out; dizzy/heart palpitating/skin sensitivity (my skin would easy become flushed) I received the shot on Wednesday morning, was tired for the rest of the day (normal) and mentally I was healthy/happy. Thursday morning, I started to feel extremely sluggish and I struggled to catch my breath. 1-10 (10 being severe) I would rank this at a 5. Friday morning is when I really felt like an 8 and my listed symptoms weighed me down. I would define these symptoms as episodes. Each episode would last a couple of minutes and I would return to my normal state. I felt an 8 till the following Sunday/ Monday. Tuesday, felt a little better.
20 2021-04-08 fainting Gave patient the vaccine approximately 9:50am. Shortly after giving the vaccine, patient fainted in ... Read more
Gave patient the vaccine approximately 9:50am. Shortly after giving the vaccine, patient fainted in her chair. Patient said she was fine, however, she fainted afterward again. We did get the patient to lie down on the floor while we call 911. EMS responders arrived and assessed her, patient did refuse to go to the hospital. We did monitor her for 45 minutes before she left our facility with her friend.
20 2021-04-10 heart rate increased At 5 PM the day after vaccination, began to experience aches and chills which progressively worsened... Read more
At 5 PM the day after vaccination, began to experience aches and chills which progressively worsened until around 1 AM, then subsided. Headache began around 8 PM and lasted until 6 AM; took one tablet of ibuprofen at 5 AM. Other symptoms included fast heart rate, minor pain at injection site, and head feeling ?cloudy? or ?stuffy?.
20 2021-04-10 fainting Otherwise healthy 20 yo female presented to observation area after her first vaccine dose. Within fi... Read more
Otherwise healthy 20 yo female presented to observation area after her first vaccine dose. Within first 5 mins while seated, talking on phone to Mom he then fainted, falling on floor. Fall witnessed, witnesses deny patient hitting head. Patient immediately regained consciousness, and appeared to be shaking. Placed in WC, while in med eval tent vitals: P 88, R16, BP 120/75, Glucose via fingerstick glucometer is 98. Patient alert, oriented. drinking apple juice. Patient admits to history of fainting after procedures such as injections. Advised her to inform healthcare personnel before vaccines or blood draws. Denies Chest pain, SOB, nausea, or pain anywhere. Denies visual changes. Patient felt well enough at 12:45, stood and walked without difficulty. Departed with friend without incident, who drove her back to dorm.
20 2021-04-11 loss of consciousness, lightheadedness, fainting After the vaccine the patient fainted in the vaccine waiting area roughly 5 minutes after the vaccin... Read more
After the vaccine the patient fainted in the vaccine waiting area roughly 5 minutes after the vaccine. The patient was unconcious for rougly 10 seconds then woke up. The patient had no other symptoms or concerns. When fainting the pharmacist on duty was beside the patient and helped them to the floor to put them in the recovery position and ensure their head did not hit the ground. After recovering the patient was attended to by EMTs who were suspecting a vasovagal reaction.
20 2021-04-11 loss of consciousness, fainting Pt has a history of fainting. Pt felt faint. Pt fainted and was unconscious for 15-20 seconds. Pt is... Read more
Pt has a history of fainting. Pt felt faint. Pt fainted and was unconscious for 15-20 seconds. Pt is CAOx3. Pts vitals are stable. Pt didn?t require transport to hospital.
20 2021-04-11 pallor, lightheadedness Vasovagal reaction, pale, did not faint, but very light headed. Threw up.
20 2021-04-12 fainting Patient fainted a few minutes after receiving the vaccine. She was fine after a couple minutes and d... Read more
Patient fainted a few minutes after receiving the vaccine. She was fine after a couple minutes and declined to have ambulance
20 2021-04-13 chest discomfort, chest pain, fainting Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Severe, Syste... Read more
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Mild, Additional Details: Pt stated that she was nervous that she would \"pass out from vaccine\", recommended she stay 30 min instead of 15 min for monitoring. Has hx of anxiety d/o & panic attacks (3x/month). Stated she felt dizzy after getting vaccine and she contributed it to that. Gave 12oz OJ, 1 protein pack (nuts & chocolate berries) and water. Only had ramen noodle soup today & was dehydrated. Checked in after 30 minutes, felt fine and was back to normal.
20 2021-04-13 lightheadedness PATIENT COMPLAINS OF NAUSEA AND VOMITING. PATIENT HAD VAGAL EPISODE AND HIT PARKED CARS IN PARKING L... Read more
PATIENT COMPLAINS OF NAUSEA AND VOMITING. PATIENT HAD VAGAL EPISODE AND HIT PARKED CARS IN PARKING LOT. PATIENT TRANSPORTED BY AMBULANCE TO HOSPITAL FOR FURTHER TREATMENT.
20 2021-04-13 fainting The patient felt dizzy when after the vaccine was administered and then fainted. The patient was gi... Read more
The patient felt dizzy when after the vaccine was administered and then fainted. The patient was given crackers and juice and recovered on their own.
20 2021-04-13 fainting While waiting in line she felt faint and collapsed - pt's brother grabbed her and lowered her to the... Read more
While waiting in line she felt faint and collapsed - pt's brother grabbed her and lowered her to the floor. Placed pt with feet up gave water. Allowed to rest. Pt stated she felt fine (21 minutes later) - walked out with her brother. BP 118/69, HR 71, RR 16 Temp 97.8, O2 100% -- > 117/71; HR 66; RR 16
20 2021-04-13 fast heart rate, fainting, hypotension Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia-Mild, Additional Details: Patient refused Benadryl, was monitored for 30 minutes. Patient felt dizzy and faint, we monitored, gave water, an ice pack. Patient's symptoms resolved after 30 minutes.
20 2021-04-14 hypotension, fainting Patient her first dose of the vaccine and 15 minutes after vaccination she fainted for a few minute... Read more
Patient her first dose of the vaccine and 15 minutes after vaccination she fainted for a few minutes. She was responsive, but had a low blood pressure of 90/70. She was observed over a period, her blood pressure up to normal. She was counseled on signs and symptoms to watch out for and if so seek medical attention.
20 2021-04-15 heart rate increased, chest discomfort Major dizziness, tightness of the chest, diarrhea, difficulty breathing, rapid heart beat, the sympt... Read more
Major dizziness, tightness of the chest, diarrhea, difficulty breathing, rapid heart beat, the symptoms began to show after the vaccination in 4 hours. At first, it was only pain in the arm where the injection occurred. Now, there is also swelling of the arm when the injection occurred.
20 2021-04-15 hypotension, platelet count decreased, low blood platelet count This patient was admitted to the Hospital ICU on 4/8/2021 after developing rigors, chills, hypotensi... Read more
This patient was admitted to the Hospital ICU on 4/8/2021 after developing rigors, chills, hypotension and a fever to 105 F after getting her second dose of Pfizer vaccine on 4/7/2021. She also was noted to have a platelet count of 12 that responded to IVIG and she was diagnosed with Immmune Thrombocytopenia.
20 2021-04-15 palpitations heart palpitations, anxiety.
20 2021-04-16 heart rate increased, blood pressure increased After I was administered the vaccine at the University, after spending a few minutes I began to feel... Read more
After I was administered the vaccine at the University, after spending a few minutes I began to feel a sensation in my throat as if it were swelling, scratching and when I swallowed I did not feel it. Every time the minutes passed I felt it more. After the 15 minutes passed, I notified him and a paramedic gave me all the vital signs which had an elevated blood pressure and an elevated pulse. They took me to the ambulance where I was under supervision. I continued with the sensation of throat and dizziness. I took the medicine that the doctor had prescribed: benadryl and prednisone in case of having an allergic reaction. I continued with the symptoms and my mother was watching me in case of having difficulty breathing and when I got home I got a little nauseous. Present tiredness and pain in the area that disappeared on Sunday. From Sunday until today I have presented insomnia since it is difficult for me to sleep and I manage to sleep a few hours.
20 2021-04-16 fainting Patient got first COVID vaccine at 9:49 AM. Pt. started having syncope reaction two to three minute... Read more
Patient got first COVID vaccine at 9:49 AM. Pt. started having syncope reaction two to three minutes after getting the injection. Pt was found in a chair on the floor, at 9:52. Pt, was found COAx3 and had a patent and self-maintained airway. Pt. was transferred to the back via a wheelchair where she laid down. Vitals were obtained with a HR of 83 BP of 115/74, RR of 14. Pt stated that she felt fine after laying down. Pt, waited in the back for fifteen minutes where her vitals remained stable. After fifteen minutes Pt, walked without any obvious difficulties to observation one where she waited for another 15 minutes. Pt went home after fifteen minutes in observation one and walked out without any further incident and without any obvious difficulties.
20 2021-04-17 fainting, loss of consciousness fainted/blacked out; fainted/blacked out; Fell on floor; Tired; achey all day; Face hurt and swellin... Read more
fainted/blacked out; fainted/blacked out; Fell on floor; Tired; achey all day; Face hurt and swelling from fall; Face hurt and swelling from fall; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient (age at vaccination: 20 years) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand: Pfizer, lot: EP7533) in left arm on 31Mar2021 12:15 at a single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was a Clinic. Medical history was none. Known allergies was no. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There are no other medications the patient received within 2 weeks of vaccination. Patient experienced fainted/blacked out, fell on floor, tired and achey all day (Face hurt and swelling from fall), all on 01Apr2021 06:30 AM with outcome of recovering. No treatment was received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on Lot/Batch number was available. Additional information has been requested.
20 2021-04-18 chest pain, inflammation of the pericardium pericarditis; Chest pain; This is a spontaneous report from a non-contactable physician. A 20-year-o... Read more
pericarditis; Chest pain; This is a spontaneous report from a non-contactable physician. A 20-year-old female patient received second dose of BNT162B2 (Batch/Lot number and expiry date was not reported), via an unspecified route of administration on 31Mar2021 as a single dose for COVID-19 immunization. Medical history included generalised anxiety from an unknown date. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 10Mar2021 for COVID-19 immunization. On 01Apr2021, the patient experienced pericarditis and chest pain. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal swab and PCR: both negative on an unknown date. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of pericarditis and chest pain which included High Dose NSAIDs. The outcome of the events was unknown. The events were assessed as serious which caused hospitalization. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The events pericarditis and chest pain are most likely intercurrent conditions and unrelated to suspect vaccine 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.
20 2021-04-18 fainting Brief fainting episode. Flushing/sweating. Given water. BPs 97/59 (pulse 62), 108/61 (pulse 72). 100... Read more
Brief fainting episode. Flushing/sweating. Given water. BPs 97/59 (pulse 62), 108/61 (pulse 72). 100% O2 sat.
20 2021-04-19 lightheadedness patient c/o shortness of breath and dizziness. Started at 2:05PM, Dr. was notified and evaluated pat... Read more
patient c/o shortness of breath and dizziness. Started at 2:05PM, Dr. was notified and evaluated patient Vitals: 100/72mm hg Pulse: 82 SPo2: 98% DX: Vasovagal syncope Monitored patient symptoms for 30 minutes patient was stable and was release home
20 2021-04-19 fainting Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient was fainted and was unresponsive. EMS was called. Father stated this was a known issue. It was more of a phobia.
20 2021-04-20 chest discomfort Chest tightness, sweating
20 2021-04-20 hypotension, fainting received vaccine while seated, fainted within approximately 30 seconds. Provider lowered her head, w... Read more
received vaccine while seated, fainted within approximately 30 seconds. Provider lowered her head, when no responsiveness after approximately 30-60 seconds, called 911. regained consciousness within approximately 60-90 seconds. She was alert and responsive when EMS arrived. Was taken by ambulance to hospital due to low blood pressure and persistent dizziness.
20 2021-04-20 loss of consciousness, hypotension Patient passed out for a few moments a few minutes after getting the vaccine. Patient fell and bit t... Read more
Patient passed out for a few moments a few minutes after getting the vaccine. Patient fell and bit their lip and had some bleeding from lip. Afterwards patient felt better, had some hypotension when standing from sitting position. Paramedics evaluated the patient. She will see the doctor out of caution, although was feeling better after the incident.
20 2021-04-20 palpitations, arrhythmia, nosebleed EXTREME heart palpitations about 9 hours after vaccine, nose bleeding. Heart palpitations continue d... Read more
EXTREME heart palpitations about 9 hours after vaccine, nose bleeding. Heart palpitations continue daily, abnormal EKG at doctors office weeks later when I had ZERO heart problems ever. Diagnosed with an arrhythmia.
20 2021-04-20 fainting Patient fainted and hit her head on floor of gym. All vital signs are normal. She has anxiety and be... Read more
Patient fainted and hit her head on floor of gym. All vital signs are normal. She has anxiety and bee allergies. Patient fainted for 30 seconds
20 2021-04-20 blood clot small clot behind my left knee; left foot had swollen; This is a spontaneous report from a contactab... Read more
small clot behind my left knee; left foot had swollen; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received BNT162B2 (lot number: ER2613) first dose on 20Mar2021 10:15 on left arm at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. Patient is not pregnant. No other vaccine in four weeks. No Covid prior vaccination, No known allergies. She took the vaccine around 10:00am and around 6:00pm (also reported as 06:30 PM) she noticed that her left foot had swollen. She consulted with her general physician and he requested that patient did an Ultra Sound exam of her left leg. The result of the exam reported a small clot behind her left knee. Therefore, doctor suggested that she reported these events to Pfizer so an evaluation is made to identify if similar events have occurred with other patients. She was concerned if she should take the second shot on 17Apr2021. AE resulted in Doctor or other healthcare professional office/clinic visit. Patient received Eliquis 5mg (two times daily) as treatment. Patient had Nasal Swab on 01Apr2021 and tested negative. The outcome of the events was not recovered.
20 2021-04-21 oxygen saturation decreased, fainting Patient had vasovagal episode manifested with shaking and numbness of the upper and lower extremitie... Read more
Patient had vasovagal episode manifested with shaking and numbness of the upper and lower extremities, skin is warm to touch and flush. Nursing Intervention: Elevate legs on dashboard, apply cold compress on nape, give cold water to drink, V/S taken O2 Sat is 98%, Pulse is 105. Informed patient on what is happening and keep her calm. Continue monitoring. After 30 minutes patient complain of increase shaking and numbness, she said no sensation in all upper and lower digitalis and did stand up to feel her legs and feet. After a while she said she feel dizzy so I sat her inside the car and elevate her legs on dashboard then she complain of SOB. Take her V/S O2 Sat is 89 Pulse is 109. After 5 minutes take her O2 Sat again and its 85 Pulse is 110. Report to my site lead about the V/S and we Administer 8L/min of oxygen. I massage her hand and arms, stay with her. After 5 minutes her O2 Sat went up to 99%, pulse is 93.give her drink and snack. Observe her for another 10minutes, V/S is stable but her shaking and numbness still there. As they leave I advised them to go to the ER if symptoms did not stop or worsen.
20 2021-04-22 blood pressure decreased, pallor 20 yr old Female patient received first dose Pfizer covid19 vaccine in left arm administered by phar... Read more
20 yr old Female patient received first dose Pfizer covid19 vaccine in left arm administered by pharmacy intern at 3:27pm . supervising pharmacist was (Name) pharmD. Prior to patient receiving the covid19 vaccine pharmD reviewed and went over all the DUR and digital patient questionnaire questions. Mother of patient was present and mentioned that in the patient's past , the patient had fainted after receiving a vaccine. PharmD told patient that because this occurred in the past, the patient will have to wait 30 minutes after vaccine administration for observation. Patient was sitting in post-vaccination area, and about 3 minutes later patient's father notified staff , that patient felt dizzy and looked pale and had blurry vision and patient was sweating. PharmD asked the patient if she had any difficulty breathing and if she felt itchy or had any rash as a result of the vaccine reaction. We immediately called the pharmacy and notified (Name) of the situation. The patient refused us to contact 911 and refused 911 care. The pharmacy manager immediately arrived to the Clinic fitting room area. Upon arrival, the pharmacy manager provided alcohol swabs to patient to inhale because at that moment we did not have ammonia inhalants. PharmD quickly made his way to the pharmacy to obtain the ammonia inhalants , which is a respiratory stimulant. The pharmD returned to the Covid19 clinic with ammonia inhalants, which were never used, because we did not see the need. Patient remained conscious the entire incident. We decided not to use epinephrine. The pharmD measured the patient's blood pressure at 3:38pm . bp reading was 109/65. Pharmacy manager took pt temperature at 3:45pm, reading was 97F. Pharmacy manager retook blood pressure at 4pm. bp reading was 93/63, pulse of 72. The pharmacy manager advised the patient to seek medical attention if patient continues to get worse. bp was lower the second reading. The pharmacy manager asked patient a second time at 4pm if patient wanted us to call 911 again, and again patient refused us to contact 911.
20 2021-04-22 loss of consciousness Woke up about 12hrs after vaccine and felt incredibly nauseous and had chills. I was walking downsta... Read more
Woke up about 12hrs after vaccine and felt incredibly nauseous and had chills. I was walking downstairs to take Tylenol and I felt like I was going to pass out. Luckily I sat down and then proceeded to pass out, although I am not sure what really happened. My mom found me about 10 seconds later confirming I wasn?t out for that long, but she was slapping my face and talking to me and I was unaware. She reported that my eyes were open. When I came to I was having cold sweats, I was clammy, and my ears were ringing. I was very scared and I don?t know what happened to me. I felt like I was dreaming when I woke up, but once my Tylenol kicked in I felt better. But it still was a very strange out of body experience.
20 2021-04-23 loss of consciousness Pfizer covid vaccine was administered to patient at around 2:10pm and was advised to stay in sight f... Read more
Pfizer covid vaccine was administered to patient at around 2:10pm and was advised to stay in sight for 15 min before leaving the store. At around 2:15pm patient started to faint. Patient was accompanied by her mother. Rph on duty rushed to the scene noticed that patient had lost consciousness and started to have a seizure. I also noticed that the patient had passed urine while unconscious. I notified my technician to call 911. I quickly grabbed an EpiPen and administered one dose into the patient thigh. I assisted the patient along with her mother until the patient regained consciousness. Paramedic arrived to the seen few mins later. They checked all vital signs and patient was responding better and but still exhibiting some tingling effect in her hands. Patient decided not to ride with the paramedics. I advised her to stay for another 30 - 45 min so that I could monitor her. She was feeling much better and was released to go home along with a EpiPen.
20 2021-04-23 fast heart rate On 04-21-2021, my muscles started to feel fatigued and I had chills. I woke up on 04/22/2021 at 5 am... Read more
On 04-21-2021, my muscles started to feel fatigued and I had chills. I woke up on 04/22/2021 at 5 am throwing up. I was throwing up all morning, having diarrhea, blurred vision, extreme fatigue, dizziness, shortness of breath, and tachycardia (160.)
20 2021-04-24 hypotension patient felt light headed thought she would pass out. SHe laid on floor with feet up. BP did get low... Read more
patient felt light headed thought she would pass out. SHe laid on floor with feet up. BP did get low but improved after laying down. SHe never acutally lost conciousness
20 2021-04-24 fainting syncopal episode; dry mouth; chills; nausea; This is a spontaneous report from a non-contactable oth... Read more
syncopal episode; dry mouth; chills; nausea; This is a spontaneous report from a non-contactable other health professional (patient). A 20-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on 12Jan2021 12:00 (Batch/Lot number was not reported), second dose on 02Feb2021 14:30 (Batch/Lot number was not reported), both via an unspecified route of administration administered in left arm, at 20-year-old female (not pregnant at the time of vaccination) at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No allergies to medications, food, or other products. The patient was not patient diagnosed with COVID-19 prior to vaccination. The patient experienced dry mouth, syncopal episode, chills, nausea on an unspecified date. The events did not result in emergency room visit or physician office visit. No treatment was received for the events. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on an unspecified date. The outcome of the events was recovered on an unspecified date. No follow-up attempts are possible, information about batch/lot number cannot be obtained.; Sender's Comments: Based on the current limited available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be totally excluded/assessed. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate
20 2021-04-25 fibrin d dimer increased, chest pain, fast heart rate Had Chest pains (thought lungs) went to urgent care, urgent care sent to Medical Center. Had Pulse o... Read more
Had Chest pains (thought lungs) went to urgent care, urgent care sent to Medical Center. Had Pulse of 168 thought drugs but too screen was all need. Told them had Covid shot 3 days before, said anxiety ended up admitting to hospital with tachycardia. Elevated D dimmer and WBC. They said I had anxiety, heart rate didn't go down after anxiety drugs x2. Ran lots of tests and sent home the rolling day with no answers and a pulse still around 100. Release from hospital at 5 pm last vitals were taken at 12pm with pulse of 96.
20 2021-04-25 hypertension, fast heart rate, low blood oxigenation Patient with PMH significant for asthma, allergies to shellfish and peanuts, presents to ED for eval... Read more
Patient with PMH significant for asthma, allergies to shellfish and peanuts, presents to ED for evaluation of difficulty breathing. Mother reports the patient had been wheezing for the past week, and gradually worsened. Per mother, prior to arrival patient could not breath and having increased respiratory distress. Just prior to arrival the patient became unresponsive. The patient was tachycardic, tachypneic, hypertensive and hypoxic. The patient was emergently intubated and placed on mechanical ventilation. Per the patient's mother. The patient received her first dose of COVID vaccine the day before arrival to the ED. Diagnosis: Acute Respiratory Failure; Acute Asthma Exacerbation verses Allergic Reaction.
20 2021-04-26 heart rate decreased, loss of consciousness, pallor Hx of vasovagal syncope prior to vaccinatons. MD was called to evaluate a patient who had fallen. Ra... Read more
Hx of vasovagal syncope prior to vaccinatons. MD was called to evaluate a patient who had fallen. Ran to patient and found her laying on floor with staff members around her. MD was told she received her vaccination, then laid down on a bench and rolled off the bench when she passed out. bench was about 2 feet tall. When MD assessed patient, she was laying on ground, awake, slightly pale, clammy with faint but palpable pulses on my exam. She was awake and alert. able to answer MD's questions but felt dizzy and had a headache. She was able to track finger, follow commands. She was lifted into a wheelchair and moved to a cot. vitals were obtained which showed BP 122/70, pulse 72, o2 sat 100%, RR 18. EMS was called after her fall given c/f head injury. We were instructed to not give patient anything by mouth. Paramedics arrived at 0805. assessed patient. Obtained vitals. positive orthostatic vital signs with HR jump >20, SBP drop ~20. Given patient could not reliably stand without c/f repeat fall, patient was taken by ambulance for further evaluation at hospital.
20 2021-04-26 heart rate increased, chest discomfort 20 YO FEMALE WITH HX OF ANXIETY WHICH MANIFESTS WITH INCREASE HR P/W CHEST STIFFNESS, INCREASE HR, L... Read more
20 YO FEMALE WITH HX OF ANXIETY WHICH MANIFESTS WITH INCREASE HR P/W CHEST STIFFNESS, INCREASE HR, LUMP ON THE THROAT 2 MINS AFTER RECEIVING 1ST DOSE OF COVID VACCINE. HER LAST ANXIETY ATTACK WITH SIMILAR SYMPTOMS OCCURRED APPROX 1 YR AGO WHICH LASTED FOR HOURS AFTER FALLING ASLEEP. SYMPTOMS WERE SELF LIMITING WITHOUT MEDS. PT FELT IMPROVEMENTS UPON ARRIVING TO OBS 1 AREA. NO LONGER HAVING CHEST TIGHTNESS OR LUMP ON THE THROAT HOWEVER STILL WITH INCREASE HR. DENIES CHEST PAIN, SOB, DIZZINESS, SYNCOPE, RASH, HA, WEAKNESS, LIGHTHEADNESS, OR VERTIGO. VITALS: 1430 LAYING 143/83; 109; 98% 1437 1223/80, 97, 100%, RR 15 1504 SITTING 121/83; 103; 98% 1518 STANDING 124/84; 102; 99% HEART- RRR; NO MURMUR; LUNGS- CTA; NO WHEEZING; CN2-12 INTACT; 5/5 MOTOR BUE AND BLE; PT ABLE TO STAND AND AMBULATE WITHOUT ASSISTANCE. FEELS MUCH BETTER BUT CAN STILL FEEL INCREASE HR; PT AND MOM DID NOT WANT TO GO TO THE ED/URGENT CARE; STATES SHE FEELS BETTER AND ANTICPATES TO IMPROVE MORE AT HOME WIHT FURTHER REST. PT WAS ADVISED TO GO TO ED IF SYMPTOMS PERSISTS AT HOME OR WORSENS. ADVISED TO ALSO CALL PCP IMMEDIATELY FOR THEIR GUIDANCE. PT WALKED WITH HER MOM AND YOUNGER SISTER TO THE CAR WITH NO CONCERNS RELEASED TIME 1520
20 2021-04-26 loss of consciousness Breif LOC after vaccine, less than 5 seconds. Became alert and responsive. Assisted via wheelchair t... Read more
Breif LOC after vaccine, less than 5 seconds. Became alert and responsive. Assisted via wheelchair to cot. Vital signs taken, stable throughout. Taken to cot to rest, taking fluids, drank 8 ounces of water. Ambulated well, accompanied to door, verbalizes that she was fine. Color pink and alert.
20 2021-04-27 fainting NEAR SYNCOPE BP 120/81mmHg HR 64 bpm O2 SAT 99%
20 2021-04-28 excessive bleeding, blood clot after 3 years of not having her period, she suddenly started bleeding heavily and having menstrual c... Read more
after 3 years of not having her period, she suddenly started bleeding heavily and having menstrual cramps. The bleeding was very clotted and seemed somewhat abnormal; after 3 years of not having her period, she suddenly started bleeding heavily and having menstrual cramps. The bleeding was very clotted and seemed somewhat abnormal; after 3 years of not having her period, she suddenly started bleeding heavily and having menstrual cramps. The bleeding was very clotted and seemed somewhat abnormal; This is a spontaneous report from a non-contactable consumer. A 20-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 20 years). The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient stated that after 3 years of not having her period, she suddenly started bleeding heavily and having menstrual cramps. The bleeding was very clotted and seemed somewhat abnormal. The patient underwent lab tests and procedures which included nasal swab: negative on an unspecified date. The patient did not have COVID prior vaccination. The patient was not pregnant. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
20 2021-04-28 fainting 1/17/2021 - Fever (unknown temp) at 2AM 1/18/2021 - Fever, chills, emesis x2, syncope (unwitnessed) ... Read more
1/17/2021 - Fever (unknown temp) at 2AM 1/18/2021 - Fever, chills, emesis x2, syncope (unwitnessed) 1/18/2021 - Seen at ED - Pt c/o feeling sick for past 2 days after receiving 2nd dose Pfizer vaccine. C/o fever & chills shortly after vaccine. Vomited x2. Treatment in ED: ondansetron HCl/PF 4mg IV x1 dose; Sodium Chloride 0.9% (NS) bolus 1,000 mL IV
20 2021-04-28 fainting Syncope. BPs 96/60 (pulse 65), 98/62 (pulse 60). Dizziness.
20 2021-04-29 hypotension, pallor 20 yr old female here to receive her 2nd dose of COVID vaccine. She stated no reactions after 1st do... Read more
20 yr old female here to receive her 2nd dose of COVID vaccine. She stated no reactions after 1st dose. After receiving dose she went to sit in chair as instructed before leaving. Two minutes later RN was notified by pharmacy staff, pt not feeling well. On approaching, pt was very pale and resting her head on friends chest. RN asked if she was having trouble breathing, she stated "A little." 911 was called and an Epi pen was brought to scene. RN asked if pt wanted to lay down and assisted her to the floor, lifting her legs up on a chair. She was very weak and had urinated on herself. She stated she had not eaten anything today and only had a little water. She was given water but only had a small sip. RN stayed by her side while waiting for paramedics to arrive. Paramedics stated BP was low and took her to Medical Center.
20 2021-04-29 loss of consciousness Fever (100.1), nausea, vomiting, fainting (21 hours after vaccine), chills, headache, body ache, sor... Read more
Fever (100.1), nausea, vomiting, fainting (21 hours after vaccine), chills, headache, body ache, sore arm, light headed/dizzy. All symptoms discovered upon waking in morning 21 hours after vaccine. Fainted 15 minutes after waking, Treated with DayQuil and sleep, Symptom length of time unknown since ongoing and treated quickly.
20 2021-04-30 brain sinus blood clot Initially presented with a headache 3 days past vaccine, presented to hospital now found to have dur... Read more
Initially presented with a headache 3 days past vaccine, presented to hospital now found to have dural venous sinus thrombosis. Currently stable on anticoagulation drip.
20 2021-05-01 loss of consciousness Passed out at around 9:58 AM, woke up feeling extreme weakness, shortness of breath, fever, and cove... Read more
Passed out at around 9:58 AM, woke up feeling extreme weakness, shortness of breath, fever, and covered in sweat.
20 2021-05-02 loss of consciousness LOC from sitting position approx at 0858 lasting maybe 30 seconds. HX LOC. Possible head trauma with... Read more
LOC from sitting position approx at 0858 lasting maybe 30 seconds. HX LOC. Possible head trauma with fall. No notable bruising/deformities upon assessment. Patient a&ox4, patient denies thinners. EMS called and arrived 0915.
20 2021-05-02 loss of consciousness I woke up at 2 am feeling sick. As soon as I got out of bed I passed out. It took about 10 minutes f... Read more
I woke up at 2 am feeling sick. As soon as I got out of bed I passed out. It took about 10 minutes for me to become conscious again. I was shaking, hot and cold, slight fever and it sounded like I was underwater. Everything was spinning. I took Tylenol for body aches and keep the fever down. I was sweating a lot. I was better by noon that same day.
20 2021-05-02 pallor Nausea, ate snack and rank water. Patient had very small breakfast. Color returned to patient's face... Read more
Nausea, ate snack and rank water. Patient had very small breakfast. Color returned to patient's face/lips. Symptoms resolved, stable, relseased from vaccination site.
20 2021-05-02 pulmonary embolism The patient was presented to ER 4/27 with progressive swelling of R arm associated with shoulder pai... Read more
The patient was presented to ER 4/27 with progressive swelling of R arm associated with shoulder pain. Admitted to ER 4/27-4/29 admitted by the doctor for right subclavian vein thrombus, right axillary and right brachial vein thrombus and bilateral pleural blebs largest measuring 2.1cm with small pulmonary emboli within segmental artery to the right lung base posteriorly and within the segmental artery to the left lower lobe, right sided thoracic outlet syndrome She was on Heparin drip and started on Eliquis Discharged on Eliquis She was on Xulane patches for birth control and was taken off Xulane after finding the clots Also of note she received Pfizer vaccine 1 week prior to presenting to ER
20 2021-05-03 fainting, pallor, loss of consciousness During waiting period, pt experienced syncope. She lost consciousness for a few seconds and fell (di... Read more
During waiting period, pt experienced syncope. She lost consciousness for a few seconds and fell (did not get injured in fall). She came back too, was very pale and sweaty. We contacted 911 and they dispatched EMS but patient refused to be evaluated. We gave water to drink, layed her down flat with elevated legs and put cold washcloths on her forehead. After approx 30 minutes she was well and able to walk away.
20 2021-05-04 ejection fraction decreased Patient had a clinical illness consistent with MIS-C after the vaccine but also had confirmed COVID ... Read more
Patient had a clinical illness consistent with MIS-C after the vaccine but also had confirmed COVID infection. Hospitalized in ICU with high fever, rash, cardiomyopathy (myocarditis), renal failure requiring steroids and IVIG.
20 2021-05-04 loss of consciousness On 5/5/2021 @ 0915 pt, received the 1st dose of the Pfizer COVID vaccine Lot # EW0167 Expiring 5/9/2... Read more
On 5/5/2021 @ 0915 pt, received the 1st dose of the Pfizer COVID vaccine Lot # EW0167 Expiring 5/9/21. At 0920, pt was observed losing consciousness in the observation area. Per report from pt sitting behind her in the observation area "she hit her head on the floor when she fell." EMT (Name), EMT (Name), Lead Nurse (Name) and Co-lead Nurse (Name) present. 0923 VS- BP: 82/54, P:61, SpO2: 99% at room air. Pt alert and oriented x3 to person, place, and time. Pt complaining of feeling weak, dizzy and lightheaded. EMT (Name) elevated her legs to put her in Trendelenburg. Pt tolerated well. No signs or symptoms of closed head injury and pupils equal, round, and reactive to light accommodation. Pt shared that she had not eaten or drank since 5/4/2021 at around 5pm. Pt also shared that she "can't remember if I told the nurse but this happens sometimes when I give blood or get injections... this also randomly happened at a birthday party when I was about 16 years old." 0932- Pt sitting in zero gravity chair eating "goldfish" crackers and drinking water. Pt states she feels "better, but not great. The back of my head is a little bit sore" Pt was educated on when to seek emergency intervention, signs and symptoms of a closed head injury, and it was advised by Lead Nurse and Co-Lead Nurse that she follow up with her PCP today. Pt was also educated that since she has a history of fainting with needles that when she returns for her second dose that she advises her nurse of that so proper safety measures are taken. Pt verbalized 100% understanding. 0943- Vital signs BP 90/62, Pulse 70, Respirations 16, SpO2 100% at room air, pt calm and stable. Pt left the facility @ 0948 in a wheelchair for safety. Pt was with her boyfriend and boyfriend stated he would drive her home and take her to follow up with her MD later today.
20 2021-05-04 palpitations Patient here at clinic today for her 2nd covid vaccine. She denies having previous vaccine reaction... Read more
Patient here at clinic today for her 2nd covid vaccine. She denies having previous vaccine reaction. She arrived in Covid Vaccine observation room after having receiving her 2nd dose of Pfizer Vaccine ER6206 at 1501. She walked in with her father and was sitting for her 15 minutes. She had been in the room about 10 minutes when she became diaphoretic. Went to check on her and sent administrative help to find RN. At her side she denied having any numbness, tingling or swelling in her mouth at current time. Said that she felt like her heart was racing. And started shaking her right arm and leg at that time and was not able to control movement. She told me she does not have any drug allergies. I put blood pressure cuff and pulse ox on her. RN in room. BP at 1520 159/105 pulse 102 respirations 20, O2 100%. RN sent me to get a provider. She gave her Benadryl 25 mg and Pepcid 40 mg orally with water. Her father had to hold the cup and give her the medicine. She swallowed without difficulty. MD in room at her side asking questions. Admin person went to get patients mother. RN on the phone with 911. 1525 bp 149/100, pulse 106, respirations 32 and O2 100%. Father and mother stated she had 2 grand mal seizures at the ages of 5 & 7. She does not take any medication for seizures currently. And they told MD that she is under currently neurology care of a right hemisphere brain tumor. Upon assessment she told MD that the feeling on right to left side was different. She stated she was becoming numb completely on right side from face to her foot. She started slurring her speech. She was unable to squeeze with her right hand. 1532 bp 154/106, pulse 92, respirations 30 and O2 99%. MD, RN and myself at her side with parents. She said she did not want to go to the hospital but MD said she wanted her to go to be and examined and monitored. Parents agreed. Paramedics arrived at 1534. MD gave them overview of what had been going on and they took over her care at 1536. They did quick assessment and with slurred speech and not being able to hold right leg or arm up they decided to load her onto the stretcher. RN and I helped them move her to the stretcher and secure her in. They left with her at 1545 and said they were taking her to hospital.
20 2021-05-04 fainting Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium
20 2021-05-04 cardiac arrhythmia, arrhythmia Cardiac dysrhythmia development (Symptomatic PAC/PVCs); Cardiac dysrhythmia development (Symptomatic... Read more
Cardiac dysrhythmia development (Symptomatic PAC/PVCs); Cardiac dysrhythmia development (Symptomatic PAC/PVCs); Cardiac dysrhythmia development (Symptomatic PAC/PVCs); This is a spontaneous report from a contactable other HCP (healthcare professional/patient). A 20-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection) via an unspecified route of administration on 06Jan2021 at 12:00 (at the age of 20-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included known allergy to tree nuts from an unspecified date and unspecified if ongoing. Other medical history was reported as no. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications ("other medications in two weeks") were reported as no. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Jan2021 the patient experienced cardiac dysrhythmia development (Symptomatic PAC/PVCs). The event resulted in an Emergency Room visit and required treatment with a Holter monitor, echocardiogram and cardiologist. The clinical outcome of the event cardiac dysrhythmia development (Symptomatic PAC/PVCs) was recovering/resolving. Since the vaccination, the patient tested positive for COVID-19 via a nasal swab on 13Apr2021 (captured in AER: 2021456226). The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported cardiac dysrhythmia development (Symptomatic PAC/PVCs) and the use of BNT162B2 cannot be fully excluded. The case will be assessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.
20 2021-05-05 loss of consciousness Patient received her vaccine and almost immediately blacked out for 10-15 seconds. Patient regained ... Read more
Patient received her vaccine and almost immediately blacked out for 10-15 seconds. Patient regained consciousness and was initially unaware of surrounding. We supported the patient and she remained upright in her seat. She was given orange juice and instructed to relax and take deep breaths. After a few minutes she felt better and moved to the observation area. After 15 more minutes the patient was back to herself and left the clinic with her significant other.
20 2021-05-05 lightheadedness, hypotension Patient began feeling nauseous and lightheaded 5-10 mins post-vaccination and alerted pharmacy staff... Read more
Patient began feeling nauseous and lightheaded 5-10 mins post-vaccination and alerted pharmacy staff. Patient vomited shortly after. Pharmacist checked blood pressure which was very low at 60/45. RPh rechecked every 5 minutes getting readings of 67/48, 80/57, 108/82. EMS was called and by arrival BP had returned to normal. Likely due to vagal response, reaction to painful stimuli.
20 2021-05-07 chest pain onset of chest pain on April 30 with progressively worsening -dx with spontaneous pneumothorax
20 2021-05-07 loss of consciousness Pt received second dose Pfizer at site. Pt known PMHx of syncope. Pt was instructed to wait 15 min... Read more
Pt received second dose Pfizer at site. Pt known PMHx of syncope. Pt was instructed to wait 15 min in observation lot in case of adverse reaction. While attempting to drive to observation lot pt lost consciousness, slumped onto steering wheel and gas pedal, and lost control of vehicle per pt statement. Pt car came to a stop past the tree line on the NW side of the property with airbags deployed. Healthcare providers immediately responded and 911 was called. Pt was placed in C-Collar and instructed to remain stationary. Vitals were obtained; BP 138/88 (105), HR 102, SPO2 94% RA, FSBG 108. EMS arrived, pt family was notified, pt was transported to hospital via EMS.
20 2021-05-12 chest pain Dizziness, loss of vision, cold sweat, chest pain. Vital signs are taken, "Dextro" sample is perform... Read more
Dizziness, loss of vision, cold sweat, chest pain. Vital signs are taken, "Dextro" sample is performed. Everything is normal and after a few minutes sitting, she reports feeling good.
20 2021-05-12 fainting PATIENT WARNED ME THAT HE HAS A NEEDLE PHOBIA, I GAVE HIM THE VACCINE, HE TOLD ME THAT HE DID BETTER... Read more
PATIENT WARNED ME THAT HE HAS A NEEDLE PHOBIA, I GAVE HIM THE VACCINE, HE TOLD ME THAT HE DID BETTER THAN OTHER TIMES, HE STAYED SITTING ON THE CHAIR, THEN HE SAID THAT HE FEEL NAUSEATED AND WANTS COLD WATER, THEN HE FAINTED, I CALLED FOR HELP, HIS MOM WAS OUTSIDE THE CLINIC IN THE LOBBY, WE CALLED HER, WE ALSO CALLED 911. HE STARTED WAKING UP AFTER LIKE 5 MINUTES, 911 WERE HERE AND CHECKED HIM, HE WAS OK, ALL HIS VITAL SIGHNS WERE NORMAL, HE LEFT THE PHARMACY WALKING WITH HIS DAD AND MOM.
20 2021-05-14 loss of consciousness passed out/Loss of consciousness resulted in concussion; concussion; became dizzy; Was experiencing ... Read more
passed out/Loss of consciousness resulted in concussion; concussion; became dizzy; Was experiencing body aches; increased thirst following vaccination; This is a spontaneous report from a contactable physician for a patient. A 20-year-old female patient received second dose bnt162b2 (PFIZER COVID-19 VACCINE), intramuscular, administered in Arm Right on 28Apr2021 08:30 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. The patient previously received first dose bnt162b2 (PFIZER COVID-19 VACCINE), on an unknown date (Batch/Lot number was not reported) for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant at time of vaccination. Concomitant medications (received within 2 weeks of vaccination) included celecoxib (CELEXA), trazodone, oral contraceptive nos (reported as oral birth control) taken for an unspecified indication, start and stop date were not reported. The patient got up at 2am 29Apr2021 to use restroom, became dizzy and passed out. She was experiencing body aches and increased thirst following vaccination. Loss of consciousness resulted in concussion. The adverse events result in: Doctor or other healthcare professional office/clinic visit. The events did not result in death, cause/prolonged hospitalization, was not life threatening, disabling/incapacitating, congenital anomaly/birth defect. The patient was not diagnosed COVID-19 prior to vaccination. Since the vaccination, the patient had not the patient been tested for COVID-19. The patient did not receive treatment for the events. The outcome of the event was recovering. Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, the event Loss of consciousness is considered most likely associated with intercurrent or underlying medical conditions, appears unrelated to the suspect drug.
20 2021-05-14 loss of consciousness Patient became light headed after walking to the waiting area and passed out. Mom stated that this t... Read more
Patient became light headed after walking to the waiting area and passed out. Mom stated that this typically happens after receiving vaccines. She laid on the floor for 5 minutes prior to coming to an upright position.
20 2021-05-14 fainting fainted; very light-headed; This is a spontaneous report from a contactable consumer (patient). A 20... Read more
fainted; very light-headed; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0153) via an unspecified route of administration at left arm on 29Apr2021 10:45 (20-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included anxiety, ADHD, and allergies to amoxicillin. Concomitant medications in two weeks included amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL) and Vitamin D3. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0153) via an unspecified route of administration at left arm on 07Apr2021 10:30 (20-year-old at time of vaccination), at single dose, for COVID-19 immunization. There was no other vaccine in four weeks. The patient was very light-headed and fainted on 29Apr2021 15:45. Adverse events resulted in Emergency room/department or urgent care. Prior to vaccination, the was not patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the events and included "Ruled out heart issue, checked blood sugar level". The outcome of the events was unknown.
20 2021-05-19 blood pressure decreased, heart failure Patient received Pfizer vaccine at 1054am Reaction started at 1105am. Patient stated blurred vision... Read more
Patient received Pfizer vaccine at 1054am Reaction started at 1105am. Patient stated blurred vision, diaphoretic, salty mouth, and nauseous. RN requested help and patient was laid back down on the ground. Cold washclothe applied to neck and forehead. 12.5/5ml Diphenhydramine given oral solution After about 20 minutes, patient verbalized she felt better - she was brought inand iupright postion and seated in an chair w/o issue. Blood pressures taken at time of incident and through out monitoring - Vital unremarkable. Rn called patient mother , who was able to come to the clinic to pick up patient. At time of pick up patient started to feel additional reaction, CF team at medical facility called for additional intervention. FNP from CF team advised to get orthostatic BP and record. Ortho Static taken with a drop in BP from laying to standing. BP was as low as 50/30 P:66 O2: 98 on RA 911 activated as patient conitnued to have sudden decrease in BP. Patient went to the hospital via EMS. Patient parents and twin sister with patient. Admin notified - chart documented.
20 2021-05-20 chest discomfort Severe twitching and jerking of neck hands and head. And trouble breathing with chest tightness
20 2021-05-20 hypotension, fainting Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed ... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient noticed blurred vision prior to fainting. Was clammy and unresponsive. Patient came to quickly, but had another episode a few minutes later. No prior history with fainting after vaccinations.
20 2021-05-20 loss of consciousness, pallor Patient was in the waiting area for about 10 minutes then turned pale and passed out. They fell out ... Read more
Patient was in the waiting area for about 10 minutes then turned pale and passed out. They fell out of the chair they were in and hit their head on the floor. They regained consciousness within about 10 seconds. EMT was called and responded to help treat and advise the patient on the next steps.
20 2021-05-21 fainting Patient felt dizzy and we made the patient lie down on her back and elevated her feet. She fainted f... Read more
Patient felt dizzy and we made the patient lie down on her back and elevated her feet. She fainted for few seconds and was back to normal in couple of seconds.. we applied cold compress on her face, neck and wrist. Observed her more than 45 minutes
20 2021-05-23 chest pain, troponin increased Chest pain starting on 5/23, 4 days after receiving the vaccine
20 2021-05-23 fainting Patient fainted in the observation area after receiving vaccine. Patient was assessed by RN and refu... Read more
Patient fainted in the observation area after receiving vaccine. Patient was assessed by RN and refused EMS. Patient appeared flushed and diaphoretic. Patient was unaccompanied but waited for her mother to pick her up. Patient left in stable condition.
20 2021-05-24 chest discomfort, chest pain [Chest Pain ] This is a 20 year old female who received the 1st Pfizer dose on 5/17/21. On 5/21/21 ... Read more
[Chest Pain ] This is a 20 year old female who received the 1st Pfizer dose on 5/17/21. On 5/21/21 at 1723, the patient reported to our urgent care facility with a chief complaint of chest tightness (hurts when laying down), difficulty breathing, and nausea since the evening of 5/20/21. Given a recent Nexplanon insertion the day prior (5/20/21), the provider had a concern for possible PE so the patient was referred to the Emergency Department. The patient arrived at the ED and was seen by the provider on 5/22/21 at 0416. The patient continued to report chest discomfort as a heaviness, squeezing, ache. The pain was constant and worse upon taking a deep breath. Following a review of labs, EKG, Troponin, physical exam, the ED provider diagnoses 'chest wall pain' and the patient was discharged home with instructions to f/u as an outpatient for any ongoing symptoms. No additional chart documentation as of this report date (5/25/21).
20 2021-05-24 heart rate increased, blood pressure increased, lightheadedness Patient received first vaccine at 0910 on 25 May 2021. Patient began to have vagal related symptoms ... Read more
Patient received first vaccine at 0910 on 25 May 2021. Patient began to have vagal related symptoms within 30 seconds of administration. Patient was experiencing headache, cool clammy skin, elevated BP and heart rate. Patient was put into the recovery position and treated for shock. At 0915 patient began experiencing itchiness in her throat. At that time 0.3mL of Epi was administered into her R deltoid. The rapid response team was contacted from the ER and patient was taken for observation and any follow up care.
20 2021-05-25 chest discomfort Intense headache, numbness on the left side of the face, constant left eye pain, chest fatigue.
20 2021-05-25 heart rate increased Increased heart rate 150 bpm for a week that went uo and down. She wears an apple watch. Headache fo... Read more
Increased heart rate 150 bpm for a week that went uo and down. She wears an apple watch. Headache for that week.nausea everyday of that week for approximately 3hours .body aches that week.
20 2021-05-25 loss of consciousness, palpitations overall not feeling well idk if its from covid but after the vaccine i have been hospitalized a few ... Read more
overall not feeling well idk if its from covid but after the vaccine i have been hospitalized a few times for heart issues. Constant heart racing, fatigue, passing out, etc
20 2021-05-25 pulmonary embolism Extreme sharp pain on right side of back when breathing - on 4/14/21 Went to primary care physician ... Read more
Extreme sharp pain on right side of back when breathing - on 4/14/21 Went to primary care physician on 4/15/21 He had blood work and x-rays done - d-dimer came back 4 Admitted to ER In ER CT done - found pulmonary emboli (severe on the side where the pain was) Admitted to ICU that night (4/15/21) Stayed in ICU for 3 days Moved to floor Discharged from hospital on 4/19/21 Still dealing with extreme fatigue (unknown cause) still on blood thinners - 5/25/21
20 2021-05-27 pallor, fainting About 5 min after giving the vaccine, patient complained of not feeling well. Symptoms included hea... Read more
About 5 min after giving the vaccine, patient complained of not feeling well. Symptoms included headache, loss of sensation in arms, light headedness. Patient appeared pale, and confused. Attempted to have patient stand up and walk to counsel room opposite where she was sat. After standing, she immediately sat down, and fainted while she was seated. Pharmacist supported her head, and her boyfriend/significant other prevented her from falling off the chair. Patient was momentarily unresponsive for about 3 seconds. During this time her eyes remained open. Once patient regained consciousness, walked her to counsel room and had her lie down on her back with her legs elevated on a chair. Blood pressure was within normal limits. Patient was feeling better in about 10 minutes, and continued to monitor for another 5. Gave water to sip on, and no additional adverse effects noted.
20 2021-05-28 palpitations, fast heart rate fever, heart palpitations, tachycardia
20 2021-06-01 heart rate irregular Significant abdominal pain, irregular heart rate (120+ while sitting), nausea and fever (100+) for 1... Read more
Significant abdominal pain, irregular heart rate (120+ while sitting), nausea and fever (100+) for 1.5 days. Went away without treatment.
20 2021-06-01 fainting Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Additional Details: Patient appear... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Additional Details: Patient appeared to have short (<1min) seizure approximately 5 minutes after having COVID vaccine administered. She woke up, eventually alert and oriented. EMS was called and responded to call. She refused ER visit stating she was feeling fine, just a little shook up.
20 2021-06-02 heart rate increased She was shaking really bad at 1:00 in the morning; Her daughter felt like she couldn't move; She di... Read more
She was shaking really bad at 1:00 in the morning; Her daughter felt like she couldn't move; She didn't sleep very much; She started not feeling well/ She really didn't feel good; Chills; Hands were very cold/ hands were freezing and finger nails purple; Fingernails were purple; Body aches; Heart was racing very fast./Her heart was beating really fast.; Low grade temperature of 103.2 F/ temperature was 101.5 F/ Fever; Arm sore and lumpy under arm pit/ It really felt lumpy under her arm pit.; Sore arms/she couldn't touch her arm pit because it hurt so much; She said her lymph nodes under her right arm seem like they are feeling better- before, she couldn't even put her arm down because they hurt so bad; She felt so sweaty; This is a spontaneous report from a contactable consumer (Patient mother). A 20-years-old female patient (daughter) received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8733, Expiry date: Jul2021) via an unspecified route of administration in right upper arm on 20May2021 13:30 as SINGLE DOSE for covid-19 immunization. Medical history and concomitant medication was not reported. Patient historical vaccination was Flu vaccine on an unknown date in Sep2020 for immunization and first dose of BNT162B2 lot Number ER8733, Expiry Date: Jul2021 on 29Apr2021 at right upper arm for COVID-19 immunization and patient experienced little sore arm but it was no big deal. On 20May2021 patient experienced sore arms, had chills, her hands were very cold and her fingernails were purple. For a 3 hour period she had low grade temperature of 103.2F. Her heart was racing very fast. The mother gave her Tylenol in 15ml liquid form at 04:00 am and the temperature went down to 2 degrees. Her heart was still racing very fast at 5am. 3 hours later at 08:00 am her temperature was 101.5 F more Tylenol was given but her heart was still racing fast. Later that day it settled down. Her temperature went down to maybe a hundred and heart rate was slowly settling down. The mother said that it was really scary. They had call the doctor on Friday and talked with the nurse two times and the nurse said that they never heard anyone experienced a fever that high with the vaccine. She is asking if this was normal and if anyone has experienced this before. She is asking if ever there would be a third or booster dose, can her daughter take it after experiencing side effects after the second dose. She went back this past Thursday 20May2021 around 1:30pm for the second dose and she felt fine. About 10 hours later that night, she started not feeling well. She had gotten her second dose 3 days before and had a low grade fever, body aches, chills and didn't feel well for 24 to 48 hours. She started not feeling well and started getting chills. She was shaking really bad at 1:00 in the morning. She really didn't feel good. She took her temperature and it was 100.5. Her hands were freezing and her finger nails were purple. Her hands were cold and she was getting a fever. She guesses that can happen. Lasted a little longer from 1:00 until about 3:30 in the morning. Caller was up with her the entire night. Her fever went up to 103.2. Her heart was beating really fast. Caller was getting really scared and was thinking about taking her to the emergency room. She thought this was really weird. She gave her Tylenol trying to hold off. She was trying not to give her too much because there are dozens of interactions. She needed to give her something. Within an hour, it brought her fever down about 2 degrees and was then around 101.5. Her heart rate was still pretty fast. Was still a bit concerned but was glad her fever went down. Other than that, she seemed fine. Her daughter was drinking a lot of water to keep hydrated and was peeing a lot because she was drinking so much water. She seemed okay after that but her heart was still beating faster. Her daughter got up, she didn't sleep very much, and got up around 8:00 am, about 4 hours after taking the Tylenol. She didn't have a high fever but it was still around 101. She gave her more Tylenol and her heart was still beating fast. Reporter did not time it to see how fast it was. She could just tell that it was beating fast, like she was doing aerobics or something. Her daughter got the shot in her right arm. It really felt lumpy under her arm pit. Caller had read that some people get that, their lymph nodes get inflamed. Consumer only gave those 2 doses of Tylenol, her daughters fever got better. Her heart rate went back to normal and she seems fine now. She said her lymph nodes under her right arm seem like they are feeling better- before, she couldn't even put her arm down because they hurt so bad. She does seem to have improved; This was last Thursday and this is Tuesday. She did call the doctors office and talked to the nurse who said she hadn't heard of a fever that high. Said that sometimes when people get a fever, their heart rate can increase and that it is not unheard of. She didn't think that she had to be seen because she was improving. It bothered her the next few days. She heard on TV that kids were getting heart inflammation. Heart beating really fast: Reporter felt her wrist and felt her heart beating really fast. Lasted a little longer, until about 3:30 in the morning. Her daughters heart was beating so fast, it felt as if she were exercising but, she was sitting still. Her daughter seems fine now and caller has been checking her every day. Arm sore and lumpy under arm pit: This happened the next morning, Friday. Her daughter felt like she couldn't move and wanted to take a shower. She felt so sweaty and she couldn't touch her arm pit because it hurt so much. Reporter had read that some peoples lymph nodes get inflamed. It seemed better as the day went on. Treatment: Had only 2 doses of Tylenol. Her daughter doesn't swallow pills, so she had given her Children's strength Tylenol that is for children ages 2-11. She had only given her 15ml, which for her wasn't a lot. It says it's for up to 80 pound kids. Gave her 15ml at 04:00 am and it did bring it down 2 degrees. She gave her the same dose at 8:00 am. It wasn't even an adult strength dose. Fever: Her daughter's fever went away. She went back to bed, she had only slept from 05:00 am to possibly 08:00am, and didn't even sleep well then. After the second dose of Tylenol, her daughter went back to bed. Later in the afternoon, when her daughter got up, it seemed like she had a fever but a low grade fever, probably around 100. She hasn't seen it go back up. It seemed like it had settled down. Caller has been checking every day. Chills: Occurred after the second dose, maybe about 10 hours after on 20May2021. Called the CDC yesterday but was not able to talk to a person. She left some messages with the vaccine adverse something but no one ever called her back. Tests: She hasn't had any blood work done recently. She had her yearly check up last September. Adverse Event: Fever, body aches, chills, shaking really bad about 1:00am. had called the doctor's office and talked to the nurse twice. Was told that if she had swelling in throat to go to the ER. Prior Vaccinations (within 4 weeks): No, her last vaccine was the flu vaccine last September. Outcome of the events sore arms, Chills, Hands were very cold/ hands were freezing and fingernails purple, Fingernails were purple, Body aches and She started not feeling well/ She really didn't feel good, Her daughter felt like she couldn't move, She was shaking really bad at 1:00 in the morning, she didn't sleep very much, Arm sore and lumpy under arm pit/ It really felt lumpy under her arm pit. and She felt so sweaty was unknown and Heart was racing very fast./Her heart was beating really fast and fever was recovered on an unknown date, She said her lymph nodes under her right arm seem like they are feeling better- before, she couldn't even put her arm down because they hurt so bad was recovering. Information on Lot/Batch number was available. Additional information has been requested.
20 2021-06-02 fainting PATIENT HAD SYNCOPE REACTION TO RECEIVING SHOT AND APPEARED TO HAVE A SEIZURE THAT LASTED A FEW SECO... Read more
PATIENT HAD SYNCOPE REACTION TO RECEIVING SHOT AND APPEARED TO HAVE A SEIZURE THAT LASTED A FEW SECONDS. PATIENT CAME TO AND WAS CONSCIOUS AND COHERENT.
20 2021-06-06 loss of consciousness Patient had a seizure and momentarily blacked out in the waiting room after administration of the va... Read more
Patient had a seizure and momentarily blacked out in the waiting room after administration of the vaccine
20 2021-06-06 pallor, lightheadedness Client received her first Pfizer shot (Lot# EW0182 EXP 08/31/21) from RN at 18:40. RN stated within ... Read more
Client received her first Pfizer shot (Lot# EW0182 EXP 08/31/21) from RN at 18:40. RN stated within 20-30 seconds after administering shot, client's eyes rolled back, and she began to pass out. The client's friend was also in the room. RN stated that she and the friend grabbed the client, held her, and she started responding to their voices within 15 seconds. RN stated she simultaneously called for help. 2nd RN ran down the hallway to grab EMT and 3rd RN called 911. From the Lead's room, Lead RN and Co-Lead RN observed 2nd RN running down the hallway. Leads proceeded to the hallway and observed a cluster of individuals at vaccination station 5. Lead RN & Co-Lead RN arrived at station 5 at 18:42. Leads observed client conscious and sitting in a chair. Thirty seconds later EMT arrived. Leads observed client was pale in color. Client stated she got dizzy, and her eyes got blurry within seconds after the shot was administered. Client stated she was hot and sweaty, but was not experiencing SOB or trouble breathing. Client was alert and oriented times 4. Co-Lead RN opened the window. RN put a wet towel on client's forehead and client was transferred to a zero-gravity chair. Client stated she had eaten and drank plenty food and fluids earlier in the day. At 18:48 client stated she was feeling better. EMT took vitals at 18:50. (BP: 82/54 HR: 42). RN took client's pulse again and stated HR: 76. Client stated she has no known allergies and takes no medications other than birth control. Client also stated she used to take medication for anxiety, but stopped taking the medication 6 months ago. Firefighter EMTs arrived at 18:54 took vitals (BP: 106/74 O2: 99 HR 68) and performed a 12-lead ECG. At this time client stated that she has never given blood because she starts to pass out when she sees blood. She also stated that she passed out 9 months prior when she saw her sister's blood drawn at the hospital. At 18:58 client's color was coming back. She stated she was no longer dizzy and felt better, but was now cold because the window was open, and her jacket had been taken off to perform the ECG. RN closed the window. Firefighters took vitals again at 19:00 with client sitting (BP: 104/70 O2: 99 HR: 70) and standing at 19:01 (BP: 106/70 O2: 99 HR: 72). Client stated she felt much better. Client declined transport to hospital. Lead RN provided client with a Pfizer fact sheet and educated client on the common side effects vs the adverse effects of the Pfizer vaccine. Lead RN instructed her to contact her HCP if the common side effects persisted beyond 2-3 days and to go to urgent care or the ER if she experienced any adverse effects. Lead RN also instructed client to call 911 if she experienced any respiratory issues once she was home. RN walked client to observation room for additional 15-minute surveillance. Client walked with a steady gait.
20 2021-06-06 fainting Patient fainted and threw up. Felt dizzy for about 10 mins
20 2021-06-07 fainting, hypertension Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generali... Read more
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hypertension-Medium, Systemic: Hyperventilation-Medium, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Shakiness-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Medium, Additional Details: Patient was given the vaccination and she moved from the immunizing chair to the waiting area. While in the waiting area, the patient passed out briefly (less than 15 seconds), revived and was complaining of blurred vision and that her brain felt "funky." She then broke out in full body hives and was administered 2x25mg benadryl tablets orally. 911 was called. Patient then began complaining that her face and body felt numb and tingly all over. Paramedics arrived and took patient to the hospital.
20 2021-06-07 fainting Patient received Covid vaccination and sat down afterward to wait. Within 10 to 15 minutes, patient... Read more
Patient received Covid vaccination and sat down afterward to wait. Within 10 to 15 minutes, patient fainted. She then had a seizure. We called 9-1-1. Patient stopped seizing and was alert by the time EMT's arrived. They checked patient, and allowed patient to leave and go home with a parent. No further problems/seizures were reported to have occurred.
20 2021-06-07 troponin increased, inflammation of the heart muscle, chest pain patient received 2nd dose of Pfizer vaccine on 6/5/21. On the evening of 6/7/21 patient developed ch... Read more
patient received 2nd dose of Pfizer vaccine on 6/5/21. On the evening of 6/7/21 patient developed chest pain. When she woke up at 0530 on 6/8/21 her chest pain was still there. At this time patient developed nausea and was brought to the emergency room. In the emergency room she was found to have a troponin of 1155. She was started on indomethacin and colchicine for myocarditis.
20 2021-06-08 chest pain I was vaccinated on Tuesday, felt normal reaction. Woke up Saturday morning with excruciating pain f... Read more
I was vaccinated on Tuesday, felt normal reaction. Woke up Saturday morning with excruciating pain from my right armpit to the bottom of my rib cage. Pain was worse every time I inhaled. My breast on the right side swelled up and became red splotchy and hot. Had fever symptoms for 2 to 3 days afterwards. The excruciating pain in my chest and rib cage subsided within 6 to 8 hours. However the swelling in my right breast and redness did not subside for about three days.
20 2021-06-09 chest pain R07.9 - Chest pain, unspecified DIZZINESS CHEST PAIN SHORTNESS OF BREATH
20 2021-06-09 chest pain O20.0 - Threatened abortion PELVIC PAIN VAGINAL BLEEDING R07.89 - Other chest pain CHEST PAIN
20 2021-06-09 loss of consciousness, chest pain Adverse effects began 3 to 4 hours after vaccination. Patient reports arm soreness with pain moving ... Read more
Adverse effects began 3 to 4 hours after vaccination. Patient reports arm soreness with pain moving down arm and into chest, back and top of jaw. Patient got up and felt dizzy. Fell over and blacked out with eyes open for a few seconds. She does not remember falling over.
20 2021-06-09 fast heart rate, chest pain R00.0 - Tachycardia, unspecified chest pain
20 2021-06-10 heart rate irregular My heart beats weird, i feel like i?m having a constant anxiety attack, i can?t eat much. my jaw hur... Read more
My heart beats weird, i feel like i?m having a constant anxiety attack, i can?t eat much. my jaw hurts sometimes, same with ears i feel like i have an ear infection
20 2021-06-10 lightheadedness, fainting PATIENT HAD VASOVAGAL REACTION, FAINTED, WAS SUPER SWEATY AND HOT, DIZZY, AND LIGHTHEADED
20 2021-06-13 pallor, fainting "Pt w/ allergies to Peanut and Nut Flavor (N/V for both). Pt has a hx of vasovagal syncope/syncope,... Read more
"Pt w/ allergies to Peanut and Nut Flavor (N/V for both). Pt has a hx of vasovagal syncope/syncope, and Asthma. Pt received first dose of Pfizer 06/12/2021 at 9:59 am. While waiting and sitting on a chair under observation around 10:06am, pt had an episode of syncope and her lips appeared pale. No fall occurred. Pt was alert and oriented right after. Ambulated to triage via wheelchair. Charge RN/onsite provider/ANM was notified. VSS: 105/66 (BP), 18 (RR), 72 (HR), 98% spo2 at 10:08am. 101/67 (BP), 24 (RR), 69 (HR), 100% spo2 at 10:30 am. As per mom, pt has a hx of syncope. Our onsite provider advised pt to see her primary care doctor on Monday. Pt was D/C with family to home around 10:30am via wheelchair. Pt was advised to see emergency services if symptoms worsen."
20 2021-06-13 fainting "Pt received first dose of Pfizer on 6/12/2021 @12:06pm. While sitting under observation @12:16 pm, ... Read more
"Pt received first dose of Pfizer on 6/12/2021 @12:06pm. While sitting under observation @12:16 pm, pt c/o dizziness and had an episode of syncope.Pt had an assisted fall w/ observation RN. Pt was A/OX4 right after. Pt was ambulated to triage area via wheelchair . No c/o of SOB, nausea, chest pain but c/o tingling in all extremities Charge RN/onsite provider/ANM notified. VS @12:18 - 86/43, 58, 100%spo2 RA, 20 (RR), @12:23pm: 92/53, 69, 98% spo2 (RA), 20 @12:32pm: 83/55, 65, 20, 100%spo2 (RA), @ 12:45pm (sitting): 89/55, 99%, 60, @12:45pm (standing): 90/57, 61, 100%. Pt was able to swallow and was given juice and saltine crackers. No prior hx of syncope. Onsite provider advised for extended observation for 15 mins. As per pt last meal was eaten around 8:00am in the morning. Pt notified her mom and as per pt, mom asked pt to drive back home. Pt was advised to seek ER services if symptoms worsen. At 12:45pm, pt was d/c home. Pt ambulated w/stable and steady gait. Pt stable and released from vaccination site."
20 2021-06-13 blood clot, nosebleed Had some crazy nosebleeds beginning 4 days after my first dose. I ended up pulling a gigantic blood ... Read more
Had some crazy nosebleeds beginning 4 days after my first dose. I ended up pulling a gigantic blood clot out of my nose during the first one. It was terrifying. I?ve had 6 nosebleeds since my first dose and I?ve never had issues with nosebleeds before. They last a long time too and each one comes with a clot. I also have bruises all over my legs and that have appeared randomly and if I get cut I take forever to stop bleeding.
20 2021-06-14 nosebleed Patient states that 2-3 days after receiving first Pfizer vaccine, she has been having significant n... Read more
Patient states that 2-3 days after receiving first Pfizer vaccine, she has been having significant nosebleeds. She reports having about 14 nosebleeds, at least 1 a day. She denies changing any medications or lifestyle changes
20 2021-06-16 chest discomfort, chest pain Feels like her heart is going to stop, chest tender and heavy, sharp pains in chest, can't sleep.
20 2021-06-17 cardiac arrest, low blood oxigenation, enlargement of the heart, anaemia Symptoms started with tightness of muscles and body aches, tightness of chest, increased blood press... Read more
Symptoms started with tightness of muscles and body aches, tightness of chest, increased blood pressure, herpes simplex A mouth sores - saw PMD received muscle relaxer, and antibiotic cream... in the 30 days prior to last event she had been having dizzy spells, chills, hot flashes, shortness of breqth, tightness of chest, darkened urine, muscle cramping and knotting, pitting edema, halo discoloration lower right extremity (she wasnt one to complain and thought her symptoms were from use of muscle relaxer) - woke AM 6/11/2021 with severe shortness of breath and was taken to ER - diagnosed with obesity, cardiomegaly, renal failure, severe anemia, hypoxia, and hypokalemia, she went into respiratory distress AM 6/12/2021 and then went into cardiac arrest. She died as a result.
20 2021-06-17 chest pain Same day as the shot she was having chest pains, hard time sleeping
20 2021-06-17 inflammation of the heart muscle, chest pain Myocarditis; chest pain; shortness of breath; This is a spontaneous report from a contactable physic... Read more
Myocarditis; chest pain; shortness of breath; This is a spontaneous report from a contactable physician. A 20-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), dose 2 via an unspecified route of administration on 19May2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient had not known allergies. Medical history included, abdominal pain ongoing, the patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID.It was reported that, On 23May2021, The patient experienced myocarditis, chest pain , shortness of breath with outcome of recovering. The patient was hospitalized for myocarditis for 5 days. The patient was hospitalized for chest pain for 5 days. The patient was hospitalized for shortness of breath for 5 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 23May2021. Therapeutic measures were taken as a result of myocarditis (myocarditis), chest pain (chest pain), shortness of breath. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of myocarditis,chest pain,dyspnoea. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
20 2021-06-17 pallor, heart rate increased She read in the Fact sheet that this could be a severe allergic reaction; shivering; temp was up; pa... Read more
She read in the Fact sheet that this could be a severe allergic reaction; shivering; temp was up; pale; dizzy; elevated heart rate; weakness; muscle ache pains; Woke up in the middle of the night; This is a spontaneous report from a contactable consumer. This 20-year-old female consumer (patient). A 20-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), dose 1 via an unspecified route of administration on 08Jun2021 (at the age of 20-yearsr-old) as 1st dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date on Jun2021, the patient experienced woke up in the middle of the night with shivering, temp was up, was pale, dizzy, elevated heart rate, weakness, muscle ache pains trying to calm down, but trying to get to relax from shaking/shivering. She read in the Fact sheet that this could be a sever allergic reaction and was wondering if she should received the second dose of the vaccine. As noted in the Fact Sheet for Recipients, should not get the Pfizer-BioNTech COVID-19 Vaccine if the patient had a severe allergic reaction after a previous dose of the vaccine or if had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. The outcome of the events were unknown. Information regarding Lot/Batch number has been requested
20 2021-06-20 fainting Patient reported history of fainting before/after vaccination in the past. Reported Phobia of needle... Read more
Patient reported history of fainting before/after vaccination in the past. Reported Phobia of needles. Patient was fine after vaccination and was let into the lobby to wait 15 minutes for observation. After about 10 minutes, patient had fainted. Patient was in chair and supported to not fall out of the chair. Patient was given water and vomited about 5 minutes later. Gave icepack and observed for another 30 minutes with no incident.
20 2021-06-20 blood clot After about a week or less following each shot of the COVID-19 vaccine, my menstrual cycle began to ... Read more
After about a week or less following each shot of the COVID-19 vaccine, my menstrual cycle began to experience SEVERE irregularities. As someone who has been on the same birth control for many many years (brand/type is NORG-EE oral contraceptives), with no previous issues and an extremely regulated cycle, the effects I experienced were far from normal. My periods came a week early, and lasted for the entirety of the rest of the cycle (totaling 2 weeks of bleeding). The bleeding was extremely heavy containing intense and large clotting for the entirety of the period. Aside from losing a tremendous amount of blood, I have experienced heavy cramping in the lower abdomen and lower/mid back regions both during these periods and even sometimes when I am not bleeding at all. These side effects coupled have caused me to feel fatigued to the point of feeling like I needed to pass out, and due to this I adopted to taking iron supplements daily during the irregular bleeding (chelated iron, 18 mg capsules as recommended). As a result of this concerning symptom, I scheduled a visit to see my primary OBGYN, and was told that this is a common issue that they have been seeing following patient vaccinations. It is my hope that my periods will be regular this month, but for now I am unsure that this issue has resolved.
20 2021-06-21 loss of consciousness It started with a numbing feeling in my left arm and somewhat of cramping in that same wrist. About ... Read more
It started with a numbing feeling in my left arm and somewhat of cramping in that same wrist. About 2 minutes later, I felt extremely dizzy and lightheaded. My boyfriend realized that I stopped responding to him and my eyes rolled back. I ended up passing out, falling to the floor, and having convulsions for about 45 seconds before waking up extremely confused.
20 2021-06-22 chest pain body aches, extreme chest pain
20 2021-06-22 heart rate decreased Client's mother came to office stating that client reported that she was feeling disoriented, as if ... Read more
Client's mother came to office stating that client reported that she was feeling disoriented, as if her heart rate was slow, light headed. Instructed that they needed to call primary provider who referred them to paramedics. Paramedics monitored. Conclusion that it was not an allergic reaction, but a "bad reaction". Client feeling better today.
20 2021-06-23 lightheadedness 05/04/2021 around 8:30 AM I started feeling effects like nausea and fatigue. The typical symptoms. T... Read more
05/04/2021 around 8:30 AM I started feeling effects like nausea and fatigue. The typical symptoms. They lasted for about a week and a half. It lasted until about 06/14/2021 and then I noticed the lymph node protrusion on Sunday and I went to the urgent care Clinic on Monday 06/14/2021and they just said it would go away. At the Doctor they did blood pressure test and an EKG and they did EKG because I had vasovagal response after touching lymph node. There was a few nights in a row about a week after the vaccine, where I had insomnia and I couldn't fall asleep at all and had to take sleep aid. Lymph node swelling did go down and isn't inflamed anymore.
20 2021-06-23 fainting Pt came to Observation area after shot c/o not feeling well. Pt fainted while sitting into w/c. BP... Read more
Pt came to Observation area after shot c/o not feeling well. Pt fainted while sitting into w/c. BP 115/63 P 71 R 16 Woke up in w/c & received water. Tolerated well. 6:30PM Pt left unassisted with family.
20 2021-06-24 fainting Syncope while sitting in chair post vaccination. HR 70. Verbally responsive to questions. Anxious... Read more
Syncope while sitting in chair post vaccination. HR 70. Verbally responsive to questions. Anxious.
20 2021-06-25 chest pain Shortness of breath, sharp shooting pain chest/ heart. Fatigue, nausea, dizziness.
20 2021-06-26 skin turning blue I administered Covid 19 immunization and pt was waiting the 15 minutes for observation. About 5 min... Read more
I administered Covid 19 immunization and pt was waiting the 15 minutes for observation. About 5 minutes later, companion said pt said she felt like she was going to faint. We gave her a cold pack for neck and I was monitering breathing and consciousness. Pt said she sill felt faint, was having difficulty breathing, difficulty seeing and hearing. Lips turned faintly blue so technician called 911 and I administered 1 dose of Epipen in left thigh. A few minutes later I gave 10ml of Dihphenhydramine liquid. EMTs responded quickly, checked pt but symptoms resolved and she was not transported. After event patient did say she had not eaten that morning.
20 2021-06-28 heart rate increased Anaphylaxis (raised heart rate, rash, nausea and vomiting, swollen lips and throat) difficulty breat... Read more
Anaphylaxis (raised heart rate, rash, nausea and vomiting, swollen lips and throat) difficulty breathing - anaphylaxis under control Cause may be a salad Breathing still doesn?t feel normal
20 2021-06-28 inflammation of the heart muscle, chest pain 4/21/21- developed cough. 5/12/21 developed shortness of breath and exertional dyspnea. 5/15/21 deve... Read more
4/21/21- developed cough. 5/12/21 developed shortness of breath and exertional dyspnea. 5/15/21 developed substernal chest discomfort, blurred vision. Went to local ED- no significant findings. 5/19/21 transthoracic echo showed LVEF 52%. 6/7/21 -symptoms resolved except for mild congestion. 6/27/21 cardiac MRI: demonstrated normal biventricular function (LVEF 63%), mild epicardial scar (mid inferolateral and lateral walls), mild patch mesomyocardial scar (mid septum), mildly elevated T1, T2 in the septum.
20 2021-06-28 fainting pt fainted, presented nystagmus of eyes, and muscular rigidity of arms and hands for less than 30 se... Read more
pt fainted, presented nystagmus of eyes, and muscular rigidity of arms and hands for less than 30 seconds following administration of vaccine.
20 2021-06-28 fast heart rate Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemi... Read more
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Tachycardia-Medium
20 2021-06-29 heart rate increased About 5 minutes after receiving the vaccine. The patient experienced dizziness, followed by accelera... Read more
About 5 minutes after receiving the vaccine. The patient experienced dizziness, followed by accelerated heart rate. Ambulance was called and patient was taken to the hospital as a precaution for observation.
20 2021-06-30 fainting Systemic: Fainting / Unresponsive-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild,... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Seizure-Mild, Systemic: Weakness-Mild
20 2021-06-30 fainting Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-M... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Additional Details: Spoke with nurse at md office and instructed to give sports drink (sugar) for shakiness
20 2021-07-01 palpitations Pain in the shoulder, feeling tired and sleepy, racing heart
20 2021-07-01 fainting Before pt got her 2nd Covid injection, she did warn me that she might faint. She said that she is a... Read more
Before pt got her 2nd Covid injection, she did warn me that she might faint. She said that she is afraid of needles. I advised to stay seated after the vaccine was given. After the injection, less than a few minutes, patient did have an episode of syncope. Mom and brother were there. I immediately got the EpiPen and told my technician to call 911. When I got to her, it looked as if she was seizuring for a few seconds, then she came out of it. I told her that I would give her the epinephrine injection and put she pushed it away and said that she was fine and not needing it. I asked mom on what they wanted me to do. She said that she wasn't quite sure. Patient then slowly became more conscious and was able to talk to me. I asked her whether she had any difficulty breathing but she said no. She said that she was just really dizzy. She was sweating a bit. She didn't eat or drink anything before coming to the pharmacy. The injection was given around 12:48pm. I kept on talking to her to make sure that she was still conscious and not passing out. Then the EMT came. They took her blood pressure. First, it was 90s/60s, then 105/70s (if I am not mistaken). Per patient, she almost passed out before at Dr. office but ever did. She didn't with her first Covid vaccine. Eventually, patient agreed to go to the ER. I called my coordinator, and informed her of what happened. I did ask mom whether I could call her to check on her and mom was okay. However, when I called around 7:20p, and I couldn't reach her. I left a VM and told them that I will checked back with her on Monday.
20 2021-07-04 loss of consciousness, fainting Patient fainted while seated on immunization bench after receiving vaccination, approximately 30 sec... Read more
Patient fainted while seated on immunization bench after receiving vaccination, approximately 30 second after while talking with her. She slouched to her side and lost unconsciousness for about 10 seconds. Patient and parent noted that patient has previously fainted after receiving vaccinations (she mentioned influenza vaccine), and even while seeing injections given on tv. They did not appear to be very concerned about situation. Patient was given water, was observed, and rested for another 15 minutes before she was ready to leave.
20 2021-07-04 pallor Within about 5 minutes of receiving the vaccine became sweaty, clammy, pale and vision became very b... Read more
Within about 5 minutes of receiving the vaccine became sweaty, clammy, pale and vision became very blurred. This lasted about 10 minutes before symptoms subsided.
20 2021-07-06 chest discomfort, fibrin d dimer increased, chest pain 8 Days following first Phizer Covid 19 shot, experienced a sharp pain in center of chest lasting ab... Read more
8 Days following first Phizer Covid 19 shot, experienced a sharp pain in center of chest lasting about 30 seconds to 1 minute. There after, chest pressure, and chest tightness continued for about 3 weeks. At times felt pain pressure in back region also. Pain level went up and down from 2 to a 4 or 5 on a scale of 10.
20 2021-07-06 chest pain, loss of consciousness, heart rate increased Subject passed-out for about 20 seconds, 5 minuets after injection. Approx. 24 to 36 hours later be... Read more
Subject passed-out for about 20 seconds, 5 minuets after injection. Approx. 24 to 36 hours later began experiencing intermittent chest pains and rapid heart beats. This has continued for the last 8 days.
20 2021-07-07 chest discomfort Started having throat tightness and chest tightness, having difficulty breathing. Lasting about 15-2... Read more
Started having throat tightness and chest tightness, having difficulty breathing. Lasting about 15-20 minutes
20 2021-07-07 chest pain, heart rate increased, fast heart rate Hugh heart rate and chest pain. Heart rate over 170; Hugh heart rate and chest pain. Heart rate over... Read more
Hugh heart rate and chest pain. Heart rate over 170; Hugh heart rate and chest pain. Heart rate over 170; This is a spontaneous report from a contactable consumer (patient). A 20-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection Batch/Lot number: EN6208, Expiration Date was not reported), via an unspecified route of administration. administered in left arm on 18Mar2021 12:00 (at the age of 20-years-old) as dose 1, single for covid-19 immunisation at hospital and Other vaccine unknown dose number via an unspecified route of administration on 18Mar2021 (Batch/Lot Number: EW0177) as dose number Unknown, single immunisation. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested for covid-19 since the vaccination. No other vaccine received in four weeks. Any other medications the patient received within 2 weeks of vaccination included Luvox, Lamical. It was reported that, on 27Mar2021 7-10 days after 1st dose, the patient experienced Hugh heart rate and chest pain. Heart rate over 170. The patient underwent lab tests and procedures which included heart rate increased: 170 on 27Mar2021. Metropol was prescribed as treatment for the adverse event. The patient visited emergency room and physician office due to events. Therapeutic measures were taken as a result of hugh heart rate and chest pain. heart rate over 170. The reporter assessed the seriousness as non-serious. The outcome of the events was reported as recovered with lasting effects. Follow-up attempts are completed. No further information is expected.
20 2021-07-09 inflammation of the heart muscle, chest pain, palpitations, blood clot Woke up with a loud heartbeat and severe chest pain, especially when breathing in - shortness of bre... Read more
Woke up with a loud heartbeat and severe chest pain, especially when breathing in - shortness of breath, dizzy/confused, anxious. Went to the emergency room and was given an ECG which was abnormal, tested positive in blood test for blood clot but was negative on a CAT scan. Doctor stated it was minor myocarditis, was perscribed ibuprofen and percocet and sent home
20 2021-07-09 fainting Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Mild, Additional Details: Patient fainted... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Mild, Additional Details: Patient fainted about 10 minutes after injection. She had not eaten prior to receiving the vaccine. Had her prop her feet up on chair while laying on ground to return blood flow to her head. Recovered without further incident.
20 2021-07-14 chest discomfort PT HAS BEEN EXPERIENCING TINGLING ARM/NUMBNESS AND CHEST TIGHTNESS SINCE RECEIVING VACCINE.
20 2021-07-14 haemoglobin decreased, chest discomfort, chest pain 20 Y female with h/o of cardiac transplant in 4/29/20 for HCM with history of early ACR 5/2020 treat... Read more
20 Y female with h/o of cardiac transplant in 4/29/20 for HCM with history of early ACR 5/2020 treated with rATG and steroids and early CAV 1 (20% mRCA lesion) on prograf and zortress. Admitted on 7/13 with symptoms of chest pain, lower extremity swelling, chest pressure and orthopnea for rule out rejection. Found to be COVID positive on transfer. On 7/13 underwent a EmBx that revealed 1R/1A. Today, on 7/14, patient denies symptoms of chest pain. Due to COVID hospitalization, patient will be given EUA of Casirivimab and Imdevimab intravenous administration prior to discharge. Deemed stable for discharge. HX OF orthotopic heart transplant on 4/29/2020 at with hypertrophic cardiomyopathy - tacrolimus/everolimus/pred immunosuppression -- tac goal 8-10 -- everolimus goal 3-8 -- current prednisone dose 5 mg daily -- RTC in 1 month for OV -- lab work on Friday - OIP: -- CMV: D+/R+- valganciclovir -- Toxo/PCP: TMP/SMZ -- fungal: posaconazole (for 3 months after last rATG ~ 8/22/2020) -CV: on pravastatin - delayed d/t elevated transaminases - osteoporosis: zoledronic acid 5mg 5/11/2020 COVID positive --appreciate ID; Casirivimab and Imdevimab today -isolation precautions
20 2021-07-14 fainting, pallor Pt fainted approximately 5-10 minutes after vaccine administration; pt had symptoms of light-headed... Read more
Pt fainted approximately 5-10 minutes after vaccine administration; pt had symptoms of light-headed, dizzy, loss of vision and hearing briefly, numbness and tingling in face and hands. Pt was very pale. Pt's feet were elevated and given a drink. Paramedics were called and assessed patient; paramedic reported normal blood pressure but slightly pulse. Pt was released without recommendation to transport. Pt mother told to call 911 if symptoms of allergic reaction occurred such as nausea, vomiting, diarrhea, rash, hives, or swelling in face, eyes, or tongue.
20 2021-07-15 chest pain Bodyaches , painfull joints ( more the knees), Fever(102 farenh) and chills the first day followed ... Read more
Bodyaches , painfull joints ( more the knees), Fever(102 farenh) and chills the first day followed by swollen lymph nodes on both sides of my neck, super swollen tonsils , which were red with white patches. Then there was a sharp pain on my chest that ran down my left arm but lasted less then a minute.
20 2021-07-15 chest pain CHEST PAIN, SORE THROAT, FATIGUE, SEVERE CHEST PAIN
20 2021-07-18 chest pain presents with chest pain and SOB after getting the Pfizer COVID vaccine this morning. She reports th... Read more
presents with chest pain and SOB after getting the Pfizer COVID vaccine this morning. She reports that she often gets chest pain and SOB when anxious. She reports that the SOB has resolved and the chest pain is getting better. She denies any wheezing or difficulty breathing. She denies any symptoms prior to the vaccine. She says she was not anxious about getting the vaccine but was not looking forward to getting it this morning.
20 2021-07-18 pallor Patient was pale and complaining of her ears feeling full and would pop when she drank. She was swe... Read more
Patient was pale and complaining of her ears feeling full and would pop when she drank. She was sweating and having flu like symptoms including nausea. We had her sip water wait in the pharmacy waiting room and discussed how she was feeling. after about 20 minutes she was starting to feel better.
20 2021-07-19 lightheadedness On both my first and second shot I got really bad brain fog. I went to the ER after my first shot on... Read more
On both my first and second shot I got really bad brain fog. I went to the ER after my first shot on June 29, 2021 but they told me it was a psychological thing and that I was freaking myself out and that it was not vaccine related but I knew the at wasn?t the case. After my first shot the pressure in my head remained for about a week and the brain fog and vision/auditory issues only occurred on the first day mainly. On my second shot today (07/20/2021) it occurred again and so I know it?s vaccine related, not psychological. On both shots it was an immediate reaction. As soon as the person began to inject the vaccine into me I would feel immediate pressure in my head (on the first shot it felt like the vaccine literally traveled to my fingertips in my left arm and up into my head, it was very strange). Then about 2-5 minutes after I got the vaccine on both occasions my vision became filled with floaters and my coherency decreased. The first vaccine was the worst as the floaters stayed longer and my vision would go in and out of bluriness more. On the second shot the floaters were very obvious for the first hour and then slowly decreased over time but it is currently 6 hours after my shot right now and I still see a couple. On my second shot my vision did blur but not as bad. Both times I felt tremendous pressure in my head and I couldn?t think straight or focus. My speech was very slow and the ordering of my words were inaccurate. My texting was bad because I couldn?t spell and the structure of my sentences was incorrect. I have issues putting words together to say what I want to say and I can?t concentrate. Both times I have stared at a wall in fixation for hours which is not normal. It?s not so much as a headache, just a lot of pressure and I?ve never experienced it with anything else in my life. After my second dose I was also extremely exhausted but could not sleep because of the pressure in my head. My memory is also affected as I cannot remember things very well. It takes me about 30 seconds to understand what someone says because I just can?t think. I feel like my cognitive processes are faulty. It?s like a very intense brain fog that affects my vision and on the first vaccine also affected my hearing as stuff sounded muffled.
20 2021-07-20 fainting, pallor Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainti... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Seven minutes after her 1st Pfizer shot, she passed out, looked pale & sweating. I gave her one Benadryl 5 mg capsule with plenty of water. We called 911, they came in but she still very pale and tired. They brought her to nearby hospital.
20 2021-07-22 nosebleed had a short pain in my armpit in the one that, in the arm that I got the vaccine; Headache/head woul... Read more
had a short pain in my armpit in the one that, in the arm that I got the vaccine; Headache/head would hurt to; my body would get really hot and really cold at the same time and then my whole body aches; my ear would hurt too; Chills; my body would get really hot and really cold at the same time and then my whole body aches; my nose would bleed from my right nostrils for about a week and then head would hurt to and my ear would hurt too; This is a spontaneous report from a contactable female consumer or other non hcp (patient). A 20-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0181), via an unspecified route of administration, administered in arm left on 19Jun2021 (at the age of 20-year-old) as dose 2, single for COVID-19 immunization. Medical history included anaemia (patient stated, I am anemic. You can probably say low iron (later confirmed as anemic). The patient concomitant medication included ferrous sulphate (FERROUS SULFATE) taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0187), via an unspecified route of administration, administered in arm left on 29May2021 as dose 1, single for COVID-19 immunization and experienced I had short pain in my armpit in the arm, I had mild headache. The patient experienced had a short pain in my armpit in the one that, in the arm that I got the vaccine, headache/head would hurt to, my body would get really hot and really cold at the same time and then my whole body aches, my ear would hurt too, chills, my nose would bleed from my right nostrils for about a week and then head would hurt to and my ear would hurt too, all on an unspecified date in Jun2021. Adverse events: patient stated, Okay, after the 1st dose, I had short pain in my armpit in the arm that I got my shot in, this is the few days after and then I had mild headache after that too. Then after the 2nd dose I had short pain the next day in my armpit again and then I had really bad headache and I have aches and chills like all over my body, my body would get really hot and really cold at the same time and then my whole body aches. Patient stated, Yes, I felt a little bit better after that the 2nd shot but about a week later I started to get a nose bleed for a week. So, every like morning my nose would bleed from my right nostrils for about a week and then head would hurt to and my ear would hurt too. Patient stated, I still have headache and I never had headache or nose bleed before. Date of vaccination: Patient stated, On the first dose it was June on a day like 4, this is actually the 1st dose. I had a short pain in my armpit in the one that, in the arm that I got the vaccine impetrated. When confirmed the date, patient stated, No, the 1st one dose on the 5th of 29th, I mean May, 29th. 2nd dose that was on June 19th. The patient underwent lab tests and procedures which included general blood test showed it was like a iron, lipid, comprehensive metallic, metabolic. Outcome of the event headache/head would hurt to was not recovered and rest of the events was unknown. Follow up attempts are needed. Further information is expected.
20 2021-07-25 lightheadedness patient experienced vasovagal symptoms post vaccine and was placed in trendelburg position of stretc... Read more
patient experienced vasovagal symptoms post vaccine and was placed in trendelburg position of stretcher.
20 2021-07-26 blood pressure decreased Patient alerted RN in observation room after feeling "a little hot and lightheaded". She continues t... Read more
Patient alerted RN in observation room after feeling "a little hot and lightheaded". She continues to say that she didn't want to fall and pass out in the room so she asked for help. Pt was asked to lay down on the cot, blood pressure was taken by this nurse and found pt to have bp of 90/52. Patient says that she usually gets nervous and scared with all shots and labwork in the past and experiences the same symptoms when getting shots.
20 2021-07-26 chest pain Patient complaint about prolonged chest pain on the night of vaccination. Unknown cause. Symptom not... Read more
Patient complaint about prolonged chest pain on the night of vaccination. Unknown cause. Symptom not-specific.
21 2021-01-02 fainting Dizzy, fainting, numbness on right leg/ face, nausea
21 2021-01-06 fainting, pallor 1825 Pt received the Pfizer vaccine. Patient sat in chair being monitored for 15 minutes. At 1832 pt... Read more
1825 Pt received the Pfizer vaccine. Patient sat in chair being monitored for 15 minutes. At 1832 pt felt lightheaded and fainted, emergency response CALLED. Patient appeared pale and diaphoretic. RNs assisted patient down to the floor with head supported with jacket and legs elevated. 1837 Patient's vital signs BP: 101/59, HR: 60, o2: 97%. Patient woke up stating that she is ok. Emergency response arrived 1838. Continued to monitor patient, @ 1845 BP: 110/71, HR: 64, o2:98%. Pt states feeling better, offered juice, pt able to tolerate 1 cup of apple juice with no complications. 1850 patient states feeling better, assisted patient to sitting position from lying down. VS obtained BP: 96/57, HR: 72, o2: 97%. Emergency response recommended patient to to the Emergency Department, but patient refused. States that she is going to go home. Advised that she call for a ride, and patient agreed. 1855 Assisted patient in the standing position, BP: 99/63, HR: 65, o2: 96%. Pt was able to tolerate more apple juice, denies any lightheaded, dizziness or headache. Patient stated that her ride was on the way. Patient agreed and continued to be monitored for another 15 minutes. Pt discharged @ 1915 in stable condition.
21 2021-01-07 heart rate increased tested positive for Covid test; tested positive for Covid test; difficulty breathing; chills; fluctu... Read more
tested positive for Covid test; tested positive for Covid test; difficulty breathing; chills; fluctuating fever; nausea; weakness; weakness/extreme fatigue; loss of taste and smell; loss of taste and smell; muscle pain; cough; sore throat; nasal drip; dizziness; fast heartbeat; injection site pain; anxiety; crying; This is a spontaneous report from a contactable healthcare professional. This 21-year-old female patient reported for herself that she received BNT162B2 1st dose on 31Dec2020 10:00 AM intramuscular at left arm for COVID-19 immunisation. Medical history included known allergies: Penicillin and Covid-19. Concomitant therapy included BC as reported. The patient experienced difficulty breathing, chills, fluctuating fever, nausea, dizziness, weakness, fast heartbeat, tiredness, loss of taste and smell, muscle pain, injection site pain, anxiety, cough, sore throat, nasal drip, crying, extreme fatigue, Etc on 31Dec2020 at 06:00 PM. The events resulted in doctor or other healthcare professional office/clinic visit, emergency. The patient was hospitalized for 1 day and received treatment included blood thinner rivaroxaban (XARELTO) and had 2 weeks quarantine. The patient had Covid prior to vaccination and tested positive for Covid test post vaccination on 01Jan2021. The outcome of the events was not resolved. Information on Lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the suspected LOE, SARS-CoV-2 test positive and the other reported events due to temporal relationship. Of note, it is reported that the patient had history of COVID 19 infection prior to the vaccination. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
21 2021-01-08 fast heart rate, chest pain, chest discomfort Severe body aches and fatigue, chills, tachycardia, chest pain and tightness, headache, stomachache,... Read more
Severe body aches and fatigue, chills, tachycardia, chest pain and tightness, headache, stomachache, gastrointestinal issues, nausea, inability to focus, fever
21 2021-01-11 chest pain Headache; Chest pains; high fever; body aches; chills; first dose 16Dec2020/ second dose 04Jan2021; ... Read more
Headache; Chest pains; high fever; body aches; chills; first dose 16Dec2020/ second dose 04Jan2021; This is a spontaneous report from a contactable pharmacist (the patient). A 21-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL1284), intramuscularly in the right arm on 04Jan2021 at 12:30 PM (at the age of 21-years-old) as a single dose for COVID-19 immunization. The patient's medical history included COVID-19. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EK5730), intramuscularly in the right arm on 16Dec2020 at 11:30 AM (at the age of 21-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 05Jan2021 at 12 AM, the patient experienced chest pains, high fever, chills, body aches, and headache. No treatment was given for chest pains, high fever, chills, body aches, and headache. The clinical outcome of chest pains, high fever, chills, body aches, and headache, was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
21 2021-01-11 fainting Recipient experienced dizziness, lightheadedness, and fainted within 15 min of vaccination. She was... Read more
Recipient experienced dizziness, lightheadedness, and fainted within 15 min of vaccination. She was given a sandwich and orange juice, which she consumed. She felt better within 1 hour. She was picked up by her mom and was driven home.
21 2021-01-11 fast heart rate Tachycardia (150 bpm), Fever (101.8), SOB, and Uncontrollable Shaking for more than 12 hours
21 2021-01-13 heart rate increased mouth sores; Nausea; vomiting; stomach cramps; sweats; joint pain; elevated heart rate; This is a sp... Read more
mouth sores; Nausea; vomiting; stomach cramps; sweats; joint pain; elevated heart rate; This is a spontaneous report from a contactable other HCP (Patient). A 21-year-old female patient received her first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) Lot #EL0140, via an unspecified route of administration on 29Dec2020 12:00 at single dose at Left arm for COVID-19 immunisation. Medical history included Behcets, dysautonomia, Irritable bowel syndrome (IBS), and COVID-19. The patient's concomitant medications included unspecified products within two weeks of vaccination. The patient previously took amoxicillin, MELOXICAM (MOBIC) minocycline and all experienced drug hypersensitivity. On 30Dec2020 12:00 the patient experienced mouth sores, nausea, vomiting, stomach cramps, sweats, joint pain and elevated heart rate. There was no other vaccine in four weeks. The patient was not pregnant. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The reporter considered all the events are non-serious and stated no treatment was received. The events outcome was not resolved.
21 2021-01-14 chest pain 1/13/21: received second dose of COVID-19 vaccine. One hour later experienced sensation of arm numbn... Read more
1/13/21: received second dose of COVID-19 vaccine. One hour later experienced sensation of arm numbness, resolved within hours. Later in evening experienced a sensation of burning in entire right arm. 1/14/21: woke at 2 a.m. with sensations of shortness of breath. At 5:30am developed muscle spasms in form of twitches in right arm and diffuse muscle discomfort. Additionally describes chest pain in substernal location with radiation to right rib cage. Chest pain reproduced and accentuated by direct pressure. Developed fever of 99.9 degrees and was turned away when going to work. Returned home and recorded temperature slightly above 100 degrees. 1/14/21: experienced continued muscle discomfort and right arm twitches. Remains short of breath but seems to be improving. 1/15/21: continued complaints of chest pain radiating from middle of chest to right side, continued shortness of breath, and whole body pain.
21 2021-01-14 palpitations Rash, Palpitations, Clammy skin
21 2021-01-17 heart rate increased, blood pressure increased Anaphylactic reaction- started shortly after. Rapid response called about 7:45. Blood pressure eleva... Read more
Anaphylactic reaction- started shortly after. Rapid response called about 7:45. Blood pressure elevated, heart rate elevated, oxygen 90, itching face/chest with a rash.
21 2021-01-17 fast heart rate, loss of consciousness, chest discomfort Next day after the 2nd dose of the COVID vaccine patient began feeling fatigued and nauseous. Then ... Read more
Next day after the 2nd dose of the COVID vaccine patient began feeling fatigued and nauseous. Then at urgent care, patient experienced difficulty breathing, tachycardia, and chest tightness. Patient also had a seizure and brief LOC. Patient went to urgent care, rapid response called and then transported to EMS to nearby hospital.
21 2021-01-17 low platelet count Rash on lower legs similar to that seen with Thrombocytopenia.; Rash on lower legs similar to that s... Read more
Rash on lower legs similar to that seen with Thrombocytopenia.; Rash on lower legs similar to that seen with Thrombocytopenia.; This is a spontaneous report from a contactable Other HCP (patient). A 21-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number= EJ1686), via an unspecified route of administration at Left arm on 05Jan2021 10:00 AM at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient's medical history and concomitant medications were unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced rash on lower legs similar to that seen with thrombocytopenia on 09Jan2021 at time of 12:00 PM. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: A possible contributory effect of suspect drug on reported thrombocytopenia cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
21 2021-01-18 heart rate decreased, fainting 1. Collapsed onto the floor within 15 minutes of vaccine administration and was unresponsive upon sh... Read more
1. Collapsed onto the floor within 15 minutes of vaccine administration and was unresponsive upon shout/tap shout and a sternal rub. 2. Pulse was elevated at ~133, her breathing did not seem altered. EpiPen was administered and EMS called.
21 2021-01-25 blood pressure increased, fainting, fast heart rate DEVELOPED ELEVATED BLOOD PRESSURE (181/106) AND TACHYCARDIA (125), SOB, FAINTNESS, NAUSEA, RED EYES.... Read more
DEVELOPED ELEVATED BLOOD PRESSURE (181/106) AND TACHYCARDIA (125), SOB, FAINTNESS, NAUSEA, RED EYES. GAVE BENADRYL 25MG PO AT 0940. BP DECREASED TO 143/88 AND PULSE 99.
21 2021-01-25 chest pain some pain in both sides of her chest; Bad taste in mouth; Pain injection site; Arm and fingers went ... Read more
some pain in both sides of her chest; Bad taste in mouth; Pain injection site; Arm and fingers went numb; This is a spontaneous report from a contactable consumer (patient) reported for self. A 21-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EJ1689) via an unspecified route of administration in left upper arm on 11Jan2021 at single dose for COVID-19 immunization. There was no medical history. There were no concomitant medications. The day of the vaccine on 11Jan2021, her arm and fingers went numb, she had pain at the injection site and had a bad taste in her mouth which has all resolved, states the following day after the vaccine, 12Jan2021, she woke up and had some pain in both sides of her chest. Wondering if these side effects are expected and about getting the second vaccine. Events outcome of arm and fingers went numb, bad taste in mouth was recovered on 12Jan2021, for pain in both sides of her chest was recovering, for pain at injection site was not recovered.
21 2021-01-26 fainting Per witness, patient "fainted", falling out of chair shortly after arriving to recovery area. Upon w... Read more
Per witness, patient "fainted", falling out of chair shortly after arriving to recovery area. Upon writer arrival patient was diaphoretic, A&Ox4 , V/S WNL (121/80, HR 99, O2 100%, Resp. 18), patient reports hx of anxiety and untreated syncopal episodes. EMS activated. Upon EMS arrival, VS 117/62, HR 116, Resp. 18, O2 100%, finger stick blood sugar 96. Patient transported to ED by EMS at own request.
21 2021-01-27 chest discomfort headache, sweating and shaking 15 minutes after vaccine During the night woke up with chest tightne... Read more
headache, sweating and shaking 15 minutes after vaccine During the night woke up with chest tightness and shortness of breath and went to the ED-xray,ekg, IV fluids and Zofran
21 2021-01-29 fainting While in monitoring area, client reported feeling dizzy and faint. Client was ambulatory. Vitals tak... Read more
While in monitoring area, client reported feeling dizzy and faint. Client was ambulatory. Vitals taken and normal. After getting out of her car, client reported cold air helped and was not experiencing symptoms any longer. Client declines EMS tranpsport for further evaluation, instructed to follow up with PCP or ER if symptoms worsen/recur. Client assisted back to car with boyfriend.
21 2021-02-03 fainting Pt got pfizer covid vaccine on 1/3 (approx 48 hrs PTA) where she a CNA. She got the vaccine in the a... Read more
Pt got pfizer covid vaccine on 1/3 (approx 48 hrs PTA) where she a CNA. She got the vaccine in the afternoon. Pt felt well on the day of the vaccine, but yesterday (1/4, one day after vaccine), pt syncoped at work in the evening. She had eaten normal meals that day. After syncopal episode, her blood sugar was normal. Her blood pressure was 76 / 56. Pt felt very lightheaded prior to syncope. No chest pain, dyspnea, no palpitations. Pt was unconscious just briefly. Pt states she did have some tingling in her R arm, R foot, and entire tongue. Pt is still having a HA. No other sxs. Has not taken anything for these sxs. When pt syncoped, she landed on soft bed, did not hit head on anything hard. Pt syncoped once previously at age 9. Pt has soreness at injection site, but no swelling or erythema.
21 2021-02-03 fainting After receiving the second dosage of my COVID vaccine at 2 PM on 02/03/21, I only had left arm pain ... Read more
After receiving the second dosage of my COVID vaccine at 2 PM on 02/03/21, I only had left arm pain near the site of the injection. However, I went to sleep and at 2 AM on 02/04/20, I started having fever, a severe HA, and myalgia that hindered my sleep. I took 500 mg Tylenol at 6 AM and went back to sleep. When I woke up at 8:30 AM, I went to use the restroom and felt dizzy with hot flashes. Immediately afterwards, I noticed that I had fainted and my mother helped me to my bed. After drinking soup and juice and having a bowel movement, I felt normal and alerted my PCP.
21 2021-02-07 chest discomfort Took pulse and it was 152; stumbling walking; mild dizziness/dizziness turned severe; Mild breathing... Read more
Took pulse and it was 152; stumbling walking; mild dizziness/dizziness turned severe; Mild breathing problems/continued breathing issues; pressure on chest; This is a spontaneous report from a contactable Other Health Professional (patient). A 21-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK 9231), via an unspecified route of administration on 21Jan2021 16:15 at single dose in Right arm for COVID-19 immunisation. Medical history included asthma, anxiety, and depression, all from an unknown date. Concomitant medication included duloxetine, lamotrigine, buspirone hydrochloride (BUSPAR), etonogestrel (NEXPLANON), ethinylestradiol, norethisterone acetate (JUNEL) in two weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 31Dec2020 02:30 PM in Right arm at single dose for COVID -19 immunisation and was tested positive for COVID on 01Jan2021; took cefdinir and experienced drug hypersensitivity. The patient reported symptoms began 12 hours after second COVID vaccine (5am on 22Jan2021). Mild breathing problems and pressure on chest. At 7am on 22Jan2021, mild dizziness started and continued breathing issues. At 12pm (noon) dizziness turned severe, was stumbling walking. Took pulse and it was 152 on 22Jan2021, checked several times. The patient went to the ER (Emergency room) and was determined it was a reaction to the vaccine. After receiving medication and fluids, pulse returned to normal after about seven or eight hours. The events resulted in Emergency room/department or urgent care. The patient underwent lab tests and procedures which included Covid-19 tested Positive on 01Jan2021, Pulse rate: 152 on 22Jan2021, Pulse rate returned to normal in Jan2021, heart ultrasound and EKG (Electrocardiogram) with unknown results in Jan2021. The patient received Fluids and medication as treatment. COVID was not tested post vaccination. The outcome of event Took pulse and it was 152 was recovered on an unspecified date in Jan2021. The outcome of the other events was recovering.; Sender's Comments: Based on the compatible time association and drug's safety profile, the events are possibly related to suspect vaccine BNT162B2 injection. 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.
21 2021-02-09 chest pain My first dose of the vaccine was on 1/14/2021. I had a mild headache and experienced dizziness and n... Read more
My first dose of the vaccine was on 1/14/2021. I had a mild headache and experienced dizziness and nausea the night of receiving the vaccine. My second dose of the vaccine was 2/8/2021. I felt tired the night of receiving the vaccine and went to bed a 8pm. I woke up at 6:10am on the 9th with a severe migraine, severe nausea and dizziness. I ate a small amount and laid back down. I got out of bed at 9am and noticed both of my eyes and face were swollen and my throat was swollen. At this point I called my doctor and spoke to a nurse on the phone, she was short saying I needed to go to ER. Personally, I did not feel it was necessary at the time so I took a Benadryl and Ibuprofen. Throughout the day I continually got worse experiencing the same symptoms as the morning including sharp chest pain, restricted breathing, a low grade fever of 100.4, severe lower back pain and leg numbness. I took more ibuprofen and placed heat on my back. I took ibuprofen PM and woke up the morning of the 10th feeling better. Still have headache, lower back pain and swelling but is better than yesterday. I will notify my doctor today of the event that occurred yesterday (2/9/2021).
21 2021-02-11 nosebleed Common low-grade fever and headache; followed by intense bloody nose with clotting
21 2021-02-11 nosebleed Pfizer #2 covid immunization. In that afternoon, developed unexpected nosebleed. Has never had this ... Read more
Pfizer #2 covid immunization. In that afternoon, developed unexpected nosebleed. Has never had this in past.
21 2021-02-16 chest pain January 10, 2021 around 1:00 AM i woke up from a sound sleep with 10/10 midsternal chest pains. I wa... Read more
January 10, 2021 around 1:00 AM i woke up from a sound sleep with 10/10 midsternal chest pains. I was seen in the emergency room for the chest pains. The emergency provider ruled out the chest pains as NOT being cardiac or Gastrointestinal related after doing countless blood tests and other various tests. I then followed up with my PCP and they said to keep an eye on it to see if it got any worse and to seek medical attention if the chest pains did get worse. After 4 days the pain went away.
21 2021-02-16 palpitations After injection, she was instructed to stay for observation. Upon checking on her, patient stated h... Read more
After injection, she was instructed to stay for observation. Upon checking on her, patient stated her heart was racing and she felt weak. She was instructed to remain for 30 more minutes of observation. Checked patient post 30 mins. and attempted to have ambulate. She stated she still felt "woozy". Conversation was had with another RN. Pulse was checked and 104. Pupils were dilated and her speech was delayed. We felt she should go to ED to be checked and she agreed. Patient was taken by W/C to ED
21 2021-02-17 chest discomfort Approximately 20 minutes after receiving 2nd dose of Pfizer Covid-19 vaccination, pt reports dull fe... Read more
Approximately 20 minutes after receiving 2nd dose of Pfizer Covid-19 vaccination, pt reports dull feeling in left-side of chest. Pt reports no difficulties breathing, rash, itching, fever, or other issues. Pt escorted to EMS who took vital signs. BP 120/85, HR 65, O2 100% on RA, Temp 98.7F. Pt provided with juice box. After approximately 20 more minutes of waiting, pt reports symptoms have not improved, but are also not worse. No other issues noted. Pt ambulated by self out of clinic home. Pt refused to have vitals rechecked.
21 2021-02-18 chest discomfort PATIENT COMPLAINS OF TIGHTNESS IN CHEST AND SLIGHT SHORTNESS OF BREATHE. PATIENTS 02 SAT WAS 97% ON ... Read more
PATIENT COMPLAINS OF TIGHTNESS IN CHEST AND SLIGHT SHORTNESS OF BREATHE. PATIENTS 02 SAT WAS 97% ON ROOM AIR, HEART RATE IS 100 AND BLOOD PRESSURE IS 106/67. OFFERED TO MONITOR ADDITIONAL 15 MINS AND PATIENT REFUSED. PATIENT STATES FELLS BETTER AFTER SPEAKING WITH R.N.
21 2021-02-18 fainting Pt experienced a brief syncopal episode about 5 minutes after receiving vacccine. No other symptoms ... Read more
Pt experienced a brief syncopal episode about 5 minutes after receiving vacccine. No other symptoms reported and episode quickly resolved. Pt stated that she has experienced syncope previously when getting a vaccine.
21 2021-02-23 heart rate increased This 21 yo corpsman advised 1/15/2021 she received her first COVID Pfizer vaccine with complaints of... Read more
This 21 yo corpsman advised 1/15/2021 she received her first COVID Pfizer vaccine with complaints of elev heart rate sensation and feeling hot immediately after her first COVID vaccine that did resolve within a few moments on it's own. She reports a sore, red, hot are at injection site that lasted for 3-4 days and resolved on own. She reported being in good health until mid February when she noticed sinus/facial pressure, nasal congestion w/nasal voice (no throat issues, just nasal muffling). She denied any fever, sob, cp, rash, ha, or other systemic symptoms and a HCP placed her on Augmentin. She completed her AB on 2/20, 2 days before her 2nd covid vaccine. ------- On 2/22/2021 she received her 2nd Pfizer Covid vaccine to left arm and went back to ER (where she works) for observation. She reported she again had sense of elevated heart rate, feeling hot and now itched all over (now about 30 min post vaccine). She reported symptoms to RN who noted onset of "hives" to midthoracic area on her back and recommended she be seen by ER. She was treated by ER MD approximately 1 hour post vaccination with MD noting a 1x1cm red raised hive to T1 region on back and no other lesions or skin rashes. She denied any SOB, cp, ha, fever, difficult swallowing-speaking, no oral swelling, no angioedema, no recent exposures-insect bites, no new food groups, soaps, detergents, lotions, cloths, etc. She was treated with I liter NS bolus, IV Benadryl, Solu-Medrol, and Pepcid. HR was 81 w/rr 16 and 100% O2 sats on arrival. Afebrile. She was released home on Prednisone, pepcid, atarax, and prn benadryl. ----- On 2/14/2021 follow up, she advised hive has resolved, she still feels itchy on and off but not taking any medications. She c/o "weird ringing sensation to bilateral ears described as a muffled sensation with some pressure. Again s/s similar to previous sinus infection except for ringing sensation. She also has a sore site, again to left arm that looks bruised and is still warm to touch (no swelling, less redness vs 2 days ago). She reports a similar red flushed vaccine site when 13 yo and receipt of first HPV vaccine (name, lot #, details unknown). She does not recall any other s/s except her mother said she was not going to get the rest of the series. Since then she has had a "nodule" in her left deltoid. She has received many other vaccines to both deltoids w/o issues.
21 2021-02-24 heart rate increased Severe breathing difficulty. Lasted 9 days which required use of albuterol inhaler every ~4-6 hours... Read more
Severe breathing difficulty. Lasted 9 days which required use of albuterol inhaler every ~4-6 hours for the first 7 of the 9 days. Breathing difficulty slowly went away over many days after the first 7-9 days. Resting heart rate was also elevated (near 130-140) as well as lightheaded feeling for a few days when breathing difficulties were most severe. Now breathing is back to normal.
21 2021-02-25 chest pain, fibrin d dimer increased, troponin increased, inflammation of the heart muscle Day of vaccine, 4hrs post vaccine: felt drunk/high/intoxicated (touch was intensified, numbing feeli... Read more
Day of vaccine, 4hrs post vaccine: felt drunk/high/intoxicated (touch was intensified, numbing feeling) Day 2-3: exhausted and fever of 102F, body aches, chills, nausea Day 4: started feeling better, fever went down with Tylenol Day 5 3am: woke up with chest pain (3.5-4/10), went away with Tums; 0930pm chest pain 6/10 while sitting at desk, increased to 7/10, lasting 2 hours by the time I went to the ER
21 2021-02-25 loss of consciousness Progress Notes (Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand AllCollapse All COVI... Read more
Progress Notes (Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand AllCollapse All COVID VACCINE CLINIC 2/24/2021 Date: 02/24/2021 Subjective Patient is a 21 y.o. adult who was seen at COVID Vaccine Clinic today for patients first dose of the COVID 19 vaccination. Patient was given the Pfizer vaccination in the left deltoid muscle. During patient's 30 minute waiting period after the injection, the patient began to experience throat tightness and itching. Patient denied rash, difficulty breathing, difficulty swallowing, wheezing, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and patient was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , drooling, increased swelling, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. PMH: includes peanut allergy, carries epi-pen. She takes 75 mg of benadryl nightly to help with insomnia and seasonal allergies. ALLERGY REVIEW OF SYSTEMS: Patient complains of itching of skin Patient denies chills, malaise/fatigue, facial swelling, itching in ears, sore throat, frequent throat clearing, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, abdominal pain, muscle aches, dizziness and headaches Previous Reactions: she was brought back to bay intially for observation as she reported to pass out when she gets shots. Shortly after injection, she developed symptoms above. No vagal issues arose. Objective Vitals Vitals: 02/24/21 1048 02/24/21 1100 02/24/21 1136 BP: (!) 153/85 106/76 124/72 Pulse: (!) 101 86 81 Resp: (!) 22 16 SpO2: 99% 100% 100% Physical Exam Vitals and nursing note reviewed. Constitutional: General: Patient is not in acute distress. Appearance: Normal appearance. Patient is well-developed. Patient is obese. Patient is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear oral airway Eyes: General: Right eye: No discharge. Left eye: No discharge. Conjunctiva/sclera: Conjunctivae normal. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Comments: Injection site without rash, erythema or swelling Neurological: General: No focal deficit present. Mental Status: Patient is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: antihistamines Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Anaphylaxis (dyspnea, stridor, drooling, tongue swelling) Close monitoring. Pt improving. Doing well with medication intervention. Pt has ride. Pt wheeled out to the front. Pt ambulates without difficulty. No dizziness. Instructions given on when she can take her next benadryl dose. APRN Electronically Signed 2/24/2021 11:25 AM
21 2021-02-27 loss of consciousness, fainting The vaccinating nurse reported that within 15 seconds of being vaccinated the patient states she nee... Read more
The vaccinating nurse reported that within 15 seconds of being vaccinated the patient states she needed to lie down and then slumped with apparent loss of consciousness. She was pulled to the floor by her companion, possibly hitting her head. She awoke, according to the nurse in about 45-60 seconds and shortly after was A&Ox4, moving all extremities. BP 127/84 P68 O2- 98% She was placed on a board and transported to ED for possible head injury The patient arrived fully alert and did not report previous episode of vasovagal syncope. After she had the incident her mother stated she had had such an episode at age 10 with a vaccine.
21 2021-02-28 heart rate irregular, blood pressure decreased approx. 20 minutes after receiving the vaccine, client started c/o tingling in her hands, arms and l... Read more
approx. 20 minutes after receiving the vaccine, client started c/o tingling in her hands, arms and legs.She was flushed and had a headache. She says she also had this reaction with her first vaccine. She continues to not feel well and went to her pcp today, bc she is c/o irreg heartbeat, tired, sore arm. Says her BP is normally low and it was high today and low grade fever. Her pcp did a rapid covid test. She is drinking large amounts of fluids to stay hydrated.
21 2021-02-28 fainting Patient fainted and hyporesponsive.; Patient fainted and hyporesponsive.; This is a spontaneous repo... Read more
Patient fainted and hyporesponsive.; Patient fainted and hyporesponsive.; This is a spontaneous report from a non-contactable other healthcare professional. A 21-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot number: En9265, intramuscular on 13Feb2021 at 14:00 (at the age of 21 years old) as a single dose in the right arm for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient fainted and was hyporesponsive on 13Feb2021. The patient did not receive treatment for the events. The outcome of the events was recovered in Feb2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on vaccine-event chronological association, a causal relationship between events fainted and was hyporesponsive and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
21 2021-03-03 loss of consciousness Patient witnessed slumped over in chair and unconscious. at approximately 12:52 PM. Patient aroused... Read more
Patient witnessed slumped over in chair and unconscious. at approximately 12:52 PM. Patient aroused with physical stimulation. Patient immediately regains consciousness. Patient oriented to person, time, place and situation. Patient reveals history of syncope to a prior flu vaccine and Gardasil vaccine. Patient then loses consciousness. Patient aroused with verbal and physical stimulation. Patient regains consciousness immediately. 911 had already been activated at this point. Paramedics assumed care at approximately 1:00 PM. Patient refused transport to hospital. Patient advised to have someone drive her home. Patient monitored until transportation arrived. Prior to leaving facility, patient reassessed at approximately 1:30 PM. Blood pressure was 139/102 mmHg and pulse 90 bpm. Patient left facility at approximately 1:35 PM to roommate. Patient escorted to car by paramedic. Patient left facility alert and oriented to person, time, place, and situation with steady gait and unlabored breathing.
21 2021-03-03 loss of consciousness blacked out for a moment, shaky before blacking out. Evaluated by EMS-Cleared
21 2021-03-06 blood pressure increased, increased heart rate, palpitations While in observation area, patient complained of racing heart and blood pressure elevation and some ... Read more
While in observation area, patient complained of racing heart and blood pressure elevation and some shortness of breath. Evaluated by EMS. BP 210/115 (average), P98-126. Able to communicate clearly entire time, some dyspnea but no respiratory distress. Due to elevated blood pressure and heart rate, she was transported to Hospital for evaluation/treatment.
21 2021-03-08 inflammation of the pericardium Pericarditis; Transaminitis; This is a spontaneous report from a contactable Other- Health Professio... Read more
Pericarditis; Transaminitis; This is a spontaneous report from a contactable Other- Health Professional (patient). A 21-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248) via an unspecified route of administration on 13Jan2021 15:15 at single dose on left arm, for covid-19 immunisation. Medical history included chronic immune Idiopathic thrombocytopenic purpura (ITP), allergies to Mushroom. The patient did not have covid prior vaccination. The patient's concomitant medications were not reported. The patient experienced pericarditis and transaminitis on 03Feb2021. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for the events for 6 days. The patient received treatment medications for the events. The lab test included Nasal Swab, covid test: negative on 05Feb2021. The outcome of events was not recovered.; Sender's Comments: Based on the limited information provided, causality relationship cannot be clearly established and cannot be excluded.The case will be reassessed should additional information become 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.
21 2021-03-12 lightheadedness PATIENT HAD A VAGAL RESPONSE WHICH SHE REPORTS IS A TYPICAL REPSONE FOR HER
21 2021-03-13 chest pain 3 days of fever reaching 101.8 degrees F, with body aches. skin sensitivity to touch, and fatigue. W... Read more
3 days of fever reaching 101.8 degrees F, with body aches. skin sensitivity to touch, and fatigue. When those symptoms first started there was a soreness under my sternum during inhalation that has since progressively gotten worse.
21 2021-03-14 heart rate increased, lightheadedness hard to fall asleep; felt like she was going to pass out/vasovagal reaction; heartbeat was high; Fat... Read more
hard to fall asleep; felt like she was going to pass out/vasovagal reaction; heartbeat was high; Fatigue; Woozy/Dizzy; hard to concentrate; feeling hot; he also felt as though was on the verge of a headache but never got one/she felt like the blood was rushing to her head; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3249), via an unspecified route of administration on 16Jan2021 09:00 at SINGLE DOSE for covid-19 immunisation. The patient medical history was none. No prior vaccinations within 4 weeks. No family history relevant to adverse events. Patient has no concomitant medications. On 16Jan2021 09:20, 20 minutes after vaccination, the patient felt like she was going to pass out reported as vasovagal reaction, and experienced heart beat was high, fatigue, woozy/dizzy, hard to concentrate, feeling hot, and felt as though she was on the verge of a headache but never got one/she felt like the blood was rushing to her head. On 16Jan2021 10:00, 1 hour after vaccination, the patient experienced had to fall asleep. On the day she got the shot she sat for a full hour with the nurse to be monitored. Then she went home. The events lasted from 09:20 until 18:00 on that day. 13 days after vaccination on 29Jan2021, 12:00 and ongoing until reporting time, the symptoms recurred about the same when they started. The patient was wondering if this could be a side effect 2 weeks after getting the shot or if she should look elsewhere on what could be causing these events. She is supposed to get the second dose on Friday and was wondering about getting the second dose after her experience. Patient wanted to know it is safer for her to have the 2nd dose. No physician office visit and emergency room visit. No prior vaccinations within 4 weeks. Outcome of the events was recovered on 16Jan2021 18:00.
21 2021-03-14 loss of consciousness approximately 5 minutes after receiving vaccination patients boyfriend said that she was filling lig... Read more
approximately 5 minutes after receiving vaccination patients boyfriend said that she was filling light headed. I went to the waiting area to check on patient and take her blood pressure. while taking patients blood pressure she had a short (1-2 seconds long) seizure and lost consciousness. Patient quickly regained consciousness and reported no additional symptoms. EMS arrived on the scene quickly and patient left with them.
21 2021-03-14 pallor One moment she was fine. The next moment she was completely pale, white as a sheet, even her lips we... Read more
One moment she was fine. The next moment she was completely pale, white as a sheet, even her lips were white. She had beads of sweat on her forehead. She said she didn't feel well, and she didn't want lunch. Then she went and vomited. We took her temperature, and it was normal. We talked to her, made sure she was oriented. She then had a bout of diarrhea in the bathroom. It took about an hour for her color to completely come back and for her to feel better. She called Pfizer and spoke to them to make a report. They told her they have not had reports like this a few days after the vaccine was given. We were not sure if she should have the 2nd round or not.
21 2021-03-15 fainting, chest discomfort Pt with mom states she feels dizzy and faint. While with EMS on site, pt states her chest felt tigh... Read more
Pt with mom states she feels dizzy and faint. While with EMS on site, pt states her chest felt tight. Mom at beside with pt.
21 2021-03-17 heart rate increased, fainting Immediately, I had increased heart rate - 194 - I fainted to the ground. I became nauseous, sick an... Read more
Immediately, I had increased heart rate - 194 - I fainted to the ground. I became nauseous, sick and had seizure like episode and then I had tingling sensation in my face and limbs. They gave me shot epi-pen - two doses. I was pretty much paralyzed for hands and legs. I was brought to hospital and they treated me there for about a week and I had muscle weakness. I gained feeling back in my hands but not in my feet. I was at Haywood for a week. Outpatient therapy and a visiting nurse for three weeks. B12; Iron; Gabapentin and that was for anxiety through it all. Test results came up as neuropathy on left side of my body. I have pins and needles pain now. I did gain my walking back. I take Gabapentin for neuropathy pain. I went to hospital - went one day and I didn't get anything back from them. I now use handicap parking for disability.
21 2021-03-17 low platelet count, platelet count decreased Patient had critically low thrombocytopenia (low platelets) discovered via lab. Platelets had previ... Read more
Patient had critically low thrombocytopenia (low platelets) discovered via lab. Platelets had previously been normal.
21 2021-03-18 chest pain, hypotension Progress Notes Nurse Practitioner COVID VACCINE CLINIC Subjective Patient is a 21 y.o. adult who... Read more
Progress Notes Nurse Practitioner COVID VACCINE CLINIC Subjective Patient is a 21 y.o. adult who was seen at SVH COVID Vaccine Clinic today for patient's second dose of the COVID 19 vaccination. Patient was given the Pfizer vaccination in the left deltoid muscle. During patient 15 minute waiting period after the injection, the patient began to experience rash, hives, throat tightness and dizziness. Patient denied difficulty breathing, difficulty swallowing, wheezing, hoarseness, stridor, itching, lightheadedness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and patient on was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting. ALLERGY REVIEW OF SYSTEMS: Patient complains of frequent throat clearing, itching of skin and headaches CONT negative Eyes negative Respiratory negative GI negative Musculo negative Previous Reactions: Itching with first Covid shot Objective Vitals Vitals: 03/17/21 1501 03/17/21 1508 03/17/21 1523 BP: (!) 157/100 (!) 154/66 (!) 170/65 Pulse: 90 84 90 SpO2: 99% Physical Exam Constitutional: Appearance: Normal appearance. Patient is well-developed. HENT: Head: Normocephalic. Right Ear: Hearing normal. Left Ear: Hearing normal. Nose: Nose normal. Mouth/Throat: Lips: Pink. Mouth: Mucous membranes are moist. No angioedema. Pharynx: Oropharynx is clear. Uvula midline. Eyes: General: Vision grossly intact. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Neurological: Mental Status: patient is alert. Psychiatric: Behavior: Behavior is cooperative. Pt had taken benadryl before her visit. She was given Zytec and still had some rash and hives, but the throat tightness had went away. She was given water and crackers while in the bay. Assessment/Plan Treatment included: antihistamines Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) Left at 3:42 Electronically Signed 3/17/2021 3:40 PM
21 2021-03-19 very slow heart rate, loss of consciousness PT c/o dizziness and lightheadedness immediately following innoculation. Pt states history of panic ... Read more
PT c/o dizziness and lightheadedness immediately following innoculation. Pt states history of panic attacks and anxiety. RN who performed innoculation stated pt eyes rolled back and her arms flexed and she lost consciousness for less than 1 minute. RN notified the MD and on site Paramedics and got them enroute. Medics evaluated pt and she was found to be bradycardic and they recommended she be further evaluated at the emergency room. Fire department arrived and transported pt to medical center in stable condition.
21 2021-03-19 heart rate increased I received my shot at 11:47 and started to lose sensation in my hands in the waiting area. After abo... Read more
I received my shot at 11:47 and started to lose sensation in my hands in the waiting area. After about 25 minutes I felt dizzy and was about to stand up but my muscles started shaking. My heart rate was checked and found to be 140. This lasted for about another 30 minutes. My heart rate went down and I was taken to a private area and checked out by EMS they gave me water and concluded it was some sort of panic attack. However, these are the same symptoms I have whenever I am allergic to a medication, NSAIDS, dicyclomine, etc. It always starts with ascending numbness from my fingers to the rest of my body. Then I start to shake and my heart rate goes way up. Usually I start to cough then vomit and my airway closes. Thankfully this time we were able to slow the process and I never experienced some of the last symptoms.
21 2021-03-20 fainting pt fainted and fell out of chair around 10 minutes after receiving Pfizer covid vaccine rx# 487548. ... Read more
pt fainted and fell out of chair around 10 minutes after receiving Pfizer covid vaccine rx# 487548. rph on duty immediately went out and cradled pt's head as pt regained consciousness and talked to her until she was fully conscious and could sit up. pt asked for water, got for her and rph sat with pt talking to her until she felt well enough to leave on her own. She was asked several times if she wanted an ambulance and pt declined. pt waited around for another 10 minutes and left without incident.
21 2021-03-20 fainting Patient experienced syncope after administration of her first COVID vaccine. Her mother is a physici... Read more
Patient experienced syncope after administration of her first COVID vaccine. Her mother is a physician and was present, providing care for her by fanning, comforting and helping her to lie down on the floor next to the waiting chairs. The patient did not faint. She did experience what appeared to be heavy breathing and light-headedness. We provided an ice pack from the immunization cart. The mother stated that the patient experiences this reaction every time she receives a vaccine due to her fear of needles. After about 30 minutes the patient was up and smiling. The family was thankful for our concern and help.
21 2021-03-22 chest pain i received my vaccine right about 12:30 that money and while waiting in the 15 minute clinic at the ... Read more
i received my vaccine right about 12:30 that money and while waiting in the 15 minute clinic at the center i felt relatively fine aside for a dry mouth which i didn't even thing was a adverse reaction at the time. i processed to continue with my day and head to my 2pm class and while sitting in my class my throat which at this point was pretty itchy and felt like it was to some extent tightening. I also started to cough and wheeze profusely which is something im use to as an asthma patient but usually something has to induce that and at this point i was literally just sitting in class. i left the class and at this point it was getting extremely hard for me to breath i was coughing and wheezing essentially in a full on asthma attack. i drove to the clinic where they first gave me an albuterol nebulizer and then tried to give me a Claritin but just a few minutes after i threw up we tried again with a Benadryl and while i was able to keep that in longer i also threw up after taking that medicine. After my breathing calmed down a bit i was released to go home but there i had a fever and headache, body chills, extreme fatigue, exhaustion. nausea and abdominal oain in my lower left side and right below my breast bone. for the rest of the night and even into today (march 23). i continued to take both Benadryl and the nebulizer over night and that has worked to help releeve symptoms but i still feel significantly unwell.
21 2021-03-22 loss of consciousness Patient received immunization. Seemed to be doing well. Was sitting in waiting area and Pharmacist n... Read more
Patient received immunization. Seemed to be doing well. Was sitting in waiting area and Pharmacist noticed patient slumped in chair. Went to patient and shook her shoulder and patient awoke. Appears patient was unconscious for just a few moments. Patient was very clammy and sweating but breathing was normal. No swelling in face or throat and could speak well with no problems. Patient was monitored for an extended amount of time and had driver to take her home.
21 2021-03-22 pallor 3/22/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination ... Read more
3/22/2021 Patient 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: PATIENT FOUND TO BE PALE, CLAMMY, COOL TO TOUCH., SLOUCHING IN CHAIR WITH EYES CLOSED, SHE IS ALERT TO PERSON, PLACE AND TIME. Assessment : Time of assessment 1855, Alert and oriented FOUND TO BE PALE, CLAMMY AND COOL. . Actions taken: PLACED ON STRETCHER WITH FEET ELEVATED, WATER OFFERED AND DRINKING, vs AT 1855 bp 65/37, p 62. o2- 100%, hob ELEVATED CONTINUES TO DRINK WATER, NOW EATING CRACKERS, vs RECHECKED AT 1859, bp- 77/58, p- 98, O2 100%, VS AT 1900 VS- BP-105/75, P-97, O2 100%, Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/22/2021 6:32 PM 0.3 mL 12/11/2020 Intramuscular Manufacturer: Pfizer, Inc
21 2021-03-22 pallor Patient was nervous before the vaccination. After vaccination she started to feel hot and cold. Her ... Read more
Patient was nervous before the vaccination. After vaccination she started to feel hot and cold. Her hearing started to fade in and out. She sought help and was directed to lay flat on the floor and breathe. She started feeling light headed and that her vision was tunneling. Her appearance was pale and her hands were clammy. Her blood pressure was taken via wrist and was normal for her (112/72). The medical professional tending to her had her continue talking, asked her to state her DOB, name, age, the date, etc. After about 5 minutes she started to feel better- she sat up and had some water and M&Ms. She then laid back down but continued to converse with us. This took place over about10 minutes from first symptoms. She remained laying down for about 10 minutes after and then slowly sat up, and when she felt comfortable sitting she tried standing up. She then went home for the day (was an employee of the store).
21 2021-03-23 lightheadedness Around 10 minutes after getting the shot, felt sudden wave of light headedness/dizziness. About 40 m... Read more
Around 10 minutes after getting the shot, felt sudden wave of light headedness/dizziness. About 40 minutes prior I had a snack and immediately after the shot I had another snack. I also had been drinking water. At one point I felt that I was close to passing out. I also had tingling/numbness in my feet/legs in certain positions and had to move them. I went through the drive through for the vaccine and so I sat in the car drinking water and breathing deeply for about 20-30 minutes. It gradually got better but never fully gone. When I got home some of the light headedness got a little worse when I had to stand up and walk even though I did it slowly. Even an hour after, side effects still lingering and have not yet gone as I fill this out.
21 2021-03-23 fainting Syncopal episode SpO2 98%@RA BP 66/32 P 54 before discharge BP = 121/71
21 2021-03-23 fainting Patient was vaccinated on 3/12021 with 1st dose Pfizer, lot EN6205 expiration date 6/30/2021. Patien... Read more
Patient was vaccinated on 3/12021 with 1st dose Pfizer, lot EN6205 expiration date 6/30/2021. Patient denied medical conditions excpet adverse reaction of seizure after HPV vaccine. Patient informed RN that she had syncopal episode at 15min and 25min after receiving the 1st dose. Her vital signs were within normal limits after. Patient denied allergies. Medication includes birth control pill. RN relayed information to PHN who texted medical team. Per medical team, patient is to wait until 28 days post 1st Pfizer dose before receiving Janssen vaccine, it is not recommended to receive Pfizer 2nd dose. Patient was advised to consult with her provider.
21 2021-03-24 chest pain, fibrin d dimer increased Chest pain, elevated D-Dimer, shortness of breath
21 2021-03-24 loss of consciousness Patient fell from chair hitting head on ground after passing out. She responded to questions with ap... Read more
Patient fell from chair hitting head on ground after passing out. She responded to questions with appropriate answers within 45 seconds. She reported feeling dizzy and thought it was related to anxiety then woke up on the floor. Patient remained on the floor while being assessed by EMS then moved to a sitting position then to a chair when safe. Patient remained in chair for 10 minutes before leaving the vaccine site.
21 2021-03-25 pallor 21 y/o client complains of nausea and dizziness. Head-to-toe assessment done. All within normal limi... Read more
21 y/o client complains of nausea and dizziness. Head-to-toe assessment done. All within normal limits except skin color was pale. BP: 94/62. Client appears to be tachypneic but states she has no trouble breathing. She is no acute distress. Client vomited 30-40 ml of brownish emesis. After client vomited, she stated she felt better. She refused ambulance assistance and preferred to go home. Co-worker was with her at the time and stated she will drive her home. At the end of monitoring time, client stated she felt better and left facility, accompanied by her co-worker, ambulatory. At the end of monitoring time, client?s color was normal and she was in no acute distress, breathing was even and unlabored. Her departure time was 1019.
21 2021-03-25 pallor 1209 HRS: Pt is a self reported 21 yo female who was found to be pale and diaphoretic in past vacci... Read more
1209 HRS: Pt is a self reported 21 yo female who was found to be pale and diaphoretic in past vaccination recovery area with report of narrowed vision with nausea, noting Pfizer vaccine (Lot #: ER8732) was administered IM to Right deltoid @ 1201 HRs. AAOx4 with stuporous gaze. Instant cold pack applied to back of neck with no improvement of symptoms. 1212 HRS: BP-90/58 (M), HR-62, RR-20, SPO2 @ 99% on RA. 1214: Pt moved from chair to floor w/ legs elevated on chair and ice pack applied to right neck vessels. Pt?s skin color improved to pink in hue w/ vision returning to baseline per her report. 1216 HRs: BP-98/68 (M), HR-75, RR-18, SPO2 @ 98% on RA. Pt denies past medical history. Denies currently menstruating or pregnant and currently taking Thiminar birth control. Reports last meal this AM. Pt reports history allergic reaction to penicillin with reported rash when she was 2 ? 3 years of age with unknown treatment provided. Denies prior illness up to 1 month ago, to include no prior COVID-19 diagnosis. 1222 HRs: Pt assisted to sitting position on floor, noting BP-112/82 (M), HR-91, RR-18, SPO2 @ 99% on RA w/ no acute changes noted. Pt reports feeling better with water provided. Transferred to chair w/ stand-by assist x 2 RNs. 1239 HRs: Pt jovial and conversing well and asymptomatic at this time. Pt reports condition at baseline to when she arrived to clinic. 1242 HRs: 1209 HRS: Pt is a self reported 21 yo female who was found to be pale and diaphoretic in past vaccination recovery area with report of narrowed vision with nausea, noting Pfizer vaccine (Lot #: ER8732) was administered IM to Right deltoid @ 1201 HRs. AAOx4 with stuporous gaze. Instant cold pack applied to back of neck with no improvement of symptoms. 1212 HRS: BP-90/58 (M), HR-62, RR-20, SPO2 @ 99% on RA. 1214: Pt moved from chair to floor w/ legs elevated on chair and ice pack applied to right neck vessels. Pt?s skin color improved to pink in hue w/ vision returning to baseline per her report. 1216 HRs: BP-98/68 (M), HR-75, RR-18, SPO2 @ 98% on RA. Pt denies past medical history. Denies currently menstruating or pregnant and currently taking Thiminar birth control. Reports last meal this AM. Pt reports history allergic reaction to penicillin with reported rash when she was 2 ? 3 years of age with unknown treatment provided. Denies prior illness up to 1 month ago, to include no prior COVID-19 diagnosis. 1222 HRs: Pt assisted to sitting position on floor, noting BP-112/82 (M), HR-91, RR-18, SPO2 @ 99% on RA w/ no acute changes noted. Pt reports feeling better with water provided. Transferred to chair w/ stand-by assist x 2 RNs. 1239 HRs: Pt jovial and conversing well and asymptomatic at this time. Pt reports condition at baseline to when she arrived to clinic. 1242 HRs: Pt ready for discharge. Pt instructed if symptoms returned to call 911, proceed to ER or call PCP. Informed pt due to response to this vaccine dose, she will need to coordinate with her PCP for follow-up dose in an appropriately equipped facility. Pt verbalized understanding w/ questions answered. Pt signed COVID-19 VAER Form & discharged ambulating to POV where father was awaiting. RN notified. Pt ready for discharge. Pt instructed if symptoms returned to call 911, proceed to ER or call PCP. Informed pt due to response to this vaccine dose, she will need to coordinate with her PCP for follow-up dose in an appropriately equipped facility. Pt verbalized understanding w/ questions answered. Pt signed COVID-19 VAER Form & discharged ambulating to POV where father was awaiting. (Site Nurse Manager) notified.
21 2021-03-26 cardiac arrest Patient contacted 911 complaining of not feeling well and difficulty breathing. Upon arrival patient... Read more
Patient contacted 911 complaining of not feeling well and difficulty breathing. Upon arrival patient was found by EMS in cardiac arrest. EMS was unable to get return of spontaneous circulation.
21 2021-03-26 pallor after receiving vaccine patient was waiting her 15 minute and was getting up to leave and then she b... Read more
after receiving vaccine patient was waiting her 15 minute and was getting up to leave and then she became dizzy and lighteaded and nauseous, pale and diapooretic and complained that her arms were tingling. She was brought back for observation and her blood pressure on arrival was 78/40, HR 80, RR18, Sat 96% she was placed in trendelenberg on the litter. Laying flat her blood pressure was 96/69, HR 80 and say 97%. Then in a sitting position 104/75, HR 90 and standing she was 104/80 HR 84 sat 98%. Patient had stood and her blood was 96/51 @ 1252 and patient felt lightheaded and dizzy she was then placed on the litter again and was continued to be observed. She was also given water and a snack, and was then placed in a semi folwers position, at 1300 her bp was 111/80 hr 82 she was given another 8 ounces of water and a snack. At 1315 her bp was 128/77 HR 94, at 1321 her bp was 117/74 HR 78 in a sitting position, at 1324 she was 121/73 hr 95 standing, at 1326 Bp was 119/71 HR 96 standing. at 1340 bp 118/72 hr 92 stable and was released.
21 2021-03-28 fainting, hypotension Low blood pressure, fainting, dizziness, headache, and numbness of the entire injected arm on day o... Read more
Low blood pressure, fainting, dizziness, headache, and numbness of the entire injected arm on day of the vaccination. Fatigue, muscle aches, headache, fever, injection sight soreness, and feeling unwell the entire day after the vaccination.
21 2021-03-28 fainting fainted when I sat down; stood up and started to feel dizzy; I felt throat pain like strep throat pa... Read more
fainted when I sat down; stood up and started to feel dizzy; I felt throat pain like strep throat pain; started feeling very intensive cramps in my lower abdomen like very intense period cramps for about 10 minutes.; felt very weak with no energy to get out of bed; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3302) via an unspecified route of administration, administered on the right arm on 11Mar2021 16:00 at a single dose for COVID-19 immunisation. Medical history included low thyroid. There were no concomitant medications. After receiving the shot of the vaccine on 11Mar2021 16:00, the patient stood up and started to feel dizzy. She was able to find a nearby chair and fainted when she sat down. When she woke up seconds later of fainting, she felt throat pain like strep throat pain and then she started feeling very intensive cramps in her lower abdomen like very intense period cramps for about 10 minutes. The patient stated that nobody in the (Pharmacy name) was prepared to react to these symptoms and the rescue took too long to come in, when they came in she was feeling better and did not see the need of going to the hospital. But it was an immediate reaction that affected 3 different parts of her body that was very painful. During the day and the day after she felt very weak with no energy to get out of bed. "I am wondering if I can still receive the second dose after this reaction to the first dose?" No treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Patient was not pregnant. No known allergies. The facility where the vaccine was administered was in a pharmacy drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was recovering.
21 2021-03-29 blood pressure increased, chest discomfort Pt complained of itchy eyes with redness on her face. She then started complaining of tightness in h... Read more
Pt complained of itchy eyes with redness on her face. She then started complaining of tightness in her chest and trouble swallowing. We called 911 and rescue came to check her. Upon arrival her BP was elevated and she was lightheaded so they took her to hospital.
21 2021-03-29 chest pain Patient notes dizziness, chest pain, and right arm numbness/pain after vaccination. Monitored with p... Read more
Patient notes dizziness, chest pain, and right arm numbness/pain after vaccination. Monitored with provider for 15 minutes without resolution and addition of nausea. Transferred to ED.
21 2021-03-29 chest pain Patient states she is having chest pain, sob, and dizziness. Did not resolve after 30 min wait. Tran... Read more
Patient states she is having chest pain, sob, and dizziness. Did not resolve after 30 min wait. Transported to ED. Provider notified.
21 2021-03-29 nosebleed Nosebleed in right nostril. I VERY rarely get a nosebleed. From what I could feel, my nose was not s... Read more
Nosebleed in right nostril. I VERY rarely get a nosebleed. From what I could feel, my nose was not sore, dry, or cracked to have made me bleed. The nosebleed occurred randomly and lasted approximately 10 minutes.
21 2021-03-29 hypotension Patient experienced low blood pressure and blurred vision. The patient recovered after 20 minutes.
21 2021-03-29 palpitations Patient felt anxious prior to coming for vaccine due to last minute sign up. Right after getting th... Read more
Patient felt anxious prior to coming for vaccine due to last minute sign up. Right after getting the vaccine she experienced her throat tightening - stated she felt off- was shaky, lightheaded and heart racing. She came to the observation station- while sitting for observation she felt she wanted to get away from everyone else and came to the check in desk. Her symptoms started to subside when I escorted her to the recliner. I gave her some Gatorade bP 90/60 pulse 80. She was feeling less anxious O2 sat done at 11:51 99 % she stated she was feeling fine . repeat BP 104/60 p 60 at noon. I checked with lead at the clinic who agreed she should stay till 12:10 She felt fine when she left this nurse discussed the plan if she needed help would be to go to urgent care or call police if it was urgent.
21 2021-03-29 fainting, chest discomfort Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemi... Read more
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild
21 2021-03-29 fainting immediately after receiving her vaccination, she reported feeling lightheaded, then syncopized for a... Read more
immediately after receiving her vaccination, she reported feeling lightheaded, then syncopized for approx 10 sec. She was taken to a private section of the arena and monitored.
21 2021-03-29 fast heart rate Two small hives on left side of neck, fatigue, headaches, body aches, increase in tachycardia sympto... Read more
Two small hives on left side of neck, fatigue, headaches, body aches, increase in tachycardia symptoms, shortness of breath. Tachycardia was treated in ER with IV saline.
21 2021-03-30 heart rate increased Post Covid vaccine while in observation area patient complained of heart beating fast, some difficul... Read more
Post Covid vaccine while in observation area patient complained of heart beating fast, some difficulty breathing, feeling anxious. Skin was warm and clammy, vital signs taken, O2 sat 100% and she developed hives on her upper chest and neck area. Benadryl 12.5 mg given x 2 , 5 minutes apart. EMS was called and patient transported to Hospital for further evaluation.
21 2021-03-30 hypertension Patient received the Covid-19 vaccine. She reports symptoms of dizziness, full feeling in the head, ... Read more
Patient received the Covid-19 vaccine. She reports symptoms of dizziness, full feeling in the head, sweaty palms. Patient has history of POTS, states she experiences same symptoms when ill {Immediate reaction less than 1 hour:5552530}. I have observed sweaty palms, hypertension. No shortness of breath or rash noted. Vital signs were taken as follows: 1055: BP 154/82, HR 90, O2 sat 97%. 1100: BP 148/104, HR 96, O2 sat 100%. 1106: BP 142/85, HR 72, O2 sat 100% 1111: BP 147/83, HR 63, O2 sat 100% 1117: BP 145/93, HR 59, sat 100% 1125: BP 146/86, HR 65, O2 sat 100% Patient waited for 35 minutes; reported improvement of symptoms. HR decreased, was able to ambulate without dizziness, and was discharged home at 1130. No shortness of breath or rash noted.***
21 2021-03-30 fainting Three hours after the vaccine, the patient experienced nausea, vomiting and had syncope at home. She... Read more
Three hours after the vaccine, the patient experienced nausea, vomiting and had syncope at home. She notice a petechial rash along her neck and chin.
21 2021-03-31 blood pressure increased Pt arrives to the observation area following her vaccination with complaints of headache and dizzine... Read more
Pt arrives to the observation area following her vaccination with complaints of headache and dizziness. She is with her mother. She arrives at 1555 with a headache and dizziness and being flushed. BP 161/120 HR 99 Oxygen 100% room air she is Aox3 1605 BP 169/123 HR 100 oxygen 100% room air remains flushed apple juice given patient tolerated well 1610 manual BP done 148/120 1620 BP 172/120 HR 104 Pt is reluctant to go to the ED by ambulance but with mother she has agreed to go and EMS notified 1625 pt complaints of nausea bp 170/109 hr 104 oxygen 98% room air 1630 pt remains flushed still complaining of a headache and arms being cold, pt covered with a jacket 1640 report given to a Crew Member and pt transported to Hospital mom to follow ambulance
21 2021-03-31 chest discomfort Caller states that she received her 1st Pfzier vaccine on 03/31/2021. At approx 4:00 pm, noted " c... Read more
Caller states that she received her 1st Pfzier vaccine on 03/31/2021. At approx 4:00 pm, noted " chest heaviness, swelling of her throat with a cough". Appears to be in no acute distress, denies difficulty of breathing and able to speak in clear, complete sentences. Instructed to seek emergency care for an evaluation.
21 2021-03-31 chest discomfort 2:25 PM: Patient reported facial itching at 2:25pm, coughing and chest tightness. Difficulty speaki... Read more
2:25 PM: Patient reported facial itching at 2:25pm, coughing and chest tightness. Difficulty speaking. BP 136/100 , HR 110, RR 24, SPO2 95%. Alert and oriented, feelscold and calmy. Medications: EPI-pen administered per protocol at 2:28pm in L thigh. 911 called, ambulance dispatched. Monitored until 2:34 BP 140/98, HR 108, SPO2 99. EMS arrived 2:45pm. Transported to hospital.
21 2021-04-01 loss of consciousness VACCINE GIVEN AND WITHIN 1 MIN FELT NAUSEOUS AND HEAD WENT BACK UNCONSCIOUS. AMONIA IHALENT USED. AW... Read more
VACCINE GIVEN AND WITHIN 1 MIN FELT NAUSEOUS AND HEAD WENT BACK UNCONSCIOUS. AMONIA IHALENT USED. AWAKENED. ASSISTED TO WHEEL CHAIR. CONTINUE TO MONITOR. FLUIDS AND CRACKERS GIVEN. BP 84/50-100 SPO2 93%. MONITORED X 30MINUTES. 12:07PM FEELING BETTER. DRINKING FLUIDS. 12:18PM EATING AND DRINKING. BP 94/60 P108. COLOR PINK. TAKEN BY W/C TO DOOR. HOME ADDITIONAL BOTTLE OF WATER GIVEN. NO N/V.
21 2021-04-02 palpitations after administration patient felt flush, heart racing, and shaky. The patient was given juice and c... Read more
after administration patient felt flush, heart racing, and shaky. The patient was given juice and crackers, then felt improved. patient was released on their own accord.
21 2021-04-02 fainting Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsiv... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient fainted shortly after injection. She recovered quickly, but felt confused, sweaty, and tingling in her arms after. She felt better after about 15 minutes, but we had to stay to observe for 30minutes after. She was feeling better by the time she left the store.
21 2021-04-04 chest discomfort, skin turning blue, pallor Feeling lightheaded, color pale, c/o chest tightness at shot table. Taken via w/c directly to privat... Read more
Feeling lightheaded, color pale, c/o chest tightness at shot table. Taken via w/c directly to private observation. Removed mask, opened doors. Lips gray. Feels "cloudy" headed. BP 59/40 HR 84. Resp 18 on r/a. 1253 O2 99% HR88 Drank 4 oz water, denies nausea. Had some pretzels for breakfast this morning. Did not drink prior to vaccine. States chest tightness gone. 1258 BP 102/87; HR 82 finished graham crackers. 1304: Sitting BP 101/85 states she feels better. Color pinker. Stood at w/c and BP recheck while standing is not palpable. Upon standing states head is clouding over again. Placed on cot, supine with legs elevated. Instructed to call friend to drive her home. 13:11 BP lying down is 114/72 HR 68 O2 99% 1330 BP 108/70 HR 78 O2 99% , still supine. 1331 BP sitting up is 118/88; stood at cot and BP standing is 127/83 1345 Taken via w/c to awaiting car driven by friend
21 2021-04-04 pallor, fainting, loss of consciousness Experienced syncopal episode while seated in chair at Exit station after receiving first dose of Pfi... Read more
Experienced syncopal episode while seated in chair at Exit station after receiving first dose of Pfizer COVID 19 Vaccine. Patient was found to be pale, diaphroretic and + LOC. Was transferred to cot and surrounded by privacy screen. 18:10 118/60 HR 70 95% SpO2. Cold packs were provided to back of neck and forehead. In addition water and snack were provided when return to full consciousness was achieved. Was observed for an additional 30 mins. Full resolution of symptoms. 18:30 140/88 HR 60 98% SpO2. No further incident occurred and patient was released to significant other and told to call 911 if symptoms worsened.
21 2021-04-04 pallor after about 10 seconds of getting vaccinated, the patient kind of rolled her eye a little bit and li... Read more
after about 10 seconds of getting vaccinated, the patient kind of rolled her eye a little bit and lips became pale and vomited later too.
21 2021-04-04 fainting, loss of consciousness Approximately 10 minutes after vaccine administration the patient told her mother she was dizzy whil... Read more
Approximately 10 minutes after vaccine administration the patient told her mother she was dizzy while sitting in a chair outside the pharmacy. I, the pharmacist, ran to the scene and the patient was regaining consciousness as I approached. Her skin was red, and she was disoriented for a moment before asking what had happened. Her mother state she began shaking, and her head slumped as she fainted momentarily. EMS arrived and determined the patient was well enough for her mother to drive her home. The patient reported nervousness, and stated before vaccination that she had dizziness and fainting with Guardisil, but that it did not occur until 3 hours after administration while she was at home.
21 2021-04-05 blood pressure increased After vaccination, felt tightness in throat, similar to GERD, and then had an anxiety reaction. Skin... Read more
After vaccination, felt tightness in throat, similar to GERD, and then had an anxiety reaction. Skin appeared flushed. BP elevated and pulse was regular, 120 beats. O2 saturation= 98%. With relaxation techniques pulse and BP came down, but skin remained flushed. Benadryl 50mg IM given in left deltoid by APRN. At 5:30 pm, pulse was 85. Parents were contacted and arrived to clinic to drive the patient home. Advised to come accompanied by parent for dose #2.
21 2021-04-05 fainting Pt had syncopal episode followiing first dose of vaccine. Easily aroused
21 2021-04-06 heart rate abnormal, chest discomfort, blood pressure fluctuation After 5 minutes my arm started burning. Then I got cold sweats. After 20 minutes I was struggling to... Read more
After 5 minutes my arm started burning. Then I got cold sweats. After 20 minutes I was struggling to breathe. It felt like something was sitting on my chest. My lips and throat also got very itchy. I went over to a paramedic who gave me IV benadryl and something for nausea. My blood pressure and HR were initially high but lowered. My O2 was fine. Then I got really light headed and my tongue, throat, and whole face got more itchy. I then went to the ER and got epipen intramusclarly in the ambulance. At the hospital I got steroids and an IV bag. Around 3:30 I started to feel normal again. I stayed under observation for 4 hours. THen got discharged with a prescription of steroids.
21 2021-04-06 fainting Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-M... Read more
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Additional Details: PATIENT FAINTED AND HIT HER HEAD ON THE FLOOR. SHORTLY AFTERWARDS, SHE GOT UP AND SAT DOWN ON THE CHAIR FOR 30 MINUTES AND DRANK WATER AND JUICE BEFORE BEING DRIVEN TO EMERGENCY ROOM.
21 2021-04-06 fainting patient fainted for 30 sec the regained consciousness
21 2021-04-07 chest discomfort Arm soreness and nausea began at 4:00pm on 04/07/2021 and are continuing. Back pain/cramps/spasms... Read more
Arm soreness and nausea began at 4:00pm on 04/07/2021 and are continuing. Back pain/cramps/spasms; headache; tightness in chest; chills began at 5:00am on 04/08/2021 and are continuing.
21 2021-04-07 loss of consciousness, heart rate increased Sweating, difficulty breathing, increased heartbeat, passing out, nausea. Given water and crackers, ... Read more
Sweating, difficulty breathing, increased heartbeat, passing out, nausea. Given water and crackers, was coached on breathing Recovered breathing and conscious within 2 min. Was held longer in order to be monitored for any repeat symptoms was released after 40 min
21 2021-04-07 loss of consciousness Immunization administered, approximately 5 minutes later while being observed, patient was holding h... Read more
Immunization administered, approximately 5 minutes later while being observed, patient was holding head and bending over - I went over to check on patient - she stated she was lightheaded, dizzy and ears were ringing. I stayed next to her as a team member got a cold bottle of water and used as a compress on back of neck. She stated it was intensifying. I had the store manager call 911 she appeared to pass out for a second as she came around she said her tongue was sore. but no problems breathing, itching , hives or swelling of tongue. the other symptoms reduced . the EMS arrived and she was feeling better. EMS took Blood pressure and heart rate - both were normal. She refused to be transported and EMS waited until she could stand. I recommended to call the primary care physician to discuss seconf dose and posssilby have the second dose at a mass vaccination site where there is a physician because it took 15 miuntes for EMS to arrive.
21 2021-04-07 fainting, loss of consciousness, blood pressure decreased Pt became anxious, sweaty and dizzy. Developed tunnel vision and loss of consciousness. Staff with p... Read more
Pt became anxious, sweaty and dizzy. Developed tunnel vision and loss of consciousness. Staff with pt at time of syncopal episode and assisted pt to floor. Pt regain consciousness within 1 minute. Pt placed on stretcher and arrived to med obs at 1558. Vitals obtained. At this time pt states she is feeling normal. At 1611 c/o dizziness and nausea. BP rechecked and notably dropped. Pt placed in the trendelenburg position. BP increased. Nausea and dizziness resolved. Snacks and water given. Pt left facility 1712, friend driving. Vitals as follows; 1600 BP 107/74 HR 85 RR 22 spo2 98% 1611 BP 97/68 HR 78 RR 20 spo2 100% 1625 BP 109/76 HR RR 18 spo2 99% 1705 BP 95/66 (standing, asymptomatic)
21 2021-04-07 fainting, loss of consciousness lost consciousness and fainted two times; lost consciousness and fainted two times; This is a sponta... Read more
lost consciousness and fainted two times; lost consciousness and fainted two times; This is a spontaneous report from a contactable consumer (patient) reported for herself that a 21-year-old female received bnt162b2, dose 1 via an unspecified route of administration, administered in right arm on 25Mar2021 15:00 (Lot Number: 10350) as single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Patient was not pregnant at the time of vaccination. Medical history included asthma, attention deficit hyperactivity disorder (ADHD), Bipolar II and post-traumatic stress disorder (PTSD). Prior to vaccination, patient was diagnosed with COVID-19 on an unknown date. No allergies to medications, food, or other products. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI 24 FE), methylphenidate hydrochloride (CONCERTA), aripiprazole (ABILIFY) and escitalopram oxalate (LEXAPRO). On 25Mar2021 15:00, the patient lost consciousness and fainted two times. Paramedics were called and she was released. The events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No treatment was received for the events. The patient underwent lab tests and procedures which included Nasal Swab: positive on 06Jan2021. The outcome of the events was recovered in Mar2021. The events lost consciousness and fainted occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.
21 2021-04-07 fainting Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsi... Read more
Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Medium, Systemic: Shakiness-Medium
21 2021-04-07 fast heart rate, hypotension severe Weakness, and body fatigue limiting ability to conduct normal activities of daily living .ad... Read more
severe Weakness, and body fatigue limiting ability to conduct normal activities of daily living .additionally tachycardia and hypotension
21 2021-04-08 loss of consciousness Systemic: Dizziness / Lightheadness-Mild, Systemic: Patient blacked out (10 sec) post vaccination-Mi... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Patient blacked out (10 sec) post vaccination-Mild, Additional Details: Post vaccination pt blacked out for 10 sec while sitting in the chair immediatly post vaccination. NP was called to assess. Patient became responsive shortly and was given water and chips via employee. Patient stated she has a fear of needles and always passes out while given blood for Hoshimotos which is in remission. Called paramedics and assessment was normal. Mother of pt came shortly after and confirmed daughter usually passes out from needles. Issued form for no liability was signed. Pt walk
21 2021-04-09 very slow heart rate, pallor Pale, dizziness, emesis, bradycardic
21 2021-04-09 chest pain Deep chest pain, trouble breathing, aches all over particularly in upper body.
21 2021-04-09 pallor Patient stated feeling blurred vision, throat tightness, anxiety, shortness of breath, patient appea... Read more
Patient stated feeling blurred vision, throat tightness, anxiety, shortness of breath, patient appeared pale Patient provided water and seen by medical team Patients blood pressure was 86/59 and heart rate 97, patient provided with water Patient advised to be seen in hospital, patient refused medical transport and signed AMA form Patient agreed to go to hospital , driven by boyfriend
21 2021-04-09 lightheadedness, fainting Set off extreme fatigue that led to syncope and near-syncope episodes; Set off extreme fatigue that ... Read more
Set off extreme fatigue that led to syncope and near-syncope episodes; Set off extreme fatigue that led to syncope and near-syncope episodes; Increased orthostatic intolerance; Increased orthostatic intolerance; Set off extreme fatigue that led to syncope and near-syncope episodes; This is a spontaneous report received from contactable consumer (patient). A 21-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: EB8727) via an unspecified route of administration in the right arm on 24Mar2021 11:30 AM (at the age of 21-year-old) as single dose for COVID-19 immunization in school or student health clinic. Medical history included ongoing POTS (Postural orthostatic tachycardia syndrome). Patient was not allergic to medications, food, or other products. 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 corticosteroids, antihistamine and NSAID (all received within 2 weeks of vaccination). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration in the left arm on 03Mar2021 10:00 AM for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Mar2021 19:30 (reported as within 8hrs of vaccination), the patient experienced set off extreme fatigue that led to syncope and near-syncope episodes. Patient did not have an episode of POTS in months until receiving second dose, the patient experienced increased orthostatic intolerance. The patient did not receive any treatment for the events. The outcome of the events set off extreme fatigue that led to syncope and near-syncope episodes and increased orthostatic intolerance was recovering. No follow-up attempts are possible. No further information is expected.
21 2021-04-09 fainting I felt severe arm pain after the injection. About 12 hours later I had a fever of 100.1 and went to... Read more
I felt severe arm pain after the injection. About 12 hours later I had a fever of 100.1 and went to bed. At 1 am I went to the restroom and passed a good deal of blood as I am on my period. I got up and then fell to the floor. Then I went to my parents bedroom and fell again. I drank two bottles of water and took Tylenol at that point and after about two hours I felt better and went to sleep. I also twisted my ankle when I fell the first time. I have never fainted nor have I had such severe cramps or passed so much blood associated with a period.
21 2021-04-11 chest discomfort Employee received first dose of vaccine and states she became nauseous. Reassurance given declined ... Read more
Employee received first dose of vaccine and states she became nauseous. Reassurance given declined crackers, did eat hard candy and small sips of water, spoke with her mom and requested to be evaluated in the Emergency Department. Once arrived in the Emergency Department employee stated she felt like her chest was going to explode. B/p 119/70, P 82, R 16, Temp 96.9.
21 2021-04-11 nosebleed Chills, vomiting on and off for about 12 hours, severe body aches, on and off fever, nose bleeds, fa... Read more
Chills, vomiting on and off for about 12 hours, severe body aches, on and off fever, nose bleeds, fatigue and shortness of breath.
21 2021-04-11 fainting Pfizer-BioNTech COVID- 19 Vaccine EUA: Vaccine recipient had syncope with fall post vaccination. The... Read more
Pfizer-BioNTech COVID- 19 Vaccine EUA: Vaccine recipient had syncope with fall post vaccination. They refused transport to the emergency room.
21 2021-04-12 chest discomfort Dizziness & chest tightness.
21 2021-04-12 fainting patient fainted but usually faints with vaccines
21 2021-04-12 fast heart rate Saturday morning, the arm felt sore - I did notice a little red spot. I felt fatigue and a slight he... Read more
Saturday morning, the arm felt sore - I did notice a little red spot. I felt fatigue and a slight headache. Saturday night to Sunday morning , the spot got bigger (on the injection site). I drew a circle around it. It got a little bigger on Sunday. They other symptoms subsided at the end of Sunday. The redness didn't seem to be going away on the injection site. On Monday, I just had the red arm and it hurt pretty bad to touch. It was tender and warm to the touch. I was at work and I felt shortness of breath just walking down the hall. I took my pulse while I was standing still and it was about 120. Near the afternoon, I was instructed to go to URGENT CARE to get it checked out. Closer to the afternoon, I started noticing that the heartrate (on my watch) it got to 164. I went to URGENT CARE and they stated it was a normal reaction to vaccine but because of my tachycardia they wanted to send me to Hospital ER. At ER they weren't worried about injection site (still pretty painful) they were worried about how fast my heartrate was going. The wanted me. The injection site and the tachycardia was back to normal.
21 2021-04-13 lightheadedness Pre-syncopal, lightheaded. Evaluated by EMS-Cleared
21 2021-04-14 hypertension Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypertension-Mild
21 2021-04-14 palpitations, loss of consciousness Patient loss consciousness. Vaccine administered around 1240, approximately at 1250 patient pass out... Read more
Patient loss consciousness. Vaccine administered around 1240, approximately at 1250 patient pass out. Observer called for help and EMS was activated at 1250. Patient was flushed and not breathing, observer pushed EpiPen 0.3mL (Lot #0FM200 Exp: OCT2021)for 10 seconds at 1252. Patient woke up, helped arrived and was moved into private patient room. Fire was called at 1254 arrived at 1303. Vital signs taken at 1258 BP: 71/39 HR:73 O2: 100% Temp:98.7 degrees Celsius. Second Vital signs taken at 1300 BP: 86/49 HR:97 O2: 99% Temp:98.7 degrees Celsius. Patient stated before passing out symptoms of light headedness and heart racing and flushed. Patient improving symptoms, transported to the Hospital at 1307.
21 2021-04-14 fainting The patient received the Pfizer vaccination and had filled out their consent form having everything ... Read more
The patient received the Pfizer vaccination and had filled out their consent form having everything checked no. After given their immunization they were instructed to sit for the required 15 minutes. AMA the patient got up from chair and approached the counter to ask if they could use a restroom. When the pharmacist approached her, she fainted and bumped her head on the dividing partition on her way down. Pharmacist went out immediately to the patient. 911 was called. The patient was already conscious again. The paramedics to her with them, as they wanted to check her. She was still orthostatic, and they advised to her they felt it would be a good idea. Employee tried to call on 4/14/21 and the patient did not answer.
21 2021-04-15 loss of consciousness Passed out and threw up within 15 minute waiting period. Since then have had a fever, body aches, he... Read more
Passed out and threw up within 15 minute waiting period. Since then have had a fever, body aches, headache, nausea, chills and joint pain.
21 2021-04-15 fainting Syncope - hydration + rest; BP 123/57; HR 70; RR 18
21 2021-04-15 blood clot Painful cramps, heavier period on first day with clots. Not my usual period, heavier.
21 2021-04-16 loss of consciousness Pt reported feeling dizzy immediately after administration of first dose. Pt lost consciousness whil... Read more
Pt reported feeling dizzy immediately after administration of first dose. Pt lost consciousness while still seated. Supported in chair by administering nurse, then transported to w/c with assistance of on-site EMTs. Pt was unconscious for less than 15 sec. Pt was diaphoretic, "clammy." VS checked by EMTs and were WNL (BP 118/70, HR 73, SpO2 97% on room air). Pt had some water and rested while seated. Pt stated she did not tell administering nurse she has a hx of vasovagal response to injections. After 20 min of monitoring in observation, VS remained WNL. Pt was alert and responsive, verbalized that she was feeling fine. Pt was told to seek further treatment if symptoms return or if new symptoms develop. Pt verbalized understanding before leaving facility.
21 2021-04-16 lightheadedness vasovagal reaction
21 2021-04-18 heart rate increased About 5 minutes after I had gotten the shot my heart rate increased pretty rapidly, my hands got pre... Read more
About 5 minutes after I had gotten the shot my heart rate increased pretty rapidly, my hands got pretty cold and I started sweating. I felt nauseous and had a throbbing headache. I went back to my room and was incredibly hazy and slept for about 10 hours. I woke up the next day and I was throwing up, there was a bit of blood in my throw up at the time. I had thrown up for three days. I still did not feel like my self and had waves of nausea, headaches, body aches for almost 2 weeks straight.
21 2021-04-18 loss of consciousness, pallor, fainting WEAKNESS, NAUSEA, VOMITING, SYNCOPE WITH URINARY INCONTINENCE. DESCRIBED FEELING WEAK AND NOT GOOD ... Read more
WEAKNESS, NAUSEA, VOMITING, SYNCOPE WITH URINARY INCONTINENCE. DESCRIBED FEELING WEAK AND NOT GOOD BEING UP EVERY HOUR WITH NAUSEA. WOKE UP AT 7AM, VOMITED AND PASSED OUT ON BATHROOM FLOOR WITH INCONTINENCE OF URINE. ROOMMATE DESCRIBED SEIZURE LIKE ACTIVITY WHILE PT WAS ON THE FLOOR. PALLOR. DIZZINESS. PT GIVEN 1L NS, CT SCAN AND LABS.
21 2021-04-18 pallor Client began to feel dizzy and lightheaded. She also complained of nausea. Nurse observed client app... Read more
Client began to feel dizzy and lightheaded. She also complained of nausea. Nurse observed client appeared pale. Nurse took pt's vitals over the next 18minutes and they remained stable. After about 18min client stated she was feeling better and was released to personal vehicle shortly after that.
21 2021-04-18 lightheadedness, loss of consciousness patient recvd vaccination with immediate onset presyncope with diaphoresis with eventual momentary L... Read more
patient recvd vaccination with immediate onset presyncope with diaphoresis with eventual momentary LOC. recovered within 3 seconds. monitored in observation for 15 minutes. patient lucid with nl BP, 100/68. no dizziness with postural changes after recovery. patient was with mother who accompanied the patient out
21 2021-04-18 fainting syncope; laid patient on the ground with feet elevated. provided water, food and ice packs
21 2021-04-19 chest pain The first 2 days she had mild nausea and headaches. The 3rd day she developed chest pain, worse on... Read more
The first 2 days she had mild nausea and headaches. The 3rd day she developed chest pain, worse on the left than right, radiates to the back. She states chest pain has continued and has been constant since then. Worse with movement, deep breaths, and lifting a heavy case at work. Rates pain 3-6/10 and describes as sharp and "twinge" with movement. She has taken OTC medication for the pain without relief. There is no where that is tender to touch. She is able to do her usual activities and states she is very active at work. Feels the pain limits her breathing at times and causes some SOB. She is able to speak in full sentences over the phone without difficulty. No audible wheeze. Had asthma as a child but much improved as an adult. Denies left arm, neck or jaw pain, lightheadedness, dizziness, nausea, vomiting, cough, fever, or sore throat. She is eating and drinking normally. She notes she has a family hx of cardiac disease and stroke. No MI before the age of 50 or sudden cardiac death that she knows of. She has a nexplanon implant and is on norethindrone and estradiol.
21 2021-04-20 chest pain 2 minutes after receiving vaccination, patient developed left upper arm pain and left sided chest pa... Read more
2 minutes after receiving vaccination, patient developed left upper arm pain and left sided chest pain, described as constant tight and heavy with a 5/10 intensity, w/o SOB, abdominal pain, pruritic, hives or swelling, no numbness or tingling, chest pain Allergy to amoxicillin - unsure of reaction Current medications include atomoxetine, Pristiq, singular, larin, trazodone heart rhythm regular, lungs clear, no facial/lip/tongue/oropharyngeal swelling. No hives and no meds given
21 2021-04-20 pallor Patient with sitting in chair stated she felt like she was gonna pass out and felt warm. Patient was... Read more
Patient with sitting in chair stated she felt like she was gonna pass out and felt warm. Patient was transferred into wheelchair and into the ems Room and put on our stretcherat 0900. Bas lins vs obtain 110/71 hr73 100% rep 18. Skin color pale . After about 10 min. Skin color cane back to normal. Pt states she felt beter. . Pt was released at09:29
21 2021-04-20 fainting Systemic: Fainting / Unresponsive-Mild, Additional Details: she became semi unresponsive, was dizzy ... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: she became semi unresponsive, was dizzy and sat for atleast 45 minutes
21 2021-04-21 lightheadedness Dizziness, vasovagal response. BPs 86/48 (pulse 74), 108/67 (pulse 88). O2 sat 100%. Hydration and r... Read more
Dizziness, vasovagal response. BPs 86/48 (pulse 74), 108/67 (pulse 88). O2 sat 100%. Hydration and rest.
21 2021-04-21 fainting Post vaccine syncope. Brought to observation tent, recovered.
21 2021-04-22 chest pain Day of Pfizer COVID-19 Vaccine, pt experienced fever, soreness under her arm, HA, chest and back ach... Read more
Day of Pfizer COVID-19 Vaccine, pt experienced fever, soreness under her arm, HA, chest and back aches and hand numbness. She took tylenol for relief--had chest pain(sometimes occurs with pain med usage). Did not reach out for medical advice. Symptoms resolved on their own.
21 2021-04-22 nosebleed Received 2 bloody noses during the day on 4/6/21, then 3 bloody noses on 4/8/21
21 2021-04-22 fainting PATIENT WITH SYNCOPE EPISODE WITH TONIX POSTURE NOTED. PATIENT AROUSED TO VERAL STIMULATION POST EPI... Read more
PATIENT WITH SYNCOPE EPISODE WITH TONIX POSTURE NOTED. PATIENT AROUSED TO VERAL STIMULATION POST EPISODE. VITAL SIGNS WERE 99/56, HEART RATE 63, RESPIRATIONS 20, OXYGEN 98%. CLEAR BILATERAL BREATH SOUNDS. NO INCREASE OF SHORTNESS OF BREATH NOTED. WATCH AN ADDITONAL 15 MINUTES.
21 2021-04-23 chest discomfort Patient reports having chest tightness a few minutes after having vaccination. She used her albutero... Read more
Patient reports having chest tightness a few minutes after having vaccination. She used her albuterol inhaler and then shortly after this she was evaluated. VSS patient denies SOB, chest pain, palpitations no sensation of airway edema. Patient given 50mg oral Benadryl and after 30 minute observation period she states symptoms completely resolved.
21 2021-04-24 nosebleed The morning after my shot (04/25/2022), at 10:00am, I experienced my first nose bleed. The nose blee... Read more
The morning after my shot (04/25/2022), at 10:00am, I experienced my first nose bleed. The nose bleed was accompanied by very bloody phlegm. This lasted for approximately 15 minutes and then stopped bleeding.
21 2021-04-24 loss of consciousness The charge nurse was called to the scene by the scribe because the patient stated that her vision go... Read more
The charge nurse was called to the scene by the scribe because the patient stated that her vision got blurry and lightheaded. Patient lost consciousness and was caught by one of the nurses. She was lowered to the yoga mat and her feet were placed on top of a chair. When the patient regained consciousness, she stated that she had no allergies, has eaten before getting the vaccine and has no history of fainting or anxiety. She has no medical history that she knows of. After talking to the patient, her vision improved and she stated that she feels better. Patient was transferred to observation and was observed for 30 min.
21 2021-04-24 fainting I fully fainted two times about 15 hours post vaccine. I could not stand up or get out of bed becaus... Read more
I fully fainted two times about 15 hours post vaccine. I could not stand up or get out of bed because I would black and and throw up when I came to.
21 2021-04-24 fainting Now in with syncopal episodes. Has had a loop recorder in place Jan 2021. dx with POTS
21 2021-04-25 loss of consciousness Patient passed out within 3 minutes of receiving vaccine.
21 2021-04-26 chest discomfort Patient with a history of anaphylactic reaction to Advil developed a possible biphasic allergic reac... Read more
Patient with a history of anaphylactic reaction to Advil developed a possible biphasic allergic reaction to Pfizer Covid vaccine (lot EN6208) given on 3/17. Patient initially had urticarial rash on 3/19 and it was treated with Benadryl and Solu-medrol. Patient was discharged on daily prednisone. However, patient returned on 3/21 with facial swelling, chest and throat tightness and shortness of breath. Prior to ED arrival, patient self-treated with EpiPen. At the ED, Benadryl, Pepcid, and Solu-medrol were given and continued for 2 days during hospitalization. No further respiratory distress developed, but the patient still had intermittent itching and rash. Patient was discharged on tapered prednisone, Benadryl as needed and Pepcid.
21 2021-04-26 chest pain Patient developed chest pain about 27 hours after 2nd Pfizer vaccine. Central chest pain, not repro... Read more
Patient developed chest pain about 27 hours after 2nd Pfizer vaccine. Central chest pain, not reproducible. She went to ED on 4/23/21 and had evaluation including D-dimer which was above 4000. Recheck on 4/26/21, D-dimer level was 177. Imaging studies and other labs negative.
21 2021-04-26 heart rate increased Patient received her vaccine around 1:10 pm and was waiting in our lobby for the recommended 15 minu... Read more
Patient received her vaccine around 1:10 pm and was waiting in our lobby for the recommended 15 minutes. After 10 minutes, her body began to seize/shake for about 10-15 seconds and then she went completely limp in the chair she was seated in. I removed her mask to help with her breathing and lifted her head slightly. She began to seize/ shake again and then woke up. Patient was disoriented and reported of head pain, feeling hot and rapid heart rate. We called 911 and EMT arrived a few minutes later, checked her vitals, which all came out normal, and spoke with the patient for a few minutes. Patient refused to go to the hospital and wanted to wait for her mother to arrive. She has no history of seizures and only takes Zyrtec OTC. The patient's mother arrived and spoke with the EMT personnel and I spoke with her as well. I recommended that the patient does not receive the second dose until she has been checked by a doctor and has been given approval to receive it. The patient recovered after about 20-30 min since the event and went home with her mother.
21 2021-04-26 heart rate increased Approximately 10 hours after injection (injection at 5pm on 4/21), the first symptoms came on sudden... Read more
Approximately 10 hours after injection (injection at 5pm on 4/21), the first symptoms came on suddenly and lasted for about 7 hours (3am-10am on 4/22). These symptoms included severe nausea, headache, weak/rapid heart rate, chills, muscle aches, and a fever of 101 degrees F. Lymph nodes in the left armpit were also swollen and painful to the touch. After 10am, the chills and fever subsided, but the headache, general muscle aches, swollen lymph nodes, and bouts of nausea persisted (these lasted the entire day). The following day (4/23), nausea and muscle aches subsided but the headache remained. The headache only came on whenever changing elevation of the head (standing up, sitting down, bending over), at which point it would be painful for a few minutes after moving. An extremely stiff, painful neck also began the same day (4/23) and persisted for approximately 2 days after injection (accompanied by the headache). Lymph nodes under the collar bone on the left side of the body also became swollen (4/23). Lymph nodes in armpit and under collarbone are still swollen 6 days after injection, although not painful.
21 2021-04-26 fainting, heart rate increased Pt is a college student. She received her 1st Covid vaccine (Pfizer) on 4/15/2021 at 4:30 pm. On 4/1... Read more
Pt is a college student. She received her 1st Covid vaccine (Pfizer) on 4/15/2021 at 4:30 pm. On 4/16/2021, pt woke up with elevated heart rate and dizzy spells. Had 2 episodes of syncope. (Was seen at Urgent Care but transferred. Pt was given IV fluids. Advised to monitor for tachycardia, dizziness. if symptoms persisted-advised to see PCP for Holter monitor. Pt reports heart rate ranges 90-100. OCC dizziness with change of position. no further syncope.
21 2021-04-26 fainting Patient had a syncopal episode after vaccine adminsitration. Normal reaction for patient after injec... Read more
Patient had a syncopal episode after vaccine adminsitration. Normal reaction for patient after injections.
21 2021-04-27 chest discomfort Patient complained almost immediately of a burning sensation on her entire arm, which progressed qui... Read more
Patient complained almost immediately of a burning sensation on her entire arm, which progressed quickly into itching on the left arm. She denied any SOB or itching of throat or mouth, however within a few minutes the itching progressed to her right side and onto her chest. She then complained of her eyes watering and then stated her chest was growing tight. EMS arrived at this point and took her to the ER
21 2021-04-27 loss of consciousness I have passed out three times.; arm pain; body aches; This is a spontaneous report from a non-contac... Read more
I have passed out three times.; arm pain; body aches; This is a spontaneous report from a non-contactable consumer (patient). A 21-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The facility type vaccine was school or student health clinic. There were no other vaccine in four weeks. On 09Apr2021 at 14:45, the patient have passed out three times. The patient also had arm pain and body aches on 09Apr2021 14:45. She had no fever, and she was well hydrated. She have not taken any medication at all since then. There was no treatment for the events. The patient had no COVID prior vaccination and has not been tested for COVID post vaccination. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
21 2021-04-29 heart rate increased, loss of consciousness She was waiting the advised 15 minutes and passed out. Rapid heart rate with fluttering eyes - unsur... Read more
She was waiting the advised 15 minutes and passed out. Rapid heart rate with fluttering eyes - unsure if it was seizure. after about 5 minutes she came to and started complaining of being cold with chills .
21 2021-04-29 pallor Feeling sweaty, ear ringing, light-headed, nausea, pins and needles after sitting back up in chest. ... Read more
Feeling sweaty, ear ringing, light-headed, nausea, pins and needles after sitting back up in chest. Vital Signs: BP 96/60 HR 63 Resp 16 O2Sat 97% Skin Signs: Clammy, Other - Pale Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally Repeat BP 120/85 Repeat HR 83 Resp 16 O2Sat 99% Skin Signs: Warm and dry Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally Initial Treatment: Given water, laid down, patient said they felt fine after laying down, vitals returned to what patient said was normal for him. Hx of previous similar symptoms with blood drawn in past. Follow up Treatment: Monitor x30 min Notes: Patient was stable. Home with mom
21 2021-04-29 platelet count decreased, low platelet count She developed red dots (petechiae) and bruising on Saturday. She also developed vaginal bleeding on ... Read more
She developed red dots (petechiae) and bruising on Saturday. She also developed vaginal bleeding on Saturday that was heavy and had clots. Her period was ending on Saturday and had been normal up to that point. She continues to have heavy vaginal bleeding. Went to PCP and routine labs revealed thrombocytopenia. She has never had thrombocytopenia before. Was sent to ED for blood transfusion and was admitted to hospital. Dishcarged home 4/27 after platelet infusion.
21 2021-04-29 lightheadedness Near syncopal episode, revived with smelling salts. Patient has history of fainting with needles. Pa... Read more
Near syncopal episode, revived with smelling salts. Patient has history of fainting with needles. Patient given food and water and recovered. Reported feeling better. Walked out without any additional complaints.
21 2021-04-29 fainting Systemic: Fainting / Unresponsive-Medium
21 2021-04-29 fainting Patient fainted not more than 2 minutes after sitting down in post vaccination waiting area. Was giv... Read more
Patient fainted not more than 2 minutes after sitting down in post vaccination waiting area. Was given gatorade and ice pack and monitored 15 more minutes and left with family member.
21 2021-04-30 fast heart rate, palpitations Patient reports a normal resting heart rate in the 70s, immediately after inject felt her heart raci... Read more
Patient reports a normal resting heart rate in the 70s, immediately after inject felt her heart racing and had tachycardia to the 140s; Patient reports a normal resting heart rate in the 70s, immediately after inject felt her heart racing and had tachycardia to the 140s; This is a spontaneous report from a non-contactable physician. A 21-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Left Arm on 15Apr2021 16:00 (Batch/Lot Number: EW0150) as SINGLE DOSE (at the age of 21 years) for covid-19 immunisation. Medical history included seasonal allergy from an unknown date, hypersensitivity of environmental allergies from an unknown date and food allergy from peanuts from an unknown date. Concomitant medications included loratadine (LORATADINE) taken for an unspecified indication; pseudoephedrine (PSEUDOEPHEDRINE) taken for an unspecified indication; albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) taken for an unspecified indication and montelukast (MONTELUKAST) taken for an unspecified indication. The patient was not pregnant when she received the vaccine. The patient did not have any other vaccine in four weeks. The patient reports a normal resting heart rate in the 70s, immediately after injection felt her heart racing and had tachycardia to the 140s (palpitations) on 15Apr2021 16:00 with outcome of recovering. The patient underwent lab tests and procedures which included heart rate: 70s on unspecified date and palpitations: 140s on 15Apr2021. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of patient heart racing and had tachycardia to the 140s. The events persisted for 5 hours and improved only after IV (0.9% normal saline) fluid bolus. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Heart racing and Tachycardia cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
21 2021-05-01 fainting syncopal Episode x2
21 2021-05-02 chest discomfort After waiting for 15 minutes after the vaccination, the patient and her mother returned to the pharm... Read more
After waiting for 15 minutes after the vaccination, the patient and her mother returned to the pharmacy. The patient had a heavy feeling in her chest and it felt like a lump in her throat. She was not having trouble breathing. I had her sit down next to her mother to monitor further. After about 5 more minutes, she felt like her symptoms were getting worse. She stated that she was feeling cold and shivering. I had her lay on the floor. I had my technician call 911. I stayed next to her to monitor. I had her also sit up to drink some water. She complained of her jaw starting to hurt and her head was throbbing. The paramedics arrived shortly after.
21 2021-05-02 chest pain Patient was administered vaccine on 05-01-2021 in the afternoon and she reported that she started ha... Read more
Patient was administered vaccine on 05-01-2021 in the afternoon and she reported that she started having adverse effects the next day (05-02-2021) and reported us this afternoon around 3 pm. Patient developed pain in the chest and it aggravates with breathing. Pt was advised to contact her PCP and go to ER if any of the symptoms worsen.
21 2021-05-02 heart rate decreased, loss of consciousness, hypotension The next morning I was standing and passed out. Was sat down and passed out again and while down I ... Read more
The next morning I was standing and passed out. Was sat down and passed out again and while down I was advised I developed a rash that moved up my neck, chest and face and was really tingly which did go away on its own later that day. My BP an HR went extremely low also
21 2021-05-04 loss of consciousness pt fainted after vaccine, pt was conscious and speaking when pharmacist arrived, paramedics were alr... Read more
pt fainted after vaccine, pt was conscious and speaking when pharmacist arrived, paramedics were already on the phone and on route, blood pressure obtained at 11:22am, paramedics arrived, assessed pt and though speaking and ambulatory without hives or rash took patient to the hospital for further tests
21 2021-05-06 fainting Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / ... Read more
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Headache-Medium, Systemic: Tinnitus-Mild
21 2021-05-07 fainting I fainted; This is a spontaneous report from a non-contactable consumer (patient). A 21-year-old fem... Read more
I fainted; This is a spontaneous report from a non-contactable consumer (patient). A 21-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported) via an unspecified route of administration, administered in left arm on 21Apr2021 12:45 as a single dose for COVID-19 immunisation. Medical history included allergies to Penicillin. The patient was not pregnant at the time of vaccination. The patient has not had COVID prior to vaccination. Concomitant medication included etonogestrel (NEXPLANON). The patient has not had any other vaccine in four weeks. The patient fainted on 21Apr2021 17:00. No treatment was given in response to the event. The outcome of the event was recovering. The patient was not tested for COVID post vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
21 2021-05-09 blood pressure increased, fast heart rate Tachycardia and elevated blood pressure; unresolved after 35 minutes. Patient transferred to ER per ... Read more
Tachycardia and elevated blood pressure; unresolved after 35 minutes. Patient transferred to ER per patient's request.
21 2021-05-09 fainting fainting, eyewitness reported seizure (patient also had scrapped left shoulder)
21 2021-05-11 inflammation of the heart muscle myopericarditis; This is a spontaneous report from a contactable consumer (patient). A non-pregnant ... Read more
myopericarditis; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 21-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 28Apr2021 at 13:00 (at 21 years old, no pregnant, Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient medical history was not reported. No other medical history and no known allergies. The patient not had Covid prior vaccination. The patient previous took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 07Apr2021 at 13:00 (at 21 years old, no pregnant, Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient's concomitant medications were not reported. The patient was ended up in the hospital with myopericarditis on 02May2021 at 06:45AM. Patient was a health 21 years old who had no heart problems before. Also had no heart problems in the family. The event was resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Hospitalized 1 day. Prescribed colchicine and metoprolol for event. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Nasal Swab): negative on 02May2021. The outcome of the event was recovering. Information about the Lot/batch number has been requested.
21 2021-05-11 fainting Systemic: Fainting / Unresponsive-Mild
21 2021-05-14 chest pain The patient stated that she had not received a vaccine in several years but that the last time she d... Read more
The patient stated that she had not received a vaccine in several years but that the last time she did, she blacked out for maybe 30 seconds and felt dizzy. She states she thinks it was because she did not eat that day and stood up too quickly because she felt ok after. I notified (pharmacist) to be on stand by in case any incidence occurred and we had smelling salts and epipen on hand. I had the patient sit in the vaccine chair afterwards and about 3 minutes later, she started screaming to the top of her lungs that she felt like she was going to die. She screamed that she couldn't breathe and that her chest and head were "killing her". She kept screaming to remove the vaccine out of her arm (the liquid). Her eyes were starting to roll, but I knew she was breathing because she was screaming to not let her die. Her mother was with her and was very nervous and wanted emergency services, so We called 911. I took the girls hands and asked her to look me in the eyes and follow my deep breaths, because I began to think it was more of a panic attack. She followed by breaths and regained some composure but was sweating profusely, so I began fanning her. After a while of talking her through taking deep breaths and assuring her she was breathing and we had emergency services on the way, she began to calm down. EMS showed up about 15-20 minutes later and she declined to go with them. I stayed with the patient the entire time. She did not faint. I believe she just had a panic attack from working herself up about the vaccine. She was a little scared since she had fainted with the last vaccine.
21 2021-05-14 fainting Patient received vaccine and within 3 minutes experienced a syncopal episode which lasted less than ... Read more
Patient received vaccine and within 3 minutes experienced a syncopal episode which lasted less than 1 minute. On presentation patient is alert and oriented X 3 stating she feels fine .EMS on site vital signs 123/77, pulse 87, pulse ox 99% room air. Patient placed in Trendelenburg position and PO fluids encouraged. After 20 minutes of observation vitals were 122/74, pulse 80, pulse ox 99% on room air. Patient maintains that she feels no symptoms, denying chest pain, palpitations. She denies any past medical history including cardiac. She agrees to follow up with her PCP if signs or symptoms return. Patient allowed to leave as a passenger with her mother driving.
21 2021-05-14 blood clot Menstrual period that was 9 days late with extremely heavy bleeding and abnormally large clots (larg... Read more
Menstrual period that was 9 days late with extremely heavy bleeding and abnormally large clots (larger than a quarter), PMS symptoms that lasted for 2+ weeks before my period started (cramps, sore breasts, tender/tingling nipples, dizziness, acne)
21 2021-05-17 pallor, loss of consciousness after the vaccination, patient walked to the waiting chairs. 10 minutes later, she was pale and ligh... Read more
after the vaccination, patient walked to the waiting chairs. 10 minutes later, she was pale and light headed. she sat back into the chair and started losing consciousness as the pharmacist called 911 at 1:03 pm. Her eyes rolled back and she started shaking while her brothers were supporting her in the chair making sure that she wouldn't fall out of the chair. she stiffened up and kept shaking while foaming at the mouth slightly. she started coming back to consciousness as she sat up and coughed up mucous. she started to feel better after this event as I also got her some water. Paramedics then arrived and took over care for her a few minutes later.
21 2021-05-17 fainting pt received covid shot and was waiting her 15 minutes. about 5 minutes later she fainted and an ambu... Read more
pt received covid shot and was waiting her 15 minutes. about 5 minutes later she fainted and an ambulance was called and took her to the hospital.
21 2021-05-18 fainting, pallor post vaccine administration, pt experienced a syncopal episode. Pt did not fall from chair. Pt vom... Read more
post vaccine administration, pt experienced a syncopal episode. Pt did not fall from chair. Pt vomited and appeared pale. Pt A+O x4, refused vitals. After a few minutes color came back to Pts face and pt stated she felt much better. Pt sat in observation area for 30 minutes and felt okay to leave. This was all done WOI.
21 2021-05-19 fainting Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt fainted a few minutes after receiving... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt fainted a few minutes after receiving the pfizer vaccine. Pt was positioned on the ground laying down and feet up on a chair. After a few mins, pt felt better. Pt asked to stay extra 30mins. Water was given. No other severe reactions were present.
21 2021-05-20 chest pain, chest discomfort 4 days after first shot, she called me complaining of bad back pain. She was going to her family doc... Read more
4 days after first shot, she called me complaining of bad back pain. She was going to her family doctor the next day for her 21 yr old well visit and was going to get it checked out then. She had a complete physical and was cleared even her lungs were clear and she was good. Tuesday night April 13th at 10pm, she told me she had "air bubbles" in her chest. I said you mean indigestion, take tums I said. She said not mom, actual air bubbles and they are popping in my chest. I said you just got your physical, you are fine. They Thursday night April 15th she started having difficulty breathing and was out of breath. She went to urgent care on April 16th because she felt awful and they saw in an X-ray that she had a "cyst" in her upper right part of her lung and her lung was about to collapse. Sent her home on bed rest with a stereos and 2 inhalers. We got her Friday night from college because the pain in her back and now her chest was worse. Took her to ER and she had a collared lung and pneuomothroax. She was admitted to the hospital and they tried to see if the lung would heal itself. It did not. They had to do surgery to repair the hole. When they were in there they saw a cobblestone texture where the hole was an they removed that texture and repaired the hole. She has never had a lung issue. Ever. She is also the 3rd person in my family to have had an adverse reaction to the shot. 6 of us vaccinated and 3 with injuries.
21 2021-05-20 loss of consciousness, fainting patient got vaccinated and immediately had a syncopal episode, she returned to consciousness almost ... Read more
patient got vaccinated and immediately had a syncopal episode, she returned to consciousness almost immediately, no problems breathing. Initial vital signs 114/74 heart rate 98, repeat vital signs 120/82 Heart rate 92, 119/77, patient declined emergency care or any medical care stated that she always passes out from vaccines. did not hit anything during syncopal episode. Patient was observed for over 60 minutes without event. Her parents came and picked her up from event.
21 2021-05-20 loss of consciousness Patient passed out after receiving the vaccine. She had no problems with the first vaccine but has ... Read more
Patient passed out after receiving the vaccine. She had no problems with the first vaccine but has had a history of passing out with other vaccinations. Patient had just gotten to the waiting area after receiving her vaccine and sat down and her mom caught her from falling from the chair. Mom held her for a few minutes as she went in and out of consciousness. When she came back to we laid her on the ground. Patients BP was taken as she started to feel better and was 120/74. Patient and mom stayed with us as she gradually started to feel better. Mom drove her home.
21 2021-05-20 lightheadedness, very slow heart rate, hypotension Dizzy, near syncopal episode. Became Bradycardic, hypotensive, diaphoretic. Symptoms resolved.
21 2021-05-20 fainting PATIENT PRESENT FOR 2ND PFIZER VACCINE, 3 MINUTES AFTER RECEIVING THE VACCINE PATIENT EXPERINCED S... Read more
PATIENT PRESENT FOR 2ND PFIZER VACCINE, 3 MINUTES AFTER RECEIVING THE VACCINE PATIENT EXPERINCED SYNCOPE. PT WAS PLACED ON HER BACK AND FEET ELEVATED. PT REGAINED CONSCIOUSNESS AFTER ABOUT A SECOND. PT REPORTED NOT HAVING ANYTHING TO EAT OR DRINK BEFORE APPOINTMENT. BLOOD PRESSURE WAS TAKEN (200/105) AND SHE WAS GIVEN A BOTTLE OF ORANGE JUICE. AMBULANCE ARRIVED IN LESS THAN 10 MINUTES. PT WAS TAKEN TO THE EMERGENY ROOM.
21 2021-05-20 fainting Patient over 10-15 minutes about 5 minutes after shot fainted and came back to several times. patien... Read more
Patient over 10-15 minutes about 5 minutes after shot fainted and came back to several times. patient also vomited.
21 2021-05-20 blood clot patient developed a blood clot
21 2021-05-21 chest pain Chest pains, nausea, soreness
21 2021-05-22 chest discomfort, chest pain nausea, vomiting, diarrhea, chest pain and tightness, lethargy, chills
21 2021-05-22 loss of consciousness 5 minutes after administration of the patients 2nd Pfizer Covid 19 vaccine the patient was in and ou... Read more
5 minutes after administration of the patients 2nd Pfizer Covid 19 vaccine the patient was in and out of consciousness, non-verbal and tremors.911 was called and the patient was transported to a medical treatment facility.
21 2021-05-22 palpitations Fatigue, chills, headache, heart palpitations, stomach pain, bruising, insomnia, change in mental st... Read more
Fatigue, chills, headache, heart palpitations, stomach pain, bruising, insomnia, change in mental status (depression), nerve pain in hands/feet
21 2021-05-22 fainting, chest discomfort Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Body A... Read more
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe
21 2021-05-23 loss of consciousness patient felt lightheaded and dizzy 10 minutes after vaccine, passed out, came through and had emesis... Read more
patient felt lightheaded and dizzy 10 minutes after vaccine, passed out, came through and had emesis for about 20 minutes
21 2021-05-23 fainting Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting /... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Weakness-Mild
21 2021-05-24 chest discomfort Right shoulder and chest discomfort, minor dyspnea
21 2021-05-24 chest pain, fibrin d dimer increased This is a 21 year old female who reported to the emergency department on 5/17/21 at 0917 with compla... Read more
This is a 21 year old female who reported to the emergency department on 5/17/21 at 0917 with complaints of intermittent chest pain since the previous Tuesday (5/11/21). She described it as light in pressure, pain 4/10, in the right upper chest/right breast area. The patient believed her chronic anxiety may be playing a role since she has recently started a new job that involves public speaking and she had stopped her paxil due to adverse effects. No pleuritic pain described, no pain on exertion described. Differential diagnosis included low risk for ACS, PE given oral contraceptives, anxiety. Given no evidence of abnormality in labs/work-up, the patient was discharged home with instructions to follow-up with PCP for any ongoing symptoms/anxiety.
21 2021-05-25 heart rate increased Pt reported "I feel like my heart is beating too fast" RN took radial pulse 94, EMS was called to ev... Read more
Pt reported "I feel like my heart is beating too fast" RN took radial pulse 94, EMS was called to evaluate. VS were WNL, Pt denied feeling like she was having an allergic reaction and symptoms improved with sips of H20 provided by clinical staff. Pt able to leave after completing 30 min observation.
21 2021-05-26 pallor, hypotension 21 y/o female with past medical history of ADHD and Depression that presents with dizziness and naus... Read more
21 y/o female with past medical history of ADHD and Depression that presents with dizziness and nausea, weakness onset post vaccination. Patient states that this is her second dose in the two-dose series. Patient denies previous reaction to 1st dose or previous vaccination in the past. Patient states that she also did not eat or take her medications this am. Patient received her vaccination to the Left arm. NP noted patient pale and diaphoretic. Patient placed into wheelchair and taken to the partitioned area with the Paramedics. Patient noted to be hypotensive (84/47 BP) patient immediately placed in Trendelenburg and placed on 2L O2 NC. Patient vitals improved, 91/54 BP, 72 HR, 98% RA, Resp 14. Patient denies difficulty swallowing, sore throat, difficulty breathing or chest pain. Patient provided with a bottle of water, a mint and a fruit bar since she did not eat today. Patient, within 15 mins, states that she is feeling better and no longer dizzy. Patient no longer diaphoretic and color has returned to her face/lips. Patient vitals rechecked, 97/65 BP and all other vitals stable. Patient instructed to sit up for 5 mins, then sitting position for 5 mins and then placed in standing position for 5 mins. Patient states that she feels better and that she is no longer symptomatic. Patient monitored for 30 mins total. Patient discharged home in stable condition with mother and sister at side.
21 2021-05-26 fainting Was extremely lightheaded right afterwards. Passed out during the 15-minute observation. Was lighthe... Read more
Was extremely lightheaded right afterwards. Passed out during the 15-minute observation. Was lightheaded the next couple of days, passed out twice more that day. Was really sick to my stomach for 3 days after, with on and off dizzy spells and lightheadedness.
21 2021-05-27 chest pain chest and throat pain 15 minutes after vaccination. Mild, resolved without treatment.
21 2021-05-27 fainting, loss of consciousness Patient fainted less than five minutes after receiving the vaccine, and was unconscious for less tha... Read more
Patient fainted less than five minutes after receiving the vaccine, and was unconscious for less than 60 seconds before waking up and sitting up. Complained of ankle pain and that she was feeling hot. Paramedics were called to assess vital signs. Patient walked out of the store after finishing with paramedics.
21 2021-05-28 loss of consciousness I started to lose my sight, at first it was my entire peripheral vision and it looked like I was loo... Read more
I started to lose my sight, at first it was my entire peripheral vision and it looked like I was looking through a black holed telescope and then I completely lost sight; Crashed into a stand and passed out; I got really dizzy; I sat in a chair where I became incredibly hot; Sweat through all my clothes; Immediately extremely cold; crashed into a stand; This is a spontaneous report from a contactable consumer (the patient). A 21-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0173) via an unspecified route of administration in left arm on 13May2021 18:00 at age of 21-year-old at single dose for COVID-19 immunisation. Prior to vaccination, the patient diagnosed with COVID-19. No known allergies. No other medical history. Concomitant medication included: the patient received birth control medication within 2 weeks of vaccination. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EP7533) via an unspecified route of administration on 19Apr2021 01:15 PM at age of 21-year-old for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 since the vaccination. The patient got really dizzy, then as she tried to walk away she started to lose her sight, at first it was her entire peripheral vision and it looked like she was looking through a black holed telescope and then she completely lost sight. She became very dizzy and crashed into a stand and passed out. While she was passed out on the floor she uncontrollably defected. Once someone helped her up, she sat in a chair where she became incredibly hot, sweat through all her clothes and then immediately extremely cold. The events onset date reported as 14May2021 09:00AM. No treatment received for the events. The outcome of the events was recovering. The report was non-serious.
21 2021-05-31 pallor Patient received the 2nd COVID vaccine (Pfizer, Lot #: EW0185 and expiration date: 08/31/2021) on th... Read more
Patient received the 2nd COVID vaccine (Pfizer, Lot #: EW0185 and expiration date: 08/31/2021) on the left arm at 0918. Patient hailed medics attention and complained of "nausea, seeing purple, and lightheadedness" at 0921. Patient was conscious, alert, and oriented x4. Patient's skins were normal for ethnicity, moisture and temperature. Pupils were equal, accommodating, and reactive to light. Patient appeared anxious and was coached by medic on her breathing. Signs and symptoms began about 2 minutes status post vaccine, but patient claimed no previous reaction with 1st dose. Patient denied any pertinent medical history, allergies, or medications. At 0923 patient was still conscious, alert, and oriented x4 and pupils were still equal, accommodating, and reactive to light. Patient then complained of "seeing everything in purple color," then stated she "could not see anything at all." Medic held up 5 fingers and patient advised she could not see them. Patient began to look pale and skins felt moist and warm. Patient was able to walk with assistance to anti- gravity chair. Nurse then responded to Medic with patient. Baseline vital signs were taken by Medic at 0926, while patient was sitting: blood pressure: 98/60, heart rate: 60, respiratory rate: 16. Patient stated that she runs cross country and that these vital signs were of normal range for her. Patient was given water to sip on. Color and moisture of skins were slowly pinking/drying up. Patient initially experienced nausea and lightheadedness but denied chest pain, shortness of breath, headache, dizziness, or blurry vision. Nurse informed the patient's mother, who was waiting outside, of the situation and brought the mother inside to the patient. At 0935, patient was able to stand her own, with a steady stance. A second set of vitals were taken: blood pressure: 100/64, heart rate: 60, respiratory rate: 14. Patient was negative for orthostatic pressures. Patient stated that symptoms had resolved and that she "felt better, just tired." Patient remained in the observation area for an additional 15 minutes. Patient was conscious, alert, and oriented x4 and skins were normal for ethnicity, moisture, and temperature at 0949. Patient able to walk on her own accord with a steady gait. Mother was driving personal vehicle. Mother and patient were educated on when to contact their primary care physician with any other concerns and when to call 911 if symptoms warrant or when go to ED.
21 2021-06-01 chest discomfort, chest pain Patient called pharmacy about 6 hours after her vaccination, stating she was having chest pain and d... Read more
Patient called pharmacy about 6 hours after her vaccination, stating she was having chest pain and discomfort and shortness of breath. Pharmacist recommended patient seek emergency care to get checked out and patient agreed.
21 2021-06-01 chest pain, pulmonary embolism Patient presented to the ER one day post second dose of vaccine with chest pain and was diagnosed wi... Read more
Patient presented to the ER one day post second dose of vaccine with chest pain and was diagnosed with pulmonary embolism.
21 2021-06-01 heart rate abnormal, hypertension, chest pain Two weeks after first COVID vaccine patient experienced an acute onset of chest pain, dizziness, hea... Read more
Two weeks after first COVID vaccine patient experienced an acute onset of chest pain, dizziness, head pressure, SOB, fast/irregular heart rate, high blood pressure, sensitivity to light, weakness and blackening of vision field.
21 2021-06-01 fainting Patient started feeling dizzy and fainted. Paramedics came and took her.
21 2021-06-03 hypotension High fever of 103.4 Had heat flashes blood pressure low 90's but was in 120 when doctor took it took... Read more
High fever of 103.4 Had heat flashes blood pressure low 90's but was in 120 when doctor took it took Ibprofen took a ice bath next day fever was 100 , then in the next few hours i was fine.
21 2021-06-05 fainting Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Me... Read more
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: patient became very faint and nauseated. she was seated, i checked her blood pressure (which stayed about 90/60 or higher), and provided water. she also expressed concern over tingling and cramping of hands. she recovered completely in less than 30 minutes.
21 2021-06-06 fainting, chest discomfort Fainting. Pt did not feel well. Felt like she was having a panic attack (chest tightness, arm tingl... Read more
Fainting. Pt did not feel well. Felt like she was having a panic attack (chest tightness, arm tingling, dizzy). Happened over the course of 10 minutes.
21 2021-06-07 loss of consciousness Around 4 AM on the day after receiving my vaccine, I experienced a fever and generalized seizure wit... Read more
Around 4 AM on the day after receiving my vaccine, I experienced a fever and generalized seizure with a loss of consciousness
21 2021-06-08 loss of consciousness PATIENT PASSOUT AFTER VACCINE WAS ADMINISTER. SHE COMPLAINED OF SOB BEFORE PASSING OUT. EPIPEN WAS A... Read more
PATIENT PASSOUT AFTER VACCINE WAS ADMINISTER. SHE COMPLAINED OF SOB BEFORE PASSING OUT. EPIPEN WAS ADMINISTERED AT 12;35 AND EMT ARRIVED AT 12:44. PATIENT RECOVERED AND REFUSE GOING TO THE HOSPITAL.
21 2021-06-08 inflammation of the heart muscle, chest pain Symptoms were undiagnosed but correlated to minor myocarditis which included shortness of breath due... Read more
Symptoms were undiagnosed but correlated to minor myocarditis which included shortness of breath due to chest pain in the heart area, lasted for about 12 hours and treated with 600 MG of ibuprofen, stopped shortly after treatment.
21 2021-06-08 fainting Systemic: Fainting / Unresponsive-Mild
21 2021-06-09 fibrin d dimer increased Abnormal, large thigh hematoma/bruise that was excruciatingly painful and ended up decaying from my ... Read more
Abnormal, large thigh hematoma/bruise that was excruciatingly painful and ended up decaying from my body
21 2021-06-09 fainting dizziness/fainting within five mins; dizziness/fainting within five mins; This is a spontaneous repo... Read more
dizziness/fainting within five mins; dizziness/fainting within five mins; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old [non-pregnant] adult female received the first dose of BNT162B2 (solution for injection; Lot unknown and expiry not provided) as a single dose via unspecified route in the left arm on 23Apr2021 at 10:30 (at 21-years-old), for COVID-19 immunization. Relevant medical history included penicillin allergy. There were no concomitant medications reported. The patient denied any COVID prior to vaccination. The patient was not pregnant at the time of vaccination and denied receiving any other vaccine within four weeks of this vaccine. On 23Apr2021 at 10:35, within five minutes of receiving the vaccine that patient experienced dizziness and fainting. The patient has not been tested for COVID since the vaccine. The patient did not receive any treatment for the events; the events did not result in visit to Emergency Room or physician office/clinic. The outcome of the events dizziness and fainting was recovered on 23Apr2021 at 10:45 after ten-minute duration. Information on the Batch/Lot number has been requested.
21 2021-06-09 fainting Unexpectedly fainting while driving; Crashed my car; This is a spontaneous report from a non-contact... Read more
Unexpectedly fainting while driving; Crashed my car; This is a spontaneous report from a non-contactable consumer (patient). A 21-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in left arm on 26Mar2021 16:00 (at the age of 21-year-old) (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The patient had no relevant medical history and no known allergies. Concomitant medication included birth control pill. On 18Apr2021 at 12:00, the patient experienced "unexpectedly fainting while driving, crashed my car." The reporter considered the events as non-serious. The events resulted in doctor or other healthcare professional office/clinic visit. There was no treatment received for the events. The patient recovered with sequelae from the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
21 2021-06-10 chest pain, heart rate increased Pain in the chest after getting it heart beating fast; Pain in the chest after getting it heart beat... Read more
Pain in the chest after getting it heart beating fast; Pain in the chest after getting it heart beating fast; This is a spontaneous report from a contactable consumer (patient). A 21-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EN6208, Expiration Date: not reported), via an unspecified route of administration, administered in left arm on 13Mar2021 at 12:00 (at the age of 21 years old) as first dose, single for COVID-19 immunisation. The facility where the vaccine was administered was reported to be "other". The patient's medical history and concomitant medications were not reported. The patient experienced pain in the chest after getting it heart beating fast on an unspecified date. Outcome of all events was unknown. No follow-up attempts are possible. No further information is expected.
21 2021-06-10 heart rate increased Arthus reaction of the left shoulder and systemic symptoms such as body aches and pains, intermitten... Read more
Arthus reaction of the left shoulder and systemic symptoms such as body aches and pains, intermittent elevated heart rate and fever.
21 2021-06-11 loss of consciousness Patient loss consciousness and was having seizures. called 911, paramedics transported patient to a ... Read more
Patient loss consciousness and was having seizures. called 911, paramedics transported patient to a hospital for observations
21 2021-06-12 hypotension, chest discomfort Resting heart rate 130-138. Chest discomfort during deep breathing. Low blood pressure between 89/70... Read more
Resting heart rate 130-138. Chest discomfort during deep breathing. Low blood pressure between 89/70 and 99/52. Fever of 102.5, achy, nausea, chills, exhaustion, dehydration.
21 2021-06-13 heart rate increased, fast heart rate, chest pain Patient reports feeling faint immediately following the injection with an elevated heart rate and na... Read more
Patient reports feeling faint immediately following the injection with an elevated heart rate and nausea. The following day she started having episodes of vomiting, nausea, anxiety, tachycardia, pain in the sternum, shoulders and back, dizziness, weight loss, exercise intolerance, insomnia, muscle weakness, fevers, and an overall "depressed feeling".
21 2021-06-13 heart rate increased The patients mother called and stated that her daughter is experience rapid heart rate of 120 bpm or... Read more
The patients mother called and stated that her daughter is experience rapid heart rate of 120 bpm or greater, fatigue, nausea, and vomiting. She was instructed to seek medical attention. The patients provider is seeing her on 6/14/21. Outcome is still pending.
21 2021-06-13 inflammation of the heart muscle, troponin increased, palpitations, fainting, inflammation of the pericardium, palpitations Fainted (05/31/21), pallpitations, heart skipping beats. Went to ER, high troponin levels. Tests don... Read more
Fainted (05/31/21), pallpitations, heart skipping beats. Went to ER, high troponin levels. Tests done, blood work, chest x-ray, echocardiogram, ct scan, cardiac catheritization, cardiac MRI. Was admitted for two nights at the hospital. Released on 06/02/21
21 2021-06-13 palpitations, heart rate abnormal, cardiac arrhythmia, chest pain Heart palpitations, multiple PVCs, chest pain that returned, dyspnea, fatigue, loss of appetite. I ... Read more
Heart palpitations, multiple PVCs, chest pain that returned, dyspnea, fatigue, loss of appetite. I was hospitalized for 4 days and am still recovering. I continued my course of treatment for pericarditis, increased the dose of ibuprofen, use lidocaine patches, and was put on prednisone. I used a heart monitor for a month and have had abnormal heart beats.
21 2021-06-14 chest pain Chest pain, vomiting, epigastric abdominal pain, nausea
21 2021-06-14 heart rate increased, palpitations Rapid heartrate (120s), shortness of breath, and palpitations started within 24 hours of second vacc... Read more
Rapid heartrate (120s), shortness of breath, and palpitations started within 24 hours of second vaccination. Went to Urgent Care on Friday, ECG completed. Urgent care sent patient to ER to be evaluated further. ER physician states rapid heartrate and symptoms likely due to the vaccine.
21 2021-06-14 pallor After receiving 2nd dose of the Pfizer Vaccine at 4:00 PM, patient was seated in the waiting area. A... Read more
After receiving 2nd dose of the Pfizer Vaccine at 4:00 PM, patient was seated in the waiting area. At exactly 4:05 PM, Patients boyfriend motioned to staff to respond to said patient and asked for water. When staff observed patient, on site RN was motioned over as well. There-in, patient was observed to be pale and sweaty, and she was seated but leaning against boyfriend for support. Upon being asked name, patient stuttered trying to state first name and could only produce ("T" sound with lips) Patient could not speak full word. By this time, blood pressure cuff and Pulse-ox were brought to assess vitals. Blood pressure - 55/35 and Pulse was 49. Respiration was 20 breaths per minute and shallow. Upon observing blood pressure, ambulance was called. Ambulance responded within 5 minutes. During time waiting for ambulance, patient had improvement and was able to state name and location. Patient was given water, could not hold but with assistance from boyfriend, was able to drink through a straw. Upon ambulance arrival, care was transferred and was transported to local hospital.
21 2021-06-16 chest pain Chest pain 6/10
21 2021-06-21 troponin increased, chest pain Patient had chest pain, shortness of breath, and a mild increase in her troponin. She was hospitali... Read more
Patient had chest pain, shortness of breath, and a mild increase in her troponin. She was hospitalized for less than 24 hours and received ibuprofen. She was discharged 6/14/21
21 2021-06-22 chest pain, fast heart rate Tachycardia, chest pain for several hours. Outcomes: resolved on its own. Cardiac stress test, X-ray... Read more
Tachycardia, chest pain for several hours. Outcomes: resolved on its own. Cardiac stress test, X-ray, echo and CT with contrast revealed no abnormalities.
21 2021-06-22 inflammation of the pericardium, inflammation of the heart muscle I have been diagnosed with myocarditis and pericarditis as a result of getting the vaccine; I have b... Read more
I have been diagnosed with myocarditis and pericarditis as a result of getting the vaccine; I have been diagnosed with myocarditis and pericarditis as a result of getting the vaccine; This is a spontaneous report from a contactable consumer (patient). A 21-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8736), via an unspecified route of administration, administered in Arm Right on 05May2021 10:00 (at age of 21 years old) as single dose for COVID-19 immunization. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No Known allergies. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. The patient's concomitant medications were none. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number=EW0158) on 14Apr2021 10:00 AM (at age of 21 years old) at right arm for COVID-19 immunisation, No reaction for 1st dose. Patient has been diagnosed with myocarditis and pericarditis on 31May2021 05:45PM as a result of getting the vaccine. This was Serious case with Seriousness criteria-Life threatening, Caused/prolonged hospitalization. No days hospitalization was 2. The adverse event result in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received for the adverse event (colchicine, rest). The outcome of the events was Recovering.
21 2021-06-22 fainting, hypotension, chest discomfort, chest pain, loss of consciousness Sat down to wait for 15 minutes like they usually ask after a new vaccine, thought I felt fine then ... Read more
Sat down to wait for 15 minutes like they usually ask after a new vaccine, thought I felt fine then next thing I know the pharmacist is waking me up telling me I went unconscious and I?m puking. I don?t remember where I am or what happened while this was happening, then my whole body goes numb and my vision goes extremely blurry and my chest is tight, then apparently I pass out again because I have EMTs waking me up after. My bp dropped extremely low, my chest and throat was tight, it was hard to breathe, my tongue felt weird, I was anxious, could hardly see for a while and it was hard to hear. I was so out of it for a while it was hard to talk. EMTs took me to the hospital. Was released that evening, but had continuing dizziness, body numbness, chest pain etc for several days before it got better. (Doctor at ER said he couldn?t fully say if it was an allergic reaction because it?s so new he didn?t have that information, but the paperwork I have from the Walgreens RX lists Several of the events I experienced as allergic reactions)
21 2021-06-23 chest discomfort Tightness and pressure in chest in the heart area. Slight fever and headache. Went to the ER for eva... Read more
Tightness and pressure in chest in the heart area. Slight fever and headache. Went to the ER for evaluation. Doctor administered IV Toradol to reduce inflammation and performed a series of tests to examine the heart. Doctor stated "possible pericarditis," but listed official diagnosis as "chest pressure with unknown cause. " Released from the ER after 7 hours.
21 2021-06-23 pallor RN vaccinated client approximately 1505 and immediately noticed client turn pale and client stated ... Read more
RN vaccinated client approximately 1505 and immediately noticed client turn pale and client stated "I feel dizzy". RN signaled RN to bring anti-gravity chair. PHN joined at 1506. Client was able to transfer herself into anti-gravity chair. PHN took vitals at 1506: blood pressure 122/82, pulse 94, oxygen sat 99%. RN brought client water. Client stated dizziness was improving at 1508. Client's Mother present and stated client had not ate or drank water all day. Client reported being nervous, but did not share information with RN. Client reported no relevant medical history, no medications and no allergies. RN gave client snack and water. Vitals at 1511: blood pressure 120/86, pulse 95, oxygen sat 99%. Vitals at 1516: blood pressure 110/80, pulse 93, oxygen sat 100%. Vitals at 1521: blood pressure 114/84, pulse 89, oxygen sat 99%. Last vitals at 1533: blood pressure 120/80, pulse 88, oxygen sat 100%. Per client dizziness has resolved. PHN advised client to follow up with provider and gave ER precautions. PHN asked client to stand from chair and take a few steps to assess for gait and dizziness. Client stated "feeling fine". Mother would drive client home. Client left facility with steady gait at 1535.
21 2021-06-25 pallor not feeling well; viral meningitis; fatty liver; pre-diabetes; weak; pale; couldn't get up; runny no... Read more
not feeling well; viral meningitis; fatty liver; pre-diabetes; weak; pale; couldn't get up; runny nose; congestion; ear infection; Illness; Headache, like someone is poking her head repeatedly, after first vaccine; This is a spontaneous report from a contactable consumer. A 21-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0179), via an unspecified route of administration, administered in right arm on 28Apr2021(at the age of 21-year-old) as single dose for covid-19 immunization. Medical history included ongoing viral meningitis (as her older sister had Viral Meningitis), diabetic, Covid-19 from Oct2020 to Dec2020, ongoing food allergies and medication allergies. Concomitant medications included caffeine/codeine phosphate/paracetamol (TYLENOL WITH CODEIN #3) for an unspecified indication from 18May2021 to 20May2021; paracetamol (TYLENOL EXTRA STRENGTH) for headache from 14May2021 to 17May2021. No additional vaccines administered on same date of the Pfizer suspect. On 08May2021 19:00 the patient experienced headache, like someone is poking her head repeatedly, after first vaccine. On 09May2021 the patient experienced ear infection. On 17May2021 the patient experienced weak, pale, couldn't get up, runny nose, congestion. The patient missed second dose, scheduled for 21May2021. On 22May2021 the patient experienced viral meningitis, fatty liver, pre-diabetes and illness. On an unspecified date the patient experienced not feeling well. The patient was hospitalized for events from 18May2021 to 31May2021 except headache and illness. The patient underwent lab tests and procedures which included lumbar puncture: viral meningitis on 19May2021. Therapeutic measures were taken as a result of ear infection. The outcome of events not feeling well, viral meningitis, fatty liver, pre-diabetic and illness was unknown while the outcome of rest all event was recovering. No follow-up attempts are possible. No further information is expected.
21 2021-06-27 hypertension Client approached EMT station complaining that her "blood pressure felt high." Client was alert an... Read more
Client approached EMT station complaining that her "blood pressure felt high." Client was alert and tracking and appeared mildly anxious. Client had a chief complaint of anxiety. Client stated that she was reluctant to receive her second dose of Pfizer and stated that now she felt anxious after waiting several minutes in the observation area. Client stated that she experienced vomiting and other mild side effects after her first COVID vaccine dose but was approved for her second Pfizer COVID vaccine dose by medical team. Client denied allergies or medical history. Assessment revealed no swelling, discoloration, hives, shortness of breath or other signs of anaphylaxis. Client stated that she felt lightheaded and denied having breakfast this morning. Airway, breathing and circulation were intact. Vital signs 1155-BP 128/98 heart rate 68 respirations 18, 02 sat-100% room air. Client was alert and oriented to person, place, time and event. Client agreed to stay an additional 30 minutes and was provided with water while she waited. Client refused any food. Client's vitals were reassessed 15 minutes later. 1210- BP 120/82 HR 79 Resp. 18 and O2 sat 98% on room air. Client refused to stay her remaining 15 minutes and stated that she felt "better? and that she wanted to "go home and eat." She refused to stay for the remainder of the 30mins. Client departed vaccination site with a steady gait.
21 2021-06-28 chest pain, chest discomfort Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional Details: Night after 1st shot, patient... Read more
Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional Details: Night after 1st shot, patient had some chest pain/pressure on/off that lasted for 3 days. Very mild & no difficulty breathing. Patient had COVID in February & had chest tightness/pressure during that infection. Patient didn't require any treatment & recovered on her own.
21 2021-06-28 fainting Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient stated that she always faints wh... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient stated that she always faints when she gets the vaccine however she did not mention that before she was given the vaccine. She was with her mom. she was given gatorate/ crackers and felt better. she was reponsive however it is a common side effect that she gets when she gets blood drawn or vaccines. the mom stated that she will always have to be with her when she gets vaccinated. Patinet did not want us to call 911. she was ok before she left.
21 2021-06-29 chest pain Fever (101° F), Chills, Body Aches, Chest Pain, Headache, Shortness of Breath
21 2021-06-30 chest discomfort did not want to eat; flushed and hot; tested positive for covid; congestion in chest; mucus cough; v... Read more
did not want to eat; flushed and hot; tested positive for covid; congestion in chest; mucus cough; vomiting and clammy; vomiting and clammy; headache; sore throad; Fever; chills; Chest tightness; coughing profusely; This is a spontaneous report from a contactable consumer or other non hcp. A 21-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 14Jun2021 13:35(age at vaccination 21 years) (Batch/Lot Number: EW0151) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient got her first dose of the Pfizer Covid 19 vaccine on 14Jun2021 and is scheduled to get the second dose on 07Jul2021. On 19Jun2021 on Saturday, after they came home from an event the patient experienced coughing profusely, a lot of congestion in her chest, then she started vomiting, she was turning red and clammy and sweating and developing a fever, states initially she treated symptoms with a cold compress, headache, chills and cold sweats. yesterday afternoon she was clammy again and continued to vomit and complaining of chest tightness as well, the patient was flushed and hot and still complaining about sore throat and still had mucus and congestion, the patient was flushed and hot and still complaining about sore throat and still had mucus and congestion. States today they decided to go to the ER, and she tested positive for Covid on 21Jun2021. she did not want to eat on an unspecified date. The patient treated with Advil and Ibuprofen/Motrin. The patient underwent lab tests which included sars-cov-2 test: positive on 21Jun2021. She Wants guidance on getting the second dose. The event outcome is Unknown for tested positive for covid, did not want to eat, flushed and hot and coughing profusely, Not recovered for Chest tightness, congestion in chest, mucus cough, sore throat and headache Recovering for vomiting and clammy, Fever and chills.
21 2021-07-02 heart rate irregular Irregular heart rate. Experiencing atrial tachycardia. Started after my first dose of covid 19 vacc... Read more
Irregular heart rate. Experiencing atrial tachycardia. Started after my first dose of covid 19 vaccine.
21 2021-07-02 fainting Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsiv... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient's mother was with her at time of vaccine administration. A few minutes later she stated her daughter was not feeling well. Patient was confused, stated she was unable to see at that time &dizzy. Then the patient lost conciousness and was unresponsive. 911 was called and epinephrine was administered due to concern for anaphylaxis. Patient regained consciousness and was responsive to questions. EMTs &police arrived, evaluated her & recommened she go to ER. Mom was going to take her to ER
21 2021-07-02 fainting I?ve been passing out since the day I got the second shot and it hasn?t stopped since. It happens ve... Read more
I?ve been passing out since the day I got the second shot and it hasn?t stopped since. It happens very frequently almost every day and I?ve tried calling to report it but I never got a response back. I went to the ER and told them I thought it was vaccine related and they said no.
21 2021-07-03 fainting AFTER VACCINE WAS ADMINISTERED SHE STOOD AND I GAVE A SHOT TO HER PARTNER AND WHEN I LOOKED UP SHE W... Read more
AFTER VACCINE WAS ADMINISTERED SHE STOOD AND I GAVE A SHOT TO HER PARTNER AND WHEN I LOOKED UP SHE WAS LOOKING FAINT, AS I STOOD UP SHE STARTED TO FALL OVER AND SHE HIT HER HEAD ON THE WALL, I CAUGHT HER AND HELPED HER TO THE FLOOR AND HAD HER PARTNER USE HIS LEGS AS A PILLOW. AFTER 5 MINUTES OF LAYING DOWN SHE WAS ASSISTED TO A CHAIR, I TOOK HER BLOOD PRESSURE AT THE ONSET OF SYMPTOMS AND IT WAS 181/70 PULSE 78. AFTER 15 MINUTES IN THE CHAIR HER BLOOD PRESSURE WAS 117/71 PULSE 65. SHE DID NOT KNOW HER REGULAR BLOOD PRESSURE, AFTER WAITING A TOTAL OF 30 MINUTES SHE LEFT THE STORE.
21 2021-07-06 chest pain Central chest pain with pain between the shoulder blades. Patient received Motrin
21 2021-07-06 chest pain Client reported an onset of chest pain the morning after receiving the 1st COVID vaccine Pfizer. The... Read more
Client reported an onset of chest pain the morning after receiving the 1st COVID vaccine Pfizer. The client described the chest pain as dull and intermittent. The client stated the chest pain resolved after about 1 hour. The client stated she has previously experienced similar "chest pain when I gets sick." The client did not take any medications for the chest pain and did not seek any medical care regarding the chest pain. The client denied any s/s of anaphylaxis following the 1st COVID vaccine Pfizer. The client has no chronic conditions. She currently takes oral contraceptive Drospirenona. The client has a history of anaphylactic reactions to eggs. Vitals obtained at 2:47 PM were as follows: HR 80, BP 128/80, and O2 99%. RN submitted a medical consult via text message. Approval to proceed with the 2nd COVID vaccine Pfizer was obtained by Vaccine Operations. RN educated the client on s/s of anaphylaxis, pericarditis, and myocarditis. The client voiced understanding of this. RN also educated the client on when to seek EMS services and when to follow up with a primary care doctor, v-safe, and recommended a 30 minute waiting period. The client voiced understanding of this. The client received the 2nd COVID vaccine Pfizer at 3:26 PM. The client tolerated the vaccine well and did not report any symptoms to the EMT's during the observation period.
21 2021-07-06 chest pain Dry face; chest was hurting; throat became tight; hives 4 days after the vaccine (just face) right s... Read more
Dry face; chest was hurting; throat became tight; hives 4 days after the vaccine (just face) right side and then "lingered" to the left side of my face"; This is a spontaneous report from a contactable consumer, the patient. A 21-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0169), via an unspecified route of administration, administered in Arm Left on 18Apr2021, as dose 1, single (age at vaccination: 21 years), for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that, on 22Apr2021, 4 days after the vaccine, she started experiencing hives (just face) right side and then "lingered" to the left side of her face, which did not hurt but were just really uncomfortable because of the fact that the hives were all over her face. She stated that she did not notice the hives until she touched her face and she took Benadryl (Strength: 25mg tablet, expiration date is Nov2022, only took 1 tablet) to see if the hives would go away and it did not. She reported that, one day after work on 24Apr2021, one week after she received her vaccination, her chest hurt and then her throat felt tight which scared her and since she was driving she went to urgent care. Reportedly, at urgent care she was given a steroid shot which helped it go away. The symptoms lasted one hour and gradually went away. Reportedly, the hives were also ended around the 25Apr2021 or 26Apr2021 after she received the steroid shot to help with her symptoms. She told that the hives went away and was clearing up and then the dry face started on the 29Apr2021 through until around the 03May2021 or 04May2021. The only after effect was her dry face. Since, her face was dry she used Aquaphor and that helped. Outcome: hives were recovered on an unknown date in Apr2021, chest was hurting and throat became tight were recovered on 24Apr2021 and Dry face was recovered on an unknown date in May2021. Follow-up attempts completed. No further information expected.
21 2021-07-07 heart rate increased INCREASED HEARTRATE AND SWELLING OF THROAT. PATIENT CAME TO ME 15 MINUTES AFTER RECEIVING THE VACCI... Read more
INCREASED HEARTRATE AND SWELLING OF THROAT. PATIENT CAME TO ME 15 MINUTES AFTER RECEIVING THE VACCINE AT APPROXIMATELY 5:01 PM. SHE STATED THE THROAT CLOSURE WAS GETTING WORSE AND HEART RATE FELT FAST. I TOOK BP TO FIND ELEVATION (DON'T REMEMBER THE EXACT VALUE). HEART RATE WAS 113 BPM AT APROXIMATELY 5:O2. (EMS WAS CALLED). 5:03 ADMINISTERED EPIPEN 0.3 MEDICS ARRIVED AT 5:05PM. PT TAKEN TO HOSPITAL BY MEDICS AT 5:10 PM
21 2021-07-08 loss of consciousness Patient experienced dizziness, little shakiness with-in 5 minutes of vaccine administration. She los... Read more
Patient experienced dizziness, little shakiness with-in 5 minutes of vaccine administration. She lost consciousness twice for about 2 to 3 seconds. I made patient laid on the floor mate, and she felt much better.
21 2021-07-08 loss of consciousness The patient came in for her first COVID vaccine. Before receiving the vaccine the patient told the p... Read more
The patient came in for her first COVID vaccine. Before receiving the vaccine the patient told the pharmacist that she passes out every single time she has a vaccine or blood work due to a vasovagal reaction. She received the vaccine and sat for about 5 minutes, the patient and her father then went to sit in the chairs that patients wait in after getting the vaccine. About 5 more minutes later she passed out. She woke up immediately and the pharmacist gave her water. She sat for a few more minutes and was okay to leave.
21 2021-07-09 fainting Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Abdominal Pain-Mild, Systemic: Dizziness / ... Read more
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Abdominal Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: CALLED EMT PATIENT WAS ATTENDED TO BY EMT
21 2021-07-15 pallor, heart rate increased Patient was sitting in chair and head tilted back with eyes rolling back in head. Head started to ti... Read more
Patient was sitting in chair and head tilted back with eyes rolling back in head. Head started to tilt forward and shaking of arms and legs happened. Shaking lasted for around 3 seconds and stopped. Once done shaking, the patient became highly alert with wide eyes )as if she was unconscious). Lost color in face and lips. Took pulse of patient and was slightly elevated around 70bpm (however, could be normal for her). Placed cold pack on back of neck. Patient was able to talk and was responsive. I had water available for her if she needed.
21 2021-07-15 fainting Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild
21 2021-07-17 heart rate increased face rash; Increased heart rate; trouble breathing; dizziness; This is a spontaneous report from a c... Read more
face rash; Increased heart rate; trouble breathing; dizziness; This is a spontaneous report from a contactable other healthcare professional (patient). A 21-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9809) dose 1 via an unspecified route of administration, administered in Arm Left on 05Feb2021 18:15(at the age of 21 years old) as single for COVID-19 immunisation at workplace clinic. Medical history included covid-19 from an unknown date and unknown if ongoing prior to vaccination. The patient's concomitant medications were not reported. The patient previously took amoxicillin and experienced drug hypersensitivity. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 05Feb2021 18:30 the patient experienced Increased heart rate, trouble breathing, dizziness, and face rash. Treatment were received for events with allergy medicine. Since the vaccination, the patient was not tested for COVID-19. Outcome of all the events were recovering. Follow-up attempts are completed. No further information is expected.
21 2021-07-17 loss of consciousness She stopped breathing; She like passed out but her eyes were still open; her vision started to go; H... Read more
She stopped breathing; She like passed out but her eyes were still open; her vision started to go; Her vision start to get blurry; She started getting very hot; her vision started to go; Her vision start to get blurry; This is a spontaneous report from a contactable consumer. This consumer reported for a 21-years-old female patient. A 21-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EY0196 and Expiry date was not reported) dose 1 via an unspecified route of administration in Left arm on an unspecified date (21-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history was none. The patient was healthy. Concomitant Medication used for Just birth control (drug name not clarified). On unspecified, same day of vaccination the patient started getting very hot, has stopped breathing, like passed out but her eyes were still open, her vision started to go, her vision start to get blurry. The reporter stated that On unspecified date after 10, 5 minutes when it happened a pharmacy tech did gave her the EpiPen (treatment) because that's how we found out of it she was not with it, she was passed out, she stopped completely. she took the vaccine and they were sitting there you know to wait to make sure she didn't have reactions she started getting very hot. She poured water on herself because she was so hot then her vision started to go and her vision start to get blurry and the patient called the reporter to come stand by her when reporter walked over there she like passed out but her eyes were still open and she was calling my name looking at me but she was looking at me but she wasn't there, she was like looking straight through me. She stopped breathing, it was a horrible experience." The reporter stated that the patient had had a severe reaction after first dose. The reporter stated that She supposed to receive 2nd dose, its the 23rd but she is not getting it. The Reporter stated, "Yes, I would like to speak with somebody in regards to what she went through and what might affect if anything else is going to happened to her." Reporter stated, "So, when I call, I will speak to a medical professional and they'll have this information to discuss it with me and help me you know, because I mean, I wanna know, what I need to pay attention to if she is gonna have more other side effects from this or what." No laboratory tests. The outcome of the events was unknown. Follow-Up: Follow-up attempts are completed. No further information is expected.
21 2021-07-19 cardiac arrest, ejection fraction decreased 4/14/21 became confused and had cardiac arrest with seizure EMS called 1757 was taken to 2 hospitals... Read more
4/14/21 became confused and had cardiac arrest with seizure EMS called 1757 was taken to 2 hospitals with multiple resuscitation efforts and defibrillations declared deceased 0042 4/15/2021
21 2021-07-19 heart rate irregular My heart beat gets really slow to where it feels like I?m panicking and can?t breathe correctly. My ... Read more
My heart beat gets really slow to where it feels like I?m panicking and can?t breathe correctly. My vision will also get fuzzy. My period didn?t come for two months.
21 2021-07-19 hypertension Upon injecting, patient said, she immediately felt like her arm was warm, radiating down her arm, up... Read more
Upon injecting, patient said, she immediately felt like her arm was warm, radiating down her arm, up to her neck. Patient said she had a sore throat prior to the shot, and she felt her throat was warm, and her face was warm. Patient said, her arm felt numb and heavy but not tingly. Pharmacist called EMS. Her vitals were normal, but her BP was slightly high because patient was experiencing anxiety. Patient said she normally suffers from anxiety. Patient's mom said, she was nervous from the morning. EMS said, it's likely a mixture of anxiety and not feeling well combined.
21 2021-07-20 blood clot Patient's arm was sore after receiving the vaccine, 3 days later she woke up with numbness. She went... Read more
Patient's arm was sore after receiving the vaccine, 3 days later she woke up with numbness. She went to the hospital and was diagnosed with a blood clot in her arm. She was placed on warfarin and the clot dissolved. Her OBGYN lowered her dose of birth control. Her PCP advised her to still get her second dose.
21 2021-07-21 chest pain Patient developed chest pain on the left side with inhalation. Left shoulder had a sharp dull pain w... Read more
Patient developed chest pain on the left side with inhalation. Left shoulder had a sharp dull pain with activity. Symptoms did not improve with ibuprofen. Patient was evaluated in the ED and her EKG came back normal.
21 2021-07-25 loss of consciousness Felt nauseous and broke out into a sweat. Reported lightheadedness and dizzy. Felt like she would ... Read more
Felt nauseous and broke out into a sweat. Reported lightheadedness and dizzy. Felt like she would pass out. Reported tingling in fingertips. Laid down for an hour. Tingling subsided and felt lightheadedness subsided; however, continued to feel nauseous. Denies vomiting, chest pain, SOB, et.c
21 2021-07-26 loss of consciousness, fainting after administration of vaccine, pt was waiting out her 15 minutes in a chair in our waiting area. P... Read more
after administration of vaccine, pt was waiting out her 15 minutes in a chair in our waiting area. Pt started experiencing a vasovagal response to the vaccine where she lost consciousness and started to twitch for around a minute. Two pharmacists responded and immediately supported her upper body and raised her legs to get blood flow back to her head. The patient came to where she was given water and we monitored her for an additional 30 minutes until her partner came to pick her up.
21 2021-07-27 heart rate increased pneumothorax, her right lung collapsed; cyst that was ready to burst on her lung; swelling in her ri... Read more
pneumothorax, her right lung collapsed; cyst that was ready to burst on her lung; swelling in her right arm under the arm and in her chest area and breast; swelling in her right arm under the arm and in her chest area and breast; a heart murmur; a high resting heart rate; Back pain; lymph node swelling under her right arm pit into her chest; swelling in her lymph nodes and in her chest that were painful; swelling in her right arm under the arm and in her chest area and breast; This is a spontaneous report from a contactable consumer (patient's mother). A 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Apr2021 (lot number EW0153), at the age of 21 years, as the first single dose, for COVID-19 immunisation. Medical history was not reported. Concomitant medication included an unspecfied low estrogen birth control (she just took a birth control pill every day, probably on it since she was 16 or 17 years old). On 12Apr2021 the patient experienced back pain. On an unspecified date in 2021 the patient experienced lymph node swelling under her right arm pit into her chest. She had swelling in her lymph nodes and in her chest that were painful and she could touch them. On 16Apr2021 the patient experienced pneumothorax (on that day she went to the urgent care and they told her that her lung was about to collapse). The reporter finally got her daughter to come home from school and she took her to the emergency room on 17Apr2021. When the lung had collapsed, she felt worse and then she was in the hospital for an entire week. This event required hospitalization from 17Apr2021 to 29Apr2021. On 23Apr2021 she had a tube in her chest that was drawing the air out and they did something where they inflated her lung to see if it would stay and it wouldn't stay so they had to do surgery on 26Apr2021. When they went to do surgery they saw that on the outer part of her lung where the hole was that it wouldn't heal and they saw that it was like a cobble stone texture on the outside of the lung. The patient was in the hospital until 29Apr2021 and she was in the ICU the entire time. She went for check-ups and everything seemed to be good and her lung had healed. The caller was trying to connect dots between her family members and she had asked her daughter how she felt right after the COVID vaccine and her daughter said that she felt like "ehhh" and then on 12Apr2021 she had the back pain, then on 13Apr2021 she had air bubbles in her chest and on 15Apr2021 she was trying to walk to bars and she was out of breath. On 16Apr2021 the urgent care said they saw a cyst that was ready to burst on her lung and she was on bed rest and was given steroids. The caller thought that the swelling and the lymph nodes and having the cobble stone texture were all from irritation and then it had made a blister that popped creating the hole. On 29Jun2021 the patient experienced heart murmur and a high resting heart rate. Around 29Jun2021, the patient was feeling like her heart was moving in her chest and that it was out of synch and not right and that it was racing high and so the reporter called their family doctor who saw the patient the next day. They did an EKG that was irregular and now she had a heart murmur. She wasn't born with that and she had never had that and she didn't leave the hospital with that. She was fine until now with her having the murmur and the high resting heart rate, around 85. The caller didn't know the exact EKG irregularities because it said "normal" but they gave a copy to her and said to bring it to the cardiologist because it was not normal. The reporter didn't know the details and won't until the follow-up appointment on 16Jul2021 which was when they would have a better idea about what they were going to call this. She had the swelling in her right arm under the arm and in her chest area and breast, she was thin breasted, this was on the right side and then her right lung collapsed. The caller says that this was not a coincidence. There was no way that she would have three family members injured if it wasn't for the COVID vaccine. Her daughter should be taking an allergy medication but she won't take it. The patient did not receive the 2nd dose (when she had gotten out of the hospital after her pneumothorax that was when she was supposed to get her 2nd dose but they didn't go get it because they couldn't risk that). Back pain resolved on an unspecified date in 2021. The other events outcome was unknown. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021899289 same reporter/product/patient, different dose/event
21 2021-07-28 chest discomfort, heart rate increased, hypotension Resting heart rate 130-138; Chest discomfort during deep breathing; Low blood pressure between 89/70... Read more
Resting heart rate 130-138; Chest discomfort during deep breathing; Low blood pressure between 89/70 and 99/52; Fever of 102.5; achy; nausea; chills; exhaustion; dehydration; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 21-year-old non-pregnant female patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0164, Expiration date: Unknown), via an unspecified route of administration, administered in arm left on 21Apr2021 (at the age of 21-year-old) as single dose for COVID-19 immunisation in other facility. No other vaccines were received in four weeks and no other medications in two weeks. The patient did not have Covid prior vaccination. The patient medical history was not reported. There were no concomitant medications. On 22Apr2021 at 16:00, the patient experienced resting heart rate 130-138, chest discomfort during deep breathing, low blood pressure between 89/70 and 99/52, fever of 102.5, achy, nausea, chills, exhaustion and dehydration. The events resulted in emergency room. The patient underwent lab tests and procedures which included blood pressure measurement: between 89/70 and 99/52 on 22Apr2021, body temperature: 102.5 on 22Apr2021, resting heart rate: 130-138 on 22Apr2021, sars-cov-2 test: negative on 22Apr2021. Therapeutic measures were taken as a result of the events with saline and Tylenol. The outcome of the events was resolved on an unspecified date in 2021.
21 2021-07-28 chest pain During registration at , , informed that she might be pregnant and was not sure whether it was safe... Read more
During registration at , , informed that she might be pregnant and was not sure whether it was safe to get the Pfizer vaccine. explained to that she could still get the vaccine even if she was pregnant. But if she had any questions or concerns regarding the vaccine and her pregnancy, she should speak to her healthcare provider first. also told staff that was allergic to Penicillin and nuts. Staff explained to her that she could still get the vaccine, but she would have to sit for 30 minutes in the observation area so that staff could make sure she did not have any adverse reactions. decided to go forward with getting the vaccine. After getting the vaccine from , was directed to sit in the observation area for 30 minutes. During this time, , would periodically check on her to see how she was feeling, and each time said she felt fine. After her 30 minutes were over, told that she felt dizzy. asked if she could stay longer in the observation area as it was unsafe for her to stand up and walk. agreed. Staff offered her some candy and water to drink. After eating some candy, said she felt better. About 6 minutes later, said she was having trouble breathing and that it was getting worse. checked her oxygen level and it was 98. Staff explained to that her blood oxygen level was normal, but said she still couldn't breathe. tried to do some breathing exercises with her. called EMS at 1:50 p.m. and then went outside and waited for them to arrive. then told staff that she was having chest pain and that it hurt. Staff continued to monitor until EMS arrived at 2:07 p.m. They assessed and then transported her to Hospital at 2:20 p.m. to have her further
21 2021-07-28 chest pain I experienced severe arm pain for a couple of days after receiving both doses. I also experienced ti... Read more
I experienced severe arm pain for a couple of days after receiving both doses. I also experienced tingles through my right arm and right breast. At first I was feeling the tingling all over, but it's not consistent. Just yesterday, the tingling felt like rain drops hitting my skin. I have swollen lymph nodes and I am currently sick. I have been sick twice now and I hardly ever get sick. I did wake up, after a nap, the night after receiving the second dose, feeling cold and later on, I had a fever. It was 80 degrees in my house. I started to experience some chest pain. I was vaping and I stopped. The pain went away after about 3-4 days. I had to take shallow breaths for those 3-4 days because of the sharp pain I would feel. I feel skeptical that my immune system has been weakened.
21 2021-07-28 fibrin d dimer increased COVID pneumonia, acute hypoxic respiratory failure
21 2021-07-28 heart rate increased, skin turning blue, loss of consciousness, pallor Patient received the shot, 10 minutes later her mother came to the pharmacy window saying her daught... Read more
Patient received the shot, 10 minutes later her mother came to the pharmacy window saying her daughter couldn't breathe. I went to speak to patient and patient said she "couldn't breathe" then lost consciousness shortly thereafter. I injected her with an epipen in her left hip. She regained consciousness about 90 seconds later. Her lips were blue, she was pale, her pulse was strong, and heartbeat rapid. She expressed a phobia of shots before the shot and her mother said she has high anxiety about shots. Was taken away via ambulance.
21 2021-07-29 heart rate increased, chest pain Diarrhea, chest pain, fast heartbeat, shortness of breath, severe headache
22 2020-12-31 increased heart rate, palpitations Reported feeling shaky and a racing heartbeat. Per the ED physician's notes, by the time patient was... Read more
Reported feeling shaky and a racing heartbeat. Per the ED physician's notes, by the time patient was evaluated in the ED, her symptoms had resolved and she was released from care with no additional follow-up necessary.
22 2021-01-02 heart rate increased I received the 2nd dose of vaccine around 2pm on 01/02/21, was feeling fine until around midnight/1 ... Read more
I received the 2nd dose of vaccine around 2pm on 01/02/21, was feeling fine until around midnight/1 am I felt chills and feverish but had a temp of 98.8 at that time, woke up around 4am with body aches, chills, fatigue, and a temp of 102.3. I was fine with these symptoms as I knew they were common side effects until my heart rate spiked from about 60 to the 160s and I began to have a throbbing headache. I could not get my heart rate to come down, I was calm and knew it was not anxiety so I went to the ER where they did blood tests, EKG, UA and gave me fluids. Everything came back normal but my heart rate continued to be elevated around 130s for a couple more hours, finally came down to about 100-110, HR is still slightly elevated and I still have a fever of 100.4 and migraine
22 2021-01-02 palpitations Rash on lower right leg above the ankle appeared the evening of the shot. One spot was visible on th... Read more
Rash on lower right leg above the ankle appeared the evening of the shot. One spot was visible on the upper left arm the day after the shot. On the third morning after the shot, at 3 a.m., was awakened to a racing heart. The racing heart was on and off until I got out of bed at 7 a.m.
22 2021-01-05 fast heart rate The patient was observed for the required time and then released from the clinic. While driving home... Read more
The patient was observed for the required time and then released from the clinic. While driving home, she felt very tachycardic. She assessed her pulse as being 165 and returned to the vaccination clinic. By the time she returned, she felt dizzy and nauseated. Medical command was contacted who advised for paramedics on site to administer 50 mg of Benadryl IV as well as 4 mg of Zofran and an IV fluid bolus. Those treatments were executed, the tachycardia resolved and the patient felt better. She was transported to the Hospital for further evaluation and treatment as a precaution.
22 2021-01-06 palpitations received 2nd dose of Pfizer COVID-19 vaccine @ 1355. At approximately 1630 began to feel heart raci... Read more
received 2nd dose of Pfizer COVID-19 vaccine @ 1355. At approximately 1630 began to feel heart racing and lightheaded. Hear rate in 130's without exertion. Patient walked over to the ED, heart rate when up to 170's and patient was treated in ED and discharged at approx. 2200.
22 2021-01-07 palpitations On the third morning after the shot, at 3 a.m., was awakened to a racing heart. The racing heart was... Read more
On the third morning after the shot, at 3 a.m., was awakened to a racing heart. The racing heart was on and off until getting out of the bed at 7 a.m.; Oe spot was visible on the upper left arm; Rash on lower right leg above the ankle; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the right arm on 31Dec2020 at 13:30 at a single dose for COVID-19 immunization at the Public Health Clinic facility (as reported). The patient's medical history and concomitant medications were not reported. The patient has no known allergies. The patient is not pregnant. The patient was has not received any other vaccine in four weeks and has not have other medications in two weeks. On 31Dec2020 at 17:30, patient reported of rash on lower right leg above the ankle appeared the evening of the shot. Then one spot was visible on the upper left arm the day after the shot (01Jan2021). On the third morning after the shot (03Jan2021), at 3 A.M., patient was awakened to a racing heart. The patient reported that the racing heart was on and off until getting out of the bed at 7 A.M. The patient did not receive treatment in response to the events. The patient assessed the events as non-serious. The outcome of the events was unknown. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since vaccination. Information on the lot/batch number has been requested.
22 2021-01-10 fainting Woke up during the night and experienced vomiting and diarrhea followed by syncope
22 2021-01-11 body temperature decreased Fever from 3:00 am to 6:40 pm (99.7 - 101.4) treated with extra strength acetaminophen. Temperature ... Read more
Fever from 3:00 am to 6:40 pm (99.7 - 101.4) treated with extra strength acetaminophen. Temperature is now 99.5 Fatigue for 1/11 and 1/12 Intermittent muscle aches on arms and calves
22 2021-01-11 deep vein blood clot, pulmonary embolism Back pain, bilateral PE and DVT
22 2021-01-11 loss of consciousness, fainting dizziness then syncope. loss of consciousness lasted a couple minutes. Patient sustained minor sup... Read more
dizziness then syncope. loss of consciousness lasted a couple minutes. Patient sustained minor superficial abrasions to her face. evaluated in clinic
22 2021-01-11 fainting Vasovagal syncope
22 2021-01-12 heart rate increased Flush face, blotchy skin, tingly fingers, rapid pulse gave 50mg Benadryl
22 2021-01-12 fast heart rate, hypertension hypertension like 190/90; I had tachycardia to 165; Flushing; This is a spontaneous report from a co... Read more
hypertension like 190/90; I had tachycardia to 165; Flushing; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EK9231, intramuscular on 06Jan2021 at single dose for COVID-19 immunization. Medical history included migraine. Concomitant medication included cyproheptadine for migraine, unspecified multivitamins; and diphenhydramine (BENADRYL) and famotidine as pre-medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Dec2020 for COVID-19 immunization, and experienced dizziness, palpitations, tingling in face and legs, myalgia, nausea, headache, fatigue. It was reported that patient got the second dose and had tachycardia to 165 and hypertension like 190/90 and had some flushing (event onset: 06Jan2021). Patient was no longer tachycardiac or hypertensive; lasted for about 30-40 minutes. Outcome of the events tachycardia and hypertension was recovered on 06Jan2021. Outcome of the event flushing was unknown.
22 2021-01-13 chest discomfort Systemic: Anaphylaxis-Severe, Systemic: Rash (other than injection site)-Medium, Systemic: chest/thr... Read more
Systemic: Anaphylaxis-Severe, Systemic: Rash (other than injection site)-Medium, Systemic: chest/throat tightness-Medium
22 2021-01-13 heart rate increased, chest discomfort Patient had onset of shortness of breath, chest tightness, elevated heart, diaphoresis.
22 2021-01-13 pallor, heart rate increased, chest discomfort Systemic: HR as high as 160. Respiratory rate of 22. "Heavy feeling in chest" Pale color of skin-Med... Read more
Systemic: HR as high as 160. Respiratory rate of 22. "Heavy feeling in chest" Pale color of skin-Medium; symptoms lasted 1 day
22 2021-01-13 palpitations, fast heart rate within 15', developed tongue swelling, dizziness, palpitations. Transferred to ED & treated with st... Read more
within 15', developed tongue swelling, dizziness, palpitations. Transferred to ED & treated with steroids, Benadryl, Pepcid. Observed in ED for 6 hrs, then d/c to home 7 will f/u with PCP re: EKG changes
22 2021-01-13 palpitations Dizziness; Palpitation; I had tingling in my face and my legs; Myalgia; Nausea; Headache; Fatigue; T... Read more
Dizziness; Palpitation; I had tingling in my face and my legs; Myalgia; Nausea; Headache; Fatigue; This is a spontaneous report from a contactable consumer (emergency department technician like a clinical assistant). A 22-year-old female patient received her first injection of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine, lot number EK9231) intramuscularly at a single dose on 17Dec2020 for Covid-19 immunization. The patient had a medical history of migraine. Concomitant medications included cyproheptadine for migraine and multivitamins. The patient experienced dizziness and palpitations initially and then little bit later on the day she had tingling in her face and legs and she had myalgia, nausea and headache and fatigue. The symptoms lasted for 2 days. The patient medicated with Benadryl and Famotidine. Outcome of the events was unknown. The patient had her second vaccine injection on 06Jan2021.
22 2021-01-13 pulmonary embolism, skin turning blue, deep vein blood clot she was diagnosed with bilateral deep vein thrombosis (DVT) and pulmonary embolism (PE); she was dia... Read more
she was diagnosed with bilateral deep vein thrombosis (DVT) and pulmonary embolism (PE); she was diagnosed with bilateral deep vein thrombosis (DVT) and pulmonary embolism (PE); This is a spontaneous report from a contactable nurse (patient). A 22-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK9231), via an unspecified route of administration in left arm on 06Jan2021 13:45 at single dose for COVID-19 immunisation. Medical history included allergy to all fish, and clots. The patient was not pregnant. There were no concomitant medications. The patient previously received 1st dose of BNT162B2 (lot numer: EH9899) in left arm on 16Dec2020 13:45 for COVID-19 immunisation and experienced left sided lower back pain on 20Dec2020. No other vaccine received in four weeks. It was reported that the patient had the first covid vaccine on 16Dec2020 and on 20Dec2020 started with left sided lower back pain and then received the second on 06Jan2021 and then on 09Jan2021 11:00 her legs became blue and swollen and she was diagnosed with bilateral deep vein thrombosis (DVT) and pulmonary embolism (PE). The patient otherwise healthy and had never had covid. Other than the clots, she had no other health issues. The patient underwent lab tests and procedures which included nasal swab: negative on 09Jan2021. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, and life threatening illness (immediate risk of death from the event), hospitalized for 2 days (in Jan2021). Adverse event treatment: heparin drip and xarelto at home. Recovered with lasting effects on an unspecified date of Jan2020. This case was reported as serious, serious criteria was life threatening, caused/prolonged hospitalization.; Sender's Comments: The underlying risk factors/predisposing condition of thrombotic diathesis have been assessed to have played a contributory role toward the events.
22 2021-01-13 fast heart rate While driving home, I felt very tachycardic. I assessed pulse as being 165 and returned to the vacci... Read more
While driving home, I felt very tachycardic. I assessed pulse as being 165 and returned to the vaccination clinic. By the time I returned, felt dizzy and nauseated. Medical command was contacted who advised for paramedics on site to administer 50 mg of Benadryl IV as well as 4 mg of Zofran and an IV fluid bolus. Those treatments were executed, the tachycardia resolved and the I felt better. I was transported to the Hospital for further evaluation and treatment as a precaution.
22 2021-01-14 chest discomfort 4 hours after receiving my Pfizer COVID vaccination, my chest started to tighten up and I became sho... Read more
4 hours after receiving my Pfizer COVID vaccination, my chest started to tighten up and I became short of breath. I took some Ibuprofen, but the pain is still there today, and it is hard for me to even walk up the stairs without becoming short of breath or being in pain.
22 2021-01-14 heart rate increased nauseau; vs: 127/77 rr-30 hr-117 o2 sat 100% 15 min recheck hr-91 1425 no further problems
22 2021-01-14 heart rate increased Headache, nausea, increased HR and RR, vomiting, fever, chills, night sweats
22 2021-01-14 palpitations Shortly after receiving vaccine started feeling foggy. upper lip began to tingle, felt numb, and st... Read more
Shortly after receiving vaccine started feeling foggy. upper lip began to tingle, felt numb, and starting swelling. Started having palpitation and having shortness of breath.
22 2021-01-16 blood pressure increased Tingling hands and lips, flushed skin, "feeling hot", increased blood pressure. Had to take 50 mg of... Read more
Tingling hands and lips, flushed skin, "feeling hot", increased blood pressure. Had to take 50 mg of Benadryl at facility, then 50 mg of Benadryl before bed due to hands still tingling. Blood pressure returned to normal after the initial dose of Benadryl. Symptoms were resolved the following day.
22 2021-01-17 chest discomfort Complaints of feeling dizzy/light headed, scratchy throat, chest tightness and a rash on her neck. ... Read more
Complaints of feeling dizzy/light headed, scratchy throat, chest tightness and a rash on her neck. Pulse ox on RA 99%. Facility Nurse sat with her for 1.5 hours and then she returned to work. Was seen by doctor but not an official office visit.
22 2021-01-17 hypotension Right after I puked I started to feel better, I felt as if I was going to faint, I felt really weak ... Read more
Right after I puked I started to feel better, I felt as if I was going to faint, I felt really weak , chills The next day I was nauseas, Blood Pressure was low again . Pain in my Arm
22 2021-01-19 chest discomfort Patient was first presenting chest tightness, chills, cold sweats, and shortness of breath. This al... Read more
Patient was first presenting chest tightness, chills, cold sweats, and shortness of breath. This all in a time course of one hour. Patient presented wheezing upon auscultation. Epinephrine dose was administered (0.3mg). Patient was monitored and continued with same symptoms. Wheezing did not improve. Second dose of epinephrine was administered sixteen to seventeen minutes prior to second dose (0.3mg).
22 2021-01-19 fainting Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Systemic: Fainting-Mild, Systemic: Visual disturbanc... Read more
Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Systemic: Fainting-Mild, Systemic: Visual disturbance ("blue spots," "dark visual waves")
22 2021-01-20 palpitations Patient received Pfizer vaccine, was sitting in observation at 14 minutes in reported (1104) feeling... Read more
Patient received Pfizer vaccine, was sitting in observation at 14 minutes in reported (1104) feeling "heart beating fast, warm, throat feels funny" Taken to ED for observation. Appeared anxious, HR 119-130. Pt without dib, throat swelling/ face swelling, itching, rash.
22 2021-01-21 increased heart rate, heart rate increased A 22 y.o. female presenting with fever, tachycardia viral symptoms in the first 12 hours after recei... Read more
A 22 y.o. female presenting with fever, tachycardia viral symptoms in the first 12 hours after receiving second dose of Covid vaccine. Was feeling well prior to that. Has soreness at her arm as well. She has a history of POTS and did detect a rapid heart rate at home. She has mild sinus tachycardia at this time reports a gradual improvement in symptoms. Fever is improving, had not had any antipyretic prior to coming in. I have low suspicion for acute infection and would favor immune response to the vaccine itself which has been reported in multiple persons receiving same vaccine. She is not hypoxic, has clear breath sounds. No thrombocytopenia on CBC. IV was placed, IV fluids given. Heart rate improved, blood pressure remained stable. Patient feels well enough for discharge on reevaluation and declined need for analgesic or antipyretic here.
22 2021-01-21 fainting dizziness then syncope; dizziness then syncope; This is a spontaneous report from a contactable Othe... Read more
dizziness then syncope; dizziness then syncope; This is a spontaneous report from a contactable Other HCP. A 22-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 11Jan2021 14:00 at single dose for COVID-19 immunisation. Medical history included situational anxiety, known allergies_penicillin. Concomitant medication included colecalciferol (VITAMIN D [COLECALCIFEROL]). The patient previously took amoxicillin;clavulanic acid (AUGMENTIN) and moxifloxacin and experienced allergies. The patient experienced dizziness then syncope on 12Jan2021 05:45. The patient underwent lab tests and procedures which included electrocardiogram: unknown results, laboratory test: unknown results. Therapeutic measures were taken as a result of dizziness then syncope. The outcome of the events was resolving. Information on batch/lot number was requested.; Sender's Comments: Based on the time association, the event syncope is possibly related to suspect BNT162B2 administration. 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.
22 2021-01-23 chest pain Chest pain, Pain on breathing deeply, numbness and tingling in left arm, hand, leg, foot
22 2021-01-24 blood pressure decreased, fainting Patient experienced syncope on the night of 1/24, hours after receiving the second dose of the Pfize... Read more
Patient experienced syncope on the night of 1/24, hours after receiving the second dose of the Pfizer COVID vaccination. Patient reported feeling "hot and clammy", claimed her blood pressure dropped, and she fainted. She presented to the ER and was released the same night. Upon follow-up on 1/25 patient reports she has recovered from her fainting episode but feels tired, achy, and generally unwell; these side effects are to be expected following the 2nd dose of the Pfizer COVID vaccine.
22 2021-01-24 heart rate increased Seizure after returning home from getting vaccination (Grand mal) 2 hours post vaccination She had a... Read more
Seizure after returning home from getting vaccination (Grand mal) 2 hours post vaccination She had an stressful episode with elevated HR and normal SPO2 5 minute after the shot which was controlled with clonazepam
22 2021-01-24 fainting Syncopal episodes X 4 on 1/23 - transferred to ed - admitted Fever chills aches on 1/22/21 pm
22 2021-01-28 fainting Vasovagal syncope response shortly after waking in the morning, only passed out for less than 30 sec... Read more
Vasovagal syncope response shortly after waking in the morning, only passed out for less than 30 seconds, required suturing for chin laceration
22 2021-01-30 heart rate increased, palpitations, fast heart rate, chest pain - Needed inhaler each night since - Jan. 25th night was worst yet, took over an hour for inhaler... Read more
- Needed inhaler each night since - Jan. 25th night was worst yet, took over an hour for inhaler to kick in. Tried steam and heating pad, little improvement - Jan. 26th Took ProAir inhaler at 2pm before shift - Little improvement - Pain still in chest - Called my primary Dr. at 4:30 - Prescribed prednisone and Advair - Thinks vaccine caused inflammatory response - Took prednisone at 8pm - Took Advair around 11 - Took ProAir inhaler around midnight - Heart racing (HR130) - SOB, pain when breathing - Localized to sternum, on either side as if something was grabbing my lungs and squeezing - Feel like lightning coursing thru my veins - Shaky I ended the up in the ER Jan. 26th. * I took prednisone at 8pm * I took Advair at 11pm * I was still having trouble breathing and my last hit of my ProAir had completely worn off * I took my ProAir around midnight * Over the course of the next two hours I was SOB, tachy (HR 130s), hot and cold flashes, pain while breathing, couldn?t catch my breath * My friends took me to the ER around 2am * At the hospital they did a 12 Lead EKG, blood work, labs, 2 chest X-rays, and a COVID-test * They gave me 0.5 mg lorazepam IV * All of my blood work and labs came back normal. * X-rays came back clear * EKG came back fine * Negative COVID test * I took a nap after the lorazepam hit and woke up feeling much better * ER doc thinks my ProAir exacerbated some anxiety because my lungs were clear and no wheezing * Discharged me with a script for lorazepam PRN x10 and instructions to follow up with my primary is back at home. * Doc said I could continue the prednisone and Advair * Woke up today and yesterday feeling better, still some pain when breathing and exhausted. Pain is mostly at top of my lungs, going across my chest. Deep breathing sometimes helps but there?s also pain upon inhalation. * Took the next doses of Advair and my Dexedrine (ADHD meds). Nothing weird yet just drained. They switched my Ventolin inhaler to ProAir, I have been taking it about five times a week so I can workout. When I was on Ventolin I didn?t have any of the side effects I have with ProAir.
22 2021-01-30 low blood oxigenation, oxygen saturation decreased Less than five minutes after receiving vaccine reported burning in stomach, followed by dizziness. P... Read more
Less than five minutes after receiving vaccine reported burning in stomach, followed by dizziness. Patient was then observed to be flushed. Patient then reported " I can't breath". EpiPen was administered into right thigh, oxygen initiated. Patient was mildly hypoxic, O2 saturation noted to be 88% after EpiPen and oxygen saturation increased to 99%. Patient was transported to ED via hospital rapid response team. Upon arrival to ED symptoms had improved. Patient was monitored in ED and discharged to home with short burst of prednisone and EpiPen. Per ED note unclear if event was true allergic reaction or vasovagal response
22 2021-01-31 chest discomfort, pallor Stridor, pallor, and reports throat closing up, EpiPen given at 1:08pm and EMS called, improvement n... Read more
Stridor, pallor, and reports throat closing up, EpiPen given at 1:08pm and EMS called, improvement noted shortly after Epi administered. B/P 100/50@ 1:18pm, EMS arrived at 1:20pm and at 1:22pm c/o breathing difficulty, chest tightness. Transported to ER
22 2021-01-31 chest pain Fatigue; Shortness of breath; Chest pain; Cough; This is a spontaneous report from a contactable con... Read more
Fatigue; Shortness of breath; Chest pain; Cough; This is a spontaneous report from a contactable consumer. A 22-year-old female patient (daughter) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that her daughter had a reaction to the COVID vaccine. The patient received the first dose of the vaccine on 23Dec2020. The adverse reaction has lasted the past three weeks to include fatigue, shortness of breath, chest pain, and cough on unspecified date. The patient is now on inhalers and she was not on inhalers before. The reporter stated that her daughter has been tested for COVID multiple times. Outcome of the events was unknown. Information on the Lot/Batch number has been requested.
22 2021-01-31 pallor Patient is a registered nurse at facility. She reported having slight itchy lips and scratchy throa... Read more
Patient is a registered nurse at facility. She reported having slight itchy lips and scratchy throat after 1st dose. Patient very much wanted full protection that 2nd dose offers in order to be safe and keep family members safe. We discussed the possibility of an increased reaction, but she wanted to go ahead and felt the benefits outweighed the risk. I considered the fact that she is a health care professional, was fully informed and that we were at a skilled nursing facility and were prepared in case she had any reaction. About 10 minutes after vaccination she seemed to be coughing and felt like her throat was maybe swelling. She seemed to be breathing ok, but I asked her to take a Benadryl, which she did. Within 5-10 minutes after that she began shaking and seemed very pale. She said her symptoms were getting worse. I told her I was going to administer an epi-pen dose. 911 was called, I administered the epipen, we had heart rate monitor and pulse ox monitor on patient and she was stable, but scared. EMT's arrived and transported patient to ER. She was later released with Benadryl.
22 2021-02-02 chest pain, heart rate increased About 5 mins after the shot I received on Sunday, I got a cooling effect in my chest and began to fe... Read more
About 5 mins after the shot I received on Sunday, I got a cooling effect in my chest and began to feel a bit off with an elevated HR of 132. I raised my hand to talk to a nurse and she said I was probably just nervous, got me a water, and said to continue to monitor symptoms. Then, after 15 minutes were up with no other symptoms I left the facility where I got the vaccine. The rest of the day I began to get a burning and cooling effect all around my sternum. It persisted through the day despite Tylenol 500 mg and worsened at night, keeping me up along with a slight fever and chills. The next morning I awoke with slightly lowered symptoms but the sternum pain would flare up on and off through the day and again was worse at night on Monday. So, I took a Benadryl and a 500 mg Tylenol and slept great. I woke up Tuesday feeling great with no fever and minimal chills and no sternal pain. I thought since I hit the 48 hour mark everything was going fine and I was recovering. I ran some errands and even went to the gym to do a mild workout. Then at about 6pm all the symptoms of the sternal pain flared up and was just as bad as Monday night. I took another 500mg Tylenol and 1 Benadryl again and they did not seem to work or help nearly as much as the night before. I woke up this morning with some pain in my sternum again and did not sleep much last night due to the pain as well. I have not taken any further medications at this time and I am also experiencing the worst fatigue I have so far today.
22 2021-02-02 heart rate irregular, blood pressure increased, heart rate increased 5 days after vaccine experienced irregular heartbeat and fast heart rate. Never had this before. W... Read more
5 days after vaccine experienced irregular heartbeat and fast heart rate. Never had this before. Went to hospital where HR and BP extremely elevated. Observed overnight in hospital, placed on beta blocker and had Holter monitoring.
22 2021-02-04 palpitations, fainting Fainted; Dizziness; Heart racing; This is a spontaneous report from a contactable consumer reported ... Read more
Fainted; Dizziness; Heart racing; This is a spontaneous report from a contactable consumer reported for herself. A 22-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Jan2021 15:45 at single dose in left arm for COVID-19 immunisation. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. Concomitant medication included lisdexamfetamine mesilate (VYVANSE), escitalopram oxalate (LEXAPRO), spironolactone and Birth control product. The patient experienced fainted morning after 1st dose with dizziness and heart racing on 22Jan2021 06:45 - had to go to ER. The patient received anti-nausea and heart monitor as treatment for the adverse event. Events outcome was unknown. Information on the lot/batch number has been requested.
22 2021-02-05 heart rate increased Patient had a tingling arm and fast heart rate. The symptoms started within 5 minutes of receiving t... Read more
Patient had a tingling arm and fast heart rate. The symptoms started within 5 minutes of receiving the COVID vaccine and it started with a tingling sensation on the back of her hand.
22 2021-02-07 fast heart rate tachycardia, headache and chills beginning approx 12 hours post vaccine, rate as high as 130s by day... Read more
tachycardia, headache and chills beginning approx 12 hours post vaccine, rate as high as 130s by day 3, given beta blocker at outside hospital on day 3 (records not available)
22 2021-02-08 chest pain itchy face, arm, and neck, chills, low grade fever, chest pain, joint pain
22 2021-02-09 chest pain c/o CP during 15 minute monitoring period. No SOB. No airway involvement.
22 2021-02-09 chest pain Chest pain; This is a spontaneous report from a contactable nurse. A 22-year-old female patient rece... Read more
Chest pain; This is a spontaneous report from a contactable nurse. A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number and expiration date unknown, via an unspecified route of administration on 22Jan2021 08:30 at single dose on right arm for COVID-19 immunization. The patient is not pregnant. The patient had no medical history and no known allergies. The patient had no other vaccine in four weeks. The patient had other medications in the last two weeks. Concomitant medication was unspecified. The patient experienced chest pain on 23Jan2021 13:00. The patient had no treatment and did not recover from the event. The patient was not tested for COVID prior and post vaccination. Information on the lot/batch number has been requested.
22 2021-02-10 heart rate increased, increased heart rate Within 2 hours of getting the shot my heart rate shot up when I was in resting position. It would go... Read more
Within 2 hours of getting the shot my heart rate shot up when I was in resting position. It would go back and forth between normal heart rate and the highest it got was 175bpm. After a week of this going on I followed up with my PCP had an EKG done and saw I had sinus Tachycardia. They put me on a Beta blocker from now until 2 weeks after my second dose to see if that slows my heart rate down.
22 2021-02-12 chest pain Fever, chills, muscular pain, chest pain, shaking, paralyzed, vomiting
22 2021-02-12 loss of consciousness, fainting Was having body aches everywhere so I got out of bed at 2:30am to take some ibuprofen. I started to ... Read more
Was having body aches everywhere so I got out of bed at 2:30am to take some ibuprofen. I started to feel lightheaded and started to get the cold sweats. Next this I know I?m waking up on the ground. I had passed out. I went to the ER and was diagnosed with syncope. I wasn?t given any treatment after they identified my EKG and vitals were normal and was discharged quickly. I feel fine right now.
22 2021-02-14 chest pain, fainting Fever (highest- 102.5 F), dizziness, muscle aches/soreness, chills, fatigue, chest pain, shortness o... Read more
Fever (highest- 102.5 F), dizziness, muscle aches/soreness, chills, fatigue, chest pain, shortness of breath, muscle weakness, night sweats, vomiting, fainting
22 2021-02-18 loss of consciousness 2 days after vaccine, she fainted and later contacted her PCP. Patient may have been dehydrated with... Read more
2 days after vaccine, she fainted and later contacted her PCP. Patient may have been dehydrated with headaches after vaccine. Advised to seek medical assistnace for ongoing issues.
22 2021-02-20 fainting Fever of 102 and dehydration contributed to a syncope collapse early the morning after vaccination (... Read more
Fever of 102 and dehydration contributed to a syncope collapse early the morning after vaccination (7:15 AM 02/20/21). Just before collapsing, I experienced nausea, dizziness, confusion, weakness, and seeing all black in my field of vision. Emergency Room doctors say it was very likely related to an adverse reaction to the second Pfizer Covid vaccination. Treatment included Tylenol and Ibuprofen, rest, and fluids.
22 2021-02-21 hypotension, fast heart rate, pallor Abdominal pain, pale, hypotensive, tachycardic. Received epi pen and transport to ER
22 2021-02-21 fainting Syncopal episodes X 4; Fever; chills; pain/aches; Condition Aggravated; This is a spontaneous report... Read more
Syncopal episodes X 4; Fever; chills; pain/aches; Condition Aggravated; This is a spontaneous report from a non-contactable consumer. A 22-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1284) intramuscularly in left arm on 22Jan2021 at single dose for COVID-19 immunization. Medical history included traumatic brain injury from 2019 and ongoing, syncope from 2019 and ongoing (both reported as current Illness: traumatic brain injury? 2019 syncope? 2019). Concomitant medication included midodrine. The patient experienced fever, chills, pain/aches, on 22Jan2021 pm, condition aggravated on 22Jan2021, syncopal episodes X 4 on 23Jan2021 - transferred to ed - admitted. Events categories per reporter was permanent disability, hospitalized (3 days in hospital), emergency room visited. No office visited. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
22 2021-02-23 fast heart rate, blood pressure increased Patient felt dizzy, nauseas, and lightheaded like she might pass out. EMS came to take a look at her... Read more
Patient felt dizzy, nauseas, and lightheaded like she might pass out. EMS came to take a look at her. Her blood pressure was elevated and her heart beat was rapid. This was not typical for her after vaccines. She felt this way around 5 minutes after receiving her second vaccine.
22 2021-02-25 fainting fainted; Nausea; Headache; Slight fever; This is a spontaneous report from a contactable consumer (p... Read more
fainted; Nausea; Headache; Slight fever; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm on 06Feb2021 17:00 at a single dose for COVID-19 immunization. Medical history included asthma. The patient's concomitant medications were not reported. The patient is not pregnant. On 07Feb2021 09:15, the patient fainted 16 hours after getting the shot. The patient also experienced nausea, headache and slight fever. The events were assessed as serious (medically significant). No treatment was received for the events. The outcome of the events was recovered on an unspecified date. Information about batch/lot number has been requested.
22 2021-02-26 chest pain Lightheaded, HA, vision changes, shaky, chest pain, facial flushing, cleared by EMS-
22 2021-02-27 pallor Developed a whole body rash 6 days after my first Pfizer vaccine. The rash was very large and covere... Read more
Developed a whole body rash 6 days after my first Pfizer vaccine. The rash was very large and covered about 80% of my body. The rash consisted of redness, small bruise spots and extreme itching. I self treated myself by taking several cool showers and took acetaminophen two times two capsules. On the second day, blotches are subsiding but I have fatigue and weariness in limbs. Skin is less red but has a sallow color and blotchy which is unusual.
22 2021-02-28 hypotension Dizziness, hypotension, HR 64 Sp02: 99% BP:100/69,C/o dizziness, reported hx of vasovagal episode... Read more
Dizziness, hypotension, HR 64 Sp02: 99% BP:100/69,C/o dizziness, reported hx of vasovagal episodes w/ blood draws. A/O x4. Marathon runner VS: HR 56, BP 80/52, Sp02: 100% After laying down, patient reported significant improvement in symptoms. Tolerating PO well
22 2021-03-02 fainting Patient fainted and was sweating while in post vaccination observation area. Patient recovered and m... Read more
Patient fainted and was sweating while in post vaccination observation area. Patient recovered and mother took patient to ED for follow up. Patient discharged from ED with no issues.
22 2021-03-03 chest pain On Monday at around 2pm I started having severe pain in my chest near my right breast, and as the da... Read more
On Monday at around 2pm I started having severe pain in my chest near my right breast, and as the day progressed it got worse with a horrible migraine. It began to radiate to the left, and Wednesday I went to Urgent Care because I was scared. My EKG & chest x-ray were clear. Today I feel even worse with migraines, chest pain (that radiates up my neck and around my back), and overall feeling gross and exhausted. My head is what?s bothering me the most along with my joint pain.
22 2021-03-03 fainting PATIENT FELT LIGHTHEADED. WHILE TRANSPORTING HER TOTHE GURNEY PATIENT HAS A SYNCOPE AND HELPEDTO THE... Read more
PATIENT FELT LIGHTHEADED. WHILE TRANSPORTING HER TOTHE GURNEY PATIENT HAS A SYNCOPE AND HELPEDTO THE FLOOR BY THE OBSERVATION NURSE. BP CHECKED READ 80/
22 2021-03-04 pallor 0925 patient in general observation, ambulated to nurse stating she felt funny. Color pale, ambulate... Read more
0925 patient in general observation, ambulated to nurse stating she felt funny. Color pale, ambulated to private observation area. States she feels nauseated. Sat in chair and given emesis bag. HR 157; O2 99%: BP 138/72. HR ausculated and rate confirmed. State she has no history of tachycardia or rapid heart beat. Denies "feeling" heart race. Denies itching, shortness of breath or difficulty swallowing. States she took her lisinopril and anxiety meds this morning. States she ate breakfast and performed her self catherization. 0940 Offered EMS transport/evaluation. Patient declined. 0942 patient states nausea resolved, BP 140/82; HR 136: O2 99% remains on rooms air. 0945 Auscultated Heart Rate at 140, strong/regular. Bilateral breath sounds clear to ausculation. Patient sitting in chair at rest. Color remains pink. Denies chest pain. 0948 Mother called patient's physician and reported to physician. PCP to return call to patient 0952 Patient to restroom, mom accompanied. 0955 Upon return from restroom, HR 160; O2 99% r/a, Denies feeling clammy, or having chest pain. denies hx of sinus tachycardia. Re-offered EMS eval due to elevated HR. Patient agreed to EMS eval. 0957 EMS activated 1013 Patient sitting in chair wringing hands. states she has excessive sweat glands and normally is very diaphoretic, states she feels dry at the moment. HR 144; O2 99% 1015 EMS and FD arrived. 1017 BP 103/61; HR 138; O2 99% and per EKG in ST per EMS monitors 1019 EMS recommended transport. Patient agreed. 1020 Transported via stretcher to ambulance to Hospital ED.
22 2021-03-05 chest discomfort Chest tightness, anxiety. BP 119/66 (pulse 81), 100% O2 sat. Given water and graham crackers.
22 2021-03-07 heart rate increased, lightheadedness, pallor Shortly after being given the vaccine the person had an episode of near-syncope where she felt light... Read more
Shortly after being given the vaccine the person had an episode of near-syncope where she felt light-headed and was not feeling well. She has had a history of this occurring in the past after an injection before (unknown if vaccination or other IM injection) and blood draws. She did not have any loss of conscious, but she became pale and diaphoretic and felt like she could pass out if she would stand consistent with a vasovagal event. She initially had an elevated pulse at 113 which came down to 65 and her blood pressure was initially 110/60 and then 98/62 on recheck. Patient was placed supine on a cot and then her legs were elevated to help her symptoms. She did have some improvement in her symptoms prior to transport to the ER via EMS at her request.
22 2021-03-09 loss of consciousness Patient in observation area after covid 19 vaccination. Patient stated she became dizzy, tried to pu... Read more
Patient in observation area after covid 19 vaccination. Patient stated she became dizzy, tried to put head between her legs. RN observer walked over to assess patient and saw that patient had approximately 10 seconds of unresponsiveness. EMS activated. Vitals signs taken BP 98/55, 99%, HR 50. 10 minutes later BP was 120/71, 100%, HR 55. Patient condition improved and patient was alert and oriented x3 in no acute distress, ambulating on transfer. Patient transferred via ems to hospital.
22 2021-03-10 fainting Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Severe
22 2021-03-12 loss of consciousness Patient stated she passes out after shots, so RN got her a wheelchair to sit in while the shot was b... Read more
Patient stated she passes out after shots, so RN got her a wheelchair to sit in while the shot was being administered. The vaccine was administered and she felt fine. While sitting for another minute she passed out in the wheelchair and the RN called for help. The patient came too. The patient was assessed by paramedics on scene and stayed an extra 30 minutes. She knew she blacked out and she went home with her mother.
22 2021-03-12 fainting syncope, hx of syncope with immunizations
22 2021-03-14 fainting patient was nervous about the injection but still got it. she said she was okay but sat down to mak... Read more
patient was nervous about the injection but still got it. she said she was okay but sat down to make sure, then fell off her chair and fainted. patient woke up shortly after and paramedics evaluated her for concussion
22 2021-03-15 haemoglobin decreased, platelet count decreased Within minutes of 2nd dose of vaccine, pt started urinating dark brown urine. This turned bloody / ... Read more
Within minutes of 2nd dose of vaccine, pt started urinating dark brown urine. This turned bloody / dark red in color. Over the next several days she had migraines, fever, nausea, diarrhea. She had a very heavy period that was not normal for her. She was treated twice for presumed UTI (once with macrobid and then with cefuroxime) in the days after the vaccine though cultures ended up negative. She was referred to me, a hematologist, when she was noted to have a dropping hemoglobin and platelet count. She appears to have a Coombs-negative hemolytic anemia and possibly ITP. She is feeling a little better but her labs remain abnormal. Please note this was reported on Pfizer website as well but I have not been contacted. Guidance would be sincerely appreciated. My cell phone was provided.
22 2021-03-15 fainting 10 minutes after receiving the first dose of Pfizer, the patient began feeling dizzy and had a synco... Read more
10 minutes after receiving the first dose of Pfizer, the patient began feeling dizzy and had a syncope event. BP 105/59. HR 59. 100% saturation on room air. Repeat vitals 10 minutes later: BP 95/39, HR 66, 100% sat on room air. Blood glucose 109. Patient noted she came from the gym and had not eaten a full meal. Patient reports passing out after donating blood, and felt similar to that experience. No history of syncope events related to vaccines.
22 2021-03-16 chest discomfort Extreme dizziness ,tightness in chest, Stomach pain extreme fatigue, muscle pain, lightheadedness
22 2021-03-16 heart rate increased Complained of dizziness and light headedness. Patient approached me with sudden dizziness. LIght hea... Read more
Complained of dizziness and light headedness. Patient approached me with sudden dizziness. LIght headed, and felt cold. After walking to treatment area, obtained vitals. Heart rate slightly elevated at 106. After sitting and talking with me for 5 minutes patient felt immediately better. She returned to recovery to finish out her time. Increased her recovery time to 30 minutes. No further issues.
22 2021-03-16 heart rate increased Pt reported to the vaccination area stating that she had a history of fainting after medical procedu... Read more
Pt reported to the vaccination area stating that she had a history of fainting after medical procedures, including vaccination. Was with her mom, in case she had an issue. Vaccination without incident. Kept pt at the vaccination area to observe. About three minutes after receiving the vaccination, pt started to shake. Was conversing. Stated she was warm, so got her a cold bottle of water. Stated she was dizzy so helped her to the floor to lay down. She had contractions of her hands, which she stated that they were numb. She recovered from the dizziness, but then had a panic attack. Her BP was normal, but her heart rate became elevated. Had her lay down until she felt better, helping to slow her breathing. After about 40 minutes,p t felt good enough to sit in the recovery area. Ensured she had water and some food to help prevent a blood sugar drop.
22 2021-03-16 lightheadedness Patient received COVID-19 vaccination. Patient reported to RN that she may have vagal response. Mo... Read more
Patient received COVID-19 vaccination. Patient reported to RN that she may have vagal response. Mother was prepared with juice. Patient received injection and then slumped back in chair and RN assisted her to the floor. A cold compress was placed on her head, patient was conscious the entire time. Mother gave her juice and patient did throw that up. Sat with patient for about 10 minutes. NP did respond to assess the patient. Patient then reported she was feeling better. We then got patient put back in chair and after about another five minutes she was placed in a wheelchair and taken to an empty room with her mother. Patient left with mother in the wheelchair and was escorted out to the car. Patient had no complaints at discharge.
22 2021-03-17 heart rate increased Heart rate went from my resting heart rate to 160 very quickly in about 2 mins. Noticed on apple wat... Read more
Heart rate went from my resting heart rate to 160 very quickly in about 2 mins. Noticed on apple watch.
22 2021-03-17 fainting fainting; Fatigue; dizziness/sleep disturbance (wake up with hot, dizzy, nauseous every few hours); ... Read more
fainting; Fatigue; dizziness/sleep disturbance (wake up with hot, dizzy, nauseous every few hours); nausea/sleep disturbance (wake up with hot, dizzy, nauseous every few hours); hot flashes/sleep disturbance (wake up with hot, dizzy, nauseous every few hours); chills; loss of appetite; unable to focus; sleep disturbance (wake up with hot, dizzy, nauseous every few hours); This is a spontaneous report from a contactable consumer (patient). A 22-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT#EL9269), via an unspecified route of administration in left arm from 02Feb2021 14:00 at first single dose for Covid vaccine. Medical history included known allergies: Oak trees, kiwi. Concomitant medication in two weeks included hydroxyzine hydrochloride (ATARAX), sertraline hydrochloride (ZOLOFT). No other vaccine was received in four weeks. The patient experienced fatigue, dizziness, nausea, hot flashes, chills, fainting, loss of appetite, unable to focus, sleep disturbance (wake up with hot, dizzy, nauseous every few hours). Adverse event start date: 03Feb2021 02:00 AM. AEs resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment was received for the events. No covid prior vaccination. Covid was tested post vaccination: nasal swab on 05Feb2021: negative. Symptoms lasting 6 days and counting. Outcome of the events was not recovered.
22 2021-03-18 fainting Tired during the day, about 14 hours later suddenly very nauseous, light headed, and faint. Develope... Read more
Tired during the day, about 14 hours later suddenly very nauseous, light headed, and faint. Developed a fever, and had shortness of breath. The next morning, arm was very sore, still a little light headed, developed a sore throat, and exhausted. Day three only feeling arm soreness and throat still sore.
22 2021-03-19 pallor Severe headache/migraine in all parts of the head, not concentrated in one location. The use of pres... Read more
Severe headache/migraine in all parts of the head, not concentrated in one location. The use of pressure and an ice pack helped, but this continued from 5am to 6pm the day following the vaccine. Temperature of 101, called doctor and was told to take ibuprofen. Pale, weakness, dizziness, nausea, throwing up continued for two hours after waking up (5am) the day after the shot was given.
22 2021-03-21 chest discomfort a 22 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 m... Read more
a 22 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot ER2613 on 3/22/2021. The patient experienced the following reaction(s) during the immediate of observation: 9:32am Patient c/o non-radiating mid "chest discomfort 2/10." Denies difficulty breathing. Patient was treated/managed as follows: 9:33am VS BP 110/60, HR 77, RR 18, 98% on room air. Patient reports symptoms may be anxiety induced. 9:44am VS BP 105/70, HR 74, RR 18, 98% on room air. Patient reports symptoms subsiding. Discomfort improved to 1/10. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. Education provided on worsening symptoms and to seek medical attention and call 911. Patient and patient mother states understanding. 9:48am Patient escorted to car with mother and nurse.
22 2021-03-21 heart rate increased Reported that approximately 15 mins after taking the vaccine she started to have have facial flushin... Read more
Reported that approximately 15 mins after taking the vaccine she started to have have facial flushing t, rapid heart rate, redness on upper chest, and difficulty swallowing, She was taken to the ED and observed and given benreayl whoch releved the symptoms after 1 1/2 hours.
22 2021-03-23 loss of consciousness, fainting The Pt is a 22 year old female who had a syncopal episode following her 2nd Pfizer vaccination to th... Read more
The Pt is a 22 year old female who had a syncopal episode following her 2nd Pfizer vaccination to the left deltoid. She states that she was "feeling nervous" before the vaccination and did not eat before her vaccine. Following administration, she felt an onset of dizziness while walking away from the vaccination tent. The Pt immediately returned to the tent, told a clinician that she was feeling unwell, and was helped into a chair where she had LOC of about 3 seconds. No head trauma. Upon evaluation, the Pt endorses lightheadedness but denies diplopia, nausea, vomiting, or diaphoresis. Pt also denies any swelling of the face/lips/eye, difficulty swallowing, tightness of the throat, or itching of the skin.
22 2021-03-23 fainting Patient received Covid-19 Vaccine today, 03/24/2021. During the 15 minute post-vaccine observation p... Read more
Patient received Covid-19 Vaccine today, 03/24/2021. During the 15 minute post-vaccine observation period, the patient began to feel faint. Her condition worsened to feeling nauseous and blurred vision, so patient asked to lie down. We found a quiet area in the employee break room for the patient to lay down. and provided her a pillow, water, cool compress for her head, and later, orange juice for her comfort. We proceeded to call 911 for medical attention. EMS professionals evaluated patient's vital signs and patient signed waiver refusing to go to hospital, since she was feeling better. Patient left on her own accord with a friend driving her home.
22 2021-03-25 pallor 3-24-21 3:54PM PT FEELS LIGHTHEADED, WARM, DIAPHORETIC, PALE'. REMOVED FLANNEL OVER SHIRT, WATER GI... Read more
3-24-21 3:54PM PT FEELS LIGHTHEADED, WARM, DIAPHORETIC, PALE'. REMOVED FLANNEL OVER SHIRT, WATER GIVEN. PT SITTING IN CHAIR. A/O, NO RESP DISTRESS. 4PM 'FEELS BETTER NOW' PINK, W/D. RESP REG WITH EASE. 4:15PM AMBULATORY TO EXIT, GAIT BRISK AND STEADY. NO DISTRESS NOTED.
22 2021-03-25 fast heart rate Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemi... Read more
Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: panic attack-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Systemic: Tingling (specify: facial area, extemities)-Severe
22 2021-03-26 heart rate increased Shortness of breath, rapid heartbeat, high fever, chills, nausea, pain all over body
22 2021-03-26 fainting ABOUT 5 MINUTES POST VACCINE, PATIENT REPORTED FEELING "ZONED OUT", DESCRIBES "LIGHT HEADED, HOT, N... Read more
ABOUT 5 MINUTES POST VACCINE, PATIENT REPORTED FEELING "ZONED OUT", DESCRIBES "LIGHT HEADED, HOT, NAUSEATED. SHE THEN HAD SYNCOPAL EVENT FOR 5-10 SECONDS WAS CAUGHT BY PA WHO WAS AT HER SIDE. IMMEDIATELY RESPONSIVE, ALERT AND ORIENTED AFTER. BROUGHT TO TRIAGE 1 BY WHEELCHAIR WITH PA AT HER SIDE AND ASSISTED TO GUERNEY. SYMPTOMS SLOWLY ABATED, PALLOR IMPROVED. BP 104/50 THEN 101/49 P 68, SPO2 96% ROOM AIR, BLOOD GLUCOSE 99. RELEASED VIA WHEELCHAIR AFTER SITTING AND STANDING AT 5:23. EMT AND NP PASSED HER AND TRANSPORTATION ATTENDANT AT 5:27 AND PATIENT WAS RETURNED TO TRIAGE ARE DUE TO NAUSEA. PHYSICIAN AGAIN EVALUATED AND ORDERED ZOFRAN. WHICH WAS ADMINISTERED AT 5:30.
22 2021-03-26 fainting Patient had vasovagal syncope
22 2021-03-27 platelet count decreased, haemoglobin decreased Her Hgb has been dropping from 11.9 06Mar down to 8.3 11Mar; platelets have also dropped down to 59 ... Read more
Her Hgb has been dropping from 11.9 06Mar down to 8.3 11Mar; platelets have also dropped down to 59 11Mar from 80 on 06Mar; She had a max AST 206 09Mar down to 118 11Mar; ALT 93 10Mar now 86 11Mar; Coombs negative hemolytic anemia; Within minutes of 2nd dose of vaccine, pt had urination of dark brown urine; migraine; fever; nausea; diarrhea; This is a spontaneous report from a contactable physician. A 22-year-old female patient received second dose of BNT162B2 (BNT162B2) intramuscular, administered in Arm Left on 04Mar2021 at 11:30 (Batch/Lot Number: EN6205) as single dose for covid-19 immunization. Medical history included allergic rhinitis. Concomitant medications included ibuprofen (IBUPROFEN), cefuroxime (CEFUROXIME), clarithromycin (MACROBID [CLARITHROMYCIN]), ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE), spironolactone (SPIRONOLACTONE), acetaminophen (ACETAMINOPHEN), ondansetron (ZOFRAN [ONDANSETRON]) and topical tretinoin, oil of oregano, Olly probiotic/prebiotic. The patient received first dose on 11Feb2021 (lot number EL9267), 11:45 AM, Intramuscular to left arm. The patient experienced coombs negative hemolytic anemia (medically significant) on 04Mar2021 at 11:45, within minutes of 2nd dose of vaccine, pt had urination of dark brown urine on 04Mar2021 11:45, migraine on 04Mar2021 11:45, fever on 04Mar2021 11:45, nausea on 04Mar2021 11:45, diarrhea on 04Mar2021 11:45, her hgb has been dropping from 11.9 06Mar down to 8.3 11Mar on 11Mar2021, platelets have also dropped down to 59 11Mar from 80 on 06Mar on 11Mar2021, she had a max ast 206 09Mar down to 118 11Mar on 11Mar2021, alt 93 10Mar now 86 11Mar on 11Mar2021. It was reported that Within minutes of 2nd dose of vaccine, pt had urination of dark brown urine. This turned to dark red/bloody urine. She felt migraine, fever, nausea, diarrhea. She started having a very heavy period which is not normal for her. She was treated twice for presumed UTI but cultures were negative. UA had no RBCs, but Hgb urine was 3+. Her Hgb has been dropping from 11.9 06Mar down to 8.3 11Mar and it appears she has a Coombs negative hemolytic anemia (haptoglobin undetectable). Her platelets have also dropped down to 59 11Mar from 80 on 6Mar. WBC/diff are normal. Her LDH was 2019 10Mar, improved today 1728. Blood smear had no schistocytes, but ADAMTS13 is pending. Her creatinine remains normal and electrolytes are largely normal. She had a max AST 206 9Mar down to 118 11Mar and ALT 93 10Mar now 86 11Mar. Alk phos was 137 mild elev 09Mar, now normal. Her symptoms are slowly improving but she still feels poorly. Several other tests are pending and we are checking daily labs right now. The patient underwent lab tests and procedures which included alanine aminotransferase: 93 (unit unspecified) on 10Mar2021, alanine aminotransferase: 86 (unit unspecified) on 11Mar2021, aspartate aminotransferase: 206 (unit unspecified) on 09Mar2021, aspartate aminotransferase: 118 (unit unspecified) on 11Mar2021, blood alkaline phosphatase: 137 (unit unspecified) on 09Mar2021, blood creatinine: normal on an unspecified date, blood electrolytes: largely normal on an unspecified date, blood lactate dehydrogenase: 2019 (unit unspecified) on 10Mar2021, blood lactate dehydrogenase: 1728 (unit unspecified) on 11Mar2021, haemoglobin: 11.9 (unit unspecified) on 06Mar2021, haemoglobin: 8.3 (unit unspecified) on 11Mar2021, haemoglobin urine: 3+ (unit unspecified) on an unspecified date, adamts-13: with pending results on an unspecified date, platelet count: 80 (unit unspecified) on 06Mar2021, platelet count: 59 (unit unspecified) on 11Mar2021 and WBC: Normal on an unspecified date. Therapeutic measures were taken as a result of the events Coombs negative hemolytic anemia, Within minutes of 2nd dose of vaccine, pt had urination of dark brown urine, Migraine, Fever, Nausea, Diarrhea, Her Hgb has been dropping from 11.9 06Mar down to 8.3 11Mar, She had a max AST 206 09Mar down to 118 11Mar and ALT 93 10Mar now 86 11Mar. Outcome of all the events was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of Coombs negative hemolytic anemia and other events due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
22 2021-03-27 fainting, palpitations Brief loss of vision; Faint; Short of breath; Palpitations; This is a spontaneous report from a cont... Read more
Brief loss of vision; Faint; Short of breath; Palpitations; This is a spontaneous report from a contactable other health professional. A 22-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), intramuscular in arm left, on 11Mar2021 at 13:00 (Lot Number EN6207), as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient did not have COVID-19 prior to vaccination. The patient experienced brief loss of vision (medically significant) on 11Mar2021 at 13:00 with outcome of unknown, faint (medically significant) on 11Mar2021 at 13:00 with outcome of unknown, short of breath (non-serious) on 11Mar2021 at 13:00 with outcome of unknown, palpitations (non-serious) on 11Mar2021 at 13:00 with outcome of unknown. Therapeutic measures were taken as a result of the events. It was reported that the events were evaluated and advanced life support (ALS) transported the patient to the emergency department (ED). It was unknown if patient was tested for COVID-19 post vaccination. Follow-up attempts are completed. No further information is expected.; Sender's Comments: The possibility that suspect drug may have contributed to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
22 2021-03-27 fainting 22yo female with reported history of covid-19 infection in March 2020 reportedly caused dysautonomia... Read more
22yo female with reported history of covid-19 infection in March 2020 reportedly caused dysautonomia as a result. She was given the vaccine while supine due to syncopal concerns in the past. Pt did have a witnessed syncopal event that she recovered from and was cleared by medical staff and ems after 30min of observation.
22 2021-03-28 chest discomfort Fever, Chills, Shaking, VOMITING from 6 pm to 3 AM. Chest tightening, Throat closure, Headache, Body... Read more
Fever, Chills, Shaking, VOMITING from 6 pm to 3 AM. Chest tightening, Throat closure, Headache, Body Aches, Severe Abdominal cramps, and Pain. Weakness, to the point of needing assistance to walk, arms tingly and numb.
22 2021-03-28 pallor patient had heavy breathing and pale color upon receiving vaccine. she did not lose consciousness or... Read more
patient had heavy breathing and pale color upon receiving vaccine. she did not lose consciousness or state difficulty breathing
22 2021-03-29 heart rate increased Patient reported feeling like she had increased heart rate. Vital signs at 1420 were as follows puls... Read more
Patient reported feeling like she had increased heart rate. Vital signs at 1420 were as follows pulse 133 bpm, oxygen saturation 100%, and blood pressure 140/90 mm Hg. At 1451 RN noted patient had redness to harms ad chest, and vital signs were as follows: pulse 102 bpm, blood pressure 162/90 mm Hg, and oxygen saturation 99%. Paramedics were called to assess patient. Paramedics assessed and monitored patient and reported patient's vitals were okay, and she did not meet medical necessity. Patient signed wavier stating she did not wish to seek medical treatment with paramedics. RN assessed patient at 1510 and the vital signs were as follows: blood pressure 140/89 mm Hg, oxygen saturation 99%, pulse 89 bpm, and RN noted redness was clearing. Patient reported she was feeling okay, and she wished to leave. RN explained to seek medical treatment if symptoms continued/ worsened, and to speak with her PCP regarding her reaction.
22 2021-03-29 fainting Received shot, 5 minutes after felt extremely nauseous , unbearable headache and dizziness. Left oka... Read more
Received shot, 5 minutes after felt extremely nauseous , unbearable headache and dizziness. Left okay after 30 minutes, walked back to office which is 30 second walk from clinic office, walked into office and vomited for 15 minutes, went to sit in chair, was completely dizzy and faint, after 5-10 minutes felt worse and worse. Got up to go to clinic and fainted, was found by security guard and rushed down to emergency room.
22 2021-03-30 hypotension, blood pressure decreased 22 yo female with near-syncope s/p receiving 1st Pfizer COVID vaccine on 03/31/21 ~1:35 pm. Pt imme... Read more
22 yo female with near-syncope s/p receiving 1st Pfizer COVID vaccine on 03/31/21 ~1:35 pm. Pt immediately started feeling lightheaded/dizzy, weak, and nauseous. She was hypotensive at 1:45 pm with BP of 66/44 and HR of 91. She did not lose consciousness. She was transferred to a recliner, given water, and was feeling better by 2:08 pm - her vitals improved to BP: 100/66 and HR: 86. She was d/c'ed to her father at 2:15 pm.
22 2021-03-30 pallor, loss of consciousness, blood pressure decreased Approximately one minute after vaccination patient lost color and was placed on the ground with feet... Read more
Approximately one minute after vaccination patient lost color and was placed on the ground with feet elevated. Patient briefly lost consciousness. Blood pressure dropped, lowest point was 100/43. Patient resumed consciousness and stated ?this happens all the time, I think I?m going to faint again?. Patient lost consciousness again. Patient resumed consciousness. Color returned to face, BP began to rise and return to baseline of 120s/60s per patient report. EMS arrived at 1620, evaluated patient and determined they were stable.
22 2021-03-31 chest discomfort Developed throat tightness followed by chest tightness and then nausea and vomiting. Blood pressure... Read more
Developed throat tightness followed by chest tightness and then nausea and vomiting. Blood pressure and pulse remained in the normal range. She received epinephrine 0.3mg IM and transported to hospital ER. Felt better by arrival to ER.
22 2021-03-31 chest discomfort EMS approached med eval staff regarding 22 yr old female after receiving first dose of Pfizer vaccin... Read more
EMS approached med eval staff regarding 22 yr old female after receiving first dose of Pfizer vaccine @1522 and began complaining of chest tightness /SOB. Does carry hx of asthma/bronchitis and left inhaler in the car. EMS staff administered 2 duoneb treatments without much improvement. Decision was made to transport to hospital setting.
22 2021-03-31 chest pain urticaria - onset at 7:15 (approx 4 hours from time of shot), localized to upper chest and felt hot,... Read more
urticaria - onset at 7:15 (approx 4 hours from time of shot), localized to upper chest and felt hot, right arm sore, had a brief second of dull chest pain (has had before) also had some shortness of breath last night took inhaler and felt better, none currently presented next day over 24 hours from injection - no injection site redness, urticaria on upper chest only, normal airway and lung exam
22 2021-04-02 fainting Pt reports that she has a history of fainting whenever she gets vaccinated and it happened this time... Read more
Pt reports that she has a history of fainting whenever she gets vaccinated and it happened this time, too. She was wheeled to the EMS area via wheelchair, where she could rest for a period of time. She received a bottle of water and cookies and she felt better.
22 2021-04-03 nosebleed 4/3/21- 12:00pm shortness of breath and lung pain develop - 9:00pm fever of 102.4 4/... Read more
4/3/21- 12:00pm shortness of breath and lung pain develop - 9:00pm fever of 102.4 4/4/21- 11:00am nose bleed (first in life not caused by trauma)
22 2021-04-03 heart rate increased I have experienced mild symptoms of rapid heartbeat, nausea, and lethargy since last night with a lo... Read more
I have experienced mild symptoms of rapid heartbeat, nausea, and lethargy since last night with a low-grade fever. It was 100 degrees on the thermometer last night and 99.5 degrees at noon today.
22 2021-04-03 fainting, loss of consciousness Patient fainted immediately following vaccine. She was seated and did not fall. She was unconscious ... Read more
Patient fainted immediately following vaccine. She was seated and did not fall. She was unconscious for only a few seconds. The technician administering asked the pharmacist for help. The patient was given water to drink. She became nauseous and was given a trashcan to vomit into. She was vomiting on and off for about 20-25 minutes. The technician remained next to the patient to observe her in case she fainted again, but she did not faint again. The technician confirmed that patient's friend was driving her home and the pharmacist cleared her to leave after she spent a total of 30 minutes in the pharmacy.
22 2021-04-04 chest discomfort Flu like symptoms (fatigue, cough, chest tightness, chills, congestion, minor headache), body aches ... Read more
Flu like symptoms (fatigue, cough, chest tightness, chills, congestion, minor headache), body aches and pains, minor Bell?s palsy, nerve tingling in hand of injection arm (same side as palsy), stabbing pain in lower abdomen similar to patient experience with allergic reaction, previous soreness of injection site
22 2021-04-04 loss of consciousness Patient received the vaccine and felt fine, and then walked out to the observation tent. As soon as ... Read more
Patient received the vaccine and felt fine, and then walked out to the observation tent. As soon as she sat down in the observation tent she started to feel dizzy and after 30 seconds her vision started to go black. Patient then fell out of the chair, and regained consciousness after 5 seconds. Patient was then helped into a wheel chair and taken to a cot and waited 30 minutes before leaving and is having a friend pick her up.
22 2021-04-06 chest discomfort C/O lip tingling/ swelling, chest tightness, tongue tingling and burning 1:12 133/85, P 94, 02-98%... Read more
C/O lip tingling/ swelling, chest tightness, tongue tingling and burning 1:12 133/85, P 94, 02-98% R18 Epi O.3 IM, experienced immediate relief 1:16 114/88 p-110 Transported by EMS to ED
22 2021-04-07 loss of consciousness Recipient received the vaccine and was waiting in the observation area. Around 10 minutes, felt hot... Read more
Recipient received the vaccine and was waiting in the observation area. Around 10 minutes, felt hot and dizzy and then lost consciousness for less than 10 seconds. She did not fall on the floor. Moved her to the cot and called emergency responders. She said she had not eaten anything that day nor had any water. Gave her water and a granola bar. EMS evaluated her and she wanted to go to the ED for further evaluation.
22 2021-04-08 chest discomfort, chest pain Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightn... Read more
Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Mild
22 2021-04-08 chest discomfort Arrived at pharmacy for 1:15 PM vaccine appointment. 10 minutes after vaccine injection, I could not... Read more
Arrived at pharmacy for 1:15 PM vaccine appointment. 10 minutes after vaccine injection, I could not swallow. Throat started to close and feel tight like I could not breathe. Tongue swelled and could not feel tongue while biting down. Chest compression on center chest. Around 1:30 PM I told sister to get a nurse and the nurse said due to my allergic reaction I needed to do the EpiPen. She administered properly in my thigh. About 1:35 PM, symptoms started to go away. Stayed until 1:45 PM and when I left I told the nurse I was leaving. Took 2 Benadryl pills in my car with water.
22 2021-04-08 heart rate increased increased heart rate
22 2021-04-08 loss of consciousness At 15 min mark after receiving vaccine: sudden loss of hearing (extremely muffled, underwater soundi... Read more
At 15 min mark after receiving vaccine: sudden loss of hearing (extremely muffled, underwater sounding), profuse sweating, and then lost vision and passed out entirely when attempted to stand up for help. After laying down, quickly regained consciousness and felt better. After effects and soreness have been minimal. Have not fainted during/after vaccine before.
22 2021-04-08 fainting, loss of consciousness Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Weakness-Se... Read more
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Weakness-Severe, Additional Details: Patient was give vaccine and fainted a couple minutes after sitting
22 2021-04-09 chest discomfort Fever (100.8 degrees), body aches (in back), chest tightness - treated with Tylenol and sleep - symp... Read more
Fever (100.8 degrees), body aches (in back), chest tightness - treated with Tylenol and sleep - symptoms started around 10 pm and were resolved by morning
22 2021-04-12 heart rate increased, palpitations, loss of consciousness, heart rate irregular, chest pain March 5, 2021: 1st dose of Pfizer vaccine. Severe site pain. March 23, 2021: 2nd dose of Pfizer vac... Read more
March 5, 2021: 1st dose of Pfizer vaccine. Severe site pain. March 23, 2021: 2nd dose of Pfizer vaccine. Felt very restless and sick during night, by the next morning symptoms really sat in. March 24, 2021: Went to Urgent Care due to fever. Had COVID-19 test (negative). Very close to passing out there (put head between knees and did not). Was sent to emergency room immediately due to heart rate (high 140s-150s. Highest known was 152 BPM). ER performed following: portable chest x-ray, blood tests, urine tests, EKG. Was told results were all normal with the exception of EKG (not told anything about it, form listed as abnormal). Passed out 2x at hospital. Was given one IV rehydration solution and released that night. Symptoms below lasted for several days: Headache Aches Nausea Aggressive shakes Shortness of breath Confusion Dizziness Site pain (also developed bump under arm) Fever - 103.8 (after 2 Advil, 2 Tylenol, 3 ice packs and eating frozen grapes) Heavy sweats Racing heart Restless March 30, 2021: Still having frequent heart palpitations (they come and go but happen several times during the day. Keep having very high heart rates). Went to doctor. While there, nurse noted irregular heartbeat that sounded like it was ?skipping a beat? and heart rate was also jumping all over the place (high pace, low pace, high, etc.). It was clear something was abnormal. Doctor gave EKG approximately 20 minutes later, EKG looked normal. Was told to come back next morning for blood work and to cut out caffeine. March 31, 2021: Came in for blood work to check thyroid. April 6, 2021: Thyroid results were normal. Still having palpitations among other symptoms (see April 12 for more info) so was told to come in. Was given ?work from home? note and referred to cardiologist. April 12, 2021: Appointment at cardiologist. Still having severe palpitations, occasional dizziness/ lightheadedness, nausea, shortness of breath, exhaustion and chest pain. Heart rate was recorded this day to have gotten up to 139 BPM-- was very high majority of the day. EKG was normal (with exception of high heart rate) but 30 mins later doctor observed high heart rate and abnormal rhythm. Was told to come back in a week and one day for a heart ultrasound and heart monitoring for three days. Still no caffeine intake since 3/30/21. Previous heart rates taken at doctor's visits over the years for comparison below. Never had any prior heart problems whatsoever: 8/29/18: 70 BPM 9/17/18: 88 BPM 10/17/18: 64 BPM 10/31/18: 73 BPM 1/21/19: 78 BPM Note: At this point, I have missed over a week and a half of work, and worked from home for over a week. I'm not any better heart wise at all over the course of three weeks post vaccine.
22 2021-04-12 fainting Patient fainted in the immunization room after immunization had been provided. Patient claimed to a... Read more
Patient fainted in the immunization room after immunization had been provided. Patient claimed to always faint after vaccines. Patient also vomited after fainting and having a drink of water.
22 2021-04-13 fainting, loss of consciousness Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Det... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: pt was dizzy and light headed after vaccine and lost conciousness for a couple of seconds. she was sweaty and a little confused for a couple of seconds. she ate and drank something after and was feeling better and we phoned 911 to check her out. she was released and doing much better.
22 2021-04-14 chest pain pt complaining of chest hurting like dull soreness. monitored an additional 15 minutes. pt better an... Read more
pt complaining of chest hurting like dull soreness. monitored an additional 15 minutes. pt better and wanted to leave. agreed to call 911 or go to er if symptom persists.
22 2021-04-14 heart rate decreased, fainting fainted and had decreased HR. has only ever fainted when she was very young. history of only one oth... Read more
fainted and had decreased HR. has only ever fainted when she was very young. history of only one other episode.
22 2021-04-14 lightheadedness Warmth, dizziness, temporary loss of hearing shortly after vaccination. No nausea, diaphoresis, or ... Read more
Warmth, dizziness, temporary loss of hearing shortly after vaccination. No nausea, diaphoresis, or tunnel vision. Near syncope prevented by lying down quickly. Typical vasovagal reaction for her. Rapid recovery with all normal vital signs. No orthostasis.
22 2021-04-15 hypotension Systemic: Sweating, Light Headed, Dizziness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypot... Read more
Systemic: Sweating, Light Headed, Dizziness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Additional Details: Patient felt dizzy, light headed, profusely sweating. Requested to lay down, then laid on the floor, small blanket under head. SBP 90 over palpable, respirations 16, pulse 60, Temp 98.4. Denied itching, shortness of breath, swelling of throat or difficulty swallowing. 911 notified, examined by EMS. Patient refused transfer to ED by EMS, father stated he would transfer to ED/Urgent Care. Patient stated she felt better, but agreed to go for further evaluation.
22 2021-04-15 low blood oxigenation Guest started hyperventilating after shot, complained of loss of motor function and felt the pain of... Read more
Guest started hyperventilating after shot, complained of loss of motor function and felt the pain of being paralyzed. And also had hypoxia.
22 2021-04-15 lightheadedness Reported dizziness and experienced vasovagal episode after vaccine . Transferred to ED.
22 2021-04-15 fast heart rate, hypotension patient reported throat tightness. vitals showed hypotension and tachycardia administered 0.3 Epi I... Read more
patient reported throat tightness. vitals showed hypotension and tachycardia administered 0.3 Epi IM symptoms improved within 5 minutes. Patient refused transport via EMS but did seek care at ER from which she was discharged without any lingering side effects.
22 2021-04-16 chest discomfort, heart rate increased Lightheaded, pulse rose from 72 bmp to 100 bmp 10 minutes after vaccine. Hives and red rash on face,... Read more
Lightheaded, pulse rose from 72 bmp to 100 bmp 10 minutes after vaccine. Hives and red rash on face, right arm, back, scalp, lips, inner lips/gum line, and back. Rash got worse the day after the second dose and caused an itchiness/ tightness of the chest and throat. Did not feel like my life was threatened so I nursed it at home with antihistamine.
22 2021-04-16 pallor, lightheadedness Patient presented for 1st dose of COVID vaccine today and had concerns of lightheadedness, nausea an... Read more
Patient presented for 1st dose of COVID vaccine today and had concerns of lightheadedness, nausea and dizziness in his post-vaccination observation period. Provider assessed the following: "appearance of vasovagal reaction with pale and clammy skin". Onsite EMS called and patient further assessed. Patient was released following observation and left of own volition, having recovered.
22 2021-04-17 chest pain Chest pain two days after
22 2021-04-18 chest discomfort Reports throat feels "Itchy" with mild chest tightness. VS stable. Resolved during observation time... Read more
Reports throat feels "Itchy" with mild chest tightness. VS stable. Resolved during observation time period. VS stable when left medical observation to go home.
22 2021-04-18 palpitations, chest discomfort, heart rate irregular Pt reported dizziness and irregular heartbeat. at 1339.Patient put in anti-gravity chair and given o... Read more
Pt reported dizziness and irregular heartbeat. at 1339.Patient put in anti-gravity chair and given orange juice. Pt vitals assessed: BP 130 mmHg, HR 122 beats/min, SpO2 100%. Patient's extremities were cold upon palpation. patient appeared dazed but was AxO x 4 and able to follow commands. Pt reported similar episode due to irregular heartbeat. Pt reported no pain, throat irritation, chest tightness, and itchiness. Patient offered EMS--pt declined. Patient reassessed in 5 minutes at approx. 1334. Patient reported throat tightness and chest tightness. patient started trembling throughout the body. Pt revealed history of prior hospitalization due to left-sided paralysis. BP 140/80 mmH, HR fluctuating 85-100 beats/minute, and RR 17 breaths/minute. EMS activated. Paramedics arrive at 1411 and assume care. Pt transported to hospital for further care.
22 2021-04-18 fainting Patient experienced syncope after 0.3ML(30 MCG) OF COVID vaccine was injected intramuscularly in Lef... Read more
Patient experienced syncope after 0.3ML(30 MCG) OF COVID vaccine was injected intramuscularly in Left arm. Patient recovered after brief syncope incident
22 2021-04-18 fainting Fainted, nauseous, light headedness, fever, chills, weakness, exhaustion.
22 2021-04-18 fainting Systemic: Fainting / Unresponsive-Mild, Additional Details: rec'v vaccine at 2:20pm, reaction of les... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: rec'v vaccine at 2:20pm, reaction of less than 2 seconds of faintness at 2:25pm, EMS was called and arrived @2:29pm, vitals were good, condition was confirmed ok and pt declined transport with EMS. Left on her own accord after a full 30 minutes post vaccine wait.
22 2021-04-19 pulmonary embolism, chest discomfort Patient stated she felt sudden onset shortness of breath and substernal chest discomfort starting 4/... Read more
Patient stated she felt sudden onset shortness of breath and substernal chest discomfort starting 4/19/2021 just after the noon hour. She presented to the ER at 1:40pm on 4/19/2021. Patient was treated immediatly, including placing patient on 2L O2, EKG performed, labwork drawn, and 1mg/kg lovenox given SQ. Patient taken for CTA of chest, which showed saddle pulmonary embolism. Patient sent for mechanical thrombectomy, which was performed in the evening of 4/19/2021, and patient admitted to Medical Center for follow up care after procedure.
22 2021-04-19 fast heart rate Vaccine administered 13:50, adverse event started 14:05. Patient had flushing/sweating, tachycardia.... Read more
Vaccine administered 13:50, adverse event started 14:05. Patient had flushing/sweating, tachycardia. BP 114/68 -- > 119/68, HR 70 -- > 70, RR = 16 -- > 16, Temp 98F -- > 98F, O2 sat = 100%. At 14:52, patient denied lightheadedness, patient stable, released from vaccination site.
22 2021-04-20 nosebleed 4/10/21: nose bleed wouldn't stop with giant clots coming out and has never had a nose bleed in life... Read more
4/10/21: nose bleed wouldn't stop with giant clots coming out and has never had a nose bleed in life. Due for 2nd vaccine Friday 4/23/21.
22 2021-04-20 heart rate increased immediate reaction; trouble breathing/shortness of breath, sweating, dizziness, hives, nausea, fast ... Read more
immediate reaction; trouble breathing/shortness of breath, sweating, dizziness, hives, nausea, fast heart rate
22 2021-04-21 fainting lightheaded, dizzy, feint, weakness, muscle fatigue
22 2021-04-22 blood pressure decreased Experienced tension headache so severe that vision was blurred and muscles in neck tensed up. To the... Read more
Experienced tension headache so severe that vision was blurred and muscles in neck tensed up. To the point where tizanidine and sumatriptan did not help. Felt extremely nauseous and intense pressure in head. Blood pressure dropped and was very sweaty. Had to be transported to ER via ambulance. Vomiting occurred for several hours. Was given Tylenol, Benadryl, zofran, imotrex, Valium, and fluids via IV. Sympoms continued for 8 hrs. 12 days later symptoms are still ongoing.
22 2021-04-22 chest pain, blood pressure increased, heart rate increased About five to ten minutes after I received my first shot, I started to feel like my throat was closi... Read more
About five to ten minutes after I received my first shot, I started to feel like my throat was closing a little. I knew it wasn?t an allergic reaction because I could still speak, but I also became very dizzy and sweaty. I stood up to go see the nurse and she took my blood pressure and it was slightly higher than normal and my heart rate was extremely elevated. I sat down on a stretcher and felt incredibly light headed and gained a metallic taste in my mouth. I also felt very nauseous and started experiencing chest pains. It felt like a panic attack but more severe and more sudden. My throat felt very tight but I could still talk, and my cheeks felt like they were on fire. My face was bright red. They gave me some water and monitored me some more and encouraged me to go to the hospital, but my symptoms subsided after about 35 minutes. After that I just felt tired and didn?t have any more symptoms.
22 2021-04-23 fainting Patient received vaccination and went to recovery area. She all of the sudden fainted and fell out ... Read more
Patient received vaccination and went to recovery area. She all of the sudden fainted and fell out of her chair.
22 2021-04-24 pallor Client complained of dizziness after receiving 1st Pfizer Covid Vaccine (Lot EW0179 Exp. 4/28/21). C... Read more
Client complained of dizziness after receiving 1st Pfizer Covid Vaccine (Lot EW0179 Exp. 4/28/21). Client alerted EMT she was feeling dizzy, lightheaded, and nauseous. EMT gave client emesis bag and water. PHN joined shortly. Upon arrival client sitting on chair, pale, mild diaphoretic and holding emesis bag. Vitals at 1250: blood pressure 100/60, pulse 79, oxygen 99%. Client stated history of anxiety with vaccines. No pertinent medical history, only medication is birth control. Vitals 1300: blood pressure 110/80, pulse 74, oxygen 99%. 1350 client stated feeling "normal". Vitals 1310: blood pressure110/80, pulse 80, oxygen 99%. Client had no complaints. Last vitals 1315: blood pressure 110/80, pulse 80, oxygen 99%. Per client no complaints, symptoms resolved. PHN advised client to follow up with primary before second dose. ER precautions given. Client left facility with steady gait at 1320.
22 2021-04-24 fainting 2 episodes of fainting with shaking; 2 episodes of fainting with shaking; foaming at mouth; Fatigue;... Read more
2 episodes of fainting with shaking; 2 episodes of fainting with shaking; foaming at mouth; Fatigue; Body aches; Headache; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at age of 22-years, on an unspecified date (Lot number was not reported), as single dose for covid-19 immunisation. Medical history included narcolepsy, dysautonomia and Postural orthostatic tachycardia syndrome (POTS). The patient was not pregnant. Concomitant medications included modafinil. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at age of 22-years, as single dose in left arm, on 26Feb2021 at 10:00 for covid-19 immunisation and she experienced fatigue, arm pain, fainting, diarrhea, hot flashes after first dose all within 48 hours. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced 2 episodes of fainting with shaking, foaming at mouth, fatigue, body aches and headaches after second dose all within 48 hours. Events outcome was unknown. Information about lot/batch number has been requested.
22 2021-04-24 fainting fainting; hot flashes; Fatigue; arm pain; diarrhea; This is a spontaneous report from a contactable ... Read more
fainting; hot flashes; Fatigue; arm pain; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 26Feb2021 10:00 at single dose for COVID-19 immunisation. Medical history included Narcolepsy, dysautonomia and POTS (Postural orthostatic tachycardia syndrome). No known allergies. Concomitant medication included modafinil. No other vaccine in four weeks. The patient experienced fainting, hot flashes, fatigue, arm pain, diarrhea, all on 26Feb2021. No treatment received for the events. No COVID prior vaccination. No COVID tested post vaccination. The outcome of the events was recovered. Information on the lot/batch number has been requested.
22 2021-04-26 chest pain Symptoms started five days after vaccine. Symptoms gradually lessened and I am now on week 4, I was ... Read more
Symptoms started five days after vaccine. Symptoms gradually lessened and I am now on week 4, I was bed ridden through week 3. Symptoms included my body feeling strange, visual disturbances, migraine aura (no previous history of migraines), chest pains, hot breath, temperature changes, faint feeling, fatigue, head pains all around head, pain in spinal chord, pain and numbness on entire body (mostly head), confusion, heat around nape of neck, ringing in ears, nausea, weight loss, strange breathing (not soreness)
22 2021-04-26 heart rate abnormal Pt exhibited signs of anxiety prior to vaccination. 1 minute post-vaccination, pt stated that she w... Read more
Pt exhibited signs of anxiety prior to vaccination. 1 minute post-vaccination, pt stated that she would like some water. Pt reported feeling dizzy and warm. 3 minutes post-vaccination, patient verbalized throat feeling "rough". Vital signs taken; abnormal values as follows: HR 102, BP 152/90. SPO2 normal at 99% on RA. No pain or swelling. This nurse called rapid response and patient was taken to Emergency Department.
22 2021-04-26 fainting SYNCOPE.
22 2021-04-26 fainting pt had a syncopal event post vaccination, was evaluated by ems and signed a refusal and left
22 2021-04-27 excessive bleeding Patient had large amount of bleeding (soaking clothing) immediately following vaccine. Bleeding has ... Read more
Patient had large amount of bleeding (soaking clothing) immediately following vaccine. Bleeding has now stopped.
22 2021-04-27 heart rate increased, blood pressure decreased, lightheadedness I got the first dose of the Pfizer Covid-19 vaccine at the Medical University. Approximately 10 minu... Read more
I got the first dose of the Pfizer Covid-19 vaccine at the Medical University. Approximately 10 minutes after administration, an allergic reaction began while I was driving alone in my car. Most notably my blood pressure dropped suddenly, causing me to almost pass out. I stopped driving and my symptoms worsened. Symptoms included shaking, sweating, nausea, confusion, rapid heart rate, red blotchy face, slightly labored breathing, itching and slight swelling of my tongue and lips, anxiety. I could still breathe, so I did not seek treatment, but sat in the parking lot of a medical building for at least an hour for symptoms to subside. Symptoms were acute for about 45 minutes and gradually decreased over four hours. The rest of the day and the next day I felt extremely weak. The following six weeks I continued to have swollen, dry, painful lips every single day and a very itchy rash on my hands and wrists. Occasionally I would wake up with swelling around my eyes. I also had an unusual reaction after eating a salad where my lips swelled even more and became numb, along with an itchy mouth. These long lasting symptoms did not go away until I got a steroid cream from a dermatologist, who denied that my reactions were from the vaccine after talking to me for only five minutes. I just believe that there are many more cases of reactions to the vaccines that have not been reported.
22 2021-04-27 fainting Fainted in the shower while shaving; This is a spontaneous report from a contactable consumer (patie... Read more
Fainted in the shower while shaving; This is a spontaneous report from a contactable consumer (patient). A 22-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 13Apr2021 at 11:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient fainted in the shower while shaving on 14Apr2021 at 15:30. There was no treatment received for the event. The outcome of the event was recovering. Information on the lot/batch number has been requested.
22 2021-04-28 haemoglobin decreased, fibrin d dimer increased, blood clot, pulmonary embolism On April 5th, 2021 I went to the E.D. , for shortness of breath and severe right shoulder pain. Whil... Read more
On April 5th, 2021 I went to the E.D. , for shortness of breath and severe right shoulder pain. While there they got a chest x-ray, ran labs, and did a chest CT. The CT revealed that I had one blood clot in my left lung and two blood clots in my right lung, as well as slight pleural effusion in the right lower lobe. They put me on Xarelto for the next 3-6 months and monthly follow up visits with my primary care provider. I was also given Hydrocodone as need. I experienced extreme pain with breathing and sort of movement for a week and half but currently only have occasional shoulder and back pain usually at the end of the day.
22 2021-04-28 heart rate increased Since my second dose, I've been experiencing migraines, shortness of breath, and an extremely increa... Read more
Since my second dose, I've been experiencing migraines, shortness of breath, and an extremely increased heart rate. While attending my routine cycle class (been attending about 3 times a week for several months) I nearly passed out which is extremely unusual. I have also been experiencing a much lighter than usual menstrual cycle. A few days following my vaccination I was also experiencing pain in my left lung (this has since subsided).
22 2021-04-28 hypotension Site: Pain at Injection Site-Mild, Systemic: vommiting-Mild, Systemic: Flushed / Sweating-Mild, Syst... Read more
Site: Pain at Injection Site-Mild, Systemic: vommiting-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Additional Details: Patient's initial pulse was 99. Five minutes later, her bp was 88/48 and her pusle was 53. Five minutes later, after her second assessment BP was 88/48 and pulse was 53. Family was notified. Five minues later, her bp was 138/86 and pulse was 63. Two more sets of vital were taken over the next 20 minutes until family arrived. Patient was attended by this nurse until she left the facility with her mother. Patient instructed to f/u with provider.
22 2021-04-28 loss of consciousness I Passed out in store while grocery shopping, 08/10/2021
22 2021-04-28 fainting, loss of consciousness passed out; fainted; migraine; feel body aches; fatigue; felt incredibly ill; nauseous; hitting head... Read more
passed out; fainted; migraine; feel body aches; fatigue; felt incredibly ill; nauseous; hitting head; This is a spontaneous report from a contactable consumer (patient). A 22-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0153), via an unspecified route of administration, administered in Right Arm on 10Apr2021 11:30 (at age of 22 years old) at single dose for COVID-19 immunisation. Medical history included Seasonal allergies, asthma, Known allergies: peanuts (mildly). Concomitant drug was Yes. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8727) on 20Mar2021 11:30AM (at 22 years old) at Left arm at single dose for COVID-19 immunisation. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. A few hours after second dose, on 10Apr2021 02:00PM, patient developed a migraine and began to feel body aches and fatigue. The next morning, patient felt incredibly ill. Shortly after rising, patient became severely nauseous and fainted, hitting head; patient became conscious and passed out again before being taken to the ER (Emergency room). All AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment (IV and anti-nausea med. administered) received for all events. The outcome of the events was Recovering. Information on the lot/batch number has been requested.
22 2021-04-30 chest discomfort, heart rate increased, blood pressure increased Increase HR & BP, dizzy, tightness in chest initially. Rph called 911 at store but the patient felt... Read more
Increase HR & BP, dizzy, tightness in chest initially. Rph called 911 at store but the patient felt stable after 30 minutes so she was able to drive home. Per patient, it took couple hours for the symptoms to subside at home.
22 2021-04-30 fainting Pt complained of feeling nauseous and faint, with ringing in the ears and visual disturbances. Pt vo... Read more
Pt complained of feeling nauseous and faint, with ringing in the ears and visual disturbances. Pt vomited. BP110/68 O2 100% RA P 86 RR16 Pt reported feeling better " a lot better" after resting and left the vacc site at 1250 pm
22 2021-04-30 fainting Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild
22 2021-05-01 fainting SYNCOPE- Patient received vaccination at 1pm, her sister was with her because she sometimes passes o... Read more
SYNCOPE- Patient received vaccination at 1pm, her sister was with her because she sometimes passes out when getting blood drawn. After leaving the vaccination room the patient sat in a chair and felt fine and was talking on the phone, around 1:05, her sister alerted us that she thought she was passing out and was talking to her trying to keep her awake. I grabbed smelling salts and when I got to the patient, she was hard to wake up so I used the smelling salts on her and she came to. Gave water and juice to patient and moved her into the vaccination room to give her space to recover. She complained of being dizzy and ears ringing, we monitored her for 30 more minutes and all symptoms had resolved. Did not seek further treatment.
22 2021-05-02 heart rate increased A rapid heartbeat, throat closed, difficulty breathing, sweating & mild fever
22 2021-05-02 lightheadedness presyncopal. Evaluated by EMS-Cleared
22 2021-05-03 chest discomfort, lightheadedness Patient got her first shot 03/25/21 and the next morning she had some shortness of breath, chest tig... Read more
Patient got her first shot 03/25/21 and the next morning she had some shortness of breath, chest tightness and headaches. It got much wore the next day. She also experienced some dizziness and pre-syncope. EMS was dispatched but did not transport her. Her O2 sat, blood pressure, pulse and temperature were all normal. She then went to a walk in clinic later that day and they told her she had a panic attack. She was still having the shortness of breath and chest tightness. She used her Pro-air and it helped somewhat.
22 2021-05-03 fainting Pfizer-BioNTech COVID-19 Vaccine EUA: After the post-observation period, vaccine recipient got up to... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: After the post-observation period, vaccine recipient got up to use the rest room and collapsed on the floor. EMS evaluated the patient (vitals, blood sugar) and observed the patient for an additional 30 minutes. Vitals were within normal limits. They were able to leave the site in the wheelchair to their car.
22 2021-05-04 platelet count decreased, haemoglobin decreased platelets have also dropped down; Hgb has been dropping from 11.9 on 06Mar2021 down to 8.3 on 11Mar2... Read more
platelets have also dropped down; Hgb has been dropping from 11.9 on 06Mar2021 down to 8.3 on 11Mar2021; LDH was 2019; Alk phos was 137 mild elevated; felt poorly; AST 206 on 09Mar2021 down to 118 on 11Mar2021; red/bloody urine; red/bloody urine; migraine; Fever; nausea; diarrhea; very heavy period; Coombs negative hemolytic anemia; Hgb urine was 3+; presumed UTI; This is a spontaneous report from a contactable physician. A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), second dose intramuscular, administered in the left arm on 04Mar2021 11:30 (lot number: EN6205) as single dose (at the age of 22-years-old) for COVID-19 immunisation. Medical history included rhinitis allergic. The patient has no known allergies. Concomitant medications included ibuprofen; cefuroxime; clarithromycin (MACROBID [CLARITHROMYCIN]); ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE); spironolactone; acetaminophen; origanum minutiflorum oil (OREGANO OIL); tretinoin; ondansetron (ZOFRAN [ONDANSETRON]) and "Olly probiotic/prebiotic"; all taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of BNT162B2, intramuscular on the left arm on 11Feb2021 11:45 (lot number: EL9267) for COVID-19 immunisation at the age of 22-years-old. The patient did not have other vaccine in four weeks. The events started on 04Mar2021 at 11:45. Within minutes of second dose of vaccine, the patient had urination of dark brown urine. This turned to dark red/bloody urine. She felt migraine, fever, nausea, diarrhea. She started having a very heavy period which was not normal for her. She was treated twice for presumed UTI but cultures were negative. UA had no RBCs, but Hgb urine was 3+. Her Hgb has been dropping from 11.9 on 06Mar2021 down to 8.3 on 11Mar2021 and it appeared she has a Coombs negative hemolytic anemia (haptoglobin undetectable). Her platelets have also dropped down to 59 on 11Mar2021 from 80 on 06Mar2021. WBC/diff are normal. LDH was 2019 on 10Mar2021 and improved to 1728 on 11Mar2021. Blood smear had no schistocytes, but ADAMTS13 was pending (unknown results). Her creatinine remains normal and electrolytes were largely normal. She had max AST 206 on 09Mar2021 down to 118 on 11Mar2021. Alk phos was 137 mild elevated on 09Mar2021 and was now normal. Her symptoms were slowly improving but she still felt poorly. Several other tests were pending, and they were checking daily labs. The adverse events resulted in a clinic visit and a visit to the emergency room. The patient received unspecified antibiotics twice for presumed UTI, ER visit gave fluids, Tylenol and Zofran ODT. The patient had no covid prior to vaccination. The patient was not covid tested post vaccination. The patient has not recovered from the events.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events coombs negative haemolytic anaemia and aspartate aminotransferase increased 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.
22 2021-05-04 pulmonary embolism 1 pulmonary embolism in the left lung, 2 pulmonary embolisms in my right lung; a slight pleural effu... Read more
1 pulmonary embolism in the left lung, 2 pulmonary embolisms in my right lung; a slight pleural effusion in the right lower lung; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received second dose of BNT162B2 (Lot Number: EM9809), via an unspecified route of administration, administered in the left arm on 13Mar2021 14:00 at 22 years-old, as a single dose for COVID-19 immunisation. Medical history included Known Allergies: Penicillin and COVID-19, both on an unknown date. Concomitant medications included ethinylestradiol, levonorgestrel (CAMRESE LO) taken for an unspecified indication, start and stop date were not reported; ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported; escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin, diphenhydramine (BENADRYL), xylometazoline hydrochloride (SUDAFED), guaifenesin and all experienced allergies. The patient previously received first dose of BNT162B2 (Lot Number: EM9809), via an unspecified route of administration, administered in the left arm on 20Feb2021 14:00 at 22 years old as single dose for COVID-19 immunisation. On 05Apr2021 18:00, the patient experienced 1 pulmonary embolism in the left lung, 2 pulmonary embolisms in the right lung and a slight pleural effusion in the right lower lung. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and considered as a Life threatening illness. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of all the events which included Xarelto and Hydrocodone. The outcome of the events was recovering.
22 2021-05-04 fainting Patient fainted and vomited approximately 5 minutes after receiving her shot. Patient was extremely ... Read more
Patient fainted and vomited approximately 5 minutes after receiving her shot. Patient was extremely nervous prior to receiving her vaccine.
22 2021-05-05 fast heart rate Two days after receiving my first dose of the vaccine I started having tachycardia. I have never had... Read more
Two days after receiving my first dose of the vaccine I started having tachycardia. I have never had this before and it concerned me. Almost 3 weeks later and I?m still having tachycardia. I still have to get my 2nd dose of the vaccine but I am scared to now.
22 2021-05-06 loss of consciousness, pulse abnormal PT LOST CONSCIOUSNESS FOR A FEW MINUTES AFTER VACCINE WAS ADMINISTERED, SLOWLY REGAINED CONSCIOUSNES... Read more
PT LOST CONSCIOUSNESS FOR A FEW MINUTES AFTER VACCINE WAS ADMINISTERED, SLOWLY REGAINED CONSCIOUSNESS BUT NOT FULLY ADHERENT, BP 82/40, WEAK PULSE, NON VERBAL, TRANSFERRED TO LOCAL ED
22 2021-05-06 fainting I am experiencing pretty significant light headed effects. Borderline passing out for seemingly no r... Read more
I am experiencing pretty significant light headed effects. Borderline passing out for seemingly no reason.
22 2021-05-08 loss of consciousness Patient past out after getting shot. Recovered within 1 minute. BP 100/60, Pulse ox 98, pulse 68. ... Read more
Patient past out after getting shot. Recovered within 1 minute. BP 100/60, Pulse ox 98, pulse 68. Evaluated for 30 minutes.
22 2021-05-08 loss of consciousness Patient was very nervous and has passed out in the past. The first time she came I told her she shou... Read more
Patient was very nervous and has passed out in the past. The first time she came I told her she should come back with a parent so she came back with mom, dad and grandma. Mom was there to help she passed out about 3 minutes after the shot. Her family knew exactly what to do with her because it has happened before. Dad came and helped get her lying down.
22 2021-05-08 pallor Client indicated they do not do well with shots. I offered wheelchair. Patient accepted. Reported H... Read more
Client indicated they do not do well with shots. I offered wheelchair. Patient accepted. Reported Hx of syncope with shots - administered shot - patient reported not feeling well within 30 seconds of injection - became pale - had emesis never fully syncopal.
22 2021-05-08 fainting They day after the first vaccine I began to feel body aches, nausea, diarrhea, and lethargy. Three d... Read more
They day after the first vaccine I began to feel body aches, nausea, diarrhea, and lethargy. Three days later my syncope from my heart condition has increased. Now I have been fainting several times a day (usually it?s just once a day or once every other day). A week after the vaccine a red spot about the size of a quarter appeared on my right wrist and then went away 12 hours later. The other symptoms didn?t improve. Then when I got the second vaccine my symptoms worsened. My nausea, lethargy, body aches and diarrhea have gotten worse and now I?m fainting even more often then I was after the first vaccine. I also feel lightheaded all day everyday. 4 days after the second vaccine a second red spot appeared on my left hand (this time about the size of a pea). It also went away 12 hours later like the first spot did. Now I am on my 5th day after the second vaccine and my symptoms still haven?t improved.
22 2021-05-09 heart flutter April 25th (within 24 hours of vaccine) I felt the typical fever, severe chills, fatigue, etc that I... Read more
April 25th (within 24 hours of vaccine) I felt the typical fever, severe chills, fatigue, etc that I'd often reported. No soreness. This was gone by the end of the day. April 26th I began feeling some light-headedness and feeling faint. My heart was fluttering every time I stood up, my vision went blurry, and I was very unstable (had to hold something to keep from falling). This feeling was bad enough to cause me to become uncoordinated and fall down the stairs while home alone. That evening I went to the ER where they verified that I was "stable" and checked for bigger issues, and sent me home without treatment. These symptoms continued for the next week. Improving a little each day. It is now May 10th and I am still experiencing some light headedness and clumsiness. Still needing to rebalance myself on something if I stand up quickly. At some point over this time, I've started making mistakes in my words and sentences. Just odd things like omitting words from phrases or confusing "up" with "over" etc. I did not notice this at first, but my co-workers did. Before the vaccine, this is not something I ever did. Correlation? Causation? Regardless, I'm still a little unwell and a little worried. But the ER seemed unconcerned, so I've been continuing about my life.
22 2021-05-09 palpitations Patient was called to come in for her second covid shot by her employer representative but was actua... Read more
Patient was called to come in for her second covid shot by her employer representative but was actually not supposed to get her second shot until the following week. Patient has cardiac history so when she got home after work, she figured out she was given the shot a week early, she notified her PCP and he told her to go to the ER. Patient felt like she was having some mild heart palpitations but decided to monitor her pulse at home and was able to return to work the next day with no further symptoms.
22 2021-05-09 lightheadedness vasovagal reaction
22 2021-05-10 hypotension 1535: Received vaccine around 0850, Denies any sign and symptoms at that time. Around 1500 suddenly... Read more
1535: Received vaccine around 0850, Denies any sign and symptoms at that time. Around 1500 suddenly felt faint, flush and saw black. Patient denies Nausea/vomiting, SOB. Patient was dizzy but was not clammy. Sat down, felt better after sitting and patient given water. Got back up after 10-15 minutes felt fine until around 1530; again felt faint, flushed and blurry vision and dizziness. Denies every losing consciousness. 1538: VS B/P 90/60, HR 78, o2Sat 92% on RA, RR-16, Sitting 1550: Medical team called; patient brought to first aid by wheelchair 1600: Verbalized feeling "much better" denies feeling flushed, nausea, vomiting, SOB, dizziness, some diaphoresis noted to forehead-cool rag applied. 1600: VS: b/p: 110/80, HR 95, O2Sat 96% on RA, RR 16, Sitting 1610: Provider on duty in attendance; assessed patient cleared for discharge home. Pt states she feels "much better" and is goo to go home. denied any further or new symptoms.
22 2021-05-10 loss of consciousness While in the recovery area, Patient was found on the floor by recovery RN. EMS immediately activated... Read more
While in the recovery area, Patient was found on the floor by recovery RN. EMS immediately activated. Patient was turned onto her left side. BP 90/50, P98 and SpO2 98% room air. Fan held to face and cool compresses applied to face. Patient regained consciousness after approx 2 mins. BP 80/58, P105, SpO2 100% room air. Care transferred to EMS.
22 2021-05-11 loss of consciousness Patient passed out during her observation period after vaccination. She hit her head on a wall and w... Read more
Patient passed out during her observation period after vaccination. She hit her head on a wall and was unresponsive. She quickly regained consciousness. Patient was given water and an ice pack. she was observed for an addition 20 minutes and left on her own accord with her parents.
22 2021-05-11 fainting Per mom of patients boyfriend, "patient collapsed/fainted on her sidewalk and they called 911." This... Read more
Per mom of patients boyfriend, "patient collapsed/fainted on her sidewalk and they called 911." This was told to me around 6pm on 05/11/21. I called Pam back at 8:30pm and asked if any new info and she said that patient had been rushed to hospital and she had no other information.
22 2021-05-12 chest discomfort, chest pain body aches, fever, weakness, fatigue, headache, nausea began the following day; then shortness of br... Read more
body aches, fever, weakness, fatigue, headache, nausea began the following day; then shortness of breath/chest pain/pain with deep breath started 3 days after vaccine. Taken to Hospital ER for evaluation. Labs collected (D dimer, CBC, CMP, Pregnancy test, PT, PTT); CXR done-noted questionable 6mm nodule; CT Scan Chest done-No pulmonary embolism found, no nodule noted-assumed to be shadowing or artifact. Symptoms continued and seen by family NP 4/30/21-wheezing noted to left upper lobe, placed on z pak and albuterol inhaler. Symptoms of shortness of breath, chest pain/pressure with deep breaths continued and started on Prednisone 20mg 5/3/21. Symptoms continued and seen again by family NP 5/7/21. Labwork collected (CBC, CMP, Thyroid panel, D Dimer, CRP, ESR, Covid antibodies) and CXR done. WBC 16 and glucose 130 related to recent steroid use. CXR normal. Covid antibodies positive; ordered PFT's and echo (to be completed 6/4/21). Shortness of breath and pressure with deep breaths continue, slightly improved at this time.
22 2021-05-12 heart rate decreased, loss of consciousness Patient with complaints of lightheadedness 30 minutes after receiving vaccination. Patient stated th... Read more
Patient with complaints of lightheadedness 30 minutes after receiving vaccination. Patient stated that she did not eat today, powerade and a lollipop provided. Shortly after, patient with complaints of dizziness and slow heart rate. Vitals at 1546: HR 65 BP 90/62 and RR 20. At 1605, patient with increased drowsiness, dizziness and a brief moment of lapse in consciousness. Evaluated by paramedics on scene and declined transport to ER.
22 2021-05-13 loss of consciousness Pt received Pfizer Covid 19 vaccine. Pt ambulated to monitoring area and sat down. After sitting d... Read more
Pt received Pfizer Covid 19 vaccine. Pt ambulated to monitoring area and sat down. After sitting down, pt lost consciousness and fell onto the floor from her chair. Pt had abrasion over right eye. Pt regained consciousness and staff assisted pt to seated position. Pt lost consciousness again briefly and was lowered to floor. HR 51, BP 83/44, SPO2 100% RA. EMS arrived and transported pt to hospital.
22 2021-05-15 chest pain Admit Date: 4/19/2021 Discharge Date: 4/23/2021 S/p 2nd COVID vaccine on 4/17, developed dyspnea on... Read more
Admit Date: 4/19/2021 Discharge Date: 4/23/2021 S/p 2nd COVID vaccine on 4/17, developed dyspnea on 4/18. COVID PCR+ on 4/19. CRP >200. Patient is a 22 y.o. female with lupus, hx of class IV lupus nephritis on multiple immunosuppressing medications who presented with dyspnea in setting of 2 months of chest pain. Pt reports chest pain, substernal, R sided x2 months. Seen as outpatient previously (February), CTA negative, no effusions at that time. Since then progressively worsening. Yesterday had new and progressively worsening dyspnea. Upon my interview, denies pleuritic pain, not clearly positional, sometimes better with sitting forward, sometimes better when supine. Upon my interview she is very tachypneic so obtaining hx is challenging. She denies anxiety at this time. Denies relief with ativan in the ER. Of note, she received her 2nd COVID vaccination on 4/17, day prior to onset of dyspnea
22 2021-05-16 fast heart rate Tachycardia, tightness in throat, dizziness- given epinephrine by EMS
22 2021-05-17 blood pressure decreased Had extreme sweating and drop in blood pressure to 52/40. Proceeded to lose vision and have chills. ... Read more
Had extreme sweating and drop in blood pressure to 52/40. Proceeded to lose vision and have chills. Faint when standing. Went to hospital.
22 2021-05-19 chest pain, chest discomfort Pt reported chest pain (mid chest, mild pressure) few minutes post vaccination & suspects it is rela... Read more
Pt reported chest pain (mid chest, mild pressure) few minutes post vaccination & suspects it is related to anxiety. Denies SOB/dizziness/difficulty breathing. AOx4; BP 124/68; HR 65. Pt reported improvement upon laying down & drinking water. Pressure pain improve, ambulated w/out difficulty. Instructed to call 911 if CP worsens or if difficulty breathing. Pt will follow, released from vaccination site in stable condition
22 2021-05-19 loss of consciousness, hypertension Within 2 minutes of receiving her first Pfizer dose, she stated she felt as though she was going to ... Read more
Within 2 minutes of receiving her first Pfizer dose, she stated she felt as though she was going to pass out. I immediately headed out to the waiting room where she was sitting post-vaccination and patient then slumped over and lost consciousness. She regained consciousness within 10 seconds. During her period of unconsciousness, she seemed to shake and tremor a bit, almost as though she was seizing . Her eyes were open the whole time she was unconscious. When she regained consciousness, she knew where she was, why she was here and refused emergency medical services to be called. She complained of being hot and nauseous. I gave her water and an ice pack. I monitored her blood pressure. Her blood pressure was slightly elevated, but came back down to normal before leaving the pharmacy. She was brought home by a family member around 6:00 pm after stating she felt much better.
22 2021-05-19 loss of consciousness Patient given the vaccination at approximately 5:25pm and around 5:27pm she stated she felt as thou... Read more
Patient given the vaccination at approximately 5:25pm and around 5:27pm she stated she felt as though she was going to pass out. I went out to the waiting area to encourage her to lie down. She slouched and lost consciousness within seconds of me approaching her. She was unresponsive for approximately 10 seconds. While unresponsive, Patient seemed to shake and her arms tensed up a bit. Once she gained consciousness, she immediately knew where she was and what she was here for. I gave her water and an ice pack because she stated she was hot. I monitored her blood pressure, which was elevated at first, but came down within 15 minutes of regaining consciousness. Patient did not want emergency services to be contacted because she stated she felt fine. She did report some nausea following the event. Patient was driven home by a family member around 6:00pm.
22 2021-05-20 chest pain Pleurisy, sharp chest pains leading to an ER visit where pleurisy was diagnosed
22 2021-05-20 loss of consciousness Immediately following vaccine administration, patient stood and felt dizzy and clinic staff notified... Read more
Immediately following vaccine administration, patient stood and felt dizzy and clinic staff notified immunizer. Immunizer sat with patient and pharmacist was notified of patient feeling unwell. Patient was partially conscious and sitting in chair, leaning against another immunizer. Pharmacist stepped away to acquire ammonia inhalant from emergency kit. Patient was then moved to the ground and was fully unconscious. Pharmacist used ammonia inhalant. Patient then awoke and was able to sit up after 5 minutes. Gave patient water, orange juice, and pretzels and directly observed patient for 15 additional minutes. Patient's family member then remained with patient until patient was feeling well enough to stand up.
22 2021-05-22 cardiac arrest Vfib cardiac arrest admitted to the ICU one week after receiving second dose of Pfizer vaccine. Uncl... Read more
Vfib cardiac arrest admitted to the ICU one week after receiving second dose of Pfizer vaccine. Unclear if related to vaccine administration but pt is 22 years old with no prior cardiac history. Pt still currently admitted but recovering.
22 2021-05-22 fainting All adverse effects were believed to onset in the first 1-2 days after vaccination, and are still on... Read more
All adverse effects were believed to onset in the first 1-2 days after vaccination, and are still ongoing 10 days later, but not reported to be severe: sore arm, fatigue, nausea, vomiting, chills, fever (mild), shaking, dizziness, syncope ( none recent), wheezing, pain in left trunk area upon deep inhalation (not sharp), cough, sputum that is sometimes brown. The parent came close to taking her to the emergency room earlier on after vaccination, but did not.
22 2021-05-23 blood pressure decreased Blood pressure immediately dropped. Continued dropping. Told to go home and drink plenty of liqui... Read more
Blood pressure immediately dropped. Continued dropping. Told to go home and drink plenty of liquids and get rest. Began vomiting that evening. The vomiting, being dizzy and sleeping continued for days. Went to Urgent Care on April 20, 2021. They gave me nausea medicine and said I should expect to feel this way for about one week. The nausea medicine helped with the vomiting, but did not help with being dizzy and sleepy. Making a trip to the ER for more answers.
22 2021-05-23 hypotension after 5 minutes of patient getting her shot felt very dizzy and almost lost consciousness and fell f... Read more
after 5 minutes of patient getting her shot felt very dizzy and almost lost consciousness and fell from her chair in the waiting room. we took her to immunization room, raised her legs, checked her blood pressure was little low and pulse normal but week, she was in and off for one minute then started to get better. we called 911 for her but she talked to paramedics on phone and declined the call . we kept her in immunization room for 10 minutes then she felt better and we asked to wait in waiting room for another 15 minutes just to make sure she is doing fine. we checked on her every 5 minutes and she was feeling much better and asked if she can leave. I called her the next day but she didn't answer but I left her a message . I also recommended the she would check with her md on the next day.
22 2021-05-23 palpitations, chest discomfort Heart racing , fever, and dizziness throughout day. Shortness of breath and chest heaviness from aro... Read more
Heart racing , fever, and dizziness throughout day. Shortness of breath and chest heaviness from around noon (24 hours after shot) through at least midnight. Took inhaler and advil which helped reduce fever and improved shortness of breath, but was still left with some shortness of breath and all the other symptoms remained
22 2021-05-23 fast heart rate, palpitations, fainting, pallor Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia-Mild, Additi... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia-Mild, Additional Details: about 10 minutes after patient got the vaccine. she fainted in the chair. her head swung back and she was shaking. she woke soon afterwards. she became increasingly pale and reported feeling palpitations with some blurred vision. nurse checked EKG with normal results. normal blood glucose readings. EMS was called for evaluation then medic transport to nearby hospital
22 2021-05-24 chest discomfort Patient had 4 large hives on her arms and body and told me she felt like her heart was pounding; no ... Read more
Patient had 4 large hives on her arms and body and told me she felt like her heart was pounding; no problems breathing; no other symptoms
22 2021-05-24 lightheadedness Felt weak/going to pass out. No loss of concousness
22 2021-05-24 fainting Nausea, "fainted"
22 2021-05-25 chest discomfort Shortness of breath, itching, facial swelling, throat and chest tightness.
22 2021-05-25 palpitations Heart palpitations for about 1-1.5 weeks
22 2021-05-26 palpitations Heart palpitations occurred four days after injection, went to emergency room on the fifth day. In t... Read more
Heart palpitations occurred four days after injection, went to emergency room on the fifth day. In the emergency room for three hours. Doctors recorded heart rate and I was given two bags of NaCl. Still occurring but are decreasing in frequency.
22 2021-05-26 fainting DIAPHOERTIC, DIZZY, SYNCOPE, ALTERED after 7-8 minutes of vaccine administration legs raised on cha... Read more
DIAPHOERTIC, DIZZY, SYNCOPE, ALTERED after 7-8 minutes of vaccine administration legs raised on chair across, fan air, v/s monitored, apple juice, crackers, icepacks to neck. EMS called but by the time they arrived patient was smiling and talking, refused to go to hospital. was discharged in stable condition after monitoring for additional 30 minutes 1322-60,16.110/84. 99% RA 1330- 69, 18, 110/78.97%
22 2021-05-29 fibrin d dimer increased Bell's Palsy, left facial nerve paralysis
22 2021-05-29 palpitations Thursday, May 27: received first Pfizer shot. Friday, May 28: headache from 0800-1300. Saturday, May... Read more
Thursday, May 27: received first Pfizer shot. Friday, May 28: headache from 0800-1300. Saturday, May 29: heart palpitations beginning approximately 1100 intermittently, currently still happening at 2300.
22 2021-05-30 fainting Patient fainted approximately 5-10 minutes after receiving her second Covid-19 vaccination
22 2021-05-31 chest discomfort Patient reports chest as feeling tight, had difficulty swallowing and breathing about a day after r... Read more
Patient reports chest as feeling tight, had difficulty swallowing and breathing about a day after receiving first dose. She reports feeling like this for a few days, and if she had not gotten better at the time of phone call she would have gone to hospital. She was advised to reach out to her doctor and to go to ER if she experiences any more difficulty breathing.
22 2021-05-31 chest pain Patient reports abnormal chest pain, weird "poking" feeling in heart, and abnormal thigh pain after ... Read more
Patient reports abnormal chest pain, weird "poking" feeling in heart, and abnormal thigh pain after receiving vaccine. She is still feeling a bit of chest pain but the worst was Monday following the vaccine administration. She has not gone to the ER but was advised to go if she experience any severe pain or difficulty breathing, and was also advised to reach out to her doctor prior to next dose.
22 2021-06-01 chest pain sharp pains on the left side of body (arm, shoulder, sometimes chest) nausea derealization
22 2021-06-01 loss of consciousness, fainting Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient received first dose of vaccine... Read more
Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient received first dose of vaccine with her mother. Prior to administration, patient mentioned she was anxious receiving shots having a history of fainting. Immediately after administration, patient stated that she was relieved. About 2 minutes later, patient's mother called for the pharmacist for help claiming patient was having convulsions and was unconscious. Paramedics were called. Patient regained consciousness after 20 secs with nausea & no recollection of loss of consciousness.
22 2021-06-02 low blood oxigenation, troponin increased, inflammation of the heart muscle Patient appears to have myocarditis/ viral pneumonia, hypoxia on 6/3/21 positive Sars-CoV-2 on viral... Read more
Patient appears to have myocarditis/ viral pneumonia, hypoxia on 6/3/21 positive Sars-CoV-2 on viral panel in ED today.
22 2021-06-02 pulmonary embolism Fatigue, increasing shortness of breath for 1-2 weeks, diagnosed with pulmonary embolus on 6/2/21 in... Read more
Fatigue, increasing shortness of breath for 1-2 weeks, diagnosed with pulmonary embolus on 6/2/21 in emergency department
22 2021-06-03 fast heart rate Patient started feeling tingling and tightness at the throat, with some tachycardia approximately 20... Read more
Patient started feeling tingling and tightness at the throat, with some tachycardia approximately 20 minutes into the vaccination (Admin: 13:43). Due to area of concern and weight, patient was administered (2) tablets of diphenhydramine 25 mg [Geri-Dryl Allergy Relief by Geri-Care] at 13:07 from our travel clinic's emergency kit. Patient reports that they had tachycardia and nervousness prior to the vaccine by 10 minutes. After further inquiry, patient had a recent asthma attack 3-days ago that was also newly diagnosed then. Patient did not have a rescue inhaler but has a prescription on hand. After, 45 minutes of watchful waiting and 32 fl. oz. of water during observation, patient was "feeling fine" and able to converse normally (with laughter), no lightheadedness or further throat sensations.
22 2021-06-05 hypotension Systemic: Dizziness / Lightheadness-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Sev... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: after shot at 2:10pm complained of sweating, asked if "Am i going to dye" very anxious, nausea, lightheaded. had pt elevate legs and took bp1: at 2:15pm 96/55 pulse 68, bpt2: 21pm 117/80 pulse 93, complained of tingleness in lower extremities, 3rd bp: at 2:29pm 120/80 pulse 88, had pt leave with friend at 2:34pm advised not to drive
22 2021-06-05 fainting The patient stood up to signal something was wrong, and she immediately sat back down. As I went ove... Read more
The patient stood up to signal something was wrong, and she immediately sat back down. As I went over to her, she was leaning over out of her chair at which time she fainted, and I had her lieing on the groung. she woke up 5-10 seconds later and didn't know what had happeneded and was upset. We moved to the immunization room and elevated her legs while applying ice packs to the back of her neck. She drank water and ate an apple. Within 45 minute she was feeling a lot better.
22 2021-06-09 brain sinus blood clot 5/20/21: - I received my 2nd dose of Pfizer vaccine - I had severe chills and fever for two days 5/2... Read more
5/20/21: - I received my 2nd dose of Pfizer vaccine - I had severe chills and fever for two days 5/23/21: - Chills & fever subsided, but I woke up with a severe headache that lasted all day long despite taking ibuprofen 5/24/21: - Headache continues so I called the Doctor, am told it?s a vaccine symptom that should subside in a couple days & get prescribed Naproxen for the pain 5/28/21: - I try to ween off the medication, but the migraine is still there and now throbbing worse than ever - I call the Doctor again, this time I?m advised to get my eyes checked out and make an appt. with my primary physician 5/29/21: - Eye exam came back healthy and normal 6/1/21: - Went to appt. with PCP and she sends me for a STAT emergency MRI that day - Get MRI scans done at 8pm - Get a call personally from primary physician at 11:30pm saying one scan is inconclusive and sends me for an emergency CTB scan at the ER immediately 6/2/21: - Two CTB scans are completed at 2am - At 4am we are seen by doctor who admits me and says he wants to contact a neurologist specialist - Neurologist comes in at 8:30am and tells me I have been diagnosed with a rare mild blood clot in my brain - Put on Eliquis blood thinner for 6 months & ButalBital Acetaminophen for migraine pain relief 6/9/21: - Met with hematologist to go over blood test results, told I am a carrier for the Factor 2 Gene Mutation
22 2021-06-09 chest discomfort Shortness of breath; Chest tightness; burning; This is a spontaneous report from a contactable consu... Read more
Shortness of breath; Chest tightness; burning; This is a spontaneous report from a contactable consumer (Patient). A 22-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6199), via an unspecified route of administration, administered in right arm on 09Mar2021 (at the age of 22-years-old), as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EK4176), via an unspecified route of administration, administered in right arm on 16Feb2021 at 12:00 as single dose for COVID-19 immunisation. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19 prior vaccination. On 09Mar2021 at 08:00 (same day of vaccination), patient experienced shortness of breath, chest tightness and burning. Patient did not receive any treatment for adverse events. The patient underwent lab tests and procedures which included SARS-CoV-2 antibody test: unknown results (Nasal Swab) on an unspecified date. Patient has not been tested for COVID-19 post vaccination. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
22 2021-06-10 chest pain, heart flutter Began to experience shortness of breath, persistent chest pain, and fluttering sensation in heart. A... Read more
Began to experience shortness of breath, persistent chest pain, and fluttering sensation in heart. All symptoms began about 5-6 days after vaccination and lasted about a week. Symptoms lessened and did not experience again after the second dose.
22 2021-06-10 chest pain, fluid around the heart, cardiac failure congestive After fully vaccinated, patient vacationed and had a negative test prior to return home (end of May)... Read more
After fully vaccinated, patient vacationed and had a negative test prior to return home (end of May). Early June, patient experienced burning chest pain & difficulty breathing. Found to be COVID positive, with elevated cardiac enzymes (troponin 0.45ng/mL). Echocardiogram showed pleural effusion, pleurisy, acute congestive right ventricular heart failure, possible myocarditis vs. severe pulmonary vascular edema, and scant pericardial effusion. Patient was transferred to hospital for higher level of care. Unknown if cardiac effects are related to vaccination or acute disease process.
22 2021-06-10 chest pain Severe left sided chest pain, ibuprofen taken, waiting on MD recommendations.
22 2021-06-10 inflammation of the heart muscle, chest pain, heart rate irregular Myocarditis; abnormal heartbeat; intense chest pain; Shortness of breath; The pain in my chest felt ... Read more
Myocarditis; abnormal heartbeat; intense chest pain; Shortness of breath; The pain in my chest felt like intense bruising. I still feel a sharp bruising pain when I lift something too heavy or turn quickly.; This is a spontaneous report from a contactable consumer (patient). A 22-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 22Feb2021 16:30 (Batch/Lot Number: EL9266) as single dose for covid-19 immunisation at the age of 22-year-old. Medical history included covid-19 prior to the vaccination. No known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID) and levonorgestrel (KYLEENA) (reported as Kyleena IUD). No other vaccine received in four weeks. It was reported that I woke up with intense chest pain two days after the first dose. Thought I was having a heart attack. Now realizing it was Myocarditis. Intense pain when moving and lifting heavy objects. Apple watch detected an abnormal heartbeat which fixed itself later on in the day. I experienced shortness of breath. The pain in my chest felt like intense bruising. I still feel a sharp bruising pain when I lift something too heavy or turn quickly. The events stated on 24Feb2021 08:00. No treatment received, and outcome of events was recovered with sequelae on unspecified date in 2021. The patient hasn't been tested post vaccination.
22 2021-06-12 chest pain Abdominal cramps, headache, fatigue, minor body aches, minor chest aches during sleep, trouble sleep... Read more
Abdominal cramps, headache, fatigue, minor body aches, minor chest aches during sleep, trouble sleeping.
22 2021-06-12 palpitations Patient had fever, chills, and then her heart started racing. In my office it was 125. I sent her to... Read more
Patient had fever, chills, and then her heart started racing. In my office it was 125. I sent her to an urgent care to rule out any arrhythmias, as we do not have an ECG.
22 2021-06-12 lightheadedness Patient suffered a vasovagal syncope without losing consciousness, pt suffers from anxiety and did n... Read more
Patient suffered a vasovagal syncope without losing consciousness, pt suffers from anxiety and did not eat, only in the morning
22 2021-06-12 fast heart rate, hypertension Difficulty breathing, Tachycardia, Hypertension, Fatigue
22 2021-06-14 loss of consciousness Pt had COVID Vax (Moderna) on June 3rd. On June 4th passed out while sitting down became lightheaded... Read more
Pt had COVID Vax (Moderna) on June 3rd. On June 4th passed out while sitting down became lightheaded and fell over, felt cold and shivering was alone has never had this happen before. no injuries felt tired and sluggish the rest of the day next day felt ok.
22 2021-06-14 palpitations, blood pressure increased Severe headaches behind R eye which started on 5/17/21 (pain alleviated with 600mg ibuprofen or with... Read more
Severe headaches behind R eye which started on 5/17/21 (pain alleviated with 600mg ibuprofen or with Excedrin), high blood pressure (143/93), heart palpitations. Headaches lasted 16 days until 6/1/21. Saw doctor on 6/2/21 but headaches never returned. All lab results and medical tests came back within normal limits.
22 2021-06-15 troponin increased, inflammation of the heart muscle, chest pain Admitted to Hospital on 6/11/21 with 2 day history of chest pain. Treated with Ibuprofen, Aspirin, ... Read more
Admitted to Hospital on 6/11/21 with 2 day history of chest pain. Treated with Ibuprofen, Aspirin, Colchicine. Discharged home on 6/16/21
22 2021-06-16 chest discomfort, chest pain A week after the vaccination I woke up at dawn with intense pain in the chest on the left side, I fe... Read more
A week after the vaccination I woke up at dawn with intense pain in the chest on the left side, I felt great pressure and pain, after that the pain persisted for approximately 2 days; A week after the vaccination I woke up at dawn with intense pain in the chest on the left side, I felt great pressure and pain, after that the pain persisted for approximately 2 days; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (Patient). A 22-year-old female patient (who was not pregnant at the time of vaccination), received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0185 and expiry dates were not provided), via an unspecified route of administration, administered in right arm on 12May2021, as a 2nd dose, single dose for COVID-19 immunisation. Medical history included COVID-19 prior vaccination from an unknown date and unknown if ongoing. The patient's concomitant medications in two weeks of COVID vaccination included contraceptives on 07Jun2021. Historical vaccine given to patient previously was dose 1 received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: EW0162), via an unspecified route of administration, administered in right arm on 21Apr2021 at 12:00 as a single dose for COVID-19 immunisation. The patient did not receive other vaccine in four weeks of vaccination. It was reported that, one week after the vaccination at 03:00 on 17May2021 she woke up at dawn with an intense pain in her chest great pressure and pain, after that the pain persisted for about 2 days, but it was not diminished and went away, after that she kept getting sharp pains in her chest occasionally times more. The patient received both doses and experienced chest pain, on the side where her heart are located. Pressure is there. Wanted to ask if there are other people talking about the same experience of heart pressure. Asked if there was a website to search for this information. No product complaint was reported. It was reported as medical information request. The outcome of the events was recovered with sequelae. Follow-up attempts are possible, additional information has been requested.
22 2021-06-17 palpitations I woke up at 4am with a racing heart, exhaustion, and severe heart palpitations. This was 3 months a... Read more
I woke up at 4am with a racing heart, exhaustion, and severe heart palpitations. This was 3 months ago and I'm still experiencing heart palpitations daily. I can't exert myself, carry heavy things, walk long distances, or be in heat without feeling as though my heart is swollen/racing/palpitating. I went to the cardiologist and told her my symptoms and she said it is likely myocarditis.
22 2021-06-18 pallor A 22 yrs old female complained she could not see anything 10 minutes after receiving Pfizer vaccine.... Read more
A 22 yrs old female complained she could not see anything 10 minutes after receiving Pfizer vaccine. She seemed sleepy,and her face and lips looked pale.She was responsive and conscious, She denied difficulty of breathing, She was hot to touch and asked for water. After approximately 5 minutes, her vision was back to normal,and her face color changed to its normal complexion. The patient has not received anything during this period. She was encouraged to be calm and breathe in and out slowly.Vitals not recorded. EMS arrived and stayed with the patient for 30 minutes.However, patient recovered to normal and went home afterwards. Her brother, who also received dose 1 of the Pfizer vaccine at the same time, had mild but similar symptoms.
22 2021-06-19 inflammation of the heart muscle, inflammation of the pericardium myocarditis/pericarditis
22 2021-06-19 fainting Patient felt dizzy. when she lowered her head she felt slightly better, but then felt dizzy again an... Read more
Patient felt dizzy. when she lowered her head she felt slightly better, but then felt dizzy again and fainted for ca 30 sec. then regained conciousness. We let he lie down. She felt better after a while, but when she sat up she felt dizzy again and lied down again. We called 911 and EMT came to check. They left withou reporting back to me. The patient left at the same time
22 2021-06-20 chest pain chest pain reported on 6/8/21
22 2021-06-20 chest pain Stabbing chest pains 12 hours after the shot that lasted for around another 24 hours. The chest pain... Read more
Stabbing chest pains 12 hours after the shot that lasted for around another 24 hours. The chest pains came along with more normal symptoms such as chills, body aches, and a fever. While the side effects and shooting stabbing pains went away, I still feel strained chest pains from time to time.
22 2021-06-20 heart rate increased Client complained of elevated heart rate following administration of vaccine via Apple watch (91 bpm... Read more
Client complained of elevated heart rate following administration of vaccine via Apple watch (91 bpm). After an hour, client requested EMS as heart rate had not returned to baseline, no other complaints. Vitals per EMS = 1) HR=85, BP=167/105, 2) HR=82, O2=100%, RR=14, BP=138/95, 3) HR=86, O2=99%, BP=144/96. Ekg = NSR with "long" ST segment. Client was transported via EMS to ER.
22 2021-06-21 lightheadedness, palpitations About 3 days later, I started noticing shortness of breath. Mine had just caused really bad allergie... Read more
About 3 days later, I started noticing shortness of breath. Mine had just caused really bad allergies. I thought it was just my allergies causing the shortness of breath. After my allergies stopped for the season, I was still having shortness of breath. About a week or two after getting my vaccine I started noticing that my dizzy spells started getting worse. I was having light headedness. I was having these beforehand, but after the vaccine they were worse. I would normally just get a little head rush (like standing up too fast), but now my vision starts getting black from the outside coming in. I almost pass out. After about 3-5 seconds, I'm able to gather myself and keep myself from passing out. I also noticed that my heart cannot take as much strain as it used to. I was having palpitations. It feels like it's attempting to stop beating. It now is triggered more easily. It's very hard for me to catch my breath and I get worn out super easily. I went and saw my PCP about 2 weeks ago for a regular routine visit and I informed her about my symptoms. She said everything looked fine and in normal ranges. They sent records to a pap specialist. I am still waiting to hear back from them to do some testing. I also talked with my therapist about some of the issues I've had because we thought it might be anxiety related, but we ruled that out. It is more medical.
22 2021-06-21 fast heart rate The first two days, I had a fever, drowsiness and increased hunger. The third day I became extremely... Read more
The first two days, I had a fever, drowsiness and increased hunger. The third day I became extremely weak and developed tachycardia and sinus arrhythmia. A visit to a cardiologist, who conducted a halter and an echocardiogram determined that I now have sinus arrhythmia and a slight thickening of my heart muscle (left ventricular hypertrophy). I had no previous health issues or heart issues before receiving the second dose of the vaccine.
22 2021-06-22 chest discomfort, chest pain Site: Redness at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic:... Read more
Site: Redness at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Medium
22 2021-06-23 chest pain, enlargement of the heart A week after I went to the ER for chest pain. I thought it was Asthma, but they did an extra and my ... Read more
A week after I went to the ER for chest pain. I thought it was Asthma, but they did an extra and my heart has enlarge. I also have an ovarian cyst.
22 2021-06-24 palpitations, increased heart rate, fast heart rate Sinus Tachycardia/SVT/Palpitations. Ongoing since January - Racing Heart -Heart beating hard -Shortn... Read more
Sinus Tachycardia/SVT/Palpitations. Ongoing since January - Racing Heart -Heart beating hard -Shortness of breath -Dizziness
22 2021-06-24 fainting Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Tinn... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Tinnitus-Medium, Additional Details: we called 911. EMT consulted with patient , but neither reported back to pharmacist. I called on 6/20/21 @ 6:10 pm and on 6/21/21 @ 10:31 am and left voicemail messages.
22 2021-06-24 fainting Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe
22 2021-06-27 chest pain costochondritis for weeks following vaccination: shortness of breath, chest pain
22 2021-06-27 fainting, hypotension Patient passed out approximately 5-10 minutes after receiving vaccine. She may have hit her head wh... Read more
Patient passed out approximately 5-10 minutes after receiving vaccine. She may have hit her head while she was falling. She then had 2 seizures. 911 was called. Patient's blood pressures were 99/58 and 95/42. Patient had only eaten granola bar and yogurt today. She had also previously passed out while getting a tattoo. Patient's mother was going to take her to hospital to get further treatment.
22 2021-06-28 palpitations Racing heart, dizziness, excessive sweating, extreme fatigue, headaches. Have seen 2 doctors now to ... Read more
Racing heart, dizziness, excessive sweating, extreme fatigue, headaches. Have seen 2 doctors now to figure out what is going on. One doctor thinks it may be POTS but have not had a test to confirm this. They also think it may be myocarditis but need to seek a second opinion.
22 2021-07-03 chest pain Chest pain, upper back pain, shortness of breath, O2 at 90% on room air, pain radiating from injecti... Read more
Chest pain, upper back pain, shortness of breath, O2 at 90% on room air, pain radiating from injection site down arm, headache, pain down left side of neck, nausea, UTI, rash
22 2021-07-03 palpitations Severe nausea lasting from march to may Dizziness Racing heart rate that would max at 120
22 2021-07-06 heart rate increased, chest discomfort New onset of rapid change in heart rate (accompanied by dizziness/lightheadedness) upon standing not... Read more
New onset of rapid change in heart rate (accompanied by dizziness/lightheadedness) upon standing noticed in May 2021. The sensation in the chest feels like heart burn but appears upon standing. Routinely heart rate will change from 66-75 BPM to 104+ BPM following a change of position from reclined to standing and only 3-5 steps.
22 2021-07-07 hypotension Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild
22 2021-07-07 hypotension Severe allergic reaction; Sweating; Nauseous; Felt like she was going to pass out; Blood pressure wa... Read more
Severe allergic reaction; Sweating; Nauseous; Felt like she was going to pass out; Blood pressure was low; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 22-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Lot number and Expiry date: Unknown), via an unspecified route of administration, administered in Arm on 18May2021 about 09:00 (at the age of 22-year-old) as dose 1, single for Covid-19 immunization. The patient medical history and concomitant medications was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient was not received any treatment and diagnosed with covid 19 and had not been tested for COVID-19 Since the vaccination. She received her first dose on 18May2021. On the same day she had a severe allergic reaction and the paramedics were called and she was taken by ambulance to the hospital. She was fine now. Shortly after getting the vaccine, within 5 minutes (on 18May2021) of getting the shot, she was still in the waiting period, she began profusely sweating. She was nauseous and felt like she was going to pass out. They called the paramedics. When the paramedics came her blood pressure was low, like 55/48. Her blood pressure had dropped dramatically. The ambulance came and took the hospital, Emergency Room.The patient underwent lab tests and procedures which included blood pressure measurement: 55/48. Treatment included they monitored her with an EKG for several hours. She was given an IV to make sure stay hydrated. She was released mid-afternoon that day after being monitored for a number of hours. She was released after she began to stabilize and blood pressure normalized. The outcome of events severe allergic reaction and blood pressure was low was recovering and other events was unknown. Information on the lot/batch number has been requested.
22 2021-07-08 chest discomfort 15 seconds after second dose, could not breathe, nausea, dizziness, lost completely feeling in both... Read more
15 seconds after second dose, could not breathe, nausea, dizziness, lost completely feeling in both arms, side cramps, chest tightness, uncontrollable shaking, feeling super cold. Vision suddenly got narrow , began seeing stars, black patches Got an epipen injected and was finally able to breathe. Paramedics arrived and took vitals and I stayed for 45 mins until vitals were back to normal. Suggested I drive in the ambulance to the ER to be monitored but it wasn?t bad enough for me to ride. Someone separately drove me to the hospital just in case and I was ok.
22 2021-07-08 heart rate increased, atrial fibrillation flutter and AFIB; anxiety; threw up; her heart was racing; This is a spontaneous report from a conta... Read more
flutter and AFIB; anxiety; threw up; her heart was racing; This is a spontaneous report from a contactable consumer (patient mother) reported patient (reporter daughter). A 22-year-old female patient received first dose of BNT162B2 (Pfizer covid-19 vaccine, Solution for Injection, Lot Number: EN6205, Expiration date: Unknown), via an unspecified route in the right arm on 07Apr2021 (age at vaccination: 22-year-old) as a single dose for covid-19 immunization. Medical history included extreme immune system and seizures that only lasted about 2 years when she was a baby. The patient concomitant medications were not reported. Patient had issues when she was born, she was 3 weeks post term, she was adopted and when all the kids would get sick, she would always get the sickest. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, few days later she felt something and thought it was anxiety, 2 weeks after vaccination from 15May2021, she woke herself up threw up and saying that her heart was racing around 8:30 in the morning, so she went and got their finger monitor, and her heart rate was out of control, so they took her to the emergency room. They tried to get her heart rate down with medications and sent us to an electro physicist, and the rest is history. Patient has been an athlete her whole life, has been in great shape with no heart problems. She was taken to the ER and they captured flutter on the EKG and AFIB issues. Later she was hospitalized and ended up having cardiac surgery about a week ago at 13:00 (16Jun2021 to 17Jun2021). Caller states that her daughter was doing really well, they had to do an ablation. Caller states they saw the cardiologist today, her daughter may have bouts of palpitations, but has had nothing since 3 days after the surgery. Caller wanted to know if AFIB has been reported as a reaction. She received her second shot of BNT162B2 (Pfizer covid-19 vaccine, Solution for Injection, Lot Number: EN6199) in the right arm on 28Apr2021. They said she will recover completely, but it will take about 3 months. She will have to be followed by a cardiologist. The patient underwent lab test and procedure on 15May2021 which included flutter on the EKG. The clinical outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
22 2021-07-09 excessive bleeding, fainting Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Weakness-Severe, Additional Details: PT received vaccine and then felt light headed and began to panic. She was being assisted by pharmacist and shift supervisor when she stood up to attempt to walk into the vaccination booth to calm down. She passed out, flew forward hitting her forhead on the corner of the wall, she was momentarily unconcious and she had a cut on her forehead and was bleeding. Shift supervisor called 911 while pharmacist tended to her until emts arrived.Her parents were contacted and she was taken to er
22 2021-07-09 blood clot The first dose I experienced flu symptoms with a body ache/chills/headache that lasted for about 2-3... Read more
The first dose I experienced flu symptoms with a body ache/chills/headache that lasted for about 2-3 days. 2nd dose, next day had a fever/chills/headache/body aches, a few days later experienced shortness in my breath, numbness, and pain in both legs, extreme lower back pain and abdominal pain/cramping and the pain is still there, I have 2 swollen lymph nodes located in my groin area. I have seen the Dr a few times and had a CT scan. They discovered I have an enlarged liver/swollen spleen that they found a blood clot, the doctor has me taking aspirin for 3 months, and will need to follow up with another CT scan
22 2021-07-11 inflammation of the heart muscle Eight hours after receiving the first dose, I experienced flu like symptoms, muscle aches, joint pai... Read more
Eight hours after receiving the first dose, I experienced flu like symptoms, muscle aches, joint pain, chills, headache, and a fever. Then those symptoms went away. I had pain in the injection site for two days. In April 2021, I spent 4 nights in the hospital. I was diagnosed with Myocarditis. I was also hospitalized for 3 days in May as well. On the 8th of July, I spent 1 day in the hospital. I received blood thinners when I was in the hospital. I am currently taking anti inflammatory medication.
22 2021-07-11 fast heart rate Tachycardia and abnormal ekg
22 2021-07-12 heart rate decreased, cerebrovascular accident, pallor Thyroid or throat area was pounding; Thyroid or throat area is pounding; legs swelled up so bad; Hea... Read more
Thyroid or throat area was pounding; Thyroid or throat area is pounding; legs swelled up so bad; Heart rate very low; circulation issues; Felt like having a stroke; Dizzy; Pitting in left leg, which was pale and had veins showing; Pitting in left leg, which was pale and had veins showing; Pitting in left leg, which was pale and had veins showing; Struggling to breathe/can't breathe; Weak; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 04May2021 12:00 (Batch/Lot Number: EL9269), as dose 1, single, at age 22 years old, for COVID-19 immunization, at a pharmacy/drug store. The patient was not pregnant at the time of vaccination. Medical history included Hashimoto's disease, Ehlers-Danlos syndrome, and Raynaud's disease, all from unknown dates, not reported if ongoing or not. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient received unspecified medications within 2 weeks of vaccination (unspecified concomitant medications). On 07May2021 (also reported as "around day 3 or day 4"), the patient started to get dizzy. On the same day, 07May2021, the patient felt like have a stroke because she could not make thoughts. She had pitting in left leg (also reported as "pitting in left left", pending clarification), which was pale and had veins showing, and she was struggling to breathe and was weak. On 09May2021 (also reported as "about day 5"), her heart rate was very low and she noticed circulation issues. On 11May2021 (also reported as "day 7"), her legs swelled up so bad. On 14May2021 (also reported as "day 10"), the patient's thyroid or throat area was pounding. The events resulted to emergency room and physician's office visits. Treatment for the events included turmeric and aspirin which the patient took every day, multiple times a day. Blood work on an unspecified date mostly came back normal. The patient reported the events were better in two weeks. Her physician advised her to skip the second dose. However, the patient received the second dose out of "fear of missing out" on 25May2021 12:00 (Batch/Lot Number: EW0178) in the left arm. The patient was recovering from the events. Follow-up attempts are completed. No further information is expected.
22 2021-07-12 increased heart rate, lightheadedness, heart rate increased 3/15/21: began feeling short of breath with any exertion as well as having tachycardia. Went to get ... Read more
3/15/21: began feeling short of breath with any exertion as well as having tachycardia. Went to get covid tested and was negative, vitals were heart rate 169 at and they sent me to an ER to be evaluated for possible . While at Hospital my heart rate continued to be 150-160 while resting and elevated with movement. D dimer was elevated at 1.67. CT angiogram of Pulmonary arteries was negative. Troponin was negative x3. Wbc were 3.08. EKG showed sinus tachycardia with possible left atrial enlargement. Tested again for covid and was negative. Hospitalized for 1 night for observation. Discharged 3/16/21 with a 1 month heart monitor. Had follow up visit with PCP on 3/19/21. Heart rate in office was 120s. EKG was performed, lying down my heart rate dropped to 70s. Orthostatic vitals were obtained. Heart rate increased with sitting and standing and blood pressure continued to decrease. Magnesium level and echocardiogram were then obtained and both came back normal. I had to be off of work for over a month due to heart rate and symptoms with it. 3/28/21: covid test performed, negative for 3rd time. 4/1/21: tilt table exam performed. Heart rate laying was 100, tilted up went well over 170 with almost passing out and shaking uncontrollably in the first 7 minutes of the test. Cardiologist ruled it as inappropriate sinus tachycardia. 4/20/21: office visit with cardiologist. Cardiologist notes, "Impression inappropriate sinus tachycardia with hypersensitivity of sinus node. Post viral syndrome without evidence of flu or Covid with negative testing. History of being previously vaccinated." Cardiologist stated to me it was most likely vaccination related since he has seen cases like this recently. Had to be put on beta blocker atenolol 12.5 mg and still taking it to this day. Heart rate still occasionally increases to 140s while on medication but is overall controlled.
22 2021-07-13 chest discomfort Since July 4th I have felt as though I can't breathe, exercise is difficult and I haven't been sleep... Read more
Since July 4th I have felt as though I can't breathe, exercise is difficult and I haven't been sleeping because it's harder to breathe when I lay down. I have chest tightness and pain.
22 2021-07-15 loss of consciousness Passed out, fever, vomit, diarrhea, sweating, chills
22 2021-07-15 fainting, loss of consciousness Pt fainted hitting R/frontal side of head. Loss of consciousness for 1-3 seconds. Ice applied to he... Read more
Pt fainted hitting R/frontal side of head. Loss of consciousness for 1-3 seconds. Ice applied to head, but no swelling or discoloration noted. BP 116/86 P80 R16 3:08 Moved to observation area to cot with legs elevated. Color improving 3:15 Pt alert & talking w/mother 3:30 Eating crackers & drinking juice. left w/o assistance with mother.
22 2021-07-17 atrial fibrillation, palpitations AFIB/flutter; threw up; Threw up and saying that her heart was racing/have bouts of palpitations/hea... Read more
AFIB/flutter; threw up; Threw up and saying that her heart was racing/have bouts of palpitations/heart rate was out of control; This is a spontaneous report from a contactable consumer (patient's mother). A 22-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right at age of 22 years on 28Apr2021 (lot number: EN6199) as single dose for covid-19 immunisation. Medical history included extreme immune system, described that patient was 3 weeks post term (as reported) and had issues when she was born, she was adopted and when all the kids would get sick she would always get the sickest; had seizures that only lasted about 2 years (not ongoing) when she was a baby. Family medical history relevant to AE was none. Concomitant medications were none. No vaccines administered on same date or within four weeks prior to the first administration date of the suspect vaccine. The patient previous took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose1 via an unspecified route of administration, administered in arm right at age of 22 years on 07Apr2021 (Lot no: : EN6205) for covid-19 immunisation, few days later she felt something and thought it was anxiety. On 15May2021, 8:30 in the morning patient threw up and was saying that her heart was racing, so she got their finger monitor, and heart rate was out of control so they took her to the emergency room. They tried to get her heart rate down with medications and sent her to an electro physicist, and the rest was history. The only reason attributed this to the vaccine was because this occurred 17 days after her second shot and patient was has been an athlete her whole life, has been in great shape with no heart problems. They captured flutter on the EKG, and saw AFIB when she was under, on 15May2021. Patient ended up having to have cardiac surgery (for AFIB) on 16Jun2021 13:00 in hospital from 16Jun2021 to 17Jun2021. Patient was doing really well, they had to do an ablation. Patient will recover completely, but it will take about 3 months. She will have to be followed by a cardiologist. Saw the cardiologist, patient may have bouts of palpitations, but has had nothing since 3 days after the surgery (19Jun2021). The outcome of the events palpitations was recovered on 19Jun2021, other events was recovering. Follow-up actions are needed. Further information has been requested.
22 2021-07-17 chest pain I have been having trouble breathing since I had the vaccine done. I get really bad chest pains just... Read more
I have been having trouble breathing since I had the vaccine done. I get really bad chest pains just from laying down and it is a daily struggle to do everyday things like walking because I get short of breath really easily after I had the vaccine done. It has been 3 and a half months now and I am still struggling trying to recover. My treatment right now is that my pulmonologist put me on Symbicort to see if it could give me a little bit of relief and I am still being seen by the cardiologist as well, and I am also using my rescue inhaler Albuterol HFA more often than before. I am taking Singulair and I was also put on a heart monitor for 2 days to check my heart rhythm to see if that has anything to do with the chest pains I have been feeling
22 2021-07-20 chest pain vomiting multiple times; Nausea; Chills; Fever; Body aches; Chest pain; This is a spontaneous report... Read more
vomiting multiple times; Nausea; Chills; Fever; Body aches; Chest pain; This is a spontaneous report from a non-contactable consumer (patient). A 22-years-old female patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine) at the age of 22-years-old, dose 2 via an unspecified route of administration, administered in Arm Left on 05Jul2021 15:45 (Batch/Lot Number: EW0198) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. Historical Vaccine included BNT162B2 for COVID-19 Immunization on 14Jun2021 at the age of 22-years-old (1st Dose, Batch/lot number: EW0196, Anatomical Location: Arm left, Administration time: 11:00 AM). Reported Adverse Events: Nausea, vomiting multiple times, chills, fever, body aches and chest pain since 06Jul2021 05:00AM. No treatment received. The event outcome was recovering. Since the vaccination, the patient has not been tested for COVID-19. Case received as non-serious. No follow-up attempts possible. No further information expected. Information about batch number has been obtained.
22 2021-07-20 heart rate increased, skin turning blue, pallor, fainting Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: temporary loss of vision-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Medium, Additional Details: pt was given vaccine and approximately 5minutes or less later patient fell out of chair and onto floor. patient was pale,unresponsive for less than 30 seconds and clammy to touch. her lips were blue. 911 was called. came to almost immediately and did not remember what happened. vision went black but came back after a few minutes. tested her blood sugar is was 114. pulse was rapid. anbulance arrived pt walked out on her own power. refused treatment from emts and refused to go to er.
22 2021-07-23 palpitations right side weakness; tingling/ numbness in limbs; muscle twitches/ spasms; palpitations; dizziness; ... Read more
right side weakness; tingling/ numbness in limbs; muscle twitches/ spasms; palpitations; dizziness; nerve, muscle & joint pain; nerve, muscle & joint pain; nerve, muscle & joint pain; altered sensations; heat & humidity intolerance; heat & humidity intolerance; difficulty concentrating/ finding words; balance and gait issues; balance and gait issues; fine muscle movement issues- hands; blurring vision; muscle spasms; tingling in limbs; This is a spontaneous report from a contactable consumer (patient) reported for herself that. A 22-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0171), via an unspecified route of administration, administered in right arm on 14May2021 10:45 (Age at vaccination: 22 year) as DOSE 2, SINGLE for covid-19 immunization. The patient past Medical history included hypothyroidism from an unknown date and unknown if ongoing and migraine from an unknown date and unknown if ongoing. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE) taken for an unspecified indication, levothyroxine sodium (LEVOTHYROXIN) taken for an unspecified indication and topiramate (TOPIRAMATE) taken for an unspecified indication. The allergies include Azithromycin. The patient previously took bnt162b2 dose 1 via an unspecified route of administration, administered in right arm on 23Apr2021, 10:45 AM dose 1, single (lot number: ER8732) for covid-19 immunization. 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 vaccine within 4 weeks prior to covid-19 vaccination. On an unspecified date in May2021, the patient experienced right side weakness, tingling/ numbness in limbs, muscle twitches/ spasms, palpitations, dizziness, nerve, muscle & joint pain, altered sensations, heat & humidity intolerance, difficulty concentrating/ finding words, balance and gait issues, fine muscle movement issues-hands and blurring vision. AE resulted in: Doctor or other healthcare professional office/clinic visit. The event outcome was not recovered. No further information is expected. Follow-Up (15Jul2021): Follow-up attempts are completed. No further information is expected
22 2021-07-25 fibrin d dimer increased Developed chronic urticaria starting shortly after second dose. Demonstrates ongoing elevation of in... Read more
Developed chronic urticaria starting shortly after second dose. Demonstrates ongoing elevation of inflammatory markers and elevated d-dimer approx 2 months after 2nd dose of vaccine.
22 2021-07-25 palpitations Around 2-3 weeks after receiving the vaccine, I was sitting and noticed my heart was racing really f... Read more
Around 2-3 weeks after receiving the vaccine, I was sitting and noticed my heart was racing really fast. The next morning it did not stop. On 5/1, I went to a doctor who said I was having an anxiety attack and was sent home. On 5/2, I was having palpations around 145/150. I went to the ER and they took my blood, and did a chest X ray. I checked in with my primary care who said I might have PAP. I went to a cardiologist who did a stress test and a 2 week and 24hr Holter monitor. No conclusive results were found so they did a tilt table test with no conclusive results. An echo of my heart was also conducted. I also get fatigued easily, headaches, dizziness, and heat flashes. I was prescribed propranolol which I did poorly on so I was put on cardanol which seems to be helping.
22 2021-07-26 hypotension, fainting, skin turning blue PATIENT DID NOT FEEL ADVERSE EVENTS UNTIL AFTER SHE LEFT OUR FACILITY AND HAD BEEN HOME AT ONSET. AD... Read more
PATIENT DID NOT FEEL ADVERSE EVENTS UNTIL AFTER SHE LEFT OUR FACILITY AND HAD BEEN HOME AT ONSET. ADVERSE EVENTS INCLUDED FAINTING (WITH A FALL), LOW BLOOD PRESSURE (80s/60s; MEASURED AT HOME), AND BLUE COLORATION OF LIPS. PATIENT RECOVERED FROM FAINTING AND HAD DINNER. SHE SLEPT POORLY OVERNIGHT AND VOMITTED UPON WAKING UP THIS MORNING. SHE IS FEELING MUCH BETTER TODAY AND BLUE COLORATION OF LIPS IS COMPLETELY GONE. HOWEVER SHE CONTINUES TO BE HYPOTENSIVE.
22 2021-07-26 pulmonary embolism It took about 2.5 weeks for non-conclusive pulmonary embolisms to appear in both the right and left ... Read more
It took about 2.5 weeks for non-conclusive pulmonary embolisms to appear in both the right and left lungs
22 2021-07-27 chest discomfort Chills; Nausea; Vomiting; Heavy chest; Restlessness; Ache; This is a spontaneous report from a conta... Read more
Chills; Nausea; Vomiting; Heavy chest; Restlessness; Ache; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 01May2021 at 11:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included PCOS (polycystic ovarian syndrome), vulvodynia and COVID-19. Concomitant medications included paracetamol (TYLENOL), ibuprofen (MOTRIN), loratadine (MANUFACTURER UNKNOWN) and diphenhydramine hydrochloride (BENADRYL); for unknown indications and from an unknown date. Past drug history included any protein pump inhibitor, latex, cinnamon, coconut and berberine (MANUFACTURER UNKNOWN). Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 01May2021, the patient experienced chills, nausea, vomiting, heavy chest, restlessness and ache. The clinical outcomes of the events chills, nausea, vomiting, heavy chest, restlessness and ache were not recovered at the time of reporting. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
22 2021-07-27 chest pain When I take deep breath my chest hurts; Chills; Pain in the arm where I got the shot; Feeling cold; ... Read more
When I take deep breath my chest hurts; Chills; Pain in the arm where I got the shot; Feeling cold; This is a spontaneous report from a contactable consumer. A 22-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0185; Expiration Date: 01Aug2021, at the age of 22-year-old), dose 2 via an unspecified route of administration, administered in Arm Right on 19May2021 as dose 2, single for covid-19 immunisation. The patient medical history included pneumonia and covid both on an unspecified date in June2020 (Last year like around June. I did get COVID like the actual COVID and that gave me pneumonia but that was back in June. I was admitted to the hospital and they prescribed some medicines to take but I dont remember those. I am not taking those medication anymore) and concomitant medications were not reported. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0170; Expiration Date: unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 28Apr2021 as dose 1, single for covid-19 immunisation. The patient stated, she got second dose of Pfizer vaccine today, during the day she was fine but had some pain in the arm where she got the shot but right now when she took a deep breath her chest hurts. She had lot of chills and wanted to know if that was normal? She stated, she was around 160 pounds, she thought she gained weight, it's around there 160, 161. It's one of that two. Stated, no just a pain reliever for this, Acetaminophen, 500 mg, this is the first time that she took it today. She did take it around 4 pm, so this was her second one. The outcome of event for when I take deep breath my chest hurts was not recovered and for the other events it was unknown. Follow up needed, further information has been requested.
23 2020-12-31 chest discomfort About 15 minutes after receiving the vaccine, the patient complained about her left arm hurting. She... Read more
About 15 minutes after receiving the vaccine, the patient complained about her left arm hurting. She also complained of chest tightness and difficulty swallowing. Patient also had vision changes. We gave the patient 1 tablet of Benadryl 25 mg and called EMS services. EMS checked her out and we advised the patient to go to the ER to be observed and given more Benadryl. Patient was able to walk out of facility herself.
23 2021-01-04 chest pain After receiving the vaccine I had some left arm soreness. The pain increased throughout the day. Abo... Read more
After receiving the vaccine I had some left arm soreness. The pain increased throughout the day. About 12 hours after receiving the vaccine the pain in my left arm became severe. I experienced nausea, fever of 100, body aches, chills, headache, diarrhea, chest pain, and left hand numbness throughout the night and into the day following
23 2021-01-05 chest discomfort Developed chest tightness, sore throat, Wheezing and flushed face
23 2021-01-05 chest pain, hypertension About 15 minutes after receiving vaccine, patient started to have chest pain and high blood pressure... Read more
About 15 minutes after receiving vaccine, patient started to have chest pain and high blood pressure. Her blood pressure was 170/110 at 2:30 and then at 2:40 it was 130/110. She was feeling better and pulse was good around 2:45pm. She did take a Benadryl that was offered. She was not having any trouble breathing or dizziness. Patient went by EMS to get checked out and was cleared by the hospital staff.
23 2021-01-06 chest pain Itchiness, chest pain, cough, chills, sneezing, body aches, headaches, shortness of breath, fatigue ... Read more
Itchiness, chest pain, cough, chills, sneezing, body aches, headaches, shortness of breath, fatigue and spitting up flem.
23 2021-01-06 pallor, loss of consciousness, very slow heart rate RespDepression & Bradycardia Narrative: Pt escorted in wheelchair to extended monitoring room appro... Read more
RespDepression & Bradycardia Narrative: Pt escorted in wheelchair to extended monitoring room approx 8 min after injection of potential antigen. As pt entered doorway, her head hyperextended and she lost consciousness in wheelchair. Pulse not palpable. Pupils dilated. Administered EpiPen to right lateral thigh. Pt gained consciousness in wheelchair and was transferred to stretcher. Remained diaphoretic and pale. Placed on NC 2 L. After stabilized, transferred to ED.
23 2021-01-06 fast heart rate, pulmonary embolism Presented to ED 1/3/2021 Tachycardia, fever, headache and myalgia. Complaints of shortness of breath... Read more
Presented to ED 1/3/2021 Tachycardia, fever, headache and myalgia. Complaints of shortness of breath.
23 2021-01-07 heart rate increased Sore arm where vaccination was administered; Intermittent nausea; Increased heart rate; anxiety; Tir... Read more
Sore arm where vaccination was administered; Intermittent nausea; Increased heart rate; anxiety; Tiredness; This is a spontaneous report from a contactable nurse (Patient). A 23-year-old female patient received the first dose of bnt162b2 (PFIZER COVID 19 VACCINE, lot number: EH9899, Batch/lot number: EK5730 as reported), via an unspecified route of administration at Right arm on 16Dec2020 17:00 at a single dose for COVID-19 immunization. Medical history included General Anxiety Disorder, depression, and COVID-19. The patient had no known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO), levonorgestrel (NORTREL[LEVONORGESTREL]). The patient experienced sore arm where vaccination was administered, intermittent nausea for 3 days, increased heart rate and anxiety for 1.5 days, and tiredness; all on 16Dec2020. There was no treatment for the adverse events. The patient did not test positive for COVID post vaccination. The event Nausea recovered in 19Dec2020, while patient recovered from the other events in Dec2020. The vaccine was administered at the hospital. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events were considered as non-serious.
23 2021-01-08 nosebleed I was congested when I woke up the day after the vaccination. I blew my nose and my mucous was tinge... Read more
I was congested when I woke up the day after the vaccination. I blew my nose and my mucous was tinged red with blood. My mucous returned to normal after a couple of hours of being awake. I have no history of nosebleeds and have no other explanation for the nose bleed except a possible vaccination side effect.
23 2021-01-09 chest discomfort, fast heart rate Approximately 1 hour after receiving the vaccine I developed tachycardia that ranged between 130 a... Read more
Approximately 1 hour after receiving the vaccine I developed tachycardia that ranged between 130 and 95, this lasted from 01/08/2021 until 01/09 ~10 AM. On 01/08 ~5 PM I began to develop a fever that reached a peak of 102.4 at 4am (01/09), despite taking 1000 mg of acetaminophen every 6 hours. Last fever recorded 01/09 ~9PM of 99.5 (while still taking 1000 mg of acetaminophen every 6 hours). Additional symptoms have been severe nausea, dizziness, lightheadedness, bilateral lower back pain with some mild bruising to the kidney region, difficulty breathing, chest pressure, shortness of breath along with a cough upon exertion (developed ~6 PM 01/08), which is still present today (01/10 1:25 PM), and an erythematous rash that covers the anterior side of the right forearm, from wrist to elbow (first noticed on 01/10 ~11 AM).
23 2021-01-10 chest discomfort Headache, nausea, body aches, tightness of chest, shallow breaths/shortness of breath, light headed... Read more
Headache, nausea, body aches, tightness of chest, shallow breaths/shortness of breath, light headed, fatigue.
23 2021-01-10 palpitations Pt received dose at 0828 and after about 15 minutes reported symptoms of: Face numbness, lip tinglin... Read more
Pt received dose at 0828 and after about 15 minutes reported symptoms of: Face numbness, lip tingling, heart racing. A rash was also noted on her chest and perhaps to her right eye. Heart rate was 99 BPM and Pulse ox was 99%. Pt was transported to the ED for evaluation. Upon call back to ED they also stated pt reported her tongue was also affected (not swollen, but either numb or tingly).
23 2021-01-12 fainting, loss of consciousness Employee was awaken at 5:30 am on 1/13/2021 by chills and a feverish feeling. She then became nauseo... Read more
Employee was awaken at 5:30 am on 1/13/2021 by chills and a feverish feeling. She then became nauseous and faint. She passed out and was noted by her mother who is a RN to have a seizure. She remained out for several minutes and then aroused. She has remained groggy the rest of today but has improved. She has a history of non-epileptic seizures since she was 14 and has been on medications for this. Employee stated she has not has any seizure activity in over a year. She did not see medical attention due to recovering quickly from this.
23 2021-01-13 fast heart rate Within 8 minutes of vaccination, the patient began to experience tachycardia with heart rate 130s. ... Read more
Within 8 minutes of vaccination, the patient began to experience tachycardia with heart rate 130s. This steadily improved over 5 minutes. About 10 minutes later, patient reported unilateral paresthesias. Taken to ED for observation. No shortness of breath. Noted with a patchy rash to right shoulder extending to right side of neck and face. Given Benadryl 25 mg IV, famotidine 20 mg IV and solumedrol 125 mg IV. Rash resolved.
23 2021-01-13 dilation of blood vessels Per MD Vasodilation reaction occurred, could of been anything.
23 2021-01-14 increased heart rate sinus tachycardia for 2 hours, rate up to 171. required ER visit for 2.5 hours. associated dyspnea a... Read more
sinus tachycardia for 2 hours, rate up to 171. required ER visit for 2.5 hours. associated dyspnea and delayed onset rash later in day. Not given epinephrine. treated with IV saline and observation. Symptoms began within 1 minute of administration of IM vaccine
23 2021-01-17 chest discomfort Patient with chest tightness, generalized fatigue, and mild shortness of breath 24 hours after recei... Read more
Patient with chest tightness, generalized fatigue, and mild shortness of breath 24 hours after receiving the COVID-19 vaccine We will obtain chest x-ray, EKG, and lab work All results reviewed in detail and with the patient Patient states that she is feeling better and she is pleased at the results Patient's oxygen saturation is 99 to 100% throughout her ED course
23 2021-01-18 blood glucose increased Blood glucose levels increased about 3 hours post vaccination and continued to be elevated, despite ... Read more
Blood glucose levels increased about 3 hours post vaccination and continued to be elevated, despite correction insulin administered, for around 36-48 hours. About 12 hours post vaccination had chills/shaking for around 30 minutes to an hour.
23 2021-01-18 chest pain, chest discomfort Received the vaccine at 10:52am, and was observed for 15 minutes in the clinic. After leaving the c... Read more
Received the vaccine at 10:52am, and was observed for 15 minutes in the clinic. After leaving the clinic, she noted slight shortness of breath on her way to her car a few blocks away. While in the car on the way home around 11:57am, she developed severe headache, nausea, chest pain, chest tightness and shortness of breath. Chest tightness is "terrible." History of asthma but has no recent exacerbation in last 3 years. Referred to urgent care at Cancer Center, which has emergency room capabilities.
23 2021-01-18 heart rate increased Second COVID injection at 1330 on 2/18/21. During her wait period, after receiving the shot, she wa... Read more
Second COVID injection at 1330 on 2/18/21. During her wait period, after receiving the shot, she was lightheaded, dizzy, felt like she would pass out. Observers noted that her skin was very flushed and her heart rate was greater than 100. Current symptoms are lightheadedness, dizziness with a sensation like the room is spinning, severe nausea, and generalized malaise.
23 2021-01-18 fainting Per email received on 1/18-So I had my first dose of Pfizer?s covid vaccine last Friday (3pm). I exp... Read more
Per email received on 1/18-So I had my first dose of Pfizer?s covid vaccine last Friday (3pm). I experienced several side effects that day: lightheadedness, dizziness, fainting, nausea, throat constriction leading to shortness of breath and difficulty in swallowing, hives, flushed face, and fatigue. The throat constriction honestly frightened me and I almost went to the ER, but it eventually went away. For Saturday and Sunday, I developed fever, muscle ache, and extreme fatigue. Today, I thought it would get better but I still have fever and the extreme fatigue has not gone away. And unfortunately, as I am typing this, I think my tongue is getting quite swollen and is making it uncomfortable to breathe and swallow
23 2021-01-18 fast heart rate The patient presented to the Emergency Department for evaluation after receiving her second Pfizer v... Read more
The patient presented to the Emergency Department for evaluation after receiving her second Pfizer vaccine for COVID-19. She reports that after the first vaccine she became tachycardic and lightheaded with symptoms resolving. About 30 minutes after receiving the 2nd dose of the vaccine she started to notice difficulty forming words, difficulty walking and feeling generally tired. Two hours after vaccine, patient arrived to Emergency Department with chief complaints of altered mental status altered sensorium and difficulty ambulating. Had difficulty word finding, speaking, ambulating altered sensation in her hands and feet.
23 2021-01-19 excessive bleeding Bleeding Upon injection Bruised skin lasting greater than 14 Days. Bruise at time of entry. Hardness... Read more
Bleeding Upon injection Bruised skin lasting greater than 14 Days. Bruise at time of entry. Hardness on injection side lasting 14 days+ Soreness lasting 14+days
23 2021-01-20 fibrin d dimer increased, chest pain Patient developed intermittent chest pain 2 days after receiving her 2nd dose of Pfizer covid vaccin... Read more
Patient developed intermittent chest pain 2 days after receiving her 2nd dose of Pfizer covid vaccine. She was seen in the ER on 1/17/2021. Pt improving. Seen for follow up by PCP on 1/19/21. Pt called office on 1/21/2021 - ongoing intermittent chest pain. Will see Cardiology.
23 2021-01-20 heart rate increased After sitting about 15 minutes, felt a bit dizzy. States had minimal breakfast; had water, oj, crack... Read more
After sitting about 15 minutes, felt a bit dizzy. States had minimal breakfast; had water, oj, crackers. Pulse device on arm showed HR 145; refused BP initially. Feeling better after po intake; still reports "shaky". Agreeable to VS: BP 122/80; HR 100. Continued sitting for 10-15 minutes and drinking water. Feels comfortable leaving; works in hospital and escorted to floor. Will be eating snack once back at work.
23 2021-01-21 chest pain Injection site soreness/muscle pain - ongoing soreness Tiredness - general tiredness/fatigue Headach... Read more
Injection site soreness/muscle pain - ongoing soreness Tiredness - general tiredness/fatigue Headache - started morning after vaccination Chills - lasted a couple hours before fever started Fever - started after chills subsided Chest pain - lasted a couple hours simultaneously with chills
23 2021-01-21 fast heart rate About 15 minutes after vaccination, patient began to experience lightheadedness and numbness, tingli... Read more
About 15 minutes after vaccination, patient began to experience lightheadedness and numbness, tingling and itching to her face. Vital signs showed tachycardia, but otherwise normal. Taken to ED and noted with rash to chest and neck. Given Benadryl 50 mg IV, famotidine 20 mg IV and solumedrol 125 mg IV in ED. The rash and lightheadedness resolved. Home with Benadryl 25 mg PO TID PRN, prednisone 60 mg daily x 3 days and famotidine 40 mg PO at HS.
23 2021-01-21 fast heart rate About 15 minutes after vaccination, patient began to experience lightheadedness and numbness, tingli... Read more
About 15 minutes after vaccination, patient began to experience lightheadedness and numbness, tingling and itching to her face. Vital signs showed tachycardia, but otherwise within normal limits. Taken to ED and noted with a rash to chest and neck. Given Benadryl 50 mg IV, famotidine 20 mg IV and solumedrol 125 mg IV. Symptoms resolved. Discharged with Benadryl 25 mg PO TID PRN, famotidine 40 mg PO at HS and prednisone 60 mg daily x 3 days.
23 2021-01-24 chest pain 10 minutes after the vaccine was administered i had an allergic reaction, headache, a fever and pain... Read more
10 minutes after the vaccine was administered i had an allergic reaction, headache, a fever and pain in the arm where the vaccine was put. The next day I woke up with faint symptoms of covid 19, pain in the chest, a little difficulty breathing, headache, dry cough and diarrhea. After a couple of days everything was fine.
23 2021-01-25 chest discomfort Intense lower/middle back pain; Chest tightness; This is a spontaneous report from a contactable oth... Read more
Intense lower/middle back pain; Chest tightness; This is a spontaneous report from a contactable other healthcare professional reporting for herself. A 23-year-old female patient received first dose of bnt162b2 (BNT162B2, lot number: EJ1686, expiry date: not reported), via an unspecified route of administration, on 12Jan2021 12:30 PM, at a single dose on left arm for COVID-19 immunization. The patient received the vaccine at a hospital. The patient was not pregnant. Medical history was not reported. The patient had no known allergies. Concomitant medications included sertraline (other medications in two weeks). The patient previously received another vaccine within 4 weeks, flu vaccine on 06Jan2021. On 12Jan2021 09:30 PM, the patient experienced intense lower/middle back pain and chest tightness. The patient was not diagnosed with COVID prior to vaccination and was not tested for COVID post vaccination. The patient received no treatment. Outcome of the events was recovering.
23 2021-01-26 chest pain Migraine afternoon of 1/25/2021. She then experienced feelings of nausea, mouth-watering, feeling o... Read more
Migraine afternoon of 1/25/2021. She then experienced feelings of nausea, mouth-watering, feeling overheated. While resting during the onset of these symptoms she then felt like she couldn't breath, experiencing pain in the sides of her chest. The next symptoms that occurred were angioedema to the face, she described her eyes getting so puffy she couldn't see. She also described her skin getting reddened and itching all over. She took Benadryl at home and started to feel better in about 1 hour.
23 2021-01-27 heart rate increased elevated heart rate at rest. It's usually 80-90 at rest and now it's 130 and it's been like this for... Read more
elevated heart rate at rest. It's usually 80-90 at rest and now it's 130 and it's been like this for 2 to 3 hours.; received other vaccine at first dose in right arm on the same date; This is a spontaneous report from a non-contactable consumer (patient). A 23-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in right arm on 15Jan2021 at 12:00 PM at a single dose for COVID-19 immunization. Medical history reported as none. The patient has no known allergies. The patient also received other vaccine at first dose in right arm on the same date. On 16Jan2021 at 05:00 PM (17:00), the patient experienced elevated heart rate at rest. It's usually 80-90 at rest and now it's 130 and it's been like this for 2 to 3 hours. The patient did not receive treatment for the event. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient had not yet recovered from the event elevated heart rate at rest. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
23 2021-01-27 loss of consciousness The evening after I got the first dose I experienced painful muscle aches starting in my legs and pr... Read more
The evening after I got the first dose I experienced painful muscle aches starting in my legs and progressing to the rest of my body, around 7pm. My left shoulder was a little achy, but no different than any other shot. About 30 minutes later I felt chills and felt really cold. I went to bed and tried to sleep. I woke up several times in pain. I did not take any pain meds. At 1am I went to the bathroom and felt nauseous and lightheaded. My vision got blurry and it felt like I was going to pass out, so I grabbed the towel rack and closed my eyes. I must have blacked out for a second and lowered myself down to the floor. I came to, and I was sitting on the ground, sweating a lot. I stayed on the floor for at least 10 minutes cooling down. (I had dressed warmly and turned on my heater after the chills started). I heard ringing in my ears while I was sitting on the floor. It went away after 5 minutes. I got up and went back to bed. I woke up at 9am and felt a lot better. Some minimal soreness. No more chills.
23 2021-01-29 chest pain Both my first and second vaccines I have and am now experiencing heart problems and troubles breathi... Read more
Both my first and second vaccines I have and am now experiencing heart problems and troubles breathing. I'm having chest pain and my arm feels like the achy pain of putting ice on a broken bone. The first vaccine I felt the pain start in my collar bone in the vein and move down. 2nd vaccine I feel like I've been running a marathon and feel pain in my chest. Fatigue both times.
23 2021-01-31 chest discomfort, pulse abnormal, chest pain Symptoms: 01/29/2021 @ 11:21 AM: Shortness of breath, chest pain, and weakness. Two hours later, c... Read more
Symptoms: 01/29/2021 @ 11:21 AM: Shortness of breath, chest pain, and weakness. Two hours later, chest pain began to feel like chest tightness. Continued for the rest of the day. 01/30/2021: Mild irritation when breathing. Getting out of breath when minimal effort in an activity. A sensation of an increased heartbeat when in reality, it would be 92 BMP. General weakness and dizziness. 01/31/2021: Same symptoms as mentioned. While taking a deep breath, I feel a mild pain around my heart.
23 2021-02-01 chest discomfort I received the COVID19 vaccine on January 22, 2021. I started to have chest tightness and somewhat o... Read more
I received the COVID19 vaccine on January 22, 2021. I started to have chest tightness and somewhat of a dry cough midday on Monday January 25, which continued until January 27. I started having congestion and runny nose on January 27, so I went and got tested for COVID on the 27. The test came back positive on January 28. On January 28 I had extreme congestion and head pressure, a bad burning sensation from my left sinus that went back to my left 2nd molar, and a runny nose. I had not gone anywhere the week prior due to studying for an exam besides to lab at school twice where everyone was socially distanced and was wearing a mask the whole time. The highest my temperature got was 99.4 with Tylenol on January 28. In addition to this, my husband got covid tested on January 28 to see if he had it, or had given covid to me and his test came back negative. We had not socially distanced and still had physical contact the entire time, and continued not to do so in our house. We have had full contact the entire time because he is working from home and most of my school is online, and he got tested again on January 30 and came back negative again. If somehow I got covid from school in a short amount of time with everyone wearing a mask, how would he not get covid from me after a full week of exposure unless I was not contagious, which makes me think I somehow got it from the vaccine. I have had adverse reactions to vaccines in the past, as I got the shingles when I was 4 as a direct result from the first chickenpox vaccine.
23 2021-02-01 heart rate increased symptoms occurred at home with following symptoms dizziness, fast heart beat (120-125) all day, gene... Read more
symptoms occurred at home with following symptoms dizziness, fast heart beat (120-125) all day, generalized body aches, pressures and tightness/numbness on the back of head. Took Tylenol 48hrs. HR still occasionally goes up. Both arms and hands occasionally goes numb with a shock feeling and drops things. PCP follow up appt 2/2. 2nd dose was in 2nd arm.
23 2021-02-02 loss of consciousness 5-10 minutes post injection, pt reported "I don't feel well" States feels hot/nauseous/weak. Assis... Read more
5-10 minutes post injection, pt reported "I don't feel well" States feels hot/nauseous/weak. Assisted to chair. Had brief (15-20 second) episode of stiffening, apnea, dusky coloring, arched back with stiff extremeties and shaking and loss of consciousness. Spontaneous respirationss returned when stiffness/arching ended, with slow return of pale/pink skin coloring. Able to converse. Remained dizzy, diaphoretic. During event pulse thread and fast. BP 84/42 post return of consciousness. 911 called. Patient transferred via EMS to ER.
23 2021-02-03 chest discomfort Time: 6 pm; Feb 4 1. Patient HR: 120. BP 131/109 2. Patient complains of neck tightening - My team ... Read more
Time: 6 pm; Feb 4 1. Patient HR: 120. BP 131/109 2. Patient complains of neck tightening - My team immediately lowered from sitting position to lying down with legs bended. Patient feels very unease, confused, disoriented Patient complained of flickering eyes and yellow lights (was staring at overhead ceiling lights yellowish in color) Patient complained of hot chest after 10 minutes
23 2021-02-03 chest pain Injection Site Pain/Muscle Pain- ongoing soreness; Injection Site Pain/Muscle Pain- ongoing soreness... Read more
Injection Site Pain/Muscle Pain- ongoing soreness; Injection Site Pain/Muscle Pain- ongoing soreness; General Fatigue; Headache; Chills; Chest Pain; Fever; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself. A 23-year-old female patient received second dose of bnt162b2 (manufacturer: Pfizer, lot number and expiration date: unknown), via an unspecified route of administration on her left arm on 21Jan2021 09:45 at single dose for covid-19 immunization. The patient's medical history included anaemia from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took the first dose of bnt162b2 on 02Jan2021 for covid-19 immunization. On 22Jan2021 at 00:30, the patient experienced injection site pain/muscle pain-ongoing soreness, general fatigue, headache, chills, chest pain, and fever. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. Information on the lot/batch number has been requested.
23 2021-02-04 heart rate increased, palpitations After the vaccine was given, Patient stated her heart became racing. Pulse taken at the time listed... Read more
After the vaccine was given, Patient stated her heart became racing. Pulse taken at the time listed it as 180. Patient also said she felt like she could not talk as if the words would not come out. She felt like she could not feel her arms and legs and felt numbness in her chest. Dizziness also occurred. Vision became blurry. That night after being released from the hospital she still had trouble walking . To this day she suffers from intense brain fog. She says she has so much to say but it wont come out. She still is having trouble walking, her gait is very unsteady. She finds herself unable to work like before and suffers from confusion.
23 2021-02-04 hypertension, fast heart rate Approximately 28min after vaccine administration, pt. was noted to have red/swollen face & SOB. Pt r... Read more
Approximately 28min after vaccine administration, pt. was noted to have red/swollen face & SOB. Pt reported hx of severe asthma. Epi pen administered by clinic RN and pt took own albuterol inhaler at 1322. 911 called. pt reported some improvement of SOB after meds, but continued w/cough and increased work of breathing. VS showed tachycardia and hypertension after epi administration. Pt reported improvements in face swelling and throat tightness after epi administration but still appeared to have labored and tachypneic breathing despite O2 sats 98-100%. Pt placed on 2L O2 via face mask to decrease work of breathing. Pt remained A&O, but developed rigors after epi administration. Paramedics and EMS arrived at approx 1328. Pt was subsequently transported to ED for further eval per EMS report.
23 2021-02-04 palpitations Pt was in observation after her COVID administration. She began to feel lightheaded, felt her heart... Read more
Pt was in observation after her COVID administration. She began to feel lightheaded, felt her heart was racing. She denied SOB, sensation of throat swelling, sense of impending doom. She reported she had not eaten for hours and felt "very hungry." She was offered juice but she states she does not drink juice. She was sipping water. She ate some crackers. Feet were elevated upon encountering pt. She was with her partner. Initial vitals: Pulse 58 O2 sat 100% BP 80/52 (pt reports her BP always "runs low") 5:35 pm vitals: Pulse 55 O2 sat 100% BP 96/70. Pt reports she is at baseline. Continued to report she felt she had worked herself up into an "anxiety attack." Pt left facility with her partner eager to "go eat." She had all contact information if she has any other sxs. Pt was in observation after her COVID administration. She began to feel lightheaded, felt her heart was racing. She denied SOB, sensation of throat swelling, sense of impending doom. She reported she had not eaten for hours and felt "very hungry." She was offered juice but she states she does not drink juice. She was sipping water. She ate some crackers. Feet were elevated upon encountering pt. She was with her partner. Initial vitals: Pulse 58 O2 sat 100% BP 80/52 (pt reports her BP always "runs low") 5:35 pm vitals: Pulse 55 O2 sat 100% BP 96/70. Pt reports she is at baseline. Continued to report she felt she had worked herself up into an "anxiety attack." Pt left facility with her partner eager to "go eat." She had all contact information if she has any other sxs.
23 2021-02-04 palpitations 41 hours after vaccine, I woke up to my heart pounding and I was trembling like I was having an anxi... Read more
41 hours after vaccine, I woke up to my heart pounding and I was trembling like I was having an anxiety attack; 41 hours after vaccine, I woke up to my heart pounding and I was trembling like I was having an anxiety attack; This is a spontaneous report from a non-contactable consumer. A 23-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL3247), via an unspecified route of administration on 19Jan2021 00:30 at SINGLE DOSE at right arm for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took amoxicillin and experienced Allergy. On 21Jan2021 05:30, 41 hours after vaccine, I woke up to my heart pounding and I was trembling like I was having an anxiety attack. I was not anxious. I called my doctor. The patient did not receive treatment for the events. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
23 2021-02-08 increased heart rate, fast heart rate Nausea prior to going to bed awakened by tachycardia, found to be sinus tachycardia in ED, respondin... Read more
Nausea prior to going to bed awakened by tachycardia, found to be sinus tachycardia in ED, responding to IV fluids No fever, headache, rash or hypotension
23 2021-02-09 inflammation of the pericardium, chest pain Woke up day after with a slight pain in chest. As day progressed pain became much worse and when t... Read more
Woke up day after with a slight pain in chest. As day progressed pain became much worse and when tried to lay down to sleep could not. Breathing in caused pain as well. She went to ER and was diagnosed with Acute Pericarditis. Was in ER for 4 hours and sent home on oral Ibuprofen 600 mg.
23 2021-02-10 fainting After being vaccinated and while waiting in the observation area, I began to feel hot and light head... Read more
After being vaccinated and while waiting in the observation area, I began to feel hot and light headed. I fainted about 15 minutes after sitting down in the waiting area and upon fainting hit my head on the floor. I regained consciousness while laying on the floor getting my vitals taken by staff. Because of the minor head injury and proximity to getting the vaccine, I accepted being taken to the ER.
23 2021-02-11 heart rate increased PT reports localized reaction started within a few hours, consisting of redness, swelling, and tende... Read more
PT reports localized reaction started within a few hours, consisting of redness, swelling, and tenderness, at injection site. Within 12 hours after 2nd dose, PT reported increased HR (reports HR baseline of ~60 and noted it would go up to 150 with ADL's; denied chest pain), excessive fatigue/tiredness (slept 18 hours), chills with occasional rigors (improved sometime on 2/11/21, but reports occasional "hot flashes" continue through today), felt feverish (did not temp; temp on 2/12/21 at time of report 99.4 to 100.0), muscle/body aches (improving), dull frontal headaches (continues), and swollen tonsillar lymph nodes (no change)all s/s lasting through time of report. Injection site redness (LA) observed 2/12/21 at 0915 and remains
23 2021-02-11 lightheadedness Patient received the Covid-19 vaccine. She reports symptoms of Vasovagal with dizziness and dark spo... Read more
Patient received the Covid-19 vaccine. She reports symptoms of Vasovagal with dizziness and dark spots in visual field. She stated 10 minutes after the vaccine she noticed symptoms. . Pt stated she had the same reaction with her first dose and felt fine an hour later. Pt was assisted to lay down flat on bed at 1225. She stated she felt warm at 1230. At 1235 she reports the dizziness has stopped. Treatment/intervention Pt was given crackers and water at 1210 and again at 1230. Patient was monitored and was vitals were taken every ten minutes. Staff reintroduced her to sitting up and raising HOB in intervals of 15 degrees. All interventions were tolerated well. Pt stated at 1255 she felt better sitting upright in the chair. At 1300 she was accompanied by staff to her vehicle were a driver was waiting for her. She stated at that time all symptoms had resolved and she would contact her PCP to notify them of her reactions to the vaccine. See vitals in documentation. Patient received the Covid-19 vaccine. She reports symptoms of Vasovagal with dizziness and dark spots in visual field. She stated 10 minutes after the vaccine she noticed symptoms. . Pt stated she had the same reaction with her first dose and felt fine an hour later. Pt was assisted to lay down flat on bed at 1225. She stated she felt warm at 1230. At 1235 she reports the dizziness has stopped. Treatment/intervention Pt was given crackers and water at 1210 and again at 1230. Patient was monitored and was vitals were taken every ten minutes. Staff reintroduced her to sitting up and raising HOB in intervals of 15 degrees. All interventions were tolerated well. Pt stated at 1255 she felt better sitting upright in the chair. At 1300 she was accompanied by staff to her vehicle were a driver was waiting for her. She stated at that time all symptoms had resolved and she would contact her PCP to notify them of her reactions to the vaccine. See vitals in documentation. - Documented by MA in electronic medical record
23 2021-02-12 pallor, lightheadedness, blood pressure decreased 5 minutes after receiving injection pt. became light headed, c/o blurry vision, nausea and pale. No ... Read more
5 minutes after receiving injection pt. became light headed, c/o blurry vision, nausea and pale. No LOC. PM Hx negative, NKA, taking no meds. On exam, pale, HR 60, BP 90/62, HeartS1, S2, RRR, Lungs CTA bilat. Post 15 min. BP 122/78, O2sat 98. A/P Vasovagal post vaccine. Good response to supine position, cold room and water. Pt. left to home with friend. Informed pt. to contact PCP. Notes by doctor Low who examined pt. on site.
23 2021-02-14 chest pain Patient reports having pain in left side of chest when breathing in deep or laughing that started 3 ... Read more
Patient reports having pain in left side of chest when breathing in deep or laughing that started 3 days after receiving the vaccine.
23 2021-02-16 chest pain Chest pain
23 2021-02-17 chest discomfort, blood pressure increased Felt like her throat was closing and was having check tightness in the lower rib area. Her heartrate... Read more
Felt like her throat was closing and was having check tightness in the lower rib area. Her heartrate was 136 and an elevated blood pressure (149/112). Went to the ER for further care.
23 2021-02-18 hypotension Suddenly low blood pressure, resulting in headache, dizziness, weakness, difficulty seeing, feeling ... Read more
Suddenly low blood pressure, resulting in headache, dizziness, weakness, difficulty seeing, feeling short of breath, and feeling faint.
23 2021-02-19 blood pressure increased, hypertension Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Hypertension-Mild, Sy... Read more
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Hypertension-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient received Pfizer Covid vaccine today and presented with swollen, tingling, itchy lips within 15 minutes of the dose. Benadryl administered to patient. 911 was called and paramedics arrived. Patient's friend returned to let us know that patient was being monitored at the ER for the next 6 to 7 hours and was doing alright. Mildly elevated blood pressure here and at ER.
23 2021-02-19 hypertension Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of... Read more
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Hypertension-Mild, Additional Details: Pt presented with swollen lips within 15 minutes of vaccination. Benadryl administered. 911 called and paramedics arrived to take to local ER. Patient's friend returned and said patient was being monitored at the ER for the next 6 to 7 hours.
23 2021-02-20 chest discomfort 29 minutes after being given the vaccine my tongue started itching and swelled up a bit, my mouth fe... Read more
29 minutes after being given the vaccine my tongue started itching and swelled up a bit, my mouth felt dry, my face became a bit reddened, puffy, and itchy, my throat began to swell a bit and my chest felt tight, giving me some discomfort when it came to breathing. I let the nurses who were keeping an eye on those waiting for 15/30 minutes know that I was having a reaction. I waited 1 more minute, and when my throat felt tighter and I had a bit more difficulty breathing, I took 1 Benadryl tablet, and waited 2 minutes, and when the symptoms were still worsening slowly, I took a second Benadryl tablet and after a few minutes my symptoms started to go away. I waited another 10 minutes and then went home when it seemed that my symptoms were going away. At 6:45pm on 2/21/2021 my throat and chest started feeling tight again and gave me mild breathing discomfort, so I took another Benadryl tablet, a few minutes later my face began to itchy and my mouth felt dry and my tongue felt a bit swollen, whereupon I took a second Benadryl tablet at 6:56pm, and then felt a wave of nausea. At 6:59pm, the feeling of tightness had not abated, but also hadn't worsened noticeably, and the itching feeling began to spread from my face to my ears and down my neck. At 7:04pm the tightness of my throat and chest began to increase some, and I started to feel some anxiety. At 7:11pm I inhaled two puffs from an albuterol inhaler used for treating asthma as my throat and chest were continuing to slowly get tighter. At 7:26pm I still felt itchy and my throat and chest still felt tight, but it wasn't noticeably worse. At 7:35pm, my throat began to feel tight enough to give me noticeable discomfort while breathing and for me to make a slight wheezing sound while breathing, and my tongue felt like it swelled a bit more, and my mouth still felt dry. At 7:51pm the Benadryl made me feel sleepy, but had no effect on my itchy skin or tightness of throat or chest. 8:00pm, my throat and chest felt tighter and I started having some difficulty swallowing and I felt very warm. 8:05pm, I had a lot of difficulty swallowing and had trouble breathing, so I went to the Emergency Room and was given an Epinephrine shot and sent home after an hour of observation.
23 2021-02-28 chest pain After my first dose, I had a sore arm for a few days. After my second dose, I had a sore arm for the... Read more
After my first dose, I had a sore arm for a few days. After my second dose, I had a sore arm for the rest of that day, and the next day I experienced many symptoms. In the morning, I was extremely tired and nauseous. By the afternoon, I had a headache and my whole body ached. In the evening, my injection arm was swollen and red, and my chest ached and made it harder to breath or sit up. I was bed ridden and unable to get up for a couple hours because it hurt too much. After some rest, water, and aspirin, I was able to get up late that night the day after my second dose. Two days after my second dose, I felt much better without any symptoms.
23 2021-02-28 heart rate increased, pallor, loss of consciousness Within 10 minutes of receiving the vaccine, developed "blackening" vision and then lost consciousnes... Read more
Within 10 minutes of receiving the vaccine, developed "blackening" vision and then lost consciousness. Uncertain about time of loss of consciousness. Other symptoms included pallor, fast heart rate, sweating, nausea and loss of bladder function. No treatment required, seen in the ED and recovered without treatment. Because she was driving a car at the time, she rear-ended the car in front of her and the airbags deployed. Underwent evaluation for motor vehicle accident as well in the ED with no injuries noted.
23 2021-02-28 fainting, hypotension Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mil... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Additional Details: @~1415 HR 63 BP 118/58; @~1430 BP128/92; @~1445 HR 71 BP: 127/87; Pt had gotten up to walk around store (stated she hadn't had an allergic reaction or fainted with a vaccine before), came back within 5 min and stated she was feeling hot, temp was 96.8. I asked pt to sit down and on her way over she fainted; denied hitting her head, only her arm. Responded almost immediately, proceeded to take vitals and monitored.
23 2021-03-01 heart rate increased, chest discomfort elevated HR, Chest pressure. HR still approx 125. -Evaluated by EMS- Cleared
23 2021-03-01 fluid around the heart, troponin increased, low blood oxigenation, ejection fraction decreased 24 y.o. female with no significant past medical history who was diagnosed with COVID-19 (NP PCR on 1... Read more
24 y.o. female with no significant past medical history who was diagnosed with COVID-19 (NP PCR on 1/27/2021) with mild symptoms (3-4 days of rhinorrhea and myalgia) and complete recovery with return to work who recently completed COVID-19 vaccine series (Pfizer 1/8/2021, 2/5/2021) now presenting for hospitalization (2/26/2021) with fever, rapidly progressive hypoxia, and hyperinflammatory state including elevated ESR, CRP, ferritin, D-dimer, and troponin (20) in the setting of positive COVID-19 NP PCR (2/26/2021) and positive S.pneumoniae urine ag with clinical diagnosis of MIS-A s/p high dose methylprednisolone and IVIG.
23 2021-03-02 chest pain Patient experienced nausea, vomiting, chest pain and seizures (history of seizures but experienced i... Read more
Patient experienced nausea, vomiting, chest pain and seizures (history of seizures but experienced it more strongly after the shot)
23 2021-03-05 loss of consciousness Patient reports a history of syncope with any sort of injection or vaccine. Five minutes after recei... Read more
Patient reports a history of syncope with any sort of injection or vaccine. Five minutes after receiving her vaccine, she felt lightheaded and lost consciousness for a few seconds. Prior to losing consciousness she asked for assistance and somebody held her up when she lost consciousness. She did not hit the ground or otherwise injure herself. Upon awakening, she was fully alert and oriented and denied any chest pain or shortness of breath. Drank Gatorade. Felt better with no recurrence after observation period.
23 2021-03-07 chest discomfort, loss of consciousness, blood pressure increased pt felt dizzy and almost passed out and couldnt walk bp went up felt like something was sitting on... Read more
pt felt dizzy and almost passed out and couldnt walk bp went up felt like something was sitting on my chest passed out and coworkers called 911 she could hear them talk but couldnt respond nausea
23 2021-03-08 loss of consciousness, heart rate increased patient became lethargic and briefly passed out 1 minute after receiving vaccine. Patient did not h... Read more
patient became lethargic and briefly passed out 1 minute after receiving vaccine. Patient did not have swelling or breathing problems so an epinephrine pen was not needed. Patient became sweaty and had muscle rigidity of her hands and arms. Patient had rapid heart rate and extreme exhaustion. Ambulance was called and patient care was passed off to the EMTs and the hospital.
23 2021-03-08 fainting Snycopal episode immediately following vaccination, patient was lowered to floor, BP slightly low at... Read more
Snycopal episode immediately following vaccination, patient was lowered to floor, BP slightly low at 92/40. Patient diaphoretic, brought to cot. Evaluated client after fifteen minutes, sent home via medical transport.
23 2021-03-09 chest pain, blood glucose increased Chest hurting, exhaustion, high blood sugars, nausea, headache
23 2021-03-09 chest pain Patient complained of itching all over, coughing, dizziness and chest pain. Happened about 7 minutes... Read more
Patient complained of itching all over, coughing, dizziness and chest pain. Happened about 7 minutes after her first dose of the Pfizer vaccine. Vital signs were within normal range while evaluating her. EMS was called but patient refused to go to the hospital. She stayed for a hour, while constantly being evaluated.
23 2021-03-10 fainting Syncope, nausea Refused Benadryl PO Pepcid, 20 mg given @ 0910
23 2021-03-12 fast heart rate nausea, tachycardia given water, waited until sx subsided
23 2021-03-13 chest discomfort started as itching on neck, then progressed to coughing and chest tightness approx 1 hour after rece... Read more
started as itching on neck, then progressed to coughing and chest tightness approx 1 hour after receiving the vaccine, then progressed to shortness of breath. Benadryl given initially. epidural pen used with progression of symptoms, as well as Pepcid and prednisone.
23 2021-03-13 cardiac arrhythmia ?Pfizer-BioNTech COVID-19 Vaccine Began shortly after injection. Fatigue, confusion (minor), Inject... Read more
?Pfizer-BioNTech COVID-19 Vaccine Began shortly after injection. Fatigue, confusion (minor), Injection site pain (moderate to severe, mild with tylenol, ice, and heat), increased cardiac PVCs.
23 2021-03-14 chest discomfort, pallor, chest pain At approx. 0855, pt reported feeling "lightheaded, nervousness, and I feel hot internally"; RN obser... Read more
At approx. 0855, pt reported feeling "lightheaded, nervousness, and I feel hot internally"; RN observed pt's bilat hand/legs shaking, pt eating/drinking water and pt appears pale; pt denies dyspnea, difficulty swallowing; pt alert and oriented x 4. Vitals taken and pt remained in observation with RN. At approx. 0905 RN obtained 2nd vitals; vitals WNL. RN observed pt to no longer have hand/leg shaking and skin color is back to pt's normal. Pt denies all other symptoms. At approx. 0915, pt states "I feel fine to go now." Pt then stays in observation and takes a phone call and continues to eat/drink. At approx. 0923 Pt reports to RN "My chest feels tight, like a stabbing pain." Pt denies dyspnea, anxiety, difficultly swallowing. ER team was paged to assist. RN obtained 3rd set of vitals. At approx. 0933 Pt reports worsening symptoms: stabbing in chest but non-radiating, lightheaded, memory fog, severe headache, hands/legs shaking uncontrollably; Pt is alert and oriented x 3 and is again, pale. At approx. 0936 ER team arrived and spoke with pt; ER did not assess/treat pt but did speak with pt. Pt denied further assessment, refused to be evaluated in ED and declined to allow this RN to contact her emergency contacts at approx. 0940. ER Team left scene at approx. 0943 and at that time pt reports she will drive herself home. At approx. 0947, pt left CENTER
23 2021-03-14 lightheadedness vasovagal reaction (i.e., dizziness, ringing in ears, feeling faint); vasovagal reaction (i.e., dizz... Read more
vasovagal reaction (i.e., dizziness, ringing in ears, feeling faint); vasovagal reaction (i.e., dizziness, ringing in ears, feeling faint)/prior instances of vasovagal reaction to getting a shot; This is a spontaneous report from a contactable consumer. A 23-year-old female patient (reporter's daughter) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN6202), via an unspecified route of administration on 26Feb2021 15:30 (at 23-years-old) at single dose (Left arm) for COVID-19 immunization. Facility type vaccine: Public Health Clinic facility. Medical history included asthma and prior instances of vasovagal reaction to getting a shot. Known allergies included sulfa drugs, penicillin, and amoxicillin. Patient had no COVID prior vaccination. Patient is not pregnant. Concomitant medication included ethinylestradiol, norgestimate (SPRINTEC), clindamycin (manufacturer unknown), triamcinolone acetonide (manufacturer unknown), tretinoin (RETIN-A), and multivitamin. Within 5 minutes on 26Feb2021 (also reported to be 03:30 PM) of receiving the vaccination, she experienced a vasovagal reaction (i.e., dizziness, ringing in ears, feeling faint). She immediately laid on the floor and the symptoms resolved within 15 minutes. No treatment was given. Patient was not COVID tested post vaccination. The outcome of the events was recovered on 26Feb2021.
23 2021-03-15 fast heart rate, pallor, hypertension, chest discomfort 23 yo F with h/o POTS who was feeling fine until about 25 minutes after the vaccine at which time sh... Read more
23 yo F with h/o POTS who was feeling fine until about 25 minutes after the vaccine at which time she developed shortness of breath, chest tightness, flushing sensation, lightheadedness with sense of impending doom and abdominal cramping. Reported she felt similar to when her POTS flares up, but that only occurs with standing which she hadn't done. HR 126 and BP 174/93 and repeat was 132 and 152/113. Oropharynx appeared normal but she appeared pale and very weak, and slumped over in the seat of the car. 911 called and EpiPen and IM Benadryl given with some improvement of symptoms. BP continued to be hypertensive and HR tachycardic. O2 sats remained stable at 99%. With her overall symptoms, concern for anaphylaxis, although her symptoms were likely multifactorial - POTS, anxiety.
23 2021-03-17 loss of consciousness Patient had history of fainting noted on patient also notified immunizer of history. Vaccine was a... Read more
Patient had history of fainting noted on patient also notified immunizer of history. Vaccine was administered and patient appeared to be ok. She was told to have a seat and wait 30 minutes to ensure patient safety. Immunizer notified me/pharmacist of patient's history and staff was informed to watch her for any adverse events. 5-10 minutes later patient walked up to counsel window and notified pharmacist she was going to faint. I asked her to please return to her seat and immediately a technician and I went out and assisted her to a chair. We provided a bottle of water and advised her to sip some. After a few more minutes she passed out in the chair. At that point we called 911. The operator advised us to lay her flat. We moved her into the training room and waited for EMT to arrive. They arrived a few minutes later. At that point she was beginning to come around. I left to return to pharmacy as she was being cared for. 20 minutes later the EMT consulted me and patient vitals were good and she was feeling much better and refused to be transported to hospital. I signed off their form as a witness of her refusal.
23 2021-03-18 chest pain Seizure; Headache; Couldn't feel lower legs; Extreme chest pains and chills; Extreme chest pains and... Read more
Seizure; Headache; Couldn't feel lower legs; Extreme chest pains and chills; Extreme chest pains and chills; Arm swelling; Pain; Itching; This is a spontaneous report from a contactable healthcare professional (patient). A 23-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration (left arm) on 02Mar2021, 16:15, as single dose for COVID-19 immunisation. Medical history included ongoing epilepsy, covid back in Dec2020, known allergies to flu vaccine and TB test and seizure (have history). Concomitant medications included levetiracetam (KEPPRA), lamotrigine (LAMICTAL), cenobamate (XCOPRI) and magnesium. The patient had no other vaccine in 4 weeks. On 02Mar2021 16:15, the patient experienced arm swelling, pain, itching, couldn't feel lower legs, extreme chest pains and chills. On 02Mar2021, at 17:15, the patient experienced headache an hour later. On 03Mar2021 01:00, the patient experienced seizure at the middle of the night around 01:00. The events resulted in emergency room/department or urgent care. The patient had Covid prior vaccination; and was not Covid tested post vaccination. Outcome of event seizure was not recovered; outcome of the rest of events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The patient had underlying epilepsy. However, based on the close temporal association, a possible contributory role of bnt162b2 to the development of seizure cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
23 2021-03-19 fainting Syncope after receiving vaccine
23 2021-03-21 blood pressure decreased throat and mouth tightening 8 minutes after injection of vaccine, difficulty talking, body tremors, ... Read more
throat and mouth tightening 8 minutes after injection of vaccine, difficulty talking, body tremors, and hive-like rash (patchy red blotches, not raised/swollen or itchy) appeared across chest and around the injection site. Took 25 mg liquid benadryl within a few minutes of reaction beginning. Took five minutes for sensation in mouth and throat to subside, rash cleared in about twenty and blood pressure came down.
23 2021-03-21 fainting, loss of consciousness EUA Pfizer-BioNTech vaccine reaction Patient fainted after receiving vaccination. Medical alert team... Read more
EUA Pfizer-BioNTech vaccine reaction Patient fainted after receiving vaccination. Medical alert team RRT called , patient escorted to ED for observation. She lost consciousness for a period of less than 1 minute.
23 2021-03-22 blood pressure decreased, hypotension Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosigned by: MD at 3/23/2021 1:26 PM ... Read more
Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosigned by: MD at 3/23/2021 1:26 PM Expand AllCollapse All COVID VACCINE CLINIC 3/19/2021 Date: 3/19/2021 MRN: 8812976 Subjective Patient is a 23 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience anxiety. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality and rapid progression of symptoms. PMH: not significant. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes watering, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, itching of skin, vomiting, abdominal pain, muscle aches, joint pain, dizziness and headaches Previous Reactions: none Objective Vitals Vitals: 03/19/21 1355 03/19/21 1413 BP: 95/62 92/63 Pulse: 99 SpO2: 100% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood is anxious. Affect is flat. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. 1415: attempt to stand patient up after she finished eating and drinking. She reports her legs feel weird and felt weak. + dizziness/lightheadedness when standing. Pt sat back down and laid back in recliner, blanket given. Monitor at this time. 1422: pt bp rechecked with new bp cuff. Still in the 90's systolic. Pt feels okay. Pt sat up in recliner. Plan to recheck bp. 1428: pt bp rechecked, still in the 90's systolic. Pt feels tired. No other new symptoms reported. Pt given another snack. 1440: pt reports feeling a little better. Repeat bp still in the 90s systolic. Pt able to stand up w/o dizziness. She was ambulated around the bay w/o assistance. States she feels as well as she did when she first got here. Assessment/Plan Treatment included: water, snacks and blanket Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Systemic reaction (hypoglycemia, hypotension, generalized rash) Decreased bp (questionable if this is her baseline), and anxiety. Pt w/o known hx of what her bp normally runs. Monitored in bay. Improved with water, snack and time. Pt able to leave w carrying her instrument w/o issues and feels well. Walked out accompanied by RN. APRN Electronically Signed 3/19/2021 2:03 PM
23 2021-03-23 chest pain Chest pain, period cramps but no/late period
23 2021-03-23 fast heart rate Fatigue and myalgias set in about 6 hours after vaccine was administered Shortly after, tachycardia... Read more
Fatigue and myalgias set in about 6 hours after vaccine was administered Shortly after, tachycardia set in with pulse at 140-150 bpm resting. Fever set in at 8 pm at 103F. One OTC Benadryl brought pulse down to 130s resting. Performed Valsalva Maneuver with pulse improvement to 110s. By morning, fever was still at 103F, with headache, muscle pain, chills, fatigue, pain at injection site, and swollen lymph nodes present. Tachycardia had resolved. Within 48 hours after vaccine was administered, all side effects had resolved except fatigue and swollen lymph nodes and headache. All side effects had completely resolved 9 days after vaccine was administered.
23 2021-03-24 blood glucose increased Blood sugar was elevated. Was about 200-250 for the following two days. Elevation started at around ... Read more
Blood sugar was elevated. Was about 200-250 for the following two days. Elevation started at around 2am. Has only started to come down after two days. Even increased basal rates through my omnipod did not help lower it by much.
23 2021-03-24 blood pressure increased, heart rate increased Patient experienced chills, numbness of lips, itching around haw area, elevated heartrate 103 bpm, a... Read more
Patient experienced chills, numbness of lips, itching around haw area, elevated heartrate 103 bpm, and lump in throat. Blood pressure slightly elevated at 121/90. Oxygen levels and breathing remained normal. Administered 25mg diphenhydramine orally. No improvement after 15 minutes. EMS called. EMS evaluated patient and took her to the hospital.
23 2021-03-24 chest discomfort, chest pain Fever, body aches, chills, vomiting, chest pressure, headache, upset stomach, mental confusion. It w... Read more
Fever, body aches, chills, vomiting, chest pressure, headache, upset stomach, mental confusion. It was fine for the most part in a day and a half. The headache and chest pain lingered for two days.
23 2021-03-24 chest discomfort 5 minutes after the shot my chest felt funny and I was extremely dizzy. I started dripping in sweat ... Read more
5 minutes after the shot my chest felt funny and I was extremely dizzy. I started dripping in sweat and almost fell out of my chair. I was taken back to the clinic and laid down. My face was beet red. The reaction ended about 20 minutes later.
23 2021-03-24 palpitations About 10 minutes after administration of COVID-19 vaccine, began to have acute onset of shortness of... Read more
About 10 minutes after administration of COVID-19 vaccine, began to have acute onset of shortness of breath, difficulty breathing and heart racing. Patient states she has a history of anaphylaxis with exposure to tree nuts and a food additive and self-administered EpiPen just prior to ED arrival. Patient states that after administration of EpiPen resolution of all symptoms. ED treatment: Prednisone 60mg PO x1 dose Benadryl 50mg capsule PO x1 dose Pepcid 20mg tablet PO x1 dose
23 2021-03-25 pallor, blood pressure decreased At approximately 0943 patient reported feeling faint, starting to lose vision, and nausea. Lead nur... Read more
At approximately 0943 patient reported feeling faint, starting to lose vision, and nausea. Lead nurse was notified and patient was assisted into anti-gravity chair. Patient assessed. Pallor noted and patient reported feeling hot and stated "I'm going to throw up". Patient given emesis bag at approx. 0944. Patient reported feeling better. Patient given water. patient denied rashes, hives, and throat irritation. Patient reported feeling scared of needles and no history of fainting after prior vaccinations. Vitals assessed at 0946: BP 90/75 mmHg, SpO2 99% RA, PR 75 bpm. Pt advised to stay for 30 mins for further observation. Vitals reassessed at 1004: BP 100/80 mmHg, SpO2 99% RA, PR 56 BPM. Vitals reassessed at 1020: BP 80/50 mmHg, SpO2 99% RA, PR 60 BPM. Pt advised to wait 20 mins due to drop in BP. Vitals reassessed at 1040: BP 100/80mmHg, SpO2 99%, PR 65 BPM. Patient denied throat irritation and stated she was feeling better. Patient advised to sign up on CDC- V-safe. Pt left facility at approx. 1045 with steady gait and unlabored breathing.
23 2021-03-25 fainting Dizziness starting around 8:30 PM, fever from 10 PM to sometime after 3 AM, syncope x2 around 8:30 A... Read more
Dizziness starting around 8:30 PM, fever from 10 PM to sometime after 3 AM, syncope x2 around 8:30 AM
23 2021-03-25 fast heart rate Tachycardia As soon as she receiver her injection she felt "shaky". No sob, cp or dizziness. Initi... Read more
Tachycardia As soon as she receiver her injection she felt "shaky". No sob, cp or dizziness. Initial vitals b/p 139/101, SaO2 99 pulse 122. Minimal food intake today. Provided water and cookie. F/U vitals 131/88, pulse 93 and Sao2 99%. Feels better after eating
23 2021-03-27 heart rate increased After receiving vaccine at 3 pm I started to have anxiety and my heart rate went up. This was presum... Read more
After receiving vaccine at 3 pm I started to have anxiety and my heart rate went up. This was presumably because I also have a needle phobia but I did almost faint and had to have on site EMT asses condition and observe for 30 minutes. At 4 pm one hour after injection face felt itchy and irritated and noticed hives on neck and jawline. Immediately administered benadryl 50 mg which made the hives subside.
23 2021-03-27 fainting Patient was observed post Covid-19 immunization for 15 minutes . During the observation period, she... Read more
Patient was observed post Covid-19 immunization for 15 minutes . During the observation period, she experienced an adverse reaction with the following symptoms: syncope. Sitting in chair, fell to right hitting head on floor, patient became alert within seconds, transported via w/c to stretcher to be assessed by EMS, vitals taken, within normal limits, CBG 94, pt being sent home on concussion protocol, Fiance driving patient home and staying with her for 24 hours. Patient refused transport to hospital. Alert oriented at discharge. Assessment : Time of assessment 0943. Alert and oriented. Paramedic on site, vitals taken Actions taken: Vitals sign taken VAERS form completed Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. Instructed to follow up with PCP for evaluation for second dose. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat.
23 2021-03-28 blood pressure decreased, hypotension Progress Notes (Nurse Practitioner) Cosigned by: MD at 3/23/2021 1:26 PM, Expand All Collapse All. ... Read more
Progress Notes (Nurse Practitioner) Cosigned by: MD at 3/23/2021 1:26 PM, Expand All Collapse All. COVID VACCINE CLINIC , 3/19/2021, Patient: Date: 3/19/2021, Patient 23 yr. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience anxiety. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality and rapid progression of symptoms. PMH: not significant. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes watering, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, itching of skin, vomiting, abdominal pain, muscle aches, joint pain, dizziness and headaches, Previous Reactions: none Objective, Vitals Vitals:03/19/21 1355 03/19/21 1413, BP: 95/62, 92/63, Pulse 99, SpO2:,100%. Physical Exam Constitutional: General: She is not in acute distress, Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood is anxious. Affect is flat. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. 1415: attempt to stand patient up after she finished eating and drinking. She reports her legs feel weird and felt weak.+ dizziness/lightheadedness when standing. Pt sat back down and laid back in recliner, blanket given. Monitor at this time. 1422: pt bp rechecked with new bp cuff. Still in the 90's systolic. Pt feels okay. Pt sat up in recliner. Plan to recheck bp 1428: pt bp rechecked, still in the 90's systolic. Pt feels tired. No other new symptoms reported. Pt given another snack. 1440: pt reports feeling a little better. Repeat bp still in the 90s systolic. Pt able to stand up w/o dizziness. She was ambulated around the bay w/o assistance. States she feels as well as she did when she first got here. Assessment/Plan Treatment included: water, snacks and blanket, Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc. mental health) and Systemic reaction (hypoglycemia, hypotension, generalized rash) Decreased bp (questionable if this is her baseline), and anxiety. Pt w/o known Hx of what her bp normally runs. Monitored in bay. Improved with water, snack and time. Pt able to leave w carrying her instrument w/o issues and feels well. Walked out accompanied by RN.
23 2021-03-29 fainting pt was shaking up and fainted after vaccination and ambulance was called. Pt was taken away by ambul... Read more
pt was shaking up and fainted after vaccination and ambulance was called. Pt was taken away by ambulance
23 2021-03-30 chest discomfort, chest pain Woke up at 12:35 AM with a fever, chills, body aches, and nausea. chills in the morning that went aw... Read more
Woke up at 12:35 AM with a fever, chills, body aches, and nausea. chills in the morning that went away, nausea was on and off and had an on and off headache. Started having intense chest pain around 10 AM- felt like pressure on my chest and almost squeezing, it kind of shot out and I could feel it in my throat and in my headache. It was still happening around 1 PM so I went to the ER after calling urgent care but the pain subsided once I was at the ER. Nausea, dizziness, haziness, and headache were on and off the rest of the day, subsiding around 6 PM.
23 2021-03-30 pallor, heart rate increased PATIENT IMMEDIATELY TURNED "LOBSTER RED" THEN VERY PALE WHITE FROM HER NECK UP. SHE STATED SHE FEL... Read more
PATIENT IMMEDIATELY TURNED "LOBSTER RED" THEN VERY PALE WHITE FROM HER NECK UP. SHE STATED SHE FELT LIGHT-HEADED AND HAD TO LAY DOWN ON THE FLOOR. SHE ALSO HAD A VERY FAST HEARTBEAT. LASTED ABOUT 5-10 MINUTES TOTAL.
23 2021-03-31 lightheadedness Patient felt pre-syncopal was placed in trendelburg position, was hydrated and rested until symptoms... Read more
Patient felt pre-syncopal was placed in trendelburg position, was hydrated and rested until symptoms resolved
23 2021-03-31 fainting After injection, upon standing up, patient became light headed. Assisted to chair. Patient immediate... Read more
After injection, upon standing up, patient became light headed. Assisted to chair. Patient immediately went limp, clammy, and unresponsive. 911 called. Assisted to floor. Legs raised. Became active at about 15 seconds, speaking to nurses. Began recovering. Pulse 96 BP 98/56 Pulse 52 Repeated vital signs when standing up, 72/47 Pulse 51 became slightly lightheaded again. Returned to laying position on floor, continued to talk to nurses. EMS arrived and took over assessment. Declined to go to hospital. Return to chair with no issues. Stood with no issues. To recovering area for further observation before leaving. In recovery area Participant lying on monitor cot post EMS departure. 1619 BP 88/56, P 65, O2 Sat 99%. Voiced lighted headedness better and mother at side. 1622 Assisted to sitting position BP 84/62. Encouraged to sit and continue hydration. 1625 Participant and mother voiced readiness to leave. Educated to monitor closely for p.m. and call 911 for s/s return and or resp. distress. Both voiced will return to urgent care / hospital if any issues. 1625 Participant stood with minimal assist. BP 90/47, P 57. Ambulating without c/o. At time participant departed Howard vaccine site via private car.
23 2021-04-01 chest discomfort Patient stated she felt short of breath, developed chest tightness, became diaphoretic immediately a... Read more
Patient stated she felt short of breath, developed chest tightness, became diaphoretic immediately after vaccine administration. Patient also reported light-headedness. 50 mg oral diphenhydramine was given and patient was sent to the emergency room for further evaluation.
23 2021-04-01 loss of consciousness, pallor pt received first dose of Pfizer COVID-19 vaccine. hx of vasovagal syncope with blood draws. per med... Read more
pt received first dose of Pfizer COVID-19 vaccine. hx of vasovagal syncope with blood draws. per medical personnel in monitoring area, noted patient unconscious at 1312 for about 15-20 seconds on the chair. as patient was waking up, she was noted to have "eyes flickering and shaking." pt diaphoretic, pale, and had emesis x1 upon waking up. CODE BLUE team on scene at 1315. BP 138/91, HR 68, RR 16, SPO2: 97. pt transported to ED via wheelchair. pt a&ox3 upon transport.
23 2021-04-01 loss of consciousness Patient stated she had previous passed out following vaccination. EMS on site in case pt passed out ... Read more
Patient stated she had previous passed out following vaccination. EMS on site in case pt passed out again. Patient passed out following vaccination and EMS was able to catch her and lower her to ground. She regained consciousness quickly and was monitored afterward. Refused any further treatment/transport as she was feeling fine upon leaving.
23 2021-04-01 fainting syncopal episode post vaccination. pt lowered to ground by spouse. hx anxiety with blood draws and v... Read more
syncopal episode post vaccination. pt lowered to ground by spouse. hx anxiety with blood draws and vaccines. did not eat today. nauseated. brought to observation, monitored, sent home
23 2021-04-04 loss of consciousness Patient stated in VARS form that she "might" pass out after receiving shot. She said that she has an... Read more
Patient stated in VARS form that she "might" pass out after receiving shot. She said that she has anxiety when receiving vaccination shots. Patient received vaccine and about one minute later the patient passed out and fell forward. I was able to catch her and lower to the ground safely. I called for pharmacist on duty to assist in the care of the patient. Less than a minute after the patient passed out she was awake and alert. The patient was asked multiple times if she needed to go to the hospital and asked if she was okay to drive home. She insisted that she faints frequently from vaccines and denied any further care. She stayed in the waiting area while being checked on several times. The patient left after she said she was "100% good." She thanked us for taking care of her and apologized for what happened.
23 2021-04-04 fainting dizzy with syncope
23 2021-04-07 loss of consciousness, fainting Patient had a synoptic episode approximately 10 minutes after receiving the vaccine. She fell and q... Read more
Patient had a synoptic episode approximately 10 minutes after receiving the vaccine. She fell and quickly regained consciousness. She recovered in a chair in about 15 minutes. She denied any injuries and did not require any emergency services.
23 2021-04-07 pallor About 5 minutes after vaccine was administered, patient became to appear pale and reported feeling u... Read more
About 5 minutes after vaccine was administered, patient became to appear pale and reported feeling unwell to me. She commented that her vision was "getting black" I noted that her pupils were dilated and that her heart rate was 50 beats per minute. She was quite diaphoretic. No loss of consciousness. She noted that she had not eaten for several hours prior to vaccine administration. Patient was given water to drink and a bottle of fruit flavored tea. After consuming fluids, she began to regain her usual skin tone and reported "feeling better, but not quite right". She was observed for an additional 20 minutes and offered crackers to eat. She called a friend to come pick her up and drive her home. She left the clinic ambulatory accompanied by friend.
23 2021-04-07 fainting Patient fainted approximately 10 minutes after receiving dose 1 of Pfizer covid vaccine LOT ER2613 ... Read more
Patient fainted approximately 10 minutes after receiving dose 1 of Pfizer covid vaccine LOT ER2613 on 4/1/21. She hit her head on the desk in the room. This was unwitnessed by any staff member. There were no bumps or open areas on patients head. Patient was immediately alert and oriented upon assessment when writer walked into room. After assessment advised patient she should go to the ED for further evaluation. Patient called her mom to come take her to the ED. Further follow up documents patient was not seen in ED.
23 2021-04-08 chest pain 23 yo FM who received first dose of Pfizer vaccine and then was noted to have shortness of breath an... Read more
23 yo FM who received first dose of Pfizer vaccine and then was noted to have shortness of breath and complaining tongue closing sensation immediately after at Vaccine Clinic --I was called to evaluate the patient. When I arrived patient was laying down on a chair with a friend, shaking with seizure like activity but alert and oriented to person place and time. Upon my arrival she was shaking, vomited x 1 and then complained about chest pain. Vitals upon my arrival: HR 58, o2 100% RR appeared to be around 22-24 (hyperventilating) BP 88 systolic (manual)--repeated by medics upon arrival minutes later 110/72. Given throat closing sensation, vomiting, shortness of breath I advised to call 911 and ordered Epinephrine x 1 which was given by RN immediately. Pt was then placed on the grown chin up, she continued to shake throughout entire body but continued to be alert and oriented. Medics then arrived on seen, started an IV, glucose by medics 84, IVF started by medics. Pt was transported to ER via medics. Pt is not a patient, last visit 2017. Pt did state she has hx of POTS and DRESS syndrome to Lamictal. Reports taking cetirizine this AM, Zofran and Oxycodone and Baclofen (prescribed by external PCP?). Prior to transport to ER pt continued to be alert oriented, but shaking and twitching throughout her body. MD verbally communicated to patient to not receive the 2nd dose given her severe anaphylaxis like reaction to the first dose of the vaccine. Pt can be referred to allergist after ER follow up by PCP. Denied pregnancy.
23 2021-04-08 loss of consciousness, chest discomfort, heart rate increased patient reported nausea to staff, lead RN was called. Diaphoresis was immediately noted patient was... Read more
patient reported nausea to staff, lead RN was called. Diaphoresis was immediately noted patient was tachypneic and anxious, denied throat swelling reported "heavy chest" has a couple "tics" tremors reported this to be someone normal. HR elevated to 130, ems called with patients permission. 2 minutes later patient lost consciousness and epi was administered. EMS updated. Patient brought to hospital via EMS
23 2021-04-08 lightheadedness Patient had a vasovagal response to the needle after being vaccinated with the Pfizer -Biontech vacc... Read more
Patient had a vasovagal response to the needle after being vaccinated with the Pfizer -Biontech vaccine dose #1.. EMS personnel were at the site, she was given the appropriate care. Patient's vitals were Pulse ox read 99% in room air, heart rate 72,blood pressure 128/86. Patient was awake and alert. after few seconds of the syncope spell. . No signs of head trauma ,denies, head and neck pain. Small abrasion noted on nasal bridge no bleeding noted. Patient was observed for an hour. Patient went home in stable condition.
23 2021-04-08 fast heart rate, chest discomfort Anxiety, tachycardia, chest tightness, nausea
23 2021-04-08 low platelet count, platelet count decreased Pt came on 4/9/2021 presenting c/ogeneralized fine pinpointed red rash (petechial), except on face s... Read more
Pt came on 4/9/2021 presenting c/ogeneralized fine pinpointed red rash (petechial), except on face since Tuesday 4/6/21, states that she gother first Pfizer COVID-19 vaccine on 4/5/2021. No itching. Patient had CBC, rapid strep, urine HCG, and COMP metabolic completed during clinic visit on 4/9/2021with results shown below including platelet count reported at 38. Labs ordered to be completed as sendout and pending results are RPR Dx w/Reflex - OS, PT w/Inr - OS, PTT, Activated - OS,Hemoglobin A1C - OS, CBC (includes Diff/Plt)-OS . Pt referred to ER for further evaluation.
23 2021-04-09 chest pain started having left arm pain and chest pain . EKG normal, pt sent home
23 2021-04-09 fainting, heart rate increased I fainted and my heart rate was 144 which is extremely high; I fainted and my heart rate was 144 whi... Read more
I fainted and my heart rate was 144 which is extremely high; I fainted and my heart rate was 144 which is extremely high; I had woken up in a sweat, had 103.6 fever.; I had woken up in a sweat, had 103.6 fever.; After fainting I threw up and continue to not feel good; After fainting I threw up and continue to not feel good; I also had a bad headache; This is a spontaneous report from a contactable consumer (patient). A 23-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient stated that, "The 24th, the day after my shot. I had woken up in a sweat, had 103.6 fever. I fainted and my heart rate was 144 which is extremely high. After fainting I threw up and continue to not feel good. I also had a bad headache and continue to have one." The adverse event result in Doctor or other healthcare professional office/clinic visit. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was not resolved. No follow-up attempts are needed. No further information is expected; information about lot/batch number cannot be obtained.
23 2021-04-09 fainting Dizzy, Left ear buzzing which lead to syncope upper arms tingling for 2-3 seconds
23 2021-04-09 fainting post vaccine syncope, upper arm tingling, pt recovered and sent home
23 2021-04-11 heart flutter Feeling like I was going to pass out at work with continued vertigo like feeling and fluttering in c... Read more
Feeling like I was going to pass out at work with continued vertigo like feeling and fluttering in chest. Went to ER and received labs and EkG with nothing outstanding. Dizziness continued for a total of 3 hours on 4/9. 4/10 I felt a brain fog and vertigo feeling for most of the day. 4/11 I felt better. 4/12 I had another episode of feeling like I was going to pass out along with brain fog. I went to urgent care and got more labs drawn.
23 2021-04-11 pallor About 5 minutes after vaccine was administered, patient became to appear pale and reported feeling u... Read more
About 5 minutes after vaccine was administered, patient became to appear pale and reported feeling unwell to NP. She commented that her vision was "getting black" NP noted that her pupils were dilated and that her heart rate was 50 beats per minute. She was quite diaphoretic. No loss of consciousness. She noted that she had not eaten for several hours prior to vaccine administration. Patient was given water to drink and a bottle of fruit flavored tea. After consuming fluids, she began to regain her usual skin tone and reported "feeling better, but not quite right". She was observed for an additional 20 minutes and offered crackers to eat. She called a friend to come pick her up and drive her home. She left the clinic ambulatory accompanied by friend.
23 2021-04-11 pallor Patient starting feeling anxious as she came to the observation area. Hyperventalating and diaphoret... Read more
Patient starting feeling anxious as she came to the observation area. Hyperventalating and diaphoretic, pale
23 2021-04-11 fainting, lightheadedness SYNCOPE/VASOVAGAL- Treatment cold packs - laid supine with feet elevated - hydration 20 fl oz water.
23 2021-04-12 fainting Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Weakness-Mild
23 2021-04-13 palpitations Heart racing, feeling as though her throat was closing, vital signs normal, clear lung sounds, PT dr... Read more
Heart racing, feeling as though her throat was closing, vital signs normal, clear lung sounds, PT drinking well, talking without difficulty
23 2021-04-13 fainting, palpitations Severe chills, shaking, fever, faintness, nausea, pounding heart, delirium, fatigue, body ache, swea... Read more
Severe chills, shaking, fever, faintness, nausea, pounding heart, delirium, fatigue, body ache, sweating
23 2021-04-13 fainting Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted after receiving her firs... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted after receiving her first dose of the Pfizer vaccine for covid 19. She\r\nwas laid down on her back. Fainting spell lasted about 2-3 minutes. She said it was usual for her to faint after immunization as a child. She didn't mention this because she thought she had outgrown it. She complained about quizziness in her stomach after the fainting spell. She was given 1 tablet of 25mg Benadryl.
23 2021-04-14 chest pain sharp shooting chest pain started 48 hours after vaccination, referred to urgent care center
23 2021-04-14 heart rate increased, chest pain Increased heart rate, heart rate elevated to 171 bpm during my work day. Heart rate episode lasted a... Read more
Increased heart rate, heart rate elevated to 171 bpm during my work day. Heart rate episode lasted an hour before going back down. Intense chest pains and sharp pain while breathing. I now have a heart rate monitor for the next two weeks to ensure nothing else happens and if it happens the doctors will be able to track everything.
23 2021-04-14 fainting patient fainted few minutes after administration. was alert and aware after
23 2021-04-15 heart rate increased 23 year old female presents with right sided neck pain x 1 day, reports associated symptoms of heada... Read more
23 year old female presents with right sided neck pain x 1 day, reports associated symptoms of headache, coughing, sore throat and myalgias s/p first dose of COVID19 Pfizer vaccine yesterday. Pt reports she couldn't sleep because she felt her heart was beating faster. Pt reports she received COVID19 vaccine dose in left deltoid. Pt denies fever, coughing, emesis, diarrhea, chest pain, SOB, lower extremity edema, lower extremity tenderness. No known sick contacts, no recent travel history. She reports she took Tylenol yesterday and today, with moderate relief. Pt offers no other complaints. Vitals at time revealed normaltensive T98.4F, HR of 100bpm Cardiorespiratory exam on auscultation +S1/S2, tachycardic at 100bpm on repeat, lungs CTAB There was a palpable tender anterior right cervical lymph node that was mobile and well circumscribed around 1x1cm. Pt was advised to take Tylenol and/or Motrin for neck pain, headache. She was discharged home with anticipatory guidance and ED precautions should she develop chest pain, shortness of breath, dizziness, jaw pain, and/or chest pressure, slurred speech. Pt was receptive to advice. She was contacted the following day, (today on 4/16/2021) and she reports she feels much better: palpitations and headache has resolved, and neck pain is improving.
23 2021-04-15 lightheadedness dizzines, near syncope
23 2021-04-15 fainting, pallor See below Patient is a 23 yof with history of vasovagal syncope c/o syncope secondary to pfizer vac... Read more
See below Patient is a 23 yof with history of vasovagal syncope c/o syncope secondary to pfizer vaccine dose 1. Witness states she was pacing back and forth in the hallway when she fell from standing position to the ground hitting her head. She was maintained in the supine position and recovered spontaneously shortly after. Appearance was pale and diaphoretic. V/S were assessed. She was provided gatorade and seated in the green chair. She reported a pressure headache in the occipital region. She denies changes in vision, numbness and tingling in hands and feet, pain in her neck or spine, and history of blood thinners. Boyfriend states she was extremely nervous prior to getting the vaccine. Patient reported
23 2021-04-15 fainting Pt experienced syncope with flushing and sweating, BP 98/59, HR52, RR18. Outcome not reported.
23 2021-04-17 heart rate increased weakness, rapid heart rate, and panic five minutes after receiving vaccine. went away on its own aft... Read more
weakness, rapid heart rate, and panic five minutes after receiving vaccine. went away on its own after a couple of minutes swelling and soreness of axillary lymph nodes five days after the vaccine, currently ongoing
23 2021-04-17 fainting Systemic: Dizziness / Lightheadedness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional D... Read more
Systemic: Dizziness / Lightheadedness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: She complained to employee of lightheadedness. By the time I went to see her she had fainted. She opened her eyes again, but felt fainty . We called 911. Administered EpiPen. Rescue came and stayed with her for about an hour when her relative came to pick her up.
23 2021-04-18 chest pain, heart failure, ejection fraction decreased, inflammation of the heart muscle, troponin increased Hospital course: 23 yo female with no significant PMH presenting to the ED with right sided CP, wors... Read more
Hospital course: 23 yo female with no significant PMH presenting to the ED with right sided CP, worse with deep inspiration. Received 2nd covid vaccination last week- mild reaction with fever thereafter. She had w/u in the ED including an EKG with inferior and septal TWI and trop of 1.61. CTA chest was negative. She was admitted. After admit, troponin trended up (1.61--3.71--4.93). CRP 49.1, ESR 21. Echo showed apex hypokinesis so with TWI on EKG and elevated trop, cardiology elected for LHC. This was normal. Cardiac MRI showed myopericarditis. She was started on high dose ASA, colchicine and bblocker for this. Likely viral etiology (Covid, Resp 4 plex negative). Trop trended down on 4/13 (CRP still rising). Cardiology was ok with discharge. Will need 2 weeks of ASA and 3 months of colchicine. No strenuous activities for that time frame. She is getting her Masters in music/violin and did not need a return to school note. Feeling somewhat better at discharge- rated pain 6/10. Internal Medicine followup in 1 week Cardiology followup in 2 months
23 2021-04-18 pallor, loss of consciousness Pt c/c of feeling dizzy. Pt appeared to be passing out. Pt sat back on the chair and unable to respo... Read more
Pt c/c of feeling dizzy. Pt appeared to be passing out. Pt sat back on the chair and unable to respond to question and looked very pale and diaphoretic. Pt was moved to the cot and had her lay down. Few minutes pt felt better and able to say her name. EMT assessed the patient and felt much better
23 2021-04-18 fainting Syncopal episode due to patients response to needles.
23 2021-04-18 fainting Patient fainted, dropped out of the chair, had a seizure
23 2021-04-19 fainting, loss of consciousness After patient received the vaccination, within moments she fainted and fell to the floor from a seat... Read more
After patient received the vaccination, within moments she fainted and fell to the floor from a seated position, pharmacists immediately responded and patient regained consciousness almost immediately. Patient reports hitting her head and a sore neck. patient was monitored by pharmacist until patient was back to baseline. Upon leaving patient states feeling fine and refused additional medical treatment at the time of leaving.
23 2021-04-19 fainting Patient fainted a few minutes after receiving the covid-19 shot.
23 2021-04-19 fainting patient feels she is about to faint BP: 102/58 Pulse: 54 o2 98% after 15 minutes BP 112/60 Pulse ... Read more
patient feels she is about to faint BP: 102/58 Pulse: 54 o2 98% after 15 minutes BP 112/60 Pulse 56 o2 98% #21 went home
23 2021-04-20 loss of consciousness Almost 12 hours after receiving the vaccine my legs felt very tingly and I passed out in the front y... Read more
Almost 12 hours after receiving the vaccine my legs felt very tingly and I passed out in the front yard
23 2021-04-20 pallor Patient sliding down in chair, became weak and slumped in chair, appears pale and sweaty. Vitals wer... Read more
Patient sliding down in chair, became weak and slumped in chair, appears pale and sweaty. Vitals were all within normal limits. Patient was offered juice but she declined due to feeling nauseous. 10 minutes later patient was given orange juice and was advised to drink it slowly. Patient states that the fainting feeling comes in waves. After finishing the juice, color came back to her face but still complained of mild dizziness, and denies nausea. Patient appears anxious and fingers are shaking. After some time, patient began to feel better and states her dizziness improved significantly. She was able to walk around and her dizziness did not return. 20 minutes later, all her symptoms subsided; fingers were no longer shaky, and she was no longer pale and sweaty.
23 2021-04-20 fainting Pt reports fear of needles, also reports history of "passing out" around needles. Client reported f... Read more
Pt reports fear of needles, also reports history of "passing out" around needles. Client reported feeling lightheaded while in observation unit post vaccine administration. Client fainted while sitting, did not fall to floor as family was sitting beside client. Client came to immediately, assessed by EMT and MD on site. vitals obtained. 1st set of vitals 100/44 HR: 47 02 sat 98%, second set of vitals 105/57 HR 58 02 sat 98%. Client left site after observation time completed without incident family at her side.
23 2021-04-20 fainting Systemic: Fainting / Unresponsive-Severe, Additional Details: Her response was not to the vaccine. A... Read more
Systemic: Fainting / Unresponsive-Severe, Additional Details: Her response was not to the vaccine. As soon as the nurse administered the shot, she said she passes out cold after ANY vaccination
23 2021-04-22 chest discomfort, chest pain Tightness in the chest with some pain starting on 04/22/2021 off and on throughout the day but getti... Read more
Tightness in the chest with some pain starting on 04/22/2021 off and on throughout the day but getting worse each time. I left work around 3 pm on 04/22/2021 with major bodyaches and extreme fatigue. Around 4 pm, I felt extremely itchy and found hives all over my arms, legs, above the injection site, cheeks, and butt. All my hives seemed to be worse on my right hand side, the side I received both vaccines in. After taking 2 Benadryl around 4:30 and taking a cold shower, I could feel the cold water turning warm from running off my hives when hitting my feet. No signs of fever. Shortly thereafter, I used Hydrocortisone cream and they left. At 6:30 am I woke up covered again, by 2pm 04/23 they are off and on.
23 2021-04-22 loss of consciousness, fainting, pulse abnormal HPI: Patient is a * year old * who presents following administration of the first dose of the COVID1... Read more
HPI: Patient is a * year old * who presents following administration of the first dose of the COVID19 vaccine in the left deltoid. Patient has a history of vasovagal syncope/reaction and was not conscious upon medical response arrival. No head trauma. Patient denies allergies. Patient denies past medical history. Patient only taking a low dose combination OCP. She states she has only eaten breakfast. She otherwise denies chest pain, difficulty breathing, swelling of the face/lips/tongue/throat, skin rash/itching, cramping abdominal pain, nausea, and vomiting. Exam (update as needed): GEN: Patient not conscious upon arrival. Upon reclining patient and elevating legs, patient alert & oriented x 4. NAD HEAD: NCAT EYES: PERRL, EOMI upon intervention. ENT: Ears normal, Nose normal, OP normal, no evidence of angioedema NECK: Supple, without LAD. CV: Weak, thready radial pulse. RRR, no m/r/g PULM: Clear to auscultation bilaterally, no accessory muscle use ABD: Soft, no tenderness. SKIN: No rashes, skin warm and dry. No erythema or edema of the injection site. MSK: FROM, MS 5/5 NEURO: Upon intervention, patient alert & oriented x 4. CN 2-12 grossly intact, no ataxia, gait steady Clinical Impression/Field Tx: Vasovagal syncope. Upon reclining patient and elevating the legs, patient regained consciousness and was A&O x 4. EMS called to the scene for further evaluation, to include EKG. Patient not actively displaying signs or symptoms of anaphylaxis. Vital signs stable upon transfer of care. Instructed patient to consult their PCP regarding the post-vaccination reaction. Patient instructed to go to emergency department should they develop chest pain, difficulty breathing, swelling of the face/lips/mouth/tongue/throat, or cramping abdominal pain with nausea/vomiting, as these are signs of possible anaphylaxis that requires immediate intervention. Medications administered: None Disposition: EMS was called to the site for further evaluation. Patient elected to not transport to the hospital and left with her parents.
23 2021-04-22 loss of consciousness Patient was standing for vaccine and passed out directly after receiving vaccine. She hit the back o... Read more
Patient was standing for vaccine and passed out directly after receiving vaccine. She hit the back of her head after syncopal episode. She did come to after a few seconds. She was taken back to an observatory room. she state she is a little nauseous. She denies shortness of breath, blurred vision, dizziness. Mild headache. Patient stood and was not dizzy. Had her walk and did not have any problems. Family history of fainting.
23 2021-04-22 palpitations c/o palpitations since covid vacc at 1530 today
23 2021-04-22 fainting 1st dose: fainted that night (about 12 hours after the shot) and got a few hives 2nd dose: fainted, ... Read more
1st dose: fainted that night (about 12 hours after the shot) and got a few hives 2nd dose: fainted, many large and itchy red hives (arms, legs, neck, abdomen)
23 2021-04-22 fainting the patient fainted 5 minutes after receiving the vaccine. She hit her head on the floor when she f... Read more
the patient fainted 5 minutes after receiving the vaccine. She hit her head on the floor when she fainted. We laid her on her back and elevated her feet. We put ice packs on her wrists and the back of her neck. we continued to monitor her for 30 minutes. She felt better when she left, however her head did hurt. We recommended that she seek further medical care to be evaluated since she did hit her head.
23 2021-04-23 chest discomfort Muscle aches, chills, fever, dizziness, chest tightness, trouble breathing, fatigue. Started in the ... Read more
Muscle aches, chills, fever, dizziness, chest tightness, trouble breathing, fatigue. Started in the middle of the night after the vaccine and lasted the whole next day, although symptoms were worst in the morning and gradually improved as the day went on.
23 2021-04-23 pallor Patient approached this RN and reported feeling dizzy and nauseaous. Patient appears sweaty and pal... Read more
Patient approached this RN and reported feeling dizzy and nauseaous. Patient appears sweaty and pale. Assisted patient to private recovery area and instructed her to lay down on gurney. Instructed patient to remove mask and take deep breaths. Patient dry heaved, but did not vomit. Vital signs as follows: 1320-96/64, P 78, RR 24, O@ 95%. 1325-112/78, P 74, RR 20, O2 97%. 1330-110/74. P 72. RR 20, O2 99%. No c/o pain. Gave patient water. After 25 minutes, patient reports feeling back to baseline. Patient no longer sweaty or pale. Patient reports her roommate will be driving her home.
23 2021-04-23 fainting 23 year old female s/p syncope after 2nd Pfizer Covid19 vaccinaton to her left deltoid. Pt was sitt... Read more
23 year old female s/p syncope after 2nd Pfizer Covid19 vaccinaton to her left deltoid. Pt was sitting outside and notified the nurse of being dizzy and thirsty. While ambulating inside had a syncope episode of about three seconds and immediately awakening very anxious. She does not remember the episode. Post VS 114/72 100 28 and 100% O2 sat on RA while in the supine position. 1307 f/u VS 100% RA with heart rate of 84 bpm. C/O of dizziness and placed back into supine position with legs elevated on car . Then placed on 10 lpm non rebreather VS at 1318 106/67 84 24 Now sitting up with NAD , reported no symptoms. Eating Cheetos and drinking a bottle of water. Also placed on RA At 1324 placed in seat, denies any symptoms at this time. VS 98% RA 96/62 85 24 At 1331 89/63 85 24 Denies any symptoms, ambulated to the bathroom without help Patient reported systolic blood pressure in the 100s. No complaints after ambulating 1137 pm 91/60 85 20 Patient reported feeling fine and requesting to go home. Advised to f/u with PCP. DCd home with steady gait MAEW, NAD a+ox3 Ate all of the cheetos and drank all of the bottle of water 16.9 ounces Reported no medical history Denies taking any medications Denies any allergies Occurred at center HCP notified of occurrence
23 2021-04-25 enlargement of the heart, pulmonary embolism Dyspnea and pleuritic chest pain onset 4/22-23, prompting presentation to ED. Found in ED on 4/24 to... Read more
Dyspnea and pleuritic chest pain onset 4/22-23, prompting presentation to ED. Found in ED on 4/24 to have central R pulmonary embolus extending into interlobar, segmental, subsegmental branches of RUL & RLL, mild R heart enlargement without evidence to suggest RH strain, and mild pneumomediastinum most notable at the thoracic inlet. Tolerating RA. Started on AC with heparin drip, transitioned to xarelto at discharge.
23 2021-04-25 heart rate increased, chest pain, blood pressure increased 3/11/21-post vaccination, slight SOB, substernal chest pain 'burning', vision blurred, O2-4lpm/NC, S... Read more
3/11/21-post vaccination, slight SOB, substernal chest pain 'burning', vision blurred, O2-4lpm/NC, SaO2 99%, VS WNL- BP 152/80, HR 84, assessment completed pt remained stable throughout. Ct requested to be transported to the hosp, ct states in ER, post vaccination, was given epi, s/s resolved in 2-3hrs, ct decided to not get the 2nd dose due to her reaction.
23 2021-04-25 loss of consciousness Patient passed out while seated about 5 minutes after vaccination
23 2021-04-26 loss of consciousness Patient passed out after the vaccination
23 2021-04-26 loss of consciousness 0945 Client arrived at vaccination table 0949 Client received Pfizer #1 0950 Safety officer called t... Read more
0945 Client arrived at vaccination table 0949 Client received Pfizer #1 0950 Safety officer called to vaccine table as patient had lost consciousness after receiving her vaccine 0950 Client transferred to EMS area where she was monitored until symptoms resolved
23 2021-04-26 fainting, loss of consciousness Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Seiz... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Medium, Additional Details: pt passed out after reporting not feeling well, 911 had been called, pt taken to hospital and released today, severe muscle twitching possible seizure like
23 2021-04-26 fainting After intern gave the vaccine , she stood up , within 30 seconds to 1 minute the patient fainted, ... Read more
After intern gave the vaccine , she stood up , within 30 seconds to 1 minute the patient fainted, the intern and the mom held on to her but she still fell to the ground . After talking to her she did not eat that morning, she did not have reactions to medicine or vaccines in past but she did faint in the past from a blood draw . As I was calling 911 patient came to. She was alert. Fire department paramedics checked her out and she was ok when she left . Patient was counseled to follow up with doctor.
23 2021-04-27 skin turning blue, blood pressure increased, chest discomfort, sinus rhythm, body temperature decreased This is a spontaneous report from a contactable consumer. A non-pregnant 23-year-old female patient ... Read more
This is a spontaneous report from a contactable consumer. A non-pregnant 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on left arm on 11Apr2021 15:45 (Batch/Lot Number: ER8733) at single dose (at the age of 23 years old) for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. Concomitant medications included mometasone furoate (ASMANEX), levocetirizine and montelukast, all taken for an unspecified indication, start and stop date were not reported. The patient experienced wit in 10 min extreme weakness, loss of vision with complete pupil dilation not exceeding 5min and without losing complete consciousness. Once vision restored, profuse sweating, pressure cranial to thoracic inlet with moderate difficulty swallowing water. Paramedics arrived. Taken orally 25mg Benadryl. Cyanosis of nail beds and lips, poor perfusion to distal extremities, low temp, normal sinus rhythm, clear lungs, BP 137/89 and pulse 92, all on 11Apr2021. Seen at urgent care within the hour, deemed adverse reaction, ruling out allergic reaction Further concern for possible adverse reaction with second dose. Seeking consult with primary care physician, The patient had no COVID-19 prior vaccination and no COVID-19 test post vaccination. The outcome of the events was recovered on an unspecified date.
23 2021-04-28 lightheadedness Pt received first dose of pfizer covid-19 vaccine and experienced vasovagal episode within a few min... Read more
Pt received first dose of pfizer covid-19 vaccine and experienced vasovagal episode within a few minutes. Pt endorsed lightheadedness and dizziness, was escorted out of her vehicle, and was guided to lay down. Pt was then offered juice and ice cream, and made a full and spontaneous recovery.
23 2021-04-28 fainting 15 minutes after vaccination. Patient felt light headed and fainted for couple seconds. She returned... Read more
15 minutes after vaccination. Patient felt light headed and fainted for couple seconds. She returned to consciousness immediately and sat down for an additional 20 minutes before heading out.
23 2021-04-29 chest pain Client complain of dizziness, chest pain and hard to breath. Seen by EMS, took vitals signs no furt... Read more
Client complain of dizziness, chest pain and hard to breath. Seen by EMS, took vitals signs no further treatment required. Stayed for 30 min , left building in no distress accompanied by mother.
23 2021-04-29 loss of consciousness 1-5 minutes after both shots: sensation of mild swelling in throat, in addition to mild dizziness/fa... Read more
1-5 minutes after both shots: sensation of mild swelling in throat, in addition to mild dizziness/faintness which passed after 5-10 minutes (no phobia of needles). Feeling of swelling in throat/difficulty swallowing lasted until about 4 hours after vaccine was given, and was more intense after second dose, though not enough to seek medical attention. In addition, after the second dose, a feeling of prickling/heat on skin, which began within 1-5 minutes of receiving the vaccine and lasted for about 5 minutes after symptoms began. No respiratory effects. No other symptoms which resembled an allergic reaction (itchy mouth, rash, adrenaline rush, etc.)
23 2021-04-29 pallor About 5 minutes after vaccine, pt stated she was not feeling well, felt lightheaded and sweaty. Pt ... Read more
About 5 minutes after vaccine, pt stated she was not feeling well, felt lightheaded and sweaty. Pt appeared pale. Applied cool wet paper towels to pt's neck and forehead, had her take deep breaths. Started to also feel nauseated. Then had her lay on exam table for a few minutes. Pt started feeling better and sat up for a few minutes. Further monitored pt for a total of 30 minutes from the time she said she did not feel well. Pt recovered, color back in face, was able to walk out of clinic area without assistance.
23 2021-04-29 fast heart rate, hypertension Nurse administered vaccine. Paramedics were on site of facility and unsure of how patient fell on fl... Read more
Nurse administered vaccine. Paramedics were on site of facility and unsure of how patient fell on floor. Patient was eventually transported to hospital. Upon talking to paramedics after clinic, they stated patient was tachycardic and hypertensive. Initial complaints of headache/dizziness.
23 2021-04-30 chest discomfort Chest pressure and shortness of breath
23 2021-04-30 loss of consciousness unconscious; seizure; throwing up while unconscious; This is a spontaneous report from a contactable... Read more
unconscious; seizure; throwing up while unconscious; This is a spontaneous report from a contactable other healthcare professional (patient). A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Ew0169), dose 1 intramuscular, administered in Arm Right on 13Apr2021 14:45 (at the age of 23years) as single dose for Covid-19 immunization. The patient is not pregnant at the time of vaccination. There were no medical history and concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that on 14Apr2021 (10:15 PM), the patient was unconscious for about 15 seconds, having a seizure for 5 seconds, and throwing up while unconscious. The adverse events resulted in Emergency room/department or urgent care. There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was recovering.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events loss of consciousness, seizure, vomiting and the suspect vaccine BNT162B2. 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.
23 2021-04-30 loss of consciousness Patient was administered vaccine at 9:30 AM and waited required 15 minutes with no adverse reaction.... Read more
Patient was administered vaccine at 9:30 AM and waited required 15 minutes with no adverse reaction. At 11:50 AM the patient passed out in room.
23 2021-05-02 hypotension 1. Headache the morning after the shot. 2. Sore arm. 3. Cold chills. The first bout started at 5AM a... Read more
1. Headache the morning after the shot. 2. Sore arm. 3. Cold chills. The first bout started at 5AM and lasted for about 20 minutes. The second bout started at around 2:45PM and lasted for around 40 minutes. 4. Low blood pressure. At around 2:20pm I started feeling dizzy and had to lay down. I took my blood pressure, and it was below normal. The dizziness lasted around 30 minutes. I've never had any issues with my blood pressure.
23 2021-05-02 fainting, pallor Pt fainted & was caught by an attendant in the 15 min. waiting area. Taken to Observation area on c... Read more
Pt fainted & was caught by an attendant in the 15 min. waiting area. Taken to Observation area on cot. Pale & diaphoretic. BP110/70 P56 pt states has history of fainting after shots. Rested 20 minutes, eating sweets, alert & active. color good. Released without assistance.
23 2021-05-03 palpitations Constant heart palpitations (day and night), feeling cold and dizzy, insomnia
23 2021-05-03 fainting Syncope episode.
23 2021-05-03 blood clot Menstrual cycle heavy blood clots - my next cycle after the first dose of covid vaccine which I rece... Read more
Menstrual cycle heavy blood clots - my next cycle after the first dose of covid vaccine which I received on 4/14, my period flow was comprised of 2 inch blood clots which I passed for an hour on 4/27. I haven?t passed period blood clots this large since I was 12 years old so I wanted to report it since I happened to get these unusual blood clots the cycle after I got the first dose. I am getting the second dose on 5/5 so I will see if the same results take place. I have reported this to my gynecologist but am waiting on her response.
23 2021-05-04 loss of consciousness Patient, received the 2nd dose of the Pfizer COVID vaccine Lot # EW0167, Expiring 05/04/21 at 1105. ... Read more
Patient, received the 2nd dose of the Pfizer COVID vaccine Lot # EW0167, Expiring 05/04/21 at 1105. EMTs noticed a client on the floor at about 1110 and rushed over to see what was going on. EMT went to tell lead nurse of the incident. The client was on the floor lying down when the EMTs and lead nurse went over to respond. Per report from one of the patients sitting next to patient in the observation area, Patient started leaning forward in her chair, started falling over, and the patient caught her before she could hit her head and slowly helped her to a lying position on the floor. Patient woke up on the floor at about 1111 and did not remember fainting. Vitals were taken at that time, P: 88, SpO2: 100, and BP: 138/96. The client upon waking up was A/O x 4 and stated that she "felt fine." She takes no medications, has no allergies, and has no medical history. The client ate some food in her car right before the appointment and explained that she had 4 shots of espresso in the morning. At about 1115 the client was slowly assisted to a chair in the observation area and was given some water to drink. The client stated that she has fainted before while donating blood about 4 years ago but that this has never happened after a vaccine. Vitals were taken again at 1121, P: 85, SpO2: 99, and BP: 120/78. Vital signs were within normal limits and the client felt "like normal". At 1135 the client verbalized feeling good and ambulated out of the facility and was able to safely drive herself home.
23 2021-05-04 fainting The patient fainted after being administered the vaccine. Patient reported history of fainting at si... Read more
The patient fainted after being administered the vaccine. Patient reported history of fainting at sight of needles. Patient refused EMS and felt fine to leave on her own after resting for 15 minutes.
23 2021-05-05 fainting Systemic: Fainting / Unresponsive-Medium
23 2021-05-05 blood clot I started my period on Tuesday (which has always been incredibly regular and predictable for 5+ year... Read more
I started my period on Tuesday (which has always been incredibly regular and predictable for 5+ years while being on birth control). I have been experiencing heavier bleeding and more clotting than average. My cramps are also worse. This never happens to me, and it only makes sense due to the vaccine. I would like there to be some organization that looks into this because I have not changed anything in my life for this to be happening.
23 2021-05-06 blood glucose increased 1:17 Patient was in the observation area post vaccination on her left arm 1st dose of Pfizer, sudden... Read more
1:17 Patient was in the observation area post vaccination on her left arm 1st dose of Pfizer, suddenly complained of drowsiness, weakness. Patient reported no food since this morning. Patient was attended by the Clinical Team. Vital signs were taken as follows : BP 154/114, HR 129, RR 18, oxygen saturation 97%. Temp 98.2. No palpitation or chest pain noted. 911 was called and came and evaluated the patient. Blood sugar was 118. Patient was advised to have a further evaluation in the hospital or urgent care. Patient was with the family, Issues were not resolved but declined to be brought in the hospital.
23 2021-05-06 fainting, loss of consciousness Fainted, passed out
23 2021-05-06 fainting patient had dizziness, lightly syncope but patient was still conscious (knowing her name, date of bi... Read more
patient had dizziness, lightly syncope but patient was still conscious (knowing her name, date of birth, where she was at..) 10 minutes after getting the vaccine. Paramedics came and checked on patient. Paramedics let patient go home after that
23 2021-05-07 loss of consciousness I got super nauseous.; I really wasn't feeling well; Then I got super hot and sweaty; Then I got sup... Read more
I got super nauseous.; I really wasn't feeling well; Then I got super hot and sweaty; Then I got super hot and sweaty; I passed out.; I had a fever of up to 103.5; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 21Apr2021 08:45 (Batch/Lot number was not reported) (at the age of 23 years old) as single dose for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. Concomitant medication included ibuprofen. The patient previously took septra and experienced allergies (known allergies); and first dose of BNT162B2 on 31Mar2021 08:45 at right arm for COVID-19 immunization. No other vaccine in four weeks. On 22Apr2021, the patient had a fever of up to 103.5 and was down to around 102 by the time of the incident (around 4:00). The patient woke up and was standing for about 3 minutes to refill water when she got super nauseous. She was making her way to the bathroom to throw up, and the next thing she knew she was on the floor. The patient was not sure how long she was passed out for though she had no reason to believe it was long. She tried to sit up, but she really wasn't feeling well, so she laid back down and closed her eyes for a bit. Then she got super hot and sweaty. Once that passed (maybe a few more minutes), she was able to check her temperature and she was down to around 101 and was able to get back to bed. No treatment for the events. No COVID prior vaccination. The patient had not been COVID tested post vaccination. The outcome of the events was recovered in Apr2021. Information about Batch/Lot number has been requested.
23 2021-05-09 heart rate increased, fast heart rate Systemic: Dizziness / Lightheadness-Mild, Systemic: Numbness (specify: facial area, extremities)-Mil... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tachycardia-Medium, Additional Details: numb tongue. bp was 117/85 however hr was elevated trended down from 150 to 134 to 114. pt stopped complaining of numb tongue and heart rate issues after emergency emt arrived. after assessment with emt she left on her own accord pretty quickly, with no complaints
23 2021-05-09 cardiac arrhythmia, chest discomfort, fast heart rate From ED note: Briefly, this is a 23-year-old female with past medical history of not allergies, ast... Read more
From ED note: Briefly, this is a 23-year-old female with past medical history of not allergies, asthma who presents for evaluation of shortness of breath, nausea and chest discomfort following Covid vaccine 30 minutes prior to presentation. Patient received her first dose of Pfizer Covid vaccine this morning, was observed and ultimately started to drive home with mother when she developed shortness of breath, nausea and chest discomfort. These have been progressive. She reports she is not taking her Flovent. No vomiting, no rash, no weakness, headache or dizziness. Remainder of history per note above. Vital signs as noted above (tachycardia, tachypneic). On physical exam, the patient is anxious appearing, hyperventilating; HEENT exam with MMM, clear conjunctivae, normal TMs & clear oropharynx without uvular swelling or edema; neck is supple; cardiovascular exam is stable with regular rhythm, mild tachycardia, no murmurs; pulmonary exam is clear to auscultation bilaterally, good aeration, no wheezes; abdomen is soft, non-tender & non-distended; neurologic exam nonfocal, moves all four extremities, 5/5 strength in upper and lower extremities, carpal spasm of bilateral hands (L>R). My impression is that this patient is having a panic attack given her rapid onset of hyperventilation, chest discomfort, and bilateral carpal spasms. Carpal spasms improved with controlled breathing. Considered anaphylaxis given patient's history, but absolutely no wheezing, rash or significant GI symptoms; no hypoxia; no hypotension. Epi-pen at bedside, but not given. Considered asthma, but no wheezing - patient is not wheezing and has good aeration on exam, she is requesting albuterol, which I think will help with her anxiety surrounding this - 2 puffs given. No evidence of persistent tachycardia to suggest PE (no OCPS). Initial ECG with sinus arrhythmia, one PVC, slightly prolonged QTc 477 - will check repeat. Patient briefly on NRB for comfort - slowly able to be weaned off and during observation in ED, symptoms improving but not completely resolved. Repeat ECG w/ NSR, slightly prolonged QTc 460. Given persistence of symptoms, patient given epi-pen and had almost complete resolution of symptoms within 10 minutes. We will plan to observe for 4 hours post-epi administration. Recommended discussion of second COVID vaccine with primary care provider but may have to avoid given this could have represented a serious allergic reaction. Recommend follow-up with PCP/cardiology for repeat EKG. Admit to Ed Observation Status Diagnosis: Allergic reaction Goals of observation: (1) Ensure continued improvement of symptoms, (2) Improved HR Interventions: (1) CRM, (2) Close monitoring, (3) Frequent exams 5/7/2021 15:00 23-year-old female received COVID-19 vaccine today and after which developed shortness of breath. Initially felt this was anxiety however symptoms persisted. Treated with albuterol as well as epinephrine and observed. Developed shortness of breath and complaints of chest pain after approximately 3 hours of observation. Repeat EKG obtained and is normal. Labs were obtained which demonstrated normal CBC. Normal D-dimer. Normal electrolytes but an elevated TSH (known hyperthyroidism). Treated with cetirizine and steroids with improvement of her symptoms. Discharged with PCP follow-up in 2 days.
23 2021-05-10 arrhythmia Arrhythmia; headache; hypersexuality; worsened muscle/join pain; fatigue; chills; vomiting; worsened... Read more
Arrhythmia; headache; hypersexuality; worsened muscle/join pain; fatigue; chills; vomiting; worsened muscle/join pain; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration, administered in left arm on 22Apr2021, at 14:45 (Lot Number: ER8736) as SINGLE DOSE for covid-19 immunization. Medical history included bipolar I disorder from an unknown date, allergy to cilantro, pollen, and lactose from an unknown date. Concomitant medication included citalopram (CITALOPRAM) taken for an unspecified indication, start and stop date 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 had not been tested for COVID-19. On 22Apr2021 at 16:00, the patient experienced arrhythmia, headache, hypersexuality, worsened muscle/join pain, fatigue, chills and vomiting. No corrective measures were taken by the patient for the reported events. The outcome was reported as not recovered for the reported events at the time of reporting.
23 2021-05-10 palpitations Weeks 1 . Extreme dizziness and headaches. Week 2.- Brain fog, disorientation, double vision, heada... Read more
Weeks 1 . Extreme dizziness and headaches. Week 2.- Brain fog, disorientation, double vision, headaches, depersonalization, dizziness, heart palpitations. Week 3-Brain fog, painful nerve pain in feet, legs, arms, hands. Hand/eye tremors. Double vision, headaches. Week 4-Brain, persistent nerve pain, leg weakness, hand weakness, disorientation , double vision, headaches , depersonalization, persistent tremors.
23 2021-05-10 fainting Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient's roommate called and stated she... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient's roommate called and stated she fainted briefly and asked what she should do. We told her to take benadryl and and to the ER but they didn't. We called back to try and see how she was doing and she never picked up the phone again.
23 2021-05-11 chest discomfort At 2 AM I woke up with a tight and heavy chest. It was difficult to breathe and I used an oximeter t... Read more
At 2 AM I woke up with a tight and heavy chest. It was difficult to breathe and I used an oximeter to check my O2, which showed 99% saturation. I checked my temperature but that was normal, around 97 F. I tried different positions to make breathing easier but the pressure would not lift. Around 3 AM I used my (expired) inhaler. Almost immediately I could feel my chest getting lighter. I used my inhaler again around 10 am. The chest tightness did not lift a noticable amount until around 2 PM. By 5 PM all tightness had subsided.
23 2021-05-11 blood clot My period flow have constantly been pretty normal. But this cycle I am have extremely heavy flowing ... Read more
My period flow have constantly been pretty normal. But this cycle I am have extremely heavy flowing and a lot of blood clots. I normally never have these.
23 2021-05-12 pallor 1100 After receiving first dose Pifzer vaccine and was standing at desk making appointment, 2 minute... Read more
1100 After receiving first dose Pifzer vaccine and was standing at desk making appointment, 2 minutes after actual vaccination felt overwhelming nausea feeling, dizziness, and actual vision blacked out. Within seconds, opened eyes and said, where am I? BP 116/78 P88 R20 Pulse ox 99%. Color initially pale. Registration person states she did not hit her head as she sat to floor on own prior to passing out. 1107 States has history of passing out with any type of procedures. She passed out 2/2018 with Nexaplanon implant for birthcontrol insertion. She also passed out in spring 2019 in grocery store. 1110. Sat up in chair. BP 124/88 P84 R18 Pulse ox 98%. States feeling much better. Skin warm and dry. Color now pink. States feeling better but anxious and shakiness of arms. Benadryl 25 mg po given for anxiety and shakiness. 1130 BP 120/81 P84 R 18 Pulse ox 99%.. 1145 Still recumbent on cot, states symptoms relieved. Has been drinking fluids and ate crackers. BP 123/71 P84 R 18 Pulse ox 99%. Sat up in high fowlers to check orthostatic BP. 123/71 P84 R18 Pulse ox 99% No further complaints at this time. 1215 Left facility. Denies any further complaints. Encouraged to follow up with PCP and advise of recent events.
23 2021-05-13 chest discomfort, troponin increased, inflammation of the heart muscle 4 days after patient received her second COVID 19 vaccine, she developed midsternal chest tightness ... Read more
4 days after patient received her second COVID 19 vaccine, she developed midsternal chest tightness radiating to bilateral jaw and left arm while driving that persisted therefore, she came to hospital for further treatment and evaluation. She was found to have elevated Troponin T 5th Gen and a cardiac MRI was done showing acute myopericarditis. She also subsequently developed EKG changes as well.
23 2021-05-13 chest pain, fainting INTERIM HISTORY (04/02/2021). 1st dose of Pfizer COVID vaccine on April 2, 2021. Urticaria then flar... Read more
INTERIM HISTORY (04/02/2021). 1st dose of Pfizer COVID vaccine on April 2, 2021. Urticaria then flared 11 days following vaccine . Developed more hives during the day. Severe hives and lip swelling then occurred 2 weeks following vaccine. Hives associated with a lot of flushing and were very uncomfortable, burning. Hives did not respond to benadryl or benadryl spray like they usually do. Sunday April 18th patient fainted two times One time she fell, another time she sat down in a chair. Went to ED on Monday April 19th 2021. Driving home from a friends house when skin became very itchy. Then broke out in hives covering entire body. Hives started in trunk and spread to neck/extremities. She later noticed GI issues and then eventually trouble breathing. ED history noted c/o tongue swelling, throat tightness, chest pain and shortness of breath. This was her worst reaction to date since starting her current medication regimen. Called friend to watch her dog and went to ER when she developed trouble breathing. She did not want to use epi pen if she did not absolutely need to use it. They did not end up giving her epi in the ER per her request. She was given IV pepcid and fluids; tryptase level was drawn. Symptoms improved with treatment. Next day she had transient hives but no hives since. Still with some intermittent flushing. Over the last few days she has noticed more uncomfortable flushing of her face . Not something that happens normally. She is not sure if she should get the 2nd COVID vaccine but would feel better if she had both. She had COVID infection in March 2020. She was symptomatic but did not require hospitalization. Rapid antibody test negative in July 2020 at urgent care center in LI.
23 2021-05-13 fainting Dizzy and syncope post vaccine with staring into space for 5-10 seconds. No loss of tone, shaking/cl... Read more
Dizzy and syncope post vaccine with staring into space for 5-10 seconds. No loss of tone, shaking/clonic activity, no falls, no incontinence, immediate return to alert and oriented. States has similar episodes in past with drug intolerance. Had nausea and vomitting with delayed diarrhea s/p the episode of syncope
23 2021-05-14 chest discomfort increase in anxiety to the point of panic attack occurring; Anxiety; Intense abdominal cramping/Abdo... Read more
increase in anxiety to the point of panic attack occurring; Anxiety; Intense abdominal cramping/Abdominal burning/cramps were at an 8 on the pain scale during the worst periods; Abdominal burning/Abdominal burning/cramps were at an 8 on the pain scale during the worst periods; vomiting since the day after the vaccine; Chills; body shakes; periods of chest tightness; shortness of breath; unable to keep food or fluid down; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at Left arm on 25Apr2021 15:15 at first dose, single for COVID-19 immunization in Pharmacy or Drug Store. Medical history included Major depressive disorder, General anxiety disorder and Known allergies to Z-Pak. concomitant medication was none (the patient was not received any medication within 2 weeks of vaccination). Patient was not Pregnant at Time of Vaccination. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported on 26Apr2021 16:45, patient experienced intense abdominal cramping and vomiting since the day after the vaccine. Chills, body shakes, and periods of chest tightness and shortness of breath. patient was unable to keep food or fluid down until she received a prescription for Ondansetron from her doctor. Abdominal burning/cramps were at an 8 on the pain scale during the worst periods. Also an increase in anxiety to the point of panic attack occurring on 28Apr2021. the adverse event result in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. treatment received for the adverse event included Ondansetron and Proair inhaler. Outcome of the events was recovering. Information on Lot/Batch number was available. Additional information has been requested.
23 2021-05-15 fainting Adult female who received her vaccine went to the observation area, became weak and faint. On site E... Read more
Adult female who received her vaccine went to the observation area, became weak and faint. On site EMS that were stationed in the observation transported to local ER. EMS Staff consulted with the patients mother regarding reason to transport, she consented.
23 2021-05-15 superficial blood clot Lost feeling on right side of body, have minimal feeling in left leg. I've developed non epileptic s... Read more
Lost feeling on right side of body, have minimal feeling in left leg. I've developed non epileptic seizures. Developed a superficial blood clot in my right arm. Muscles spasms so bad that my jaw/eyes clenches and I'm unable to swallow my spit. Occasionally I have apnea from the spasming. I cannot walk unassisted due to right side partial paralysis. I have developed a stutter. I cannot lift my right arm above my head nor can i pick up the right leg. I've developed foot drop of both feet.
23 2021-05-16 heart rate increased, fainting I felt dizzy so I grabbed the edge of the bathroom counter, the next thing I knew I was on the bathr... Read more
I felt dizzy so I grabbed the edge of the bathroom counter, the next thing I knew I was on the bathroom floor and couldn't move. My mom said I was out for 1-2 minutes before she found me. I have never fainted before ever. This only happened once. But the following week my heart rate when standing would reach 130-145 bpm. The following weekend I experienced a longer than normal menstrual cycle with heavier bleeding than normal, even while I was still on my birth control.
23 2021-05-17 chest pain After second dose: I was fine for the first day. I got it at 10 am and then around 7pm started feeli... Read more
After second dose: I was fine for the first day. I got it at 10 am and then around 7pm started feeling chills and started to feel sick. A few hours later I got a fever and then got very sore. The next day around 5 pm I got a horrible pain in my upper back and stretched to my chest. It was unbearable. It did not hurt to breathe but it hurt to sit. It hurt in increments. I do not think it was muscular as it didn?t hurt when I moved or stretched. This lasted into the night. Next day, today, all is well. Just sore arm.
23 2021-05-17 low blood pressure, anaemia, haemoglobin decreased 3 days of severe fatigue, dizzy w/ change of position, feeling of her head spinning when getting out... Read more
3 days of severe fatigue, dizzy w/ change of position, feeling of her head spinning when getting out of bed or up from a chair & sometimes when sitting. "feeling confused, trouble concentrating, very tired". Hands feeling cold, not tingling.
23 2021-05-18 nosebleed [May 7] Persistent headache in bottom back of headache, beginning in the morning. Around 5pm, headac... Read more
[May 7] Persistent headache in bottom back of headache, beginning in the morning. Around 5pm, headache intensified and I almost called a doctor, thinking something had ruptured. The next 2 days [May 8, May 9], I experienced a couple nosebleeds.
23 2021-05-20 chest pain The night of vaccine, started with fever, aches and sweats, all resolved by 5/11/21. on 5/12/21 ches... Read more
The night of vaccine, started with fever, aches and sweats, all resolved by 5/11/21. on 5/12/21 chest pain and difficulty breathing began. Was admitted to Hospital that night.
23 2021-05-21 chest pain, chest discomfort Injection site reaction onset about 3 hours following the vaccination. These symptoms include deltoi... Read more
Injection site reaction onset about 3 hours following the vaccination. These symptoms include deltoid muscle pain, deltoid swelling, as well as left scapular and trapezius pain. Exacerbation of asthma 7 hours after vaccination with wheezing, cough with secretions, chest and back pain. Woke up the next morning (5/21) at 8am with 100.7°F fever, body aches, headache, chills, worsened cough with secretions, nausea, chest tightness, chest pain, neck pain, back pain, body aches, and loss of appetite. Injection site symptoms remained the same. After an urgent care visit with a negative covid test, I purchased Severe Cold and Flu medication as well as VapoRub to help relieve my symptoms. I took these as advised per the packaging and my symptoms eased some. On 5/22 I woke up with neck pain, headache and mild cough with no fever and less chest tightness. Injection site and surrounding muscles are still sore but the swelling has gone down.
23 2021-05-22 lightheadedness Patient experienced an episode vasovagal syncope within a few minutes of receipt of vaccine while wa... Read more
Patient experienced an episode vasovagal syncope within a few minutes of receipt of vaccine while waiting the recommended 15 minutes in the waiting area. Patient was seated while episode occurred and hit their forehead on the ground as a result of falling out of chair. EMS was contacted as a result of this
23 2021-05-23 fainting Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Additional Details: patient reported dizziness, and fainted 13 minutes after vaccine administered, paramedics called, helped patient sit on ground to lie down with feet elevated until help arrived, patient refused transport to hospital but had a friend pick her up to avoid driving.
23 2021-05-24 loss of consciousness, pallor 10:25 am vaccine administered, patient observed to be sweaty, losing color in face and losing consc... Read more
10:25 am vaccine administered, patient observed to be sweaty, losing color in face and losing consciousness at 10:33 am. Pharmacist held head until consciousness regained ( less than 5 seconds). Patient was given water, a candy for possible low blood sugar, 911 was called and pulse, blood pressure and blood glucose were checked. Patient was transported to hospital for monitoring.
23 2021-05-24 loss of consciousness Felt dizzy and had body aches the next day. Went to work and passed out
23 2021-05-24 fainting syncope, nausea, feeling of going to pass out, sweating hot. sat and drank water. was fine but had h... Read more
syncope, nausea, feeling of going to pass out, sweating hot. sat and drank water. was fine but had her mother come and take her home
23 2021-05-25 chest discomfort swelling of my lymph node under my armpit on the same arm as my shot; chest started to tighten a bit... Read more
swelling of my lymph node under my armpit on the same arm as my shot; chest started to tighten a bit; body aches; chills; fever persisted for 24 hours and surpassed 100.4; lymph node pain; headache; fatigue; This is a spontaneous report from a non-contactable consumer. A 23-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Feb2021 10:45 (Batch/Lot number was not reported) (at the age of 23) as single dose for covid-19 immunisation. Medical history was none. No known allergies. There were no concomitant medications. The patient experienced swelling of my lymph node under my armpit on the same arm as my shot on 17Feb2021 22:00, chest started to tighten a bit on 17Feb2021 22:00 with, body aches on 17Feb2021 22:00, chills on 17Feb2021 22:00, fever persisted for 24 hours and surpassed 100.4 on 17Feb2021 22:00, lymph node pain on 17Feb2021 22:00, headache on 17Feb2021 22:00, fatigue on 17Feb2021 22:00. No treatment received. No COVID prior vaccination. No COVID tested post vaccination. Most symptoms subsided after 36 hours, but lymph node pain, headache, and fatigue persisted for a bit longer. The outcome of fever was unknown, of the other events was recovered on an unknown date No follow-up attempts are possible; information about lot/batch number cannot be obtained
23 2021-05-25 chest discomfort pt experiencing fever, HA, and chest tightness
23 2021-05-25 chest pain the back of her tongue felt numb/developed a numb tongue; throat was itchy then sore/her throat was ... Read more
the back of her tongue felt numb/developed a numb tongue; throat was itchy then sore/her throat was sore and itchy; throat was itchy then sore/her throat was sore and itchy; chest pain; not quite normal breathing/uncomfortable breathing/heavy breathing that was more of an irregular breathing; Fatigue; her lungs felt swollen; This is a spontaneous report from a Pfizer-sponsored program via a consumer reported for a patient (reporter's mother). A 23-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 17Apr2021 (Lot Number: EW0162) (at the age of 23-year-old) as single dose for covid-19 immunization. Medical history included asthma and diagnosed at age 2, allergy and allergy to bull dogs. Concomitant medications included budesonid taken for allergy, start and stop date were not reported; formoterol fumarate dihydrate taken for allergy, start and stop date were not reported. The patient experienced her lungs felt swollen in Apr2021, the back of her tongue felt numb/developed a numb tongue on 17Apr2021, throat was itchy then sore/her throat was sore and itchy on 17Apr2021, chest pain on 17Apr2021, not quite normal breathing/uncomfortable breathing/heavy breathing that was more of an irregular breathing/out of breath walking up the steps on 17Apr2021 and fatigue on 17Apr2021. A family member had some reaction to the first pfizer covid-19 vaccine. Wanted to know where can she find information to determine if the second vaccine shot is safe. 40 minutes from the time of the injection the back of her tongue felt numb and her throat was itchy then sore. About 40 minutes after that those symptoms went away. Later in the day she had chest pain and not quite normal breathing. After using her asthma inhaler twice in a short time this dissapated. Fatigue remained for about a week. Her daughter was prescribed Metronidazole 500mg (she initially thought it was penicillin) and the packaging information of the antibiotic says not to receive any vaccines. She was scheduled for her second dose next Tuesday (18May2021) and wanted to know if it would this be applicable to the Pfizer BioNTech Covid 19 vaccine. Mother calling on behalf of daughter who received the first dose of the Pfizer BioNTech Covid 19 vaccine on 17Apr2021. She was told to wait 30 minutes after the vaccine and was okay, however after 40 minutes after the vaccine she developed a numb tongue, her throat was sore and itchy. This subsided within about 30 minutes (also reported as 40 minutes). About 4 hours after the vaccine she developed chest pain and uncomfortable breathing. Her daughter states her lungs felt swollen, and was out of breath walking up the steps. She did use her AuviQ and albuterol inhaler and the first dose of AuviQ didn't work so she repeated it and it helped. She called the doctor and used her peak flow meter and the doctor on call stated that her reading was okay and did not need further medical attention. After that evening those side effects went away. Caller has a past medical history of asthma and allergies to bulldogs. If she was even around someone who has been near a bull dog she will develop chest symptoms. Mother spoke with CDC and they told her as long as her daughter didn't go to the ER it was okay for her to receive the vaccine and wanted to know if she get her second dose of the Pfizer BioNTech Covid 19 vaccine. She is scheduled to receive it next Tuesday (18May2021). Her doctor said that some people react to the polyethylene glycol and want to know if she could get tested for that. After the patient received the vaccine, her tongue was numb and her throat was sore and itchy but it went away. This started 40 minutes after the patient received the vaccine. 4 hours after the patient received the vaccine, she had chest pain and heavy breathing. The caller is nervous because the patient has only had this chest pain during a severe allergic reaction in the past. The patient do about the second dose. The patient was also prescribed an antibiotic this week and the antibiotic paperwork said not to have any vaccines while taking that product. The patient is due for the second dose of the vaccine this week, is it okay to get because she will still be on the penicillin. This event happened after receiving the first dose of the vaccine on 17Apr2021. The patient also had fatigue for a week. The patient had the heavy breathing that was more of an irregular breathing. The patient's lungs felt swollen, it felt like there was weight on her chest, it was uncomfortable breathing. The caller felt out of breath walking up the steps. The caller used her inhaler twice. The patient underwent lab test included investigations: the on call doctor had the patient do the peak flow meter and it was fine, over 550 on 17Apr2021. No more information was available. The doctor also had the patient press her chest to see if there was pain when she touched it and there was not so the on call doctor felt comfortable not making the patient go to the emergency room. Caller reports that her daughter received her first vaccine dose on 17Apr2021 and afterwards experienced a severe reaction with symptoms including, tongue swelling, sore throat, and Chest pain. Caller reported that it didn't getm severe enough for her to need an Epi pen. Caller reports that they have an appointment to see her doctor as well, for further discussion. She calls today to ask if symptoms with the second dose are expected to be worse than they were with the first shot and timing of the second dose. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID- 19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. The outcome of the event her lungs felt swollen was unknown, the event fatigue was recovered in Apr2021, the other events was recovered on 17Apr2021. Information on lot/batch is available; further information has been requested.
23 2021-05-25 chest pain One day after I received the Pfizer shot, in my left arm, I started to experience sharp chest pains.... Read more
One day after I received the Pfizer shot, in my left arm, I started to experience sharp chest pains. I was not able to take deep breaths without shooting pain, and the left side of my chest was sore. The sharp chest pain lasted for a day, but I am still experiencing soreness.
23 2021-05-27 loss of consciousness Headaches beginning Apr 21-25 Pain through right thigh Apr 24 Headache Bursts on right side of head ... Read more
Headaches beginning Apr 21-25 Pain through right thigh Apr 24 Headache Bursts on right side of head began Apr 26- now Drowsy beginning Apr 26-now 1 sec blackout while sitting up on Apr 26 Side pain in upper right abdominal area beginning May 13 General malaise continues everyday Shooting leg pain continues through right thigh
23 2021-05-28 chest discomfort Chest tightness; hard to breathe; Vomiting; This is a spontaneous report from a contactable consumer... Read more
Chest tightness; hard to breathe; Vomiting; This is a spontaneous report from a contactable consumer. A 23-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in Arm Left on 25Feb2021 11:00 (Batch/Lot Number: EL3247) as single dose, for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced drug hypersensitivity. Patient received first dose of bnt162b2 for covid-19 immunisation on 04Feb2021 01:00 PM (Lot number: EL3247) in left arm. On 26Feb2021 01:45 AM, patient experienced chest tightness to the point it was hard to breathe and vomiting also occurred. Outcome of events was recovering. No follow-up attempts are possible. No further information is expected.
23 2021-05-28 chest pain, inflammation of the heart muscle Myocarditis; chest pain, troponin leak, peaked at 0.12. Improved w/ Maalox and Famotidine, essential... Read more
Myocarditis; chest pain, troponin leak, peaked at 0.12. Improved w/ Maalox and Famotidine, essentially self-limited.
23 2021-05-31 chest pain Sore arm; chest pain; body aches; This is a spontaneous report from a contactable consumer (patient)... Read more
Sore arm; chest pain; body aches; This is a spontaneous report from a contactable consumer (patient). A 23-years-old non-pregnant female patient received bnt162b2 (Pfizer, Solution for injection, Lot Number: EL3248), dose 2 via an unspecified route of administration, administered in arm left on 02Feb2021 04:15 (at the time of 23-years-old) as second dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient had not covid. Post vaccination, the patient had not testet covid. No other vaccine received in four weeks. The patient previously took bnt162b2 (Pfizer, lot number: EL3248) on 14Jan2021 04:45 (at the time of 23-years-old) am in left arm dose 1 for covid-19 immunisation. The patient experienced sore arm, chest pain and body aches on 02Feb2021 12:00. The patient not received treatment for events. The outcome of events was recovering. No follow-up attempts are needed. No further information is expected
23 2021-05-31 loss of consciousness Patient seemed fine after dose then complained of feeling dizzy. She passed out after sitting down.
23 2021-06-01 fainting Systemic: Chills-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Syste... Read more
Systemic: Chills-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Mild, Systemic: Weakness-Medium, Additional Details: EMT and paramedics came
23 2021-06-01 fainting Syncope, several events with associated severe headaches and fatigue.
23 2021-06-02 deep vein blood clot, pulmonary embolism Went into ER with leg pain the night of 5/14. Admitted into ICU 5/15 for deep venous thrombosis in t... Read more
Went into ER with leg pain the night of 5/14. Admitted into ICU 5/15 for deep venous thrombosis in the leg and pulmonary embolisms in the lungs. Symptoms in leg started a few days prior to admittance. Was put on Heparin via shot and then IV. Clotting grew worse overnight with leg swelling, leading to an inability to walk. After increased elevation leg improved and was put on an oral dose of Eliquis. Was put on oxygen in the ICU and took portable oxygen home when discharged on 5/17. Also tested positive for strep 4/11. Was advised to file a report by my PCP.
23 2021-06-03 chest discomfort Pt had a scheduled appt at 1235 pm for her 2nd dose of pfizer covid vaccine on 6/4/21 at our store .... Read more
Pt had a scheduled appt at 1235 pm for her 2nd dose of pfizer covid vaccine on 6/4/21 at our store . Pt stated that she had some "chest tightness" shortly after the first dose (~4/24/21). After reviewing VAR filled out by patient today, I consulted with pt about having a reaction to the first dose. Pt stated that EMS observed her for 30 minutes after the 1st vaccination and patient self-reports that she recovered without the use of an epi pen (pt does carry an epipen on her at all times) within that 30 minute window and was allowed to leave. We administered 2nd dose with the understanding that patient recovered from 1st dose with no breathing difficulties or swelling of tongue or throat (just chest tightness as reported by pt). After administering the second dose today, Pt began to show signs of an allergic reaction ~ 5 minutes after administration and we administered the epi-pen and 911 was called. Observed that pt vomited and complained of chest tightness, tight throat , difficulty breathing and being hot and "sleepy" after second shot. Pt appeared to be alert and oriented and was sitting in a chair. EMS arrived and pt is now under their care. We dont know the lot number of the 1st covid vaccination but the lot used today was EW0167 with an expiration of 8/31/21.
23 2021-06-05 fainting, fainting Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Mild, Additional Details: fainted immedia... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Mild, Additional Details: fainted immediately after injection
23 2021-06-06 heart rate increased, blood clot 2/23 vaccination Within 12 hours, I started shaking, spiked fever, HR increase, SOB, out of body exp... Read more
2/23 vaccination Within 12 hours, I started shaking, spiked fever, HR increase, SOB, out of body experience, scary experience. Called 911 transported to ER. Monitored cardiac unit for 24 hours, HA. Two months of HAs. I went home and I don't recall exact how everything transpired. I do remember they wanted follow up with PCP. I developed blood clots in R arm, platelets were high since getting vaccinated. *originally diagnosed with colitis but now diagnosed with Chrohns disease. 1/16 I did have a personal injury in a parking lot that exacerbated the issues, I was vaccinated after. *In transition with new doctors now and have not really discussed the potential of this being caused by vaccine, focused more on pain management. **before this vaccine, I was relatively healthy before, no issues.
23 2021-06-06 lightheadedness, heart rate increased, loss of consciousness Patient ,, was vaccinated at approximately 2:15pm today at Vaccine Clinic. While in the observation... Read more
Patient ,, was vaccinated at approximately 2:15pm today at Vaccine Clinic. While in the observation area post-vaccine, patient lost consciousness at approximately 2:20pm for 60-90 seconds. Patient was not nervous, did not feel dizzy, nauseous, or feel she had an allergic reaction to the vaccine. Patient is an employee of Environmental and was accompanied by a co-worker. PA evaluated the patient, initial pulse rate was 104, a few minutes later was 87, then rose again to 97.BP was 125/78. Patient reported feeling weak and cold, has not eaten or had anything to drink today except a cup of coffee and cookies in the morning. PA assessed the patient vasovagaled due to dehydration, not due to a reaction from the vaccine. Patient drank 3 small bottles of water, ate saltine crackers and a granola bar. EMS was called and we attempted to cancel as the nurse was going to take the patient to ED, but EMS arrived on site already, assessed the patient and the patient refused to go to the ED by nurse or EMS. Patient was observed until 3:12pm and went home in an Uber. Patient info: Appointment #D11KA5Q
23 2021-06-06 pulse abnormal, pallor, loss of consciousness Patient received (Pfizer) Covid vaccine on this date at 10:25 AM. Patient alert, oriented after vacc... Read more
Patient received (Pfizer) Covid vaccine on this date at 10:25 AM. Patient alert, oriented after vaccination, walked with mother to lobby for monitoring without difficulty. Patient returned to exam room with assistance of staff member stating that she felt lightheaded at 10:28AM. Patient assisted to chair, talking to staff, then became pale, and began to lose consciousness. With assistance from their doctor, patient was lowered to floor and legs elevated. BP 89/58, P72, sp02 98% on room air. Patient pale, diaphoretic, pulse stable but thready. Once lowered to floor and bilateral lower extremities elevated, patient alert and oriented. Patient attempted to stand with assistance from staff at 10:32 and noted with loss of consciousness again, lowered to floor and bilateral lower extremities elevated by nurse and MD. Patient immediately regained consciousness once lying on floor with extremities elevated. Patient alert and oriented x3, talking with staff without difficulty, mother by side. EMS contacted for transport to ED for evaluation and treat. Patient kept lying with lower extremities elevated. Vital signs at 10:35am BP 90/60, 87, sp02 98%. Patient monitored continuously by nurse. Vital signs at 10:44am BP 97/66, P80, Sp02 100% on room air. Patient alert and talkative. Denies pain. Cool compress applied to forehead. Denies any complaints at this time. EMS arrived and patient transported to ED at 10:47. Report called to nurse in ED at 10:58am.
23 2021-06-06 blood clot, palpitations, loss of consciousness 4/30 - Five minutes after the vaccine, I passed out. I felt uncontrollably shaky and my vision went ... Read more
4/30 - Five minutes after the vaccine, I passed out. I felt uncontrollably shaky and my vision went white. I was not anxious prior to getting the vaccine and felt terror afterwards. 5/1 - I developed severe depression and suicidal ideation. I reported to those around me that I did not feel safe. I am not diagnosed with depression and did not experience depression prior to the vaccine. I felt suicidal, completely hopeless, anxious, and was uncontrollably bursting into tears without an identifiable trigger. 5/2 - I developed shooting pain in my legs and arms. It felt like a pulsating, stabbing pain that throbbed. It was unlike any pain I had experienced ever before. 5/3 - I developed a metallic taste in my mouth that could not be washed away with water or food. It was extremely noticeable. 5/4 - My period came a week early. I have been on birth control for seven years and have never experienced any changes in my menstrual cycle. I made no other lifestyle or health changes other than the vaccine. The period was extremely heavy, full of clots, and was painful. It lasted longer than usual, until about 5/9. 5/16 - I developed another period only a week after the first period. This period was equally as heavy and long-lasting. It remained until about 5/21. Following the vaccine, I began suffering from heart palpitations, leg cramps, and random pains. I did not experience these prior to the vaccine. I cannot identify the date these symptoms began, but it was within the first week of taking the vaccine.
23 2021-06-07 loss of consciousness Patient received vaccination and was told to sit in waiting area for observation. Patient chose to s... Read more
Patient received vaccination and was told to sit in waiting area for observation. Patient chose to sit in car in parking lot. Family member ran inside to alert pharmacy staff that patient had passed out and might be having seizure. Patient was unconscious for approximately a minute. Patient was awake when staff went outside. Patient requested an ambulance be called. Family believed it might have been because she hadn't eaten since breakfast. Paramedics arrived and took patient to hospital.
23 2021-06-07 blood clot About three days after vaccine, I started bleeding and getting blood clots. I went to ER to make sur... Read more
About three days after vaccine, I started bleeding and getting blood clots. I went to ER to make sure I wasn't miscarrying. I wasn't that day. Everything looked okay. Baby was measuring much smaller than it should be. I kept bleeding lightly for a couple of days. Tuesday I was bleeding heavily - I went to ER again. Hormone levels - were going up but not as they should be. From Tuesday - Friday, I didn't bleed. I started bleeding on Saturday again. And I'm still bleeding. I called my OB today and she is going to call me back in the morning to let me know what to do. I was last seen on Friday at ER again. Pregnancy History - One other pregnancy - carried twins fine. Estimated date of delivery for this pregnancy - January 17, 2022.
23 2021-06-09 loss of consciousness, pallor pt says she started feeling pain around the injection site. She then felt dizzy, had blurred vision... Read more
pt says she started feeling pain around the injection site. She then felt dizzy, had blurred vision and was nauseated. Her eyes were half shut and then she blacked out. She then had a seizure with shaking and convulsions. She came to and felt weak and was clammy feeling and was pale. Her hand arms and hands were tingling. Paramedics took her to ER. They took vitals, did CT and lab work. She was discharged to go home and FU w/ PCP. On 6/10/21 she saw PCP where they did more lab work. Her 2nd dose is scheduled on 6/29 at her doctors office where she will have medical supervision. Pt says she is feeling better today but still has pain from where she fell when having the seizure.
23 2021-06-09 fast heart rate, heart rate increased heart rate randomly increased to 180 BPM. 200-300 BPM in the ambulance; SVT; light-headedness; This ... Read more
heart rate randomly increased to 180 BPM. 200-300 BPM in the ambulance; SVT; light-headedness; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 06May2021 17:45 (Batch/Lot Number: EW0182) as 2ND DOSE, SINGLE for covid-19 immunization. Medical history included premature menopause from an unknown date and unknown if ongoing. Patient previously received the first dose via an unspecified route of administration, administered in the left arm on 15Apr2021 08:00 (Batch/Lot Number: EW0169), for covid-19 immunization. The patient's concomitant medications were unspecified (there are medications that the patient received within 2 weeks of vaccination). On 07May2021 18:45, the day after the second shot, patient's heart rate randomly increased to 180 BPM. 200-300 BPM in the ambulance. The ER cardiologist thought it was a SVT. She also had light-headedness. Events resulted in Emergency room/department or urgent care visit. Outcome of events was unknown. No follow-up attempts are needed. No further information expected.
23 2021-06-09 fainting Passing out five minutes after dose, extreme dizziness for 24 hrs and randomly passing out. Numbness... Read more
Passing out five minutes after dose, extreme dizziness for 24 hrs and randomly passing out. Numbness, which after about 10 hrs turned into extreme tingling sensation in feet, legs, hands, arms, face and neck. Tingling sensation is still present to this day 2 months after first vaccination however it comes and goes, especially present under periods of stress which never happened before until I received the vaccine. I haven?t not received the second dose because I?m too scared I will completely lose feeling in my body and it will never returner I will develop Guillian-Barre syndrome as a result.
23 2021-06-09 cardiac arrhythmia Fatigue; confusion; injection site pain (moderate to severe, mild when treated with tylenol, ice, an... Read more
Fatigue; confusion; injection site pain (moderate to severe, mild when treated with tylenol, ice, and heat); increased cardiac PVCs; Upper abdominal cramping; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EN6202) via an unspecified route of administration, administered in left arm on 13Mar2021 at 16:00 (at 23 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included Ehlers-Danlos Syndrome-Hypermobility type, fibromyalgia, and severe obesity; all from unspecified date. Known allergies: kiwi, penicillins, and sulfa. The patient previously took cefdinir (OMNICEF), esomeprazole sodium (NEXIUM), and levaquin on unspecified date and experienced allergies. Concomitant medications included sertraline hydrochloride (ZOLOFT), lamotrigine (LAMICTAL), dexlansoprazole (DEXILANT), tethinylestradiol/norethisterone (BALZIVA), norethisterone (CAMILA), and "zerte" (as reported); all from unspecified date for unspecified indication. The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient experienced fatigue, confusion, injection site pain (moderate to severe, mild when treated with tylenol, ice, and heat), increased cardiac PVCs, and upper abdominal cramping; all non-serious on 13Mar2021 at 17:00. No treatment received for the other events. Outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
23 2021-06-10 fast heart rate During monitoring period post initial Pfizer COVID-19 vaccine, pt experienced lip swelling, "ball in... Read more
During monitoring period post initial Pfizer COVID-19 vaccine, pt experienced lip swelling, "ball in throat," itching, lightheaded, sweaty, then chills, dizziness, fatigue, tachycardia, heaviness all over. Medications Given: Epi-Pen injection 0.3ml SC in left thigh, Benadryl 25mg IM for itching given before and after Epi-Pen due to severe itching/rash. Patient has had severe anaphylactic reactions to other vaccines previously that was not disclosed during intake. Patient remained in extended Observation for over 2 hours. VS: 140/82, P-79, Resp 17, O2 97% on RA. Refused to transfer to ER after observation. Later presented to ER with swollen eyes and SOB, rashes, sore throat and took fexofenadine at home. Given additional diphenhydramine 25mg IV and methylprednisolone 125mg IV. Discharged from ED with medrol dosepak.
23 2021-06-11 fainting Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed ... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Vomiting-Mild, Additional Details: Patient stated that she traditionally has needle phobia. She was very worked up after the shot and became feeling dizzy/light-headed. Walked patient over to the bench so she could lie down flat, but we did not make it to the bench before she became week and passed out. She never became unconscious. Pharmacist blunted the fall and held patient head. Soon patient immediately vomited. Felt better and did not want 911. She rested on the bench for 30 minutes and began to feel better and left.
23 2021-06-11 fainting Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medi... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium
23 2021-06-13 chest discomfort, palpitations ED visit, Non-prescription medication, Prescription medication Anaphylaxis Received this first dose ... Read more
ED visit, Non-prescription medication, Prescription medication Anaphylaxis Received this first dose at theme park . PMHx of POTS syndrome who presents to the ED with c/o allergic reaction. Patient reports she received her first COVID vaccination dose earlier today (Pfizer) and about 20 minutes after her vaccine, she developed a flushed face with heart palpitations, chest tightness and shortness of breath. After EMS arrival, she received 0.3mg epinephrine with 50mg Benadryl with improvement in her symptoms. She otherwise denies any fevers, cough or nausea, vomiting or diarrhea. EKG 12 lead; also received Famotidine 20 mg injection/oral, Prednisone 20 mg, Solu-medrol
23 2021-06-14 heart rate increased, chest pain At the time of the first vaccine dose, my heart rate was elevated to over 100 bpm while just sitting... Read more
At the time of the first vaccine dose, my heart rate was elevated to over 100 bpm while just sitting in my car. I was monitored there and cleared to go about my normal life after. In the coming months, I continued to see an elevated heart rate, both while resting and also while exercising especially. In May, I had to go to the the ER after waking up in the middle of the night with a heart rate at 150 bpm, which did not come down for at least an hour. I have also had chest pains routinely now. I am concerned I am dealing with myocardia now.
23 2021-06-16 chest pain Patient had 1st dose Pfizer 6/11/2021 at 1:18pm. She stayed in observation area for 15 minutes with ... Read more
Patient had 1st dose Pfizer 6/11/2021 at 1:18pm. She stayed in observation area for 15 minutes with no reactions noted. Patient left and returned 10 minutes later with complaints of severe to left arm, chest and right foot. Patient also stated she had itching in throat with soreness, however declined shortness of breath/difficulty breathing. No swelling to throat noted, no wheezing present upon auscultation. Patient was administered 10mg of Cetrizine and vitals obtained (BP-138/94, HR-77, RR-18). Injection site assessed- slight warmth noted around site, however no further abnormalities noted. DON and Curative Medical Directors informed of event. Patient informed that 911 will be called as her symptoms could turn into anaphylaxis. Patient refused an ambulance and stated she would take herself to the hospital. Shortly after, patients mom came to site and advised patient to go to hospital via an ambulance. 911 was called as patient agreed, and within 10 minutes, ambulance arrived. During the wait for the ambulance, additional vitals were obtained (BP-154/80, HR-78, RR-16); (BP-118/72, HR 75, RR-16). Once ambulance arrived to site around 2:13pm, a review was done by EMS- they stated patients reaction was mild, however felt it wise patient be brought to hospital for further investigation/observation. Patient agreed and was taken by ambulance at 2:17pm. Patient remained alert and oriented during entire event. At no point did patient state difficulty breathing/shortness of breath.
23 2021-06-17 pulmonary embolism suffered a PE; This is a spontaneous report from a non-contactable consumer via a sales representati... Read more
suffered a PE; This is a spontaneous report from a non-contactable consumer via a sales representative. A 23-years-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 23-years-old, via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included hereditary gene disorder with lupus. The patient's concomitant medications were not reported. The patient experienced suffered a PE (pulmonary embolism) on an unspecified date with outcome of unknown. Her team of physicians treating her acutely, did not feel it was attributed to the vaccine and rather due to a hereditary gene disorder with lupus. Event took place after use of product. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
23 2021-06-20 chest discomfort Patient complained of feeling dizzy, itchy throat and feeling numb, chest tightness and difficulty ... Read more
Patient complained of feeling dizzy, itchy throat and feeling numb, chest tightness and difficulty breathing. Patient was given benadryl 12.5mg/5ml (given 30ml) initially but patient complained of difficulty breathing at that time she was given epipen injection 0.3mg. EMS was called and patient was taken to a local hospital
23 2021-06-22 heart rate increased, hypertension, chest pain Tingling in hands, shaking, inability to sleep, chest paint, numbness in throat, high blood pressure... Read more
Tingling in hands, shaking, inability to sleep, chest paint, numbness in throat, high blood pressure, fast beating heart.
23 2021-06-22 hypertension, heart rate increased, chest pain Tingling in hands, shaking of entire body, numb neck, chest pain, high blood pressure, high heart ra... Read more
Tingling in hands, shaking of entire body, numb neck, chest pain, high blood pressure, high heart rate
23 2021-06-23 ischemic chest pain, heart rate increased Heart pain; Rapid heart beat; Arm pain shooting through arm; This is a spontaneous report from a con... Read more
Heart pain; Rapid heart beat; Arm pain shooting through arm; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm left on 12Mar2021 15:15 (Batch/Lot number was not reported) (at the age of 23 years old) as 1st dose, single dose for COVID-19 immunization. Medical history included allergies to sulfa from an unknown date. The patient's concomitant medications were not reported. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Mar2021 at 20:45, the patient experienced rapid heart beat, heart pain, arm pain shooting through arm. The outcome of the events was not recovered. Information on the batch/lot number has been requested.
23 2021-06-24 chest discomfort Chest pressure, headache, joint pain and tingling sensation that lasted from June 16th until today J... Read more
Chest pressure, headache, joint pain and tingling sensation that lasted from June 16th until today June 25. Visited urgent care on the 20th and was prescribed a high dosage of ibuprofen. EKG came normal. As of June 25, the side effects are slowly wearing off.
23 2021-06-24 chest pain Chest pain, shortness of breath, fatigue
23 2021-06-24 heart rate increased, fainting, palpitations On the day of the vaccine 1st dose Pfizer, about 45 minutes later, I started feeling like I was hav... Read more
On the day of the vaccine 1st dose Pfizer, about 45 minutes later, I started feeling like I was having a heart attack. I had tingling down my arm, increase heart rate, and chest pains. This lasted for a couple of hours. I did not do anything and it went away with time. I did not seek any medical care. I felt well enough and decide to get the 2nd dose. About 2 days after the 2nd dose, I start to get heart palpitations and it was not going away. I was also having syncope multiple times a day. About a month and 1/2 later, I decided to go to the emergency room. I was hospitalized for 4 days. I was tested for many things and everything came back normal. I was prescribed folic acid and lidocaine pain patches for my lower back pain. I am still having symptoms of accelerated heart rate, syncope and heart palpitations. I am to be followed up with a cardiologist and my appt is next month. Lot number of both vaccine doses unknown (it was not on the vaccine card).
23 2021-06-24 fainting Pfizer-BioNTech COVID-10 Vaccine EUA. Patient came to vaccine clinic. Patient told vaccinator that ... Read more
Pfizer-BioNTech COVID-10 Vaccine EUA. Patient came to vaccine clinic. Patient told vaccinator that she has a history of passing out with needles. Vaccinator administered the vaccine, patient was doing well and moved to the monitoring area. Patient was sitting in a chair for 15 minute observation period. She began to have soreness to arm about 5 minutes after sitting down then began to feel lightheaded and immediately had syncopal episode. Staff was present and reported legs shaking and loss of bladder during episode. Patient was lowered to the ground and Rapid Response was contacted. Patient was taken to KU ED.
23 2021-06-25 heart rate increased Sore arm, increased and loud heartbeat, shortness of breath, lightheaded, and tinnitus.
23 2021-06-26 ischaemic stroke Felt dizzy, faint, and hot after 2nd vaccine. Nurse sat with her until she felt better. 5/14/21... Read more
Felt dizzy, faint, and hot after 2nd vaccine. Nurse sat with her until she felt better. 5/14/21, she had an acute ischemic stroke. Many tests ran during 4 day hospital stay including CT scan, MRI, several blood tests, echocardiogram, TEE heart test. Discovered vegetation in heart that they decided must have broken off and caused the stroke that killed about a third of the right side of her brain and there was one time spot on the left side of her brain. Had loss of strength and mobility in upper left side of body (mainly left hand and left side of face). Discharge papers gave diagnosis of acute ischemic stroke and Libman Sacks endocarditis. Blood tests have shown that there was no infection that caused problems. Have been unable to determine cause.
23 2021-06-28 chest pain, heart rate increased Pain in chest, fast heartbeat and shortness of breath. Pain began 6-28-21 at 5pm and has persisted ... Read more
Pain in chest, fast heartbeat and shortness of breath. Pain began 6-28-21 at 5pm and has persisted through today 6-29-21.
23 2021-06-29 chest pain Fever (maximum 102F); chest pain,central breast bone lasting approximately 4 hours; This is a sponta... Read more
Fever (maximum 102F); chest pain,central breast bone lasting approximately 4 hours; This is a spontaneous report from a contactable consumer. A 23-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Right on 30Mar2021 12:30 (Age at vaccination 23 years) as dose 2, single for covid-19 immunisation. Medical history included migraine. Concomitant medications included fremanezumab (AJOVY [FREMANEZUMAB]), depovera. Patient had allergic to amoxicillin. Patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) dose 1 on 09Mar2021 12:30 for covid-19 immunization. The patient was not pregnant at the time of vaccination. 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 31Mar2021 08:30 The patient experienced fever (maximum 102f), chest pain, central breastbone lasting approximately 4 hours. The patient underwent lab tests and procedures which included pyrexia was (maximum 102f) on 31Mar2021. Patient did not receive any treatment. On an unspecified date in 2021, the patient had recovered from the events. No follow-up attempts are needed. No further information is expected.
23 2021-06-29 chest pain some shortness of breath; Chills; body aches (in the chest and the back of the neck; soreness at inj... Read more
some shortness of breath; Chills; body aches (in the chest and the back of the neck; soreness at injection site; Chest ache; increase in shortness of breath (having difficulty standing up and moving around; increase in shortness of breath (having difficulty standing up and moving around; This is a spontaneous report from a contactable consumer (patient self-reported). A 23-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ER8729 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 09Apr2021 at 01:30 PM (age at vaccination: 23 years), as a single dose for COVID-19 immunization at school or student health clinic. The patient's medical history and concomitant medications were not reported. The patient did not have any known allergies and allergies to medications, food, or other products. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EP6955 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 19Mar2021 at 01:30 PM (age at vaccination: 23 years), as a single dose for COVID-19 immunization at school or student health clinic. The patient did not receive any other vaccine in four weeks. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that on 10Apr2021, the patient experienced chills, body aches (in the chest and the back of the neck), soreness at injection site, some shortness of breath, chest ache, increase in shortness of breath (having difficulty standing up and moving around). The adverse events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if patient received treatment for the adverse event. Outcome of the events was recovering. Information on Lot/Batch number was available. Additional information has been requested. Follow-up attempts completed. No further information expected.
23 2021-06-30 blood pressure increased asthma attack; throat began to tighten / throat remained constricted; feel itchy; Dryness of throat;... Read more
asthma attack; throat began to tighten / throat remained constricted; feel itchy; Dryness of throat; hives; extreme fatigue; nausea; mild fever; high BP; dehydrated; This is a spontaneous report form a contactable consumer (patient herself). A 23-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0179) via an unspecified route of administration in right arm on 26May2021 10:00 as dose 2, single (at the age of 23-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient was not diagnosed with COVID-19, prior to vaccination. The patient had not been tested for COVID-19, since the vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as Other. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient medical history included asthma. Patient was highly allergic to wasp venom, mild allergy to other insect venom. The concomitant medications included ascorbic acid (VITAMIN C ACID). Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0171) via an unspecified route of administration in right arm on 05May2021 11:00 as dose 1, single for COVID-19 immunization. Patient did not have any reaction upon first dose. On 26May2021 at 10:10, 10 minutes after receiving vaccine patient experienced dryness of throat which was ignored on account of hot weather. Approximately 20 minutes after receiving vaccine, throat began to tighten and she began to feel itchy. Within 10 minutes afterwards, she experienced an asthma attack which she treated with a Ventolin inhaler. However, her throat remained constricted and hives began to develop. She dissolved 2000 mg of vitamin C in water and drank it after which these symptoms began to recede. She also took 1 dose of Histal medication. Over the following 36 hours she experienced extreme fatigue and nausea, accompanied by a mild fever and persistent itching. She visited centre for diagnosis and was informed that she had a high BP and was dehydrated. She was released 4 hours later and placed on steroids to aid in combatting any remaining histamines. Patient received treatment as ventolin, steroids, Benadryl. The reported seriousness was life threatening. The adverse event resulted in emergency room/department or urgent care. The outcome of the events was recovering. Follow up attempts are needed. Further information has been requested.
23 2021-06-30 chest pain, heart rate increased, hypertension, heart rate increased, chest pain, hypertension Within the first day, my hands felt swollen and would not stop tingling. I had awful chest pain and ... Read more
Within the first day, my hands felt swollen and would not stop tingling. I had awful chest pain and neck numbness 24 hours after the vaccine. Two days after the vaccine, I felt fatigued, had a very rapid heart beat (130 bpm while sitting), and had hypertension (BP: 182/92). I had to go to the emergency room twice due to high blood pressure and a very rapid heart beat (both visits were on the Staurday two days after my vaccine). For 9 whole days after the vaccine, I felt fatigued, no appetite, I was not able to sleep, and I felt lots of chest paint.
23 2021-06-30 palpitations, inflammation of the heart muscle myocarditis; Heart palpitations; This is a spontaneous report from a non-contactable consumer (patie... Read more
myocarditis; Heart palpitations; This is a spontaneous report from a non-contactable consumer (patient). A 23-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration, administered in Arm Left on 14Jun2021 at 05:00 PM (at the age of 23-years-old) as a single dose for covid-19 immunisation at Pharmacy/drug store. The patient medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration, administration on 22May2021 at 09:00 AM (at the age of 23-years-old) as a single dose for covid-19 immunisation. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 14Jun2021, the patient experienced myocarditis, and heart palpitations. Events resulted in emergency room visit. Treatment received was unknown for events. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
23 2021-07-01 deep vein blood clot Approximately 1 week after my second dose of the Pfizer-BioNTech COVID-19 vaccine on May 1st I start... Read more
Approximately 1 week after my second dose of the Pfizer-BioNTech COVID-19 vaccine on May 1st I started experiencing right calf pain. On May 11th, I was diagnosed with a DVT in that same calf.; Approximately 1 week after my second dose of the Pfizer-BioNTech COVID-19 vaccine on May 1st I started experiencing right calf pain. On May 11th, I was diagnosed with a DVT in that same calf. I was ad; This is a spontaneous report from a contactable consumer (patient). A 23-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: EW0172) via an unspecified route of administration on 24Apr2021 (at the age of 23-year-old), as dose 2, single in right arm for COVID-19 immunization. The patient's medical history included migraine, anxiety, and panic attack from an unknown date and unknown if ongoing. Concomitant medication included alprazolam (XANAX), paracetamol (TYLENOL), ethinylestradiol, norethisterone acetate (JUNEL) and Keto Karma Fat Burn Red; all taken for unspecified indications, start and stop dates were not reported. The patient previously took Aimovig and experienced drug allergy. The patient's historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: ER8734) via an unspecified route of administration on 02Apr2021 (at the age of 23-year-old), as single dose in right arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 01May2021 at 17:00, 7 days and 17 hours (approximately 1 week) after the administration of the second dose of vaccine, the patient experienced right calf pain. On May 11th, 17 days after the administration of the second dose of vaccine, the patient was diagnosed with a deep vein thrombosis (DVT) in that same calf. Adverse events resulted in Emergency Room visit and Physician Office Visit. Treatment medication included blood thinners. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome for the events was resolving Information about lot/batch number was provided. Additional information has been requested. Follow-up attempts are completed. No further information is expected.
23 2021-07-01 fainting After waiting 10 minutes patient completely tilts to her right side and is awakened by an employee. ... Read more
After waiting 10 minutes patient completely tilts to her right side and is awakened by an employee. Patient states that she feels dizzy, very warm, whole body was twitching and was sweating profusely. Patient also felt the urge to vomit.
23 2021-07-02 pallor, chest pain Within 5 minutes of administration, patient experienced soreness, stomach ache, and dizziness. Patie... Read more
Within 5 minutes of administration, patient experienced soreness, stomach ache, and dizziness. Patient was given water and advised to sit down. Few minutes later, patient seemed pale and complained of experiencing slight chest pain. I offered the patient to call emergency on her behalf, however patient denied. Eventually, patient agreed and paramedics were called and patient was transferred to the hospital.
23 2021-07-02 fast heart rate Tachycardia; Motion sickness; Numbness of right forearm; Entire body swelling all extremities; itchy... Read more
Tachycardia; Motion sickness; Numbness of right forearm; Entire body swelling all extremities; itchy red rash: face, neck, upper chest, forearms, thighs, back eyebrows; severe frontal occipital lateral stabbing headache; sore & tender body; sore & tender body; chills; blurry vision; light sensitivity; foggy memory; swollen neck/neck was swelling; nauseated vomiting/Nausea and vomiting; nauseated vomiting/Nausea and vomiting; burning sensation; Right upper shoulder discomfort with swelling that goes into her neck; Light sensitivity; having a rash; rash is itching; scaling, and her skin is peeling; scaling, and her skin is peeling; redness; severe headache; This is a spontaneous report from a contactable Nurse (patient's mother). A 23-year-old female patient (daughter) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ER8737 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 07Apr2021 at 11:00 AM (age at vaccination: 23 year) as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine in four weeks. The patient's medical history included anemic, eczema, gastric reflex, known allergies: citrus food, latex gloves, Compazine, Augment, and headaches from concussions. Concomitant medications included Ferrous Sulfate, Diethylpropion HCL, and glucose, sodium chloride (DNS). The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. There was a product complaint to report. On 07Apr2021 12:30, the patient experienced swollen neck/neck was swelling, nauseated vomiting/nausea and vomiting, entire body swelling all extremities, itchy red rash: face, neck, upper chest, forearms, thighs, back eyebrows, severe frontal occipital lateral stabbing headache, sore, tender body and chills. On 07Apr2021, the patient experienced right upper shoulder discomfort with swelling that goes into her neck, light sensitivity, having a rash, rash is itching, her skin is peeling, redness and severe headache. On 09Apr2021, the patient experienced motion sickness and numbness of right forearm. On 12Apr2021, the patient had tachycardia and scaling. When probed to determine when the tachycardia began, the caller mentioned that the tachycardia was noted at the doctor's office. She confirmed the tachycardia began Monday, 12Apr2021. She clarified it was her second doctor's visit so if the caller gave the wrong date, they were able to find it by her records on her second doctor's visit. Caller confirmed with her daughter the tachycardia was still intermittent, it comes and goes. It seems to be that it has improved. She could consider it was medically significant because they didn't know what the root cause was. Her daughter has never experienced tachycardia before being dosed with the Pfizer vaccine. There was not treatment for tachycardia. Her daughter was still having a rash; she was breaking out intermittently. She confirmed she did not report online that her daughter was intermittently breaking out. At that time when she filed the report online, the rash just broke out. At that time, she didn't know if her daughter's rash was going to abate and then re-appear. If so, then she would have had to re-open a new event with a new date and time and rate it. She just looked at her daughter's skin, it's peeling. These were very itchy. Caller then clarified most of these events started the day of the vaccine, 07Apr2021 at 12:30 PM. She confirmed some of these events were reported online on the date of the incident and were still present. The severity of each event was on a grading scale, and right now her daughter's grading scale was 10. Online, the patient couldn't even tell how they really were feeling. The severity of each event needed to be asked. By the lack of getting all the information and the less Pfizer has, the better it looks for Pfizer. When probed for outcome, the caller confirmed the rash was still ongoing and it was medically significant because she was going to have to take her to dermatologist. She has been using hydrocortisone cream as treatment of the rash and it's not working. She did not have the NDC, LOT,EXP for the cream. She explained the skin peeling/scaling has been ongoing. Her skin breaks out in a rash and then becomes really scaly and then it peels. She clarified overall, she had a rash, but the rash was itching, had redness, scaling, and her skin was peeling. On scale of 1 to 10, the caller would rate this event as a 10. She confirmed and that it's continuous/ongoing and had not improved. Stated the rash was not to any localized area on her daughter's body, it's all over. She clarified further the rash can appear on her daughter's eyes, chin, cheeks, forearm, wrist, and leg. The severe headache was reported on the day of the vaccine as well as the rash, too. The severe headache was ongoing; caller gives it a grade 10+. She confirmed the headache was medically significant. It did prevent her daughter from driving a car, reading, or doing activities. Caller added that the headache was also disabling because it disables her daughter from functioning at her normal capacity, she's been hindered. Her normal activities she could not perform if the headache was present. The headache was described as stabbing, excruciating pain and burning sensation. When probed for the outcome of her daughter's severe headache, the caller explains it's in between persistent and worsening. On a good day, it's a grade 8.5. On a bad day, it's a grade 10+. No medical treatment for headache, she was not really allowed to do anything. She was waiting for Pfizer vaccine to wash out of her daughter's system. She explained her daughter was laying low and not introducing any more drugs to enter her body since she had a reaction. Caller again stated they were waiting for Pfizer's vaccine to wash out of her daughter's system because they feel as though something was triggering the rash that keeps appearing and the headaches were still there on a grade level of 10+. Her daughter was afraid to take medications, so they were having to do treatments like hot compresses to her daughter's head and neck, massaging her head/neck/back and turning the lights off. The Nausea and vomiting began on 07Apr2021 and was still ongoing. No treatment for nausea. Her daughter just gets still and goes to sleep. When the headaches were excruciating, it brings on nausea and vomiting. Also, she noticed motion sickness. When her daughter was riding in the car and she was experiencing a headache, she had terrible motion sickness. Caller confirmed the caller never had this motion sickness prior to the vaccine. The motion sickness was still ongoing. Her daughter was not treating the motion sickness in any way. She states maybe her daughter has taken one Zofran because it was so bad. No further details provided. The numbness of the right forearm started on 09Apr2021. She confirms the numbness is still ongoing, it comes and goes, intermittently and did not receive any treatment. On 07Apr2021, her entire neck was swelling, left and right side. The left side was better but the rightnside had intermittent swelling, there was ongoing swelling on the right side of her neck and did not receive any treatment and just rubbing of her daughter's neck. Her daughter also has right upper shoulder discomfort with swelling that goes into her neck that was ongoing. She confirmed this event to be medically significant and it has hindered her daughter's normal activity if her shoulder was swollen too bad and she was hurting. Her daughter just started physical therapy. The light sensitivity was still ongoing. If her daughter was not experiencing a headache, the light sensitivity was pretty good and treatment included dark rooms/ black out. Her daughter was following up with an allergy testing by the allergy doctor. She has to find out if there were any active ingredients in the Pfizer vaccine that triggered her daughter's reaction. Caller stated, "something in the COVID-19 vaccine triggered her daughter's body to react the way that it did". Her daughter also was following up with a dermatologist. Her primary care physician requested her daughter to be followed up with her allergy doctor and to be tested. Caller requested Pfizer's adverse team or someone to call and let the caller know how Pfizer follows up with their patients and how well Pfizer's values each patient. The patient's symptoms have not abated. The events of swelling, nausea, vomiting, tachycardia, motion sickness, hypoaesthesia, musculoskeletal discomfort, photophobia, rash, rash pruritic, skin exfoliation, erythema and headache were considered to be medically significant. The events caused the patient to visit emergency department and physician's office. The patient received IM Benadryl 50mg and IM Solumedrol steroid as treatment for the events. The outcome of tachycardia was recovering and for burning sensation it was unknown, and for all the other events, it was not recovered.; Sender's Comments: There is a reasonable possibility that the events nausea, vomiting, pruritic rash, erythema, and severe headache were related to BNT162b2 based on known drug safety profile and close temporal relationship. The association between the events swelling, tachycardia, motion sickness, hpyoaesthesia, musculoskeletal discomfort, photophobia, skin peeling, and scaly skin with BNT162b2 can not be fully excluded based on temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
23 2021-07-04 palpitations Flashes (feeling like muscle tensing but muscles aren?t actually tensed, disorientation, pressure on... Read more
Flashes (feeling like muscle tensing but muscles aren?t actually tensed, disorientation, pressure on brain) immediately after both Pfizer doses. Heart palpitations 2 weeks after 2nd dose - diagnosed as iron deficiency. Started taking multivitamin/mineral pills with iron and had horrible reaction (felt like it was hard to breath, extreme fatigue and couldn?t even sit up, extreme nausea) went to ER and blood/ekg/chest X-ray all normal. Let go and during the night had blood rushing, neck swelling, flicking lights when eyes closed. Tried 2 different iron pills, same reaction. Went to Er again and all tests negative. Trying to supplement iron through food (week 4-now). In beginning, week 4 - not getting enough iron from food and constantly feeling short of breath and blood rushing (felt like a lot of blood was being pumped at a time even though pulse was normal). Found iron fortified cereal and it helped shortness of breath, but re-triggered flashes. Flashes getting worse in intensity, length, and frequency. Exertion also shortness of breath and not oxygenating properly walking fat and doing anything more exertional.
23 2021-07-08 pallor Patient experienced dizziness, weakness, nausea, and pale skin after receiving her 1st COVID vaccine... Read more
Patient experienced dizziness, weakness, nausea, and pale skin after receiving her 1st COVID vaccine.
23 2021-07-12 fainting Patient fainted in the store a few minutes after receiving the shot. EMS came to evaluate patient; ... Read more
Patient fainted in the store a few minutes after receiving the shot. EMS came to evaluate patient; after drinking water and having a snack, she felt fine enough to return home.
23 2021-07-16 lightheadedness, fainting Patient had a reaction to first dose and came back for second dose. Hospital said she was fine to ge... Read more
Patient had a reaction to first dose and came back for second dose. Hospital said she was fine to get it and it was not a seizure but she should eat before the dose this time. Pharmacist discussed incidence with her and she agreed to wait in lobby for 30 minutes. patient received vaccine and was walked to lobby to sit. She got up a few minutes later to report feeling dizzy. She walked over to consultation window and fainted before pharmacist could reach her. She came to immediately, 911 was called and they said she had a vasovagal reaction. She declined going to hospital as she felt fine and sat for 30 more minutes before leaving.
23 2021-07-16 blood clot Period clotting and heavy period bleeding
23 2021-07-17 ischemic chest pain whole chest hurt, and it felt like the pain was stemming from my chest or my heart more to be exact;... Read more
whole chest hurt, and it felt like the pain was stemming from my chest or my heart more to be exact; I think it was minor heart inflamation; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received BNT162B2 (BNT162B2, Solution for injection, Batch number: ER8729) via an unspecified route of administration on 04May2021 at 15:00 (at the age of 23-years-old) in the left arm as dose 2, single for covid-19 immunisation. Facility of vaccination was workplace clinic. The patient medical history included mildly allergic to raw pineapple. Concomitant medications were not provided. The patient previously received first dose of BNT162B2 (Lot Number: EW0161), via an unspecified route of administration, administered in left arm on 13Apr2021 at 15:00 (at the age of 23-years-old) as single dose for covid-19 immunisation with no reaction on previous exposure to vaccine. 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. Since the vaccination, the patient had not been tested for COVID-19. On 05May2021 the patient experienced "my whole chest hurt, and it felt like the pain was stemming from my chest or my heart more to be exact. It was for 3 days after the shot and then it resolved itself on its own. (I think it was minor heart inflammation)". No treatment was received for the events. Outcome of the events was recovered on an unknown date in May2021. Information on Lot/Batch number was available. Additional information has been requested. Follow-up attempts are completed. No further information is expected.
23 2021-07-17 chest pain I started having chest pains. Thought I was having a heart attack.
23 2021-07-18 chest pain 30 minutes post Pfizer COVID-19 Vaccine, burning/warm sensation in chest for 2-3 minutes. No pain. ... Read more
30 minutes post Pfizer COVID-19 Vaccine, burning/warm sensation in chest for 2-3 minutes. No pain. Extreme Fatigue for 4 days post vaccine Severe Cotton Mouth for one week and ongoing Severe loss of apatite for a week and ongoing
23 2021-07-19 blood pressure decreased, heart rate increased Pt tested 6/14 when she presented to Hospital because she could not bring down the high fever, was a... Read more
Pt tested 6/14 when she presented to Hospital because she could not bring down the high fever, was administered IV fluids, and received 3 shots, Azithromycin (antibiotic) & Decadron (steroid). Pt reported feeling weak, having an elevated pulse, & blood pressure drop to 71/54- was discharged when fever came down and BP was at 111/80.
23 2021-07-19 loss of consciousness Approximately 10 minutes after receiving the vaccine, the patient passed out. She was sitting outsi... Read more
Approximately 10 minutes after receiving the vaccine, the patient passed out. She was sitting outside the pharmacy, waiting for 15 minutes as instructed. She was only out for a few seconds and had regained consciousness by the time I reached her. She was given a drink to sip on and she waited for another 20 minutes before leaving. We repeatedly asked her how she was feeling and she said better and said she was ok when she left around 6:30pm
23 2021-07-20 fainting Systemic: Fainting / Unresponsive-Medium
23 2021-07-21 ischemic chest pain, chest discomfort, chest pain Started having chest pain almost immediately the same day. The pain in my heart has become more fr... Read more
Started having chest pain almost immediately the same day. The pain in my heart has become more frequent. The Pain feels deep within my heart. I also feel discomfort in my chest almost all day like my chest is too small for my heart. Breathless. It feels like having a heart attack 3 - 4 times in a week.
23 2021-07-21 chest pain Chest pain comes and goes all day starting from last night until 9pm today. Headache is also another... Read more
Chest pain comes and goes all day starting from last night until 9pm today. Headache is also another symptom.
23 2021-07-25 hypotension Seated in observation room after receiving 1st dose of Pfizer COVID 19 vaccine, pt reported feeling ... Read more
Seated in observation room after receiving 1st dose of Pfizer COVID 19 vaccine, pt reported feeling lightheaded and sweaty. RN elevated her feet onto a second chair facing the patient while 2nd RN obtained vital signs. Pt was hypotensive with BP 72/44. Otherwise vital signs were within normal limits. Pt remained with her feet elevated for several minutes and reported feeling better. Pt tolerated lowering her feet to the floor. BP was 97/67 She ate some of her lunch and then tolerated standing and walking. Left ambulatory, asymptomatic.
23 2021-07-25 fainting Patient fainted several minutes after receiving the vaccination. Patient was conscious and did not ... Read more
Patient fainted several minutes after receiving the vaccination. Patient was conscious and did not hit her head. She was taken out by the paramedics
23 2021-07-26 loss of consciousness Less than 5 minutes following administration patient fell lightheaded and dizzy then passed out. Her... Read more
Less than 5 minutes following administration patient fell lightheaded and dizzy then passed out. Her boyfriend caught her on her way to the floor. She was unconscious for less than 1 minute. Patient then laid on the floor flat on her back for 5 minutes then moved to a chair and sat in an upright position for an additional 15 minutes. Patient then felt better and left the pharmacy.
23 2021-07-27 chest discomfort, heart rate increased flu like symptoms fever, chills which then progressed to headache , rapid heart rate, chest tightne... Read more
flu like symptoms fever, chills which then progressed to headache , rapid heart rate, chest tightness and worsening shortness of breath the next day , patient was advised to seek medical attention at urgent care
23 2021-07-27 chest pain, chest discomfort Really lethargic and fatigued; Tested positive for the Covid virus; Tested positive for the Covid vi... Read more
Really lethargic and fatigued; Tested positive for the Covid virus; Tested positive for the Covid virus; Can't taste or smell; Can't taste or smell; Horrible stomach ache; Diarrhea; Exhausted/really lethargic and fatigued; Felt ill, run down and not herself; Voice was gone and was very cracky; Did not feel good; Throat sore and vocal cords hurting; Throat sore and vocal cords hurting; Freezing cold and had the chills; Freezing cold and had the chills; Woke up in a puddle of sweat and hair was soaking wet and dripping; Nose really runny and super congested; Nose really runny and super congested; Deep cough/a little cough; Feels nauseas; Her energy was very low; She thought she caught the flu and was not thinking that it was Covid; freezing and shaking; She didn't have an appetite the first couple of days; She felt horrible in her chest and it was hard to breathe; Chest sore and felt like pressure on her chest; Chest sore and felt like pressure on her chest; This is a spontaneous report from a Pfizer sponsored program by a contactable consumer (patient). This 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration Arm Left on 25Feb2021 14:00 at age of 23 year-old (Lot: EL9267) as DOSE 1, SINGLE, Arm Left on 19Mar2021 11:00 at age of 23 year-old at DOSE 2, SINGLE (Lot # EN6208) for covid-19 immunisation. Medical history included none. Concomitant Products included ongoing lisdexamfetamine mesilate (VYVANSE) Has been taking since grade 10 at Believes it is 40mg, once daily for Attention deficit hyperactivity disorder. No prior vaccinations within 4 weeks.On 09Jul2021, she tested positive for Covid-19. States that she does not know the exact strain that it was. She is trying to get genome sequencing done so that they can find out. She has one but, she is (withheld) and has a PCP back home. She hasn't given them any info about her having Covid yet. She hasn't called her physician. She saw someone in the clinic. She hasn't told them yet, so she wants to call them first. In the clinic, they assumed it was as sinus infection and the prescribed her with Amoxicillin. She was taking it last week when she didn't know that she had it yet. She is still taking it right now. They gave her nasal spray and she did that for 2 days completely and it is clear now. She had every possible symptom she can think of. On Tuesday, 06Jul2021, she woke up with a horrible stomach ache and diarrhea. When she got to campus, she was more exhausted on 06Jul2021 and just felt ill and run down, not herself on 06Jul2021. Her voice was so gone. She did not feel good on 06Jul2021. She felt like that is probably because she took the vaccine while she was sick. She had all this work to do, so she went through it. She took her Vyvanse medication instead of resting and it almost masked the symptoms but, she felt ok for an hour, then all of a sudden she had to go to bed because she felt so sick. She just thought it was food she had eaten because of her birthday. She had eaten cake and a whole lot of junk food. She usually eats really healthy. She went to clinic that morning to see patients. She also had no voice and it was very crackly/ Voice was gone and was very cracky on 06Jul2021. Her throat didn't hurt, it was just very sore and her vocal chords were hurting on 06Jul2021. It hurt to talk. Those were the only 2 symptoms she had the first day. She felt ill, fatigued and her body started to hurt and she felt really tired. She came home and didn't feel like she usually did. She just felt really sick. She could taste and smell, it was all still there. She is still getting the runs though out the day. She was with family and 2 friends and did not pass anything on to them. They are all vaccinated. That night, she was exhausted and went to bed early, then she was freezing cold, had the chills but didn't take her temperature in Jul2021. She took Nyquil and Dayquil. She woke up again at night and was freezing and shaking and Woke up in a puddle of sweat and hair was soaking wet and dripping in Jul2021. She felt horrible. She thought she caught the flu and was not thinking that it was Covid in Jul2021. That day, she kind of tried to get though school and do work online. She was feeling really crummy. All of those symptoms, she had the next couple of days. Then her Nose really runny and super congested in Jul2021. her throat didn't really hurt but she had a kind of deep cough in Jul2021. This was the last night before she saw the doctor. She had tried going for testing the day before but the lines were 3 hours. She booked a test and a doctor's appointment for the next day because she thought she caught the cold or flu. One night, she woke up again and it was the same, with chills and sweat but, her chest was really sore. It felt like pressure on her chest in Jul2021. It felt not normal, like it was maybe a variant. She was super contagious and vaccines may not be fully effective against them. She felt horrible in her chest and it was hard to breathe in Jul2021. When going up and down the stairs, she would get really tired and was out of breath. She tested at the Drive through. It was a nasal swab in each nostril. That night, 08Jul2021, when she had dinner, she couldn't taste anything or smell anything on 08Jul2021. She thought, it must be Covid. The next day, she went to the clinic and saw a Nurse Practitioner. She made her put her head down to see if there was pressure in the sinuses. She tested her breathing and her lungs, everything was clear. She didn't really think it was Covid. She put her on amoxicillin and has been taking that ever since. She tested positive (09Jul2021) was when she was starting to feel better but really, she was still tired and exhausted. Her energy was very low in Jul2021. She was only really sick for 3 full days. On Saturday, she was really lethargic on 10Jul2021 and fatigued. She knew she was getting better, just not 100 percent. When she knew that it was Covid, if it wasn't for the vaccine, she didn't think she would be able to tough it out. She still can't taste or smell at the moment. She is in self isolation. She feels completely normal. If she hadn't gotten the Covid test, she would have never thought that it was Covid. She feels 90% right now. She is back to studying. Horrible stomach ache and Diarrhea: Did not last very long, would say, like 30 minutes and then it passed. Still has diarrhea every morning but it may because of the amoxicillin. Lethargy and fatigue and all of the other symptoms: They were all on 6Jul2021, 7Jul2021 and 8Jul2021. On 9Jul2021, she started to get better. Treatment included Before Friday, when she saw the Nurse practitioner on 9Jul2021, she started taking the Flonase. She only did it a couple of times. It was fluticasone propionate, Flonase nasal spray and Sodium chloride nasal spray, 1 spray in each nostril. She only did it 3 times since she got it. Her nose was really runny through out the time and super congested. The only thing is that her stomach feels a little nauseous and has a little cough. Her cough has gotten way better, so much better. The nausea/ Feels nauseas didn't happen that often in Jul2021. She didn't have an appetite the first couple of days in Jul2021. Just today, she is a little nauseated but, it may not be Covid. No Emergency Room and Physician Office. She went to the clinic. She barely had any symptoms from the second dose. She looks like she has Covid and it is not good. Was tested prior to getting the vaccine and was negative. Outcome of the event Tested positive for the Covid virus, Nose really runny and super congested, Nose really runny and super congested was unknown. Outcome of the event hard to breathe, Exhausted/really lethargic and fatigued, Felt ill, run down and not herself, Voice was gone and was very cracky, Did not feel good, Throat sore and vocal cords hurting, Freezing cold and had the chills, Woke up in a puddle of sweat and hair was soaking wet and dripping, Deep cough/a little cough, Really lethargic and fatigued, Chest sore and felt like pressure on her chest, Feels nauseas, Her energy was very low, She thought she caught the flu and was not thinking that it was Covid, freezing and shaking, She didn't have an appetite the first couple of days was recovering. Outcome of the event Horrible stomach ache was recovered in Jul2021. Outcome of the event Diarrhea, Can't taste or smell was not recovered. (Parent) Evaluation Comment: Pfizer withheld reviewed this complaint and agrees with the site assignment, investigation decision, classification, sub-classification, and priority. The reported lot number is valid and an investigation will be performed. QA Review & Rationale: The complaint and its classification have been reviewed. No immediate containment actionis required. The complaint, its priority, and its classification have been reviewed and determined to be appropriate. A full investigation will be performed. This is a complaint for lack of effect of lot EN6208 of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE. The initial scope of this investigation is limited to the reported finished goods lot EN6208 pending review of lot genealogy. The investigation will include a review of the returned complaint sample (if received) and reserve samples, if necessary. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EN6208 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EN6208, fill lot EN5338, and the formulated drug product lot EN5329. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The complaint for an adverse event requested by safety with the use of the PFIZER-BIONTECH COVID-19 VACCINE lot EL1283 was investigated. The investigation included reviewing the manufacturing and packaging batch records, retained reference samples, deviation investigations and an analysis of the complaint history for the reported lot and product type. The final scope was expanded to the reported finished goods lot EL1283, fill lot EL1281, and the bulk formulated drug product lot EL1279. A complaint sample or photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. The complaint was not confirmed. Follow-up attempts are completed. No further information is expected.
23 2021-07-28 loss of consciousness She had a history of vasovagal response & let me know ahead of time. Mom was also present. I got an ... Read more
She had a history of vasovagal response & let me know ahead of time. Mom was also present. I got an ice pack, crackers, hard candy & water ready for her. Had her sit in a seat with feet elevated. A few minutes post she said she could feel it coming on & lost consciousness for about 15 seconds. She came back to & we put an ice pack on her neck. Mom & I had her lay on the floor with feet elevated & ice pack on the back of her head. Her color came back & she asked for some water. She said she was much better & we let her lay there for the 15 minutes. Mom & her left 30 minutes after
24 2021-01-05 chest discomfort 2-3 hours after vaccination developed a "weird feeling" or brain fogginess. At 1545 she developed bo... Read more
2-3 hours after vaccination developed a "weird feeling" or brain fogginess. At 1545 she developed body aches, chills, dizziness, and chest tightness prior to falling asleep on her couch. She woke up drenched in sweat and took some Emergen-c. Overnight she developed a headache which woke her up and she took Excedrin. This AM se continues to have body aches, dizziness, and a slight headache, but denies feeling any disorientation now.
24 2021-01-05 fast heart rate I felt very fatigued starting around 6pm. Severe chills began around 9pm, followed by a fever. The f... Read more
I felt very fatigued starting around 6pm. Severe chills began around 9pm, followed by a fever. The fever went from 100.1 to 102.2 over the course of about an hour (11:30pm-12:30pm), at which time I took 400mg of ibuprofen. The fever was 102.1 thirty minutes after taking the ibuprofen. Along with the fever I experienced tachycardia, body and muscle aches, and moderate to severe deltoid pain at the injection site. I believe the fever broke around 3:00am. The fatigue and body aches lasted about 24 hours since they began, but the majority of the rest of my symptoms were gone after the fever. The arm pain at injection site was noticeable and painful for about 72 hours before subsiding.
24 2021-01-06 blood pressure increased, heart rate increased Rapid heart rate >170, flushing, chills, shaking, increased blood pressure
24 2021-01-06 blood pressure increased Patient complained of dizziness and fatigue during 20 minute post injection monitoring period. She h... Read more
Patient complained of dizziness and fatigue during 20 minute post injection monitoring period. She had elevated BP 183/90 and HR 102. Paramedics were called and she was transferred to the hospital for further evaluation.
24 2021-01-06 palpitations, fast heart rate a strong, whole body heat, and flushing; a strong, whole body heat, and flushing; Tachycardia; Palpi... Read more
a strong, whole body heat, and flushing; a strong, whole body heat, and flushing; Tachycardia; Palpitations; This is a spontaneous report from a contactable Nurse. This Nurse reported similar event for 6 patients. This is 3rd of 6 reports. A 24-Year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Pfizer employee reporting on behalf of a friend, reported her friend texted her last night, 30Dec2020, at around midnight. The nurse and 5 other registered nurses she works with, had a serious reaction right after receiving the COVID-19 Vaccine. Caller said she had a strong, whole body heat, and flushing. She said she became tachycardic and had palpitations that lasted a few minutes. Caller said there were 5 other registered nurses that received the COVID-19 Vaccine at the same time and had the same exact symptoms she experienced. Outcome of events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 vaccine cannot be excluded for events flushing, feeling hot, tachycardia and palpitations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-2021001345 same reporter/drug/event, different patient.
24 2021-01-06 fast heart rate Within 25-30 minutes, patient began having "itching in her throat" and tachycardia on assessment
24 2021-01-07 heart rate increased, chest pain Increased heart rate of 124; clammy hands; nausea; calf pain; extreme muscle and joint pain; extreme... Read more
Increased heart rate of 124; clammy hands; nausea; calf pain; extreme muscle and joint pain; extreme muscle and joint pain; shortness of breath; coughing; chest pain; This is a spontaneous report from a contactable Other Health Professional (patient). A 24-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number was unknown, via an unspecified route of administration in the left arm, on 30Dec2020 08:00 at a single dose for COVID-19 immunization. Medical history included asthma and drug hypersensitivity to sulfa. The patient was not pregnant. The patient had not received any other vaccines in four weeks prior to Covid vaccine. The patient's concomitant medications included birth control and multivitamin, both unspecified. The patient experienced increased heart rate of 124, clammy hands, nausea, calf pain, extreme muscle and joint pain, shortness of breath, coughing and chest pain, all on 02Jan2021 12:00 PM with outcome of recovering. The events are reported as non-serious with no treatment received. The patient had no covid prior vaccination. She was not tested for covid post vaccination. Information on the lot/batch number has been requested.
24 2021-01-07 pallor, heart rate increased, blood pressure increased Pfizer-BioNTech COVID-19 Vaccine Patient was administered vaccine at 0951. Patient reports not feel... Read more
Pfizer-BioNTech COVID-19 Vaccine Patient was administered vaccine at 0951. Patient reports not feeling well. Got a rush of feeling very warm and shaky. Upon assessment patient is pale, diaphoretic and has a rapid bounding pulse. Moved patient to exam room where we assisted her to lay down. Hooked her up to vitals machine for a set of vitals. HR-140-150, BP 146/88, O2 100%, R-24. Upon patient laying down she started to complain of her throat feeling hot and tingly. She began to develop a blotchy rash first noted above BP cuff on right arm, but quickly spread up neck and down trunk. Assessed mouth and throat, no swelling of tongue or lips noted. Patient still c/o feeling hot and tingly on neck and all the way down to her legs. Blotchy rash had subsided. HR dropping to 80-90 and BP came down to 124/82. O2 remained 100% throughout. Patient transferred to emergency department.
24 2021-01-08 chest discomfort Chest tightness Shortness of breath on exertion
24 2021-01-08 fast heart rate, hypertension Fever up to 102.9, chills, headache, hypertension, tachycardia, dyspnea.
24 2021-01-11 palpitations Approx 10-15 post vaccine, employee said she felt lightheaded and like her heart was racing. Within ... Read more
Approx 10-15 post vaccine, employee said she felt lightheaded and like her heart was racing. Within 10 minutes she said she felt difficulty breathing, She then vomited. The observation nurse at the clinic administered Epi Pen and called a Code. The employee was transported to the Emergency Dep't and then to intensive care. She was placed on an Epi drip.
24 2021-01-12 chest discomfort fever (101.3 F), chills, very mild headache, very mild chest tightness, body aches. Started around 1... Read more
fever (101.3 F), chills, very mild headache, very mild chest tightness, body aches. Started around 1:00 AM Monday (15 hours after administration). Took tylenol 1000 mg every 4-6 hours. Fever resolved around 4:30 PM Monday. Body aches resolved around 10:00 PM Monday night. Symptoms fully resolved by Tuesday
24 2021-01-12 palpitations Upon receiving vaccination patient began feeling light headed and dizzy. Symptoms later included pa... Read more
Upon receiving vaccination patient began feeling light headed and dizzy. Symptoms later included palpatations.
24 2021-01-13 heart rate increased my normal heart rate is about 57-63 and my heart rate the morning after my vaccine, about 24 hours l... Read more
my normal heart rate is about 57-63 and my heart rate the morning after my vaccine, about 24 hours later, was 98. I was going for a regular follow up visit with my doctor, i was very sleepy, not anxious, my heart rate should have been with in normal limits. its currently 4:43 pm the same day and my heart rate is in the low 90s.
24 2021-01-13 palpitations Patient given 1st dose of Pfizer vaccine to right deltoid by vaccinator on 1/14/2021 at 1322. At 132... Read more
Patient given 1st dose of Pfizer vaccine to right deltoid by vaccinator on 1/14/2021 at 1322. At 1325 patient reports the following symptoms: shaky and also visibly noted shaking of bilateral hands, reports verbally not feeling nervous beforehand of vaccine or needle, throat felt closed at first after vaccinated but then felt improved, states throat felt different, feels heart beat fast and then not. Reported to nurse, writer and once assessed: alert and oriented to person place and time, speech clear, patient sitting at the time, oxygen saturation 98% on room air, pulse varies from 98 to 118. Gave 1 capsule of 25mg Benadryl orally and 911 called. EMS arrived and they evaluated patient, left clinic with EMS at 1410. Writer called ED RN and gave report. Patient left sitting in a wheelchair.
24 2021-01-14 chest pain I had normal symptoms (headache, aches, muscle and joint pain, fatigue) shortly after the injection.... Read more
I had normal symptoms (headache, aches, muscle and joint pain, fatigue) shortly after the injection. Around 5pm, I began feeling worse. I woke up at 1am and started feeling a chest pain: both sharp pains and a dull throb. It continued when I woke up and has throughout the day.
24 2021-01-14 palpitations nausea; headache; palpitation; chills; Fatigued; took my temperature orally and ran a fever of 101.7... Read more
nausea; headache; palpitation; chills; Fatigued; took my temperature orally and ran a fever of 101.7; first dose of bnt162b2 on 18Dec2020 at 12:30 PM, second dose on 05Jan2021 at 16:00; first dose of bnt162b2 on 18Dec2020 at 12:30 PM, second dose on 05Jan2021 at 16:00; soreness/body aches; initially had injection site pain; This is a spontaneous report from a contactable nurse (patient). A 24-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), intramuscularly on 05Jan2021 at 16:00 on Left arm at single dose for COVID-19 immunization in hospital. Medical history included Atopic Dermatitis and had Known allergies with Nickel, Cobalt, Dust Mites, Grass pollen. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications reported as no. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685) intramuscularly on 18Dec2020 at 12:30 PM on Left arm at single dose for COVID-19 immunization at age of 24-year-old. The patient initially had injection site pain and soreness on 05Jan2021. On 06Jan2021 she went to work and was fatigued with body aches, nausea, headache, palpitation and chills during her shift at 07:00 AM. She came home and took her temperature orally and ran a fever of 101.7 that evening on 06Jan2021. She took acetaminophen and managed to lower the fever. As of today 08Jan2021, current complaints were fatigue, body aches, and a headache. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as a result of event fever included acetaminophen. The outcome of the events fatigue, body aches and headache was not recovered; outcome of event Fever was recovered on 08Jan2021; outcome of the other events was unknown. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
24 2021-01-14 fast heart rate, chest pain, hypertension 5 min after vaccine admin pt had 5/10 Chest pain, Hypertensive 166/100, Tachycardia 135. Pt receive... Read more
5 min after vaccine admin pt had 5/10 Chest pain, Hypertensive 166/100, Tachycardia 135. Pt received 25 mg benadryl IM once at onset of symptoms. Resolved at arrival to ED.
24 2021-01-15 palpitations heart racing, hot inside, hives on neck, offered benadryl , which she declined.
24 2021-01-17 chest pain CHEST PAIN WITH COUGH, FATIGUE, CONGESTION, MINOR SORE THROAT,
24 2021-01-17 heart rate increased almost pass out; Chills; nausea; diarrhea; abdominal pain; clammy; elevated heart rate; dizzy; This ... Read more
almost pass out; Chills; nausea; diarrhea; abdominal pain; clammy; elevated heart rate; dizzy; This is a spontaneous report from a contactable consumer (patient's parent). A 24-year-old female patient (pregnant: No) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via an unspecified route of administration on left arm on an unspecified date in Dec2020 at single dose for COVID-19 immunization. The relevant medical history included asthma, migraines and anxiety all from an unspecified date. Concomitant medications included ethinylestradiol, etonogestrel (NUVARING), topiramate (TOPAMAX), verapamil and sertraline hydrochloride (ZOLOFT). The patient experienced chills, nausea, diarrhea, abdominal pain, clammy, elevated heart rate, almost pass out, dizzy, all on 05Jan2021. The patient had no treatment for the events. No covid prior vaccination. The patient underwent lab test included heart rate showed elevated on 05Jan2021, Nasal Swab showed negative on 06Jan2021. The outcome of the events was not recovered.
24 2021-01-18 chest discomfort Reported chest tightness
24 2021-01-18 chest discomfort Systemic: chest tightness, twitching of arms and legs-Mild; symptoms lasted 1 day
24 2021-01-18 chest pain Third day after receiving the vaccine I have been continuously experiencing sparatic and sharp pains... Read more
Third day after receiving the vaccine I have been continuously experiencing sparatic and sharp pains mainly in my chest but also in my stomach and occasionally my back. It mainly shows up in my chest. Sharp and achey pains all in different spots at different times. This has been occurring now for 6 days and has not gotten better with time or any medicine I?ve been instructed to take by physician. Sometimes it throbs, sometimes it aches, sometimes it?s sharp and sudden. There is no consistency other than how painful it is. The pain has gotten more intense this evening 1/19/21. I have not experienced more than a half hour without any pain. It has been ongoing since 1/13/21. I woke up last night at 2:45am with a throbbing pain on the left side of my chest.
24 2021-01-19 palpitations Got COVID vaccine dose #1 around 0740-0745, waited the 15 minutes then was driving home from hospita... Read more
Got COVID vaccine dose #1 around 0740-0745, waited the 15 minutes then was driving home from hospital, throat felt a radiating warmth from the inside, hard to swallow, heart was racing, felt light headed and shakey. Pulled over and called EMS at exactly 0816. Symptoms subsided after 20 minutes. EMS took vitals but did not get transported to hospital.
24 2021-01-19 fainting -fatigue -severe muscle aches -headache -nausea -dizziness/syncope -hot flashes/chills
24 2021-01-20 chest discomfort 45 min after vaccination pt felt she had some tightness in the throat and chest. Unable to different... Read more
45 min after vaccination pt felt she had some tightness in the throat and chest. Unable to differentiate if was caused by her anxiety or the vaccine. After exam in clinic felt improved but still given Benadryl and monitored , no worsening symptoms felt all sx had resolved at the time of discharge
24 2021-01-20 chest pain Headache; muscle cramps; chills; diarrhea; chest pain; This is a spontaneous report from a contactab... Read more
Headache; muscle cramps; chills; diarrhea; chest pain; This is a spontaneous report from a contactable nurse (patient). A 24-year-old non-pregnant female patient received second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL1284), via an unspecified route of administration in the left arm on 10Jan2021 at a single dose for COVID-19 immunization. The patient was vaccinated in a hospital facility. Medical history included irritable bowel syndrome (IBS), endometriosis, chronic headaches, birth control, and sulfonamide allergy (reported as known allergy to Sulfa). The patient had no Covid prior vaccination. Concomitant medications included montelukast and unspecified medication for birth control. The patient previously received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EJ1685) in the left arm on 20Dec2020 17:30 at a single dose for COVID-19 immunization. The patient was tested for Covid post vaccination of the first dose and had negative nasal swab on 01Jan2021. The patient did not receive any other vaccine in four weeks. The patient experienced headache, muscle cramps, chills, diarrhea, and chest pain on 11Jan2021. No treatment was received for the reported events. The outcome of the events was not recovered.
24 2021-01-20 heart rate increased heart rate was 123 when she woke up (resting); temperature showing 101.8; felt a little itchy around... Read more
heart rate was 123 when she woke up (resting); temperature showing 101.8; felt a little itchy around injection site; arm pain; felt sick; Massive headache; stomach cramps; joint pain; the back of her ribs hurt; nausea; couldn't get warm; chills; goosebumps; This is a spontaneous report from a contactable other HCP. A 24-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 09Jan2021 12:00 at single dose on right arm (Lot number: Eu9231) for covid-19 immunisation. Medical history included allergies to Rosemary, sage, and lavender. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). No other vaccine in four weeks. No covid prior vaccination. The patient previously received first dose of BNT162B2 (Lot number: EJ1685) on 12Dec2020 12:00 AM on right arm. The patient experienced felt a little itchy around injection site and arm pain on 09Jan2021 09:00 PM, when she got home and ready for bed she felt sick on 09Jan2021, massive headache, stomach cramps, joint pain, the back of her ribs hurt, nausea, couldn't get warm chills, goosebumps on 09Jan2021. Patient took ibuprofen at 2300. She woke up at 0224 (10Jan2021) with her heart racing and with a fever. Watch showing her heart rate was 123 when she woke up (resting), temperature was taken at 0250 (10Jan2021) showing 101.8 it felt like she was warmer though. Patient took more ibuprofen, ate something, and re temped yielding 100.8, heart rate dropped to 91, then 88 as of 0300. Outcome of events was recovering. No covid tested post vaccination.
24 2021-01-20 pallor 4:28pm vaccinated 4:47pm c/o lightheadedness, weakness; patient placed in semi-reclining chair; brie... Read more
4:28pm vaccinated 4:47pm c/o lightheadedness, weakness; patient placed in semi-reclining chair; brief medical h/o revealed the following: Stated that she has severe allergies to shellfish, nuts, carries epipen; takes Benadryl every night, 50mg for excema; BP 145/88, HRT 87, states breathing fine; denies tightness in chest or difficulty breathing; states she believes it may be due to anxiety, had anxiety prior to being vaccinated. Sips of water tolerated well; patient appears pale, hands shaking. As requested by patient, fiance came up to comfort her 4:56pm patient states she feels lightheaded; given cool cloth for forehead; BP 132/88, HRT 94. States that she ate full lunch, felt nauseous at 2:30pm, believes it was due to anxiety about getting the vaccine 5:01pm BP 142/73; states her mouth feels like it is tingling; given 25mg benadryl liquid by mouth, tolerated well. 5:10pm BP 136/79, HRT 87 Patient requested to use rest room; was wheeled to bathroom with assist to toilet, tolerated well; 5:24pm BP 132/85, HRT 73 5:47pm feels better, BP 131/83, 72 HRT Discharged ambulating, with fiance accompanying and parents outside waiting to drive her home; patient will stay at parents' house tonight.
24 2021-01-20 fainting Syncope approximately 5-7 minutes after receiving vaccination. Patient spontaneously recovered appro... Read more
Syncope approximately 5-7 minutes after receiving vaccination. Patient spontaneously recovered approximately 20-30 seconds later. She had recurrent vomiting over the next hour. She was observed. At no time did she have recurrent syncope of develop rash or respiratory or upper airway symptoms. No medications were administered. Due to her persistent vomiting she was transported to the ER for further evaluation.
24 2021-01-20 fast heart rate, chest pain Migraine (not responsive to medicines), dizziness, chest pain, tachycardia, shortness of breath, bac... Read more
Migraine (not responsive to medicines), dizziness, chest pain, tachycardia, shortness of breath, back pain.
24 2021-01-21 fibrin d dimer increased, pulmonary embolism, palpitations Patient received Pfizer vaccinations on 12/29/20 and 1/19/21. She woke up on 1/20 with hot flashes, ... Read more
Patient received Pfizer vaccinations on 12/29/20 and 1/19/21. She woke up on 1/20 with hot flashes, fatigue and chills. Later in the day she developed a headache. This morning (1/22) as she was walking to her car to go to work she developed dyspnea and palpitations. She had a portable pulse ox and noted HR was 125 and PO2 97%. She went to ED, COVID neg, d-dimer positive, CT chest negative for PE. Potassium was low. Patient was discharged home.
24 2021-01-21 pallor Individual received the vaccine and was initially stable. Approximately 10 minutes after receiving t... Read more
Individual received the vaccine and was initially stable. Approximately 10 minutes after receiving the vaccine, she reported increasing dizziness and became extremely pale with BP 73/44. She became nauseated and vomited. She also reported numbness in the right arm and hand. A doctor was onsite to evaluate. She eventually recived epinephrine 1 amp. She had improving symptoms and remained very pale and shaky. Her BP improved to 94/66, HR 88, and O2 sats 100%.
24 2021-01-21 fast heart rate Pruritis, shaking, nausea, tachycardia, rash to arms, chest and back.
24 2021-01-22 lightheadedness, pallor Patient received 1st dose of Pfizer vaccine. Patient likely vasovagal, blood pressure 56/33 initiall... Read more
Patient received 1st dose of Pfizer vaccine. Patient likely vasovagal, blood pressure 56/33 initially. Patient stated that she almost completely lost her vision. Patient extremely pale and cold and clammy. Patient stated she did eat breakfast this morning and had not had a reaction like this in the past. Patient provided with a sugar source and was placed supine. Blood pressure 105/63. Patient monitored for 30 minutes and sent home.
24 2021-01-23 chest pain, fainting, skin turning blue Nausea, vomiting, fainting, chest pains, arm/hand turned blue. Transported via ambulance to er for b... Read more
Nausea, vomiting, fainting, chest pains, arm/hand turned blue. Transported via ambulance to er for being unconscious
24 2021-01-23 chest pain Chills, body aches, fever, headache, chest pain, pain when breathing, abdominal pain, muscle pain
24 2021-01-24 chest pain, chest discomfort In addition to arm pain for two days, I also had chest pains/tightness. I felt the chest tightness t... Read more
In addition to arm pain for two days, I also had chest pains/tightness. I felt the chest tightness the morning after getting the vaccine. The chest tightness continued until 1/23. It was not a constant pain, but sometimes when I would move a certain way, my chest would hurt. The spot that hurt is right in the middle of my chest. It got worse when I would exercise and breathe heavily. The chest pain continued to stop and come back for several weeks. The night after I received the vaccine, I felt dizzy and felt as if I would pass out, but did not. This only happened one time and was better when I woke up the next morning. The weekend after I got the vaccine, I was worried I might have covid, so I got tested for covid, but the results came back negative.
24 2021-01-24 fast heart rate, blood pressure decreased 5 minutes after injection I got an itchy mouth/ tongue, dizzy/light headed, flushed, tachycardia. I ... Read more
5 minutes after injection I got an itchy mouth/ tongue, dizzy/light headed, flushed, tachycardia. I was monitored for an hour after. Blood pressure dropped slightly less than my normal but not of concern and returned to baseline
24 2021-01-26 heart rate increased Within 11 minutes of receiving my first dose of the Covid-19 vaccine, I became extremely hot and sta... Read more
Within 11 minutes of receiving my first dose of the Covid-19 vaccine, I became extremely hot and started sweating. My face turned bright red and my heart rate increased to 152 beats per minute. My respirations became very labored and my blood pressure was 187/97. I was monitored for 30 minutes afterwards. The nurse placed ice packs on the back of my neck to cool down. She continually monitored my vital signs. Upon leaving my blood pressure was still elevated, but improved.
24 2021-01-27 heart rate increased Rapid heart rate; Feeling shaky and anxious; Feeling shaky and anxious; This is a spontaneous report... Read more
Rapid heart rate; Feeling shaky and anxious; Feeling shaky and anxious; This is a spontaneous report from a contactable nurse (patient). A 24-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number:EL0142, expiration date unknown) , via an unspecified route of administration in the left arm on 14Jan2021 at 09:15 AM at a single dose for COVID-19 immunization. Medical history included COVID-19 on unknown date prior to vaccination, patient had no known allergies. Patient is not pregnant. Concomitant medications included over the counter (OTC) vitamins. The patient had not received other vaccines in four weeks. On 14Jan2021, the patient experienced rapid heart rate noted in the 150s approximately five minutes after receiving first dose lasting only a few minutes and was feeling shaky and anxious. There was no treatment received for the adverse events. The patient was not tested for COVID post vaccination. The outcome of the event rapid heart rate was recovered on 14Jan2021 while the rest of events was unknown.
24 2021-01-27 palpitations, heart rate increased 2:40pm Patient reported feeling "weird" after seeing blood after receiving Pfizer vaccine. Patient's... Read more
2:40pm Patient reported feeling "weird" after seeing blood after receiving Pfizer vaccine. Patient's pulse was elevated and felt her "heart racing" and "nausea". Vitals taken every 5 minutes. Patient given 25mg of Diphenhydramine by mouth. Patient was alert and oriented.
24 2021-01-30 chest pain Arm soreness at injection site worsened throughout the day - continuing for about 15 hours; about 17... Read more
Arm soreness at injection site worsened throughout the day - continuing for about 15 hours; about 17 hours (12:30am) after the injection took place, dizziness, unexplainable arm and chest pains (in the non-injected arm), headache, and fatigue occurred until I went to sleep; I woke up with a fever and fatigue about 7 hours later (8am), went back to sleep, and woke up feeling normal about 4 hours later (12pm)
24 2021-01-31 heart rate irregular, heart rate increased Shaky, throat felt different, felt hear beat fast and then not
24 2021-01-31 loss of consciousness Experienced 20 second tonic seizure w/ loss of consciousness. No prior history of seizures.
24 2021-01-31 lightheadedness After second COVID vaccine, patient had nausea, lightheadness, and newar-syncopal event. Patient wen... Read more
After second COVID vaccine, patient had nausea, lightheadness, and newar-syncopal event. Patient went to the ED for further monitoring and labs were drawn. Patient then discharged from the ED.
24 2021-02-01 palpitations At around 7PM 01/29/2021, I was at the store to get groceries when walking around the store became d... Read more
At around 7PM 01/29/2021, I was at the store to get groceries when walking around the store became difficult due to being out of breathe. When I got home the body aches got worse and I started getting severe chills and could not stop shaking. That night was difficult to sleep because of the pain I was in. When I woke up the next day, 01/30/2021, I was dizzy, severe fatigue, had severe migraines, I could not breathe when standing up and moving around, my heart was racing, and it felt like I had a sun burn all over my body. I called the nursing coordinator for that day and asked what to do and she said to go to the ER. When I arrived at the ER, they said I had 100 degree temp., I was tacky. They gave me medicine for the pain and the doctor said I was having a adverse reaction to the vaccine but by the next day I would feel better. I went home and slept after the ER all day and night and by Sunday 01/31/2021, I was feeling better after excedrine and advil
24 2021-02-01 fainting dizziness and fainting. REsolved completey.
24 2021-02-02 palpitations 4 days after the vaccine, heart palpitations began. I had no prior history of these palpitations. Th... Read more
4 days after the vaccine, heart palpitations began. I had no prior history of these palpitations. They were so frequent to the point where I had to go to my doctor. He heard them with his stethoscope and believed they were Premature ventricular contractions. (PVCs). After almost 3 weeks, they slowly diminished. I just got my 2nd shot today, and I am hoping it does not continue.
24 2021-02-03 hypotension Hypotension; nauseous; dizzy/feeling extremely faint; This is a spontaneous report from a contactabl... Read more
Hypotension; nauseous; dizzy/feeling extremely faint; This is a spontaneous report from a contactable other healthcare professional (patient). A 24-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration in left arm on 16Jan2021 03:30 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient have no known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 16Jan2021 03:30, the patient experienced hypotension, nauseous, dizzy/feeling extremely faint. The patient underwent lab tests and procedures which included monitoring and check of vitals with unknown results. Outcome of the events was recovered on Jan2021. Information on batch/lot number was requested.
24 2021-02-04 chest discomfort Chest discomfort and tightness
24 2021-02-04 chest pain BODY ACHES, CHEST PAIN
24 2021-02-05 chest discomfort Approximately 10 minutes after receiving vaccination I was called to the observation area where pati... Read more
Approximately 10 minutes after receiving vaccination I was called to the observation area where patient was complaining of difficulty swallowing and tightness in the chest. She denied itching, wheezing or difficulty breathing, lightheadedness, nausea, swelling of lips or face or mouth. Also denied history of anxiety. Patient was mildly anxious, not in distress, verbalizing well. No visible urticaria or oral abnormalities, no angioedema. lungs clear heart RR&R. She c/o worsening sense of difficulty swallowing and tightness in chest and was given an EpiPen dose of .3ml IM. She improved thereafter regarding subjective symptoms but became "jittery." paramedics arrived and evaluated her, asked her to stand up (from reclining) and she did well. Approximately 30-40 minutes later she was picked up by family members and asked to follow up with ER, paramedics or PMD as needed. i advised that I did not see a reason to not get the 2nd dose of vaccine . I gave her my name and contact information.
24 2021-02-07 nosebleed, loss of consciousness, fainting Symptom onset within 10 hours after vaccination: Swelling >5cm at injection site, significant pain a... Read more
Symptom onset within 10 hours after vaccination: Swelling >5cm at injection site, significant pain and throbbing in extending down the arm of the injection site, swelling extending down to the forearm. Syncope and loss of consciousness occurred with trauma to the forehead and nose causing nose bleed. Unable to determine how long patient lost consciousness. When patient woke up, she was laying in a pool of blood from nose bleed and patient described shaking/rigors that were only relieved by taking Ibuprofen 800mg Q8H for 6 days. Denies fever. Due to syncope and head trauma, patient suffered concussion with symptoms of HA, blurry vision, difficulty concentrating, and fatigue.
24 2021-02-07 loss of consciousness, hypotension, heart rate decreased felt herself losing consciousness; Low blood pressure following event (50/20); My vision went blurry... Read more
felt herself losing consciousness; Low blood pressure following event (50/20); My vision went blurry first; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 25Jan2021 at 09:30 at a single dose in the workplace clinic for COVID-19 immunization. Medical history included asthma and history of vasovagal syncope following vaccinations; this adverse reaction to the vaccination directly aligns with other episodes that have occurred to her following vaccinations/interactions with needles (ie. blood draws). The patient had no COVID prior to vaccination. The patient is not pregnant. Concomitant medication included levonorgestrel (MIRENA). On 25Jan2021 at 09:30 (after getting the vaccine), the patient felt herself losing consciousness, her vision went blurry first and she was able to brace herself by lying down against a wall, and low blood pressure following event (50/20). Blood pressure and pulse rose over the next 25 minutes. 15 minutes more of observation was completed. The patient did not receive treatments for the events. The patient was not tested for COVID post vaccination. The patient recovered from the events. Information on the Batch/Lot number has been requested.
24 2021-02-09 chest pain Left arm has been sore/ soreness that runs from my shoulder all the way to my hand; Soreness that ru... Read more
Left arm has been sore/ soreness that runs from my shoulder all the way to my hand; Soreness that runs from my shoulder all the way to my hand; Burning inside my upper left arm to my shoulder and chest; Burning inside my upper left arm to my shoulder and chest; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 24-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via intramuscular route of administration, on 11Jan2021 (at the age of 24 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history was none. The patient previously received the first dose of BNT162B2 (lot number/expiration date: not provided) on 23Dec2020 (at the age of 24 years old) at 07:45 PM via intramuscular route of administration as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication (other medications taken in two weeks) were none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks (other than the first dose of BNT162B2) prior to the COVID vaccine. On 18Jan2021 at 07:30, the patient experienced left arm has been sore. The patient described it as "my left arm had been sore this past week of 18Jan2021, it is a soreness that runs from my shoulder all the way to my hand, then goes up again and concentrates from my upper left arm it starts burning inside my upper left arm to my shoulder and chest and stays the burning for a few seconds to a minute". The events were reported as non-serious. The patient did not receive any treatment for these events. The outcome of the events left arm sore, shoulder sore, and burning inside upper left arm to shoulder and chest was unknown. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
24 2021-02-09 heart rate increased Elevated heart rate at rest (125bpm) 24 hours after 2nd dose.; This is a spontaneous report from a n... Read more
Elevated heart rate at rest (125bpm) 24 hours after 2nd dose.; This is a spontaneous report from a non-contactable consumer (patient). A 24-year-old female patient (pregnant: unknown) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 22Jan2021 13:45 at single dose in right arm for COVID-19 immunization. The patient's medical history was none, no known allergies. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 on 07Jan2021 11:45 in right arm for COVID-19 immunization. Facility type vaccine at Hospital. No other vaccine in four weeks. No other medications in two weeks. On 23Jan2021 13:00, the patient experienced elevated heart rate at rest (125bpm) 24 hours after 2nd dose. No treatment received for the event. No COVID prior vaccination and no COVID tested post vaccination. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
24 2021-02-10 loss of consciousness Patient was given second dose. 30 minutes later she sat down on a couch and was breathing short and... Read more
Patient was given second dose. 30 minutes later she sat down on a couch and was breathing short and shallow. She was not responsive and mildly shaking. I gave her an Epipen shot and in less than a minute she was a wake and feeling much better. She drank some water. 911 was not called because her mother was a nurse and was nearby. She came and picked her up and took her to a doctor. I checked on the patient this afternoon and she is feeling fine other than feeling tired. She has a medical history of weight loss surgery and not dieting properly. The administrator of the home said she has a history of not feeling well and almost fainting from not eating properly after her weight loss surgery.
24 2021-02-11 palpitations Chills and fever around 8 hours after vaccine Throwing up and nauseous shortly after (still current... Read more
Chills and fever around 8 hours after vaccine Throwing up and nauseous shortly after (still currently dealing with this on 2/11) Pain between shoulder blades Heart pounding and shortness of breath
24 2021-02-16 heart rate increased From 3:00pm on 1/8 to the morning of 1/12, experienced high fevers, severe body aches, chills, fatig... Read more
From 3:00pm on 1/8 to the morning of 1/12, experienced high fevers, severe body aches, chills, fatigue, night sweats, and headache. My heart rate was consistently in the 110s-120s and my blood pressure was in the 100s/40s. My highest temperature was 103.5. My fiancé is a nurse who took care of me at home. I alternated Tylenol and ibuprofen for the aches and fever. I slept the majority of each day and was unable to perform my activities of daily life or exercise. I lost my appetite for about 1 week. I had no sense of taste in Sunday, which slowly returned over the next week. I was concerned about the loss of taste so I scheduled a COVID-19 swab which came back negative on 1/11.
24 2021-02-16 palpitations Pt was in observation room when she stated to me that she felt dizzy and like her heart was "beating... Read more
Pt was in observation room when she stated to me that she felt dizzy and like her heart was "beating fast." She stated it was approx 5-10 minutes after her vaccine was administered. I explained that I would like to extend her observation time to 30 minutes, and perhaps longer if she didn't feel better then. I offered her water and food. She declined water and asked for "a snack." I re-evaluated her approximately every 5 minutes over the next half hour.
24 2021-02-18 lightheadedness Approximately 10 minutes into waiting after injection, patient stated she felt like she might "pass ... Read more
Approximately 10 minutes into waiting after injection, patient stated she felt like she might "pass out". She then experience into post-vagal posturing with no clonic activity, no loss of bowel/bladder. After approximately 1 minute, she become coherent postictal. BP was 138/87, pulse was 66 bpm. She later reported that she has had a history of a "reaction to needles" but that she did not experience it when she got the flu shot last fall.
24 2021-02-22 chest discomfort She received her vaccine on 2/17/2021 at 7:30 am. Immediately after receiving her vaccine, she start... Read more
She received her vaccine on 2/17/2021 at 7:30 am. Immediately after receiving her vaccine, she started to feel lightheaded and stated she felt shortness of breath. She also felt her chest tight. She said she was monitored at the Vaccination Site for a longer period due to her feeling light headed, shortness of breath, and chest tightness. On 2/18/21, she still felt light headed. She started to feel fatigue and body aches from her waist up. On 2/18/ 21 she still felt lightheaded, fatigue, and body aches from her waist up. She treated these symptoms with ibuprofen. She felt lighted, fatigue. and body aches from her waist up for 48 hours.
24 2021-02-22 pallor, heart rate decreased 0715: pt c/o dizziness, "can't see," "fuzzy" post 2nd dose of Pfizer COVID-19 vaccine. pt a&ox3, pal... Read more
0715: pt c/o dizziness, "can't see," "fuzzy" post 2nd dose of Pfizer COVID-19 vaccine. pt a&ox3, pale, and diaphoretic. VS 65/39, HR 51, RR 16, SPO2 99 on RA, T 98.4. laid patient on the ground with bilateral extremities above level of the heart. 0720: VS BP 97/53, HR 66, RR 16, SPO2 98 on RA. pt states she feels better. CODE BLUE team arrived at 0723. Blood glucose = 97. pt refused transfer to the ED for further evaluation.
24 2021-02-25 fast heart rate hallucination; severe confusion; dizziness/light headedness; disorientation; fatigue; tachycardia; a... Read more
hallucination; severe confusion; dizziness/light headedness; disorientation; fatigue; tachycardia; anxiety; full body weakness; full body muscle aches; chills; headache; This is a spontaneous report from a contactable healthcare professional (patient). A 24-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3247), intramuscular in left arm on 22Jan2021 at a single dose for COVID-19 immunisation. Medical history included generalised anxiety and allergies: Sulfa sensitive. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient's concomitant medications were not reported. On 22Jan2021, 45-60 minutes after vaccination, patient experienced hallucination, severe confusion, dizziness/light headedness, disorientation, fatigue, tachycardia, anxiety, full body weakness, then on 22Jan2021, 8 hours after, patient had full body muscle aches, headache, chills, fatigue, confusion, hallucination, anxiety, tachycardia, 16 hours after, experienced confusion, full body muscle aches, headache, chills, fatigue, confusion, hallucination, tachycardia, anxiety, then 48 hours after, had confusion, full body muscle aches (TYLENOL helped), headache, fatigue, confusion, hallucination, tachycardia, anxiety, then 1 week after vaccination, patient was experiencing confusion, anxiety, and hallucinations throughout the entire week. Patient was unsure if she ever had a fever, as she did not check her temperature. The events were reported as non-serious. The patient underwent lab tests and procedures which included COVID saliva test: negative on 27Jan2021 and negative on 10Feb2021. Therapeutic measures were taken as a result of full body muscle aches. No treatment was received for the other adverse events. The outcome of the events was recovered with sequelae.; Sender's Comments: Based on the limited information currently available, a possible contributory role of the suspect drug in the reported event hallucination cannot be completely excluded given the known suspect drug profile and/or implied temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regul atory Authorities, Ethics Committees and Investigators, as appropriate.
24 2021-02-26 chest pain Chest pain, cough, post-nasal drip
24 2021-02-27 hypotension, fast heart rate Immediate tachycardia, hypotension, severe headache, dizziness, and rash. Was then dismissed from he... Read more
Immediate tachycardia, hypotension, severe headache, dizziness, and rash. Was then dismissed from her workplace Hospital to go to MAIN Hospital ER for evaluation since she is an adult. Was evaluated in ER and given steroid pack and sent home. She was seen in my clinic 2 weeks later with continued complaints--though less severe. This was after her first vaccine--will not be getting the second per my recommendation.
24 2021-03-01 chest pain 2/28- 1am: chills, muscle ache, stiff joints - hard to sleep 7am-5pm: headache, nausea, fever, musc... Read more
2/28- 1am: chills, muscle ache, stiff joints - hard to sleep 7am-5pm: headache, nausea, fever, muscle aches, stiff joints (neck and back), chills 6pm-9pm: only nausea went away (Went to bed) 2/29 (all day) Woke up with a really stiff neck/upper body, shortness of breath and chest pain while breathing, exhausted, headache. Shortness of breath getting better throughout the day, headache didn?t leave. Still exhausted
24 2021-03-02 skin turning blue, palpitations, chest discomfort Pfizer given on Friday evening 6.30pm waited for 12 mins as requested before leaving. Felt fine and ... Read more
Pfizer given on Friday evening 6.30pm waited for 12 mins as requested before leaving. Felt fine and well. Early saturday morning 1am woke up with acheing bruise sensation at injection site. Woken up twice during the night Saturday (1am-6am) feeling cold and covered in sweat. Saturday morning around 10am, bruised feeling and tender at the back of the injected arm. Sore to touch that area and also sore to touch injection site. Saturday Evening around 6pm pins and needles tingling sensation in both feet and also sharp stabbing pain on and off in left calf muscle. Saturday night waking from sleep sweaty and disoriented. Sunday morning 10am light foggy feeling headache. Taken paracetamol with no change. Same symptoms continued on and off but were manageable at home. Monday evening dizziness during the day time and fstigue. Feeling of being drunk, everything in slow motion. Chest tightness began monday evening 8pm aprox (like my asthma symptoms) tickle in throat but no cough. Woken up feeling cold but sweating. Tuesday morning mild headache again front of head. Chest tightness persisting but taken usual asthma medications. Tuesday evening 6pm Palpitations began. More of a hiding feeling than heart racing. Stronger than I have ever felt before and more frequent (6-8 times in 30 mins) Felt light headed again, hands and feet freezing cold and blue colour, body trembling, called NHS 111 advised A&E. Had blood tests, ECG and BP monitoring. ECG normal at the time but heart shows working harder than it should. Still waiting on blood results Weds (3/3/21)
24 2021-03-03 heart rate increased, chest discomfort sudden feelings of nausea; dizziness; rapid heart rate; sweating; tingly sensation in extremities; s... Read more
sudden feelings of nausea; dizziness; rapid heart rate; sweating; tingly sensation in extremities; sudden fatigue; confusion; Chest tightness and pressure; This is a spontaneous report from a contactable healthcare professional (patient herself). A 24-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EN9581) on 13Feb2021 12:30 PM, via unknown route of administration, at the age of 24-year-old at single dose in Left arm for COVID-19 immunization. The patient medical history includes known allergies: Penicillin, Sulfur meds. The patient concomitant drug includes desvenlafaxine succinate (PRISTIQ). 10 mins after shot (as reported), the patient experienced sudden feelings of nausea, dizziness, rapid heart rate, sweating, tingly sensation in extremities, sudden fatigue, confusion. Chest tightness and pressure lasting 4 days. All the events reported started at 13Feb2021 12:45 PM, resulted in: [Emergency room/department or urgent care, Prolongation of existing hospitalization (vaccine received during existing hospitalization)]. Treatment was reported as no. No COVID prior vaccination. No COVID tested post vaccination. The event outcome of 'Chest tightness and pressure' was recovered on 17Feb2021 and the rest of event was recovered in Feb2021.; Sender's Comments: Based on the temporal relationship, the reasonable possibility of an association between reported events and suspect product BNT162B2 cannot be ruled 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.
24 2021-03-03 lightheadedness, loss of consciousness Loss of consciousness Vasovagal response Immediately after Covid-19 vaccine patient vasovagal respon... Read more
Loss of consciousness Vasovagal response Immediately after Covid-19 vaccine patient vasovagal response brief LOC approximately 6-7 seconds, diaphoretic, pale. VS: 100/65, P 54, Sp02:100% RA EMS on scene-assumed care
24 2021-03-03 fainting Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Mild, Systemic: Nausea-Mild, Additional D... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Mild, Systemic: Nausea-Mild, Additional Details: recieved vaccine after 10 min she became unresponsive. She was laid on the ground and given an epi dose by the nurse awhile the pharmacist called 911. She started to come back after 3 min she opened her eyes. The rescue came and asked anyone whoe was not family to leave. They gave her the ok to go. We contacted the pateint today. Her father says she is doing well and only complained of a mild HA and mild nausea last night. Will be seeing her doctor for further recommendations.
24 2021-03-05 heart rate increased increase heartrate, redness on neck, lightheaded within 15-20 minutes of receiving vaccine. No diff... Read more
increase heartrate, redness on neck, lightheaded within 15-20 minutes of receiving vaccine. No difficulty breathing . Monitored closely for 2 hours and Heartrate had stabilized within 15 minutes. Called the following day and only complained of a sore arm and denied any further problems.
24 2021-03-09 chest discomfort Fever greater than 102; Swollen lips; red welt a injection site; pain at injection site; swollen inj... Read more
Fever greater than 102; Swollen lips; red welt a injection site; pain at injection site; swollen injection site; chills; body aches; headache; chest pressure and tightness; This is a spontaneous report from a contactable other HCP (patient). A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL8982), intramuscular on 29Jan2021 15:00 at single dose for covid-19 immunization. Vaccine location was right arm and it was the second dose. Patient is not pregnant. The facility type vaccine was School or Student Health Clinic. Patient intramuscularly received the first dose of vaccine on 08Jan2021 04:15PM (also at age of 24 years old) at right arm with lot number EL8982 for covid-19 immunization. Medical history included chronic sinusitis from an unknown date, allergies to sulfa medications. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient's concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine nor received any other medications within 2 weeks of vaccination. The patient experienced Fever greater than 102, Swollen lips, large red welt a injection site, pain at injection site, swollen injection site, chills, body aches, headache, chest pressure and tightness on 30Jan2021 03:00 AM. Patient didn't receive treatment for the adverse events. The outcome of events was recovered in 2021.
24 2021-03-11 pallor, lightheadedness, palpitations Anaphylaxis - Throat swelled almost completely closed, wheezing, lightheadedness (nearly passed out)... Read more
Anaphylaxis - Throat swelled almost completely closed, wheezing, lightheadedness (nearly passed out), throat/neck and injection site were very itchy and swollen, face/eyes swelled up, turned very pale all over, heart palpitations, etc. The next day - severe, horribly painful burning sensation all throughout my body. Even clothing lightly touching my skin felt like hot razors cutting in to me. Residual swelling of the face/ arm. Migraine. For two weeks after - Very large, hard lump under my skin at the injection site. It was about the size of my hand and was very painful. After a few weeks it went away. Treatment- large amounts of benadryl. The pharmacist wanted to use an epipen and send me to the hospital, but I refused because I could still get some air in (doctor later told me that my reaction was so severe I should have gone to the hospital). I had to keep taking large amounts of benadryl for the next few days to keep the reaction down a bit.
24 2021-03-12 platelet count decreased After my first dose vaccine I went to see my hematologist. At the time of the vaccine, I was 24 week... Read more
After my first dose vaccine I went to see my hematologist. At the time of the vaccine, I was 24 weeks pregnant. I am now 30 weeks pregnant and the reason I went to see my hematologist is because my platelets dropped. I had lab work done the week of 02-22-2021 through 02-26-2021. I also had soreness at the injection site and a palpable lymph node under my armpit that was present for 24 hours then it resolved. I will also be receiving treatment with IV, IG and prednisone medication starting this week of 03-15-2021 through 03-19-2021.
24 2021-03-14 heart rate increased heart palpitations, shaky, weakness/sluggish, waited 15 minutes, cleared
24 2021-03-14 loss of consciousness Passed Out; upset stomach; Dry heaving; Stomach Cramps; Chills; Fever; This is a spontaneous report ... Read more
Passed Out; upset stomach; Dry heaving; Stomach Cramps; Chills; Fever; This is a spontaneous report from a non-contactable consumer (patient). A 24-year-old female patient (not pregnant) received bnt162b2 (lot number unknown), via an unspecified route of administration, at Left arm, on 05Feb2021 16:15 at SINGLE DOSE for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks. The patient experienced woke up out of her sleep, upset stomach. Dry heaving. Stomach Cramps. Chills. Fever. Passed Out. Adverse event started on 06Feb2021 12:00 AM. No treatment AE. The outcome of the event was recovered in Feb2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
24 2021-03-16 palpitations After my second dose of Pfizer vaccine, I developed fever, chills, headache, tiredness, muscle pain,... Read more
After my second dose of Pfizer vaccine, I developed fever, chills, headache, tiredness, muscle pain, hypersensitive skin to touch (not a rash, but my skin is more sensitive and a light rubbing on skin all over my body could cause pain). I also had several series of premature heart beat.
24 2021-03-17 chest pain Shortness of breath (~6 hours post-vaccine), fever (24 hours post-vaccine), chills (~18 hours post-v... Read more
Shortness of breath (~6 hours post-vaccine), fever (24 hours post-vaccine), chills (~18 hours post-vaccine), joint pain (12 hours post-vaccine), extreme fatigue (~18 hours post-vaccine), shaking hands (~18 hours post vaccine), chest pain (12 hours post-vaccine)
24 2021-03-17 oxygen saturation decreased Sore throat, fever, cough, low pulse ox, headache, face flushing, fatigue, body aches
24 2021-03-17 fainting Patient fainted after immunization.
24 2021-03-22 blood glucose increased, loss of consciousness Patient reported feeling dizzy and briefly loss consciousness after walking over to the first aid ar... Read more
Patient reported feeling dizzy and briefly loss consciousness after walking over to the first aid area. Patient was clammy, sweating. Vital signs were obtained at 3:17pm blood pressure 87/73, pulse 52, temp 96.8, respiration 17. Pt denied any medical history. Pt reported while donating blood had a similar reaction. EMS called and arrived at 3 :30pm. Pt stated she felt shaky, anxious, and lightheaded. FSBS 131. Pt reported feeling cold. EMS left the facility at 3:40pm. Pt declined EMS services, vital signs were rechecked at 3:20pm 134/69, 52, 17, 97.0, denied any pain. client stayed with nurses for 30 extra minutes and reported feeling better, no longer feeling light-headed, reported feeling weak. Pt was advised to call someone to pick her up as she drove herself. Pt declined stating that she lives an hour away and will be ok to drive herself home.
24 2021-03-22 hypotension Lightheaded, fuzzy. BP low 90/50.
24 2021-03-22 pulmonary embolism Bilateral pulmonary embolism. No clots detected in legs. Treatment: removed from birth control, Eli... Read more
Bilateral pulmonary embolism. No clots detected in legs. Treatment: removed from birth control, Eliquis (10mg) for 3 months
24 2021-03-22 fainting Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient was in waiting area after receiving the first dose of the Pfizer COVID vaccination. Patient began feel dizzy and passed out and feel out of chair and hit head on ground. Pharmacist and nurse checked on patient. Gave patient water and ice and called 911. Patient left with boyfriend to drive her home after fire department and paramedics checked her out.
24 2021-03-24 nosebleed Recurrent nose bleeds. I?ve never had them in my life i have now been getting them every single day ... Read more
Recurrent nose bleeds. I?ve never had them in my life i have now been getting them every single day sometimes 2-3 times a day
24 2021-03-24 palpitations Patient stated she began to have heart plalpitations a couple mins after sitting down then followed ... Read more
Patient stated she began to have heart plalpitations a couple mins after sitting down then followed by vision and hearing by the time nurse arrived. Patient stated feeling like she going to pass out then asked nurse to hold her hand. EMT arrived checked vital signs all within normal limit per patient. Patient then states that everytime she is in a medical setting she pass out or has vision and hearing loss due to panick and anxiety attack. Stated everytime to gives blood she has this is sure. Patient also refused homecare.
24 2021-03-24 fainting left arm is very sore, painful to touch and difficult to move; left arm is very sore, painful to tou... Read more
left arm is very sore, painful to touch and difficult to move; left arm is very sore, painful to touch and difficult to move; fainted /vasovagal syncope episode; might have convulsed on the floor; out of breath; nausea; dizziness; This is a spontaneous report from a non-contactable consumer (reported for herself). A 24-year-old female patient (not pregnant at the time of vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered in Arm Left on 11Mar2021 15:00 (Lot Number: EN6199) at the age of 24 years old as single dose for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication received within 2 weeks of vaccination included levonorgestrel, ethinyl estradiol (reported as "Levonor-E Estrad"). Facility where the most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Mar2021 15:15, Few minutes after vaccination patient fainted and might have convulsed on the floor. Patient became conscious after a couple min. Patient had spouts of nausea and dizziness. 2 hr after dose (11Mar2021) patient was out of breath and went to a hospital. Doctors suppose that the incident was a vasovagal syncope episode. After 18 hr (12Mar2021) patient's left arm was very sore, painful to touch and difficult to move. The events resulted in Emergency room/department or urgent care. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. No covid prior vaccination. No covid tested post vaccination. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
24 2021-03-26 fainting, loss of consciousness PATIENT CAME IN ALERT AND ORIENTED. STATED HAD A REACTION IN PAST TO VACCINES AND HAS FAINTED. PREVI... Read more
PATIENT CAME IN ALERT AND ORIENTED. STATED HAD A REACTION IN PAST TO VACCINES AND HAS FAINTED. PREVIOUS VACCINE FOR GOING OUT OF COUNTRY. PATIENT AGREED ALONG WITH MOTHER TO GET VACCINE TODAY. PATIENT RECEIVED VACCINE WITH NO INCIDENT. WE HAD HER SIT THERE AND SHE STARTED FEELING FAINT. SECOND VACCINATOR ALSO NEXT TO PATIENT. PATIENT DID FAINT AND SEEMS TO HAVE A SMALL SEIZURE AS HAD INVOLUNTARY ARM MOVEMENT AND HAD LOST CONSCIOUSNESS. PATIENT BECAME ALERT IN ORIENTED WITHIN 30 SECONDS. PATIENT STATED FELT BETTER BUT CALLED 911 FOR THEM TO COME ACCESS HER. MOM CALLED INTO ROOM AND STATED THIS INCIDENT HAD OCCURRED BEFORE. FIRE DEPARTMENT (EMS) IN STORE AND RESPONDED ALMOST IMMEDIATELY. PATIENT WAS ON FLOOR AT THIS TIME BY DIRECTIONS OF PHARMACY STAFF WITH FEET ELEVATED. BREATHING NORMAL, ALERT AND ORIENTED BUT APPEARS PALE (MOM STATES NORMAL SKIN COLOR). PATIENT ASSESSED BY EMS AND BLOOD PRESSURE LOW. PATIENT AGREED TO GO GET CHECKED OUT BY HOSPITAL DUE TO LOW BLOOD PRESSURE, PALE. LEFT WITH EMS STAFF.
24 2021-03-28 chest pain The next day I started feeling extreme fatigue. Other symptoms I?ve had are chest pain, congestion, ... Read more
The next day I started feeling extreme fatigue. Other symptoms I?ve had are chest pain, congestion, a slight cough, and brain fog. I have mucus buildup as well.
24 2021-03-28 chest pain Patient having SOB, chest pain, fever, extreme fatigue
24 2021-03-28 fainting Syncope Dizziness
24 2021-03-30 arrhythmia Heart arrhythmia; This is a spontaneous report from a contactable consumer (patient herself). A 24-y... Read more
Heart arrhythmia; This is a spontaneous report from a contactable consumer (patient herself). A 24-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration in the right arm on 08Mar2021 at 11:00 AM as a single dose for COVID-19 immunisation. The patient had no other vaccines in four weeks, did not have COVID prior to the vaccination, was not tested for COVID after the vaccination, had no known allergies, and no other medical history. There were no concomitant medications. The patient experienced heart arrhythmia on 09Mar202. Therapeutic measures were taken as a result of heart arrhythmia which included Beta blocker/s. Outcome of the event was unknown. Information about the lot/batch number has been requested.
24 2021-03-31 chest discomfort, fibrin d dimer increased, pulmonary embolism 3/23 developed chest tightness with shortness of breath 3/26 dry cough 3/30 +D-Dimer 14,103. CT show... Read more
3/23 developed chest tightness with shortness of breath 3/26 dry cough 3/30 +D-Dimer 14,103. CT showing pulmonary emboli right main pulmonary artery and left lower lobar artery.
24 2021-03-31 loss of consciousness Pt was waiting required 15 minutes in a chair. After about 8 minutes from receiving vaccine- Pt bega... Read more
Pt was waiting required 15 minutes in a chair. After about 8 minutes from receiving vaccine- Pt began to pass out and lose conciousness. Pt could not speak and her eyes began to roll back in her head and her body began to convulse slightly. Administered Epipen to pt in left thigh and she responded immediately. She came to and within a few minutes was able to say her name and count backwards from 10. 911 had been called. paramedics assessed pt. They asked her if she wanted to go to ER and she said yes.
24 2021-03-31 fainting Patient fainted. We sat her down. Offered to call an ambulance. gave her some orange juice to drink.... Read more
Patient fainted. We sat her down. Offered to call an ambulance. gave her some orange juice to drink. We monitored blood pressure and made sure she was not driving home.
24 2021-04-01 blood pressure decreased, fast heart rate Patient had a drop in blood pressure and tachycardic
24 2021-04-01 heart rate increased, hypotension Within 20 minutes of vaccine dose, patient developed a rapid heart rate, poor blood pressure, hot fl... Read more
Within 20 minutes of vaccine dose, patient developed a rapid heart rate, poor blood pressure, hot flashes/sweating, shortness of breath and was sent to the ER. Patient received fluids and monitoring; was discharged 3-4 hrs later. 30 minutes after discharge, patient returned to ER with throat swelling and shortness of breath -- > discharged 4 hrs later on Benedryl and steroids (with prescription to continue prednisone Dosepak, Pepcid, and Benadryl).
24 2021-04-02 chest discomfort Patient (DOB: 09/11/1996) received the 1st COVID vaccine (Pfizer, lot #: ER9729, expiration date: 04... Read more
Patient (DOB: 09/11/1996) received the 1st COVID vaccine (Pfizer, lot #: ER9729, expiration date: 04/07/2021) at 1145. EMT observed the client looking distressed and uncomfortable, so he approached her in the observation seating area around 1150. Patient expressed ?tightness in chest? and ?felt like she was going to black out, about 1 minute and 30 seconds into her 15 minute observation period.? EMT gave the client a water bottle and made sure it was safe to move the client, before transferring her into the zero- gravity chair.RN, PHN responded next. Client stated she has no known allergies, has no medical conditions to be aware of, and has no previous reactions to any other vaccines. First set of vitals were taken at 1153 while client was sitting; client was alert and oriented, Blood Pressure (BP): 112/88, Heart Rate (HR): 108, Respiratory Rate (RR): 28, skin was warm, dry, tact and normal for ethnicity, capillary refill was within normal limits. Nurse observed the client?s hands to be shaking. Client was then advised to stay an additional 30 minutes by the EMTs for further observation- client agreed. Client reported the feeling of tightness in her chest resolved around 1156. She also expressed that ?she had never had a panic attack before and that the medical environment made her feel uneasy because she does not like needles.? Second set of vitals were taken at 1158 while client was sitting; client was alert and oriented, Blood Pressure (BP): 100/65, Heart Rate (HR): 64, Respiratory Rate (RR): 20, skin was warm, dry, tact and normal for ethnicity, capillary refill was within normal limits. Nurse observed the shaking in the client?s hands had resolved. Last set of vitals were taken 1223 while client was sitting; client was alert and oriented, Blood Pressure (BP): 110/70, Heart Rate (HR): 60, Respiratory Rate (RR): 17, skin was warm, dry, tact and normal for ethnicity, capillary refill was within normal limits. After this set of vitals, the client stated she ?was feeling way better.? Nurse educated client on the importance of eating and hydrating before she receives her second dose and that if she had additional symptoms or questions to call her provider. Client walked out the vaccine site with a steady gait.
24 2021-04-02 loss of consciousness Shortly after receiving vaccine patient started to pass out she did loose consciousness and was low... Read more
Shortly after receiving vaccine patient started to pass out she did loose consciousness and was lowered to the floor she was out for approximately 30 seconds, ammonia was used on patient and she responded. She was placed on a back board and brought back to the medical observation area, on arrival she stated that she started to get blurry vision and remembers waking up on the floor. Her blood pressure on arrival was @ 1153 110/75 HR 78 and pulse ox 100% on oxygen. She was continued to be monitored and her blood pressure at 1200 was 105/72 HR 81. At 1215 her bp was 118/77 patient was given 8 ounces of water. She was placed in a sitting position and her blood pressure was 110/75, Heart rate 79 and pulse ox 100%. She was then placed in a standing position at 1251 and she was positive for orthostasis bp 94/63 heart rate 78 and she quickly became symptomatic she was laid back down again. she was given another 8 ounces of water. ortho bps were attempted again at 1259 and her bp was 103/69 heart rate 80, and then at 1:06 she was 105/70 and heart rate 78 patient was still symptomatic but did not exhibit the bp drop as she did previously. She was continued to be monitored and due to her continued symtpoms with position changes we had recommended that she go tot he ER to be evaluated. She declined and called a friend to pick her up. She was released in a wheelchair rom the site
24 2021-04-02 fainting, pallor patient got vacccination at 4:55 patient had syncopal episode while sitting immediately after vaccin... Read more
patient got vacccination at 4:55 patient had syncopal episode while sitting immediately after vaccination. patient was lowered to floor then place in stretcher in trendelenberg BP 110/55, HR 59 oxygen was 98%on arrival to observation area, patient complained of nausea, and was pale, she was clammy to touch. Patient was hydrated with 8 ounces of water, and was observed for 1 hour with bp monitoring. at 5:20 bp was 95/57 HR 56 and oxygen was 98% , she reported feeling a little tired with no other symptoms,. no complaints, she was offered more water but does not feel like she can drink any more . her HOB was increased to 45 deg with no complaints she was able to maintain the HOB to 45 degrees with no complaints. at 5:25 her BY was 101/52 HR 59, @ 5:45 bp was 101/66, she was placed in a sitting position on the side of the bed and at 6pm ER bp was 109/75. in a standing position at 6:05 her BP was 114/63 HR 83 and oxygen was 99%. Patient was released with her significant other via wheelchair.
24 2021-04-04 platelet count decreased nausea, vomiting, weakness and malaise, diffuse body rash presented to ER with rash, platelets 94 an... Read more
nausea, vomiting, weakness and malaise, diffuse body rash presented to ER with rash, platelets 94 and right upper lobe pneumonia tested negative in ER for COVID
24 2021-04-05 chest discomfort Tight chest, anxiety. Vitals wnl - given water.
24 2021-04-05 fainting, loss of consciousness Patient complaining of syncopal episode. States that she lost consciousness for a few seconds. C/O s... Read more
Patient complaining of syncopal episode. States that she lost consciousness for a few seconds. C/O stomach ache. Transport refused.
24 2021-04-05 fainting Pt has syncopal episode/seizure following first dose of covid vaccine
24 2021-04-06 heart rate increased Patient was in the observation area after her first dose of the Covid vaccination. Patient reported ... Read more
Patient was in the observation area after her first dose of the Covid vaccination. Patient reported to our staff that she felt her heart beating rapidly about 10 minutes after the vaccination. EMS was called. Patient was instructed to lie down on her back and feet elevated. The exact elevated heart rate was unknown. After about 2-3 minutes, the heart rate went down and measured about 84 BPM. Patient was starting to calm down at that point but remained lying down until EMS arrived. EMS checked her vitals and all were within normal limits. Patient walked out with EMS.
24 2021-04-06 loss of consciousness Patient had just received covid vaccine. She was still seated in immunization room and said she fel... Read more
Patient had just received covid vaccine. She was still seated in immunization room and said she felt dizzy and then passed out. She then started having a seizure a few seconds later. She seized for about 2 minutes. Patient was breathing but unconscious.
24 2021-04-06 loss of consciousness Dizziness, Lightheadedness,Loss of Consciousness,Weakness "Approximately 10 minutes after receiving... Read more
Dizziness, Lightheadedness,Loss of Consciousness,Weakness "Approximately 10 minutes after receiving first COVID-19 vaccine, patient reported she felt lightheaded. Denies CP, SOB, throat swelling. Denies any hx of severe allergic reaction or anaphylaxis. Reports hx of similar reactions after receiving the flu shot. On initial evaluation: BP 126/69 HR 68 RR 16 O2 sat 97% ORA After sitting in a wheelchair for approximately 15 minutes she reports symptoms had resolved other than a very mild headache. No signs of anaphylaxis or severe allergy Patient released after monitoring. State she feels comfortable driving home."
24 2021-04-06 pallor dizzy; nauseated; my vision was a bit fuzzy; my ears started ringing very loud; I was twitching and ... Read more
dizzy; nauseated; my vision was a bit fuzzy; my ears started ringing very loud; I was twitching and that I wasn't very coherent; color was coming back to my face; Felt tired; a sore arm; muscle spasms; This is a spontaneous case received from a contactable consumer(patient). A 23-year-old female non-pregnant patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 23Mar2021 19:00 as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 23Mar2021, 10-15 minutes after getting the shot she felt very dizzy and nauseated. As she was leaving the pharmacy to go to car her vision was a bit fuzzy. When she sat back down she had to close her eyes because she was so dizzy and her ears started ringing very loud. Her roommate said that she was twitching and that she wasn't very coherent. She went back to get the pharmacist who brought Wal-Dryl and a sprite. After sitting and drinking for another 10-15 minutes she felt slightly better and color was coming back to her face. Felt tired and dizzy the rest of the night. Felt fine the next day just a sore arm. She had a few muscle spasms since getting vaccinated. The patient lab tests included sars-cov-2 test negative: negative on 09Feb2021 type: Nasal swab, sars-cov-2 test negative: negative on 15Mar2021 type: Nasal swab. The action taken in response to the events for bnt162b2 was not applicable. Outcome of the events was Recovered on an unspecified date. Follow-up attempts are needed. Information on the lot/batch number has been requested.
24 2021-04-06 fainting, loss of consciousness Systemic: Confusion-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Visual Changes/Distu... Read more
Systemic: Confusion-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Pt arrived to recieve Pfizer vaccine. Pt reported that they experience fainting with vaccines and blood draws. Vaccine given. Mother of pt present. Pt passed out and was not responding to name. Pt regained clear vision and was able to respond normally within 5 minutes. Pt stayed and left with mother after 30 minutes.
24 2021-04-07 chest discomfort A few minutes after receiving the vaccine, the patient began to feel dizzy. After sitting in a chai... Read more
A few minutes after receiving the vaccine, the patient began to feel dizzy. After sitting in a chair for a few minutes she felt too weak to remain seated, at which point the patient was moved to the floor. The patient said she experienced some tightness in her chest, and 911 was called. EMS arrived within a couple of minutes.
24 2021-04-08 chest discomfort Patient reported chest tightness/warmth within 15 minutes of vaccination. Patient was transported t... Read more
Patient reported chest tightness/warmth within 15 minutes of vaccination. Patient was transported to ER by EMS.
24 2021-04-09 chest discomfort CC/tightness & SOB post Vax. Hx of asthma & Anxiety BP 130/70, HR 90, 19 02 99% RA Lungs clear BUL/... Read more
CC/tightness & SOB post Vax. Hx of asthma & Anxiety BP 130/70, HR 90, 19 02 99% RA Lungs clear BUL/BLL MD @ bedside Pt states she feels better.
24 2021-04-09 chest pain, oxygen saturation decreased High fever for longer than 24 hours (101°+), shortness of breath with O2 dropping to 90%, chest pai... Read more
High fever for longer than 24 hours (101°+), shortness of breath with O2 dropping to 90%, chest pain 9/10 threshold, general weakness, fatigue/exhaustion. Chest pain and shortness of breath remaining 2 weeks post injection.
24 2021-04-09 loss of consciousness 7 AM (about 21 hours after I received the second dose) I woke up having the most intense nausea I h... Read more
7 AM (about 21 hours after I received the second dose) I woke up having the most intense nausea I have ever experienced. I went to my kitchen to get water and passed out, dropping the glass I was in the process of getting from the cabinet, and I crashed. I felt so horrible I just tried to get back to my bed at that point without getting water. I passed out again trying to get back to my bed, bruising my right knee and my ribs. One the most horrible feelings I have experienced. I stayed on the floor for a bit recovering the second spell. My sister heard the commotion and quickly brought me water and Tylenol. My head felt full of pressure that I couldn?t get rid of by holding my nose and blowing. Eventually that went away. I stayed in bed for the rest of the day drinking water and Gatorade. I felt like I had an intense flu for the remainder of the day with chills and fever. The following day I needed more sleep but felt better. Now today, Saturday I feel better, but I still feel shocked at how intense my body?s reaction was to the second dose.
24 2021-04-09 fainting, nosebleed, platelet count decreased currently in hospital (ICU). Fainting, lightheadedness, extreme fatigue, petechiae, extremely low pl... Read more
currently in hospital (ICU). Fainting, lightheadedness, extreme fatigue, petechiae, extremely low platelet count, possibly kidney damage, nose bleed, weakness,
24 2021-04-09 fainting Fainting and dizziness about four hours later
24 2021-04-10 heart rate increased After getting the shot, felt lightheaded, pulse raced, sweating, flushing of face. Since getting the... Read more
After getting the shot, felt lightheaded, pulse raced, sweating, flushing of face. Since getting the shot I have developed allergies to everything including smells, sunlight, foods previously tolerated, heat, etc. I have now been diagnosed by a specialist with MCAS.
24 2021-04-10 fainting Pt became nauseous and dizzy after the administration of the Pfizer vaccine. She had a syncopal epis... Read more
Pt became nauseous and dizzy after the administration of the Pfizer vaccine. She had a syncopal episode and vomited- Bp 87/43. After regained consciousness she had an additional syncopal episode. D5 NS was administered IV. 911 was contacted. Pt refused to transfer to the hospital. Pt was alert and oriented x 4, speech was clear., and she self ambulated without difficulty. She was escorted home by her roommate.
24 2021-04-11 loss of consciousness Patient notified staff of vasovagal history to vaccines prior to dose. LOC was witnessed by staff, l... Read more
Patient notified staff of vasovagal history to vaccines prior to dose. LOC was witnessed by staff, lasting 5 seconds with rapid recovery. Vital signs remained stable after multiple checks over 30 minutes.
24 2021-04-11 palpitations Migraine-came around Friday about 6:15 pm, slowly went away during 3 days Heart Palpitations-Saturda... Read more
Migraine-came around Friday about 6:15 pm, slowly went away during 3 days Heart Palpitations-Saturday night, lasted for 2 days Nausea-duration of 3 days starting Saturday Dizziness-Saturday, all day and Sunday in the morning
24 2021-04-11 fainting Systemic: Fainting / Unresponsive-Severe, Additional Details: While resting after injection, patient... Read more
Systemic: Fainting / Unresponsive-Severe, Additional Details: While resting after injection, patient fainted and fell out of chair and hit head on the ground. Paramedics responded and patient did not want to go with the as she felt better. WE gave ice and water and monitored until patient left under her own power.
24 2021-04-12 hypotension, fainting Syncope while waiting in the waiting period for the 15 minutes. I felt weird and nauseous and starte... Read more
Syncope while waiting in the waiting period for the 15 minutes. I felt weird and nauseous and started having tunnel vision.
24 2021-04-12 fainting pt fainted immediately after administration for approx 5 seconds, called 911, pat came to and was ok... Read more
pt fainted immediately after administration for approx 5 seconds, called 911, pat came to and was ok. she was checked out by EMS and pronounced OK
24 2021-04-12 fainting Site: Itching at Injection Site-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: patient ha... Read more
Site: Itching at Injection Site-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: patient has severe anxiety -Mild, Systemic: Shakiness-Mild, Additional Details: patient suffers from severe anxiety. Patient reported it has happened before with other vaccinations
24 2021-04-13 chest discomfort Throat and chest tightening, heating up, swelling. Difficulty breathing. Occurred initially after 5-... Read more
Throat and chest tightening, heating up, swelling. Difficulty breathing. Occurred initially after 5-10 min of vaccine injection. Symptoms have been reoccurring in episodes since day of injection to present day.
24 2021-04-13 loss of consciousness Patient Allergies: NKA 14:53 patient received the covid vaccine Pfizer Lot:EW0162 Expiration:7/21 do... Read more
Patient Allergies: NKA 14:53 patient received the covid vaccine Pfizer Lot:EW0162 Expiration:7/21 dose 0.3ml in left deltoid, then slid off the chair, nurse caught her and slid her to the ground provided support for her head, ensure the area was clear, she went unconscious for 15 seconds then regain conscious, vitals were taken, BP-133/89, Pulse-81, SPO2 97%, numeric pain scale 0/10. Patient was A &O x 4 person, time, place, and situation-----------------------------------------------RN 14:56 reassessed vitals BP-131/68, Pulse- 71, R-16 even and unlabored, Spo2 98%, numeric pain scale 0/10, she was A&O x 4 person, person, place and situation, patient denies chest pain, denies shortness of breath, denies hx of going unconscious, she was moved to a chair for observation, will continue to monitor------------------------------------------------------------RN 15:07 contacted to alert her of the situation and to follow next step of protocol, will continue to monitor the patient-------------------------------------------------RN 15:15 patient denies any chest pain, denies shortness of breath, denies dizziness, A&Ox4 person, place, time, and situation-----------------------------------------------------------------RN 15:24 reassessed the patient vitals BP-108/63, Pulse-70, SPO2-99% , numeric pain scale 0/10, denies chest pain, denies shortness of breath, denies dizziness, A&Ox4 person, place, time, and situation, had patient raise for chair slowly reported no dizziness, had patient walk back and forth w/ no assistance, observed a steady and even gait, patient denies any dizziness, provided education to follow up with primary care or head to urgent care, if patient starts to experience shortness of breath or anaphylaxis to call 911, both patient and partner verbalized understanding, the partner verbalized that he would be driving the patient home---------------------------------------------------------------------------------------------------------------------------------
24 2021-04-13 fainting The patient experience syncope after administration of the vaccine. The patient was given juice and... Read more
The patient experience syncope after administration of the vaccine. The patient was given juice and resolved. The patient was released on their own accord.
24 2021-04-13 blood clot Severe Vascular Thrombosis (vomit, loss of balance, numbness in arms and legs, lost of speech, impai... Read more
Severe Vascular Thrombosis (vomit, loss of balance, numbness in arms and legs, lost of speech, impaired vision) had to be hospitalized for 4 days, and had some brain damage from the thrombosis.
24 2021-04-14 chest pain Left arm tingling from neck to fingers, weakness, chest pain, muscle twitch. Evaluated by EMS-Refusa... Read more
Left arm tingling from neck to fingers, weakness, chest pain, muscle twitch. Evaluated by EMS-Refusal to transport.
24 2021-04-14 heart rate increased Extreme shortness of breath rapide pulse; warm and sweaty; oxygen saturation = 100%; anxious
24 2021-04-14 pallor Lightheaded, increased respirations, tingling in hands and feet (numbness), pale, hyperventilation. ... Read more
Lightheaded, increased respirations, tingling in hands and feet (numbness), pale, hyperventilation. EMS checked, helped her to regulate her breathing. Stated this happens when she gets shots.
24 2021-04-15 loss of consciousness Stated that she "Passed Out." It was reported by observer individual exhibited rolling eyes activ... Read more
Stated that she "Passed Out." It was reported by observer individual exhibited rolling eyes activity.
24 2021-04-15 fainting, chest discomfort Syncope the evening of 4/12, witnessed by family. Woke up sweaty, chills and disoriented. Within 30 ... Read more
Syncope the evening of 4/12, witnessed by family. Woke up sweaty, chills and disoriented. Within 30 minutes overall felt much better. Residual symptoms the following day - chest tightness, anxious, fatigue.
24 2021-04-16 loss of consciousness, heart rate increased The patient received the Pfizer vaccine, given by HCP. After the vaccine, the patient felt a little ... Read more
The patient received the Pfizer vaccine, given by HCP. After the vaccine, the patient felt a little anxious with increased heart rate so she asked HCP for a bottle of water. HCP went to get the water and informed the pharmacist on duty. Both pharmacist and HCP came back to the patient. She got the bottle and was about to open the bottle, but closed her eyes and started shaking like having a seizure and passed out. She came back right after passing out but didn't know what happened. She then started shaking again for a few seconds but didn't pass out. Everything happened so quickly when she remained sitting on the chair. We called 911 and paramedics came. She mentioned that the seizure happened to her before, maybe once or twice a year. When paramedics came, they checked her blood pressure and it was ok. We asked her and she wanted to come to the hospital to check out to make sure that she is ok.
24 2021-04-17 chest pain Within 24 hours I developed a problem with breathing, I cannot take a deep breath without intense pa... Read more
Within 24 hours I developed a problem with breathing, I cannot take a deep breath without intense pain in my chest. Sitting or leaning forward causes the pain to get worse. I also have a very very large red splotch that is continuing to get larger since receiving the shot, and that arm /side has intense pain
24 2021-04-17 heart rate increased, palpitations 1/18/21: I woke up around 9 in the morning feeling my heart racing and pounding. I put on my Apple w... Read more
1/18/21: I woke up around 9 in the morning feeling my heart racing and pounding. I put on my Apple watch and to check my heart rate and it was 140 beats per minute. The highest it went up to was 175 beats per minute. I was not feeling anxious or having an anxiety attack so I'm not sure what caused this. I have had anxiety attacks in the past, but I've never felt my heart pound and race like that. My heart rate went down to 115 - 130 beats per minute. At around 11 am when my heart rate was still not going down, I went to the Urgent Care where I was referred to go to the Emergency Room.
24 2021-04-19 heart rate increased, blood pressure increased, chest discomfort 4/4: Woke up Easter Sunday with the following symptoms: sweats, chills, uncontrollable shaking, fati... Read more
4/4: Woke up Easter Sunday with the following symptoms: sweats, chills, uncontrollable shaking, fatigue, dizziness, nausea, and shortness of breath. Went to Urgent Care, but it was closed for the holiday, so instead went to ER. See Item 19 for details. I was discharged within an hour because there was nothing seriously wrong with me, doctor wrote it off as a stomach bug and ordered me to rest and hydrate. 4/4 - 4/10: Virtually every day for this week went the exact same. I would wake up between 6-7am, feel nauseous, weak, no appetite, and shaking. Walking around my apartment would leave me utterly exhausted. I would nap from 9am-12pm, then again from 2-4pm. Ate very little, drank water and sports drinks when awake. Breathing was still shaky. Occasional diarrhea. 4/10: Although slightly less ill than the previous 6 days, I still felt weak, shaky, and exhausted. I went back to Urgent Care this time, and the doctor examined me. She noted my left ear was very inflamed and suspected an ear infection. She prescribed me a week of amoxycilin and told me to rest and eat bland foods. 4/12: After 2 days on the antibiotics, some of my symptoms cleared. I was no longer shaking or having shortness of breath, and although still tired, I did not sleep for half the day as I had the previous week. My appetite was not fully there yet, and in the mornings of this week I would wake up feeling nauseous for about 2 hours. On this day 4/12 my period also started, which is unusual. It was not due to start until around April 17th. My period is very regular and light due to being on birth control, so I consider this abnormal. The flow was also very heavy. 4/17: Heavy flow of my period slows significantly and is now just a slight pink/brown color. I only need a liner to contain it. This is also my last day of antibiotics, so I buy a probiotic supplement in the hopes that it will help settle my gut. 4/17-present (4/20): The morning nausea and lack of appetite are still present despite being off the antibiotics. Occasional discomfort in abdomen/chest. Unexplained muscle soreness in hips, legs, back, and chest. My bowel movement schedule has also completely changed. Normally I do not experience a bowel movement until late morning, after 10am. But for the past 2 weeks I have been woken up around 5:30am with a sudden urge. At the beginning of my illness it was diarrhea but now it has transitioned to slightly more solid feces. It is not really diarrhea anymore.
24 2021-04-19 loss of consciousness Student became lightheaded and dizzy after the vaccine and passed out while sitting in the chair an... Read more
Student became lightheaded and dizzy after the vaccine and passed out while sitting in the chair and fell off chair landing face first onto the floor. PA to the students side immediately and student was breathing but not alert. Student aroused easily but 9-1-1 was called as a precaution due to student hitting head. Student was observed but was not transported via EMS. No meds were given and he was able to ambulate out to the clinic without issues after the episode.
24 2021-04-19 fainting The patient had a syncope episode 2 minutes after administration of the vaccine. The patient recove... Read more
The patient had a syncope episode 2 minutes after administration of the vaccine. The patient recovered and was released on their own accord.
24 2021-04-20 oxygen saturation decreased, loss of consciousness Within 10 minutes of receiving vaccine I started blacking out, ears ringing, sweating and low oxygen... Read more
Within 10 minutes of receiving vaccine I started blacking out, ears ringing, sweating and low oxygen. Immediate abdominal pain and urge to empty bowels.
24 2021-04-20 fainting Patient denied symptoms during 15-minute required observation period. When she got up from chair to... Read more
Patient denied symptoms during 15-minute required observation period. When she got up from chair to pick up vaccination card, endorsed near-syncope and bilateral lower extremity weakness like "she felt she was walking in sand." Denies visual symptoms, oral swelling, dyspnea, pruritis, nausea. Patient sat back down and was attended to. She was noticeably nervous (hand/leg shaking). SpO2 99%, HR 62. Patient endorses history of anxiety that is treated with beta blocker. Patient felt back to her baseline after approximately 15 additional minutes of rest and sipping on water. Trial of ambulation at that time with complete resolution of symptoms. She was cleared to return to work with return precautions.
24 2021-04-21 nosebleed Bloody nose, happened after I sneezed after I woke up from a nap, pretty heavy blood flow and didn?t... Read more
Bloody nose, happened after I sneezed after I woke up from a nap, pretty heavy blood flow and didn?t stop, started coming out of both nostrils. The left nosebleed kept going but the right nose bleed stopped after a little while. Kept on bleeding for maybe 8 to 10 minutes as I cooked lunch, I plugged the nostril with a paper towel until it clotted three or four times but the flow still didn?t stop. I used to have nose bleeds frequently when I was a young child but don?t really have them often anymore. After plugging it with a paper towel was not successful, I tried pinching my nose bridge and leaning forward which worked a little bit better but I could tell that the flow hadn?t stopped because the blood and the bloody mucus would collect in my throat and I had to spit it out. I applied a Vaseline like jelly balm in order to moisturize the skin in my nostrils. About maybe around half an hour after my nose bleed started the flow has abated and I am able to do my tasks without having to spit out the bloody clotted mucus that slides into my mouth and throat. I think I have only had a few nose bleeds that I can remember that were as bad as this, probably only two or three. I ate lunch and did not notice a change in my perception of taste. Currently experiencing a very mild headache.
24 2021-04-21 fainting Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Weakne... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Weakness-Severe
24 2021-04-22 blood glucose increased Client arrives to observation tent. Stated she was feeling dizzy and nautious. Client decied to lay ... Read more
Client arrives to observation tent. Stated she was feeling dizzy and nautious. Client decied to lay her self to the ground. Client declines any injury. RN and Ems assess client. VS 98%02 123/85 BP 89HR. Client ststes she has a history of type 1 diabeted and cilliac disease. Also states she has a hx of passing out when recieving vaccine/shots. Client has a continious blood sugar monitor. Blood glucose reads as 141.
24 2021-04-22 chest pain Chest pain, cough, head congestion, runny nose, sore throat, headache, fatigue, aches
24 2021-04-22 nosebleed Day 14 after vaccination, noticed gum bleeding and skin rash for petechia. I had 3 nose bleeds a wee... Read more
Day 14 after vaccination, noticed gum bleeding and skin rash for petechia. I had 3 nose bleeds a week prior at different days.
24 2021-04-23 blood glucose increased A week later, I had an anaphylactic reaction to a kit kat bar. I had previously ate kit kats with no... Read more
A week later, I had an anaphylactic reaction to a kit kat bar. I had previously ate kit kats with no issue. I had to be intubated and hospitalized. After extubation, I continued to have anaphylaxis at least once a day with no correlation to what I was eating or drinking. I also began having a severe auto immune flare up with body pains in my legs, back, and stomach immobilizing me with generalized weakness.
24 2021-04-23 chest discomfort Nausea, vomiting, difficulty breathing, tight chest, injection site pain, body aches.
24 2021-04-23 fainting Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed ... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: during post vaccination observation period, patient fell to floor, never lost consciousness, immunizing tech alerted pharmacist on duty, patient was alert but lightheaded while laying on back, we elevated feet using her chair, provided ice pack for head and water bottle for hydration. Patient remained lying down with feet elevated for about 15 minutes then returned to seated position with ice pack on top of head. Patient was observed by staff and parent/friend 30 minutes before leaving.
24 2021-04-24 chest pain, chest discomfort Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hy... Read more
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Mild
24 2021-04-24 fast heart rate, fainting fainting; seizure; Tachycardia; dizziness; This is a spontaneous report from a contactable consumer.... Read more
fainting; seizure; Tachycardia; dizziness; This is a spontaneous report from a contactable consumer. This 24-year-old non-pregnant female consumer (Patient) reported that she received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine; Solution for injection; Lot number: unknown; Expiry date: Unknown) via an unspecified route of administration in the right arm on 07Apr2021 at 12:45 PM. The patients past medical history included Postural orthostatic tachycardia syndrome. The patient was allergic to Phenergan and Zofran. 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 vaccination, patient had not tested for COVID-19. Concomitant medication was not reported. On 10Apr2021, at 12:00PM the patient developed Tachycardia, dizziness, fainting and seizure. The patient did not receive any treatment for the events. The outcome for the events was recovering. Information about Lot/batch number is requested.
24 2021-04-25 arrhythmia heart arrhythmia
24 2021-04-25 lightheadedness, loss of consciousness The patient experienced presyncope, nausea, and blacked out for about 20 minutes 2 hours after recei... Read more
The patient experienced presyncope, nausea, and blacked out for about 20 minutes 2 hours after receiving the vaccine.
24 2021-04-25 fainting Patient presents a potential reaction to the COVID19 vaccine. I was called to assess the patient in ... Read more
Patient presents a potential reaction to the COVID19 vaccine. I was called to assess the patient in the vaccination area. Immediately after vaccination, the patient had a vasovagal episode with syncope. Upon my arrival, the patient was alert and had been placed in a supine position with legs elevated. The patient was taking PO hydration and feeling much improved. Per the patient, this is routine for them with vaccination. Plan: Moderate vasovagal episode with syncope, which is common for the patient. We discussed future compensatory measures to avoid these events. The patient was at baseline at discharge and returned home with a partner as the driver.
24 2021-04-26 fainting SYNCOPE
24 2021-04-27 chest pain body-wide hives, chest pain,, shortness of breath, swollen hands and feet, dizziness, upset stomach,... Read more
body-wide hives, chest pain,, shortness of breath, swollen hands and feet, dizziness, upset stomach, vomiting, low grade fever, fatigue, sore throat. The night after vaccine I got hives, a fever, and chills. Took Benadryl and Asprin and slept. When awoke, fever broke but all the other symptoms began and remained for the entire day. Woke up this morning, all symptoms remain aside from chest pain, though the hives are considerably worse.
24 2021-04-27 fainting, hypotension This incident occurred at a mass vaccination clinic. After the individual received her 2nd COVID-19... Read more
This incident occurred at a mass vaccination clinic. After the individual received her 2nd COVID-19 vaccine, she walked over to the monitoring area and sat down. After a few minutes she became dizzy and disoriented, and then fainted. She woke up face down on the floor surrounded by a RN, EMT, and Paramedic. Baseline of vitals obtained, registering a low BP. Patient was monitored until VS were all WNL. After patient was considered in stable condition, she was asked to walk a lap around the indoor venue to ensure she was well enough to leave. She did so without issue and stated she felt "back to normal" and was ready to leave. Patient was released at 15:07.
24 2021-04-28 chest discomfort Tightening; heating up; swelling of throat; swelling of throat and chest; throat closing; shortness ... Read more
Tightening; heating up; swelling of throat; swelling of throat and chest; throat closing; shortness of breath; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0153), dose 1 via an unspecified route of administration, administered in Arm Left on 10Apr2021 at 14:00 (at the age of 24-years-old) as a single dose for COVID-19 immunization. Medical history included COVID-19 diagnosis in May2020, COVID-19 test taken via nasal swab on 01May2020 was positive. The patient had never had an allergic reaction in her life and she was not allergic to anything that she knew of. There were no concomitant medications (no medications within 2 weeks prior to vaccination). The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine.The patient received her first vaccine on 10Apr2021. After the shot she felt her throat closing. She experienced Tightening, heating up, swelling of throat and chest within 10 minutes of vaccine administration, also reported as at 14:15. They called the Paramedics, who gave her Benadryl injection when they picked her up from the site where she received her vaccination, which was a drug store. She was then transported to the emergency department. She was hospitalized and treated with Benadryl injection for the Tightening, heating up, swelling of throat and chest. She was monitored for 3-4 hours, and her symptoms were not worsening and she was able to leave the hospital. Ever since, this is the 9th day, everyday she had severe shortness of breath. She had no wheezing. Her chest clenches. It scared her so she had gone to the Emergency Department 2 more times for it. She had gone there 3 times in total. She had been to the Emergency Room a few times and saw doctors there. Her throat closing stopped later that evening and had come back about 4 times. Since then, she was not sure if it was just the sensation of the throat closing because it is coupled with shortness of breath. She had the sensation of throat closing about 4 times. She was short of breath every day since receiving the vaccine and up to 4 times each day. Sometimes it was worse than others. She had it while on the call (19Apr2021) and rated it 4/10. On 14Apr2021 she went to the Emergency Department in the middle of the night. She rated that episode as 9/10. Episodes of symptoms had been ongoing and reoccurring since the day of vaccine administration. She had a COVID-19 test post vaccination in Apr2021 (unknown results). The outcome of Tightening/ Chest tightness, heating up, swelling of throat and chest, throat closing and severe shortness of breath was not recovered.
24 2021-04-28 chest pain PATIENT RECEIVED PFIZER IMMUNIZATION ON 26APR2021 AND STARTED HAVING CHEST PAIN ON 28APR2021. PATIEN... Read more
PATIENT RECEIVED PFIZER IMMUNIZATION ON 26APR2021 AND STARTED HAVING CHEST PAIN ON 28APR2021. PATIENT WENT TO EMERGENCY ROOM AND WAS TREATED.
24 2021-04-28 skin turning blue, pallor Client c/o feeling dizzy, 12she had the wherewithal to get down onto the floor. Public Health Nurse... Read more
Client c/o feeling dizzy, 12she had the wherewithal to get down onto the floor. Public Health Nurse placed ice pack to back of neck, offered water and juice. Client became lethargic, pallor, cyanosis of the lips. FD and EMS was on site, provided care and was sent to hospital via EMS.
24 2021-04-28 fainting, hypotension, lightheadedness Within 15-minutes of vaccination, the patient had a near-syncopal episode and became diaphoretic and... Read more
Within 15-minutes of vaccination, the patient had a near-syncopal episode and became diaphoretic and dizzy. EMS evaluated the patient on-site. Initially, the patient was hypotensive (66/42), but was administered 600mL normal saline and BP improved (127/96). EMS transported the patient to Hospital Emergency Department. In the ED, the patient stated they experienced feeling lightheaded after vaccination. The patient was hypotensive (96/57) on arrival. Patient noted they had been working at a golf club in the sun the last few days and may be dehydrated. The physician administered 324mg PO Aspirin. Given the patient's concerns and labs/test results, the patient was discharged with vasovagal near-syncope and hypokalemia.
24 2021-04-29 excessive bleeding I have only gotten the first shot so far. I got the shot last Sunday and then on the following Tuesd... Read more
I have only gotten the first shot so far. I got the shot last Sunday and then on the following Tuesday I went to donate plasma. I frequently donate plasma. I had no side effects from the shot up until that point. Immediately after donating, I got in my car and looked down to see that my needle injection site from donating was pouring out an excessive amount of blood. I lost all vision and the employees helped to rebandage the site and put pressure. That had never happened before after donating. It seemed that my blood failed to clot.
24 2021-04-29 loss of consciousness developed slight nausea while walking about 14 hours after second dose and that quickly turned into ... Read more
developed slight nausea while walking about 14 hours after second dose and that quickly turned into loss of hearing and vision after standing still for a few minutes. Blacked out for about a minute and lost consciousness but was able to still stand either because I was holding onto something or someone was helping me (not sure). Came to and was drenched in sweat and stomach was churning. Hearing and vision came back after a few minutes. About an hour later, full body chills and body aches.
24 2021-04-29 fainting Systemic: Fainting / Unresponsive-Mild, Additional Details: pt briefly lost consciousness... no inju... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: pt briefly lost consciousness... no injury..did not fall...came to quickly\r\nshe was nervous and had not eaten breakfast
24 2021-04-30 loss of consciousness PATIENT PASSED OUT 5 MINUTES AFTER VACCINE ADMINISTRATION. PATIENT WAS SITTING ON THE PHONE WITH HE... Read more
PATIENT PASSED OUT 5 MINUTES AFTER VACCINE ADMINISTRATION. PATIENT WAS SITTING ON THE PHONE WITH HER MOM- FELT DIZZY AND STOOD UP TO WALK TO FRONT OF PHARMACY. PASSED OUT IN FRONT OF PHARMACY INTO DISPLAY AND CUT FOREHEAD
24 2021-05-01 chest discomfort 8 hours after vaccination, felt tightness in chest, chills, and nausea. 17 hours after vaccination, ... Read more
8 hours after vaccination, felt tightness in chest, chills, and nausea. 17 hours after vaccination, felt body aches and headaches for a span of 12 hours.
24 2021-05-01 nosebleed Pain/soreness around injection site beginning approx 2 hours after vaccine. Fatigue and body aches b... Read more
Pain/soreness around injection site beginning approx 2 hours after vaccine. Fatigue and body aches beginning approx 11 hours after vaccine administration. Fever began approx 12 hours after vaccine -- peaked at 100.4 degrees. Treated with acetaminophen 20 hours post-vaccination, which brought fever down to 99.1. Took another dose of acetaminophen 27 hours after vaccination. Body aches subsided approx 42 hours after injection. Nose bleed 50 hours after vaccine -- this also occurred for me after receiving the first dose, but did not report.
24 2021-05-01 pallor During the post-vaccination observation, patient started to feel weak and turn pale. Our pharmacy br... Read more
During the post-vaccination observation, patient started to feel weak and turn pale. Our pharmacy brought patient back to the pharmacist in the immunization. She began to experience the anaphylactic reaction and a dose of Epipen 0.3mg was given to patient by the pharmacist. The pharmacist called 911 and after a few minutes patient started to feel better and and skin turned back to normal. Pharmacist continued to observed patient until paramedic team arrived.
24 2021-05-02 chest pain isolated to the left sided chest pain 8 hours later. non radiating. feels better when she touches it
24 2021-05-02 excessive bleeding Received her first dose Pfizer vaccine (LOT#: EW0173 EXP: 8/2021) at 1009 on 5/02/21. PHN was alerte... Read more
Received her first dose Pfizer vaccine (LOT#: EW0173 EXP: 8/2021) at 1009 on 5/02/21. PHN was alerted by EMT who was told by patient that vaccinator made her anxious about the vaccine. Patient stated that vaccinator told her she was bleeding more than usual and that there was a small bump on her arm. EMT contacted patient at 1015. Patient reported swelling and hematoma at injection site. At 1025 patient reported feeling anxious and was crying. PHN assessed patient and reassured her the swelling in her arm was going down. PHN educated patient on worsening signs and symptoms at injection site and treatment of swelling. Patient verbalized understanding. PHN asked EMT to take vital signs. EMT took patients vital signs at 1033. BP: 140/111, pulse: 72, RR: 20. EMT reassessed patient at 1040. Patient stated that she was feeling a lot better and less anxious. EMT retook patients vital signs at 1042. BP: 142/108, pulse: 66, RR: 20. Patient had completed her observation time. Patient left at 1045 by herself, unassisted with a steady gait.
24 2021-05-04 chest discomfort slight shortness of breath in the next few minutes; chest and back tightness began; chest and back t... Read more
slight shortness of breath in the next few minutes; chest and back tightness began; chest and back tightness began; rash and hives across my face; rash and hives across my face; This is a spontaneous report from a contactable Nurse (patient). A 24-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9262 and expiration date was not reported), via unspecified route of administration in left arm on 26Jan2021 at 05:00 PM, as single dose for COVID-19 immunisation. The patient's medical history included GERD, migraines, depression, anxiety and allergy to peanuts and codeine. The concomitant medication included Amitriptyline, lansoprazole, Zyrtec and multivitamin. The historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142 and expiration date was not reported), in left arm on 03Jan2021 at 03:30 PM for COVID-19 immunisation. On 26Jan2021 at 17:05 patient experienced chest and back tightness began and slight shortness of breath in the next few minutes. Reported symptoms to on duty nurses who immediately laid down and checked vitals. BP 138/98, P 102, O2 98. On 26Jan2021 at 17:00 Nurses reported that she had broken out into a rash and hives across her face and chest. Given O2 at 2 Liters per minute. She was taken to the ER and given a steroid nebulizer, benadryl and claritin. Discharged and prescribed 20mg prednisone QD (every day) for 5 days, and a pro-air albuterol inhaler prn (as needed). Facility type vaccine: Doctor's office/urgent care. The patient did not other vaccine in four weeks. The adverse event resulted in emergency room/department or urgent care visit. The patient received corrective treatment for the adverse events. No COVID prior vaccination and no covid tested post vaccination. The outcome of the event was recovering. Follow-up attempts are completed. No further information is expected.
24 2021-05-04 fainting Around 5 minutes post vaccine, the patient fainted in the observation area. She fell out of her chai... Read more
Around 5 minutes post vaccine, the patient fainted in the observation area. She fell out of her chair face down on the ground. WIthin one minute, she regained conciousness and informed staff that she has passed out at least 3 times prior due to fear of needles. EMS was called to examine the patient due to hitting her head during the fall. Her vitals signs read: 115/74 BP, 99% O2 sat, with HR in the 70's, and RR 14-16. The paramedics cleared her to resume her day without further medical attention.
24 2021-05-04 fainting Nausea, faint, around 11pm that night felt very weak Next day soreness in my right arm nothing crazy... Read more
Nausea, faint, around 11pm that night felt very weak Next day soreness in my right arm nothing crazy About 5 days later was very ill, couldn?t get out of bed, and developed strep throat
24 2021-05-04 fainting Patient was light headed after shot. Sat for 30 minutes and walked around with supervision for anoth... Read more
Patient was light headed after shot. Sat for 30 minutes and walked around with supervision for another 10 minutes. When leaving Patient fainted and was having shortness of breath. Epi pen administered and Patient was taken to the hospital.
24 2021-05-05 chest pain I started having horrible upper back left shoulder blade pain that was tight on 4/26/21 mid afternoo... Read more
I started having horrible upper back left shoulder blade pain that was tight on 4/26/21 mid afternoon. I thought I may have slept weird. Two days later and it?s worse and it spread to my neck and other right shoulder blade. It?s so sharp and awful. It?s gotten worse. Today it?s awful and it spread to the ride side of my chest. Same type of pain. I feel like I can?t breathe in that well and my lungs burn.
24 2021-05-05 nosebleed Systemic: Patient has had 3 nosebleeds lasting a few minutes each 1-2 days after vaccine given.-Mild... Read more
Systemic: Patient has had 3 nosebleeds lasting a few minutes each 1-2 days after vaccine given.-Mild, Additional Details: Patient came to the pharmacy and said after the second dose of pfizer vaccine on 05/03/21 the next day (5/4/21) she had a nosebleed lasting a few minutes as well as to 2 other nosebleeds on 05/05/2021 each only for a few minutes. Patient said she doesn't ever get nosebleeds but noticed that her nose was very dry. Patient said she was feeling fine and didn't need immediate treatment. She was encouraged to notify doctor of this & had talked to the pharmacist on phone about how to treat dryness.
24 2021-05-05 loss of consciousness Passed out.
24 2021-05-06 fainting DIZZY, TINNITIS, SYNCOPE, EMESIS, SEEN BY PARAMEDICS, PROVIDED GATORADE AND SNACK, SYMPTOMS IMPROVED... Read more
DIZZY, TINNITIS, SYNCOPE, EMESIS, SEEN BY PARAMEDICS, PROVIDED GATORADE AND SNACK, SYMPTOMS IMPROVED, REFUSED TRANSPORT, AMA SIGNED.
24 2021-05-08 chest discomfort Headache, nausea, swollen lymph nodes, tender/painful breasts, lump in left breast, tight chest/hear... Read more
Headache, nausea, swollen lymph nodes, tender/painful breasts, lump in left breast, tight chest/heart
24 2021-05-09 chest pain 5/10/21 @ 1:59 Patient c/o tingling of the lips. 50mg of Benadryl tab where administered by mouth. ... Read more
5/10/21 @ 1:59 Patient c/o tingling of the lips. 50mg of Benadryl tab where administered by mouth. 5/10/21 @ 2:35 Patient c/o of chest pain, EMS was Called.
24 2021-05-09 pallor 15 min after receiving vaccination patient became nauseous and became pale. She then became overco... Read more
15 min after receiving vaccination patient became nauseous and became pale. She then became overcome with dizziness and had to immediately sit down for 30 minutes. After sitting her nausea and dizziness had improved enough to stand up and she was feeling better again.
24 2021-05-09 fainting, loss of consciousness FELT HOT AND FAINTED, UNCONSCIOUS X 5 SECS THEN WOKE UP. CODE GREEN CALLED, AOX3, REFUSED TRANSPORT,... Read more
FELT HOT AND FAINTED, UNCONSCIOUS X 5 SECS THEN WOKE UP. CODE GREEN CALLED, AOX3, REFUSED TRANSPORT, AMA SIGNED.
24 2021-05-10 chest discomfort, palpitations, chest pain Assessment Differential Diagnoses URI, bronchitis, bronchiolitis, allergic rhinitis, atypical pneu... Read more
Assessment Differential Diagnoses URI, bronchitis, bronchiolitis, allergic rhinitis, atypical pneumonia, community-acquired pneumonia, asthma exacerbation, COPD exacerbation Red Flag Symptoms Shortness of breath, fever, chest tightness, chest pain, palpitations, wheezing Subjective Chief Complaint Headache and myalgias HPI via Virtual visit 24 year old female complains of COVID-19. Patient is a nurse at the hospital. Yesterday, she developed a headache along with neck and shoulders achiness. Last night, she came home with no appetite, has pressure in her chest. Feels tight and makes her cough. She has had 1 dose of of the covid vaccine. Denies fever. Has no headache currently. She has not taken anything.
24 2021-05-10 chest pain DOB: 11/06/1994. Received her second dose Pfizer vaccine (LOT#: EW0179 EXP: 8/2021) at 1426 on 5/10... Read more
DOB: 11/06/1994. Received her second dose Pfizer vaccine (LOT#: EW0179 EXP: 8/2021) at 1426 on 5/10/21. Patient alerted one of the ancillary at site and stated that she was not feeling well. Ancillary staff alerted EMT Cand EMT. EMT's sat patient down on zero gravity chair. Patient stated that she felt a burning sensation in her chest and her throat about 10 minutes after the vaccine. PHN arrived on scene and offered patient water and asked EMT to take patients vital signs. EMT took vital signs at 1500. BP: 130/82, HR: 83, RR: 22, O2: 100%. Patient stated that she has a history of anxiety and does not take medications for her diagnosis. Patient was ANOX4, skin warm, normal. Patient stated that breathing slowly, drinking water and talking are her coping mechanisms for her anxiety. PHN asked patient to stay an extra 30 minutes for observation. EMT reassessed patient and re-took vital signs at 1515. BP: 116/65, HR: 62, RR: 20, O2: 100%. Patient stated that she no longer had any burning sensation but still felt anxious. EMT reassessed patient and re-took vital signs at 1530. BP: 111/61, HR: 75, RR: 20, O2: 100%. Patient stated that she no longer felt any burning sensation but still felt anxious. Patient had completed observation time but asked to stay a little longer. Patient stayed 8 minutes extra. EMT reassessed patient. Patient stated she was feeling better and no longer felt anxious. Patient was educated on worsening signs and symptoms of side effects of the vaccine and when to seek help from EMS. Patient verbalized understanding of education. Patient left vaccination site at 1538 unassisted with a steady gait.
24 2021-05-10 loss of consciousness, fainting Patient received vaccine and about 10 minutes after came up to the consult window for a glass of wat... Read more
Patient received vaccine and about 10 minutes after came up to the consult window for a glass of water. Patient stated that she felt light headed and immediately fainted back and hit her head against wall and on the floor. Patient did regain back consciousness immediately after falling, but laid on ground until medic arrived. Patient was shaking per post shock and was stating "feeling warm." Did provide water as well as a jacket to rest her head and a cool compress. Mother was there by the side of patient and calmed her down while paramedics arrived. At around 3:50 medic arrived and took blood pressure and examined patient further. Patient seemed fine but required further evaluation by medic.
24 2021-05-10 lightheadedness, chest discomfort Patient reported presyncope approximately 15-20 minutes after vaccination. She was assessed by this ... Read more
Patient reported presyncope approximately 15-20 minutes after vaccination. She was assessed by this provider with nursing support, and found to have intermittent presyncopal sensation. A history was obtained, which patient reported good breakfast, one caffeinated beverage, appropriate fluid intake. Allergy to amoxicillin (hives and swelling). Only medication was OCP. Vitals were 140/90 by manual cuff, SpO2 100%, RR 16, HR 66. Cardiopulmonary auscultation and neurologic exam (cranial nerves) were within normal limits. She was moved to a partitioned section of the vaccine site, and reported feeling slightly better, however continued with presyncope. She was noted to have mild 2 beat nystagmus on quick head motions, and syncopized. She returned to consciousness quickly, however at this time EMS was called due to prolonged nature of symptoms and limited resources at vaccine site. She was transitioned to a stretcher with assistance, and EMS arrived. She reported chills and was covered with her jacket. She syncopized again during EMS assessment, and was easily arousable, but at this time reported chest tightness. EMS applied 3-lead EKG which appeared normal on the monitor, SpO2 was 97% and respirations continued normally, and heart rate was in the 80s, with blood pressure 141/85. She was taken by EMS to the nearby Emergency Department.
24 2021-05-11 loss of consciousness Pt reported "blacking out" after injection; transferred to observation; given food, water and juice ... Read more
Pt reported "blacking out" after injection; transferred to observation; given food, water and juice and then felt better. VS stable (BP 105/62; HR 83; RR 18; O2 sat 100%), NAD, tested ambulation and reported no dizziness or fatigue, pt steady on feet. Pt deemed stable and released from vaccination site.
24 2021-05-12 increased heart rate, heart rate increased, hypertension Severe Panic Attacks and Anxiety, high blood pressure, high heart rate, red welts on forearms and ch... Read more
Severe Panic Attacks and Anxiety, high blood pressure, high heart rate, red welts on forearms and chest. Anxiety still persistent after 6 weeks
24 2021-05-13 nosebleed Heavy nose bleed, headache, fever, soreness around body
24 2021-05-14 loss of consciousness passed out; sweating; turned blue; This is a spontaneous report from a contactable other healthcare ... Read more
passed out; sweating; turned blue; This is a spontaneous report from a contactable other healthcare professional (hcp reporting for self). A 24-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EW0173, expiry date not reported) via an unspecified route of administration, administered in left arm on 01May2021 18:00 (at the age of 24 years old) as first dose, single for covid-19 immunization. The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. On 01May2021 18:00, patient immediately started sweating after getting the shot then passed out within a couple minutes. Pharmacist told the patient that she turned blue and they injected her with Epipen. Patient woke up after and felt fine. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were reported as serious medically significant. Since the vaccination, the patient was not tested for COVID-19. The patient recovered from the events reported on an unspecified date in May2021.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events loss of consciousness, hyperhidrosis and skin discolouration cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
24 2021-05-14 pallor On Friday, May 14th, 2021 client received her first dose of Pfizer COVID vaccine to left deltoid (LO... Read more
On Friday, May 14th, 2021 client received her first dose of Pfizer COVID vaccine to left deltoid (LOT # EW0182, EXP 5/15/21) at approximately 11:04 AM. Pt verbalized the only medication she is on is hormonal birth control, and has a history of a Penicillin allergy, no further allergies or conditions indicated. After receiving the vaccine, the client told RN that she has a history of anxiety and syncopy after blood draws. Pt sat at the vaccine station and stated she was feeling very weak and anxious. Co-lead RN and Lead RN noticed pt across the room and went to assess around 11:10. Upon observation, pt looked pale in color and had cool, clammy skin. While at vaccine station, pt had small emesis x2 at 11:12 am. At 11:10 am vitals were taken by EMT : BP: 126/89, HR: 99, O2: 100%. Client was escorted to the zero-gravity chair and was given a bottle of water and Gatorade. Upon assessment by EMTs client's last meal was cereal at 09:00 am. At 11:35 am vitals were taken: BP: 88/74, Hr: 77, RR: 16, O2 sat: 99%, with a strong radial pulse. Immediately after, Co-Lead RN offered pt chips as pt had no further episodes of emesis. Pt sat in zero-gravity chair eating chips and vitals were taken again at 11:55 am, BP: 88/78, HR: 79, RR: 20, and O2: 98%. At that time pt stated that she was ?feeling much better?. At 12:05 pm, final vitals were taken, BP: 95/65, HR: 74, RR: 20, O2: 98%. Patient was alert and oriented x4 during entire interaction. No further interventions indicated. Pt was educated by Co-Lead RN and Lead RN on signs and symptoms of adverse reactions and when to go to the ED/call MD. Pt was able to ambulate with her brother-in-law to her car unassisted with a steady gait at approximately 12:07 pm.
24 2021-05-15 fainting Fainted while waiting in the waiting area. She was sweating also. She gained conscious after few min... Read more
Fainted while waiting in the waiting area. She was sweating also. She gained conscious after few minutes and left the store. Asked to call ER but she refused.
24 2021-05-16 chest discomfort, chest pain Soreness at injection site; Body aches; Tightness/pain in chest along sternum (vertical)
24 2021-05-17 loss of consciousness The patient was given her vaccine at 1:05 pm and after her dose as she went to sit in the observatio... Read more
The patient was given her vaccine at 1:05 pm and after her dose as she went to sit in the observation area she passed out. She fell to the ground and hit her head. She was unconscious for about 1-2 minutes and then came to. EMS arrived to evaluate her and she was taken to the Hospital
24 2021-05-17 fainting She fainted for approximately 2 minutes.
24 2021-05-19 fainting Experienced syncope at 8am on 5/20/21 after feeling chills and fever. Experienced 3 back-to-back epi... Read more
Experienced syncope at 8am on 5/20/21 after feeling chills and fever. Experienced 3 back-to-back episodes of syncope.
24 2021-05-23 heart rate increased, chest pain Within 20 minutes I felt like I couldn?t breathe my whole body went numb and I felt like I was gonna... Read more
Within 20 minutes I felt like I couldn?t breathe my whole body went numb and I felt like I was gonna pass out. I had chills, cough, nausea, body aches, loss of appetite , shortness of breath , accelerated heart, and chest pain. Since the day of the vaccine I have been struggling with my physical and mental health. I?ve been in and out of hospitals, doctors, specialist.
24 2021-05-23 troponin increased, chest pain Chest pain, troponin elevation
24 2021-05-25 enlargement of the heart, oxygen saturation decreased Caught during Bariatric surgery. No symptoms beforehand. Oxygen levels crashed on table. Labs show ... Read more
Caught during Bariatric surgery. No symptoms beforehand. Oxygen levels crashed on table. Labs show increased WBC over 10-14 hr period. Pneumonia like symptoms, wasn?t confirmed by IMDrs or tests, chest X-ray showed enlarged heart (mild)
24 2021-05-26 coughing up blood Coughing up blood, after second vaccine; Feverish, after second vaccine; Lymph nodes swollen, with b... Read more
Coughing up blood, after second vaccine; Feverish, after second vaccine; Lymph nodes swollen, with bruising under arm, after second vaccine; Under arm bruised, after second vaccine; This is a spontaneous report from a contactable nurse (patient's grandmother). A 24-year-old female patient received bnt162b2 (Pfizer Covid shot), dose 2 (at the age of 24 years) via an unspecified route of administration, administered in left deltoid on 09May2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included ongoing polycystic ovaries from a couple of years ago and allergic to peanut butter from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient received the first shot of bnt162b2 one month ago (Apr2021) for COVID-19 immunization. The patient experienced coughing up blood, feverish, lymph nodes swollen, with bruising under arm/under arm bruised all on 11May2021 after second vaccine. Outcome of events was unknown. The events did not require a visit to Emergency Room or Physician Office; no treatment was given. Events coughing up blood, feverish, lymph nodes swollen were reported as serious medically significant, event under arm bruised was non-serious. Information on Lot/Batch number was requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a close temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
24 2021-05-26 pallor 10-15 min after vaccination pt. c/o throat felt tight and closing, blurry vision, faint/ pale, slow ... Read more
10-15 min after vaccination pt. c/o throat felt tight and closing, blurry vision, faint/ pale, slow to process cognitive and respond/ Pt . put in supine position/ given Benadryl 50 mg PO with no response. Epinephrine 1mg IM/RD / color improved, shallow, rapid respirations, lung sounds CTA in all lobes. EMS arrived 32 min after covid vaccine given. Pt. transferred to Hospital.
24 2021-05-26 fainting, lightheadedness Patient fainted at 10.15 when she was waiting in the waiting area after the vaccine. She quickly cam... Read more
Patient fainted at 10.15 when she was waiting in the waiting area after the vaccine. She quickly came about. PA and EMT treated for Vasovagal Episode. Patient mentioned she fainted previously at a flu shot y ears ago and that she hadn't eaten all day. Pulse ox and blood pressure was ok, blood sugar was low. She was given 15 mg liquid glucose.
24 2021-05-27 fast heart rate Tachycardia, elevated temperature without fever, dizziness, generalized weakness, malaise
24 2021-05-28 blood pressure decreased, loss of consciousness, fainting, loss of consciousness, fainting A 24 y.o female fainted and appeared to have a seizure. She loss consciousness and had muscle contra... Read more
A 24 y.o female fainted and appeared to have a seizure. She loss consciousness and had muscle contractions. The seizure was approximately 2 minutes. Patient did not hit her head or injury any part of her body. She was gradually dismounted from the chair and placed on the floor. 1st B/P reading was 70/40, then 108/63. Patient after waking up was alert and oriented X3. Once EMS arrived she was assessed and encouraged to go to the hospital for follow up. Patient and father refused to go to the hospital. They verbalized "She has an important exam for school". Patient stated she will follow up after her exam.
24 2021-06-01 chest discomfort Patient reports having chest discomfort about 5-10 minutes after getting vaccination. Vitals stable,... Read more
Patient reports having chest discomfort about 5-10 minutes after getting vaccination. Vitals stable, she was observed for 30 minutes and patient notes symptoms have improved.
24 2021-06-01 chest discomfort 30 minutes after vaccine patient began to hyperventilate, and felt chest tightness. I stayed with p... Read more
30 minutes after vaccine patient began to hyperventilate, and felt chest tightness. I stayed with patients until the paramedics arrived.
24 2021-06-01 fainting Immediately after vaccine patient stood up and became dizzy and passed out. B/P 95/61 at 6:02 had pa... Read more
Immediately after vaccine patient stood up and became dizzy and passed out. B/P 95/61 at 6:02 had patient lay down and gave crackers and juice. B/P 101/65 at 6:39. Patient was feeling better and left with significant other
24 2021-06-01 fainting Pt had received her first vaccine and was in the observation area. She was seen to have slumped in h... Read more
Pt had received her first vaccine and was in the observation area. She was seen to have slumped in her chair, preceding a syncopal episode. The patient remained in her chair during the episode. Pt informed us after the syncopal episode that she had felt as if she fell asleep. She has no medical history of seizures or syncope in the past. She did have limb movement during the period of syncope. The episode seemed to last no more than 15 seconds. The patient quickly woke and began speaking to us. She was clammy and sweaty, vitals were completely normal as taken by the RNs. She was observed in the private area for > 15 minutes, given drink and crackers, tolerated well. She ambulated well and had her fiancé pick her up. She will follow up with her PCP this week. vitals: BP: 120/80, P 72, O2 98%
24 2021-06-02 heart rate increased, palpitations Racing heart with heart palpitations. Started on second/third day after vaccination. Heart began rac... Read more
Racing heart with heart palpitations. Started on second/third day after vaccination. Heart began racing throughout the day and pulse was high (over 115 pulses) while solitary and not moving. Lasted three days after throughout the day off and on and still having small heart issues in the morning.
24 2021-06-02 fainting, loss of consciousness So at around 9pm the evening of my shot, I started feeling feverish so I went to the other room to g... Read more
So at around 9pm the evening of my shot, I started feeling feverish so I went to the other room to get my temperature and while I was waiting for my temperature to be recorded, I started to feel lightheaded and I called out for help. I woke up on the floor, I woke up to my roommate and boyfriend standing over me. They were on the phone with 9-1-1. I was out for about a minute and unresponsive. According to them, my arm was flailing and seizure-ish. I went to the ER, I was taken by EMS services. They gave me fluids and ran bloodwork and monitored me. They sent me home, I did have another episode of what I think was an episode of memory loss/passed out. I just remembered waking up in a room alone. I was at the ER for about 4-5 hours. They gave me IV fluids and I don't remember what else, some sort of supplement. It was magnesium oxide they gave me. When I left the ER I was really exhausted, and feverish and gross and I was pretty sick for the remaining two days. I didn't sleep well that night, I had a fever the following day and into the second day upon returning home as well.
24 2021-06-06 heart rate increased Patient states feeling anxiety. Patient states she felt nausea. No vomit and rapid heart rate. HR... Read more
Patient states feeling anxiety. Patient states she felt nausea. No vomit and rapid heart rate. HR 88, RR 22. 6:25pm Patient left accompanied by aunt. was walking c/1 steady gait with vitals within normal limits. Patient recommended to seek medical attention if any other adverse reactions arise.
24 2021-06-06 loss of consciousness, nosebleed I got the vaccine some time in the night when i was taking a shower i noticed arm soreness. when i w... Read more
I got the vaccine some time in the night when i was taking a shower i noticed arm soreness. when i went to bed around 11pm from the top of my shoulder down to my finger tips it was swollen and had arm pain. I tried to go to bed and about 30 minutes later i went to get up to grab some advil. I checked in the mirror to see if there was redness and got light headed. Next thing i know i passed out. I woke up on the floor and a big pool of blood i dont know how long i was out for. I had a nose bleed and had a bruise on my head, I could leave the bath room because i was shaking so bad and couldnt use any force to get up. After 45 mins that i went to my room and called my mom who is a physican i sat on the floor for 3 or 4 hours until i could get the nose bleed to stop. I ended up then getting into bed and the shacking had stopped after 800 mg of advil. I checked my pupils for signs of cuncussion. the 1/25 i had my first appointment and we checked to see if i broke my nose. after that the next days they did see signs of concussion with sleeping 20 hours a day and blurry vision. I went back to med center to get an mri and eeg to see about the concussion because they were worried since i didnt know how long i was out for. They also sent me to a concussion specialist. I had follow up care about the concussion for a month or so. For about a week floowing the vaccine i was taking 800mg 3times a day for the tremor's and fever
24 2021-06-06 loss of consciousness Patient had two tonic-clonic seizures 8 hours apart and was unconscious for up to 10 minutes. Seizu... Read more
Patient had two tonic-clonic seizures 8 hours apart and was unconscious for up to 10 minutes. Seizures were closed eye seizures that started upon falling asleep. Patient had no prior history of seizures before the vaccine. Both times patient was transported via Emergency Paramedics to ER.
24 2021-06-07 fainting Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsiv... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Mild, Additional Details: Patient fainted shortly after recieving the first dose of the Pfizer COVID19 vaccine. Her brother was able to catch her before she hit the floor and regained consciousness 10 seconds after fainting. She felt flushed, sweaty and dizzy. She was seen by EMTs who arrived on site and pronounced her fine. Patient refused to go to the hospital to get checked out. Patient remained in the pharmacy until she was able to successfully walk around the store anf felt fine before leaving.
24 2021-06-07 blood clot Patient presented for 2nd dose and reported having a blood clot the day after receiving her first do... Read more
Patient presented for 2nd dose and reported having a blood clot the day after receiving her first dose. She is unsure if it was due to the vaccine or her vascular malformation. She did not seek medical help or receive a diagnosis from a medical professional. States the clot dissolved on its own. Pfizer Covid vaccine
24 2021-06-08 inflammation of the heart muscle Myocarditis requiring hospitalization
24 2021-06-09 blood clot massive blood clot from her thigh to her ankle; incapable of walking; serious pain in my left thigh/... Read more
massive blood clot from her thigh to her ankle; incapable of walking; serious pain in my left thigh/muscle strain; serious pain in my left thigh/muscle strain; leg fell asleep; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm on 11May2021 at 14:45 as a single dose for COVID-19 immunization. The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was taking unspecified birth control medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was on her second week of completing the vaccine. The patient reported that on Thursday night, 20May2021, she was just laying down on her couch watching Netflix with her laptop on her lap, her leg fell asleep but she didn't think anything of it because once she started walking around it went back fine. However, on 21May2021, Friday morning, she was having serious pain in her left thigh. She believed it was a muscle strain. The patient did a cold compress, warm bath and took Tylenol from Friday to Saturday. She thought it got better but by 23May2021, Sunday night, she was incapable of walking on her own and needed assistance just to go to the bathroom. On 24May2021, she went to Urgent Care and they stated that she may have a blood clot so she went to the ER (Emergency Room). While at the ER they said she had a massive blood clot from her thigh to her ankle. She would need a procedure done to remove it and was later admitted into the hospital and scheduled for the procedure. Blood thinners and suctioning out the blood clot was done as treatment. The patient been tested for COVID-19 (nasal swab) on 24May2021 with a result of negative. The outcome of the events was unknown.
24 2021-06-10 chest pain, heart rate increased About 12 hours after the second dose I felt extremely sick. I had a fever, chills, body aches, sore ... Read more
About 12 hours after the second dose I felt extremely sick. I had a fever, chills, body aches, sore throat and extreme exhaustion. Around 30 hours later I started to have severe chest pain. It was hard to breathe and for a few hours I was worried I was going to have a heart attack. I put on my Apple Watch to record my heart rate and it was jumping from the 70?s to the 115?s just laying in bed. Now after reading that I am not the only one who had severe chest pain I am worried about any long lasting effects since I decided not to go to the doctor for these chest pains.
24 2021-06-10 chest pain Pt called on 6/11/21 stating she has experienced pain at the side of her chest that comes and goes a... Read more
Pt called on 6/11/21 stating she has experienced pain at the side of her chest that comes and goes after receiving the Pfizer COVID-19 vaccine on 6/10/21. She currently does not have PCP and referred her to see a physician as soon as possible. She said she will contact urgent care first.
24 2021-06-10 fainting fainting from heavier menstruation; Sore arm; body aches; low grade fever 99.1; menstruation 3 days ... Read more
fainting from heavier menstruation; Sore arm; body aches; low grade fever 99.1; menstruation 3 days early; Heavy menstruation; Lethargic; fatigue for 4 days; Headache; dry throat; thirsty; This is a spontaneous report from a contactable consumer. A 24-years-old non-pregnant female patient received bnt162b2 (BNT162B2) dose 2 via an unspecified route of administration, administered in left arm on 13Apr2021 09:45 (Batch/Lot Number: EW0161) at the age of 24 years old as a single dose for covid-19 immunisation and dose 1 via an unspecified route of administration, administered in right arm on 23Mar2021 at 09:45 (Batch/Lot Number: EP6955) at the age of 24 years old Medical history and concomitant medications were not reported. The patient previously took amoxicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Apr2021 at 1500 the patient experienced Sore arm, body aches, low grade fever 99.1, menstruation 3 days early, Heavy menstruation, Lethargic, fainting from heavier menstruation, fatigue for 4 days, Headache, dry throat, thirsty. The patient was not hospitalized for the events. The outcome of the events was recovered with sequelae. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
24 2021-06-10 fainting About 5 minutes after Pfizer shot, patient fainted and felt dizzy. No shortness of breath. Called ... Read more
About 5 minutes after Pfizer shot, patient fainted and felt dizzy. No shortness of breath. Called 911 and paramedics came.
24 2021-06-10 fainting PT RECEIVED 2ND DOSE OF PFIZER VACCINE, WAS WAITING IN THE POST VACC WAITING AREA THEN SHE ASKED FOR... Read more
PT RECEIVED 2ND DOSE OF PFIZER VACCINE, WAS WAITING IN THE POST VACC WAITING AREA THEN SHE ASKED FOR WATER. SHE APPEARED GLASSY-EYED AS SHE WAS APPROACHING THE COUNTER SO I WALKED OUT TO ASK IF SHE WAS OK. AS SOON AS I GOT OUT THERE, SHE STARTED TO FAINT. WE CAUGHT HER AND HAD HER LAYING ON THE MAT WHILE EMS WAS CALLED. BLOOD PRESSURE WAS 112/84 P 106 (TOOK THIS AFTER SHE REGAINED CONSCIOUSNESS IN A FEW SECONDS). WHEN SHE CAME TO, SHE SAID SHE HAD NOT EATEN RECENTLY, HAD ONLY HAD COFFEE TO DRINK TODAY, SO HAD HER LIE DOWN WITH HER FEET ELEVATED. SHE BEGAN TO VOMIT INTO THE TRASHCAN. EMS ARRIVED, EVALUATED HER AND ALL VITALS WERE NORMAL, SHE SAID THAT SHE HAD PASSED OUT PREVIOUSLY AFTER A VACCINE, BUT DID NOT INDICATE THAT ON HER QUESTIONNAIRE (PCQF).
24 2021-06-10 fast heart rate Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Letha... Read more
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: symptoms consistent with serotonin syndrome, likely unrelated to vaccine after discussion with caregiver-Medium, Systemic: Headache-Medium, Systemic: Tachycardia-Medium, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: Pt on multiple sertonergic agents and additionally admitted to taking st john's wort, which was never discussed with psych or pharmacy. Pt never had trouble breathing and was released with husband and 2 caregivers with instructions to call MD immediately and report to ER. Not likely related to vaccination, however reporting just in case. symptom onset was almost immediately after vaccination.
24 2021-06-10 troponin increased, inflammation of the pericardium, palpitations, chest pain, chest discomfort 4 days after my second dose, I started feeling chest tightness and slight pain, which increased in s... Read more
4 days after my second dose, I started feeling chest tightness and slight pain, which increased in severity over the next couple of days. Late on April 11, 2021, I went to the ER because my heart was racing and my chest pain had become much worse. They ran several tests, and I was admitted into the hospital for two nights and diagnosed with pericarditis. The troponin levels in my blood were very high, which made the doctors think I had myocarditis, but an echocardiogram revealed no inflammation of my heart. I?m on an 8-week course treatment of colchicine, and was taking ibuprofen and omeprazole for 5 weeks.
24 2021-06-13 chest pain, heart rate increased, ischemic chest pain, inflammation of the heart muscle I suspect I had a mild case of myocarditis - the morning after my second COVID shot, I woke up with ... Read more
I suspect I had a mild case of myocarditis - the morning after my second COVID shot, I woke up with a heart rate over 100bpm (according to my Apple Watch). My normal resting rate is about 60bpm, so this was a huge jump. Even though I spent most of the day in bed, my heart rate continued to be over 100bpm. In addition, I had chest pain in my heart area (it hurt every time I breathed deeply), along with a 100 degree Fahrenheit fever, chills, and aches. Most symptoms went away after a day of first appearing, however my chest pain persisted for another 3-4 days. The first day I worked out after my second shot (~9 days after), I also had heart pain that I had never experienced before. I did not go to the doctor as I thought it would go away on its own, which it eventually did after about 12 days after my second shot.
24 2021-06-13 heart rate increased Heart rate began to increase into the 120?s around noon but I did not notice. I began to feel chills... Read more
Heart rate began to increase into the 120?s around noon but I did not notice. I began to feel chills around 7pm and my heart rate was 128. I started running a fever of 101.4 shortly after with chills. I took extra strength Tylenol and checked my temperature again at 3am and my fever was 100.3 with chills. I took Motrin and went back to sleep. I woke the next morning hot and sweaty with a temperature of 97.8.
24 2021-06-14 fainting, loss of consciousness At approx. 1057 pt received first dose of Pfizer COVID vaccine, pt has known hx of anxiety with bloo... Read more
At approx. 1057 pt received first dose of Pfizer COVID vaccine, pt has known hx of anxiety with blood draw or vaccines, subsequently she was asked to wait x15 min sitting in the lobby, per nursing staff pt ambulated to lobby with no abnormal gait noted and sat down in a chair. At approx. 1108 pt started to c/o inability to breathe, dizziness and presented syncope. Pt was triaged by Doctor, VS obtained T: 97.7 P: 65 R:17 B/P: 100/67 O2: 97%.. Pt recovered consciousness approx. 2-3 minutes and was transferred to a private room. Pt was alert, answered Doctor questions while in supine positiion. Pt was assisted to a fowler's position with c/o slight dizziness. Doctor proceeded to further assess pt by completing a neurological and strength test to which pt followed directions and completed test fairly well. EKG completed per Doctor, process explained to pt prior to conducting EKG, all metal was removed, with 2 more set of vitals completed:1120 T: 97.6 P: 85 R: 18 B/P: 103/72 and 11:49 T: 97.8 P: 68 R: 16 B/P: 101/70. Post last set of vitals pt was asked to stand and ambulate around the room. Per pt she felt better and was able to ambulate with no assistance required. Pt A&O x3, with Mother driving her back home.
24 2021-06-15 chest discomfort, fast heart rate Developed tachycardia and chest tightness after vaccination. No shortness of breath, dizziness, nau... Read more
Developed tachycardia and chest tightness after vaccination. No shortness of breath, dizziness, nausea or rash. Symptoms resolved without treatment in about 37 minutes.
24 2021-06-15 loss of consciousness, pallor The patient began to feel light headed/ dizzy and nauseous. Within minutes she lost color in her fac... Read more
The patient began to feel light headed/ dizzy and nauseous. Within minutes she lost color in her face became very sweaty and passed out. The paramedics were called .All of her vitals checked out. The patient chose to go to hospital for further evaluation. The patient reported that she had only had breakfast that day. We gave her some water as well as some juice .
24 2021-06-15 fast heart rate, low blood oxigenation tachycardia, dyspnea exertional hypoxia, positional tachycardia, fatigue, Symptoms started about 12 ... Read more
tachycardia, dyspnea exertional hypoxia, positional tachycardia, fatigue, Symptoms started about 12 hours after 2nd dose of vaccine. still experiencing symptoms 7 weeks later; no cause found yet
24 2021-06-16 chest pain, chest discomfort Chest pain. tightness and sharpness in the center of chest. This lasted for three days. treated with... Read more
Chest pain. tightness and sharpness in the center of chest. This lasted for three days. treated with ibuprofen.
24 2021-06-17 heart rate increased Pt was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . Duri... Read more
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 and rapid heart rate. Assessment : Time of assessment . 8:40am- Alert and oriented able to respond to questions but blank stare. Mom accompanying, at her side.She was discharged home on Wednesday from medical center after a 4 day stay for seizure like activity after passing out at home on Saturday. CT at hospital showed chronic sinusitis. Has continued with coughing and nasal congestion since discharge. Actions taken: 8:43am- moved out of pt area and laid on stretcher. B/P 127/83, HR-66. C/O feeling hot. No breakfast or fluids taken in this AM. OJ given and water. 8:45am- Talking and laughing with mom still verbalizes dizziness. 8:49am-B/P 124/72, HR- 67. 9am- Sat on side of stretcher B/P 115/79, HR- 68, O2 sat 100% on room air. Verbalizes she feel some dizziness. 9:05am- Stood up,B/P 123/89, HR- 68 became very dizzy and unsteady on feet, immediately laid back down. Encouraged to drink water. 9:14am- Sat up on stretcher, no dizziness. B/P 118/67, HR-67. 9:17am- Stood up, denies dizziness. B/P-119/67, HR- 68. 9:18am- ambulating without complaints. No dizziness, HA, SOB and alert and oriented x4. 9:20am- Discharged home and will be home with mom all day, she has a post hospital f/u appt with her PCP today. Will relay with information to them. Medications administered: No medication administered.
24 2021-06-21 heart rate increased, chest pain Fever, elevated heart rate 30+ point above normal. Stomach pains and stomach cramps. Fatigue. Back a... Read more
Fever, elevated heart rate 30+ point above normal. Stomach pains and stomach cramps. Fatigue. Back aches. Overall bad feeling. Rare chest pain.
24 2021-06-21 fainting Patient reported feeling faint as soon as she was injected then she fainted in the chair she was sit... Read more
Patient reported feeling faint as soon as she was injected then she fainted in the chair she was sitting in. Seconds later she had a seizure lasting approx. 7 to 10 seconds. When she woke up she said she'S had seizures before ?but not for a while?. She also said she hadn?t eaten that day. She rested in our facility's Clinic until she felt well enough to go home. In the Clinic she was given some glucose tablets and water and the NP checked her blood pressure. The patient consulted with her doctor by phone . When I spoke with the patient on 6/4/21 she had plans to see her doctor and possibly be referred to a neurologist.
24 2021-06-22 palpitations Starting the day after my second vaccine, I had heart palpitations which felt like my heart was beat... Read more
Starting the day after my second vaccine, I had heart palpitations which felt like my heart was beating very hard/skipping beats/squeezing/?glugging?. It happened intermittently a few times an hour throughout the day but I attributed it to my fever (101F). The next day my fever was gone but heart palpitations remained. They continued for the next week, albiet slightly reduced in frequency. At that point I made a dr appt. I had an EKG and wore a 24 hr holter monitor which both showed no irregularities. Now, 1.5 months after my second dose of the vaccine, the irregular beating has reduced greatly and does not impact my daily life
24 2021-06-22 blood clot Heavy, painful menstrual cycle with extreme clotting that has lasted over a month.
24 2021-06-23 chest discomfort woke up from sleep with tightness in chest about 3:00 am April 26th, couldn't take deep breath and c... Read more
woke up from sleep with tightness in chest about 3:00 am April 26th, couldn't take deep breath and could hardly breath, left arm started going numb when i got to the ER at 4 am. Felt like my heart was going to beat out of my chest. couldn't lay down. had a sharp pain in the left side of my chest. This lasted almost the whole day Monday the 26th, would get a little better then woke up again on the 27th with the same pain. My pain was at about an 8.5/10. I would take tylenol and ibuprofen to control the pain. After about 5 days the pain had gone completely away.
24 2021-06-24 chest pain, heart rate increased The day after my vaccination i had a bad cheat pain, i thought it was gas. The next day after noon i... Read more
The day after my vaccination i had a bad cheat pain, i thought it was gas. The next day after noon i started to get rapid and hard heartbeats that were a little annoying. I thought those were only momentary, but they lasted all night. And since then, every day i have that same symptom that makes me t up at nights because of the loud heart beat
24 2021-06-24 chest pain Had strong contractions (20 weeks pregnant) 10 minutes after injection (2nd dose). Contractions on a... Read more
Had strong contractions (20 weeks pregnant) 10 minutes after injection (2nd dose). Contractions on and off all day; Had strong contractions (20 weeks pregnant) 10 minutes after injection (2nd dose). Contractions on and off all day.; chest pains on and off along with heartburn sensation.; chest pains on and off along with heartburn sensation.; This is a spontaneous report from a non-contactable consumer (reporting on herself). A 24-years-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number and Expiry date was not reported), via intramuscular, administered in Arm Left on 11Jun2021 as dose 2, single for COVID-19 immunization. Medical history included anaemia, anxiety disorder, arrhythmia all from an unknown date and unknown if ongoing. Concomitant medication(s) included iron (IRON) taken for supplementation therapy, start and stop date were not reported and prenatal vitamins. The patient previously took augmentin [amoxicillin;clavulanic acid] and experienced drug hypersensitivity and BNT162B2 for COVID-19 immunization and experienced maternal exposure during pregnancy. Patient did not receive other vaccines within 4 weeks prior to the COVID vaccine and Prior to vaccination, patient was not diagnosed with COVID-19. It was reported that had strong contractions (20 weeks pregnant) 10 minutes after injection (2nd dose). Contractions on and off all day. Also reporting chest pains on and off along with heartburn sensation. The mother was 21 Weeks pregnant at the onset of the event. The mother was due to deliver on 25Oct2021. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
24 2021-06-24 heart rate abnormal, heart rate increased Short of breath in recent weeks, heart rate on June 9,2021 was up to 135 resting rate, abnormal hear... Read more
Short of breath in recent weeks, heart rate on June 9,2021 was up to 135 resting rate, abnormal heart rhythms (extreme fast or slow beating)
24 2021-06-24 palpitations After the first dose had a headache, after second dose started having heart palpitations. Anxiety ha... Read more
After the first dose had a headache, after second dose started having heart palpitations. Anxiety has gotten worse.
24 2021-06-25 chest pain, chest discomfort Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: sh... Read more
Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: sharp chest pain and shortness of breath. on and off since 1st dose-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Additional Details: She states that some of her chest pain is sharp and causes shortness of breath. She had to take a break at work and sit for 30 minutes. She is going to have appointment with PCP to check it out before her 2nd dose.
24 2021-06-27 chest pain Upper central chest pain, described as squeezing/ sharp. Pain is worse with walking. Pain is bett... Read more
Upper central chest pain, described as squeezing/ sharp. Pain is worse with walking. Pain is better if she leans forward or lays all the way back. Patient also endorses pain in neck and back. Pulmonary embolism is considered.
24 2021-06-27 excessive bleeding On Day 2 after the vaccine I started my menstrual cycle a week early. I am never early. I had cramps... Read more
On Day 2 after the vaccine I started my menstrual cycle a week early. I am never early. I had cramps, breast tenderness, and began bleeding.
24 2021-06-28 palpitations heart palpitations, very bad for about 2 months after getting first shot of the vaccine went to the... Read more
heart palpitations, very bad for about 2 months after getting first shot of the vaccine went to the doctor and they did EKG and other tests to see outcome - unknown at this time, however, said it could be likely from having COVID in January and/or getting the vaccine in April
24 2021-06-28 low platelet count D69.6 - Thrombocytopenia, unspecified E87.1 - Hypo-osmolality and hyponatremia
24 2021-06-30 chest discomfort, fast heart rate, low blood oxigenation Tachycardia (up to 155); hypoxia; chest tightness.
24 2021-07-06 fainting patient fainted for about 5 sec, 2 min after pfizer covid 1st shot. No symptom of allergic reaction... Read more
patient fainted for about 5 sec, 2 min after pfizer covid 1st shot. No symptom of allergic reaction. 911 was called and EMT check out and release patient home.
24 2021-07-07 ischemic chest pain Pain around the heart; This is a spontaneous report from a non-contactable consumer (patient). A 24-... Read more
Pain around the heart; This is a spontaneous report from a non-contactable consumer (patient). A 24-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EP6955 and Expiration date: unknown), via an unknown route of administration on 09Apr2021 (at the age of 24-year-old) as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has no known allergy. Patient did not receive any other vaccine within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and not tested for COVID-19 since the vaccination. On an unknown date, the patient experienced pain around the heart. The event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the event. Outcome of event was recovering. Follow-Up (01Jul2021): Follow-up attempts are completed. No further information is expected.
24 2021-07-07 fainting Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium
24 2021-07-10 palpitations, fast heart rate Heartbeat raising like tachycardia; going up 115 and then dropped down to 65; Average heartbeat is a... Read more
Heartbeat raising like tachycardia; going up 115 and then dropped down to 65; Average heartbeat is around 65-70 but still feels like heart is racing; It felt some pain in my ribs every time; I do have medicine allergy; heightened anxiety; This is a spontaneous report from a contactable consumer(patient) reported that. A 24-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, dose 1 via an unspecified route of administration on 11May2021 (age at vaccination was 24-year-old) (Lot Number: EW0173 Expiry date was UNKNOWN) as a SINGLE DOSE for covid-19 immunisation. Medical history included asthma and Anaphylaxis to some food allergies from an unknown date and unknown if ongoing. Concomitant medication included albuterol sulfate 90 mcg (Inhaler about 1-2 puffs as needed) (ALBUTEROL SULFATE) taken for asthma, start and stop date were not reported; loratadine (took every 12 hours rather than 24 hours, but do not know the dosage) (CLARITINE) taken for an unspecified indication, start and stop date were not reported. On an unknown date patient stated that few days after vaccination probably on thursday started feeling like her heartbeat was raising a little bit, but she didn't really think it was that much figured it was maybe because she worked out that morning or maybe she had much coffee or something. she didn't do anything in last couple of days and her heartbeat has been going up and down doing actually nothing, it was 115 and then dropped to 65. It feels almost like tachycardia. Average heartbeat was around 65-70 but it still feels like heart was racing even though she was taking oxygen puff and it says normal. On Friday her heart rate going up every time. she was breathing in the right side of her chest and it was about for 30 minutes. It felt like there was some pain almost in her ribs every time she takes a deep breath to relax herself, the patient had medicine allergy. She mentioned that her heart would start racing out of nowhere, which had then caused her heightened anxiety. While sitting down, her pulse would go up to 115 then drop to 50- 60. She already went to a doctor and they were not sure, so she was referred to a cardiologist. She mentioned that it was almost like sinus tachycardia. No treatment received for the events. The patient underwent lab tests and procedures which included heart rate 115, going up 115 and then dropped down to 65, heart rate 65, going up 115 and then dropped down to 65, heart rate 65-70, average heartbeat was around 65-70. The outcome of the events was unknown. Information on the lot/batch number has been requested.
24 2021-07-13 hypotension, fast heart rate, fast heart rate, palpitations, low blood pressure During first episode, patient experienced sudden-onset shortness of breath, tachycardia, and heart p... Read more
During first episode, patient experienced sudden-onset shortness of breath, tachycardia, and heart palpitations. Patient promptly visited the emergency room where multiple EKGs were recorded and heart rate was measured in the 150-160 range resting. Patient was given IV metoprolol to slow heart rate. Patient then followed up with primary care provider and was given a Holter monitor to wear for 48 hours and received a referral to a cardiologist. Patient then attended appointment with cardiologist who provided her with a 30 day heart monitor. Two days later, patient experienced another episode that caused her to visit the emergency room again. After being discharged, patient continued to experience episodes of tachycardia, shortness, or breath, and palpitations coupled with dizziness, fatigue, and hypotension. Patient made another visit to her primary care provider due to more frequent episodes and constant dizziness with hypotension. Primary care provider suspects supraventricular tachycardia and orthostatic hypotension and prescribed Midodrine to patient to raise blood pressure and combat dizziness.
24 2021-07-14 chest discomfort, chest pain Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: A... Read more
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Tingling (specify: facial area, extemities)-Severe
24 2021-07-14 pallor Pt got very hot and pale. Felt very nauseous.
24 2021-07-14 palpitations, chest pain, loss of consciousness I woke up shortly after falling asleep feeling as though someone had punched me in the chest as hard... Read more
I woke up shortly after falling asleep feeling as though someone had punched me in the chest as hard as they could. I was unable to draw in a breath or breathe at all. I shook my boyfriend awake and he could see I was passing out. My head began to fall back as I passed out from lack of oxygen. After this I was weak and was short of breath. An ambulance was called. I also ended up going to the ER. Throughout weeks after I had other heart episodes and tests. It was believed to be possible heart arrhythmias. I had a heart monitor for about two and a half weeks for testing. We have still not found answers and I still have episodes where my heart will randomly take off and race uncontrollably and I will get faint. I deal with chest pain on a regular basis. I have no history of heart issues and previously was always told I had a healthy heart. My current medications I have been on for some time and have never caused me issues. Ever since I received my second vaccination my heart hasn?t been the same.
24 2021-07-14 palpitations, heart rate increased, chest pain Stabing chest pains, increased heartbeat(resting heart rate is now about 85-90 while it used to be a... Read more
Stabing chest pains, increased heartbeat(resting heart rate is now about 85-90 while it used to be about 65-70), heart pounding, pain in neck vessels while doing any exercise (even walking or light cleaning), have to take breaks from doing things because I feel like I am going to pass out, It is still ongoing as of today 07/15/2021 Haven't received any treatment
24 2021-07-17 chest pain Difficulty breathing; Chest pain; Upper back pain; This is a spontaneous report from a contactable c... Read more
Difficulty breathing; Chest pain; Upper back pain; This is a spontaneous report from a contactable consumer (patient). A 24-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EW0191, expiration date: un-known) via an unspecified route of administration in Arm Right on 21Jun2021 at 04:30 PM (at the age of 24-year-old) as single dose for covid-19 immunization. Medical history included Congenital anamoly (ARSA), and No known allergies reported. Concomitant medications (taken within 2 weeks of vaccination) included Sertraline and Hydroxyzine. It was reported that 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 was not tested for COVID-19 since the vaccination. On 25Jun2021 at 10: PM, the patient experienced difficulty breathing, chest pain, and upper back pain. No therapeutics measures were taken for events. The events resulted to visit Emergency room/department or urgent care. Device Date: 27Jun2021. The outcome of the events was reported as not recovered. Follow-up attempts were completed. No further information was expected.
24 2021-07-17 chest pain pain in my left arm; felt weak; left armpit started to hurt; pain moved to the chest; application of... Read more
pain in my left arm; felt weak; left armpit started to hurt; pain moved to the chest; application of the vaccine reddened an area of my arm; it got hot; back ache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 24-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: EW0180), via an unspecified route of administration, administered in arm left on 28Jun2021 16:30 (at the age of 24-year-old) at dose 2, single for covid-19 immunisation. Medical history included asthma. Patient had no known allergies. Concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: EW0182) via an unspecified route of administration, administered in arm left on 07Jun2021 10:30 (at the age of 24-year-old) at dose 1, single for covid-19 immunisation and experienced pain in the arm that was bearable. 1 dose of the vaccine that patient received on 07Jun2021, after about 2 hours, patient had pain in my arm that was bearable, that pain lasted 3 days. 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. Reported events: 1 dose of the vaccine that patient received on 07Jun2021, after about 2 hours, patient had pain in my arm that was bearable, that pain lasted 3 days. second dose that patient received on 28Jun2021 at 4:30 pm patient started a pain in patient left arm around 2 hours after the vaccine, after 12 hours after the vaccine patient felt weak, patient left arm hurt. patient left armpit started to hurt and patient took analgesic which helped patient for 8 hours. After this, patient back and both armpits began to ache, but being stronger on the right, but that pain moved to the chest subjecting pressure for about 2-3 min. This on the night of 29Jun2021 to whatever it takes patient another analgesic. Early on 30Jun2021, patient left arm and armpit continued to hurt but patient back and left armpit no longer that night (8:00 pm) patient left arm 3cm below the application of the vaccine an area of patient arm became red for 2 nights and warmed up. Patient already fine. Patient received treatment with analgesic for adverse events. Outcome of the events was resolved on an unspecified date in 2021.
24 2021-07-18 loss of consciousness, fainting, cardio-respiratory arrest Vasovagal syncope, code blue called, patient regained consciousness and did not require further trea... Read more
Vasovagal syncope, code blue called, patient regained consciousness and did not require further treatment. Patient did not visit ED. Patient did report after vasovagal episode that they typically respond like this after administration.
24 2021-07-18 lightheadedness, loss of consciousness 05/08/2021 (about 12 days after 2nd vaccine): Started feeling a little dizzy. Short bursts of dizzin... Read more
05/08/2021 (about 12 days after 2nd vaccine): Started feeling a little dizzy. Short bursts of dizziness lasting no longer than 20-30 seconds occurring about 1-3 times a day at most. Did nothing about it because it was extremely manageable. From 5/08-06/18: Dizziness continues in small time frames throughout this period of time. Doesn't get better but also does not get worse. 06/18/2021: Dizziness worsens slightly and finding it hard for eyes to focus at work. Did nothing about it because it was manageable at the time. 06/22/2021: Dizziness has become unmanageable. Eyes won't focus, room is spinning, feel slightly nauseous, feel like I'm going to pass out, can't do my work properly. Go to walk in clinic right after work. Taking a ride share because I am so dizzy I am nervous to drive. Find that I have an impacted ear-clean it out and go back home. 06/23/2021: Go back in to work. Think I'm feeling better. Almost pass out at work, dizziness is worse than before. Leave work early and spend the rest of the week working from home. 06/24/2021: Dizziness does not improve. Barely able to get work done. Dizziness progresses into a headache and feel nauseous all the time. Go to walk in clinic again and get referred to an ENT. 06/26/2021: Do some digging on the internet and find antihistamines provide some relief for vertigo. Take 1 10mg dose of Zyrtec and feel some relief about 2 hours later. 06/28/-7/02: Return to work for the week because Zyrtec has provided enough relief that it is relatively easy to get work done. Manage to get things done enough. 06/30/2021: Go to ENT. Do hearing tests, etc. and Dr. says ears are not the cause and everything looks good. Get referred to a neurologist. 07/02/2021: Pass out. Feel so dizzy I can't figure out which way is up or down. 07/06-07/09: Continue to work out of the office. Feeling same as previous week. Zyrtec still providing some relief. 07/09/2021: Pass out again. Super dizzy again. 07/12-07/15: Work out of the office again. Zyrtec starts to feel like it is not providing relief anymore. 07/15/2021: Leave work early and work from home the rest of the week. Go to pharmacy and buy Claritin, Allegra, and generic brand Claritin 07/16/2021: Take Allegra and think it provides relief. It works well enough. 07/17-07/19: Allegra is no longer working and back to square 1. Pushing through symptoms and trying to manage at work. No clue what is causing symptoms. 07/17/2021: Take Allegra
24 2021-07-19 heart rate increased, chest discomfort February 2021 I received my 2nd dose of Pfizer. A day later I experienced flu like symptoms which we... Read more
February 2021 I received my 2nd dose of Pfizer. A day later I experienced flu like symptoms which went away within 3 days. About a week later I experienced dizziness and nausea. I did not have an appetite and could not eat well for about 3 weeks. I got an upper endoscopy which found mild acid irritation to my stomach (gastritis) and I was placed on medication. I then proceeded to get a gastric stomach emptying test, HIDA scan for constant nausea. I went to PT for dizziness. This is now July and I have been to an ENT doctor, received CT scan for dizziness checking my sinuses. Went to a neurologist for an MRI for headaches and dizziness. Everything came back fine but I am now to the point I can barley work and it is July. I have gone to acupuncture as well but nothing is working. On Friday I ate gummy bears and my heart rate went to 160, chest tightness, tongue itchy and shaking. The hospital did not find anything and reported this as an anxiety attack. I ate gummy bears again on Sunday and the same thing happened. I am wondering if the shot trigger this and how can I get help? I was fine before this and I am looking for answers. I am not blaming the shot, I would just like feedback on how to help. Thank you.
24 2021-07-20 chest pain Difficulty breathing, consistently lightheaded, fogginess, inability to sleep and extreme difficulty... Read more
Difficulty breathing, consistently lightheaded, fogginess, inability to sleep and extreme difficulty waking in morning, severe shooting pain in right arm at sight of injection still months later, chest pain, eye pressure
24 2021-07-21 blood pressure increased, heart rate increased, palpitations Heart racing; Thirst; The shot made her so dehydrated.; breathlessness with the increased heart rate... Read more
Heart racing; Thirst; The shot made her so dehydrated.; breathlessness with the increased heart rate; her blood pressure was 166/102 with a heart rate of 130; her blood pressure was 166/102 with a heart rate of 130/The highest her heart rate got was 166. Then, it would go to 130 or 120.; This is a spontaneous report received from a contactable consumer (patient). A 24-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EW0175 and expiry dates was not provided, 24-years-old at the time of vaccination) via an unspecified route of administration on left arm on 10Jul2021 (11:40, Saturday), at unknown dose single for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. The patient was perfectly fine before the vaccine. Six hours later on 10Jul 2021, her heart started racing, she did not think about it at first. She road it out through the day. The next day, her heart was still racing. She went to Urgent care, and her blood pressure was 166/102 with a heart rate of 130 on an unspecified dated in Jul 2021. It was 100% from the shot. Her doctor downplayed it. He said he hopes it does not stop her from taking the second one, and she said what an idiot. Racing heart has been reported though. The patient did not have a history of high blood pressure or abnormal heart rates. It was sad because she did not get any other side effects. Other than this she feels 100 percent. Heart racing is not a good feeling. she just went to the walk-in pharmacy at the grocery store, she got the vaccine 48 hours ago on the 10Jul2021 at 11:40 am. Last night (on unspecified date), she went to the ER. She was told to drink a lot of water before the shot. Even her pharmacist told her that. The shot made her so dehydrated. She was drinking bottles of water down constantly. She went to the ER, and it looked like she did not drink any water. It depleted her. It made her so thirsty, and her heart was racing. It seemed like it would improve, but it kept spiking. The highest her heart rate got was 166. Then, it would go to 130 or 120. Her blood pressure last night was 105/71. The first and second day the thirst was worse. Today it has improved. She also experienced breathlessness with the increased heart rate. Her mother told her to go to the urgent care, she had an appointment tomorrow (on unspecified date) with her regular physician in the morning, she called drug safety over the weekend but could not understand the agent. The outcome of the event Heart racing, her blood pressure was 166/102 with a heart rate of 130 and Thrist was recovered on unspecified date in Jul2021, the outcome for event breathlessness with the increased heart rate and Dehydration was unknown. Information on Lot/Batch number was available. Additional information has been requested.
24 2021-07-25 dilation of blood vessels Extremely prominent veins on upper chest on left side after covid vaccine. Haven't gone away at all ... Read more
Extremely prominent veins on upper chest on left side after covid vaccine. Haven't gone away at all since then. Got an ultrasound to check for blood clots. No blood clots but veins are still very odd.
24 2021-07-27 blood pressure decreased, pallor Pt. received her first dose of COVID - 19 vaccine Pfizer 0.3 ml IM on her Lt. deltoid at 08:39 am on... Read more
Pt. received her first dose of COVID - 19 vaccine Pfizer 0.3 ml IM on her Lt. deltoid at 08:39 am on 07/28/21.Pt c/o Lt upper arm tingling at 8:41 am. Nurse did massage on her Lt. arm site area. Then pt. c/o dizziness at 8:42 am. Pt looked pale & conscious. Nurses assisted pt. lay on the examination bed. BP:97/57,P:47,SPO2:96%.at 8:47 am. Pt said that she did not eat her breakfast & did exercise for 1.5 hrs. before the vaccination. BP: 101/64, P:56, SPO2:96% at 08:50 am & pt. said that she had no more dizziness & no tingling on her Lt. injection site arm. Pt said that she was fine & other discomfort. Pulse:60 at 8:51 am. BP:101/64, P:56 at 8:58 am. Cont. monitor pt. Pt alert & conscious. BP:101/64, P 54, SPO2:97% at 9:02 am. BP:101/64, P:56, SPO2:97% at 9:12 am. Pt was monitor for 30 min., & left the facility at 9:14 am without distress noted & in stable condition.
24 2021-07-27 hypotension, fainting Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Medium
24 2021-07-28 loss of consciousness Patient immediately felt dizzy after receiving vaccination. Gave her a cold pack. That seemed to h... Read more
Patient immediately felt dizzy after receiving vaccination. Gave her a cold pack. That seemed to help. She moved to a different chair. Within 2 minutes she passed out and fell out of the chair which resulted in a gash on her forehead. Patient was unconscious and warm to the touch. Paramedics were called. She came to and knew who she was, where she was, but was very lethargic and groggy. Paramedics took her to the hospital for evaluation.
25 2021-01-01 chest pain Almost immediately to maybe 3 minutes after I received the vaccine my tongue started tingling and th... Read more
Almost immediately to maybe 3 minutes after I received the vaccine my tongue started tingling and the sides of my tongue began to burn. I also had a slight red rash on my chest that began to burn and itch. These are similar to the reaction I have after I eat cinnamon. It wasn?t severe like my shellfish allergy where I go into anaphylactic, but it was definitely a reaction. My tongue was then slightly swollen that day into the next day. Very slightly swollen. Just enough that I noticed it because I kept biting my tongue. The burning and tingling lasted for maybe an hour after. I was slightly dizzy as well, but nothing too bad. I was seen by the ER team to make sure I didn?t go into anaphylactic and then I was allowed to return home. Others I walked by stated my face was bright red and I got very hot. Following that I had extreme exhaustion. I couldn?t even make it home without having to pull my car over to try and wake myself up. I am feeling fine now, but just wanted to make this known for study purposes. I plan on getting the second shot on 1-19-21.
25 2021-01-01 pallor, fast heart rate She became flushed with tachycardia, then nauseated. Skin pale. Face is itchy. No shortness of br... Read more
She became flushed with tachycardia, then nauseated. Skin pale. Face is itchy. No shortness of breath. Symptoms started 20 minutes following administration of vaccine and resolved about 30 minutes thereafter. EMS came - thought it could be related to anxiety.
25 2021-01-03 blood pressure fluctuation, fast heart rate Around midnight I woke up and was extremely confused, felt like I had pretty bad cold, had some hiv... Read more
Around midnight I woke up and was extremely confused, felt like I had pretty bad cold, had some hives and started having some shortness of breath, that it kept waking me up. I also got nauseous. Almost threw up but did not. Took Benadryl and felt better. Had fever 100F in the morning, felt very fatigued next day. Went to work and the symptoms came back and they were intensified. I could barely walk. Took Benadryl and they decided to wheel me to the ER. I was unable to talk, I did not make sense. They gave me Benadryl and made me wait in the ER. I had tachycardia my pulse was fine. My BP was jumping around. I never had problems with that. At the ER they told me to take Benadryl and Pepcid for the next 3 days. My fever went down while I was at the ER. The next morning I checked it again and no more fever and I was feeling a lot better. I also had a slight headache, not bad. I called my PCP and they do not think it might be a good idea to receive the 2nd dose.
25 2021-01-03 chest pain Sore arm, sore throat, post nasal drip, congestion, chest pain
25 2021-01-03 heart rate increased, chest discomfort Increase from baseline heartrate of 60 to 110, feeling of mild chest tightness with no abnormal lung... Read more
Increase from baseline heartrate of 60 to 110, feeling of mild chest tightness with no abnormal lung sounds, all other vital signs remained within normal limits. Stated throat felt slightly itchy, resolved without treatment after 2 hours. Patient kept under observation.
25 2021-01-03 heart rate increased Difficulty Breathing, fast heartbeat, dizziness and weakness. Body aches and nausea
25 2021-01-03 pallor Became nauseous, pale, faint after first dose .
25 2021-01-03 fast heart rate About 5 minutes after the injection, employee reported having had tickling/itching in throat, facia... Read more
About 5 minutes after the injection, employee reported having had tickling/itching in throat, facial flushing, and tachycardia. A rapid response was called, and was given Benadryl. She was brought to ED for monitoring and treatment, where she received more Benadryl + Famotidine. After receiving the medications, symptoms subsided, and she was discharged home.
25 2021-01-04 chest discomfort About 20 minutes after I had a numb tongue and tingling. I was observed in the ED. Later that evenin... Read more
About 20 minutes after I had a numb tongue and tingling. I was observed in the ED. Later that evening, around 9 PM I had upper lip tingling and numbness. The next day I woke up with upper lip swelling. I also forgot to mention that I had some chest tightness.
25 2021-01-05 blood pressure decreased History of vasovagal responses with immunizations. Occurred 8 minutes post injection. Gave juice and... Read more
History of vasovagal responses with immunizations. Occurred 8 minutes post injection. Gave juice and crackers. 0818 BP 73/59 placed on litter in trendelenberg position. 0825 113/69, 0826 BP 116/80 standing. At 0834 BP 127/78. Symptoms improved. Released from clinic. 30 minutes total observation time.
25 2021-01-05 chest pain Ringing in ears Sore lymph nodes Main soreness on left leg and hand on left side (only one sided p... Read more
Ringing in ears Sore lymph nodes Main soreness on left leg and hand on left side (only one sided pain)? Neck pain and chest soreness Fatigue/tiredness
25 2021-01-05 heart rate increased, blood pressure decreased she got tunnel vision; almost passed out; Blood pressure dropped to 70/50; heart rate went up to 140... Read more
she got tunnel vision; almost passed out; Blood pressure dropped to 70/50; heart rate went up to 140; whole body got cold and tingly; whole body got cold and tingly; This is a spontaneous report from a contactable pharmacist (patient) reported for herself. A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer Biotech; lot number: EL0142) via an unspecified route of administration at left arm on 30Dec2020 at 12:45 PM at a single dose (dose number: 1) for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was workplace clinic. Medical history included premature ventricular contractions (PVCs). No known allergies (no allergies to medications, food, or other products). The patient was not pregnant. No other vaccine in four weeks and no other medications in two weeks. The patient experienced adverse events included blood pressure dropped to 70/50, heart rate went up to 140, whole body got cold and tingly and she got tunnel vision and almost passed out. The events all started on 30Dec2020 at 12:45 PM. The events were reported as non-serious. No treatment received for events. The outcome of events was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the close temporal relationship, the association between the event tunnel vision with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
25 2021-01-08 hypotension Patient stated being lightheaded. Checked vitals and and blood pressure was a little low. Took blood... Read more
Patient stated being lightheaded. Checked vitals and and blood pressure was a little low. Took blood pressure again after 10 minutes and was back to normal. Gave orange juice and water.
25 2021-01-09 palpitations dizzy and heart racing; denies respiratory issues
25 2021-01-09 fast heart rate ER visit on 12/25/2020 for tachycardia and SOB. She was to follow up with her PCP.
25 2021-01-10 fast heart rate headache, lightheadedness, vertigo, fever, chills, nausea, stomach cramps, tachycardia. All lasting ... Read more
headache, lightheadedness, vertigo, fever, chills, nausea, stomach cramps, tachycardia. All lasting 18 hours.
25 2021-01-11 chest pain I received the vaccine on 12/29 at approximately 12:30 pm. On 12/31 I woke up with itching in my sca... Read more
I received the vaccine on 12/29 at approximately 12:30 pm. On 12/31 I woke up with itching in my scalp. On 1/1 the itching started spreading throughout my body. I have continuously been itching since 12/31. The itching is all over my scalp, arms, hands, back, and legs. I have recently developed a pain/pressure in the back of my head, that feels like I have smacked it against a wall. I have also recently developed pain in my chest. I have seen my PCP, dermatologist, and ED drs and no one can find a route cause for my reaction.
25 2021-01-11 lightheadedness, pallor, fast heart rate, palpitations Near syncope, tachycardia with palpitations, nausea, dizziness, shakiness, pallor, fever
25 2021-01-11 lightheadedness bilateral leg weakness, near syncopy
25 2021-01-11 fainting Feverish, chills, body soreness and aches, fatigue, feeling faint/could pass out, lethargic, headach... Read more
Feverish, chills, body soreness and aches, fatigue, feeling faint/could pass out, lethargic, headache
25 2021-01-11 fast heart rate Fever, chills, nausea, body aches, tachycardia; Fever, chills, nausea, body aches, tachycardia; Feve... Read more
Fever, chills, nausea, body aches, tachycardia; Fever, chills, nausea, body aches, tachycardia; Fever, chills, nausea, body aches, tachycardia; Fever, chills, nausea, body aches, tachycardia; Fever, chills, nausea, body aches, tachycardia; This is a spontaneous report from a contactable nurse (patient). This 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose in the right arm on 04Jan2021 08:30 for Covid-19 immunisation. Medical history included Covid-19 on an unknown date. The patient's concomitant medications were not reported. The patient experienced fever, chills, nausea, body aches, tachycardia on 04Jan2021 20:30 with outcome of unknown. Therapeutic measures were taken as a result of fever, chills, nausea, body aches, tachycardia included Tylenol, Ibuprofen, Benadryl. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
25 2021-01-12 chest discomfort Pfizer-BioNTech COVID-19 Vaccine EUA Symptoms experienced: Chest heaviness. Denies all other symptom... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Symptoms experienced: Chest heaviness. Denies all other symptoms. Patient transported to ER via wheelchair for evaluation. Upon re-evaluation in ER, patient felt back to her baseline and was discharged
25 2021-01-12 hypertension Systemic: Nausea-Mild, Systemic: itching at injection site, high blood pressure around 160 but dropp... Read more
Systemic: Nausea-Mild, Systemic: itching at injection site, high blood pressure around 160 but dropped; symptoms lasted 0 days
25 2021-01-12 fainting near syncope
25 2021-01-13 chest discomfort Body aches, chills, extreme fatigue, fever of 101.0, chest pressure and sore throat. Treatment inclu... Read more
Body aches, chills, extreme fatigue, fever of 101.0, chest pressure and sore throat. Treatment include Tylenol with no improvement.
25 2021-01-13 heart rate increased, chest pain Heart rate shot up to 170 with numbness of feet.; Heart rate shot up to 170 with numbness of feet.; ... Read more
Heart rate shot up to 170 with numbness of feet.; Heart rate shot up to 170 with numbness of feet.; Chest pain; feeling like I was going to vomit and faint; feeling like I was going to vomit and faint; This is a spontaneous report from a contactable other hcp (patient). A 25-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at 11:45 at single dose in left arm for covid-19 immunization. There was no medical history. Concomitant medication included valaciclovir hydrochloride (VALTREX), topiramate (TOPAMAX), lamotrigine (LAMICTAL), duloxetine hydrochloride (CYMBALTA), ziprasidone hydrochloride (GEODON). On 06Jan2021 at 12:30, The patient experienced heart rate shot up to 170 with numbness of feet, started to feel chest pain, and feeling like she was going to vomit and faint. The events required emergency room visit and were reported as serious per hospitalization. Heart rate at the hospital was 135-140 where two EKG were done and fluids were given. An x-ray of the heart was done and blood work was completed. The patient didn't receive treatment for the events. The patient didn't 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. The outcome of the events was resolved in Jan2021. Information on batch/lot number has been requested.; Sender's Comments: There is a reasonable possibility that the event "feeling like she was going to vomit" was related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the other reported serious events with BNT 162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
25 2021-01-13 hypotension temperature of 99.5; Excessive/Severe itching from head to toe/itching has progressively gotten wors... Read more
temperature of 99.5; Excessive/Severe itching from head to toe/itching has progressively gotten worse; experiencing slight headaches; low blood pressure; This is a spontaneous report from a contactable other-HCP (patient). A 25-years-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot: EL1284) via an unspecified route of administration on 29Dec2020 12:30 at single dose for COVID-19 immunisation. The patient was allegic to Sulfa products and Nickel products. Concomitant medication included bupropion hydrochloride (WELLBUTRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Dec2020 08:00 AM, the patient experienced excessive/severe itching from head to toe that started 2 days after the vaccine was administered. The itching has progressively gotten worse. She had also been experiencing slight headaches, low blood pressure, and temperature of 99.5 on 31Dec2020 08:00. Events resulted in doctor or other healthcare professional office/clinic visit. The patient received Medrol Dose pack as treatment. Events outcome was not recovered.
25 2021-01-13 fast heart rate Bad chills for the last 8 hours so far Mild nausea Lightheaded Tachycardic Temp 99.5
25 2021-01-14 chest discomfort chills, fever 100.6, headache and chest tightness, denies shortness of breath and cough. Treatment i... Read more
chills, fever 100.6, headache and chest tightness, denies shortness of breath and cough. Treatment include: Tylenol, patient has history of asthma and report using her inhaler daily. She denies chest congestion. Outcome: chills, fever resolved, report residual headache and continued chest tightness recommend to follow-up with primary care doctor- currently working
25 2021-01-17 heart rate increased, palpitations, chest discomfort, palpitations Immediately got redness of injection site feeling of nausea. Needed to take my mask off to get fresh... Read more
Immediately got redness of injection site feeling of nausea. Needed to take my mask off to get fresh air. Nurse moved me to reclining chair and I proceeded to get very hot and feel like my heart was racing and skipping. The nurse noted some hitching and fast pulse, instructed me to take some breaths. And monitored my vitals. Noted my eyes feeling weird. They had epinephrine ready to draw up if my throat closed.. After 30 minutes I felt much better and they said my heart rate had slowed , I was able to leave. About a half hour after leaving, I got very tired, and my eyes still felt odd. Could feel my heart rate increasing again. Began to get itchy/puffy eyes and nasal congestion with a tight chest. I took a benadryl and left work at the advisement of one our nurses to pull over and call emergency services if allergies turn anaphylatic. Within 30 minutes of the benadryl allergies cleared up and I just needed to sleep.
25 2021-01-17 loss of consciousness Aches, chills, loss of consious (passing out 1/13) lock jaw bilaterally, lumbar pain with swelling (... Read more
Aches, chills, loss of consious (passing out 1/13) lock jaw bilaterally, lumbar pain with swelling (unable to see spine anymore), body sweats, dizziness. Lasting 24 hours, 3 doses of benadryl
25 2021-01-18 blood pressure increased, palpitations, fast heart rate tachycardia; shortness of breath; elevated blood pressure 165/90; tired; stomach upset; felt unwell;... Read more
tachycardia; shortness of breath; elevated blood pressure 165/90; tired; stomach upset; felt unwell; This is a spontaneous report from a contactable other health professional (patient). A 25-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced on 04Jan2021 felt unwell, tired, stomach upset (it continued all week) and on 07Jan2021 tachycardia and shortness of breath. Clinical course: she was feeling very like short of breath and her heart racing, had elevated blood pressure 165/90, usually it was normal. The patient was sent to the emergency room (ER) and got worked up, she had a complete blood panel, everything came back normal; she had a chest X-Ray and 2 bags of fluid, then the patient was discharged. The patient outcome of the events was recovered. The information on the batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
25 2021-01-18 blood pressure increased, fast heart rate allergy; Short of breath; Tachycardia/my heartrate was like 140 - 150; Blood pressure was like 165 o... Read more
allergy; Short of breath; Tachycardia/my heartrate was like 140 - 150; Blood pressure was like 165 over 114/my blood pressure just like skyrocketed; Upset stomach; Tired; Started to feel not very good/not feeling like wonderful/overall sickness; Muscle ache; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL014 (can't really tell), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. Medical history included allergy and heartburn. Concomitant medication included omeprazole for heartburn, cetirizine hydrochloride (off-brand for Zyrtec) as allergy medicine and a birth control medicine. Consumer stated, she just was calling this number because she didn't necessarily know if she had an adverse reaction or a symptom. She just wanted to report it and see if maybe you had any insight if this has happened to anybody else. Consumer further stated, she had an adverse reaction where she had to go to the emergency room. So, she didn't know if it was from the Vaccine or not because her reaction was very delayed. She got her vaccine on 31Dec2020, New Year's Eve and then starting on Monday after the vaccine on 04Jan2021. She started to feel not very good, it was mostly just like overall sickness, just as muscle aches, tired, having upset stomach so that was after 4 days. Patient had allergy from an unspecified date. And then on 07Jan2021, a week after she got the vaccine, she had signs of tachycardia and her blood pressure just like skyrocketed, her blood pressure was like 165 over a 114 and her heartrate was like 140 - 150. And she worked in healthcare, which was why she was one of the first ones to get the vaccine and she went to the ER and got worked up and they couldn't find, nothing was abnormal with her labs or blood work. She even had a chest X-ray and they couldn't find anything and they just gave her fluids and sent her home. And she was home now and still not feeling like wonderful, she felt better though but she just wanted to report that and see if there was any correlation. She didn't really know because it was so delayed, a week later. So she just wanted to report it. Consumer further stated, she forget to tell one thing, she was also short of breath on 07Jan2021. So that was why they had sent her to ER because of Tachycardia, shortness of breath and her blood pressure was really high. They didn't give her any medicine they just gave two big bags of fluid and then they discharged her. Consumer stated, she was scheduled to have her second one, she thought it was 14Jan2021. She wanted to know if she should get the second one. Consumer stated, when she went into the ER she had a lot of lab work. She didn't even know what all they did but a lot like, blood panels, she checked everything was there, that was on Thursday, last week, 07Jan2021. Consumer stated no treatment was received for the events. Outcome of the events was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
25 2021-01-18 chest pain Fever of 101; Dizzy/Lightheaded; Chills; Chest pain; I just had arm pain; This is a spontaneous repo... Read more
Fever of 101; Dizzy/Lightheaded; Chills; Chest pain; I just had arm pain; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. There were no medical history and concomitant medications. The patient experienced fever of 101 (unit unspecified), felt dizzy, lightheaded, chills, chest pain and had arm pain; all on an unspecified date. The patient reportedly took paracetamol (TYLENOL) as treatment for the events reported. Outcome of events was unknown. Information on the Lot/Batch number has been requested.
25 2021-01-18 heart rate irregular 1357 client complained of a lump in her throat feeling; sensation of having trouble swallowing; feel... Read more
1357 client complained of a lump in her throat feeling; sensation of having trouble swallowing; feels hot at back of neck 1358 BP 152/106 P 140 R 12 SpO2 99% LOC A&O x 3; Skin cool, pink and dry; Resps unlabored and lungs clear-no wheeze or stridor; heart regular and pulse strong 1405 BP 142/88 P 116 R 12 SpO2 99% Resps continue unlabored; sensation of lump in throat continues; EMS notified 1410 BP 136/84 P 108 R 12 SpO2 99% Resps unlabored; sensation still present; pulse has an irregularity; EMS arrived; Handoff given to EMS crew; client dispositioned to local ED at Hospital
25 2021-01-18 loss of consciousness, fainting Syncope Woke up from a nap, stood up about 1 minute later I started seeing black and woke up on the... Read more
Syncope Woke up from a nap, stood up about 1 minute later I started seeing black and woke up on the floor. Went to ER and all tests and labs were normal.
25 2021-01-18 fainting Sunday, 2 days after vaccination, pt had vasovagal episode and was taken to the ER via ambulance.
25 2021-01-18 transient ischaemic attack transient ischemic attack I was working and felt unusually exhausted, lost vision in my right eye f... Read more
transient ischemic attack I was working and felt unusually exhausted, lost vision in my right eye for over an hour, and called my boyfriend to tell him I wasn't feeling well and that I would try to make it through my work shift. I then called him back 4 minutes later and failed to form words, and also could not type words. I felt like I was going to faint and have no recollection of 10 minutes during that time. I had to leave work to go to the emergency room. I had a massive headache for 3 days following my TIA.
25 2021-01-19 excessive bleeding I started having cramps Friday night and Saturday morning I started bleeding, by Saturday evening I ... Read more
I started having cramps Friday night and Saturday morning I started bleeding, by Saturday evening I was passing clots and tissue. ER doctor and nurses did tests and found I was having a miscarriage.
25 2021-01-19 hypotension, loss of consciousness, heart rate decreased 15 hours after vaccine, I woke up with a severe headache and extreme fatigue. 18 hours after vaccine... Read more
15 hours after vaccine, I woke up with a severe headache and extreme fatigue. 18 hours after vaccine, I showered and felt very dizzy. I thought the water was too hot, so I turned the shower head off and got extremely nauseous. I laid on my bathroom floor for an unknown amount of time. I thought I felt ok enough to get up to get clothes on and wake my mom up. I remember fumbling with the bathroom door and that's the last thing I remember. My mom told me that she heard me say "oh God," followed by a thud. She discovered me lying face down on the dining room floor. My blood pressure was low, as well as my heart rate (47). EMS was dispatched to my residence due to extreme dizziness. Due to the fall, I had a chin laceration requiring stitches, a bruised fifth digit on my left hand, as well as a bruised left hip.
25 2021-01-19 fainting, heart rate decreased, hypotension Low Heart Rate Low Blood Pressure Dizzy/Faint Sweaty
25 2021-01-20 heart rate increased Headache, chills, rapid heartbeat, fever, shaking hands, fatigue
25 2021-01-20 loss of consciousness Loss of consciousness; Muscle aches; Headache; Nausea; Vomiting; Dose1 26Dec2020, dose 2 12Jan2021; ... Read more
Loss of consciousness; Muscle aches; Headache; Nausea; Vomiting; Dose1 26Dec2020, dose 2 12Jan2021; Dose1 26Dec2020, dose 2 12Jan2021; This is a spontaneous report from a contactable nurse. A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on the right arm second dose on 12Jan2021 12:15 at a single dose (lot number: EK4176) and intramuscular on the right arm first dose on 26Dec2020 10:15 at a single dose (lot number: EL1284) for COVID-19 immunisation. Medical history included asthma. Concomitant medication included Women's multivitamin within two weeks of vaccination. The patient had no allergies to medications, food, or other products; was not diagnosed with COVID-19 prior to vaccination, did not receive any other vaccines within four weeks prior to the COVID vaccine and was not pregnant at the time of vaccination. The most recent COVID-19 vaccine was administered at a hospital facility. On 13Jan2021 03:30, the patient experienced muscle aches, headache, nausea, vomiting and loss of consciousness. Treatment was not received for the events. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovering. Information on the lot/batch number has been requested.
25 2021-01-21 body temperature decreased 1/20/2021: Around 20:00, I started to feel a little achy. Checked my temperature, it was 99 degrees ... Read more
1/20/2021: Around 20:00, I started to feel a little achy. Checked my temperature, it was 99 degrees F. 1/21/2021: Around midnight, I woke up in a cold sweat, shaking. My entire body hurt and I had a headache. I checked temp again. It was at 102 degrees. I went back to sleep. I woke up again around 2:00, temp was 103. I took 1000 mg of Tylenol and drank water. Around 4:00, I checked temp again. I was back down to 101. I called into work. I kept sleeping all day and took 1000 mg of Tylenol every four hours. Symptoms slowly subsided throughout the day. By 22:00, I was down to 98.8 degrees before bed. 1/22/2021: I woke up at 4:00 and checked temp. It was still at 98.0. I go to work. My hands are tingling and I am hot with no increased temperature. It is now 9:00 and my hands are still tingling.
25 2021-01-21 chest discomfort On the following day of vaccine employee started to experience body aches, headaches, and chest tigh... Read more
On the following day of vaccine employee started to experience body aches, headaches, and chest tightness.
25 2021-01-21 heart rate increased, chest pain Was driving home after waiting my 15 minutes. Throat started to close up, tingling sensation through... Read more
Was driving home after waiting my 15 minutes. Throat started to close up, tingling sensation throughout entire body, rush of heat, dizziness, increased heart rate. Made it back to the site (closest medical professionals near me) where my throat still felt swollen but I could breathe. Chest hurt and was still dizzy. Was given 50mg Benadryl & 20mg Pepsid. It seemed to come and go in waves but I still went to the ER. ER doc said what he saw I was experiencing was anxiety. Pharmacist who had been with me the whole time could tell that my neck and throat had been swollen but had gone down with the Benadryl. ER administered anti nausea meds and a steroid shot. Also prescribed steroids for a few days. Received the shot at 6:45, initial reaction occurred around 7:10, went to the ER around 8:45
25 2021-01-22 blood pressure increased, heart rate increased Patient received second Pfizer vaccine dose. Patient quickly developed an increased heart rate (up ... Read more
Patient received second Pfizer vaccine dose. Patient quickly developed an increased heart rate (up to 170s) and increased blood pressure to (160s/90s). Patient was transferred to the Emergency Department for further evaluation.
25 2021-01-22 heart rate increased, blood pressure increased Five minutes after vaccine, I started having trouble breathing. Thought it was anxiety attack but I ... Read more
Five minutes after vaccine, I started having trouble breathing. Thought it was anxiety attack but I didn't feel anxious. I felt light headed and I don't get that with my panic attacks; At 15 minutes, my heart was beating really fast. They checked my vitals - pulse and BP was elevated. Pulse is over 130 and normally when I have an anxiety attack it doesn't go above 110. Went to the ER . The breathing felt better after thirty min after being in ER and Blood pressure 1-2 hours later went down. No treatment. After about two weeks I saw my primary care doctor for check up.
25 2021-01-24 blood pressure decreased, skin turning blue, pallor WBCs and neutrophils and platelets elevated 3 hours later; WBCs and neutrophils and platelets elevat... Read more
WBCs and neutrophils and platelets elevated 3 hours later; WBCs and neutrophils and platelets elevated 3 hours later; WBCs and neutrophils and platelets elevated 3 hours later; Coat hanger neck/ shoulder pain; Coat hanger neck/ shoulder pain; flushed; felt uncomfortable; couldn't sit still; feeling clammy; saw spots; BP dropped to 60s/30s; felt like throat was closing; couldn't breathe well; hands were numb; lips were white/ blue; This is a spontaneous report from a contactable nurse (patient). A 25-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT# EL1283), via an unspecified route of administration in right arm on 07Jan2021 13:30 at first single dose for COVID-19 immunization. Medical history included asthma, fibromyalgia, idiopathic hypersomnia, seasonal allergies (dust, ragweed, pollen, dander), covid-19. Concomitant medication in two weeks included duloxetine hydrochloride (CYMBALTA), modafinil, montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC), ergocalciferol (VIT D). No other vaccine in four weeks. 1-2 min after shot the patient became flushed and felt uncomfortable/ couldn't sit still, began feeling clammy, saw spots, BP dropped to 60s/30s, all other vitals stable, felt like throat was closing and couldn't breathe well, hands were numb, lips were white/ blue. No itching or hives. Resolved with trendelenburg and rest, fluids given in ED. WBCs and neutrophils and platelets elevated 3 hours later. Coat hanger neck/ shoulder pain for the next few days. Adverse event start date was 07Jan2021 01:30. Event resulted in emergency room/department or urgent care. Covid was not tested post vaccination. Outcome of the event was recovering.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the reported events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
25 2021-01-24 chest discomfort Adverse event-directly after receiving the vaccination, it felt as if I was having a serious allergi... Read more
Adverse event-directly after receiving the vaccination, it felt as if I was having a serious allergic reaction as I had just consumed tree nuts or dates (for which I am most allergic)-my throat felt super funny and itchy-my chest got tight-was working harder to breath-got a rash that covered my hands and arms-felt dizzy/light headed and weak Treatment-Benadryl (IV 9:18pm given) and pepcid (10:28pm given) Outcome-benadryl was able to stop the allergic reaction and took about 36 hours to fully recover with continued allergy medication and one more dose of benadryl the next day
25 2021-01-24 chest pain Headache; Muscle soreness/ muscle soreness and knots; Muscle soreness/ muscle soreness and knots; Se... Read more
Headache; Muscle soreness/ muscle soreness and knots; Muscle soreness/ muscle soreness and knots; Severe joint pain; Muscle tightness; Chest pain; Moderate chills; Exhaustion; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 25-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3248) via an unspecified route of administration on right arm on 11Jan2021 06:30 at single dose for COVID-19 immunisation. Medical history included nail patella syndrome. Concomitant medication included ethinylestradiol, levonorgestrel (LESSINA), escitalopram. There was no other vaccine in four weeks. The patient had not COVID prior vaccination. The patient had not COVID tested post vaccination. The patient previously took amoxicillin and experienced allergies. The patient received the first dose of BNT162B2 (Brand: Pfizer, Lot number: EH9899) on right arm on 21Dec2020 16:00 PM for COVID-19 immunisation. First dose came with moderate muscle fatigue and joint pain, chills, headache and fatigue. Events occurred 7 days post vaccination. Second dose had almost immediate side effects beginning post vaccination beginning with headache, then muscle soreness. Followed by severe joint pain and muscle tightness, including chest pain. Moderate chills. Exhaustion. Both instances were elevated with ibuprofen, water, and a night's rest. Upon waking after second dose side effects, muscle soreness and knots probably from muscle tightness night before. A muscle relaxant might have helped. All events started from 11Jan2021 17:00. No treatment received for muscle tightness and muscle disorder, treatment was received for the other remain events. The outcome of the event was recovering.
25 2021-01-24 fainting Nausea; diarrhea; vomiting/Throwing up; Hot and sweaty from head to toe; Hot and sweaty from head to... Read more
Nausea; diarrhea; vomiting/Throwing up; Hot and sweaty from head to toe; Hot and sweaty from head to toe; Fainted in the bathroom; Chills and could not stay warm; could not stay warm; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 12Jan2021 (reported as yesterday) around 11 AM as a single dose for COVID-19 immunization, lot number: EL0140 3-4. Medical history and concomitant medications were reported as none. First vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on unknown date via an unspecified route of administration for COVID-19 immunization lot number: EL0140. Patient stated that she experienced side effects such as vomiting, diarrhea, fainting while going to the bathroom 14 hours after receiving her second shot of the Covid vaccine. She wanted to know if these were normal side effects and if she should seek medical attention. Patient reported the side effects that she had from the second dose of the Pfizer COVID Vaccine. She has gotten no answers regarding the side effects and she wanted to speak with someone about it. She got the second dose on 12Jan2021 (reported as yesterday) around 11 AM. She felt pretty normal. By 5 PM she got chills and could not stay warm. She thought it was normal. Then over night she got really nauseous, had diarrhea and was throwing up. She was hot and sweaty from head to toe. She tried to get up afterwards and fainted in the bathroom. She was reading what the pharmacy gave her for mild to moderate side effects, and none of what she experienced are listed on there. She also stated that nausea started around 1 AM this morning. It has persisted and is intermittent. Diarrhea occurred a little after 1 AM she got up to pee. Then went back to bed. Then about 10 minutes later had to go to the bathroom, and it started then. It is still occurring this morning. It last happened around 9 AM. She has not eaten anything new. Throwing up Lasted for about 15 minutes and fainted occurred one time. Patient recovered from chills and could not stay warm on 12Jan2021, she recovered from throwing up, hot and sweaty from head to toe and fainted in the bathroom on 13Jan2021, she had not recovered from nausea, diarrhea.
25 2021-01-25 chest discomfort Complained of pressure in chest, was anxious prior to vaccination. VS 154/100, HR 138. Asked to remo... Read more
Complained of pressure in chest, was anxious prior to vaccination. VS 154/100, HR 138. Asked to remove mask and took slow deep breaths, no improvement. 141/100 HR 103, complained of tongue feeling thick, speech impacted. Transfer to ED via stretcher
25 2021-01-27 chest discomfort Chest heaviness; This is a spontaneous report from a contactable pharmacist. A 25-years-old female p... Read more
Chest heaviness; This is a spontaneous report from a contactable pharmacist. A 25-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, via an unspecified route of administration on 08Jan2021 at a single dose, for covid-19 immunization. Medical history included allergies from shellfish-derived products. The patient's concomitant medications were not reported. The patient experienced chest heaviness on 08Jan2021. Patient was transported to ER for evaluation. Upon re-evaluation in ER, patient felt back to baseline and was discharged. The outcome of event was recovered. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
25 2021-01-28 chest discomfort Hx asthma. Pt c/o tightness in chest as with asthma.
25 2021-01-28 heart rate increased Numbness/tingling in bottom lip around 3 hours after shot, went away around 6 hours after shot Woke... Read more
Numbness/tingling in bottom lip around 3 hours after shot, went away around 6 hours after shot Woke up next day with significant muscle aches, fatigue mainly in my upper body (arms, neck, back). As the day progressed, dizziness and brief period of accelerated HR (have had incidents of elevated HR a couple months ago before receiving the vaccine)
25 2021-01-28 pallor, fast heart rate swelling at injection site; swollen lymph nodes at under arm; Dizziness/Then felt like going to fain... Read more
swelling at injection site; swollen lymph nodes at under arm; Dizziness/Then felt like going to faint; Nausea; I became pale, diaphoretic, and tachycardia (100s).; I became pale, diaphoretic, and tachycardia (100s).; I became pale, diaphoretic, and tachycardia (100s).; Headache; Severe pain at injection site; Fatigue; Muscle weakness; For about 12 hours or so I had on and off fever and chills; For about 12 hours or so I had on and off fever and chills; This is a spontaneous report from a contactable Nurse (patient). A 25-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249), via an unspecified route of administration on 13Jan2021 19:00 at single dose in Left arm for COVID-19 immunization. Medical history included allergies to Sulfa drugs, attention deficit hyperactivity disorder (ADHD), seasonal allergic rhinitis. Concomitant medication included ibuprofen (ADVIL), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), fluticasone propionate (FLONASE), clarithromycin (CLARITIN). Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) on 23Dec2020 18:00 at single dose which was administered at Left Arm for COVID-19 immunization. There were no other vaccines received in four weeks. The patient did not have covid-19 prior to vaccination and covid-19 not tested post vaccination. The patient started with dizziness and nausea on 14Jan2021 12:30. Then felt like she was going to faint on 14Jan2021 12:30. The patient became pale, diaphoretic, and tachycardia (100s) on 14Jan2021 12:30. Also had a headache and severe pain at injection site as well as fatigue and muscle weakness on 14Jan2021 12:30. For about 12 hours or so the patient had on and off fever and chills as well the rest of the symptoms listed above which started from 14Jan2021 12:30. Today (40+ hours later) on 15Jan2021, the patient developed swelling at injection site and swollen lymph nodes at under arm. No treatment received for the reported events. The outcome of the events was recovered in Jan2021.
25 2021-02-02 heart rate increased Mild anaphylaxis less than 5 min after injection. Symptoms onset immediately, including dizziness, r... Read more
Mild anaphylaxis less than 5 min after injection. Symptoms onset immediately, including dizziness, rapid heart rate, tightening of the throat, making breathing/swallowing difficult, ears felt strong pressure/itch. Symptoms went away on their own, but several episodes of similar symptoms/intensity persisted throughout the evening roughly every 30min-1hour.
25 2021-02-02 heart rate increased Rapid heart rate starting about 3 hours after vaccination. Heart rate at resting ranging from 110-15... Read more
Rapid heart rate starting about 3 hours after vaccination. Heart rate at resting ranging from 110-150 bpm. Also experiencing dizziness, shakiness, clamminess.
25 2021-02-02 loss of consciousness PATIENT LOST CONCIOUSNESS ALMOST IMMEDIATLEY FOLLOWING VACCINATION. 911 WAS CALLED BUT PATIENT REGAI... Read more
PATIENT LOST CONCIOUSNESS ALMOST IMMEDIATLEY FOLLOWING VACCINATION. 911 WAS CALLED BUT PATIENT REGAINED CONCIOUSNESS WITHIN MINUTES AND REFUSED MEDICAL ASSISTANCE. SHE INDICATED THAT THIS TYPE OF EVENT HAS HAPPENED PREVIOUSLY AND LEFT ON OWN ACCORD AFTER RESTING FOR ABOUT 15 MINUTES.
25 2021-02-02 fainting Brief Syncopal episode immediately following vaccine administration. Patient regained consciousness ... Read more
Brief Syncopal episode immediately following vaccine administration. Patient regained consciousness within 30 sec. she had some sweating immediately following but no other symptoms. Medical and EMS responded. BP 98/50 P 70 Patient has a history of syncope when ever she gets a shot.
25 2021-02-03 chest discomfort Patient received the 1st dose of the Pfizer COVID vaccine and was being observed for the 30 minute ... Read more
Patient received the 1st dose of the Pfizer COVID vaccine and was being observed for the 30 minute observation due to history of :severe allergic reaction (anaphylaxis) as a child, with unknown etiology. About 20 minutes into the observation period patient began complaining of tightness in her chest and heaviness in her shoulders. respiratory rate = 20 and unlabored; breathing spontaneously with O2 saturation 100% on room air; BP 116/69, Pulse 103 Mentation: Alert Skin: Cool at onset of symptoms, per EMS recommendation, the patient was placed on oxygen 2 liters via nasal canulaO2 saturations remained at 100 %. Patient noted slight improvement of her symptoms after about 15 minutes with oxygen continuing at 2 liters/Nasal cannula. Continued to observe patient for another 10 minutes, after which time the patient began to complain of a scratchy feeling in her throat, swelling around her mouth, itching and flushing of her face. At 19:05, EMS administered 0.3 mg intramuscular, Epinephrine via auto-injector into patient's right thigh. After 5-6 minutes post-Epi administration, the patient reported having relief of symptoms. Vital signs obtained (BP 108/69, pulse 108) and oxygen saturation stable at 100% on room air. Patient was advised, she would need further evaluation in the Emergency Department after receiving the dose of Epinephrine via auto-injector. Patient was advised to be transported via ambulance. Patient declined transport via ambulance. Patient called a friend to give her a ride to the Emergency Department. EMS personnel called report to the ED. Patient was alert, oriented x3 throughout the adverse event and stable upon leaving the clinic at 40 minutes after Epi had been administered. Vaccine providers were notified of the adverse symptoms post vaccine. Patient will follow-up with her primary provider and allergy provider to determine if second dose will be a possibility to receive.
25 2021-02-03 chest discomfort I received my 1st Covid shot on 12/21/20 and was diagnosed with Covid on 12/28/20. The day prior to ... Read more
I received my 1st Covid shot on 12/21/20 and was diagnosed with Covid on 12/28/20. The day prior to testing positive I had been notified that I had been in close contact with someone who had tested positive. I did not have any symptoms when I tested positive on 12/28/20 except for a headache later that night. The next day I felt fatigued and had nasal congestion. On 12/30/20, i noticed that I had lost my sense of smell and my sense of taste was altered. I also felt mild chest tightness however my o2 sats remained above 95%. The congestion and fatigue only lasted for two days and my sense of smell and taste had come back by 1/1/21. The chest tightness has persisted even now after testing negative but has diminished over time and occurs less frequently.
25 2021-02-03 heart rate increased Arm pain happened 4 hours after vaccination.; Dizziness; weakness; heart rate went to 140 30 minutes... Read more
Arm pain happened 4 hours after vaccination.; Dizziness; weakness; heart rate went to 140 30 minutes after the shot. Heart rate went down 1 hour after; This is a spontaneous report from a contactable consumer. This 25-year-old female consumer (patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunization on 18Jan2021 at 13:00. Relevant history and concomitant drugs were unknown. No known allergies. No other medical history. The patient received her first dose of BNT162B2 on unknown date. The patient experienced dizziness and weakness on 18Jan2021 at 01:45 pm. The heart rate went to 140 30 minutes after the shot. Heart rate went down 1 hour later, but she was still having dizziness. The patient also had arm pain 4 hours after vaccination on 18Jan2021. No treatment was received. The outcome of event was recovering. The patient did not receive any other vaccine in four weeks. The patient did not have COVID infection prior vaccination. The patient did have COVID test post vaccination. Information about Lot/Batch number is requested.
25 2021-02-03 palpitations Pounding heart rate; rapid heart rate like it was pounding out of her chest; Felt faint; This is a s... Read more
Pounding heart rate; rapid heart rate like it was pounding out of her chest; Felt faint; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3246), intramuscular in left arm, on 15Jan2021 at 14:15, at 0.3 mL, single, for COVID-19 immunization. The patient's medical history included attention deficit hyperactivity disorder (ADHD). The patient's concomitant medications included amfetamine aspartate monohydrate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (MYDAYIS), buspirone hydrochloride (BUSPAR), and ethinylestradiol/ norethisterone acetate (MICROGESTIN). The patient previously took cefotaxime sodium (OMNICEF) and amoxicillin sodium/clavulanate potassium (AUGMENTIN) and experienced allergies to both drugs. The patient worked on a COVID-19 study. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital facility. On 18Jan2021 at 03:00 AM, the patient had a pounding heart rate beginning two days after vaccination and had felt faint. The patient received her first dose on Friday and then last night (3 AM; also reported as 2-3 AM) she started having rapid heart rate like it was pounding out of her chest. It woke her up in the middle of the night around 2-3 AM so it was this morning around 2-3 AM. The patient can still feel like her heart is pounding out of her chest, but it is improved a little bit since it began. It is a little better now but is still persistent. No treatment was given for the adverse events. The patient was not sure if that is something that has been reported before. She did not know what to do but she wanted to try to find out if it was because of the vaccine. The patient did report it online already, she did the event reporting, but she would be happy answer more questions. The patient has not been tested for COVID-19 post-vaccination. The patient was recovering from the events
25 2021-02-04 chest discomfort, blood pressure increased Patient states had tightness in chest, shortness of breath, headache and lightheaded. Flushing of th... Read more
Patient states had tightness in chest, shortness of breath, headache and lightheaded. Flushing of the face, elevated blood pressure.
25 2021-02-04 loss of consciousness Passed out; Pulseless for 30 seconds; Feel dizzy and nauseous; Feel dizzy and nauseous; This is a sp... Read more
Passed out; Pulseless for 30 seconds; Feel dizzy and nauseous; Feel dizzy and nauseous; This is a spontaneous report from a contactable Other Health Professional (patient). A 25-year-old female (not pregnant at the time of vaccination) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown since not available/provided to reporter at the time of report completion), via an unspecified route of administration at left arm on 22Jan2021 11:45 at single dose for COVID-19 immunization at a Nursing Home/Senior Living Facility. The patient's medical history included known allergies: Sulfa and poppy seed. No other known medical history/conditions. For concomitant medications, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took amoxicillin, clarithromycin (BIAXIN) and cefaclor (CECLOR), and experienced drug allergy. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for COVID-19 since the vaccination. After receiving the vaccine, the patient was sitting in the observation area for about 10 minutes when she started to feel dizzy and nauseous. She raised her hand up and called for the nurse to come over. She passed out. She was pulseless for 30 seconds and they had to begin giving her CPR chest compressions. She woke up lying on the ground and was taken to the emergency room (ER) where they ran tests to see how she was doing and for observation for several hours. The patient was "discharged" this afternoon and was doing better. The events result in emergency room/department or urgent care. Treatment was received for the events, ER observation and care, and CPR chest compressions. The patient underwent lab tests and procedures which included test on 22Jan2021: unknown results. The outcome of events at the time of last observation was recovering. The reporter's assessment of the events was non-serious, no results in death, no life threatening, not causing/prolonging hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. Information on the lot/batch number has been requested.; Sender's Comments: The reported passed out and pulseless for 30 seconds were likely related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship. However, considering the clinical course and medical history, other cause(s)/confounding factors cannot be excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
25 2021-02-04 pallor, heart rate irregular, chest discomfort, very slow heart rate During the 15 minute post-vaccination observation window, Patient began reporting dizziness and ches... Read more
During the 15 minute post-vaccination observation window, Patient began reporting dizziness and chest heaviness. She denied SOB, itching, throat irritation, or rash. Denies previous adverse reaction to vaccine or injectible. Vital signs obtained: BP 112/75 O2 sats 98% on room air Heart rate inconsistent by automatic monitor Apical HR 57 with irregular rhythm Gen: WDWN Asian female with mild distress CV: irregular heart rate, bradycardic Resp: CTA bilaterally, no wheezing Skin: pale, no rashes/hives Neuro: awake, alert, oriented x 3 Medcom called, report given, and patient transported via wheelchair to hospital adult ER triage.
25 2021-02-07 blood pressure increased, heart rate increased, pallor dizziness; increased heart rate; increased blood pressure; flushed; weakness; shakiness; lethargy; c... Read more
dizziness; increased heart rate; increased blood pressure; flushed; weakness; shakiness; lethargy; chilled; in particular hands were very cold; pale color; slurred speech; mental fog; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 25-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EL3249), via an unspecified route of administration at site of right arm on 20Jan2021 09:30 at single dose for COVID-19 immunization. Medical history reported as none. Concomitant medication included vitamin D3 and iron (SLOW RELEASE IRON) and daily multivitamin. Within minutes of receiving the dose on 20Jan2021 at 09:45 AM, dizziness, increased heart rate, increased blood pressure, flushed, weakness, and shakiness. About an hour after receiving the dose on 20Jan2021, lethargy, chilled, in particular hands were very cold, pale color, mental fog, and slurred speech. The patient did not receive any treatment from events. The outcome of events was recovered in Jan2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The reported temporary mental fog/mental impairment was likely related to first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship and clinical course of the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
25 2021-02-07 chest discomfort 10:03AM Light headed, flushed, chest tightness. BP 138/84, HR 92, SPO2 98%. Pt placed in supine po... Read more
10:03AM Light headed, flushed, chest tightness. BP 138/84, HR 92, SPO2 98%. Pt placed in supine position. VS monitored. Fluids given. PT AOPPT. 10:10AM BP 103/70, HR 83, SPO2 97%. 10:223AM BP 150/95, HR 97, SPO2 100%. 10:40AM BP 138/91, HR 98, SPO2 100%
25 2021-02-07 pallor About 10 minutes after receiving dose 1 of her Pfizer Covid-19 vaccine, Patient felt dizzy, nauseous... Read more
About 10 minutes after receiving dose 1 of her Pfizer Covid-19 vaccine, Patient felt dizzy, nauseous, looked pale, and was diaphoretic.
25 2021-02-08 blood pressure decreased, fainting syncopal episodes; Vomited 40+ times; blood pressure dropped to 70/40; Elevated bilirubin; elevated ... Read more
syncopal episodes; Vomited 40+ times; blood pressure dropped to 70/40; Elevated bilirubin; elevated liver enzymes (ALT, AST); elevated liver enzymes (ALT, AST); This is a spontaneous report from a contactable other health professional (patient herself). A 25-year-old female patient (non-pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0142), via an unspecified route of administration on 28Dec2020 12:30 in right arm at single dose for covid-19 immunization. The patient had COVID prior vaccination. Concomitant medication in two weeks included levothyroxine sodium (SYNTHROID), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient experienced vomited 40+ times, syncopal episodes, blood pressure dropped to 70/40, elevated bilirubin, elevated liver enzymes (ALT (alanine aminotransferase), AST (aspartate aminotransferase)) on 28Dec2020 19:30. Events resulted in emergency room/department or urgent care. IV fluids were received for events. The patient was not tested COVID post vaccination. Outcome of elevated bilirubin was recovered on an unspecified date, and outcome of other events were recovering.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported syncope cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
25 2021-02-09 heart rate increased, blood pressure decreased Within 15 minutes my vision began to blur, I became shaky and disoriented. My heart rate increased a... Read more
Within 15 minutes my vision began to blur, I became shaky and disoriented. My heart rate increased and it felt as though my blood pressure decreased rapidly. After 30 minutes my symptoms had worsened and I was so disoriented I was not able to seek medical attention while being observed. I exited the building and once I got into my car my face (specifically under my eyes and on my cheeks) began swelling and a red burning rash appeared. By the time I got home (10 more minutes) I needed Benadryl immediately, I was not able to complete my sentences and all other symptoms had become more intense. I continued to take Benadryl every 4 hours for the next few days due to the symptoms consistently rebounding. I had one episode of throat tightness but it passed without use of my epipen. I checked my pulse and blood pressure frequently with the lowest reading being 93/60. Lethargy, shakiness, confusion, high heart rate all are still present after 5 days. The rash went away after 48 hours.
25 2021-02-09 fast heart rate, pulmonary embolism Patient developed rapid onset of dyspnea, light headedness and tachycardia. Was taken to the ED wher... Read more
Patient developed rapid onset of dyspnea, light headedness and tachycardia. Was taken to the ED where she was treated with an antihistamine and IV fluids. Symptoms resolved. 6 days after the vaccine, was having shortness of breath and left arm pain (not the arm where injection was received) and was diagnosed with a pulmonary embolism.
25 2021-02-11 loss of consciousness At 7:00am the morning after receiving my second dose of the vaccine, I arose from bed and went to th... Read more
At 7:00am the morning after receiving my second dose of the vaccine, I arose from bed and went to the bathroom to brush my teeth. At the sink, I immediately started feeling extremely dizzy and lightheaded and felt like I was going to throw up. I was also extremely clammy and started sweating. I tried to make my way to the kitchen to get a glass of water and blacked out and the next thing I remember is waking up on the floor of my apartment hallway covered in sweat and screaming and crying. I called my primary care physician's office and spoke with a triage nurse who advised me to go to the ER for examination due to my loss of consciousness and lingering feelings of dizziness, nauseous, and body aches.
25 2021-02-13 excessive bleeding Instant bleeding, hematoma, pink around injection site, and lump. The next day there is purple bru... Read more
Instant bleeding, hematoma, pink around injection site, and lump. The next day there is purple bruising that has expanded and the injection site is warm to the touch. It is mildly painful in that region as well as to move my left shoulder. There is also a lump in that area.
25 2021-02-13 heart rate increased, heart rate irregular, increased heart rate Had my second covid vaccine 2/12/2021 at 11:55am and woke up 4:30am 2/13/2021 with irregular heart r... Read more
Had my second covid vaccine 2/12/2021 at 11:55am and woke up 4:30am 2/13/2021 with irregular heart rate, shortness of breath, wheezy, achy, and so weak I could barely move. My Mom is a Nurse Practitioner, checked my pulse and felt an irregular beat, my heart rate was fast 105 beats/min at rest and 142 beats/min with exertion, oxygen was 91% and I had a fever 100.5F orally.
25 2021-02-13 palpitations, increased heart rate, heart rate abnormal 25-year-old female presents to the emergency room for evaluation. Patient reports that this morning... Read more
25-year-old female presents to the emergency room for evaluation. Patient reports that this morning she was taking a warm shower. She started having very fast palpitations and felt short of breath with associated lightheadedness. This was very severe for approximately 2 minutes. States she got out of the shower and had to sit down. She put on her smart watch and states her heart rate was greater than 200 at that time. After approximately 2 minutes her heart rate decreased in the 130-150 range and she had mild symptoms for approximately 30 minutes. Her symptoms have subsequently resolved.
25 2021-02-13 lightheadedness Arm soreness began 7PM on 2/11. Vasovagal syncope episode at 2:25AM on 2/12; triggered by combinati... Read more
Arm soreness began 7PM on 2/11. Vasovagal syncope episode at 2:25AM on 2/12; triggered by combination of arm soreness, body aches, and low-grade fever. Senses returned back to normal within 5-10 minutes. Consistent low-grade fever from 1AM on 2/12 until 6PM on 2/13. Treated with 1000mg liquid acetaminophen every 6 hours per manufacturer instructions. Notable ache in legs (akin to Restless Leg Syndrome) from 3AM on 2/12 until around 9AM on 2/13. Urge to move calmed by acetaminophen. Highest recorded fever: 99.5°F at 9AM on 2/12. Fever subsided as of 6PM on 2/13.
25 2021-02-14 hypertension, heart rate increased Rash/hives all over body, increased blood pressure, heart rate 150. Struggling to breathe.
25 2021-02-14 lightheadedness, loss of consciousness Sudden LOC, possible seizure (rigidity) for 5 sec, no post-ictal state, but some disorientation. 99 ... Read more
Sudden LOC, possible seizure (rigidity) for 5 sec, no post-ictal state, but some disorientation. 99 on RA,118/76, 99-103 HR, tachypnea to 26. Assessed by EMS, pt refused transport- paramedic got AMA signed. Vasovagal response, Confusion, Disorientation, Loss of consciousness
25 2021-02-15 palpitations Pt felt that heart was racing and some shortness of breath. @ 1328 HR 118, BP 132/98. Recheck @ 1... Read more
Pt felt that heart was racing and some shortness of breath. @ 1328 HR 118, BP 132/98. Recheck @ 1352 HR 75, BP 130/98, RR 24. Pt feels recovered after resting and feels alright to drive home.
25 2021-02-16 blood pressure increased C/O flushing , scratchy and dry throat , anxious elevated BP : 157/114 elevated HR : 111 ... Read more
C/O flushing , scratchy and dry throat , anxious elevated BP : 157/114 elevated HR : 111 improved after approx. 10 minutes, HR: 89 BP : 148/84 DECLINED taken to ER.
25 2021-02-18 fast heart rate, arrhythmia Arrhythmia; Tachycardia, BP 103/min; This is a spontaneous report from a contactable other HCP. A ... Read more
Arrhythmia; Tachycardia, BP 103/min; This is a spontaneous report from a contactable other HCP. A 25-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264) on 05Feb2021 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. The patient received first dose of BNT162B2 on 14Jan2021 at 03:45 pm on left arm. Concomitant medications were not reported. On 05Feb2021 at 15:00 the patient experienced Tachycardia with BP 103/min and Arrhythmia. No treatment was given for reported events. At the time of the reporting the patient had not yet recovered from the events. The information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal relationship, the association between the event arrhythmia with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
25 2021-02-21 fainting Syncope
25 2021-02-21 fast heart rate Fever; headache; tachycardia; left arm pain; muscle pain; stomach upset; This is a spontaneous repor... Read more
Fever; headache; tachycardia; left arm pain; muscle pain; stomach upset; This is a spontaneous report received from a contactable nurse (patient). A 25-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection and lot number: EL9282) at the age of 25 years intramuscularly to left arm on 28Jan2021 13:00 at single dose for Covid-19 immunisation in hospital. Medical history included Kyphosis. The patient had no known drug allergy (NKDA). The patient had no concomitant medications. Patient previously the first dose of BNT162B2 at the age of 25 years for Covid-19 immunisation. The patient did not receive other vaccine in four weeks. The patient was not pregnant. The patient did not have COVID prior to vaccination. The patient underwent nasal swab (antigen) test on 20Jan2021 with negative result. On 28Jan2021 16:00 the patient experienced fever, headache, tachycardia, left arm pain, muscle pain and stomach upset. Therapeutic measure was taken as a result of the events and included treatment with PANADOL 500mg. Outcome of events was recovering. No follow-up attempts are possible. No other information was reported.
25 2021-02-23 palpitations, chest pain At 9:40 started to feel like my heart was racing, a weight on my chest, pain in my left chest area. ... Read more
At 9:40 started to feel like my heart was racing, a weight on my chest, pain in my left chest area. Called nurse when I got to work, and they recommended going to ER. Was light headed when walking, slight headache, and chest pain moved between left chest, left arm, middle of chest.
25 2021-02-25 lightheadedness patient had vasovagal reaction and felt light headed. She got on the ground herself and put her feet... Read more
patient had vasovagal reaction and felt light headed. She got on the ground herself and put her feet up, prevented fainting. She recovered within minutes and was given apple juice. This has happened before with other needles and procedures. She fully recovered after about 10 minutes.
25 2021-03-04 blood pressure decreased, lightheadedness, pallor, skin turning blue I made sure to hydrate and eat well the day of the vaccine. I have had no allergic reactions to any ... Read more
I made sure to hydrate and eat well the day of the vaccine. I have had no allergic reactions to any medications/ injections in the past and I was not worried about this one. I didn't take any meds beforehand besides my normal morning modafinil. I have no fear of needles. I received the vaccine in the auditorium about 1:25pm. The RN did a fantastic job, went through all of the information, no pain at all with the injection. As I was sitting in my chair for monitoring, a few minutes in I began to feel very uncomfortable. I felt clammy/sweaty and kept shifting my weight in my seat. I didn't want to make a big deal of it at first because I worried it was all in my head. But I became more and more uncomfortable. I laid my head down on the little desk, no help. I closed my eyes, no help. About 10 minutes or so in I decided to ask if they had water available. I slowly got up and walked to the back of the room. I couldn't even get the question out of my mouth before the nurse told me to sit down. Apparently I was white as a ghost. They got a wheelchair and wheeled me to the space behind the auditorium. By then I was starting to feel like my throat was closing and I saw spots in my peripheral vision. It was kind of a blur from there. I tried to take deep breaths. I drank a few sips of water and poured some on a paper towel to wet my forehead (and spilled all over my lap because I was a little disoriented at this point). My BP was 60s/40s and then 60s/30s. A rapid response was called. They moved me to a cart flat on my back with my legs elevated. My fingers and toes were starting to go numb and my lips were apparently blue/ white. After laying for a few minutes in Trendelenburg my BP began to resolve and my breathing started to ease a bit. No further intervention was done by the rapid team. I was taken by the Rapid RN to the ED for monitoring. They eventually pushed the cart into a room and took some vitals and an EKG. They had me stand and move to a wheelchair. I felt horrible but improved from before. They had me sit in a wheelchair in the lobby for a few hours before taking me back and placing an IV and drawing labs (I believe it was 3 hours from the initial reaction). I gave a urine sample. They then put me in a wheelchair and wheeled me back into the lobby for some more time. Then, they wheeled me back to a room where they gave some lactated ringers and a PA and MD saw me. By then my BP and breathing was completely resolved. The MD said he wasn't fully convinced it was just a vasovagal episode because I haven't had issues with vaccines in the past and I was well hydrated and my HR was normal. It partly fit the picture for an allergic reaction/ severe immune response d/t the feeling of throat closing, the BP drop, and the elevated WBCs. They advised that I list the vaccine as an allergy and do not get the second dose, especially since I had COVID back in September.
25 2021-03-06 chest discomfort chest pain, fever, nausea
25 2021-03-06 heart rate increased ~8 hours after injection: achy, shaky, chills ~hour 9-12 after injection: splitting headache - slept... Read more
~8 hours after injection: achy, shaky, chills ~hour 9-12 after injection: splitting headache - slept and woke every hour ~hours 25-27 after injection: throbbing headache, lightheaded, overheating, minor vomiting, Increased heart rate
25 2021-03-07 palpitations tongue itching, palpitations with flushing sensation
25 2021-03-07 increased heart rate, chest pain 05:35PM STATES 'FEELS LIKE SHE WILL PASS OUT, NAUSEA & HAS CHEST PAIN'. PLACED ON COT AND CARDIAC MO... Read more
05:35PM STATES 'FEELS LIKE SHE WILL PASS OUT, NAUSEA & HAS CHEST PAIN'. PLACED ON COT AND CARDIAC MONITOR. A/O, PINK, W/D, RESP WITH EASE, NO DIAPHORESIS, NO DECREASED LOC. SINUS TACH ON MONITOR. 5:49PM ASA P.O./CHEWED. IV STARTED PER SQUAD. SMALL AMT EMESIS (APROX 2 TSP). TRANSPORTED TO ER PER SQUAD.
25 2021-03-08 hypotension patient received first and second dose from her employer. Second dose given 5 days ago and she has ... Read more
patient received first and second dose from her employer. Second dose given 5 days ago and she has had continued vomiting, dizziness and hypotension. No fever, chills, or URI
25 2021-03-08 lightheadedness 1/14 vaccination @ 12 By 1:30 I was experiencing light headedness, brain fog. I went to leave work e... Read more
1/14 vaccination @ 12 By 1:30 I was experiencing light headedness, brain fog. I went to leave work early and experienced a near syncopal episode. Co workers took vitals. O2 was fine, BP was low. Monitored at work for a couple hours and then helped home. *anemic **heaviest day of period ***was informed by vaccine administer that these factors would not be a barrier to getting the vaccine.
25 2021-03-09 blood pressure increased Weakness, tunal vision, high B/P, nausea
25 2021-03-09 heart rate increased My heart rate elevated to 120bpm; This side effect was unexpected, uncomfortable; This side effect w... Read more
My heart rate elevated to 120bpm; This side effect was unexpected, uncomfortable; This side effect was unexpected, uncomfortable and resulted in me being unable to work for the rest of the day.; This 25- year-old female patient contactable consumer (reported for herself) received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot EL3247), via an unspecified route of administration, on 03Feb2021 at 1:00 PM (at the age of 25-years-old) as a single dose for COVID-19 immunization, in left arm. She has had no other vaccines in the past 4 weeks. Patient has not taken any medications in the past 2 weeks. The patient has no relevant medical history and is not taking any concomitant medications. The patient is not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 03-FEB-2021 13:05, she reported: my heart rate elevated to 120bpm approximately 5 minutes after receiving the Pfizer COVID19 vaccine. This side effect was unexpected, uncomfortable and resulted in me being unable to work for the rest of the day. This side effect lasted approximately 36 hours. Patient did not receive any treatment. The outcome of the events heart rate elevated and unable to work the rest of the day was recovered. It was reported that since the vaccination, the patient had not been tested for COVID-19.
25 2021-03-10 pallor Patient felt nauseous, dizzy, sweaty and fatigued. She looked pale and clammy. Allowed to rest with... Read more
Patient felt nauseous, dizzy, sweaty and fatigued. She looked pale and clammy. Allowed to rest with feet above her head. Water given. She recovered after 30 minutes
25 2021-03-10 pallor Patient felt nauseous, dizzy, sweating and fatigue. She looked pale and clammy. She recovered after ... Read more
Patient felt nauseous, dizzy, sweating and fatigue. She looked pale and clammy. She recovered after 30 minutes.
25 2021-03-10 fast heart rate C/o anxiety prior to administration. Approx 15 minutes after administration individual developed inc... Read more
C/o anxiety prior to administration. Approx 15 minutes after administration individual developed increased anxiety, headache, dizziness, tachycardia, shakiness, and sweatiness. VS: 95/51 HR 63. Evaluated and monitored, provided PO fluids, improvement noted. No transport.
25 2021-03-11 chest pain Sharp chest pain occurring every 1-5 minutes from 7:00pm to 9:30pm, roughly 24 hours post-vaccinatio... Read more
Sharp chest pain occurring every 1-5 minutes from 7:00pm to 9:30pm, roughly 24 hours post-vaccination. Pain was a non-radiating, sharp, stabbing pain in the center of the chest. Tums taken at both 7:30pm and 9:00pm did not alleviate pain. Symptoms had resolved upon waking up the next morning. I was not woken up by any symptoms throughout the night.
25 2021-03-15 chest pain 2 days after, lightheaded, weak, intermittent chest pain, blurry vision, shortness of breath next da... Read more
2 days after, lightheaded, weak, intermittent chest pain, blurry vision, shortness of breath next day headaches
25 2021-03-17 hypertension, lightheadedness Diarrhea began about 2 hours after inject as well as fever; Diarrhea began about 2 hours after injec... Read more
Diarrhea began about 2 hours after inject as well as fever; Diarrhea began about 2 hours after inject as well as fever; BP had increased to 170s SBP and 120s DBP; Experienced a near syncopal episode; Dizzy/Light headed; Eyes were fluttering; Nausea; Vomiting; This is a spontaneous report from a contactable nurse (patient). A 25-year-old female patient received second dose of BNT162B2, via intramuscular in left arm on 29Jan2021 08:30 am at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included PCOS. Concomitant medication included celecoxib (CELEXA [CELECOXIB]), buspirone hydrochloride (BUSPAR). The patient previously took keflex [cefalexin] and cipro [ciprofloxacin] and experienced Known allergies: Cipro and Keflex. Historical vaccine of BNT162B2 at 25 year on 08Jan2021 for covid-19 immunisation. The patient stated on 29Jan2021 10 minutes post vaccine at 08:45 am she became lightheaded and dizzy. It was reported that her eyes were fluttering and experienced a near syncopal episode. Further assessment showed that her BP had increased to 170s SBP and 120s DBP. Her baseline SBP was 1-teens and 1-tens. She also experienced nausea and vomiting at that time. She was taken to ER for cardiac monitoring and eval. BP returned to normal spontaneously. Diarrhea began about 2 hours after inject as well as fever. Highest fever noted was 102.3. Discharged home from ER. Symptoms has subsided 24hrs post vaccine. The patient underwent lab tests and procedures which included blood pressure measurement: increased to 170s sbp and 120s dbp on 29Jan2021, blood pressure measurement: normal on 2021, body temperature: 102.3 on 29Jan2021. The facility where the most recent COVID-19 vaccine was administered was hospital. 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 been not been tested for COVID-19. The adverse events resulted in emergency room. No treatment was received for the adverse events. The outcome of the events recovered on an unspecified date of 2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect vaccine BNT162B2 to the event blood pressure high cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
25 2021-03-18 chest pain, fainting Pt had the pfizer Covid shot. she was sick from the first shot on Feb 4 2021. Fever , headache an... Read more
Pt had the pfizer Covid shot. she was sick from the first shot on Feb 4 2021. Fever , headache and chills. She decided to get the second pfizer on March 4. Immediate chest pains then 15 min later, syncope , followed by myoclonic or seizure type activity of both the RT upper and lower extremities. This was seen by me in the emergency room. She was given ativan and the seizure type movement stoped. I called her today on 03-19-2021, She told me she was sick for five days following the second pfizer, Had headaches. body aches and fevers. but today was doing well.
25 2021-03-18 loss of consciousness Patient received vaccine and shortly after lost consciousness briefly. once patient came to, mention... Read more
Patient received vaccine and shortly after lost consciousness briefly. once patient came to, mentioned she had taken Valium prior to appointment to reduce anxiety, also diagnosed with needle phobia in the past. patient was observed further in a private room by MD, and after 30 minute wait, patient was evaluated and able to go home with mother whom had brought her to appointment. no further care was done.
25 2021-03-18 lightheadedness Pt experienced a vasovagal episode and emesis x1 post-vaccination at 11:30 AM. BP manually measured ... Read more
Pt experienced a vasovagal episode and emesis x1 post-vaccination at 11:30 AM. BP manually measured at 128/78, pulse ~100, O2 sat 100%. Pt instructed to recline to the supine position and episode self resolved without further sequelae.
25 2021-03-20 chest pain Severe chest pain that felt like it was moving from injection site into left upper chest. Pain then ... Read more
Severe chest pain that felt like it was moving from injection site into left upper chest. Pain then moved to middle of chest then to right side and back and forth from 1:30am to 3:30am. Pain then became constant in left upper chest area near collarbone. BP started at 156/95 around 1:45am then decreased to 127/87 around 2:30am
25 2021-03-21 lightheadedness Lightheadedness, diaphoretic. Pt observed for 45 mins in observation area, had vasal vagal response ... Read more
Lightheadedness, diaphoretic. Pt observed for 45 mins in observation area, had vasal vagal response after receiving vaccine. OK to D/C home. Vitals on D/C 114/96 BP HR 85 O2 99%.
25 2021-03-22 chest discomfort Client felt flushed, hands were tingly, chest pressure
25 2021-03-22 chest pain Severe burning sensation and chest pain with discomfort in talking and breathing.
25 2021-03-24 blood pressure increased Within minutes I became very dizzy and could not move my head or my eyes without feeling like I woul... Read more
Within minutes I became very dizzy and could not move my head or my eyes without feeling like I would faint or fall over.; blood pressure was checked and found to be 155/110; This is a spontaneous report from a contactable healthcare professional (patient). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 25-year-old, via an unspecified route of administration, administered in left arm on 09Mar2021 15:45 (Lot Number: EN6206) as single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS), atrial septal defect, obsessive-compulsive disorder (OCD), depression, post-traumatic stress disorder (PTSD), and was normally hypotensive with an average of about 100/50. The patient has no known allergies. No COVID prior vaccination and no COVID test post vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included fluvoxamine (FLUVOXAMIN), valaciclovir (VALACYCLOVIR), and hydroxyzine; all taken for an unspecified indication, start and stop date were not reported. On 09Mar2021 15:45 (also reported as within minutes), the patient became very dizzy and could not move her head or eyes without feeling like she would faint or fall over. Her blood pressure was checked and found to be 155/110, and she was normally hypotensive with an average of about 100/50. Her blood pressure dropped, and the dizziness went away within 1-2 hours. The patient received EMT treatment/monitoring for the events. The patient recovered from the events on an unspecified date.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of dizzy and blood pressure increased due to temporal relationship. Case will be re-assessed upon the additional information provided. 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.
25 2021-03-24 hypertension I have been experiencing high blood pressure between about 140/90 and 130/85 with headaches and tinn... Read more
I have been experiencing high blood pressure between about 140/90 and 130/85 with headaches and tinnitus. Blood pressure remains high throughout the day and was first noticed on 03/20/2021. I first took my blood pressure after noticing a mild headache that was not alleviated with hydration or OTC pain medication. Headaches have returned intermittently since 03/20/2021 but now only lasts 1-2 hours. Tinnitus was noticed several weeks ago (specific date is unknown) and is a mild and quiet but constant high frequency ringing. Unsure if any of these are related but I have never had tinnitus and my blood pressure is not this high nor do I have headaches often or back-to-back.
25 2021-03-24 fast heart rate, blood pressure increased, chest discomfort Tachycardia; tightness in chest; shortness of breath; headache; Lightheaded; Flushing of the face; E... Read more
Tachycardia; tightness in chest; shortness of breath; headache; Lightheaded; Flushing of the face; Elevated blood pressure; This is a spontaneous report from a contactable nurse. This nurse reported for a 25-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN5318) intramuscular to deltoid right on 05Feb2021 10:45 at single dose for covid-19 immunization. The patient's medical history included polycystic ovarian syndrome (PCOS) and asthma. She was allergic to shellfish, latex (asthma) and foods. Concomitant medications included drospirenone and ethinyl estradiol; oxybutynin, MULTIVITAMIN, probiotics and colecalciferol (VITAMIN D3); drospirenone, ethinylestradiol betadex clathrate (YAZ). On 05Feb2021 10:45, the patient had tightness in chest, shortness of breath, headache, lightheaded, flushing of the face and elevated blood pressure. AE resulted in doctor or other healthcare professional office/clinic visit. The patient took Benadryl as a treatment for the events. As of 10Mar2021, Patient received vaccine at 10:45. Patient came to ask for help at 11:05, it was reported the patient require medical intervention Corticosteroids; Other (please specify), Pepcid. the patient seen in the Emergency Department. the patient not hospitalized. the patient not admitted to an Intensive Care Unit. It was reported signs and symptoms involved organ involvement includes Multiorgan: Yes, Cardiovasccular (tachycardia Vitals taken at hospital); Respiratory (tightness in chest shortness of breath); Patient has started taking metoprolol for elevated blood pressure and hydroxyzine. On 05Feb2021, the patient underwent electrocardiogram (EKG) and results was unknown. The patient did not receive any recent vaccines for any other conditions or for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported or around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient provided information regarding the reported adverse events with the use of the product. It was considered that there was no causal effect for Pfizer product to the adverse event. Outcome of the event tachycardia was unknown and rest of the events was recovering. Follow-up (10Mar2021): New information received from a contactable Nurse reported for a patient in response to HCP letter sent included: Case upgraded to serious, Suspect drug details (anatomical location), Medical history details (foods allergy, latex (asthma)), New lab test (EKG), New event (tachycardia) and Clinical information.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between the suspect drug and the serious events cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
25 2021-03-27 chest discomfort C/O Heaviness in her chest and difficulty breathing with tingling to her lips. B/P 108/68; Pulse 8... Read more
C/O Heaviness in her chest and difficulty breathing with tingling to her lips. B/P 108/68; Pulse 82. R 20. Recovered. States did not know what anaphylaxis meant but knew she was allergic to PNC & Benadryl. Advised to receive next dose at MD Office. Recovered.
25 2021-03-29 blood pressure increased, heart rate increased Due date July 7th, 2021. 1st pregnancy. On 3/27 I had an elevated BP and HR in the evening, almost... Read more
Due date July 7th, 2021. 1st pregnancy. On 3/27 I had an elevated BP and HR in the evening, almost 24 hours after vaccination. BP was 135/72 and HR was 120. Normal BP for me is around 118/76 and HR is normally between 96 and 106. This was the second time I had elevated BP and HR after receiving the Pfizer vaccine.
25 2021-03-29 chest discomfort, fast heart rate Patient presented for the 2nd dose of the Pfizer-BioNTech COVID-19 vaccine, reporting arm soreness a... Read more
Patient presented for the 2nd dose of the Pfizer-BioNTech COVID-19 vaccine, reporting arm soreness after 1st dose of Pfizer vaccine. Patient received 2nd dose and was asked to remain for observation for 30 minutes given history of severe allergies. Twenty minutes after administration, patient reported sensation of throat and chest tightness. Within 2-3 minutes, patient became more hoarse, began coughing, had audible wheezing. No swelling noted in mouth or around lips or at vaccination site. Patient denied nausea. Epinephrine 0.3 mg (EpiPen) IM and diphenhydramine 50 mg IM were administered to patient and emergency response team was called to site for further evaluation. Vital signs normal except for tachycardia to HR 107. No audible wheezing on lung ausculation on reassessment after 5-10 minutes. Patient was transferred to ED for further assessment, but left prior to evaluation by an ED provider. Patient was unable to be reached by telephone for follow-up at number provided.
25 2021-03-29 heart rate increased, blood pressure increased Due date is July 7th, 2021. This is the first pregnancy. I had a high resting heart rate and elevate... Read more
Due date is July 7th, 2021. This is the first pregnancy. I had a high resting heart rate and elevate BP for one day. BP was 148/78 and HR was 135 on March 10th. I went to my doctor's office and she has me monitoring my BP and HR every day.
25 2021-03-29 fainting FAINTING
25 2021-03-30 chest discomfort high fever; chest tightness; Vicious vomiting; left eye swelling; restlessness; body aches; headache... Read more
high fever; chest tightness; Vicious vomiting; left eye swelling; restlessness; body aches; headache; difficulty breathing; difficulty speaking; shortness of breath; This is a spontaneous report from a contactable consumer (patient). This 25-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EN7206) at the age of 25 years, via an unspecified route of administration at single dose in the left arm on 07Mar2021 10:00 AM for COVID-19 immunisation. Medical history included asthma. Concomitant medications included salbutamol (ALBUTEROL HFA), lansoprazole (PREVACID), both taken for an unspecified indication. Previously the patient received the first dose of BNT162B2 (Lot Number: EL9266) at the age of 25 years on 13Feb2021 10:00 AM in the left arm for COVID-19 immunisation. On 07Mar2021 23:00, the patient experienced high fever, chest tightness, vicious vomiting, left eye swelling, restlessness, body aches, headache, difficulty breathing, difficulty speaking, shortness of breath. No treatment required. The events required a visit to the physician's office. The outcome of the events was not recovered. The vaccine was administered at a Clinic. 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. The patient had not been tested for COVID-19 since the vaccination.
25 2021-03-30 loss of consciousness For 36 hours after the vaccine she had a low grade fever and chills. She also had fatigue and body a... Read more
For 36 hours after the vaccine she had a low grade fever and chills. She also had fatigue and body aches that lingered for several days. 10 days after the vaccine she had an episode of partial loss of consciousness that was later diagnosed as a seizure and she has had 2 subsequent seizures and has now been diagnosed with epilepsy.
25 2021-03-30 pallor Date and time adverse event started: right after vaccine started she napped now can not feel fingers... Read more
Date and time adverse event started: right after vaccine started she napped now can not feel fingers Did the adverse event start after the first or second vaccination? second pins and needles in fingers, pale and cold fingers advised to go to an ED , She will go to hospital 3/30-Return call received from patient, no improvement in symptoms, still has numbness/tingling in left arm and no feeling in fingertips. Seen at ER yesterday, advised by staff to take ibuprofen and follow up in one week. No radiology exams done. No other complaints. Does not have PCP, advised to f/u as directed and/or return to ER if symptoms get worse.
25 2021-03-30 fainting, hypertension Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: .closed eyes when dissy about 6 to 7min after injection. leaned on wall while sitting then went to floor. does not remember getting to floor. nurses and pharmacist came to comfort as she came too. pt was passed out for just a brief couple seconds from when she got to floor. blood pressure was checked was high. then as she recovered pressure started to return to normal. also used ice pack on neck and head to feel better.** pt has history of passing out from needle. got ears pierced at age 14.
25 2021-03-30 fainting Delirium; Fainting episode with convulsions; Fever with Chills; Nausea; Dizziness and disoriented; D... Read more
Delirium; Fainting episode with convulsions; Fever with Chills; Nausea; Dizziness and disoriented; Dizziness and disoriented; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient (not pregnant) received first dose of bnt162b2 (Batch/Lot Number: EN6207), via an unspecified route of administration, administered in left arm on 18Mar2021 08:30 as single dose for covid-19 immunization. Medical history included cystitis interstitial from an unknown date and unknown if ongoing. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) taken for an unspecified indication, start and stop date were not reported. The patient experienced delirium, fainting episode with convulsions, fever with chills, nausea, dizziness and disoriented on 18Mar2021 09:00. No other vaccine in four weeks. The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. No treatment received. The outcome of events was resolving. No Covid prior vaccination. No Covid tested post vaccination. Not Known allergies.
25 2021-03-30 fainting Patient fainted briefly. Her face was flushed. time was 2:45 PM.
25 2021-03-30 fast heart rate Immediate "funny feeling" in throat, hives on face. Given Epipen and sent to ER for observation and ... Read more
Immediate "funny feeling" in throat, hives on face. Given Epipen and sent to ER for observation and treatment with Pepcid, Prednisone and Benadryl. Fully recovered kept for 9-10 hours due to tachcardia. Also given IV fluid. Seen by telemedicine followup 3/31/2021 by me in the office, No additional meds given by ER and none needed at this time.
25 2021-03-31 blood pressure increased Patient received first dose Pfizer at 4:30 pm. Around 6:30 pm she began to experience shortness of ... Read more
Patient received first dose Pfizer at 4:30 pm. Around 6:30 pm she began to experience shortness of breath, weakness, "shaking" in legs, lightheadedness, dizziness, nausea and hives. She presented to the emergency room and her blood pressure was elevated. She was given Zofran and Benadryl in the ER. After administration of the medications, her shortness of breath and hives began to improve. She remained in the ER for 3 hours for observation then was discharged. No epinephrine was administered during her visit.
25 2021-03-31 chest pain chest pain, 4/10, eyes tingling. Evaluated by EMS-Cleared
25 2021-04-01 hypotension, fainting Patient expressed seeing spots then fainted, hypotensive, vitals stabalized, refused of transport
25 2021-04-01 palpitations 12 hours after receiving my 2nd dose of the Pfizer COVID-19 vaccine, I experienced the following: Se... Read more
12 hours after receiving my 2nd dose of the Pfizer COVID-19 vaccine, I experienced the following: Severe body aches Fever (100.4 average throughout the day, highest was 101.7) Chills No appetite Nausea Diarrhea Severe fatigue Severe joint pain Muscle Weakness Sore Throat Racing heart Confusion Sore arm from injection site These symptoms lasted the entire day of April 1, 2021. My symptoms on April 2, 2021 are not as severe and I do not have a fever.
25 2021-04-02 fast heart rate Patient was dizzy, lightheaded, and had tachycardia. They had tingling in hands and feet. No anaphyl... Read more
Patient was dizzy, lightheaded, and had tachycardia. They had tingling in hands and feet. No anaphylaxis noted. They were transported by EMS.
25 2021-04-03 nosebleed Nose bleed, headache, low grade fever
25 2021-04-03 fainting Sweatiness and shortness of breath immediately after vaccination, stood up to go get snack & walked ... Read more
Sweatiness and shortness of breath immediately after vaccination, stood up to go get snack & walked a short distance before getting blurred vision/ringing in ears and then fainted
25 2021-04-04 fainting Patient received 1st dose of Pfizer COVID vaccine and subsequently fainted roughly 5 minutes after r... Read more
Patient received 1st dose of Pfizer COVID vaccine and subsequently fainted roughly 5 minutes after receiving dose. Patient never lost consciousness but did suffer a minor bruise on head once after fainting.
25 2021-04-05 fainting, loss of consciousness, fainting Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe
25 2021-04-05 fainting patient was in the observation area and fainted from her chair to the floor. Observation nurses were... Read more
patient was in the observation area and fainted from her chair to the floor. Observation nurses were able to arouse her immediately and transferred her from the observation area to the EMS room via wheelchair. Patient reported that she has "issues" when she gets her blood drawn bur has never passed out before. She denies chest pain, shortness of breath or nausea at this time. She was given H2O and allowed to rest on the gurney, all vitals were WNL 128/87 pulse 75 pulse ox 100%. Pt was discharged in stable condition to father who was driving her home @ 12:35pm.
25 2021-04-06 loss of consciousness Felt light-headed, passed out and recovered within 1 to 2 minutes
25 2021-04-07 blood pressure decreased, pallor, loss of consciousness Patient looked very pale and felt neasous and lightheaded. she was out of conscience for 20 seconds... Read more
Patient looked very pale and felt neasous and lightheaded. she was out of conscience for 20 seconds then came back. Called 911 ,paramedics arrived at the scene in like 3 minutes and put her in the ambulance after an examination. Patient was able to talk to paramedics and answering their questions. They diagnosed her problem being low blood pressure.
25 2021-04-07 loss of consciousness Patient received the vaccine around 10:00 AM. Her husband was vaccinated immediately after her. We e... Read more
Patient received the vaccine around 10:00 AM. Her husband was vaccinated immediately after her. We explained to the husband that they needed to wait around about 15 minutes to make sure they did not have any issues with the vaccine. She asked where the bathroom was while he was being vaccinated. When he was done with his vaccine, I was helping another patient register for his covid vaccine. The husband came running to the counter and stated his wife had called and said she woke up on the bathroom floor. So I immediately came and told RPH on duty and called 911. Then went and checked on the patient and asked what happened and I told her I called EMS and they were going to come check on her to make sure she was okay. I then went and told the store manager what had occurred. EMS came and checked on her and took her vitals and asked if she needed to be transported to the hospital at which time she declined and said she was okay. We told her that if she felt bad later to call 911, or call her doctor. The husband then took her home.
25 2021-04-07 palpitations few minutes after injection, patient felt heart racing, throat tight, felt dizzy and warm, headache ... Read more
few minutes after injection, patient felt heart racing, throat tight, felt dizzy and warm, headache on and off, hr on watch said 115, brought to obs, 1453 bp 191/108 hr 86 rr 18 sats 99% ra. 1457 bp 169/106 hr 100 rr 20 sats 99% on ra, states feeling better after resting. vs repeated and around same every few minutes, discussed ems transporting patient to ed for further eval, patient agreeable. upon ems transport at 1525, bp 152/96 hr 85 rr 20 sats 99% on ra. report provided to ems and patient taken to hospital.
25 2021-04-07 pulmonary embolism, chest pain Pulmonary Embolism: presented with chest pain and shortness of breath found to have pulmonary emboli... Read more
Pulmonary Embolism: presented with chest pain and shortness of breath found to have pulmonary embolism on CT angiogram. Symptoms resolved after 3 weeks of anticoagulation. No evidence of DVT.
25 2021-04-08 chest pain C/o sharp pain in left side of head that migrated down her arm & across her chest. She was shaking a... Read more
C/o sharp pain in left side of head that migrated down her arm & across her chest. She was shaking all over & felt "warm all of a sudden" she was Extremely anxious. Code Green called when H2O & trying to calm her down didn't work. paramedics arrived to assess.
25 2021-04-08 lightheadedness Vasovagal event, dizziness and light headness
25 2021-04-09 loss of consciousness Systemic: Dizziness / Lightheadness-Severe, Systemic: Patient lost consciousness, unable to respond.... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Patient lost consciousness, unable to respond. -Severe, Additional Details: Within 5 minutes of dose, patient lost consciousness, unable to respond. Lowered to the ground. Pulse and breathing checked as positive. BP checked 113/70, HR 78. 911 emergency services called. However, within 1 minute, patient regained consciousness and was able to converse. She reported exercising prior to dose and being slightly dehydrated. She reported passing out after a prior Hep B vaccine which was not reported on her initial screening. She was able to sit up within 5 minutes, drank water
25 2021-04-09 palpitations, chest pain heart palpitations; chest pain; shortness of breath; Shaky/light Headed; Chest pain moved from left ... Read more
heart palpitations; chest pain; shortness of breath; Shaky/light Headed; Chest pain moved from left side, to arm; This is a spontaneous report received from a contactable consumer via e-mail forwarded by Medical Information Team. A 25-years-old non-pregnant female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6203 and Expiration Date was not reported) via an unspecified route of administration in left arm on 24Feb2021 09:00 as single dose for COVID-19 immunization. Medical history included Asthma, allergies, CREST and known allergies. Morphine reaction at age 2. Concomitant medication(s) included fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]); montelukast sodium (SINGULAIR); nortripolyn; multivi and neddy pot all taken for an unspecified indication. Patient did not have covid prior vaccination. It was reported that 40 minutes after receiving it, patient started to get heart palpitations, chest pain, and shortness of breath. Shaky/light headed when standing. Chest pain moved from left side, to arm, to middle of chest. As result patient goes to Emergency room/department or urgent care. Patient received the treatment of Ativan to help with the heart rate. The outcome of the events was recovering.
25 2021-04-09 fainting Systemic: Dizziness / Lightheadness-Medium, Systemic: fainting but responsive-Medium, Systemic: Weak... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: fainting but responsive-Medium, Systemic: Weakness-Medium
25 2021-04-09 fast heart rate Paresthesia (12:30 PM) Allergic reaction (numbness and swelling in lips) Malaise Tachycardia (hear... Read more
Paresthesia (12:30 PM) Allergic reaction (numbness and swelling in lips) Malaise Tachycardia (heart rate 160 when checked into ER) The doctors gave me two bags of fluids, prednisone, benedryl, Pepcid, Tylenol, and Motrin. They monitored me from 3:30-7:40
25 2021-04-10 blood glucose increased Blood sugar numbers through the roof. After 48 hours, low 300s despite aggressive treatment.
25 2021-04-11 loss of consciousness, fainting Patient fainted while sitting in the waiting area about 5 minutes after receiving her first dose of ... Read more
Patient fainted while sitting in the waiting area about 5 minutes after receiving her first dose of the Pfizer COVID Vaccine. Patient was unconscious briefly, but woke up after less than a minute a little disoriented. She was sweating and felt very hot, except for her hands that were cold. We gave her water and an ice pack to cool her down and waited with her until paramedics came to treat her. She seemed alert and that the issue had mostly resolved as she left with paramedics approximately 15 minutes later, but it is unknown what happened after she left with them.
25 2021-04-11 loss of consciousness Pt c/o pain at injection site during vaccination administration. Pt became nauseous, blurred vision,... Read more
Pt c/o pain at injection site during vaccination administration. Pt became nauseous, blurred vision, LOC x2 episodes, and diaphoresis. Pt repeatedly stated, "I can't see." Pt hyperventilating at time of arrival to med obs. Assisted in slowing breathing with positive effect. Pt assisted to stretcher from w/c and place in position. Pt reports vision back to almost baseline after repositioning. Pt given apple juice and crackers. Prior to d/c to home, pt reported left eye remained slightly burred and requested her father pick her up at staff suggestion for safety. VS at 1702: BP 57/44, recheck 68/44 (placed in trendelenburg position), HR 65, RR 24, O2 sat 100% on RA. VS at 1710: BP 106/82, HR 66, RR 18, O2 sat 100% on RA. VS at 1715: BP 104/73, HR 61, RR 18, O2 sat 99% on RA. VS at 1728: BP 109/80, HR 62, RR 17, O2 sat 99% on RA. VS at 1733: BP 106/80,, HR 68, RR 18, O2 sat 98% on RA. No s/s of distress at time of discharge. Pt escorted to exit via w/c with staff per protocol.
25 2021-04-12 chest pain headaches, body aches, chest pain, trouble breathing, signs/symptons of pneumonia
25 2021-04-12 hypotension, fainting Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-M... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Additional Details: patient fainted immediately after vaccinated. patient speaking within 15 seconds of fainting spell. Epi administered to right thigh. patient put supine on floor with knees up and c/o nausea. patient reported she had previously fainted after ob/gyn visit. Patient reports hx of low BP.
25 2021-04-12 fainting Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild, Additional Details: Pateint fainted ... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild, Additional Details: Pateint fainted after getting her first dose of the vaccine. Patient fainted while sitting in the chair, the immunizer led her down to the floor. Patient was alert in 20 seconds of fainting, she was not aware of what had happend. Patient was asked if she was having difficulty breathing. Patient was having hard time resposing, epinephrin was adminstered and 911 was called at 11:29am.
25 2021-04-13 blood pressure increased, chest discomfort 10 minutes after the injection I felt my blood pressure rise up. When I got home it was 134/94, mac... Read more
10 minutes after the injection I felt my blood pressure rise up. When I got home it was 134/94, machine told me I had mild hypertension. When I measured a few hours later it was at 137/90. It remained like that until the evening when it lowered back down to 120/87. Later that evening, I had a fever and took Tylenol to help. My headache got worse in the evening as well. Arm was sore. This morning (day after my 1st dose) my BP was at 108/79, fever creeped up as the day went on, body aches, arm was hurting more, headache continued, pressure on chest made it a bit hard to breathe, dizziness, some nausea, brain fog.
25 2021-04-13 blood pressure increased pt felt light headed and warm with increased blood pressure. after additional 15 minutes and ice pac... Read more
pt felt light headed and warm with increased blood pressure. after additional 15 minutes and ice pack she felt better
25 2021-04-14 heart rate decreased Dizziness, lowered resting heart rate, body feels like lead
25 2021-04-14 loss of consciousness, hypotension, fainting Syncope 10 minutes after administration while in waiting area. In and out of consciousness for 10 mi... Read more
Syncope 10 minutes after administration while in waiting area. In and out of consciousness for 10 minutes. Severe hypotension per EMS. Once laid supine patient recovered fully and was not transported to hospital. No interventions or studies done.
25 2021-04-14 loss of consciousness, pallor Patient experienced a seizure within 2 minutes of receiving vaccine. seizure lasted approximately 30... Read more
Patient experienced a seizure within 2 minutes of receiving vaccine. seizure lasted approximately 30 seconds. patient recovered and then experienced another brief seizure approximately 5 minutes later. This lasted about another 30 seconds. Seizures displayed muscle rigidity, slight shaking, and dilated pupils. patient became pale and unconscious during these seizures.
25 2021-04-14 loss of consciousness Systemic: Seizure-Severe, Additional Details: pt had seizure approximately 5 minutes after receiving... Read more
Systemic: Seizure-Severe, Additional Details: pt had seizure approximately 5 minutes after receiving vaccination,was sitting in waiting are,stood up,passed out,hit head,then seized.was short.called 911.pt apparently has history of seizures with vaccination.was cleared by ems. worker called pt at 6 pm and pt was fine..
25 2021-04-14 fainting Syncope
25 2021-04-14 fainting At 2:43pm patient received the vaccine in her arm. At 2:50pm my pharmacy technician witnessed the pa... Read more
At 2:43pm patient received the vaccine in her arm. At 2:50pm my pharmacy technician witnessed the patient standing up from her chair and walk up to the pharmacy counter then faint into the pharmacy immunization booth. My technician states the patient did not hit her head on a wall. At 2:51pm my pharmacy technician brought the incident to my attention and we both ran to the patient to address the situation. The patient was unresponsive, so I ran and dial 911 then instructed my tech to take the phone. I then ran back to the patient and patted her back, said her name and asked her if she could hear me. It was at that moment the patient's eyes flickered and the patient had what looked to me like a 10 second seizure in the chair inside the pharmacy booth. Once the patient was done what I could only identify as seizing, she came to and I asked her if she new her name and where she was. The patient answered correctly and then asked me "Have you had anyone with a reaction like this before?". I answered that I have not personally witnessed a reaction like this before. My technician had 911 still on the phone and they instructed her to stand out front of the store to await the ambulance. A first responding officer came in and asked about the witnesses to the incident then took over for caring for the patient.
25 2021-04-14 superficial blood clot Evening of April 1, 2021, 10:00pm- Noticed "hard lump" on top of left foot. Severe pain and tendern... Read more
Evening of April 1, 2021, 10:00pm- Noticed "hard lump" on top of left foot. Severe pain and tenderness on top of left foot. Friday April 2, 2021, 2:00pm - Medical visit: Family Practice, Diagnoses: Left Foot Pain, Subcutaneous Nodule Of Foot. Ultrasound ordered. Tuesday April 6, 2021, 10:30am - Ultrasound of lower left foot, Diagnoses: Thrombophlebitis Of Superficial Lower Left Extremity Tuesday April 6, 2021, 4pm - Emergency Department. Ultrasound of full left leg. Additional pain, tenderness, and swelling.
25 2021-04-15 loss of consciousness Patient reported not feeling well 15 to 20 seconds after administration. Went limp and was caught by... Read more
Patient reported not feeling well 15 to 20 seconds after administration. Went limp and was caught by pharmacist. Awoke about 20 seconds afterwards feeling light-headed. Patient continued to sit and was monitored for 30 minutes afterwards. She fully recovered and left the store.
25 2021-04-15 loss of consciousness About an hour after her vaccine, patient called and said that she was nauseous, vomiting, had passed... Read more
About an hour after her vaccine, patient called and said that she was nauseous, vomiting, had passed out twice, a rash from the injection site up to her throat, and her arm was swollen from the elbow up. I told her to take Benadryl and to go to the ER or to the immediate care. I followed up with her the next day and she went to the ER, she said the Benadryl helped her out significantly and that she was feeling much better that day. She was still inquiring about the second shot but, she was following up with her MD on Wednesday.
25 2021-04-15 fainting I had the Pfizer-BioNTech vaccine on 4/6 and felt dizzy 30 minutes later. The dizziness continued fo... Read more
I had the Pfizer-BioNTech vaccine on 4/6 and felt dizzy 30 minutes later. The dizziness continued for the next 84 hours. On 4/9 (three days after vaccination), I fainted on my driveway as I was heading home around noon time. I felt dizzy the whole afternoon but were trying to help out the groceries from the car. I fell down on the concrete driveway with two bags of groceries on my hand. I did not blackout, but were not able to get up for 10 seconds due to the dizziness. I eventually recovered from the dizziness 84 hours after the first dose of vaccine. I injured my knee as I fell, but the wound were treated at home immediately. As for the sore arm, I could not hold any items heavier than 1 lb. The arm soreness went away after 48 hours with ice pack applied on upper arm(injection area).
25 2021-04-16 chest pain, palpitations I started getting heart palpitations that night that haven't stopped. I couldn't sleep and all day t... Read more
I started getting heart palpitations that night that haven't stopped. I couldn't sleep and all day the next day I have having chest pain, heart palpitations, and physical feeling of panic although mentally I was fine. it felt like I kept having adrenaline rushes
25 2021-04-16 heart rate increased Sore arm, fever, elevated heart rate, chills, and aches
25 2021-04-17 chest discomfort Body aches, fatigue, chest tightness
25 2021-04-17 pallor About 5 minutes after pt received the Pfizer Covid IMZ she felt faint. She turned very pale. We had ... Read more
About 5 minutes after pt received the Pfizer Covid IMZ she felt faint. She turned very pale. We had her lie down on the floor and raised up her legs on a chair. I applied cold towels to her neck and her forehead. She laid down for 30 minutes and sat up for a few minutes and then rose up and went back to work. Pt stated that she has a fear of needles and she faints every time she has her blood drawn.
25 2021-04-18 anaemia, blood clot Period began a week earlier than usual and thus far as been very heavy with additional clotting. So ... Read more
Period began a week earlier than usual and thus far as been very heavy with additional clotting. So far I am on day 3 of this period and had to change my cup 4 times throughout the night where I usually only need to change it once or twice. As I am very anemic this is concerning.
25 2021-04-19 hypertension, heart rate increased 1:40P COMPLAINED OF RAPID HT RATE, SWEATING AND ANXIETYSHE WAS DIAPHORETIC, HYPERVENT, AND SLIGHTLY ... Read more
1:40P COMPLAINED OF RAPID HT RATE, SWEATING AND ANXIETYSHE WAS DIAPHORETIC, HYPERVENT, AND SLIGHTLY HYPER- TENSIVE. 133/83 HR 97 O2 98%. PLACED ON STRETCHER, GIVEN H2O STATED THIS HAPPENED TO A LESSER DEGREE WITH FIRST VACCINE. IT HAS BEEN 21/2 MTHS SINCE FIRST DOSE ASHE WAS ANXIOUS ABOUT RECEIVING SECOND DOSE. 2P 122/87 HR 88 O2 100%. COLD CLOTH TO HEAD , SEMI FOWLERS POSITITO FACILITATE BREATHING. 2:05 FEELING BETTER. DANGLED WITHOUT DIFF. AMBULATED TO BR WITH SUPERVISION. FELT BETTER AFTER AMBULATING. 2:15 121/74 HR 87 02 100% SKIN WARM AND DRY. DENIES UNTOWARD EFFECTS. DISCHARGED
25 2021-04-19 loss of consciousness Patient LOC decreased resulting in her hitting another vehicle with her vehicle. Pt Conscious and re... Read more
Patient LOC decreased resulting in her hitting another vehicle with her vehicle. Pt Conscious and responsive 119/81, 68, 98% O2. VS Remained WNL at 09:54 and 10:05.
25 2021-04-20 loss of consciousness Seizure like activity, shaking and brief loss of consciousness. Called 911, transferred to local hos... Read more
Seizure like activity, shaking and brief loss of consciousness. Called 911, transferred to local hospital.
25 2021-04-21 chest pain, chest discomfort I received my first shot on April 6th, 2021, and on April 18th, 2021 I experienced extreme numbness ... Read more
I received my first shot on April 6th, 2021, and on April 18th, 2021 I experienced extreme numbness with slight pain in the fold and shoulder of my arm. I went to the ER and they took a cat scan of my neck and reported back that everything looked normal - the nurse said it was most likely Cervical Radiculopathy. Then the following morning around 11 AM, I experienced very intense burning in my chest starting on the right side, eventually moving to the left encompassing my entire upper chest. I also experienced a very bad migraine, which I am typically used to but this one was more of a pressure headache between my temples that I felt in my ears and jaw. I made the decision to go back to the ER and to a different one this time. The ER failed to administer a Covid-19 test and to take bloodwork - both faults that family and friends in the medical field have pointed out to me. The doctor there had me receive an IV, a chest X-Ray, and an EKG. The X-Ray and EKG were both normal. The doctor had ordered a Covid-19 test but the nurse forgot to administer it before my discharge. In my IV I received Benadryl and Reglan along with typical IV fluids. I was also given Pepcid and Mylanta. At the end of my visit, the doctor concluded that he thought it was my acid reflux acting up - gastroenteritis. I went home and continued to experience chest burning, tightness, occasional numbness/pains in my body, and very, very bad headaches. On top of that, I could barely swallow - it felt as if my throat was closing. I took Pepcid and Tums and neither really did anything. After seeing a Cardiologist this same week, they ordered an Echocardiogram and routine bloodwork (metabolic panel). I will also be following up with a GI, and I received a Covid-19 test today and am awaiting the results. It is possible I contracted Covid before my shot, but it is also possible that I am having a delayed reaction to my first vaccination as well. Who knows.
25 2021-04-22 chest discomfort High fever (101°F), chills, fatigue, and burning eyes 12h post-injection. 1000mg acetaminophen woul... Read more
High fever (101°F), chills, fatigue, and burning eyes 12h post-injection. 1000mg acetaminophen would reduce fever to ~99°F within 1.5h of dosing, only to return to the high 100/low 101°F range once it starts to wear off. Fever broke in the early am hours of 4/22/21, with the chills going away as fever was gone. The burning eye sensation and tiredness were no longer present upon waking am of 4/23/21. Itchy skin and hives on feet around noon on 4/21/21. Hives on feet disappeared on their own by early pm of 4/22/21. Itchy and sensitive skin persists as of time of this report in early pm 4/23/21. Shallow breathing (normal and deep breaths were painful), wheezing, and feeling like I'm breathing through a sponge and that there is concrete (serving as weight) in my chest every time I inhaled began early am 4/21/20. I began producing mucus from deep coughs as of late pm 4/22/21 and that also continues to the time of this report, accompanied by wheezing and slightly deeper (but still shallower than normal) breathing.
25 2021-04-22 loss of consciousness While the patient was waiting, seated for 5 of the 15 minutes, post-vaccination she began to feel li... Read more
While the patient was waiting, seated for 5 of the 15 minutes, post-vaccination she began to feel light headed. The patient shortly after expressing this concern slumped over in the chair, shaking and twitching, for a few moments (likely 60 seconds or less) before regaining normal stature and attention. The patient expressed some changes in her field of vision, a continuation of feeling light-headed, and a ringing in her ears. EMS was called to evaluate the patient, concerned that the patient had experienced seizure activity. EMS arrived shortly after, evaluating the patient's current state and vitals. After assessment, EMS determined this was a syncopal episode related to the patient's anxiety around the vaccination and cleared the patient to drive themselves home after resting on-site. Patient rested and recovered in pharmacy vaccination room for an additional 20 minutes before leaving.
25 2021-04-24 fainting I move around and I feel like something about to faint; breast feeding; intermittent dizziness; hea... Read more
I move around and I feel like something about to faint; breast feeding; intermittent dizziness; headaches; I have to laid down, and I feel like teh room is spinning little bit; This is a spontaneous report received from a contactable consumer (patient). A 25-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8729 and expiry date: Jul2021) via an unspecified route of administration in left arm on 06Apr2021 (at the age of 25-year-old) as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included folic acid, iron (PRENATAL). Reporter states she talked to a safety agent and reported her side effects and safety agent referred her to MI for inquiry. The patient experienced intermittent dizziness (dizziness), lightheadedness (dizziness), breast feeding (inappropriate schedule of product administration). Reports has become worse. concerned as she is at home with a toddler. also reports headaches (headache) also states she is breast feeding. On 06Apr2021 it was reported as consumer stated the concern, "she got her vaccine today that's at 8:45, it said if she got any other symptoms other than what was on that sheet she should report it and she had a another symptom and she was concerned if that's or not related to vaccine or not. But she very dizzy, very light headed she move around and she feel like something about to faint and she has to laid down, and she feel like the room is spinning little bit." The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected. Follow-up (06Apr2021): New information was received from a spontaneous report via a contactable consumer includes: Suspect product information, concomitant medication, Events "Faint and Vertigo" and clinical information was added.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021383728 same reporter/ drug, different AE/ patient.
25 2021-04-25 blood pressure decreased Patient sweating profusely, diaphoretic, dizziness, states had nothing to eat after midnight, BP 65/... Read more
Patient sweating profusely, diaphoretic, dizziness, states had nothing to eat after midnight, BP 65/58 P98 R22 O2 sat@99% on room air, no respiratory distress noted, was monitored by staff for 20 minutes, Given food - Blood sugar 111 mg/dl. BP readings 90/60 P88 R20, patient states feeling better, Patient stated feeling well to go home
25 2021-04-25 chest discomfort Pt c/o chest tightness on and off, alert and verbally responsive, no c/o pain no change LOC. no SOB.... Read more
Pt c/o chest tightness on and off, alert and verbally responsive, no c/o pain no change LOC. no SOB. Pt. assisted to lie down on bed then symptoms of chest tightness relieved after resting. !:19pm V/s BP 132/89 102bpm, 19cpm, 99%RA 1:45pm V/S BP 122/71 90bpm, 19cpm, 99%RA #21 stable, and went home
25 2021-04-25 chest discomfort Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: A... Read more
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Rash Generalized-Mild, Systemic: Chills-Severe, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Severe, Systemic: Weakness-Mild, Additional Details: Patient recieved vaccination. 15 minutes later patient stated she wanted to stay a little longer with a feeling of uneasiness and muscle trembling/shaking and feeling cold. 27 minutes later patient stated she felt a sudden tightness in her chest and a shortness of breathing. Patient requested to get an epi-pen injection due to the difficulty in breathing. Patient had epi-pen injected into left thigh at 4:46 pm .
25 2021-04-25 hypotension, pallor, lightheadedness, fainting Patient had syncope, dizziness, vaso-vagal response, lightheadedness, pale, mild hypotension. Given ... Read more
Patient had syncope, dizziness, vaso-vagal response, lightheadedness, pale, mild hypotension. Given juice, laid down, vitals stabilized, ambulated appropriately. Released from vaccination site.
25 2021-04-25 loss of consciousness She was sitting in a chair in our post vaccination area required after vaccination is administered a... Read more
She was sitting in a chair in our post vaccination area required after vaccination is administered and passed out and fell to the floor. We immediately called 911 and I checked for breathing and pulse and she had both. She was non responsive for a minute or two but eventually became aware of what happened. I waited with her until paramedics arrived. Paramedics/EMT's arrived at the scene within 10 minutes and rendered aid. She was taken to the Medical center.
25 2021-04-26 loss of consciousness, fainting Patient received Pfizer Covid Vaccine Dose 2 (LOT EW0175 EXP 08/2021). Patient was in post-vaccinat... Read more
Patient received Pfizer Covid Vaccine Dose 2 (LOT EW0175 EXP 08/2021). Patient was in post-vaccination observation area sitting in char when she began to feel dizzy and lightheaded. She fell from chair to floor. Both HMs assigned to observation area stated they heard impact to the floor and other patient sitting in area witnessed patient hitting head on the floor. Nurse was notified at 0743 by HM and nurse responded. When nurse arrived, patient had eyes closed but immediately opened eyes with contact. Nurse was notified of fall and that she lost consciousness for about 30 seconds upon syncope episode. Code was called at 0745. Vitals taken (BP 94/65, HR 80, RR 16, 92 BG). Patient continued talk and stated she had nothing to eat this morning and has a known history of syncope/vasovagal with vaccinations and blood work. Code team arrived at 0747 and Code secured at 0751. Patient was escorted by code Team to Emergency Department for further evaluation.
25 2021-04-26 palpitations Approximately 72 hours after 2nd dose of Covid-19 vaccine, began experiencing rapid palpitations of ... Read more
Approximately 72 hours after 2nd dose of Covid-19 vaccine, began experiencing rapid palpitations of heart that have continued on for a week after vaccination date.
25 2021-04-27 chest discomfort Sore arm - 1.5 days, went away Migraine - 3 days, Tylanol Body Ache - 3 days, Tylanol Nausea & Vomit... Read more
Sore arm - 1.5 days, went away Migraine - 3 days, Tylanol Body Ache - 3 days, Tylanol Nausea & Vomiting - 4 days ; Diarrhea - 2 days - Was treated in the ER for IV fluids for 2 different days. Day 1 I had Nausea, vomiting and diarrhea. Day 2, nausea and vomiting. I couldn't keep water down so I was treated with 2 bags of fluids and some anti-nausea medication, abdominal pain was present. Anti-nausea medication prescribed. Day 3 - Nausea and Dry heaving. Day 4- Intense abdominal pain and vomiting, went back to ER for an IV bag of fluids and given 2 IV anti-nausea medications and 1 nasty drink that numbs/sooths the stomach. Given a higher anti-nausea prescription and one to coat the stomach. Chest tightness: 1 day, went away Fatigue - 5 days, bed rest.
25 2021-04-27 heart rate decreased, chest discomfort, chest pain The morning after receiving the second COVID19 vaccine, I had the usual side effects of fever (spiki... Read more
The morning after receiving the second COVID19 vaccine, I had the usual side effects of fever (spiking at 103), chills, muscle soreness, etc. However, when those symptoms subsided by the afternoon, I then developed intense chest pains and pressure that lasted multiple hours. At the direction of my primary care doctor, I went to an urgent care where my blood pressure was around 140/80 (I do not have a personal history of high blood pressure, and it was just checked at a normal rate at few weeks prior to receiving the vaccine) and my resting heartrate sat in the high 140s. The urgent care I went to at the time did not have a working EKG; however, they monitored my vitals and provided Motrin for the pain. After about an hour at urgent care, my resting heartrate lowered to 130s and the pain subsided. By the next morning, it still hovered around 110 and my blood pressure remained slightly elevated; however, the chest pains and pressure had completely subsided. The timeline for pain lasted roughly 5 hours, the timeline for heightened resting heart rate and blood pressure lingered for about 12 hours.
25 2021-04-28 haemoglobin decreased, chest pain Pt vaccinated with second Covid vaccine Wed, awoke Fri night with chest pain lasting an hour, recurr... Read more
Pt vaccinated with second Covid vaccine Wed, awoke Fri night with chest pain lasting an hour, recurrent CP Sat morning prompting urgicenter visit who referred to Hospital
25 2021-04-28 fainting Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushe... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: patient was given vaccine, during observation period fainted in her chair. patient was brought to the floor and legs were elevated. patient awakened and felt dizzy and had mild flushing. patient was given water, sat down for about 15-20 minutes until full recovery. patient left with no further issues.
25 2021-04-28 fainting Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-M... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium
25 2021-04-29 palpitations Patient called this morning to report that she started to experience dull, numb, and tingling sensat... Read more
Patient called this morning to report that she started to experience dull, numb, and tingling sensation last night at bedtime. She ignored it but sensation did not go away. Sensation has extended from top to bottom on the right side of her body. In addition, she started having heart palpitation this morning. She called MD but they referred her back to the pharmacy. She is currently taking amitriptyline and stated that in the past on September 2019, she experienced the same heart palpitation when her body was under great stress. She does not think this is serious enough to go to urgent care at this time and will continue to monitor. Rph educated patient that paraesthesia is listed as one of the side effects on CDC website for this vaccine and recommended patient to continue to monitor the side effects. If symptoms worsen, she will need to go to the emergency room. Also, Rph recommended patient to potentially avoid second dose since her body has a strong reaction against this vaccine.
25 2021-05-01 loss of consciousness Pain in neck and back, fever, cold sweats, upset stomach, chills, passed out three times
25 2021-05-03 heart rate increased, fainting tongue tingling, feeling of passing out, feels like fast heart rate, pt cleared and left site.
25 2021-05-03 loss of consciousness Patient passed out after receiving first dose of covid vaccination. She fell to the floor and hit he... Read more
Patient passed out after receiving first dose of covid vaccination. She fell to the floor and hit her head. Patient stated that this has happened before when having blood drawn. After she laid on the floor for a period of time she felt better.
25 2021-05-03 pallor After she was vaccinated she said " I need to lay down " I need water" "I get anxious " she stared ... Read more
After she was vaccinated she said " I need to lay down " I need water" "I get anxious " she stared look pale. she ask to let her lay down on the floor we assisted her to the floor and called rapid response. I put some alcohol behind her ears and brought a wheel chair. she was able to get on the chair we took vitals @2:52 BP 113/76, P 73, O2 95 she said "This happens all the time when I get shots" . Response team arrived and saw that vitals were good and offered her to go to the ER to get checked out and she refused. I took her vitals again @3:05 125/65, P 70, O2 97. Took her to the hallway she wait 30min and she looks and said she was ok and insisted " this happen all the time i get a vaccine." I then walked her to the parking lot.
25 2021-05-04 low blood platelet count, platelet count decreased Pt is 25 yo female who received the first dose of the Pfizer COVID-19 vaccine in March 2021 develope... Read more
Pt is 25 yo female who received the first dose of the Pfizer COVID-19 vaccine in March 2021 developed diffuse petechiae and oral bleeding approximately 3 weeks after the vaccine and went to her PCP's office and labwork revealed a platelet count of ~15k cells/mm3. She went to the emergency department at Medical Center and was diagnosed with ITP by a hematologist who recommended that she not receive the second covid vaccine given the risks outweigh the benefits with her new diagnosis/possible reaction to the vaccine. She was treated with IVIG and prescribed corticosteroids and discharged. Two weeks later she was visiting friends in another city and developed a severe headache. She presented to our facility and was found to have a subdural hematoma on imaging and a platelet count of 9k cells/mm3. She was aggressively treated for her ITP with high dose IVIG, romiplostim, and rituximab and has stabilized neurologically with the SDH stable - though her platelets have been treatment refractory despite transfusions and the aforementioned therapy. Remains admitted at our facility.
25 2021-05-04 pallor Patient was not feeling well after receiving Pfizer Covid-19 Vaccine. Patient was pale and complain... Read more
Patient was not feeling well after receiving Pfizer Covid-19 Vaccine. Patient was pale and complaining dizziness and nausea. after a few minutes, these symptoms are gone.
25 2021-05-04 palpitations, coughing up blood After the 1st dose, I had a headache, sore arm, sore joints and fatigue for exactly a week after the... Read more
After the 1st dose, I had a headache, sore arm, sore joints and fatigue for exactly a week after the shot was administered. It's been a week since dose 2, and my side effects have been worse. Migrane, body aches, arm soreness, fatigue, cough/hoarse/post nasal drip and having chills to feeling like I was burning. It started when I lost my voice about 3 hours after injection, and worsened over the following 3 days before starting to get better a few days ago Still have a headache and am sore, though, with hoarseness in my voice and a dry throat. Trying to sleep for longer and drink plenty of water. Went to the Dr. due to spitting blood on Thursday morning. Was informed it was just post nasal drip, but still had to have an EKG done due to a racing heart. Everything looked fine, but I've been in contact with them re: my symptoms in the following day. Glad to be doing my part for public health, but these have gone on awhile!
25 2021-05-05 loss of consciousness, pallor Patient was administered vaccine. As soon as it was over, she turned sheet white and passed out (on... Read more
Patient was administered vaccine. As soon as it was over, she turned sheet white and passed out (onto her husband's shoulder). Both arms and legs went straight and rigid while she was unconscious. 911 was called immediately. When she came to, she started vomiting. Blood pressure was taken, 80/50. Patient refused to go to the hospital. Paramedics brought her out of the store.
25 2021-05-05 blood clot Significant change in menses. Typically cycles once every three months with continuous birth control... Read more
Significant change in menses. Typically cycles once every three months with continuous birth control use. Menses in January (after first vaccination) was significantly heavier with passage of clots.
25 2021-05-06 blood pressure decreased, loss of consciousness Loss of conscious, we called emergency services and they came and evaluated the patient she had a dr... Read more
Loss of conscious, we called emergency services and they came and evaluated the patient she had a drop in blood pressure they gave her juice and waited 30 mins and evaluated her again and her blood pressure returned to normal level and she went home
25 2021-05-06 chest discomfort Extreme fatigue, dizziness, nausea, and chest tightness. Started about a week after the 2nd dose of ... Read more
Extreme fatigue, dizziness, nausea, and chest tightness. Started about a week after the 2nd dose of the vaccine and was the worst approximately 2.5 weeks out. Slight improvements after 3 weeks but symptoms persist. Not able to stand/move for more than 5-10 minutes at a time. Chest tightness worsens when sitting upright and is slightly improved when lying on side. Had multiple labs run and all were within normal range. Doctor's only recommendation is to wait for symptoms to resolve on their own.
25 2021-05-06 heart rate increased PATIENT HAD AN ANXIETY MOMENT FOLLOWING VACCINE. VITALS WERE TAKEN, EVERYTHING WAS WITHIN NORMAL RAN... Read more
PATIENT HAD AN ANXIETY MOMENT FOLLOWING VACCINE. VITALS WERE TAKEN, EVERYTHING WAS WITHIN NORMAL RANGE EXCEPT HEART RATE WHICH WAS 107. PATIENT WAS INSTRUCTED TO BREATHE. PATIENT REQUESTED TO GO TO THE HOSPITAL. WE ASKED IF SHE WOULD LIKE TO GO PRIVATE AUTO BUT DECLINED. PATIENT WAS ALSO ASKED IF A FAMILY MEMBER WANTED TO COME PICK HER UP, SHE SAID SHE WANTED TO GO VIA AMR. PATIENT WAS TRANSPORTED TO HOSPITAL FOR FUTHER EVAULUATION.
25 2021-05-06 fainting During observation period after vaccination (5 minutes post-injection), patient experienced nausea a... Read more
During observation period after vaccination (5 minutes post-injection), patient experienced nausea and tried to go to the bathroom. She fainted on the way but recovered and regain consciousness after 30 seconds. RPh on duty attended the patient and asked if patient's family member if they want us to call 911, patient's family member stated that she has prior experience of low blood sugar post-immunization but it's not reported on the VARS form. After patient received some water and orange juice from the store. After staying seated for 20 more minutes, patient recovered and left. RPh will do a follow up check in call with patient after 3 days.
25 2021-05-08 loss of consciousness Immediately after injection patient passed out and then began to seize. Seizure did not last longer ... Read more
Immediately after injection patient passed out and then began to seize. Seizure did not last longer than 30 seconds and then shortly after patient recovered. 911 was called, vitals were checked and patient refused to be transported to the ER. No past history of seizures.
25 2021-05-08 palpitations Within a day of receiving my second dose of Pfizer, I have discovered an extreme sudden sensitivity ... Read more
Within a day of receiving my second dose of Pfizer, I have discovered an extreme sudden sensitivity to caffeine. Prior to my second shot, I have never had any issues with caffeine tolerance, no matter the amount of caffeine ingested, but after my second dose, I come down with shakes, heart palpitations, and mild nausea within only a few sips of a caffeinated product/black coffee.
25 2021-05-09 chest discomfort Nauseous, chest tightness, blurred vision. Pt. verbalized that she passed out. BP #176/36, P 60, O... Read more
Nauseous, chest tightness, blurred vision. Pt. verbalized that she passed out. BP #176/36, P 60, Ox 98%, RR 36, BP #2 81/40. Water given as per pt. request. Pt. instructed to take small sips. Pt. verbalized that she is feeling better. f/u BP 90/60, at 2:05pm, BP 81/47@2:07pm. f/u BP 100/50 @2:12pm. Pt. verbalized that she still feels nauseous, having chest tightness and blurry vision. Pt. transported to stretcher by EMS. Pt. legs elevated BG assessed @91. BP 92/48. Pt. states she is feeling better, not feeling nauseous anymore, does have a little chest tightness. f/u BP 98/57@2:31pm. Pt. reports that she has a history of anxiety. At 2:50pm pt. left with father. Pt. instructed to f/u with primary doctor and call 911 is symptoms persist.
25 2021-05-09 fainting Pt. fainted right after getting vaccinated. B/P 110/70, HR 74, R 19. Pt stated, "I faint most of t... Read more
Pt. fainted right after getting vaccinated. B/P 110/70, HR 74, R 19. Pt stated, "I faint most of the time when I see needles." At 3:10 pm pt. stated, "I feel better now." Pt. is alert and oriented x4. 3:26 pm pt stated , "I'm ok now I want to go home." Pt. went home at 3:25 pm.
25 2021-05-10 chest pain The patient states oln 4/26/2021 about 1 week after her vaccination, she had a swollen throat and he... Read more
The patient states oln 4/26/2021 about 1 week after her vaccination, she had a swollen throat and her neck felt bigger but it did not affect her breathing. On 5/3/21 she noticed chest pain that lasted till 5/7/2021. She did not call pharmacy or report her symptoms until she came to receive her second Pfizer Covid-19 vaccination on 5/11/2021. She stated that she did not contact her doctor and that she still wanted to take the 2nd covid vaccination. The patient received her injection and left without and reaction.
25 2021-05-11 deep vein blood clot DVT
25 2021-05-12 palpitations, increased heart rate, fibrin d dimer increased Patient reported symptomatic heart palpitations after receiving the 2nd dose of the Pfizer SARS-CoV... Read more
Patient reported symptomatic heart palpitations after receiving the 2nd dose of the Pfizer SARS-CoV2 mRNA vaccine on 5/11/2021 at 1pm which lasted a few hours. She then presented to her urgent care clinic around 3pm and was transferred to the Hospital ED. She was found to be in sinus tachycardia to HR 140s-150s. Work-up as described below was largely unrevealing. Plan for TTE on this hospital admission. Overall believe that severe anxiety is a the driving factor behind her sinus tachycardia, and that the SARS-CoV2 vaccination was just coincidental in time course.
25 2021-05-14 palpitations The night of - into the day after my first shot I noticed severe body temperature irregularities in ... Read more
The night of - into the day after my first shot I noticed severe body temperature irregularities in my body. It felt like my feet were freezing and my arms/legs were cold and my core was regular temperature. Every time I got up I had extreme hot flashes and heart palpitations. Overall I didn?t experience anything else past a slight headache but the temperature changes were extremely uncomfortable and I went to the ER to be evaluated because I was worried there was something wrong. This feeling lasted for a few weeks.
25 2021-05-15 chest discomfort, chest pain Headache and fatigue about 3 hours after the shot. (05/03/2021) Fever, body aches, tightness in ches... Read more
Headache and fatigue about 3 hours after the shot. (05/03/2021) Fever, body aches, tightness in chest, and wheezing 13 hours after the shot. Treated with Advil. (05/03/2021) Fever, body aches, and extreme shortness of breath the next day. Treated with Advil. (05/04/2021) The day after that, shortness of breath while walking or talking. Trouble breathing and strong upper chest pain when walking 500 feet. (05/05/2021) The shortness of breath continued for about 3 more days after that. (05/06/2021 - 05/08/2021)
25 2021-05-16 fainting, skin turning blue, palpitations About 10 hours after I received the vaccine I felt my heart racing, then I felt dizzy, and I fainted... Read more
About 10 hours after I received the vaccine I felt my heart racing, then I felt dizzy, and I fainted. My friend who was with me stated I stopped breathing. I was gasping for air and I turned blue. * I am healthy and never had any health issues*
25 2021-05-18 blood vessels inflammation Henoch-Schonlien purpura/nasty rash, severe joint paint and itchy/burning skin; vasculitis; This is ... Read more
Henoch-Schonlien purpura/nasty rash, severe joint paint and itchy/burning skin; vasculitis; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: Lot Number: EW0164), via an unspecified route of administration, administered in the left arm on 22Apr2021 at 17:00 as a single dose for COVID-19 immunization. The patient did not have any relevant medical history. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol, levonorgestrel (VIENVA); ibuprofen, phenylephrine hydrochloride (manufacturer unknown); montelukast (manufacturer unknown) and loratadine (manufacturer unknown), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient been tested for COVID-19. The patient previously received the first dose of BNT162B2 on 01Apr2021 at 16:00 (lot number: er8733) on the left arm for COVID-19 immunization. On 24Apr2021 the patient experienced Henoch-Schonlien purpura (vasculitis). The patient had a nasty rash, severe joint pains and itchy/burning skin. The patient visited the emergency room/department or urgent care due to the events. The patient was prescribed steroids as treatment for the event. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
25 2021-05-19 chest pain, chest discomfort Anaphylaxis: extreme fatigue, chest tightness/ pain, shortness of breath, cough, skin redness/ rash ... Read more
Anaphylaxis: extreme fatigue, chest tightness/ pain, shortness of breath, cough, skin redness/ rash on both arms and face, itchiness, confusion/disorientation 45 minutes post injection
25 2021-05-19 fainting EXPERIENCED EXTREME DIZZINESS AND FAINTING SYMPTOMS WITHIN MINUTES OF ADMINISTRATION. PATIENT WAS VE... Read more
EXPERIENCED EXTREME DIZZINESS AND FAINTING SYMPTOMS WITHIN MINUTES OF ADMINISTRATION. PATIENT WAS VERBALLY RESPONSIVE.
25 2021-05-19 fainting Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: spoke with patient after recovery: patient states she started to feel light headed after vaccination. patient was seated when she fell over and fainted. patients was brought to lying position and legs raised. after awakening, patient felt, confused, had tinnitus, flushing, and very warm. was given water and fanned to cool down. patient states that she never has passed out before. after 15-20 minutes patient fully recovered and left with no further issues.
25 2021-05-20 chest discomfort Tight chest, burns when breathing, reacted with my tattoo and made it raise up and get vumpy
25 2021-05-20 heart rate increased Vaccine given approximately 4pm, Friday April 30th. Insomnia (cannot sleep at all during the night)... Read more
Vaccine given approximately 4pm, Friday April 30th. Insomnia (cannot sleep at all during the night). Approximately 5am, begin to feel aches and malaise. Approximately 6am, aware of faster heartbeat and anxiety. Begin to feel dizzy and sit up in bed. Nausea begins. 6:10am vomit. Feel better after vomiting though achey, weak, shakey. Further dizzy spells throughout the next 6-8 hours, every time I get out of bed, but no further vomiting. At 10:55am, blood pressure is 86/58 with pulse at 94. Headache throughout the day. Abnormal fatigue lasts approximately 72 hours. Left arm is, of course, very sore at site of injection for approximately 36 hours. Treatment: rest and hydration (Gatorade & water). Ice at injection site for sore arm. Outcome: full recovery within 72 hours.
25 2021-05-20 fainting, blood pressure decreased Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Additional Details: She passed out... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Additional Details: She passed out for a brief moment a few minutes after the vaccine. We called 911. Fire Dept checked her and all vital signs are normal. The paramedic think that she had a brief panic and her blood pressure went down. She was with her mom and mom said this kind of event happened before and she was not concerned.
25 2021-05-22 chest pain, palpitations have palpitation a few hours after the vaccine, this symptom alleviates after 3 days. However, start... Read more
have palpitation a few hours after the vaccine, this symptom alleviates after 3 days. However, started to have heart/left chest pain around 2 days after the vaccine,
25 2021-05-22 fast heart rate I had shortness of breath and now have chronic tackycardio that in now on meds for and have to see a... Read more
I had shortness of breath and now have chronic tackycardio that in now on meds for and have to see a cardiologist for.
25 2021-05-23 chest pain The evening of 4/18 my daughter began feeling short of breath, and had pains in her chest. She wait... Read more
The evening of 4/18 my daughter began feeling short of breath, and had pains in her chest. She waited a while but then had difficulty breathing and extreme chest pain so she went to the ED. Over the next several hours they performed a chest Xray, EKG, urine tests, and blood tests (metabolic panel, CBC, test for heart muscle injury, blood clotting problem test)
25 2021-05-24 arrhythmia, chest pain, inflammation of the heart muscle After receiving my second dose, I was seen by my primary doctor for suspected Celiac disease (which ... Read more
After receiving my second dose, I was seen by my primary doctor for suspected Celiac disease (which came back positive). I had a strange medical episodes during the bloodwork (April 15th) that they originally assumed was anxiety. Symptoms were shortness of breath, lightheadedness, and loss of feeling in extremities. I?m a first responder and did not feel this was anxiety, but didn?t argue and forgot about it until it happened again. I had my second episode on April 20th, and debated going to the ER for it. A third episode on April 23rd did put me in the ER. I proceeded to have more episodes on almost a daily basis after that and started monitoring blood pressure, pulse, blood sugar, and food intake at home (some of my bloodwork levels were off due to the celiac). I purchased a heart rate monitor, a blood glucose meter, and a smartwatch to monitor some of my symptoms. Both devices (monitor and watch) would later flag me as having a suspicious heart rhythm (heart monitor could be for fast/slow rhythm or for arrhythmia, smartwatch flagged me as Afib twice). I could not recreate these results when my husband wore the devices. Episodes could be as brief as 45 mins or last more than 12 hours. I have a high pain tolerance and illness tolerance, and had to leave work several times due to my symptoms (extremely abnormal for me). After several more appointments with my primary doc and another visit to the ER (where they did another EKG, an X-ray, and more bloodwork), things were still coming back inconclusive. After about April 28th, I started having significant chest pain with my episodes. The ER checked me for possible clotting related to the heart issues and my birth control pills. My arrhythmia could not be captured on their devices. My doctor has since diagnosed it as suspected myocarditis (pending more testing). We?ve ruled out all possible things related to my Celiac diagnosis, and can?t seem to find a cause for this. I had a few things I brought to her attention that may be the cause (pinched nerve at chiropractors, covid vaccine) and she says it may be the vaccine, and said I should report it to you.
25 2021-05-24 chest discomfort In the postvaccination observation clinic, the patient complained of new "tightness" in her upper ai... Read more
In the postvaccination observation clinic, the patient complained of new "tightness" in her upper airway. She says that this is similar to reactions to grasses that she has had in past. In past, her symptom has responded completely to diphenhydramine 50 mg PO. No respiratory distress either now or in past. On physical exam, she is not in distress, appears clinically well. A- allergic reaction P- Diphenhydramine 50 mg PO now, given at 12:20 pm. Continued observation x 30 min from the time of medication, with full resolution of symptoms. Discharged.
25 2021-05-24 hypertension, heart rate increased Nausea; Dizziness; Weakness; Fast heartbeat; High blood pressure; Injection site pain; Low grade fev... Read more
Nausea; Dizziness; Weakness; Fast heartbeat; High blood pressure; Injection site pain; Low grade fever; Fatigue; Headache; Muscle aches; Chills; This is a spontaneous report from a contactable consumer (patient). A 25-years-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 26Jan2021 09:00 (Batch/Lot Number: EL3249) (at the age of 25-years-old) as single dose for covid-19 immunisation. Medical history included endometriosis, known allergies to most antibiotics, Guaifenesin, Venlafaxine, peanuts and eggplant. The patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm left on 05Jan2021 09:00 (Batch/Lot Number: EK9231) as single dose for covid-19 immunisation. Concomitant medication(s) in two weeks included escitalopram oxalate (LEXAPRO), levocetirizine dihydrochloride (XYZAL) and levonorgestrel (MIRENA) taken unknown indication from unknown date. No other vaccine was taken in four weeks of time. Patient did not have COVID prior to vaccination and was not tested post vaccination for the same. On 26Jan2021 at 20:00 patient experienced dizziness, weakness, fast heartbeat, high blood pressure, injection site pain, low grade fever, fatigue, headache, muscle aches, chills and nausea. No treatment was taken as a result of events and outcome of all the events was reported as recovering. Follow-up attempts are completed. No further information is expected.
25 2021-05-25 chest discomfort, ischemic chest pain, heart rate irregular Heart pain, chest tightness, irregular heartbeat. Started on May 23, 2021 and is still present on Ma... Read more
Heart pain, chest tightness, irregular heartbeat. Started on May 23, 2021 and is still present on May 26, 2021 although not as intense.
25 2021-05-25 chest pain, inflammation of the pericardium, increased heart rate Pericarditis with chest pain, treated with cochicine on 2/21/2021 Patient was pregnant, induced lab... Read more
Pericarditis with chest pain, treated with cochicine on 2/21/2021 Patient was pregnant, induced labor on 4/19 for poor maternal weight gain and hyperemesis
25 2021-05-25 heart rate increased Aside from the usual chills, body aches, etc, I ended up calling my doctor over a separate concernin... Read more
Aside from the usual chills, body aches, etc, I ended up calling my doctor over a separate concerning issue - very high heart rate. I woke up at 8am the day after getting my 2nd Pfizer dose, walked to use the restroom, walked back to bed, and laid back down. Within a couple minutes I noticed my heart felt like it was racing and I was out of breath as if I had just come back from a jog, not a trip to the restroom. Heart rate continued fluctuating from 105-115bpm just laying in bed. Was also feeling fatigued, nauseous, dizzy when standing up, and with slight difficulty breathing. Called advice nurse after 30min of no change. They had me check heart rate manually (had been going off FitBit), and timing was consistent with what FitBit was reading . Nurse advised to keep resting and drink lots of water, scheduled follow-up with a Doctor later in the morning. It should be noted that I had been alternating between water and Pedialyte constantly all day, starting 5/17 through when this happened (and then the next few days as well), so I should not have been dehydrated. Follow-up call with Dr. (on-call Dr., not my usual one) was scheduled for 11:45am, and by then all concerning heart symptoms had passed. The Dr. basically reiterated what the nurse had told me, in keeping up with fluids. And that sometimes temperature change, even if you don't completely get a fever, can cause a high heart rate. As more information is coming out regarding younger people developing myocarditis after the mRNA vaccines however, I wanted to mention this in case it could possibly be related.
25 2021-05-26 heart failure, inflammation of the heart muscle myopericarditis, HFrEF. medication therapy ongoing
25 2021-05-26 chest pain Elevated heart rate and intermittent chest pain. Took doubled dose of regular steroid for approx 3 d... Read more
Elevated heart rate and intermittent chest pain. Took doubled dose of regular steroid for approx 3 days which improved chest pain. Chest pain resumed following return to regular steroid dose. Intermittent elevated heart rate and chest pain continues at time of submission of this form on 5/27.
25 2021-05-26 fainting, heart rate increased High heart rate, fainting, convulsing or seizure, vomiting
25 2021-05-26 fainting Patient fainted after the shot. Her chin hit the carpet and started bleeding. Friend was in the room... Read more
Patient fainted after the shot. Her chin hit the carpet and started bleeding. Friend was in the room when it happened. We claimed up her wound and she felt better. Patient then went to get stitchings.
25 2021-05-27 chest pain Numbness in arm, chest pain and bad taste in mouth. Evaluated by EMS-Cleared
25 2021-05-27 loss of consciousness, fainting, pulse abnormal Lose consciousness and faint as well as began to have a seizure; Lose consciousness and faint as wel... Read more
Lose consciousness and faint as well as began to have a seizure; Lose consciousness and faint as well as began to have a seizure; Lose consciousness and faint as well as began to have a seizure; Vitals were not great, faint pulse, dilated pupils; Vitals were not great, faint pulse, dilated pupils; Vitals were not great, faint pulse, dilated pupils; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 12May2021 09:45 (Batch/Lot Number: EW0182) (at the age of 25 years old) as 1st dose, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included COVID-19. Concomitant medication included lithium taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and had allergies. Facility where the most recent COVID-19 vaccine was administered was in Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12May2021 10:00, the patient experienced lose consciousness and faint as well as began to have a seizure, vitals were not great, faint pulse and dilated pupils. After vaccine administration, patient began to lose consciousness and faint as well as began to have a seizure. EMT's were called vitals were not great, faint pulse and dilated pupils. The adverse event result in Emergency room/department or urgent care. Treatment received for the adverse event included ambulance ride, EMT's (as reported). The patient was recovering with lasting effects. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered with sequelae on unspecified date.
25 2021-05-28 pallor 5 mins after Pt received Pfizer vaccine started to feel nauseated, felt like she was going faint, co... Read more
5 mins after Pt received Pfizer vaccine started to feel nauseated, felt like she was going faint, color pale white.
25 2021-05-28 fainting five days after my first COVID vaccination, i fainted and split my chin open. we believe i got a con... Read more
five days after my first COVID vaccination, i fainted and split my chin open. we believe i got a concussion upon impact and was given a tetanus booster at the same time they glued my chin together
25 2021-05-30 chest pain All of the below occurred after Pfizer shot #2 administered on 4/1/2021. Pfizer shot #1 was administ... Read more
All of the below occurred after Pfizer shot #2 administered on 4/1/2021. Pfizer shot #1 was administered on 3/12/2021 with minimal effects lasting less than 24 hours (arm soreness, flu-like symptoms, etc.). 1) Severe worsening of costochondritis (chronic chest pain) to the point of breathing difficulty and inability to lie down. Began 4/1/2021 and became unbearable the evening of 4/7/2021, requiring an ER trip the same night (see Item 19). This pain has since continued to come and go, worse than I ever had it before the vaccine. 2) Very severe worsening of tinnitus (ringing/pulsing in ears) - lasted 1.5 months, from 4/1/2021 to around 5/15/2021. 3) Severe hormone imbalance symptoms (waves of severe nausea occurring several times daily, extremely late and painful/heavy period, swelling in ankles & feet, etc.) for ~1.5 months, from late April 2021 to around 5/15/2021. I cannot identify any other changes or life factors besides the vaccine that would have caused these issues.
25 2021-06-01 fainting Systemic: Fainting / Unresponsive-Medium
25 2021-06-02 chest pain, palpitations Nausea, hot flashes, and chest pain with racing heart about a half hour after being given the Covid ... Read more
Nausea, hot flashes, and chest pain with racing heart about a half hour after being given the Covid vaccine. Pepcid and Zyrtec given.
25 2021-06-02 heart rate increased Patient received the 2nd COVID vaccine (Pfizer, Lot #: EW0187 and expiration date: 08/31/2021) aroun... Read more
Patient received the 2nd COVID vaccine (Pfizer, Lot #: EW0187 and expiration date: 08/31/2021) around 1439 on the left arm. Patient walked up to the observation desk around 1449, during her 30 minute observation period, with complaints of "dizziness, rapid heart rate, and feeling hot." Patient was conscious, alert, and oriented x4 and claimed symptoms began 2 minutes status post vaccine administration. Patient denied any reaction after receiving the 1st dose of Pfizer vaccine and denied experiencing any chest pain, headache, nausea, vomiting, or diarrhea. EMTs had patient sit in the anti- gravity chair for further evaluation. Nurse responded to EMTs with patient. At 1455, EMT obtained baseline vital signs, while patient was sitting: blood pressure: 124/70, heart rate: 72, respiratory rate: 15. Pupils were equal, accommodating, and reactive to light. Skins were warm, dry, and normal. Chief complaint of "dizziness, rapid heart rate, and feeling hot" was reassessed and patient stated that symptoms had subsided. Patient explained that the symptoms had a sudden onset, but lasted less than 1 minute. Patient has a history of migraines and an allergy to Penicillin. Patient stated that she had a similar reaction after receiving a dose of Benadryl, earlier this year. Patient told EMTs that she had eaten toast, tofu, and salad about an hour and a half prior to coming to the vaccination site, with limited fluid intake. EMTs gave the patient a water bottle to sip on. At 1502 a second set of vital signs were obtained by EMT, while the patient was sitting: blood pressure: 116/68, heart rate: 74, respiratory rate: 15. Pupils were equal, accommodating, and reactive to light. Patient was advised to stay an additional 30 minutes in observation for continued evaluation. Patient stated she "felt better" and all symptoms had improved. Final set of vital signs were taken at 1514 by EMT, while patient was standing: blood pressure: 114/64, heart rate: 72, respiratory rate: 12. Pupils were equal, accommodating, and reactive to light. Skins were warm, dry, and normal. Patient was negative for orthostatic pressures. At 1540, patient stated she "felt normal and that all symptoms were gone." Patient had finished the water bottle provided. Patient was then educated on expected/ adverse reactions, when to follow up with her primary care provider, and the use of V- Safe. Patient ambulated with a steady gait on her own accord out of the facility.
25 2021-06-03 hypertension 156/96 BP & 140/92BP During routine OBGYN visit. Diagnosed with Chronic Hypertension. 4 pregnancies'... Read more
156/96 BP & 140/92BP During routine OBGYN visit. Diagnosed with Chronic Hypertension. 4 pregnancies' and no live birth. 9/23/2021 for current est. DOD.
25 2021-06-05 fainting Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / ... Read more
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: When patient was given vaccine she appeared calm, She told me she did not like needles. Said she had Tetnus vaccine in recent past and was more anxious about that than she needed to be. Said she had scheduled thios vaccine 1 hour prior and wanted to get it over with. She moved outside vaccine area to seat. Approx. 2 min later,she approached drop off counter,asking for water and said felt faint. She fell and her face hit base of a plastic floor stand. Mouth bleeding,
25 2021-06-07 fainting Patient received her 2nd dose of Pfizer. She was counseled to sit and stay for 15 minutes. She was s... Read more
Patient received her 2nd dose of Pfizer. She was counseled to sit and stay for 15 minutes. She was sitting and then suddenly she fainted. When this happened, her glasses cut her skin open on her forehead along her left eyebrow. Her blood pressure was 100/61. We called 911 and then came and took her to the hospital.
25 2021-06-08 pallor 13 minutes into 15 minute observation, patient began c/o feeling nauseous. Patient offered water and... Read more
13 minutes into 15 minute observation, patient began c/o feeling nauseous. Patient offered water and began to dry heave. Patient vitals obtained BP 87/35 P48 T 97.1. Patient continued to drive heave with an emesis x 1. Patient given crackers. Patient noted very pale and sweating. Second set of vitals obtained at 9:54 patient lying on cot observed with BP 103/62 P 72 T97.1 PO 100% room air, expressing she was feeling better at this time. Father of patient present during this matter. During the time patient noted laying flat she expressed she felt better and her initial color began to return. At 10:16 Patient seated sitting up BP 117/75 P69 T 97.5 PO 100 room air. Noted talking and laughing with dad. Patient expressed she had not had any prior reactions to any vaccines/medications and none with the first. Patient did express she had gone to the gym prior to coming to vaccine clinic and had eaten after working out at the gym. Patient standing BP 115/69 P 78 T 97.5 PO 100% Room air. Patient standing and able to ambulate without feeling light headed. No nausea expressed. Patient felt well enough to leave with her dad. Lead made aware of this matter.
25 2021-06-09 nosebleed States that she has had a nosebleed. States that she never has had a nosebleed before. Bled on a... Read more
States that she has had a nosebleed. States that she never has had a nosebleed before. Bled on a tissue - less than the size of a quarter.
25 2021-06-12 chest discomfort Staring 5 hours after the vaccine a tightness in the chest started. It was difficult to breathe. By ... Read more
Staring 5 hours after the vaccine a tightness in the chest started. It was difficult to breathe. By the next day it was difficult to move because of what felt like a band around my chest. It feels like I am running out of air doing my normal routine. I have started moving excessively slowly as I can't get a deep breath. It is four days after the vaccine and I am considering going to the er because it is not clearing up. I started taking Benadryl and Claritin yesterday which has greatly relieved the symptoms (not gone but brought to a manageable level), but everytime the medication wears off it comes back in full force.
25 2021-06-13 heart rate increased Racing heartbeat for ~3 days. Went to doctor 3/30/2021 but symptoms subsided.
25 2021-06-13 fluid around the heart Pericarditis with effusion
25 2021-06-14 chest discomfort At 1700 MA approached LVN stated PT felt dizzy. LVN approached PT and assessed. PT stated feeling di... Read more
At 1700 MA approached LVN stated PT felt dizzy. LVN approached PT and assessed. PT stated feeling dizzy, VS Pulse 89 RR18 BP 124/81, O2 100% RA. At 1710 PT stated throat feels like it's closing up, and chest feels tight. RRT was called. RRT arrived 1712 with MD and 2 members of staff. RRT Assessed and administered epinephrine. RRT administered O2 via NC. Pt was released to family member in stable condition.
25 2021-06-14 chest pain, inflammation of the pericardium Pericarditis. Had chest pain starting the 13th at 2 a.m. The next day I woke up in extreme pain aga... Read more
Pericarditis. Had chest pain starting the 13th at 2 a.m. The next day I woke up in extreme pain again and went to urgent care. Pain was 8/10. Got an ekg at urgent care and they sent me to the ER. Got an ekg at the ER and an X-ray and then a CT scan. Then was told it was Pericarditis potentially due to the COVID vaccine. I?m healthy and have no history of issues so my ER doctor told me to report it online to the CDC.
25 2021-06-14 fainting Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Additional Details: Pat... Read more
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Additional Details: Patient was given 2nd dose of Covid Vaccine, and instructed to remain seated for a minimum of 15minutes after vaccination. Patient had fainted, fallen out of her chair and scraped her face on the carpet. Ambulance was called. Patient was placed in supine position, and remained conscious while awaiting ambulance. EMTs determined patient should go to ER based on vitals.
25 2021-06-15 heart rate increased Started feeling lightheaded, fatigued, dizzy, nauseous about one week after 2nd dose. Heart rate rap... Read more
Started feeling lightheaded, fatigued, dizzy, nauseous about one week after 2nd dose. Heart rate rapidly spikes (up to 163 bpm) for minor tasks such as getting the mail, taking out the trash, vacuuming, etc. Worsened rapidly for another week and could not get off the couch for several days. Has improved some but energy is still at 75% 2 months later and have been unable to work since April. Seen several doctors for blood tests and cardiologists for EKG, Holter monitor, and echocardiogram.
25 2021-06-16 hypotension Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium
25 2021-06-16 pallor, loss of consciousness, fainting Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Sys... Read more
Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium, Additional Details: patient lost consciousness within few minutes post injection; came to soon after but was disoriented asking for help, saying her kids are calling after her; she appeared very pale; rph helped her to the floor; she rested for about 10 minutes; an attempt to sit up was unsuccessful at that point as nausea, dizziness, visual changes came right back; at that point technician called 911; paramedics assessed the pt -bp & hr were normal. however, 40 mins post-injection pt still had all above symptoms
25 2021-06-19 ischemic chest pain Outside of my heart started hurting after 38 hours of getting the vaccine. I wake up from the pain i... Read more
Outside of my heart started hurting after 38 hours of getting the vaccine. I wake up from the pain it was very sharp pain where my heart it. But my heartbeat was normal and not pounding. I don't think it was my heart that was hurting. It was kind of outside of my heart. It was hurting a lot for 10 minutes. I tried to deep breath and it made it hurting more. Whenever i tried to move it hurted a lot. After 10 mins it was getting better enough for me to go back to sleep. But for the 10 minutes I thought i was going to die.
25 2021-06-19 chest pain, chest discomfort Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tig... Read more
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Headache-Mild, Systemic: Nausea-Mild, Additional Details: patient was given vaccine around 5:00 pm. after 15 minutes patient complaiend of lightheadidness, 15 minutes later developed slight difficulty breathing followed up throat tightness. after another 15 minutes of no improvement, benadryl was given. after 15-20 minutes, patient began to recover. after another 15 minutes patient was well enough to leave on her own with no further issues.
25 2021-06-19 pallor, fainting PATIENT FAINTED, FEET AND HANDS CURLED INWARD, EYES ROLLED BACK. SHE REGAINED CONSCIOUSNESS AFTER A... Read more
PATIENT FAINTED, FEET AND HANDS CURLED INWARD, EYES ROLLED BACK. SHE REGAINED CONSCIOUSNESS AFTER ABOUT 45-60 SECONDS.. PATIENT WAS SEATED AND DID NOT FALL. PATIENT WAS VERY PALE AND SWEATY.
25 2021-06-19 fainting Pt passed out after getting the shot. When pt recovered after 5 mins,she started vomiting and was re... Read more
Pt passed out after getting the shot. When pt recovered after 5 mins,she started vomiting and was really shaken
25 2021-06-20 heart rate increased, palpitations Numbness in feet and hands Restlessness/Ticks/Twitches of Body Motion Sickness with slight movements... Read more
Numbness in feet and hands Restlessness/Ticks/Twitches of Body Motion Sickness with slight movements/vertigo Tunneling Vertigo/Feelings of Passing Out Extreme Nausea/Lack of Appetite Flushed Face Painful sinuses Insomnia Rapid Heartbeat Heart Palpitations Random Heart Rate Spikes Shortness of Breath Nausea/Rapid Heartbeat/Weakness after a meal Super Thirsty Feeling of disassociation from body/floating swollen back of neck, tender to the touch, at base of skull. Touching causes very bad nausea Burning sinuses Tingling teeth
25 2021-06-20 fainting Fainting a few minutes after waking up, the day after the 2nd dose. Nausea and headache all day also... Read more
Fainting a few minutes after waking up, the day after the 2nd dose. Nausea and headache all day also feeling of sea legs and dizziness.
25 2021-06-22 brain sinus blood clot Patient presented to hospital with headache 6/21/21. CT head with contrast showed 1. Sinus thrombosi... Read more
Patient presented to hospital with headache 6/21/21. CT head with contrast showed 1. Sinus thrombosis suspected in the patient's sigmoid and transverse right sinus. 2. No venous infarction or other acute finding identified. MRA neck showed thrombosis of right jugular vein and right sigmoid sinus. Patient started on heparin drip. Transitioned to Eliquis by neurologist and hospitalist. Remains hospitalized at this time.
25 2021-06-22 pallor About 5 mins after vaccination, pt appeared to being having a seizure: her whole body was stiff--arm... Read more
About 5 mins after vaccination, pt appeared to being having a seizure: her whole body was stiff--arms and legs and torso board straight, eyes wide open but not seeing anything and her whole body was tremoring. All color had drained from her face. It lasted about 20-25 seconds. When it stopped she asked where she was and what had happened. She was breathing hard and and was very warm to the touch and reported that she felt like she had been watching TV. Her arms and legs were tingling for about 10 mins after. EMS was called and responded but pt refused to go to hospital. Per self-report she has never had a seizure before
25 2021-06-26 chest discomfort, chest pain Moderate chest tightness/discomfort in left pectoral area (also soreness/aching), trouble getting a ... Read more
Moderate chest tightness/discomfort in left pectoral area (also soreness/aching), trouble getting a full breath - symptoms got better over the course of a week
25 2021-06-28 heart rate increased, palpitations Second vaccine dose was on Monday, Friday night started with severe tremors, cold chills, severe hea... Read more
Second vaccine dose was on Monday, Friday night started with severe tremors, cold chills, severe heart palpitations, extreme rapid heat beat, heart pounding. Very scary, couldn't sleep. After 24 hours it hadn't gone away so I sought medical treatment at an emergency room. They did tests and said everything as normal. They sent me home with an antihistamine to take as anxiety medicine. Heart palpitations lessened but extreme symptoms persisted for 3 more days. It has been 10 days since my hospital visit and symptoms have mostly gone away. Terrible experience.
25 2021-06-28 pallor After giving the vaccine, patient complained of a flushing feeling across her body. While waiting fo... Read more
After giving the vaccine, patient complained of a flushing feeling across her body. While waiting for 15 minutes after the vaccine, patient began to feel light headed and dizzy. She complained that her vision became cloudy. Her color was extremely pale and said she felt like she was going to pass out. We gave her a bottle of water and a bottle of orange juice. I sat with her and her mother to monitor her. After drinking most of the juice, she began to feel better and her vision was back to normal. She never lost consciousness. After about 30 minutes, she felt well enough to leave.
25 2021-06-29 chest pain, troponin increased Patient received 2nd dose of Pfizer COVID-19 vaccine on 6/16/21. She reported having myalgia, inject... Read more
Patient received 2nd dose of Pfizer COVID-19 vaccine on 6/16/21. She reported having myalgia, injection site pain, and some breathlessness following the dose. The following day, she noted sharp chest pain worse when she took a deep breath. She went to bed she woke up on 6/18 with worsening sharp chest pain worse with deep breath, worse with laying back and better with sitting up: 8/10 intensity without radiation. She did feel short of breath when having the pain. Patient's ESR was elevated at 30. hs-CRP was 69. Patient was given IV morphine and Toradol for symptomatic treatment. Troponins trended up with values of 0.029, 0.070, and 0.546ng/mL. Echocardiogram was performed, which showed normal pericardium and normal LV and RV size and function. Patient was discharged with prescriptions for colchicine and ibuprofen.
25 2021-06-29 chest pain chest pain on the left side; neck pain also on the left side; This is a spontaneous report received ... Read more
chest pain on the left side; neck pain also on the left side; This is a spontaneous report received from a contactable consumer, the patient. A 25 years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route on 19Mar2021 at 15:45, (at the age of 25-years-old) on the left arm as a single dose, for COVID-19 immunisation. The medical history and concomitant medications were not reported. 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 four weeks prior to the vaccination. On 19Mar2021, at 16.30, after an hour of vaccination, the patient experienced slight chest pain and neck pain on the left side. No treatment was received by the patient for the reported events and 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 chest pain on left side and neck pain on left side was recovered on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
25 2021-06-29 fainting, loss of consciousness 13 hours after vaccine: extreme, violent shaking (chills) lasting about 12 hours 19 hours after vacc... Read more
13 hours after vaccine: extreme, violent shaking (chills) lasting about 12 hours 19 hours after vaccine: dizziness, then fainting (brief loss of consciousness) 20 hours after vaccine: intense migraine for 12 hours
25 2021-06-30 heart rate increased patient said her legs were numb, her face was warm and tingly, and appeared she had trouble breathin... Read more
patient said her legs were numb, her face was warm and tingly, and appeared she had trouble breathing
25 2021-07-01 inflammation of the heart muscle Severe Myocarditis
25 2021-07-05 chest pain, cardiac arrhythmia So on the Saturday after my vaccine, I was having chest pains which were like shooting pains which w... Read more
So on the Saturday after my vaccine, I was having chest pains which were like shooting pains which was pretty strange. I was driving so I pulled over and had some water then continued on. I had dinner and it continued, these shooting pains in my chest. I called the paramedics and had them evaluate me. They hooked me up to an EKG machine and they were alarmed and they recommended I go with them to the ER. I don't really know why they were that alarmed, I didn't feel that bad. The paramedic was like I have been working in cardiac care for 15 years. They wouldn't even allow me to walk down my stairs, they put me in a wheelie thing and I got in the paramedic vehicle. They said I was having premature ventricular contractions. They tested my blood levels and all that stuff and I was not having any indication of a heart attack or anything. They sent me home the next day, on 4/4/2021.
25 2021-07-05 heart rate irregular Extra and extremely strong heart beating, makes me hard to sleep and feel tired during the day.
25 2021-07-07 chest pain Hives all over body, chest super painful having a hard time breathing, sharp pains when I took deep ... Read more
Hives all over body, chest super painful having a hard time breathing, sharp pains when I took deep breaths
25 2021-07-07 coughing up blood Coughing up a little bit of blood. It?s not much but enough to worry me.
25 2021-07-08 chest discomfort Pt phoned this nurse 7/9/21 11:55 am stating that on 7/6/21, 4 hours after vaccination, she experien... Read more
Pt phoned this nurse 7/9/21 11:55 am stating that on 7/6/21, 4 hours after vaccination, she experienced loss of vision momentarily and chest tightness. Pt stated the black vision resolved almost immediately but chest tightness lasted 17 hours. Pt stated that she did not seek emergency medical care and that symptoms are fully resolved currently.
25 2021-07-15 chest pain, very slow heart rate pt. presented to ED with sudden onset of severe chest pain. While in the ED she experienced sudden ... Read more
pt. presented to ED with sudden onset of severe chest pain. While in the ED she experienced sudden rapid onset of loss of sensation and motor function in bilateral lower then uper extremities. She also became brdycardic and hyptensive. She was able to weakly shrug shoulders and maintain airway, otherwise no strength or sensation below C4 level. MRi/CT revealed intramedullary hemorrhage spanning C1-T10 with lesion around the cervicothoracic junction causing hematomyelia. This was treated with various procedures and medications throughout her stay in critical care and med surg units until her discharge on 06/17/21. She is currently in rehab facility
25 2021-07-15 loss of consciousness, pallor Pt lost conciousness x1-2 minutes, Diaphorectic, pale. Moved to w/c to resting area. Has HX of Vaga... Read more
Pt lost conciousness x1-2 minutes, Diaphorectic, pale. Moved to w/c to resting area. Has HX of Vagal Syncope. BP 92/62 P72 R18 1:15 Resting color pink 1:30 BP 104/72 Left with boyfriend w/o assistance.
25 2021-07-16 heart rate decreased, fainting, hypotension pt slightly collapsed, paramedics called low heart rate and blood pressure
25 2021-07-16 heart rate irregular I received my first dose of the Pfizer vaccine on May 7th, 2021, and felt fine (no adverse reactions... Read more
I received my first dose of the Pfizer vaccine on May 7th, 2021, and felt fine (no adverse reactions aside from a sore left arm). Then, I received my second dose on May 28th, 2021, and again had no adverse reactions aside from a bit of soreness on my injected arm and fatigue. Then, on June 4th, I went to my practitioner for a routine appointment and in checking my pulse, it was noticed that it was irregular and wouldn't regulate. I went for an EKG the next day (June 5th) and it showed I had a sinus arrhythmia but an otherwise normal. Follow-up EKG on July 13th still showed the arrhythmia but it was less sporadic and pulse was regulated.
25 2021-07-17 chest pain Moderate to severe pain in the chest between rib bones; Pins and needles & numbness of extremities, ... Read more
Moderate to severe pain in the chest between rib bones; Pins and needles & numbness of extremities, limbs; Pins and needles & numbness of extremities, limbs; This is a spontaneous report from a contactable consumer (Patient). A 25-year-old female (non-pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0177, Expiration Date: not reported), via an unspecified route of administration in left arm on 23Jun2021 17:00 as dose 2, single for COVID-19 immunization. Historical vaccine included dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0187, Expiration Date: not reported), via an unspecified route of administration in left arm on 02Jun2021 16:00 for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included Mental health issue, likely depression. Concomitant medication(s) included escitalopram and plantago ovata fibre (FIBER SUPPLEMENT). The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination,the patient had not been tested for COVID-19. The patient experienced moderate to severe pain in the chest between rib bones (medically significant), pins and needles & numbness of extremities, limbs on 24Jun2021 03:00. Reported seriousness was non-serious. Device Date was 24Jun2021. It was unknown if patient received treatment or not. The outcome of the events were not recovered. Information on Lot/Batch number was available. Additional information has been requested. Follow-up attempts are completed. No further information is expected.
25 2021-07-17 nosebleed couldn't lift her arm; couldn't sleep on that side, and had trouble with everyday things; It kind of... Read more
couldn't lift her arm; couldn't sleep on that side, and had trouble with everyday things; It kind of goes like a numb thing; talking in her sleep and pointing at things; Sore throat; Nauseous; Nosebleeds; Pain at injection site; Fatigue/ very heavy fatigue; Not feeling well; It was definitely worse in the first 7 to 10 days/ It has lightened up; Headache; Muscle between her shoulder has been very tight since she had the vaccine on the left side; she fell asleep/she doesn't take naps and yesterday and today she took a 3 hour nap.; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient) reported that a 25-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EWO172, Expiry date: unknown, at the age of 25-year-old), dose 1 via an unspecified route of administration, administered in Arm Left on 08Jun2021 10:30 or so as dose 1, single for covid-19 immunisation. Medical history included asthma from an unspecified date and ongoing (She has had it her entire life), insomnia from an unspecified date and ongoing (She was diagnosed in high school), Borderline anemia from an unspecified date in May2021 and ongoing (It began in the beginning of May), diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity, Cholesterol (Her grandpa had high cholesterol. Concomitant medication included fluoxetine at 20 mg from 20May2021 and ongoing and ascorbic acid, folic acid, iron, lysine hydrochloride, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine, zinc sulfate (MULTIVITAMIN IRON) pill from an unspecified date and ongoing (every other day) for Borderline anemia. She had taken it for a couple weeks back in May and was eating foods to try and boost her iron and with the iron pill was overdosing. The patient experienced pain at the injection site and was feeling fatigue on 08Jun2021. She wanted to hold on getting the second dose because she is not feeling well. She has been doing better than she has been over the past week. Pain at injection site was really bad the first and continued throughout the rest of the week. It was her second week, and she couldn't lift her arm, sleep on that side, and had trouble with everyday things. That is when she started to get concerned and annoyed. She put ice on it last night and over the past week has been trying Dayquil and Nyqui. She took Daytime Cold and Flu Multi Symptom Relief, lot: 9LKO654, expiration date: Apr2021. The lot has either an O or 0. She doesn't know where the Nyquil. She doesn't remember when she took them. In the first week she tried to make use of the medications she had. When she tries to do exercises, she still gets pain. Her arm wanted to go to sleep like it did not want her to use it. It has lightened up. It was definitely worse in the first 7 to 10 days. She can move her arm now. When she touches her arm it does hurt, but the pain kind of gets less throughout the day. It kind of goes like a numb thing and wants to go to sleep. On 15Jun2021 or 16Jun2021 she thought she was good to go, and the next day she was nauseous on 08Jun2021, her arm was hurting, she had a headache on an unspecified date, and she had a sore throat. She thought she was doing better, but normally she doesn't take naps and yesterday and today she took a 3-hour nap. In the middle of something she will fall asleep. The first week she was watching a movie with her siblings and they said she fell asleep in the middle of it but was talking in her sleep and pointing at things. It is a very heavy fatigue. Sore throat would be the first thing she noticed when she woke up in the morning. It was definitely the morning after she had the vaccine, and for the first week it was every day she woke up with a sore throat and later had a nose-bleed. She chalked it up to being dehydrated and drank coconut water. Another symptom she noticed only for the first week that started on 08Jun2021 was nosebleeds. That does not commonly happen. She tries to stay hydrated and drink water. It was the first 7 to 10 days where she had a nosebleed al-most every day. She has a pain that causes headaches where the muscle between her shoulder has been very tight since she had the vaccine on the left side. She tries to put ice on it, and it does cause a headache every now and then. She tries to take cold showers and an ice pack to relax the muscle. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations within 4 weeks was none. The outcome of events Pain at injection site, It was definitely worse in the first 7 to 10 days and nauseous was Recovering and for Fatigue, Headache was Not recovered and for rest of the events it was unknown.
25 2021-07-17 loss of consciousness, fainting Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: pt pr... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: pt prone to fainting due to vagal-vasal response. she expected it, her mom was with her. she did faint for about 30-40 seconds and then came to.
25 2021-07-18 chest pain Fatigue, severe chest pain that's causing me to cry.
25 2021-07-20 increased heart rate, chest pain 25 year old otherwise healthy female who presented with chest pain 1 week after her March 4, 2021 PF... Read more
25 year old otherwise healthy female who presented with chest pain 1 week after her March 4, 2021 PFizer-BioNTech COVID-19 vaccine. Chest pain was initially constant and severe, alleviated with leaning forward, worsened with lying supine. She visited her local Emergency Department 4 times and has had 1 outpatient cardiologist visit. Labs, including troponin, ESR, CRP, EKG, echo and echo stress test were negative. Naproxen and colchicine started empirically which alleviated her pain. Patient's chest pain is still persisting daily 4 months later, although no longer constant. Chest pain now lasts few minutes at a time without clear trigger. Pt is not pregnant, no history of drug allergy, no medical history of other illness.
25 2021-07-20 fainting Patient had dizziness and fainting and was notified by the patient's mother. Patient could not sit ... Read more
Patient had dizziness and fainting and was notified by the patient's mother. Patient could not sit upright an was laid down. Patient was not responsive for 5 to 10 seconds. Patient regained consciousness and was able to give her name and reason for her visit to the pharmacy for her Covid vaccination. 911 was called and the fire department and ambulance arrived and checked vitals and advised the patient to go to the ER with them. Patient refused to go with the ambulance and was advised by fire department and personnel to go to the ER on their own. Patient left and was accompanied with her mother and brother.
25 2021-07-22 blood clot Blood clot
25 2021-07-23 blood pressure increased, heart rate increased, palpitations But it felt like I was dying,I thought I was having a heart attack; panic disorder; my left arm star... Read more
But it felt like I was dying,I thought I was having a heart attack; panic disorder; my left arm starting getting a sensation of pins and needles; My bp and heart rate were so elevated for a month; I could feel my left chest muscle tensing up; dizziness/light headed ness; fatigue; My heart then started to palpitate; My bp and heart rate were so elevated for a month.; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 25-year-old female (Non-pregnant) consumer received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Er8736, Expiry Date: Unknown), via an unspecified route of administration, administered in right arm on 24May2021 at 14:00 (at the age of 25-years-old) as dose 2, single for covid-19 immunization at Pharmacy or Drug Store. Medical history included PCOS, depression, insulin resistance, asthma, allergies all from unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included which patient received within 2 weeks of vaccination included Prenatal vitamins, Tylenol. No known allergies reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Er8731, Expiry Date: Unknown), via an unspecified route of administration, administered in right arm on 03May2021 at 15:00 (at the age of 25-years-old) as dose 1, single for covid-19 immunization and experienced with some chills and fatigue for the first 24 hours. The patient was not diagnosed with COVID-19, prior to vaccination and has not been tested for COVID, since the vaccination. After second vaccine, she had no side effects until exactly 6 days after her second dose. On 30May2021 at 9:30 PM, patient experienced as her left arm started getting a sensation of pins and needles. Her heart then started to palpitate and she could feel her left chest muscle tensing up. She thought that she was having a heart attack, so her husband rushed her to the ER. While in the waiting room, she calmed down and realized it wasn't life threading. She also was experiencing extreme dizziness, light headedness, and fatigue. She never had dealt with this before until her vaccine. But it felt like she was dying. Her BP and heart rate were so elevated for a month. She went to her primary and was diagnosed with panic disorder. She went home and it happened again for an hour and she took magnesium and went to sleep. It happened about every other day for three weeks after that. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken for the events caused which included Zoloft, hydroxyzine, and Xanax and was terrified to ever stop because that was the scariest month of her life. Seriousness as reported as No. On 30May2021, patient underwent lab test which included Blood pressure measurement and heart results increased. The outcome of all events was recovered with sequel/ Recovered with lasting effects. Follow-Up (15Jul2021): Follow-up attempts are completed. No further information is expected.
25 2021-07-28 chest discomfort Pressure center of chest lasted a few seconds within the hour of the injection. Onset of red, pinpoi... Read more
Pressure center of chest lasted a few seconds within the hour of the injection. Onset of red, pinpoint rash over anterior chest and shoulders. Red with some itching. No SOB, no swelling
25 2021-07-28 chest discomfort 30 minutes post-COVID vaccine, patient complained of shortness of breath, tingles all over body, lig... Read more
30 minutes post-COVID vaccine, patient complained of shortness of breath, tingles all over body, lightheadedness, chest tightness, and difficulty swallowing. Epinephrine was given at clinic where she received the vaccine and was then taken to the ED>
25 2021-07-28 chest pain Mental fog; Acid reflux; Chest pain; Diaphoretic; Exhaustion; Muscle pain; Joint pain; Fever; Chills... Read more
Mental fog; Acid reflux; Chest pain; Diaphoretic; Exhaustion; Muscle pain; Joint pain; Fever; Chills; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0172) via an unspecified route of administration in the left arm on 01May2021 at 08:45 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any other medications within two weeks of vaccination. The patient previously took Keflex and had received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0162) via an unspecified route of administration in the left arm on 10Apr2021 at 09:00 (at the age of 25-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 02May2021 at 11:00, the patient had experienced mental fog, exhaustion, muscle pain, joint pain, fever, chills, diaphoretic, nausea, acid reflux and chest pain. The clinical outcome of the events mental fog, exhaustion, muscle pain, joint pain, fever, chills, diaphoretic, nausea, acid reflux and chest pain was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
25 2021-07-29 hypotension, fainting Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Additional Details: Patient fain... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Additional Details: Patient fainted twice and called 911 but patient left for home afterwards