chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dysphagia, Dyspnoea, Erythema, Injection site erythema
Clinical narrative: developed hives neck and abdomen. redness , swelling and induration at the site of the injection L arm. Tender and warm to touch. some SOB, anxiety, throat discomfort. No lips or tongue swelling, some difficulty swallowing? Prescribed antihistamines. Prednisone  and epi pen. Got better the second day
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Oropharyngeal discomfort, Skin warm, Tenderness, Urticaria
Clinical narrative: developed hives neck and abdomen. redness , swelling and induration at the site of the injection L arm. Tender and warm to touch. some SOB, anxiety, throat discomfort. No lips or tongue swelling, some difficulty swallowing? Prescribed antihistamines. Prednisone  and epi pen. Got better the second day
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Computerised tomogram, Deafness unilateral, Magnetic resonance imaging
Clinical narrative: Hearing loss, treated with steroids.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Constipation, Flatulence, Paraesthesia, Pyrexia
Clinical narrative: Woke up with acute stomach pain, fever, tremor, reported to have ?tingly? feet when he walked. Stomach pain not experienced before in the past in this manner. Got treated at urgent care and received an x-ray, which showed constipation and trapped gas. Negative COVID PCR. Treated with Motrin and Miralax. Stomach pain subsided 12 hours late, fever subsided 24 hours later.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Tremor, X-ray abnormal
Clinical narrative: Woke up with acute stomach pain, fever, tremor, reported to have ?tingly? feet when he walked. Stomach pain not experienced before in the past in this manner. Got treated at urgent care and received an x-ray, which showed constipation and trapped gas. Negative COVID PCR. Treated with Motrin and Miralax. Stomach pain subsided 12 hours late, fever subsided 24 hours later.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: PATIENT WAS GIVEN 0.25ML OUT OF MODERNA BOOSTER VIAL INSTEAD OF GETTING 0.5ML
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was getting 1st booster vaccine (pfizer). After vaccine was given, the administrator noticed patient already got 1st booster and the shot she got today should be second booster. But second booster is not approved for non-immunocompromised patients.  Informed mother of the mistake and she said it was okay. She said she can't remember that her daughter got the first booster and believes her daughter did not get the first booster shot even though it is on her vaccine card.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: The vaccine vial was not diluted with the diluent and the medical assistant drew 0.2 ml from the vial for the 5y -11 y Pfizer COVID vaccine. The patient was given 0.2 ml. However it was not diluted as it should have been.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: The patient received 0.2 ml of undiluted vaccine. The diluent was not added.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: The diluent was not added properly. The medical assistant said she only added 0.22 ml instead of 2.2 ml.  The amount drawn and given to patient was 0.2 ml but not sure if medical assistant added diluent or if she did not add enough.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac flutter, Dizziness, Electrocardiogram ambulatory abnormal
Clinical narrative: Sudden dizziness when I turned my head or stood up: light-headedness and fluttering of heartbeat. After several days, the sudden dizziness symptoms went away. Light-headed symptoms occasionally remain. Atrial fibrillation continues.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose normal, Blood test normal, Liver function test normal, Pruritus, Renal function test normal
Clinical narrative: I have had severe itching on the soles of my feet for over a week. I?ve gone to an immediate care center and emergency room for treatment.  I also went to my doctors office and was seen by a RN.  I had  blood work done and all results came back normal (liver and Kidney functions normal and blood sugar normal.   I am currently taking an anahistomine to release itching. I?m concerned that it  is not improving.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Eye pain, Fatigue, Headache, Menstrual disorder
Clinical narrative: Stabbing pain starting head and rotating body sites, behind my eye, then in my joints elbow, knee, pins needle stabbing intensity, aching tired fever, arm unable to move for 1 week, stabbing pins and needles rotating paint stays in one area for a minute to 30 minutes or so then rotates ro a knew area, then reoccured at the beginning of menstrual cycle    horrible on month one then less and less each month thereafter, now occasional stabbing pain
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain, Paraesthesia, Pyrexia
Clinical narrative: Stabbing pain starting head and rotating body sites, behind my eye, then in my joints elbow, knee, pins needle stabbing intensity, aching tired fever, arm unable to move for 1 week, stabbing pins and needles rotating paint stays in one area for a minute to 30 minutes or so then rotates ro a knew area, then reoccured at the beginning of menstrual cycle    horrible on month one then less and less each month thereafter, now occasional stabbing pain
Age: 0.92
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Skin rashes all over the back, as well as the abdomal area of the patient
Age: 97.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Narrative:  Patient passed away at home under the care of hospice at approximately 6:15pm on 5/18/22.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Cyanosis, Death, Hyporesponsive to stimuli, Peripheral coldness, Respiratory arrest
Clinical narrative: Narrative:  Pt with h/o frontotemporal dementia. Caregiver states about 4:30-5:00 am she went to check on him, change him etc. States he felt very cold, then she noticed his nails were blue and he didn't seem to be breathing. Her daughter was in the apartment with her at the time. They called 911. Patient was DNR. He was reported deceased on their arrival. States that she noticed yesterday he was not as responsive. He did not seem to be in any pain. She is thankful that he was able to be home with family when he passed and that he was comfortable.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Death
Clinical narrative: Narrative: Patient passed away due to COVID-19. He had received the COVID-19 vaccine.
Age: 90.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death
Clinical narrative: Narrative:  Patient passed away due to COVID-19. He had received the COVID-19 vaccine.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death
Clinical narrative: Narrative: Patient passed away due to COVID-19. He was hospitalized and had received a COVID-19 Vaccine.
Age: 92.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Death
Clinical narrative: Narrative: Pt. passed away on 3/25/22 at approximately 8:30pm under the care of Hospice.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Narrative: Patient died at 8:30 pm on 4/21/22 at home under the care of Hospice.
Age: 92.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Death
Clinical narrative: Narrative:  Pt died 3/22/2022 while hospitalized at hospital.
Age: 101.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Cardiac failure, Death
Clinical narrative: Narrative:  pt was under hospice for HF for some time prior to death
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cardiac arrest, Death, SARS-CoV-2 test positive
Clinical narrative: Narrative: pt had first 2 doses of COVID Vaccine, then was COVID positive 1/19/22; pt died from cardiac arrest on 2/2/22 while in COVID ward at outside hospital
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Cough, Death, Fibrin D dimer increased, General physical health deterioration
Clinical narrative: Narrative:  84 year old male admitted on May 29 2022 with with worsening hallucinations. He was found to be COVID positive on June 7 2022 during routine surveillance screening and had mild hypoxia, cough, and wheezing. He had received Moderna vaccine x 3 on February 11 2021, March 11 2021, and December 7 2021. He was treated with remdesivir 200 mg IV x 1 then 100 mg daily x 4 days and methylprednisolone 20 mg IV q8h x 3 days and then dexamethasone 6 mg orally daily x 5 days. On June 8 2022 patient was noted to have an elevated D-dimer and found to have PE. He was noted to have clinical deterioration and went to comfort care on June 13 2022 and expired on June 15 2022.
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hallucination, Hypoxia, SARS-CoV-2 test positive, Wheezing
Clinical narrative: Narrative:  84 year old male admitted on May 29 2022 with with worsening hallucinations. He was found to be COVID positive on June 7 2022 during routine surveillance screening and had mild hypoxia, cough, and wheezing. He had received Moderna vaccine x 3 on February 11 2021, March 11 2021, and December 7 2021. He was treated with remdesivir 200 mg IV x 1 then 100 mg daily x 4 days and methylprednisolone 20 mg IV q8h x 3 days and then dexamethasone 6 mg orally daily x 5 days. On June 8 2022 patient was noted to have an elevated D-dimer and found to have PE. He was noted to have clinical deterioration and went to comfort care on June 13 2022 and expired on June 15 2022.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Narrative:  Hospitalized on 6/29/22
Age: 96.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death
Clinical narrative: Narrative: Patient passed away due to COVID-19. He had received a COVID-19 Vaccine.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness lightheaded Narrative: V/S checked. Observed for 30 minutes.  Felt better.
Age: 100.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death
Clinical narrative: Narrative: Patient passed away due to COVID-19. He had received a COVID-19 vaccine.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death
Clinical narrative: Narrative: Patient passed away due to COVID-19. He had received the COVID-19 vaccine.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Death
Clinical narrative: Narrative:  PATIENT PASSED AWAY DUE TO COVID-19. PT WAS HOSPITALIZED HAD RECEIVED THREE COVID-19 VACCINE AT THE TIME OF DEATH.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Headache CHILLS Narrative:
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death
Clinical narrative: Narrative:  Patient passed away due to COVID-19. He had received the COVID-19 vaccine.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Death
Clinical narrative: Narrative: Patient passed away due to COVID-19. He was hospitalized and had received the COVID-19 vaccine.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Pruritus
Clinical narrative: Narrative:  Patient presented for COVID moderna booster, had 3 previous doses with no reported side effects. apprx at 14 min post vaccine, patient reported feeling itchy on top of head and difficulty swallowing, fnp presented to eval patient, per provider instructions writer admin 12.5mg po liquid Benadryl, writer monitoring, patient reports symptoms worse, per provider instructions ems activated patient given additional 12.5 mg dose of liquid benadryl, epi pen ready and available Patient is a&ox3, resp even nonlabored, speech clear, answering approp, Mood is pleasant. Affect is congruent. Thought Processes are intact. no rashes / redness / swelling noted patient remained seated in private vehicle continous monitoring by writer while awaiting ambulance patient contacted 2 family members independ via his cell phone to notify he was being transmitted to hospital, No adventitious sounds (such as wheezing, rhonchi, or rales) heard when speaking over the phone, his voice is clear and can speak in full sentences without sob, ems arrived on site stand by assist patient to stretcher, report given by writer to ems attendent, problem list , med list provided, Local emergency room note indicates: EMS gave 2 doses of EpiPen injections and 2 doses of Benadryl. Patient able to complete sentences Normal no chest pain shortness of breath now. No nausea vomiting no headache or visual symptoms his throat feels tight. In the ER patient received methylPREDNISolone 125 mg Route: IV; Rate: bolus; Site: left forearm; 14:15 ED course: Patient is feeling better almost back base line. Mild itching in the right cvr ear area no rash. Vitals normal and her cardiopulmonary monitoring. Given prednisone RX to have on standby. Family to keep an eye on him overnight his daughter and son-in-law live with him They will come and pick him up.
Age: 89.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death
Clinical narrative: Narrative:  Patient passed away due to COVID-19. He had received the COVID-19 vaccine.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death
Clinical narrative: Narrative:  PATIENT PASSED AWAY DUE TO COVID-19. HE WAS HOSPITALIZED AND HAD RECEIVED THE COVID-19 VACCINE.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Death
Clinical narrative: Narrative:  PATIENT PASSED AWAY DUE TO COVID-19. PT WAS HOSPTILIZED AND FULLY VACCINATED AT THE TIME OF HIS DEATH.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death
Clinical narrative: Narrative:  PATIENT PASSED AWAY DUE TO COVID-19 . HE WAS IN THE HOSPITIZED AND HAD RECEIVED A COVID-19 VACCINE.
Age: 94.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death
Clinical narrative: Narrative:  Patient passed away due to COVID-19. He had received the COVID-19 vaccine.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, Dyspnoea, Pneumonia, Pulmonary embolism
Clinical narrative: Narrative: as described in events, do not believe death related to vaccine/booster. had received 3 doses of Moderna covid vaccine/booster previously with no reaction
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Narrative: as described in events, do not believe death related to vaccine/booster. had received 3 doses of Moderna covid vaccine/booster previously with no reaction
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Intensive care, Pyrexia, Respiratory failure, SARS-CoV-2 test positive
Clinical narrative: Narrative:  73 year old male admitted on June 4 2022 with from long-term care after testing COVID positive on surveillance screening. He had a fever fo 101F and was transferred to intensive care without evidence of respiratory failure. He had received Moderna vaccine x 3 on December 28, 2020, January 26 2021, October 27 2021. He was treated with remdesivir 200 mg IV x 1 then 100 mg daily x 4 days and dexamethasone 6 mg IV daily x 5 days. He clinically improved and returned to long-term care on June 25 2022 after completing quarantine.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Hypoxia, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Narrative: 74 year old female admitted on June 6 2022 with after testing positive in long-term care. She was noted to have fever and hypoxia on transfer to acute care unit for isolation.. He had received Moderna vaccine x 3 on December 28 2020, January 26 2021, and October 29 2021. She was treated with remdesivir 200 mg IV x 1 then 100 mg daily x 4 days, dexamethasone 6 mg IV x 5 days then dexamethasone 6 mg orally x 5 days.. She remained in the acute care unit until June 17 2022 while quarantining and was transferred back to long term care.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Productive cough
Clinical narrative: Narrative: 81 year old male admitted on June 16 2022 with productive cough x 2 days. He had received Moderna vaccine x 4 on January 29 2021, March 1 2021, October 1 2021, and June 10 2022. He was treated with remdesivir 200 mg IV x 1 then 100 mg daily x 4 days. He was discharged back to long term care July 6 2022 after quarantine was complete.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bacteraemia, COVID-19, Enterococcal infection, Hypoxia, SARS-CoV-2 test positive
Clinical narrative: Narrative: 79 year old male admitted on May 19 2022 with E. faecalis bacteremia with likely urinary source. On May 25 2022 patient was found to be COVID-19 positive and was hypoxic. He had received Pfizer vaccine x 2 on March 1 2021 and March 22 2021 at an outside facility. He was treated with dexamethasone 6 mg x 7 days and remdesivir 200 mg IV x 1 then 100 mg daily x 4 days. He completed his isolation on June 15 2022 and as discharged to SNF for management of other medical problems.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, Body temperature increased, COVID-19, COVID-19 pneumonia, Cough
Clinical narrative: Narrative: Received 1st Pfizer COVID vaccine on 01/16/21, 2nd dose of Pfizer on 2/16/21. No boosters noted. Pt admitted to ICU with COVID-19 infection on 7/1/22. This is a 73-year-old male who has been admitted via emergency room with diagnosis of bilateral Covid pneumonia and acute hypoxic respiratory failure..Patient required 2 to 2.5 L of FiO2 by nasal cannula and SPO2 and ranging between 94 to 96%. No fever or chills are noted. Has scanty dry cough.. Tmax noted since admission is 101.3 degrees.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Intensive care, Pneumonia
Clinical narrative: Narrative: Received 1st Pfizer COVID vaccine on 01/16/21, 2nd dose of Pfizer on 2/16/21. No boosters noted. Pt admitted to ICU with COVID-19 infection on 7/1/22. This is a 73-year-old male who has been admitted via emergency room with diagnosis of bilateral Covid pneumonia and acute hypoxic respiratory failure..Patient required 2 to 2.5 L of FiO2 by nasal cannula and SPO2 and ranging between 94 to 96%. No fever or chills are noted. Has scanty dry cough.. Tmax noted since admission is 101.3 degrees.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Death
Clinical narrative: Narrative:  PATIENT PASSED AWAY DUE TO COVID 19 .HE HAD RECEIVED COVID-19 VACCINE
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death
Clinical narrative: Narrative: Patient passed away due to COVID-19. He was hospitalized and had received several COVID-19 Vaccine.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Death
Clinical narrative: Narrative:  PATIENT PASSED AWAY DUE TO COVID-19. HE WAS HOSPITALIZED AND HAD RECEIVED THREE COVID-19 VACCINE.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death
Clinical narrative: Narrative: Patient passed away due to COVID-19. He was hospitalized and received a COVID-19 vaccine.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death
Clinical narrative: Narrative: Patient passed away due to COVID-19. He had received the COVID-19 vaccine.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Death
Clinical narrative: Narrative: Patient passed away due to COVID-19. He had received the COVID-19 vaccine.
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death
Clinical narrative: Narrative: Patient passed away due to COVID-19. He had received the COVID-19 vaccine.
Age: 90.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death
Clinical narrative: Narrative: Patient passed away due to COVID-19. He had received the COVID-19 vaccine.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest, Death
Clinical narrative: Narrative: 72yo male patient received a Covid healthcare professional vaccine (J&J) EUA on 4/8/2021. Pt died on 6/18/2022. Patient self-present to community emergency facility Emergency Notification Intake Date Presenting to the Facility: 06/18/2022 Chief Complaint: Cardiac Arrest Primary Diagnosis: Patient Admitted? No. ED/Death Note. Expired 6/18/2022 @ 2315 Appears death is not related to vaccine given long time between vaccine given and date of death from cardiac arrest.
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: Narrative: Per 1/11/22 note: Influenza vaccine is contraindicated: Severe allergic reaction (e.g. anaphylaxis)j to a vaccine component Comment: Patient stated that she had ANAPHYLAXIS REACTION to the flu vaccine This reaction occurred at another clinic. No other documentation available.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Audiogram, Magnetic resonance imaging head, Myoclonus, Surgery, Tympanometry
Clinical narrative: Two days after receiving the second Pfizer COVID 19 vaccine developed Myoclonus of the middle ear.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Disturbance in attention, Dizziness, Ear discomfort, Gait disturbance
Clinical narrative: Two days after receiving the second Pfizer COVID 19 vaccine developed Myoclonus of the middle ear.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoacusis, Impaired work ability, Loss of personal independence in daily activities, Magnetic resonance imaging, Muscle twitching
Clinical narrative: Two days after receiving the second Pfizer COVID 19 vaccine developed Myoclonus of the middle ear.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Sleep disorder, Tinnitus, Tremor, Vertigo
Clinical narrative: Two days after receiving the second Pfizer COVID 19 vaccine developed Myoclonus of the middle ear.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: 01/18/22 presents to EC ED for recurrent abdominal pain. PMHx of PAD, PCI with DES on Brilinta. Recent PMH of total aortic occlusion.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, COVID-19, SARS-CoV-2 test positive
Clinical narrative: 01/18/22 presents to EC ED for recurrent abdominal pain. PMHx of PAD, PCI with DES on Brilinta. Recent PMH of total aortic occlusion.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dysstasia, Gait disturbance, Muscular weakness
Clinical narrative: Severe weakness (needed physical therapy to regain some strength) - still experiencing some weakness  , non-epileptic seizures (never had a seizure before) - still experiencing , extreme dizziness - still experiencing , sharpe sensations through limbs - still experiencing,
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Computerised tomogram, Dizziness, Echocardiogram, Electrocardiogram
Clinical narrative: Severe weakness (needed physical therapy to regain some strength) - still experiencing some weakness  , non-epileptic seizures (never had a seizure before) - still experiencing , extreme dizziness - still experiencing , sharpe sensations through limbs - still experiencing,
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electromyogram, Inappropriate schedule of product administration, Magnetic resonance imaging, Seizure, Sensory disturbance
Clinical narrative: Severe weakness (needed physical therapy to regain some strength) - still experiencing some weakness  , non-epileptic seizures (never had a seizure before) - still experiencing , extreme dizziness - still experiencing , sharpe sensations through limbs - still experiencing,
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tilt table test
Clinical narrative: Severe weakness (needed physical therapy to regain some strength) - still experiencing some weakness  , non-epileptic seizures (never had a seizure before) - still experiencing , extreme dizziness - still experiencing , sharpe sensations through limbs - still experiencing,
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: hospitalized with covid; fully vaccinated
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, COVID-19, Nausea, SARS-CoV-2 test positive
Clinical narrative: 01/14/22 presents to EC ED for "weakness and nausea". PMHx of "CAD s/p 3 stents (12/2021), HFrEF, dilated cardiomyopathy, HTN, ESRD, and T2DM"
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Cough, Dizziness, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: 07/05/22 transferred to Inpatient Rehab Unit "Lower extremity wounds".  PMHx of "ESRD on HD" "COPD"  "type 2 diabetes, hypertension, hyperlipidemia, A. fib, chronic diastolic heart failure, COVID-19 in January 2022, and chronic bilateral lower extremity wounds"
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Limb injury, SARS-CoV-2 test positive
Clinical narrative: 07/05/22 transferred to Inpatient Rehab Unit "Lower extremity wounds".  PMHx of "ESRD on HD" "COPD"  "type 2 diabetes, hypertension, hyperlipidemia, A. fib, chronic diastolic heart failure, COVID-19 in January 2022, and chronic bilateral lower extremity wounds"
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Feeling abnormal, Feeling hot
Clinical narrative: cold sores on her lips; Pain at the injection site; Swelling at the injection site; Lethargy; Fever; Cramps; Diarrhea; Nausea; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number X2X35, expiry date 12th May 2023) for prophylaxis.   On 1st July 2022, the patient received the 2nd dose of Shingrix. On 2nd July 2022, 1 days after receiving Shingrix, the patient experienced injection site pain, injection site swelling, lethargy, fever, cramp, diarrhea and nausea. On 4th July 2022, the patient experienced cold sores. On an unknown date, the outcome of the injection site pain, injection site swelling, fever, cramp, diarrhea and nausea were recovered/resolved and the outcome of the lethargy and cold sores were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, lethargy, fever, cramp, diarrhea, nausea and cold sores to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-JUL-2022 Reporter's comment: The patient self-reported this case. The patient received dose of Shingrix vaccine and upon the following day post vaccination she developed lethargy, fever, cramps, diarrhea, nausea, as well as pain and swelling at the injection site. 3 days after vaccination, the patient also experienced cold sores on her lips. The patient stated that most of the symptoms had resolved except for the lethargy and the cold sores.  The reporter gave permission to follow up with healthcare professional. The reporter consented to follow-up.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Lethargy, Myalgia, Oral herpes, Pain in extremity
Clinical narrative: cold sores on her lips; Pain at the injection site; Swelling at the injection site; Lethargy; Fever; Cramps; Diarrhea; Nausea; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number X2X35, expiry date 12th May 2023) for prophylaxis.   On 1st July 2022, the patient received the 2nd dose of Shingrix. On 2nd July 2022, 1 days after receiving Shingrix, the patient experienced injection site pain, injection site swelling, lethargy, fever, cramp, diarrhea and nausea. On 4th July 2022, the patient experienced cold sores. On an unknown date, the outcome of the injection site pain, injection site swelling, fever, cramp, diarrhea and nausea were recovered/resolved and the outcome of the lethargy and cold sores were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, lethargy, fever, cramp, diarrhea, nausea and cold sores to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-JUL-2022 Reporter's comment: The patient self-reported this case. The patient received dose of Shingrix vaccine and upon the following day post vaccination she developed lethargy, fever, cramps, diarrhea, nausea, as well as pain and swelling at the injection site. 3 days after vaccination, the patient also experienced cold sores on her lips. The patient stated that most of the symptoms had resolved except for the lethargy and the cold sores.  The reporter gave permission to follow up with healthcare professional. The reporter consented to follow-up.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: cold sores on her lips; Pain at the injection site; Swelling at the injection site; Lethargy; Fever; Cramps; Diarrhea; Nausea; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number X2X35, expiry date 12th May 2023) for prophylaxis.   On 1st July 2022, the patient received the 2nd dose of Shingrix. On 2nd July 2022, 1 days after receiving Shingrix, the patient experienced injection site pain, injection site swelling, lethargy, fever, cramp, diarrhea and nausea. On 4th July 2022, the patient experienced cold sores. On an unknown date, the outcome of the injection site pain, injection site swelling, fever, cramp, diarrhea and nausea were recovered/resolved and the outcome of the lethargy and cold sores were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, lethargy, fever, cramp, diarrhea, nausea and cold sores to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-JUL-2022 Reporter's comment: The patient self-reported this case. The patient received dose of Shingrix vaccine and upon the following day post vaccination she developed lethargy, fever, cramps, diarrhea, nausea, as well as pain and swelling at the injection site. 3 days after vaccination, the patient also experienced cold sores on her lips. The patient stated that most of the symptoms had resolved except for the lethargy and the cold sores.  The reporter gave permission to follow up with healthcare professional. The reporter consented to follow-up.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Injection site pain, Injection site swelling, Lethargy, Muscle spasms
Clinical narrative: cold sores on her lips; Pain at the injection site; Swelling at the injection site; Lethargy; Fever; Cramps; Diarrhea; Nausea; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number X2X35, expiry date 12th May 2023) for prophylaxis.   On 1st July 2022, the patient received the 2nd dose of Shingrix. On 2nd July 2022, 1 days after receiving Shingrix, the patient experienced injection site pain, injection site swelling, lethargy, fever, cramp, diarrhea and nausea. On 4th July 2022, the patient experienced cold sores. On an unknown date, the outcome of the injection site pain, injection site swelling, fever, cramp, diarrhea and nausea were recovered/resolved and the outcome of the lethargy and cold sores were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, lethargy, fever, cramp, diarrhea, nausea and cold sores to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-JUL-2022 Reporter's comment: The patient self-reported this case. The patient received dose of Shingrix vaccine and upon the following day post vaccination she developed lethargy, fever, cramps, diarrhea, nausea, as well as pain and swelling at the injection site. 3 days after vaccination, the patient also experienced cold sores on her lips. The patient stated that most of the symptoms had resolved except for the lethargy and the cold sores.  The reporter gave permission to follow up with healthcare professional. The reporter consented to follow-up.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Oral herpes, Pyrexia
Clinical narrative: cold sores on her lips; Pain at the injection site; Swelling at the injection site; Lethargy; Fever; Cramps; Diarrhea; Nausea; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number X2X35, expiry date 12th May 2023) for prophylaxis.   On 1st July 2022, the patient received the 2nd dose of Shingrix. On 2nd July 2022, 1 days after receiving Shingrix, the patient experienced injection site pain, injection site swelling, lethargy, fever, cramp, diarrhea and nausea. On 4th July 2022, the patient experienced cold sores. On an unknown date, the outcome of the injection site pain, injection site swelling, fever, cramp, diarrhea and nausea were recovered/resolved and the outcome of the lethargy and cold sores were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, lethargy, fever, cramp, diarrhea, nausea and cold sores to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-JUL-2022 Reporter's comment: The patient self-reported this case. The patient received dose of Shingrix vaccine and upon the following day post vaccination she developed lethargy, fever, cramps, diarrhea, nausea, as well as pain and swelling at the injection site. 3 days after vaccination, the patient also experienced cold sores on her lips. The patient stated that most of the symptoms had resolved except for the lethargy and the cold sores.  The reporter gave permission to follow up with healthcare professional. The reporter consented to follow-up.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient through other manufacturer (Pfizer) concerned a 48 year old female . The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no drug allergy. The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1802068 expiry: UNKNOWN) dose was not reported, 1 total administered on 30-MAR-2021 12:00 to right arm for prophylactic vaccination. Age at time of vaccination 48 years old. No concomitant medications were reported. The patient additionally received non-company suspect vaccine included Pfizer Biontec covid-19 vaccine (tozinameran) (Dose number in series 2) ( batch number: FH8027 expiry: UNKNOWN, form of admin, route of admin, and were not reported) dose was not reported, administered on 02-DEC-2021 12:00 to right arm for prophylactic vaccination.  On an unspecified date, the patient experienced covid-19 infection for which patient received Pfizer drug (unspecified) as a treatment. The patient received non-company co-suspect Pfizer drug (unspecified) (form of administration, route of administration, batch number: G00470, and expiry were not reported) dose was not reported, administered from 12-JUN-2022 to 16-JUN-2022 for treatment of COVID-19. The patient was not receiving any other medications/products within 2 weeks of starting COVID-19 treatment. On 26-JUN-2022, the patient had symptoms returned tested positive again (captured as confirmed covid-19 infection) (Dose number in series 2) which led to confirmed clinical vaccination failure (Dose number in series 1). Laboratory data (dates unspecified) included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint, and reference number requested.; Sender's Comments: V0: 20220716757-COVID-19 VACCINE Ad26.COV2.S- confirmed clinical vaccination failure.The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient through other manufacturer (Pfizer) concerned a 48 year old female . The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no drug allergy. The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1802068 expiry: UNKNOWN) dose was not reported, 1 total administered on 30-MAR-2021 12:00 to right arm for prophylactic vaccination. Age at time of vaccination 48 years old. No concomitant medications were reported. The patient additionally received non-company suspect vaccine included Pfizer Biontec covid-19 vaccine (tozinameran) (Dose number in series 2) ( batch number: FH8027 expiry: UNKNOWN, form of admin, route of admin, and were not reported) dose was not reported, administered on 02-DEC-2021 12:00 to right arm for prophylactic vaccination.  On an unspecified date, the patient experienced covid-19 infection for which patient received Pfizer drug (unspecified) as a treatment. The patient received non-company co-suspect Pfizer drug (unspecified) (form of administration, route of administration, batch number: G00470, and expiry were not reported) dose was not reported, administered from 12-JUN-2022 to 16-JUN-2022 for treatment of COVID-19. The patient was not receiving any other medications/products within 2 weeks of starting COVID-19 treatment. On 26-JUN-2022, the patient had symptoms returned tested positive again (captured as confirmed covid-19 infection) (Dose number in series 2) which led to confirmed clinical vaccination failure (Dose number in series 1). Laboratory data (dates unspecified) included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint, and reference number requested.; Sender's Comments: V0: 20220716757-COVID-19 VACCINE Ad26.COV2.S- confirmed clinical vaccination failure.The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 4.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Anaemia, Arthralgia, Aspartate aminotransferase increased, C-reactive protein increased, Epstein-Barr virus test negative
Clinical narrative: Had fever, hives & joint pains 3 days after vaccination. Lasting 9 days total.
Age: 4.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Full blood count abnormal, Inflammatory marker increased, Joint swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Had fever, hives & joint pains 3 days after vaccination. Lasting 9 days total.
Age: 4.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Pyrexia, Rash, Rash erythematous, Red blood cell sedimentation rate increased, Respiratory viral panel
Clinical narrative: Had fever, hives & joint pains 3 days after vaccination. Lasting 9 days total.
Age: 4.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: SARS-CoV-2 test negative, Urine analysis normal, Urticaria, Weight bearing difficulty, X-ray limb normal
Clinical narrative: Had fever, hives & joint pains 3 days after vaccination. Lasting 9 days total.
Age: 4.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Arthralgia, Pyrexia, Urticaria
Clinical narrative: Had fever, hives & joint pains 3 days after vaccination. Lasting 9 days total.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death on 07/09/2022
Age: 43.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Injection site discomfort, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: There was a bit of soreness at the injection site following the shot. Nothing major. The next day, I felt a little firmness in the area, and it was a bit more tender. With each passing day, the swelling got bigger. A firm swollen orb has been forming under the skin, growing bigger and more turgid each day.  It got to be the size of a marble, then the size of a gumball, and today, it's actually expanding in shape and is (pretty much exactly) the size and shape of a Cheeto Puff.  The area is warm to the touch. There is visible redness radiating around the area, and it is slightly itchy. There is discomfort and minimal soreness, but no pain.
Age: 43.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: There was a bit of soreness at the injection site following the shot. Nothing major. The next day, I felt a little firmness in the area, and it was a bit more tender. With each passing day, the swelling got bigger. A firm swollen orb has been forming under the skin, growing bigger and more turgid each day.  It got to be the size of a marble, then the size of a gumball, and today, it's actually expanding in shape and is (pretty much exactly) the size and shape of a Cheeto Puff.  The area is warm to the touch. There is visible redness radiating around the area, and it is slightly itchy. There is discomfort and minimal soreness, but no pain.
Age: 12.0
Sex: M
Vaccine: COVID19, HPV9, MNQ, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: COVID 19 Pfizer dose given beyond use date.  There were no signs or symptoms of side effects.  There was no treatment necessary.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: COVID 19 Pfizer dose given beyond use date.  There were no signs or symptoms of side effects.  There was no treatment necessary.
Age: 36.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Arthralgia, Asthenia, Fatigue, Muscular weakness, Myalgia
Clinical narrative: About 5 hours after the shot, my RIGHT (opposite from injection) arm/shoulder experienced intense muscle/joint/tendon pain/weakness. Massage did not seem to help. This arm feels incredibly tired and sore. I am physically active and lifted weights earlier in the day ? but nothing out of the ordinary until this totally random flare-up. No pain, swelling, or anything anywhere prior.
Age: 36.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Pain in extremity, Tendon pain
Clinical narrative: About 5 hours after the shot, my RIGHT (opposite from injection) arm/shoulder experienced intense muscle/joint/tendon pain/weakness. Massage did not seem to help. This arm feels incredibly tired and sore. I am physically active and lifted weights earlier in the day ? but nothing out of the ordinary until this totally random flare-up. No pain, swelling, or anything anywhere prior.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac imaging procedure, Diarrhoea, Dizziness, Headache, Injected limb mobility decreased
Clinical narrative: Shot 1: Extreme vaginal bleeding for 6 weeks straight; Shot 2: Nausea, dizziness, vomiting, diarrhea, pounding headache and inability to raise right arm above shoulder.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Magnetic resonance imaging, Nausea, Scan brain, Ultrasound Doppler
Clinical narrative: Shot 1: Extreme vaginal bleeding for 6 weeks straight; Shot 2: Nausea, dizziness, vomiting, diarrhea, pounding headache and inability to raise right arm above shoulder.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage, Vomiting, X-ray
Clinical narrative: Shot 1: Extreme vaginal bleeding for 6 weeks straight; Shot 2: Nausea, dizziness, vomiting, diarrhea, pounding headache and inability to raise right arm above shoulder.
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Agitation, Erythema, Feeling abnormal, Immunisation reaction, Injection site erythema
Clinical narrative: Swelling redness extreme  pain within 8 hours of vaccine. Injection site and whole deltoid muscle Hot to touch swollen hard very red. Fever. Agitated climbing the walls. Saying arm felt dead or dying. Had to mark arm with black perm marker to check the swelling.  Weird birthmark shaped marking from vaccine. I've used ice packs.. Zyrtec for antihistamine.  Ibuprofen  and Tylenol  for pain. Rest.
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site induration, Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: Swelling redness extreme  pain within 8 hours of vaccine. Injection site and whole deltoid muscle Hot to touch swollen hard very red. Fever. Agitated climbing the walls. Saying arm felt dead or dying. Had to mark arm with black perm marker to check the swelling.  Weird birthmark shaped marking from vaccine. I've used ice packs.. Zyrtec for antihistamine.  Ibuprofen  and Tylenol  for pain. Rest.
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Swelling
Clinical narrative: Swelling redness extreme  pain within 8 hours of vaccine. Injection site and whole deltoid muscle Hot to touch swollen hard very red. Fever. Agitated climbing the walls. Saying arm felt dead or dying. Had to mark arm with black perm marker to check the swelling.  Weird birthmark shaped marking from vaccine. I've used ice packs.. Zyrtec for antihistamine.  Ibuprofen  and Tylenol  for pain. Rest.