chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Polymerase chain reaction, SARS-CoV-2 test
Clinical narrative: On 27Jan2021 tested positive for the PCR/She got the rapid and PCR test results back on 29Jan2021 and they were positive for COVID.; This is a spontaneous report from a contactable consumer (patient, self-reported) from sponsored program . A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, into upper left arm below the shoulder, on 19Jan2021, just after noon, around 12:30 or 1:00 PM, as a single dose for COVID-19 immunization. Ongoing medical history included, seasonal allergies, sinus issues, sinus infection and head pressure. Concomitant medications included celecoxib (CELEBREX), azithromycin, from 25Jan2021 for sinus infection and methylprednisolone acetate (MEDROL) from 26Jan2021 to 31Jan2021 and then from Feb2021, for sinus infection and head pressure. It was described as she started treatment for sinus infection on 25Jan2021. He put her on Azithromycin 250mg, six pack, and also Medrol Pack. She started the Medrol pack on the twenty sixth and finished it on 31Jan2021. Then she started her again on Medrol Pack yesterday because she still has head pressure. Clarified Medrol Pack as Methylprednisolone. She is on the second round and will finish it on Tuesday. Caller doesn't have NDC, lot, and expiry for Azithromycin or Medrol Pack. She doesn't have the product but has the paperwork. Patient did not receive any other medications, prior Vaccinations (within 4 weeks). She had her first vaccine on 19Jan2021. Four days later she started getting sick. She thought she had a sinus infection. Then after that patient got sick, Doctor prescribed to take antibiotics and steroids. She went for her annual physical on 21Jan2021. She was in his office two days after the vaccine. The doctor treated her for a sinus infection but thought she should get tested. Clarified that she got sick on 22Jan2021. She didn't get tested until the twenty seventh when she had the PCR test. On 27Jan2021 tested positive for the PCR and on 29Jan2021 tested positive for Rapid Test (She got a rapid on 29Jan2021. She got the rapid and PCR test results back on 29Jan2021 and they were positive for COVID). She was scheduled for the second shot on the 09Feb2021. She would like to be able to get her second shot. She was asking if she could get the second shot of the Pfizer COVID-19 vaccine after she gets well. Outcome of the event was unknown.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Hypoaesthesia, Paraesthesia, Small fibre neuropathy, Tinnitus
Clinical narrative: Worsening neuropathy: increase in paresthesias still present at the two weeks. Constant electric buzzing/pins needles sensations in legs and an increase in numbness patches all over body.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Pyrexia
Clinical narrative: Fever and stomach pains
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Head discomfort
Clinical narrative: Pfizer-BioNTech COVID-19   Vaccine  Symptom started a few minutes after the vaccine, around 1:50pm, and lasted until approximately 5:30pm. Symptoms: ear or head pressure. Felt like when driving from a height altitude to a lower one, and the fast change of heights causes the ears to get plugged with a feeling of great pressure.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Headache, Hypoaesthesia, Limb discomfort
Clinical narrative: within 10-30 minutes of injection: -left cheek and forehead redness and swelling; cheek/facial swelling not fully resolved as of 3/19/21 (31 days post injection) -numbness, muscle weakness left arm and left leg; leg "heaviness"/numbness symptoms remain as of 3/19/21 (31 days post injection) within hours of injection: -headache, extreme fatigue; fatigue mostly resolved 5-6 days later, headache - primarily left side of face, across bridge of nose, severe pulsing ache intermittent for approximately 6 days. -left eye peripheral vision slightly obscured; resolved 24-36 hours later. -involuntary muscle twitches left side of face, left arm and hand.  Mostly resolved 3 days.  please see Continuation Page
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Muscular weakness, Swelling face, Visual field defect
Clinical narrative: within 10-30 minutes of injection: -left cheek and forehead redness and swelling; cheek/facial swelling not fully resolved as of 3/19/21 (31 days post injection) -numbness, muscle weakness left arm and left leg; leg "heaviness"/numbness symptoms remain as of 3/19/21 (31 days post injection) within hours of injection: -headache, extreme fatigue; fatigue mostly resolved 5-6 days later, headache - primarily left side of face, across bridge of nose, severe pulsing ache intermittent for approximately 6 days. -left eye peripheral vision slightly obscured; resolved 24-36 hours later. -involuntary muscle twitches left side of face, left arm and hand.  Mostly resolved 3 days.  please see Continuation Page
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Muscular weakness
Clinical narrative: Pt complained bilateral upper extremity weakness and dizziness post vaccination during her initial 15 minute observation. She was taken into the tent and observed for another 30 minutes with RN present. 2:19 BP 140/85 HR 85 R 18, T 97.5. 2:24 BP 180/92. Pt denies acute distress, admitted she ?ate pizza and soda before getting into the clinic which could have increased my pressure. But I feel fine?. Pt left the clinic alert and oriented x 4, ambulatory self on a steady gait,. Writer walked pt to her car.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Tremor, Vomiting
Clinical narrative: Shortness of breath, shaking hands, felling weighed down, vomiting
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Rash erythematous, Rash pruritic
Clinical narrative: Bruising at injection site the day after the shot (and is still present). Then 8 days after the injection--itchy red rash, which is still present.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Apoptosis, Biopsy colon abnormal, Biopsy small intestine abnormal, Biopsy stomach abnormal, Blunted affect
Clinical narrative: Eight hours after receiving vaccination patient developed explosive diarrhea.  This lasted for weeks.  She ended up being hospitalized twice and was eventually diagnosed with lymphocytic colitis. She has never had this before. In consult with gastroenterology it is believed that because she received immunotherapy 2 months prior to vaccination that her immune system was primed.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis microscopic, Collagen disorder, Cytomegalovirus test negative, Diarrhoea, Duodenitis
Clinical narrative: Eight hours after receiving vaccination patient developed explosive diarrhea.  This lasted for weeks.  She ended up being hospitalized twice and was eventually diagnosed with lymphocytic colitis. She has never had this before. In consult with gastroenterology it is believed that because she received immunotherapy 2 months prior to vaccination that her immune system was primed.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Gastritis, Gastrointestinal inflammation, Gastrointestinal injury, Helicobacter test negative, Herpes simplex test negative
Clinical narrative: Eight hours after receiving vaccination patient developed explosive diarrhea.  This lasted for weeks.  She ended up being hospitalized twice and was eventually diagnosed with lymphocytic colitis. She has never had this before. In consult with gastroenterology it is believed that because she received immunotherapy 2 months prior to vaccination that her immune system was primed.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Varicella virus test negative
Clinical narrative: Eight hours after receiving vaccination patient developed explosive diarrhea.  This lasted for weeks.  She ended up being hospitalized twice and was eventually diagnosed with lymphocytic colitis. She has never had this before. In consult with gastroenterology it is believed that because she received immunotherapy 2 months prior to vaccination that her immune system was primed.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Parosmia, Taste disorder
Clinical narrative: Tasted and smelled strong clinical alcohol, swollen eyes
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: CLIENT RECEIVED A PFIZER VACCINE INSTEAD OF MODERNA VACCINE. CLIENT WAS DUE FOR HER SECOND DOSE OF MODERNA ON 3/18/21.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Pt received pfizer as 2nd dose instead of Moderna. Pt receved Moderna for 1st dose.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain in extremity
Clinical narrative: EXTREME ARM PAIN INTO COLLAR BONE AREA AND THROUGHOUT SHOULDER & INTO NECK FOR 3 DAYS.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Myalgia, Nausea
Clinical narrative: Severe headache, muscle aches, nausea, sore injection area
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Patient received vaccination and passed out.  Patient states that he has a history of fainting after receiving vaccination.  Patient was given water and cold compresses was applied to patients head to help cool him off.  Patient's vitals were obtained and everything was normal except blood pressure.   Blood pressure was found to be 99/42.  After approximately 15-20 mins patients BP was 100/60.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administered first dose of Moderna vaccine today. Did not disclose receipt of J&J vaccine on 3/12/21. No adverse reactions at this time.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Throat tightness
Clinical narrative: Pt reported facial itching and trace throat tightness post-injection at 11:10 am. Given 25mg Benadryl PO and symptoms resolved with additional monitoring time.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Muscle spasms, Paraesthesia, Paraesthesia oral
Clinical narrative: Moments after injection, left side of upper and lower lips began to tingle.  A minute later, they began to go numb.   After approximately 5 minutes, the left side of face went numb.   Left palm of hand became 'prickly' and very itchy.    Began cramping in the left foot, on the arch.    The foot cramping resolved within a half hour.   Face numbness resolved approximately 4 hours.  Palm of hand approximately 2 hours.   Numb lips resolved by noon the following day.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Moments after injection, left side of upper and lower lips began to tingle.  A minute later, they began to go numb.   After approximately 5 minutes, the left side of face went numb.   Left palm of hand became 'prickly' and very itchy.    Began cramping in the left foot, on the arch.    The foot cramping resolved within a half hour.   Face numbness resolved approximately 4 hours.  Palm of hand approximately 2 hours.   Numb lips resolved by noon the following day.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Cardiac monitoring normal, Electrocardiogram normal, Hyperhidrosis, Palpitations
Clinical narrative: On 2/14 started experiencing heart palpitations, tremors, sweating    No previous history of anxiety or depression
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Stress echocardiogram normal, Tremor
Clinical narrative: On 2/14 started experiencing heart palpitations, tremors, sweating    No previous history of anxiety or depression
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Taste disorder
Clinical narrative: weird taste in mouth right after shot - and tingling on left side of tongue and roof of mouth
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, Dyspnoea, Fatigue, Parosmia
Clinical narrative: Loss of taste and smell, Parosmia, Fatigue, Pain breathing
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, Dyspnoea, Fatigue, Myalgia
Clinical narrative: Loss of taste and smell, Parosmia, Fatigue, Pain breathing
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Parosmia
Clinical narrative: Loss of taste and smell, Parosmia, Fatigue, Pain breathing
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Purpura, Rash
Clinical narrative: patient developed purpuric rash on the arm from the shoulder to just below the elbow that has persisted
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Pain, Pyrexia
Clinical narrative: Extreme pain in neck, shoulder, left arm and lower back, hip, leg.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Chills, Clavicle fracture, Cognitive disorder, Facial bones fracture
Clinical narrative: Patient had chills and low fever (99.4) 8 hours after vaccine.  Patient went to bed early (8 PM).  Patient awoke about 2 AM on 03/09/2021, walked through a dark hallway, and fell down a flight of steps.  Injuries include 17 fractures (5 vertebrae, 9 ribs, 1 clavicle, 1 area of lower rear skull, and nose), collapsed lung, brain bleed, and cognition issues.  This may be a sleep walking or hallucination issue.  Patient has no previous history of sleep walking or hallucinations.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Laboratory test, Pneumothorax, Pyrexia, Rib fracture
Clinical narrative: Patient had chills and low fever (99.4) 8 hours after vaccine.  Patient went to bed early (8 PM).  Patient awoke about 2 AM on 03/09/2021, walked through a dark hallway, and fell down a flight of steps.  Injuries include 17 fractures (5 vertebrae, 9 ribs, 1 clavicle, 1 area of lower rear skull, and nose), collapsed lung, brain bleed, and cognition issues.  This may be a sleep walking or hallucination issue.  Patient has no previous history of sleep walking or hallucinations.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Skull fracture, Spinal fracture
Clinical narrative: Patient had chills and low fever (99.4) 8 hours after vaccine.  Patient went to bed early (8 PM).  Patient awoke about 2 AM on 03/09/2021, walked through a dark hallway, and fell down a flight of steps.  Injuries include 17 fractures (5 vertebrae, 9 ribs, 1 clavicle, 1 area of lower rear skull, and nose), collapsed lung, brain bleed, and cognition issues.  This may be a sleep walking or hallucination issue.  Patient has no previous history of sleep walking or hallucinations.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was inadvertently and incorrectly administered a moderna dose when she had received the Pfizer dose on 2/8/21. I counseled her based on CDC recommendations and told her she would not need any further doses of either vaccine. I further counseled patient to report any adverse events immediately to myself or her PCP. I will continue to check in with patient to monitor her progress.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Patient complained of an itching tongue, throat, and lips to the clinic nurse.  No objective symptoms noted.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Migraine, Pain, Pyrexia
Clinical narrative: Chills, joint and body aches, fever and migraine. Got the test on Friday and did not feel better until Tuesday morning.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Injection site pain
Clinical narrative: Chills  Fever Fatigue Joint pain Injection site pain  Lightheadedness
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chills  Fever Fatigue Joint pain Injection site pain  Lightheadedness
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Hypopnoea, Pallor, Pulse abnormal, Unresponsive to stimuli
Clinical narrative: The patient received his vaccine.  Within a minute he  started rubbing his neck.  I asked him if he was okay.  He stated he was, it was just his neck hurting. He  told me it's was going on for a long time and he is supposed to have surgery soon to correct the problem.  He began to lean forward.  I again asked if he was okay.  He said he was but when I asked him to sit up for me, his color was pale.  Myself and the patients wife accompanied him to the holding area where the EMT's were on standby.  The patient was able to walk.   02 applied at 8l/m per FM rebreather. A+)x2  Temp: 98.6  B/P 0/40  P:69 weak and thready,  Skin: pale; coool; clammy.  Respirations 20 shallow ;  The patient after about a minute or so with the O2 mask asked that the mask be removed.  He said he felt better without the  02.   Spo2= 97%  on RA.  The patient was transfered to the stretcher. The EMT's started an IV and placed the patient on a heart monitor. The patient was transfered to the ambulance for transfer. The patient became unresponsive for approximately 90 while en route to the hospital.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Dizziness, Fall, Fear of injection, Vertigo
Clinical narrative: Patient fell on floor at 3:45pm. Patient states that "felt room starting to spin. A little lightheadedness. I do not remember falling on the floor." Patient states "every time I've gotten a shot I have almost always passed out." Patient is afraid of needles. Patient came to and was laying on stomach. EMTs got patient up slowly to cot. B/P 147/89, pulse 67, O2 97%. Patient once moved to cot was alert and oriented.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram normal, Syncope, Troponin normal
Clinical narrative: Dizziness and syncope; required IV fluids and hospital observation.  Fully recovered.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Hives on legs and feet with difficulty breathing shortly after vaccination. Treated by EMS with 50mg benadryl, Oxygen, and 125mg solu-medrol. Sent out to ER.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Blood gases, Dizziness, Dyspnoea, Electrocardiogram normal, Headache
Clinical narrative: reports acute onset posterior headache, lightheadedness, and SOB post-vaccination (Pfizer) at 11:15 am. AMR emergency response notified, EKG benign. Pt hypertensive to 175/80, typical BP measurements reportedly 110s systolic. Pt reportedly has not had anything to eat for 8-12 hours. CBG on site at 97 per AMR. Transported to ED
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: reports acute onset posterior headache, lightheadedness, and SOB post-vaccination (Pfizer) at 11:15 am. AMR emergency response notified, EKG benign. Pt hypertensive to 175/80, typical BP measurements reportedly 110s systolic. Pt reportedly has not had anything to eat for 8-12 hours. CBG on site at 97 per AMR. Transported to ED
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: PAIN, CHILLS, BODY ACHES, AND FEVER
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Hot flush
Clinical narrative: Dose 1 was given at 9 am on Friday morning Feb 26, 2021.  I was fine until mid afternoon the next day when I started experiencing a bad headache.  The headache was severe from Saturday Feb 27, 2021 evening until Monday morning February 28, 2021.  After that I was fatigued and very tired until Wednesday, March 3, 2021.  Dose 2 was given this morning, March 19, 2021 at about 9:30 am.  On the drive home at 10 am, I started feeling the heaviness again.. as if a large heavy blanket is draped over my shoulders.  This feeling comes in waves and I often experience hot flashes with the heavy feeling.  No headache yet (fingers crossed!)
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain, Injection site pruritus
Clinical narrative: Inflammation, pain, hardening and hot the area and after a week the redness returns to the heat in the area and hardening with a little itching after it had been removed.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth
Clinical narrative: Inflammation, pain, hardening and hot the area and after a week the redness returns to the heat in the area and hardening with a little itching after it had been removed.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase normal, Albumin globulin ratio normal, Aspartate aminotransferase normal, Avulsion fracture, Basophil count decreased
Clinical narrative: 2/23/21  84 y.o. female who presents with complaint of syncopal episode that happened about 6:30 p.m..  Patient was working with a family member to has across the street for a visit when she started feeling dizzy with unsteady gait and shortly after passed out and was cut by the family member.  Family member says she was out for about 10 min and then came around.  The patient complained of some headache but denies chest pain, nausea vomiting, abdominal pain, cough or shortness of breath.  Patient has not been eating or drinking because she has and lost some.  Has some food after this episode but was brought in because of continued dizziness.  3/15/21  84 y.o. female who presents with a skin tear on the left forearm and abrasion on the left temporal area after she tripped at home prior to arrival.  Patient states she has mobility issues and normally uses a walker but she did not.  Patient is on home oxygen.  Patient denies loss of consciousness or neck pain but is on Eliquis due to atrial fibrillation and stroke.  She does have a pacemaker.  Patient denies any other injuries..
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Blood albumin decreased, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium decreased, Blood chloride normal
Clinical narrative: 2/23/21  84 y.o. female who presents with complaint of syncopal episode that happened about 6:30 p.m..  Patient was working with a family member to has across the street for a visit when she started feeling dizzy with unsteady gait and shortly after passed out and was cut by the family member.  Family member says she was out for about 10 min and then came around.  The patient complained of some headache but denies chest pain, nausea vomiting, abdominal pain, cough or shortness of breath.  Patient has not been eating or drinking because she has and lost some.  Has some food after this episode but was brought in because of continued dizziness.  3/15/21  84 y.o. female who presents with a skin tear on the left forearm and abrasion on the left temporal area after she tripped at home prior to arrival.  Patient states she has mobility issues and normally uses a walker but she did not.  Patient is on home oxygen.  Patient denies loss of consciousness or neck pain but is on Eliquis due to atrial fibrillation and stroke.  She does have a pacemaker.  Patient denies any other injuries..
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatinine normal, Blood glucose normal, Blood immunoglobulin A increased, Blood immunoglobulin G increased, Blood potassium normal
Clinical narrative: 2/23/21  84 y.o. female who presents with complaint of syncopal episode that happened about 6:30 p.m..  Patient was working with a family member to has across the street for a visit when she started feeling dizzy with unsteady gait and shortly after passed out and was cut by the family member.  Family member says she was out for about 10 min and then came around.  The patient complained of some headache but denies chest pain, nausea vomiting, abdominal pain, cough or shortness of breath.  Patient has not been eating or drinking because she has and lost some.  Has some food after this episode but was brought in because of continued dizziness.  3/15/21  84 y.o. female who presents with a skin tear on the left forearm and abrasion on the left temporal area after she tripped at home prior to arrival.  Patient states she has mobility issues and normally uses a walker but she did not.  Patient is on home oxygen.  Patient denies loss of consciousness or neck pain but is on Eliquis due to atrial fibrillation and stroke.  She does have a pacemaker.  Patient denies any other injuries..
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Blood sodium normal, Blood urea normal, Carbon dioxide abnormal, Cerebellar atrophy, Chest X-ray abnormal
Clinical narrative: 2/23/21  84 y.o. female who presents with complaint of syncopal episode that happened about 6:30 p.m..  Patient was working with a family member to has across the street for a visit when she started feeling dizzy with unsteady gait and shortly after passed out and was cut by the family member.  Family member says she was out for about 10 min and then came around.  The patient complained of some headache but denies chest pain, nausea vomiting, abdominal pain, cough or shortness of breath.  Patient has not been eating or drinking because she has and lost some.  Has some food after this episode but was brought in because of continued dizziness.  3/15/21  84 y.o. female who presents with a skin tear on the left forearm and abrasion on the left temporal area after she tripped at home prior to arrival.  Patient states she has mobility issues and normally uses a walker but she did not.  Patient is on home oxygen.  Patient denies loss of consciousness or neck pain but is on Eliquis due to atrial fibrillation and stroke.  She does have a pacemaker.  Patient denies any other injuries..
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Computerised tomogram head, Decreased appetite, Differential white blood cell count abnormal, Dizziness
Clinical narrative: 2/23/21  84 y.o. female who presents with complaint of syncopal episode that happened about 6:30 p.m..  Patient was working with a family member to has across the street for a visit when she started feeling dizzy with unsteady gait and shortly after passed out and was cut by the family member.  Family member says she was out for about 10 min and then came around.  The patient complained of some headache but denies chest pain, nausea vomiting, abdominal pain, cough or shortness of breath.  Patient has not been eating or drinking because she has and lost some.  Has some food after this episode but was brought in because of continued dizziness.  3/15/21  84 y.o. female who presents with a skin tear on the left forearm and abrasion on the left temporal area after she tripped at home prior to arrival.  Patient states she has mobility issues and normally uses a walker but she did not.  Patient is on home oxygen.  Patient denies loss of consciousness or neck pain but is on Eliquis due to atrial fibrillation and stroke.  She does have a pacemaker.  Patient denies any other injuries..
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Encephalomalacia, Eosinophil count decreased, Gait disturbance, Glomerular filtration rate decreased, Haematocrit decreased
Clinical narrative: 2/23/21  84 y.o. female who presents with complaint of syncopal episode that happened about 6:30 p.m..  Patient was working with a family member to has across the street for a visit when she started feeling dizzy with unsteady gait and shortly after passed out and was cut by the family member.  Family member says she was out for about 10 min and then came around.  The patient complained of some headache but denies chest pain, nausea vomiting, abdominal pain, cough or shortness of breath.  Patient has not been eating or drinking because she has and lost some.  Has some food after this episode but was brought in because of continued dizziness.  3/15/21  84 y.o. female who presents with a skin tear on the left forearm and abrasion on the left temporal area after she tripped at home prior to arrival.  Patient states she has mobility issues and normally uses a walker but she did not.  Patient is on home oxygen.  Patient denies loss of consciousness or neck pain but is on Eliquis due to atrial fibrillation and stroke.  She does have a pacemaker.  Patient denies any other injuries..
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Haemoglobin decreased, Haemorrhage intracranial, Headache, Loss of consciousness, Lymphocyte count decreased
Clinical narrative: 2/23/21  84 y.o. female who presents with complaint of syncopal episode that happened about 6:30 p.m..  Patient was working with a family member to has across the street for a visit when she started feeling dizzy with unsteady gait and shortly after passed out and was cut by the family member.  Family member says she was out for about 10 min and then came around.  The patient complained of some headache but denies chest pain, nausea vomiting, abdominal pain, cough or shortness of breath.  Patient has not been eating or drinking because she has and lost some.  Has some food after this episode but was brought in because of continued dizziness.  3/15/21  84 y.o. female who presents with a skin tear on the left forearm and abrasion on the left temporal area after she tripped at home prior to arrival.  Patient states she has mobility issues and normally uses a walker but she did not.  Patient is on home oxygen.  Patient denies loss of consciousness or neck pain but is on Eliquis due to atrial fibrillation and stroke.  She does have a pacemaker.  Patient denies any other injuries..
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Mean cell haemoglobin concentration decreased, Mean cell haemoglobin decreased, Mean cell volume decreased, Mean platelet volume normal, Metabolic function test abnormal
Clinical narrative: 2/23/21  84 y.o. female who presents with complaint of syncopal episode that happened about 6:30 p.m..  Patient was working with a family member to has across the street for a visit when she started feeling dizzy with unsteady gait and shortly after passed out and was cut by the family member.  Family member says she was out for about 10 min and then came around.  The patient complained of some headache but denies chest pain, nausea vomiting, abdominal pain, cough or shortness of breath.  Patient has not been eating or drinking because she has and lost some.  Has some food after this episode but was brought in because of continued dizziness.  3/15/21  84 y.o. female who presents with a skin tear on the left forearm and abrasion on the left temporal area after she tripped at home prior to arrival.  Patient states she has mobility issues and normally uses a walker but she did not.  Patient is on home oxygen.  Patient denies loss of consciousness or neck pain but is on Eliquis due to atrial fibrillation and stroke.  She does have a pacemaker.  Patient denies any other injuries..
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Monocyte count decreased, Neutrophil count increased, Osteochondral fracture, Platelet count normal, Pleural effusion
Clinical narrative: 2/23/21  84 y.o. female who presents with complaint of syncopal episode that happened about 6:30 p.m..  Patient was working with a family member to has across the street for a visit when she started feeling dizzy with unsteady gait and shortly after passed out and was cut by the family member.  Family member says she was out for about 10 min and then came around.  The patient complained of some headache but denies chest pain, nausea vomiting, abdominal pain, cough or shortness of breath.  Patient has not been eating or drinking because she has and lost some.  Has some food after this episode but was brought in because of continued dizziness.  3/15/21  84 y.o. female who presents with a skin tear on the left forearm and abrasion on the left temporal area after she tripped at home prior to arrival.  Patient states she has mobility issues and normally uses a walker but she did not.  Patient is on home oxygen.  Patient denies loss of consciousness or neck pain but is on Eliquis due to atrial fibrillation and stroke.  She does have a pacemaker.  Patient denies any other injuries..
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Protein total normal, Red blood cell count normal, Red cell distribution width increased, Scan with contrast, Skin abrasion
Clinical narrative: 2/23/21  84 y.o. female who presents with complaint of syncopal episode that happened about 6:30 p.m..  Patient was working with a family member to has across the street for a visit when she started feeling dizzy with unsteady gait and shortly after passed out and was cut by the family member.  Family member says she was out for about 10 min and then came around.  The patient complained of some headache but denies chest pain, nausea vomiting, abdominal pain, cough or shortness of breath.  Patient has not been eating or drinking because she has and lost some.  Has some food after this episode but was brought in because of continued dizziness.  3/15/21  84 y.o. female who presents with a skin tear on the left forearm and abrasion on the left temporal area after she tripped at home prior to arrival.  Patient states she has mobility issues and normally uses a walker but she did not.  Patient is on home oxygen.  Patient denies loss of consciousness or neck pain but is on Eliquis due to atrial fibrillation and stroke.  She does have a pacemaker.  Patient denies any other injuries..
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Skin laceration, Syncope, Troponin I increased, X-ray limb abnormal
Clinical narrative: 2/23/21  84 y.o. female who presents with complaint of syncopal episode that happened about 6:30 p.m..  Patient was working with a family member to has across the street for a visit when she started feeling dizzy with unsteady gait and shortly after passed out and was cut by the family member.  Family member says she was out for about 10 min and then came around.  The patient complained of some headache but denies chest pain, nausea vomiting, abdominal pain, cough or shortness of breath.  Patient has not been eating or drinking because she has and lost some.  Has some food after this episode but was brought in because of continued dizziness.  3/15/21  84 y.o. female who presents with a skin tear on the left forearm and abrasion on the left temporal area after she tripped at home prior to arrival.  Patient states she has mobility issues and normally uses a walker but she did not.  Patient is on home oxygen.  Patient denies loss of consciousness or neck pain but is on Eliquis due to atrial fibrillation and stroke.  She does have a pacemaker.  Patient denies any other injuries..
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pyrexia, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Developed red itchy smooth feverish rash on legs and arms starting after 7 days and still have rash to this date .  Joints ached. Took antihistamine tablet and also acetaminophen but that  did not help so quit taking anything.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient received first dose of vaccine 3 weeks prior with no issues. She returned today 24 hours after 2nd dose and had a swollen, red, warm area at the site of injection that measured about 2 inches by 2 inches. She said she wasn't experiencing any other systemic symptoms.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Lymph node pain, Pharyngeal swelling, Pruritus, Rash
Clinical narrative: Within 2 to 3 minutes after the shot, I experienced swelling in my throat. My glands were sore. I was monitored for 30 minutes by the nurse and as the symptoms were not getting worse she suggested I drive home and take Benadryl. It was a 45 minute drive. Halfway home (about one hour after my shot) I started experiencing itching, swollen tongue, swollen lips. I took 62.5 mg of Children?s Benadryl and met up with my husband and he drove me to the ER, arriving at about 10;15.  After being there about 15 minutes some of my symptoms started going away. At about 11 a rash appeared on my chest. The ER doctors gave me Pepcid 10 mg around 1130 or so. They just charge me and recommended I follow up with my allergy doctor.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: Within 2 to 3 minutes after the shot, I experienced swelling in my throat. My glands were sore. I was monitored for 30 minutes by the nurse and as the symptoms were not getting worse she suggested I drive home and take Benadryl. It was a 45 minute drive. Halfway home (about one hour after my shot) I started experiencing itching, swollen tongue, swollen lips. I took 62.5 mg of Children?s Benadryl and met up with my husband and he drove me to the ER, arriving at about 10;15.  After being there about 15 minutes some of my symptoms started going away. At about 11 a rash appeared on my chest. The ER doctors gave me Pepcid 10 mg around 1130 or so. They just charge me and recommended I follow up with my allergy doctor.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Rash
Clinical narrative: Immeditely after my first shot on March 7  I felt fine (except some mild soreness at injection site).  A full week later, on March 14, I had some mild chills, fatigue, headache, and a red itchy rash. The rash was located on my right inner forearm, my left inner thigh, my lower back and hip area, and my ears. No rash on injextion site arm. I took benadryl and used a topical 1% hydrocortisone cream, and the rash eventually subsided after 5 days.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Immeditely after my first shot on March 7  I felt fine (except some mild soreness at injection site).  A full week later, on March 14, I had some mild chills, fatigue, headache, and a red itchy rash. The rash was located on my right inner forearm, my left inner thigh, my lower back and hip area, and my ears. No rash on injextion site arm. I took benadryl and used a topical 1% hydrocortisone cream, and the rash eventually subsided after 5 days.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia oral, Throat tightness
Clinical narrative: Patient reported "throat tightening" and "tingling lips" approximately 15 minutes after receiving the vaccine. Vitals WNL, patient awake, alert, and oriented duration of monitoring. EMTs arrived 8 minutes after they were called, and patient was brought to local hospital for monitoring.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous, Rash papular
Clinical narrative: very large raised red rash that is itchy - covid arm
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Pain
Clinical narrative: 03/17: Head ache 03/18: Left-side body ache; overall bad; chilled; no fever
Age: 1.5
Sex: M
Vaccine: DTAPIPV, FLU4, HEPA, HIBV, MMRV, PNC13
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Quadracel was administered to patient before recommended age of 4 years old by accident.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Pruritus
Clinical narrative: Itching all over her body; tongue was numb; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 03Feb2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Batch/lot number: EL8982) via an unspecified route of administration in the left arm on 28Jan2021 15:55 (at the age of 68-years-old) as a single dose for COVID-19 immunization. The patient medical history included allergy to all antibiotic and eggs. The patient had no family medical history relevant to event. Concomitant medications were not reported. The patient previously received flu shot in Sep2020 for immunization in which she had no reaction. The patient did not administered additional vaccines on same date of the Pfizer suspect. On 28Jan2021, half an hour after the vaccination, the patient experienced a bad reaction-itching all over her body and her tongue was numb. She was still itching but was better; she has taken Zyrtec and all kinds of things for this event. The patient did not visit emergency room and physician office. The numb tongue had gotten better but then Monday it was numb again. She took more Zyrtec and it was better today. No relevant tests performed. The caller said she was really upset because her doctor told her that she cannot take the second vaccine due to her reaction. She wanted to know if she has any protection from just one dose. The outcome of the events was recovering.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye swelling, Fatigue, Hypoaesthesia oral, Urticaria
Clinical narrative: Patient participated in a mass vaccine event with the local school system administered by local pharmacy.  After the vaccine was administered the patient was instructed to wait 30 minutes so she could be observed by a school nurse.  She said she noticed her lips were beginning to feel numb and looked in the mirror and noticed her face was beginning to turn red.  The nurse came over to assess the patient when she noticed the patient was developing hives on her face and neck and her eyes were becoming swollen.  The fire department with a paramedic unit was on site and came over to assess the patient.  They did not administer any medications as their protocol did not call for medications if the patient was not having difficulty breathing.  In the meantime 911 had been called and an ambulance arrived on site.  The patient refused transport and the ambulance left the site.  The nurse, pharmacist, and school staff would not allow the patient to leave the site until further evaluation for approximately 30 more minutes.  The nurse and pharmacist insisted the patient receive 50mg of diphenhydramine orally, and she agreed to comply.  The patient's friend was on site and agreed to drive the patient home and stay with her for at least four more hours.  The friend was instructed to call 911 if any of the symptoms worsened.  The patient was provided with an additional 2 x 25mg diphenhydramine capsules to take in  case needed.   The nurse called the patient at 1pm, and the patient indicated her symptoms were resolving.  The nurse called the patient again at 3pm, and the patient indicated she felt much better. The pharmacist called the patient on 03/15/21 at 4:45pm for additional follow-up.  The patient indicated she felt "wiped out" all day on 03/13/21 but felt much better by 03/14/21.  The pharmacist instructed the patient that even though she did not have an anaphylactic reaction she should NOT take the second dose of the Moderna vaccine, and that she should not receive the Pfizer vaccine either.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Patient participated in a mass vaccine event with the local school system administered by local pharmacy.  After the vaccine was administered the patient was instructed to wait 30 minutes so she could be observed by a school nurse.  She said she noticed her lips were beginning to feel numb and looked in the mirror and noticed her face was beginning to turn red.  The nurse came over to assess the patient when she noticed the patient was developing hives on her face and neck and her eyes were becoming swollen.  The fire department with a paramedic unit was on site and came over to assess the patient.  They did not administer any medications as their protocol did not call for medications if the patient was not having difficulty breathing.  In the meantime 911 had been called and an ambulance arrived on site.  The patient refused transport and the ambulance left the site.  The nurse, pharmacist, and school staff would not allow the patient to leave the site until further evaluation for approximately 30 more minutes.  The nurse and pharmacist insisted the patient receive 50mg of diphenhydramine orally, and she agreed to comply.  The patient's friend was on site and agreed to drive the patient home and stay with her for at least four more hours.  The friend was instructed to call 911 if any of the symptoms worsened.  The patient was provided with an additional 2 x 25mg diphenhydramine capsules to take in  case needed.   The nurse called the patient at 1pm, and the patient indicated her symptoms were resolving.  The nurse called the patient again at 3pm, and the patient indicated she felt much better. The pharmacist called the patient on 03/15/21 at 4:45pm for additional follow-up.  The patient indicated she felt "wiped out" all day on 03/13/21 but felt much better by 03/14/21.  The pharmacist instructed the patient that even though she did not have an anaphylactic reaction she should NOT take the second dose of the Moderna vaccine, and that she should not receive the Pfizer vaccine either.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Cerebrovascular accident, Communication disorder, Computerised tomogram head abnormal, Ischaemic stroke
Clinical narrative: COVID and stroke December 2020.  Patient's mother talked to him at 4:30 and he said he was not feeling well.  Driving to work when coworkers found pt after he curbed his vehicle with AMS. Right side deficit with aphasia, unknown last normal. Pt had sz upon EMS arrival and 2.5mg versed given. was initially unresponsive while going into the CT suite and apparently had a seizure as soon as he arrived to the ED.  but alert by the time he was done with CT head, CTA and CTP. He was followed to the ED assigned room and he was more alert but aphasic and only say 'yep' and did not follow commands. He was able to move his left side initially but not to command. about 2 minutes later he was able to move his right lower extremity to pain followed by right upper extremity.   He is febrile with temp >103F.  Diagnosed with seizure and Left acute arterial ischemic stroke, MCA.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Mental status changes, Pyrexia, Right hemisphere deficit syndrome, Seizure
Clinical narrative: COVID and stroke December 2020.  Patient's mother talked to him at 4:30 and he said he was not feeling well.  Driving to work when coworkers found pt after he curbed his vehicle with AMS. Right side deficit with aphasia, unknown last normal. Pt had sz upon EMS arrival and 2.5mg versed given. was initially unresponsive while going into the CT suite and apparently had a seizure as soon as he arrived to the ED.  but alert by the time he was done with CT head, CTA and CTP. He was followed to the ED assigned room and he was more alert but aphasic and only say 'yep' and did not follow commands. He was able to move his left side initially but not to command. about 2 minutes later he was able to move his right lower extremity to pain followed by right upper extremity.   He is febrile with temp >103F.  Diagnosed with seizure and Left acute arterial ischemic stroke, MCA.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: COVID and stroke December 2020.  Patient's mother talked to him at 4:30 and he said he was not feeling well.  Driving to work when coworkers found pt after he curbed his vehicle with AMS. Right side deficit with aphasia, unknown last normal. Pt had sz upon EMS arrival and 2.5mg versed given. was initially unresponsive while going into the CT suite and apparently had a seizure as soon as he arrived to the ED.  but alert by the time he was done with CT head, CTA and CTP. He was followed to the ED assigned room and he was more alert but aphasic and only say 'yep' and did not follow commands. He was able to move his left side initially but not to command. about 2 minutes later he was able to move his right lower extremity to pain followed by right upper extremity.   He is febrile with temp >103F.  Diagnosed with seizure and Left acute arterial ischemic stroke, MCA.