chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pruritus, Rash
Clinical narrative: On the day of my shot, I had a severe headache.  The following day, I had some body aches but the headache and body aches were gone by the end of the second day.  Starting 3/14, I developed an itchy, mildly painful rash on forearms, hands, and lower leg - ongoing.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test abnormal, Chills, Dyspnoea, Dystonia, Hypoaesthesia
Clinical narrative: Approximately 30 minutes after vaccine, patient started to have Rigors without fever, teeth chattering, Body Dystonia and shaking. ER X 2- Hypokalemia, SOB - Dystonic reaction Transient numbness.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypokalaemia, Tremor
Clinical narrative: Approximately 30 minutes after vaccine, patient started to have Rigors without fever, teeth chattering, Body Dystonia and shaking. ER X 2- Hypokalemia, SOB - Dystonic reaction Transient numbness.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Cardiac stress test, Chest pain, Confusional state, Coordination abnormal
Clinical narrative: Approximately 30 minutes after vaccine, patient started to have Rigors without fever, teeth chattering, Body Dystonia and shaking. ER X 2- Hypokalemia, SOB - Dystonic reaction Transient numbness.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Dystonia, Echocardiogram, Electroencephalogram, Full blood count
Clinical narrative: Approximately 30 minutes after vaccine, patient started to have Rigors without fever, teeth chattering, Body Dystonia and shaking. ER X 2- Hypokalemia, SOB - Dystonic reaction Transient numbness.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Livedo reticularis, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Metabolic function test
Clinical narrative: Approximately 30 minutes after vaccine, patient started to have Rigors without fever, teeth chattering, Body Dystonia and shaking. ER X 2- Hypokalemia, SOB - Dystonic reaction Transient numbness.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Petechiae, Rash, SARS-CoV-2 test negative, Sensory overload, Skin discolouration
Clinical narrative: Approximately 30 minutes after vaccine, patient started to have Rigors without fever, teeth chattering, Body Dystonia and shaking. ER X 2- Hypokalemia, SOB - Dystonic reaction Transient numbness.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness, Tremor, Urine analysis
Clinical narrative: Approximately 30 minutes after vaccine, patient started to have Rigors without fever, teeth chattering, Body Dystonia and shaking. ER X 2- Hypokalemia, SOB - Dystonic reaction Transient numbness.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: patient was injected with an empty syringe... I apologized and informed her of the mistake made and injected her again with the syringe with vaccine.  I explained to her of the error and told her that I wanted her protected and injected her again.The reason was that patient needed a different needle length and I  was unfortunately distracted by my conversation with her.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Dysuria, Urinary tract discomfort
Clinical narrative: About a day after vaccination I began experiencing discomfort & difficulty urinating. This has continued to occur through today (18Mar2021). Symptoms appear to be lessening as time goes by.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Lymphadenopathy, Swelling, Tenderness
Clinical narrative: Presents with chief complaint of left chest wall swelling.  The patient states that she has a history of Covid prior and received a Madera vaccine 2 days ago.  This was the first vaccine.  She states that she had a significant amount of redness and swelling at the vaccine site on her left arm initially.  Yesterday she started noticing some swelling above the clavicle on the left-hand side and was concerned that this could be a blood clot given her history of Covid.  She states it is tender to the touch.  She has not had a fever and denies any redness.  No history of similar in the past and no prior venous thromboembolism.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient received Pfizer COVID-19 vaccine 1/2/2021.    Exposed to infected coworker.   Although asymptomatic patient positive by PCR for COVID-19.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Oropharyngeal pain, Pain, Pyrexia, Urticaria
Clinical narrative: Fever 105, vomiting, weakness sore throat, pain everywhere,  hives on arms
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fever 105, vomiting, weakness sore throat, pain everywhere,  hives on arms
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Pfizer-BionTech Covid-19 Vaccine EUA  Woke up around 0530 AM, with a rash covering my chest, stomach, groin, scalp, and upper legs.  The rash was very itchy.  Took Benadryl and applied hydro cortisone cream which reduced the rash, but didn't eliminate in upper groin area.  If it doesn't subside, I'll be contacting my primary care.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Polymerase chain reaction, Rash, Urticaria
Clinical narrative: Pfizer-BionTech Covid-19 Vaccine EUA  Woke up around 0530 AM, with a rash covering my chest, stomach, groin, scalp, and upper legs.  The rash was very itchy.  Took Benadryl and applied hydro cortisone cream which reduced the rash, but didn't eliminate in upper groin area.  If it doesn't subside, I'll be contacting my primary care.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Asymptomatic
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Hypoaesthesia oral, Paraesthesia, Paraesthesia oral
Clinical narrative: light headed tingling/numb hands, fingers, arms, legs, feet, chest and lips  Health department gave me a dose of Benadryl.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: After 8 days from the initial COVID19 (Moderna) vaccine shot, the patient had a red circle that was 1 1/2" in diameter when first noticed.  It was very warm to the touch, did have some pain, and a bit of swelling.  Over the next few days, the red circle grew in size ... At it's largest size it was 5" in diameter, and wrapped around her arm like a band.  The red area did include the injection site on her left arm.  She said it was very uncomfortable, was "itchy," and described the experience like having poison ivy.  It took about a week to fully recover and the redness to go away.
Age: 1.33
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient came in for an WC  appointment on 3-17-21 at 2:30 pm . Provider ordered DTAP and  patient was given a TDAP  by MA  by mistake. Mother was notified of vaccine error and educated on signs and symptoms of an allergic reaction. No Adverse events reported from mother.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Disorientation, Fatigue, Gait disturbance
Clinical narrative: Received the vaccine, no reactions at all, went shopping all afternoon, and went to bed, woke up at 4:00 AM with a super bad headache and a fever.  Laid back down in bed, worse headache she has ever had and does get migraines.   She did have the size of about an egg with a rash on the arm itself.  She was disoriented, had chills and clammy, felt like she wanted to throw up but did not, fatigue.  The intense headache lasted until this morning 3/18/21.   She took 600 mg of Ibuprofen initially and then 500 mg every 4-6 hours of Tylenol, which helped.  The headache is pretty much gone, small fever, able to walk better this afternoon.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Peripheral swelling, Pyrexia, Rash
Clinical narrative: Received the vaccine, no reactions at all, went shopping all afternoon, and went to bed, woke up at 4:00 AM with a super bad headache and a fever.  Laid back down in bed, worse headache she has ever had and does get migraines.   She did have the size of about an egg with a rash on the arm itself.  She was disoriented, had chills and clammy, felt like she wanted to throw up but did not, fatigue.  The intense headache lasted until this morning 3/18/21.   She took 600 mg of Ibuprofen initially and then 500 mg every 4-6 hours of Tylenol, which helped.  The headache is pretty much gone, small fever, able to walk better this afternoon.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising
Clinical narrative: Several hours after receiving the Pfizer vaccine I noticed a very dark blue bruise at the injection site. I still have this bruise, about the size of a Nickle, 12 days later. There is no pain or discomfort associated with this nor do I have any other side effects.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Patient appeared pale, sweating, and complained of dizziness presenting within 5 minutes of vaccination during the recommended observation time. Patient was given a cold cloth around the back of his neck and his blood pressure was taken and it was 82/58.  Patients O2 sat was 98 and pulse was 78. Patient stated that he was allergic to nuts. We asked if he had eaten breakfast this morning and he stated that he had a bowl of cereal. I instructed for someone to have him sit on the ground and to get him some candy  and a sugary drink.  A package of skittles was presented along with a Mountain Dew.  After finishing both the candy and Mountain Dew  (aprox 4 mins) the patient started to get a little color back and he stated he was feeling much better.  A second set of vitals was then taken which were  BP: 106/78 the O2 sat 98 and Heart rate was again at 78.  We instructed the patient to please hang around for 30 more minutes and after that time left with the person he was with.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Skin weeping
Clinical narrative: rash on right thigh.  Red bumps, itch, 4 inch circular shape, oozy like poison ivy, but no contact with poison ivy. No pain, just itch.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: patient passed away within 60 days of receiving a COVID vaccine
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Pain in extremity, Rash papular
Clinical narrative: SORENESS UNDER RIGHT ARM AND RAISED RED RASH AT INJECTION SITE
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: same as with covid. Extreme fatigue body aches fever chills. (I had covid in January)
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Respiratory arrest
Clinical narrative: RHC 3/15/21.  No significant reaction from vaccine. Had sore arm.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure immeasurable, Chest discomfort, Cough, Heart rate increased
Clinical narrative: Patient brought back to chemo room for 1st dose of Pfizer BioNTech vaccine. LOT: ER2613  Man Exp: 07/20/2021. Patient appeared anxious about receiving vaccine but was alert and oriented x4 and ambulatory with no other complaints. No previous reactions to vaccinations per patient. Patient received Covid vaccine at 1002, patient started coughing and complaining of chest tightness at 1005 with auditory wheezing. First Epi given at 1005 and O2 was placed on patient via face mask at 15L. 911 was then called. O2 saturations at beginning of reaction in the high 80's and dropping, HR 150's. Unable to obtain blood pressure throughout episode at clinic. IV access attempted and unsuccessful x1 at clinic. Saturations continued to drop into low 70's with no improvement of respiratory symptoms. Decision was made to give second Epi and was given at 1010. Before second attempt to establish IV access EMT arrived. Patient was transferred to stretcher and taken to Ambulance via EMS staff.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Wheezing
Clinical narrative: Patient brought back to chemo room for 1st dose of Pfizer BioNTech vaccine. LOT: ER2613  Man Exp: 07/20/2021. Patient appeared anxious about receiving vaccine but was alert and oriented x4 and ambulatory with no other complaints. No previous reactions to vaccinations per patient. Patient received Covid vaccine at 1002, patient started coughing and complaining of chest tightness at 1005 with auditory wheezing. First Epi given at 1005 and O2 was placed on patient via face mask at 15L. 911 was then called. O2 saturations at beginning of reaction in the high 80's and dropping, HR 150's. Unable to obtain blood pressure throughout episode at clinic. IV access attempted and unsuccessful x1 at clinic. Saturations continued to drop into low 70's with no improvement of respiratory symptoms. Decision was made to give second Epi and was given at 1010. Before second attempt to establish IV access EMT arrived. Patient was transferred to stretcher and taken to Ambulance via EMS staff.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Vertigo
Clinical narrative: On the 10th I had a severe stomachache for about 4 hours. On the 11th I developed vertigo which continued through Sunday the 14th, at which time a telehealth provider prescribed meclizine. I started meclizine on the 14th and that calmed it down. I took meclizine for a few days. Hoping it's gone now and doesn't come back. Pretty sure this was related to the vaccine.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Palpitations, Vertigo
Clinical narrative: Pt reported palpitations and feeling flushed ,  as well as vertigo.  Symptoms resolved within 5-10 minutes with rest.  No uticaria, dyspnea, weakness.  Pt departed after 15 additional minutes
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Dizziness, Fatigue, Headache
Clinical narrative: 4 hrs after shot I started to feel nauseous and lightheaded. By 6:30pm I had also had abdominal cramping, headache, vertigo, fatigue, a mild fever and joint pain in addition to the nausea. These symptoms worsened over the course of the night until the fever broke around 2:30am. The highest I remember the fever getting was 101.3 degrees, taken with both a forehead and ear scan thermometer. This morning I have abdominal soreness and fatigue but no other symptoms.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vertigo
Clinical narrative: 4 hrs after shot I started to feel nauseous and lightheaded. By 6:30pm I had also had abdominal cramping, headache, vertigo, fatigue, a mild fever and joint pain in addition to the nausea. These symptoms worsened over the course of the night until the fever broke around 2:30am. The highest I remember the fever getting was 101.3 degrees, taken with both a forehead and ear scan thermometer. This morning I have abdominal soreness and fatigue but no other symptoms.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Disorientation, Dizziness, Fall, Haemorrhage
Clinical narrative: Janssen COVID-19 Vaccine EUA I blacked out while getting ready for work.  I was feeling a little light headed and thirsty.  Next thing I know, I was on the floor. When I came to, I was disoriented and very sweaty.  The fall caused a cut to my head, bleeding and a bruised elbow. Within an hour, I was feeling less dizzy.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Head injury, Hyperhidrosis, Thirst
Clinical narrative: Janssen COVID-19 Vaccine EUA I blacked out while getting ready for work.  I was feeling a little light headed and thirsty.  Next thing I know, I was on the floor. When I came to, I was disoriented and very sweaty.  The fall caused a cut to my head, bleeding and a bruised elbow. Within an hour, I was feeling less dizzy.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: A sharp pain in the arm and then a tingly sensation for over 10 minutes.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Headache, Hypoaesthesia, Pain, Pyrexia
Clinical narrative: Fever, headache, generalized "achiness" for 36 hrs post vaccine beginning on 3/11/2021. Caller states that last night while walking, he experienced "bone pain" in left leg, foot began dragging and leg numbness from knee down. Denies any pain, reports that he was able to walk home. Caller states that he went home and went to sleep, woke up 1.5 hrs later and symptoms had resolved. No other symptoms. Advised to contact PCP. Also advised of s/s of needing emergent care, such as SOB, chest pain, and/or neuro changes
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Computerised tomogram head, Facial paralysis, Magnetic resonance imaging
Clinical narrative: Twenty seven days after my second vaccination I developed Right side of face paralysis and went to ER. After steroids and valcyclovir I was 100 percent recovered.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: International normalised ratio decreased, Pain in extremity
Clinical narrative: My arm was a little sore. My blood test went from 2.9 to 1.9 (protime INR) Had a regular appointment with my cardiologist and he said to report it.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; BP 208/68 (pulse 64). Monitored 30 minutes, BP 190/68.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Flank pain, Injection site pain, Pain, Pain in extremity
Clinical narrative: Patient reported within minutes after receiving her first Shingrix dose she had pain radiating down her arm, side, and leg. It almost felt like a sharp line of pain on the left side only from the injection site to her fingertips, down her left side and a little into her back, and down her left leg. I explained that severe arm soreness is unfortunately a known side effect of the vaccine. She said it lasted 5-6 days. I hadn't heard of the sharp radiating pain before, almost sounded like some kind of nerve pain. I told her I would report it.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Pain, Sinus disorder
Clinical narrative: Weakness, Body aches, headache, sinus issues
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: approx. 10 minutes after receiving #2 Moderna vaccine, patient c/o chest tightness and shortness of breath, after patient's mask was removed and patient took deep breaths she stated she felt better
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Acute onset supraclavicular lymphadenopathy (ipsilateral to injection, 7 days after injection)
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Injection site erythema, Injection site induration
Clinical narrative: At 6 am the following morning after my vaccine, I had a slight fever, chills, body aches, nausea and extreme fatigue.  I am an active adult with a lot of energy but I stayed in bed all day only to get up for chicken noddle soup.  By evening I felt worse and was shivering so badly I bundled myself up put an extra cover on my bed to get warm, but the body aches were still ravaging my body.  The nausea symptoms had gone away mid afternoon.  I took tylenol around 1 pm and then again at 8 pm.  By 10:30 pm I woke up in a complete sweat and I felt fine.  All the body aches and uncontrollable shivering had vanished.  Today, which is day 2 after the vaccine, I am just a bit fatigued, The point of injection is still swollen and red and hard, but overall I'm  feeling much better.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Nausea, Pain, Pyrexia
Clinical narrative: At 6 am the following morning after my vaccine, I had a slight fever, chills, body aches, nausea and extreme fatigue.  I am an active adult with a lot of energy but I stayed in bed all day only to get up for chicken noddle soup.  By evening I felt worse and was shivering so badly I bundled myself up put an extra cover on my bed to get warm, but the body aches were still ravaging my body.  The nausea symptoms had gone away mid afternoon.  I took tylenol around 1 pm and then again at 8 pm.  By 10:30 pm I woke up in a complete sweat and I felt fine.  All the body aches and uncontrollable shivering had vanished.  Today, which is day 2 after the vaccine, I am just a bit fatigued, The point of injection is still swollen and red and hard, but overall I'm  feeling much better.
Age: 44.0
Sex: F
Vaccine: UNK
Symptoms: Hypersensitivity
Clinical narrative: Severe allergy after an hour and half of injection: given a shot of a steriod and a shot of benadryl with 7 days of allergy treatment
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Diarrhoea, Fatigue, Nausea
Clinical narrative: Felt nauseous  3/12-3/15, feeling exhausted March 16 and 17, this morning several bouts of diarrhea ( and last night as well) and I am dehydrated
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Dysarthria, Dyspnoea, Pharyngeal swelling
Clinical narrative: SWELLING OF THROAT, DIFFICULTY BREATHING/SPEAKING.  ANAPHYLACTIC REACTION.  RECIEVED 0.3ML EPHRINEPHRIN, EMS CALLED AND PATIENT EVALUTAION WAS PERFORMED.  PATIENT WAS RELEASED ON OWN ACCORD. PATIENT DENIED FURTHER TREATMENT.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast discomfort, Breast pain, Breast swelling, Breast tenderness
Clinical narrative: After first vaccine I developed a rash under both arms that was hard pustules and then the skin became very sensitive and my breasts became sore and swollen.  I also had swelling under my injection site arm. This almost  cleared up before my 2nd vaccine except for the skin sensitivity and swelling under both arms. After the 2nd vaccine 3/3/21 within 48 hours my breasts became very swollen and painful and the under arm sensitivity became much worse. It is 2 weeks since the second dose and my breasts are still slightly swollen and tender. This is hopefully resolving, but was very painful and uncomfortable.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral, Eye haemorrhage, Retinal haemorrhage
Clinical narrative: I developed bleeding of the left eye in front of the retina.  Broken blood vessels.  Had my second vaccine and it happened again 3 days later   Call me for more information
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Apnoeic attack, Bilevel positive airway pressure, Blood creatinine increased, Blood lactic acid, Blood urea increased
Clinical narrative: On 3/14/21 @ 2304 : 77-year-old female patient presents emergency room with generalized fatigue body aches dry cough shortness of breath and subjective fevers as aggressive worsening since Friday.  Patient received a 2nd dose of the pfizer COVID-19 vaccine on Friday 3/12/21 and states her symptoms worsened since then.  Chest x-ray showed patchy bilateral infiltrates with concern for COVID pneumonia, also questionable vascular congestion as patient does have significant history of heart failure with pacemaker.  EKG revealed paced rhythm 87 beats per minute.  Emergency room patient was placed on BiPAP and responded well, patient was given vancomycin and cefepime for sepsis protocol.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Bradypnoea, Cardiac telemetry, Chest X-ray abnormal, Confusional state, Cough
Clinical narrative: On 3/14/21 @ 2304 : 77-year-old female patient presents emergency room with generalized fatigue body aches dry cough shortness of breath and subjective fevers as aggressive worsening since Friday.  Patient received a 2nd dose of the pfizer COVID-19 vaccine on Friday 3/12/21 and states her symptoms worsened since then.  Chest x-ray showed patchy bilateral infiltrates with concern for COVID pneumonia, also questionable vascular congestion as patient does have significant history of heart failure with pacemaker.  EKG revealed paced rhythm 87 beats per minute.  Emergency room patient was placed on BiPAP and responded well, patient was given vancomycin and cefepime for sepsis protocol.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram, Endotracheal intubation, Fatigue, Intensive care
Clinical narrative: On 3/14/21 @ 2304 : 77-year-old female patient presents emergency room with generalized fatigue body aches dry cough shortness of breath and subjective fevers as aggressive worsening since Friday.  Patient received a 2nd dose of the pfizer COVID-19 vaccine on Friday 3/12/21 and states her symptoms worsened since then.  Chest x-ray showed patchy bilateral infiltrates with concern for COVID pneumonia, also questionable vascular congestion as patient does have significant history of heart failure with pacemaker.  EKG revealed paced rhythm 87 beats per minute.  Emergency room patient was placed on BiPAP and responded well, patient was given vancomycin and cefepime for sepsis protocol.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Lung infiltration, Mechanical ventilation, Moaning, N-terminal prohormone brain natriuretic peptide increased, Nausea
Clinical narrative: On 3/14/21 @ 2304 : 77-year-old female patient presents emergency room with generalized fatigue body aches dry cough shortness of breath and subjective fevers as aggressive worsening since Friday.  Patient received a 2nd dose of the pfizer COVID-19 vaccine on Friday 3/12/21 and states her symptoms worsened since then.  Chest x-ray showed patchy bilateral infiltrates with concern for COVID pneumonia, also questionable vascular congestion as patient does have significant history of heart failure with pacemaker.  EKG revealed paced rhythm 87 beats per minute.  Emergency room patient was placed on BiPAP and responded well, patient was given vancomycin and cefepime for sepsis protocol.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Neutrophil count increased, Pain, Pulse absent, Pyrexia, Resuscitation
Clinical narrative: On 3/14/21 @ 2304 : 77-year-old female patient presents emergency room with generalized fatigue body aches dry cough shortness of breath and subjective fevers as aggressive worsening since Friday.  Patient received a 2nd dose of the pfizer COVID-19 vaccine on Friday 3/12/21 and states her symptoms worsened since then.  Chest x-ray showed patchy bilateral infiltrates with concern for COVID pneumonia, also questionable vascular congestion as patient does have significant history of heart failure with pacemaker.  EKG revealed paced rhythm 87 beats per minute.  Emergency room patient was placed on BiPAP and responded well, patient was given vancomycin and cefepime for sepsis protocol.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Tachycardia, Tachypnoea, Ventricular tachycardia, White blood cell count normal
Clinical narrative: On 3/14/21 @ 2304 : 77-year-old female patient presents emergency room with generalized fatigue body aches dry cough shortness of breath and subjective fevers as aggressive worsening since Friday.  Patient received a 2nd dose of the pfizer COVID-19 vaccine on Friday 3/12/21 and states her symptoms worsened since then.  Chest x-ray showed patchy bilateral infiltrates with concern for COVID pneumonia, also questionable vascular congestion as patient does have significant history of heart failure with pacemaker.  EKG revealed paced rhythm 87 beats per minute.  Emergency room patient was placed on BiPAP and responded well, patient was given vancomycin and cefepime for sepsis protocol.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Ear discomfort, Pruritus
Clinical narrative: states was driving home from VA and started having a lot of burning and itching to right ear then became short of breath
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: body aches(entire body, including eyeballs) fever 99.8 lasting 24 hours
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate increased, Insomnia, Pain
Clinical narrative: Throbbing arm pain, splitting headache, tachycardia, heart rate up to 115, fatigue, insomnia,, left eyelid swollen
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling of eyelid, Tachycardia
Clinical narrative: Throbbing arm pain, splitting headache, tachycardia, heart rate up to 115, fatigue, insomnia,, left eyelid swollen
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Administered 1.0 mL in place of 0.5 mL of vaccine
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Fatigue, Hyperacusis
Clinical narrative: Day 1, Monday March 15, vaccination day. well hydrated and rested. Fatigue set in about 4 h post-inoculation. Enough to require lying down for some spells during working hours. Day 2: Tuesday March 16, woke up with inner ear pain in right ear. Treated with ibuprofen which made it manageable. Pain level ~ 4 on assessment chart (moderate) without NSAIDS. Sensitive in right ear to sound from work headphones. no tinnitus. Day 3: Wednesday March 17, pain in right ear was intermittent and continued throughout day . No ibuprofen was taken this day. In evening, pain was more severe/sharp but intermittent. Pain level assessment  ~ 8. and seemed to reach into eustachian tubes. Day 4: Thursday March 18, pain in right ear is much less severe, pain level assessment  1-2 by noon.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Dyspnoea, Epinephrine, Somnolence
Clinical narrative: Appx 5 minutes after receiving vaccine patient became short of breath, felt light headed, developed urticaria over arms and chest, and itchy throat.  BP stable initially, no wheezing, however appx 2 minutes later began wheezing/coughing and appearing drowsy. Epinephrine 0.3 mg IM given as well as 50 mg Benedryl IV, 02 by nasal cannula. Patient remained conversant and responsive throughout but drowsy and coughing. BP  and SPO2 remained stable until EMS arrived to take to emergency room.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Urticaria, Wheezing
Clinical narrative: Appx 5 minutes after receiving vaccine patient became short of breath, felt light headed, developed urticaria over arms and chest, and itchy throat.  BP stable initially, no wheezing, however appx 2 minutes later began wheezing/coughing and appearing drowsy. Epinephrine 0.3 mg IM given as well as 50 mg Benedryl IV, 02 by nasal cannula. Patient remained conversant and responsive throughout but drowsy and coughing. BP  and SPO2 remained stable until EMS arrived to take to emergency room.
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin, Fatigue, Pyrexia, Rash
Clinical narrative: Rash over entire body but severe  primarily on hands, legs and buttock.  Several days before rash, extreme tiredness,   As rash appeared two days of fever going as high as 102.  Several doctors visits to diagnose rash.   Biopsy done.   Oral Prednisone and prescription strength cortisone cream.
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Biopsy, Body temperature, Fatigue, Malaise, Perivascular dermatitis
Clinical narrative: Rash over entire body but severe  primarily on hands, legs and buttock.  Several days before rash, extreme tiredness,   As rash appeared two days of fever going as high as 102.  Several doctors visits to diagnose rash.   Biopsy done.   Oral Prednisone and prescription strength cortisone cream.
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: Rash over entire body but severe  primarily on hands, legs and buttock.  Several days before rash, extreme tiredness,   As rash appeared two days of fever going as high as 102.  Several doctors visits to diagnose rash.   Biopsy done.   Oral Prednisone and prescription strength cortisone cream.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Injection site rash
Clinical narrative: 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.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Mental disorder, Pruritus, Skin warm
Clinical narrative: Patient developed a red, warm, and itchy left upper extremity, from shoulder to elbow about a week after her injection. Has been waxing and waning for the past week. No further systemic symptoms.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Strong metallic taste in my mouth that lasted for about 28 hours. It did stop after 28 hours. No adverse impact from having this side effect.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain threshold decreased, Paraesthesia
Clinical narrative: sharp ache sensation going up Right side of neck behind ear.  Sensation decreased and turned to tingling "all feelings are internal, feels like icy hot on my neck"  no pain with palpation, injection site WNL, no redness, welling or warmth, no pain at injection site or arm, no los of ROM.
Age: 0.33
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: no additional AE details; administered after improper storage; Rotateq dose: 0.5 ml; This spontaneous report was received from a medical assistant and refers to a 4-month-old patient of an unknown gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported.  On 01-FEB-2021, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 0.5 ml (vaccine underdose), lot # 1742461 (valid lot #), expiration date reported and upon internal validation also established as 17-NOV-2021, and improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml, lot # T026959 (valid lot #), expiration date reported and upon internal validation established as 11-MAR-2023 (strength, route of administration and anatomical location were not provided for both products) for prophylaxis. The data logger registered, that the vaccines before administration were stored at the temperature of 9.9 degree Celsius (C) for 35 minutes (improper storage of product in use). No previous temperature excursion detected. No additional adverse event was reported.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: 1 year old male patient received an expired dose of VAQTA; This spontaneous report as received from a medical assistant refers to a 1-year old male patient. The patient's medical history, historical drugs, previous drug reactions, allergies, concurrent conditions, and concomitant therapies were not reported.  On 09-FEB-2021 the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) 1 dosage form, lot # S030587, expiration date on 06-JAN-2021 (expired vaccine used) for prophylaxis (strength, dose, frequency, route of administration, and anatomical location, were not reported).
Age: 44.0
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took first two doses of Vivotif on consecutive days; Spontaneous report received on 31JAN2020.  A 44-year-old adult female consumer (weight: 135 pounds/61.24 kg and height: 167.64) who "took first two doses of Vivotif on consecutive days by mistake" (PT: Inappropriate schedule of product administered). She was receiving Vivotif (typhoid live oral TY21A) capsule (lot number: 3003306 and expiry date: OCT2020) as typhoid vaccination. The consumer took first and second dose of Vivotif on 29JAN2020 and 30JAN2020 respectively. Action taken with Vivotif with respect to the reported event was not applicable. The outcome was unknown.  The patient's medical history included allergies (unspecified) and hepatitis B.  Concomitant medications included birth control pills, levothyroxine, loratadine, quetiapine, Flonase (fluticasone) for allergies. The consumer was also taking shots for hepatitis B and was in the middle of regimen, at the time of report.  Company Comment: A consumer took first two doses of Vivotif on consecutive days by mistake (Inappropriate schedule of product administered) instead of taking them on every other day. Considering the nature of the event, the causality is assessed as not applicable with Vivotif.; Sender's Comments: A consumer took first two doses of Vivotif on consecutive days by mistake (Inappropriate schedule of product administered) instead of taking them on every other day. Considering the nature of the event, the causality is assessed as not applicable with Vivotif.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Exposure via skin contact, Eye irritation, Fatigue, Injection site pain
Clinical narrative: Reports being tired; Eyes were very irritated; I had a little diarrhea; Had a sore on my arm, it was hard; Had a sore on my arm, it was hard; The injection leaked a bit of liquid from the injection site; The injection leaked a bit of liquid from the injection site; A spontaneous report was received from a consumer who was also a 69-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced being a little bit tired, a little diarrhea, the injection leaked a bit of liquid from the injection site, dry eye irritation, and injection site sore and hard.  The patient's medical history included dry eyes. Products known to have been used by the patient were not provided.  On 11 Jan 2021, prior to the onset of the events, the patient received one of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.    On 11 Jan 2021, as the mRNA-1273 vaccine was being given, the patient noted that the injection leaked a bit of liquid from the injection site. She denied a topical reaction. She reported that the side effects were mild, and she was fine that evening.  On 12 Jan 2021, she reports having a sore on her arm that was hard.   On 13 Jan 2021, she reported that she had a little diarrhea, and her eyes were very irritated, but she noted that she has dry eye to account for this.   On 15 Jan 2021, the diarrhea was almost resolved.   Treatment information was not provided.   Action taken with mRNA-1273 was not reported.  The outcome of the events, eye irritation and a little diarrhea, were resolving. The outcome of the events, being a little bit tired and injection site sore and hard, was not provided. The outcome of event, topical exposure at injection site, was resolved on 11 Jan 2021.; Reporter's Comments: The patient's medical history of dry eyes remains a contributor for the event of eye irritation. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site extravasation, Vaccination site induration
Clinical narrative: Reports being tired; Eyes were very irritated; I had a little diarrhea; Had a sore on my arm, it was hard; Had a sore on my arm, it was hard; The injection leaked a bit of liquid from the injection site; The injection leaked a bit of liquid from the injection site; A spontaneous report was received from a consumer who was also a 69-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced being a little bit tired, a little diarrhea, the injection leaked a bit of liquid from the injection site, dry eye irritation, and injection site sore and hard.  The patient's medical history included dry eyes. Products known to have been used by the patient were not provided.  On 11 Jan 2021, prior to the onset of the events, the patient received one of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.    On 11 Jan 2021, as the mRNA-1273 vaccine was being given, the patient noted that the injection leaked a bit of liquid from the injection site. She denied a topical reaction. She reported that the side effects were mild, and she was fine that evening.  On 12 Jan 2021, she reports having a sore on her arm that was hard.   On 13 Jan 2021, she reported that she had a little diarrhea, and her eyes were very irritated, but she noted that she has dry eye to account for this.   On 15 Jan 2021, the diarrhea was almost resolved.   Treatment information was not provided.   Action taken with mRNA-1273 was not reported.  The outcome of the events, eye irritation and a little diarrhea, were resolving. The outcome of the events, being a little bit tired and injection site sore and hard, was not provided. The outcome of event, topical exposure at injection site, was resolved on 11 Jan 2021.; Reporter's Comments: The patient's medical history of dry eyes remains a contributor for the event of eye irritation. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Blood bactericidal activity, Infectious mononucleosis, Streptococcal bacteraemia
Clinical narrative: Streptococcus in blood; Tested positive for mononucleosis; A spontaneous report was received from a 27-year-old, female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and tested positive for Mononucleosis and Streptococcus in blood.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 11 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 23 Jan 2021, she tested positive for Mononucleosis and Streptococcus in blood. Treatment for the event included Amoxicillin for 3 weeks.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the events was unknown.; Reporter's Comments: This case concerns a 27-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted event of streptococcus in blood and the non-serious unlisted event of Infectious mononucleosis.  The events occurred 13 days after the first dose of mRNA-1273. Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Head injury, Laboratory test, Magnetic resonance imaging
Clinical narrative: TIA diagnosis at hospital; Conscious after fall; Dizzy/ lightheadedness; Head bump (temple area and ear caused by hit sink during fall); A spontaneous report was received from a consumer who was also a 90-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced transient ischemic attack, fall, dizzy lightheadedness, and a head bump.   The patient's medical history, as provided by the reporter, included transient ischemic attack; the patient experienced 3 events in 2020.  No relevant concomitant medications were reported.   On 23 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number 030L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 25 Jan 2021, the patient experienced dizzy lightheadedness and a fall, resulting in a head bump in her temple and ear caused by hitting the sink as she fell. The patient was hospitalized following the fall and diagnosed with transient ischemic attack.   On 26 Jan 2021, the patient received magnetic resonance imaging and a laboratory test.  On 27 Jan 2021, the lightheadedness and head bump had resolved.  Action taken with mRNA-1273 in response to the event(s) was not reported.   The outcome of the events, transient ischemic attack and fall, was considered resolved on 25 Jan 2021. The outcome of the events, lightheadedness and head bump, was considered resolved on 27 Jan 2021.; Reporter's Comments: This case concerns a 90-years-old female patient with a relevant medical history of three TIA within last year, who experienced a serious unexpected event of Dizziness and Transient ischaemic attack and non-serious unexpected events of Fall and Head injury.  The events of occurred approximately 2 days after first dose of mRNA-1273, lot # 030L20A. Treatment details were not provided.  Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded. However, patient's advanced age and prior history of TIA are considered significant confounders.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: TIA diagnosis at hospital; Conscious after fall; Dizzy/ lightheadedness; Head bump (temple area and ear caused by hit sink during fall); A spontaneous report was received from a consumer who was also a 90-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced transient ischemic attack, fall, dizzy lightheadedness, and a head bump.   The patient's medical history, as provided by the reporter, included transient ischemic attack; the patient experienced 3 events in 2020.  No relevant concomitant medications were reported.   On 23 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number 030L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 25 Jan 2021, the patient experienced dizzy lightheadedness and a fall, resulting in a head bump in her temple and ear caused by hitting the sink as she fell. The patient was hospitalized following the fall and diagnosed with transient ischemic attack.   On 26 Jan 2021, the patient received magnetic resonance imaging and a laboratory test.  On 27 Jan 2021, the lightheadedness and head bump had resolved.  Action taken with mRNA-1273 in response to the event(s) was not reported.   The outcome of the events, transient ischemic attack and fall, was considered resolved on 25 Jan 2021. The outcome of the events, lightheadedness and head bump, was considered resolved on 27 Jan 2021.; Reporter's Comments: This case concerns a 90-years-old female patient with a relevant medical history of three TIA within last year, who experienced a serious unexpected event of Dizziness and Transient ischaemic attack and non-serious unexpected events of Fall and Head injury.  The events of occurred approximately 2 days after first dose of mRNA-1273, lot # 030L20A. Treatment details were not provided.  Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded. However, patient's advanced age and prior history of TIA are considered significant confounders.