chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Dysarthria, Headache, Injected limb mobility decreased, Pain
Clinical narrative: Patient received Boostrix vaccine in left deltoid on 6/20. Administration was uneventful. Patient did not wince or complain of any pain during administration. Patient called pharmacy around 10:30 Sunday morning 6/25 saying that she received a shot on Tuesday, but this morning when she woke up, she stated that she could not move her left arm. She said she had to use her right arm to lift her left arm. She also stated she had a bad headache and the pharmacist on duty noticed that her speech was more slurred than usual. The patient was home alone. Pharmacist was concerned that patient may have been having a stroke. When patient didn't answer return phone call, pharmacist contacted someone for a wellness check. EMS went to the house and pt. refused medical care. Pt. called the pharmacy on 6/27 to request refills. When I asked how she was feeling, she said " I feel great". I specifically asked about her arm to which she said " I did a lot of housework yesterday and it worked the pain out",
Age: 3.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Moderna bivalent 10 mcg dose given instead of 25 mcg dose
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypoxia, Respiratory failure
Clinical narrative: HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY HYPOXEMIA
Age: 0.58
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Moderna bivalent 10 mcg dose given instead of bivalent 25 mcg dose
Age: 50.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ischaemic stroke, Obstructive sleep apnoea syndrome, Symptom recurrence
Clinical narrative: OBSTRUCTIVE SLEEP APNEA ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 3/6/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 78.0
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Pt. had previously had two doses of the Hep A-Hep B vaccine.   He was given Heplisav-B instead of a third dose of the Hep A-Hep B vaccine.
Age: 0.67
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Moderna bivalent 10 mcg dose given instead of bivalent 25 mcg dose
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction, Symptom recurrence
Clinical narrative: ACUTE NON ST ELEVATION MI 1/13/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chronic respiratory failure, Hypoxia, Respiratory failure
Clinical narrative: CHRONIC HYPERCAPNIC RESPIRATORY FAILURE HYPOXIA
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypoxia
Clinical narrative: HYPOXIA
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Underdose
Clinical narrative: COVID-19 mRNA LNP-S, bivalent PF 6mos-5yrs (Moderna), 10 mcg/0.2 mL (wrong dose given- under dosed)
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: Retrieving data. Wait a few seconds and try to cut or copy again.
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Symptom recurrence
Clinical narrative: ACUTE RESPIRATORY FAILURE 2/24/2023 &  1/10/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling
Clinical narrative: Within 2 hours of vaccine administration pts entire upper L arm began to swell parents administered benedryl that night and through the following day without relief.  Went to urgent care on day 3, prescribed amoxicillin for possible cellulitis, parent also continuing benedryl.  Symptoms gradually improved and now resolved.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac ablation, Electrocardiogram
Clinical narrative: Patient developed atrial fibrillation for the first time, later required ablation.  No risk factors for atrial fibrillation.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: Patient was administered a dose of the monovalent COVID-19 vaccines after they were no longer authorized. Patients' parents were notified and did not report any symptoms.
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction, Hypoxia
Clinical narrative: ACUTE NON ST ELEVATION MI HYPOXIA
Age: 11.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was 11 years and 8 months at the time of  vaccine administration. Vaccine is indicated for 12 years and up only. No adverse reactions reported.
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: Angioedema
Clinical narrative: ANGIOEDEMA, INIT
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiovascular evaluation, Computerised tomogram thorax abnormal, Condition aggravated, Dyspnoea, Gait disturbance
Clinical narrative: On 08APR2022 I experienced shortnees of breath while bending over and had repeated episodes of shortness of breath and diffuculty performing normal tasks including walking normal distaneces.  I had a complete cardiac and pulmonary workup no reason could be found for the shortness of breath.  Pulmonologists ordered Pulmonary tests and CT scans.  Function diminished and not improved with Albuterol or Symdicort.  CT scan shows infiltrate and micro nodules these come and go with scans.  Pulmonolgists thinks that it is due to secretions getting into lungs from my conditions of Gird and RHI.  Shortness of breath is ongoing on a daily basis despite attempts to diminish secretions.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, Increased bronchial secretion, Loss of personal independence in daily activities, Lung infiltration, Pulmonary function test decreased
Clinical narrative: On 08APR2022 I experienced shortnees of breath while bending over and had repeated episodes of shortness of breath and diffuculty performing normal tasks including walking normal distaneces.  I had a complete cardiac and pulmonary workup no reason could be found for the shortness of breath.  Pulmonologists ordered Pulmonary tests and CT scans.  Function diminished and not improved with Albuterol or Symdicort.  CT scan shows infiltrate and micro nodules these come and go with scans.  Pulmonolgists thinks that it is due to secretions getting into lungs from my conditions of Gird and RHI.  Shortness of breath is ongoing on a daily basis despite attempts to diminish secretions.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary mass
Clinical narrative: On 08APR2022 I experienced shortnees of breath while bending over and had repeated episodes of shortness of breath and diffuculty performing normal tasks including walking normal distaneces.  I had a complete cardiac and pulmonary workup no reason could be found for the shortness of breath.  Pulmonologists ordered Pulmonary tests and CT scans.  Function diminished and not improved with Albuterol or Symdicort.  CT scan shows infiltrate and micro nodules these come and go with scans.  Pulmonolgists thinks that it is due to secretions getting into lungs from my conditions of Gird and RHI.  Shortness of breath is ongoing on a daily basis despite attempts to diminish secretions.
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Respiratory failure
Clinical narrative: ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE
Age: 92.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction, Acute respiratory failure, Respiratory failure
Clinical narrative: ACUTE NON ST ELEVATION MI ACUTE NON ST ELEVATION MI (NSTEMI), TYPE 2 MI (SUPPLY/DEMAND) ACUTE HYPOXEMIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: Patient was administered a dose of the monovalent COVID-19 vaccines after they were no longer authorized. Patients' parents were notifed and did not report any symptoms.
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Symptom recurrence
Clinical narrative: ACUTE RESPIRATORY FAILURE 2/18/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Angina pectoris, Chronic respiratory failure, Obstructive sleep apnoea syndrome, Respiratory failure
Clinical narrative: ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE STABLE ANGINA CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Age: 61.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event
Clinical narrative: No adverse event happened - was told I had to fill this out anyway.
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Angiogram, Arthralgia, Asthenia, Back pain, CSF red blood cell count positive
Clinical narrative: Neurological: Bilateral ascending  LE numbness, increasing weakness, fatigue, tremors, dizziness,  breathing difficulties when exercising,  muscle cramping, heaviness off upper and lower extremities
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chest discomfort, Chest pain, Decreased appetite, Dizziness, Dyspnoea
Clinical narrative: Neurological: Bilateral ascending  LE numbness, increasing weakness, fatigue, tremors, dizziness,  breathing difficulties when exercising,  muscle cramping, heaviness off upper and lower extremities
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dyspnoea exertional, Electromyogram, Facet joint syndrome, Fatigue, Headache
Clinical narrative: Neurological: Bilateral ascending  LE numbness, increasing weakness, fatigue, tremors, dizziness,  breathing difficulties when exercising,  muscle cramping, heaviness off upper and lower extremities
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypoaesthesia, Imaging procedure abnormal, Intervertebral disc degeneration, Intervertebral disc protrusion, Intervertebral disc space narrowing
Clinical narrative: Neurological: Bilateral ascending  LE numbness, increasing weakness, fatigue, tremors, dizziness,  breathing difficulties when exercising,  muscle cramping, heaviness off upper and lower extremities
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Laboratory test, Limb discomfort, Lumbar puncture abnormal, Magnetic resonance imaging head, Magnetic resonance imaging spinal abnormal
Clinical narrative: Neurological: Bilateral ascending  LE numbness, increasing weakness, fatigue, tremors, dizziness,  breathing difficulties when exercising,  muscle cramping, heaviness off upper and lower extremities
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Muscle spasms, Muscular weakness, Neck pain, Nerve conduction studies, Neurological symptom
Clinical narrative: Neurological: Bilateral ascending  LE numbness, increasing weakness, fatigue, tremors, dizziness,  breathing difficulties when exercising,  muscle cramping, heaviness off upper and lower extremities
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Night sweats, Osteoarthritis, Paraesthesia, Peripheral coldness, Piriformis syndrome
Clinical narrative: Neurological: Bilateral ascending  LE numbness, increasing weakness, fatigue, tremors, dizziness,  breathing difficulties when exercising,  muscle cramping, heaviness off upper and lower extremities
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Raynaud's phenomenon, Respiration abnormal, Scan with contrast, Scan with contrast abnormal, Spondylitis
Clinical narrative: Neurological: Bilateral ascending  LE numbness, increasing weakness, fatigue, tremors, dizziness,  breathing difficulties when exercising,  muscle cramping, heaviness off upper and lower extremities
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Tremor, Weight decreased
Clinical narrative: Neurological: Bilateral ascending  LE numbness, increasing weakness, fatigue, tremors, dizziness,  breathing difficulties when exercising,  muscle cramping, heaviness off upper and lower extremities
Age: 86.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Hypoxia, Symptom recurrence
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXIA 2/26/2023  &  2/20/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 78.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Blood test, Computerised tomogram normal, Hypoaesthesia, Magnetic resonance imaging normal, Paraesthesia
Clinical narrative: She got her vaccine, the only reaction she had was soreness at the vaccine site, pink in the skin and soreness that lasted a few days, unusual for her as she never had any symptoms of any kind with the other ones.  On 6/16/23 she woke up that morning with the right side of her body pins and needles and numbness from her neck down to her toes, especially in her right arm and hand.   She was taken to the ER as they were worried as she was thinking she may have had some type of stroke.  From there she was transported to a bigger hospital where she was admitted over night.  She had hemisensory deficit right side of body.  They did CAT scans, MRI's, neck cervical spine scan.  They could not find a reason for this happening.  They discharged her with recommendations for possible medications, but they did not give her any.  She was told to follow up with a neurologist and could not get into see one.  She has an APT at the Clinic on 7/6/23 with a neurologist.    She still has the same symptoms, not getting any better.  Does not know if it's from the vaccine or not.  All the other vaccines that she had were Pfizer vaccines and she never had any symptoms from any of them.
Age: 78.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Scan normal, Sensory loss, Vaccination site erythema, Vaccination site pain, X-ray
Clinical narrative: She got her vaccine, the only reaction she had was soreness at the vaccine site, pink in the skin and soreness that lasted a few days, unusual for her as she never had any symptoms of any kind with the other ones.  On 6/16/23 she woke up that morning with the right side of her body pins and needles and numbness from her neck down to her toes, especially in her right arm and hand.   She was taken to the ER as they were worried as she was thinking she may have had some type of stroke.  From there she was transported to a bigger hospital where she was admitted over night.  She had hemisensory deficit right side of body.  They did CAT scans, MRI's, neck cervical spine scan.  They could not find a reason for this happening.  They discharged her with recommendations for possible medications, but they did not give her any.  She was told to follow up with a neurologist and could not get into see one.  She has an APT at the Clinic on 7/6/23 with a neurologist.    She still has the same symptoms, not getting any better.  Does not know if it's from the vaccine or not.  All the other vaccines that she had were Pfizer vaccines and she never had any symptoms from any of them.
Age: 78.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Hypoaesthesia, Laboratory test, Paraesthesia
Clinical narrative: She got her vaccine, the only reaction she had was soreness at the vaccine site, pink in the skin and soreness that lasted a few days, unusual for her as she never had any symptoms of any kind with the other ones.  On 6/16/23 she woke up that morning with the right side of her body pins and needles and numbness from her neck down to her toes, especially in her right arm and hand.   She was taken to the ER as they were worried as she was thinking she may have had some type of stroke.  From there she was transported to a bigger hospital where she was admitted over night.  She had hemisensory deficit right side of body.  They did CAT scans, MRI's, neck cervical spine scan.  They could not find a reason for this happening.  They discharged her with recommendations for possible medications, but they did not give her any.  She was told to follow up with a neurologist and could not get into see one.  She has an APT at the Clinic on 7/6/23 with a neurologist.    She still has the same symptoms, not getting any better.  Does not know if it's from the vaccine or not.  All the other vaccines that she had were Pfizer vaccines and she never had any symptoms from any of them.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: Patient was administered a dose of the monovalent COVID-19 vaccines after they were no longer authorized. Patient was notified and reported he had no symptoms.
Age: 91.0
Sex: M
Vaccine: COVID19-2
Symptoms: Angina pectoris
Clinical narrative: STABLE ANGINA
Age: 83.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Chronic respiratory failure, Respiratory failure
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Rash, Rash erythematous
Clinical narrative: 15 minutes after administration of the vaccine, patient was noted in the clinic waiting room to have a rash that wrapped around his back and abdomen and towards his neck. Rash was flat and red. No signs of trouble breathing. MD assessed patient and spoke with mom about further treatment and further signs of a reaction to watch for. Baby left clinic with mom.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Generalised tonic-clonic seizure
Clinical narrative: Moderna vaccine was administered outside of clinic- reported by patient ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------------------------- EPILEPSY, GENERALIZED CONVULSIVE, INTRACTABLE 4/6/2023 LATE EFFECT OF STROKE
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypotension, Symptom recurrence
Clinical narrative: HYPOTENSION 2/9/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 75.0
Sex: U
Vaccine: COVID19-2
Symptoms: Breast cancer, Breast enlargement, Mammogram normal, Metastases to liver
Clinical narrative: Had mammogram 11/2022 that was normal.  Then presented with left breast enlargement and diagnosed with breast cancer and mets to liver
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Headache, Injection site pain, Malaise, Musculoskeletal stiffness
Clinical narrative: Red blotches with blisters on body Severe arm pain at injection site Headache Stiff Neck General malaise
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash macular
Clinical narrative: Red blotches with blisters on body Severe arm pain at injection site Headache Stiff Neck General malaise
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: Pt was seen for a well visit on 6/23/23. 2 weeks prior he had a horsefly sting and had to go to the ED for epi due to facial swelling and hives. Was given a course of steroids, famotidine, benadryl and symptoms eventually resolved. Was well at WCC 6/23.  Received menquadfi vaccine.  Later that night had redness around the injection site, minor swelling but no other rash. The next day it was swollen/hot/itchy.  Thought to be a local reaction.  However 2 nights later he began having hives:  initially on  his back, groin, and chest.  They continued to spread but would fade a bit with benadryl and then come back full force.  Went to the ED 6/26 where he was given prednisone. Currently taking prednisone 60mg q d, benadryl or hydroxyzine.  Uritcaria continue to come and go. Concern for reaction to Menquadfi vaccine since had local reaction and then systemic hives. No angioedema, wheeze, vomiting.  Would not repeat this vaccine w/o allergy evaluation.
Age: 0.33
Sex: F
Vaccine: PNC13
Symptoms: Underdose
Clinical narrative: Patient didn't receive full dose of vaccine some of spell out.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site bruising, Injection site scar
Clinical narrative: Pt experienced local bruising around injection site. She returned 5 weeks later with faint bruise and firm "scar" at injection site
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Neuropathy peripheral, Symptom recurrence
Clinical narrative: NEUROPATHY 2/15/2023  &  2/14/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cerebral artery occlusion, Cerebrovascular accident
Clinical narrative: ACUTE STROKE DUE TO OCCLUSION OF LEFT MIDDLE CEREBRAL ARTERY
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pulmonary embolism
Clinical narrative: ACUTE PULMONARY EMBOLISM
Age: 51.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction
Clinical narrative: ACUTE NON ST ELEVATION MI
Age: 49.0
Sex: M
Vaccine: MMRV
Symptoms: Unevaluable event
Clinical narrative: none
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Cellulitis, Headache, Pyrexia
Clinical narrative: Headache and fever day 2. Day 4 post injection developed cellulitis. Required antibiotics and steroid course. NSAIDs and ice packs.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: There were no adverse events.  There were no vaccines given within 1 month prior to 5/17/23.  This vaccine was the only vaccine given on 5/17/23.
Age: 10.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient and her grandmother request Covid Booster (Bivalent) I took patient label to the Pharmacy (at this facility the Pharmacist draws up the medication/vaccines and hands it to the  nurse) to request the vaccine. I request child 10 year old Pfizer Bivalent vaccine. Patient label given to the Pharmacist, Pharmacist drew up vaccine and placed label on syringe.  She placed vaccine color coated in orange with Pfizer PEDS C19 VAX Bivalent (AGE 5-11) on syringe under patient label. I went to room patient was in with grandmother (guardian) verified the patient by Name and DOB per policy and I administered vaccine IM in Left Deltoid.  I went back to chart the vaccine in the computer and that is when I noticed that the grandmother COVID vaccine and the Patient had the same lot number.  Appeared Pharmacist had drawn up both vaccines from same vial.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Hypoxia, Sepsis
Clinical narrative: ACUTE RESPIRATORY FAILURE 4/18/2023 SEPSIS WO ACUTE ORGAN DYSFUNCTION HYPOXIA 4/11/2023 SEPSIS WO ACUTE ORGAN DYSFUNCTION
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Hypotension, Lumbar vertebral fracture, Lymphoma, Pulmonary embolism
Clinical narrative: ACUTE PULMONARY EMBOLISM 3/23/2023 L5 VERTEBRAL OTHER TYPE FX, INIT HYPOTENSION 3/23/2023 L5 VERTEBRAL OTHER TYPE FX, INIT ACUTE RESPIRATORY FAILURE 4/10/2023 L5 VERTEBRAL OTHER TYPE FX, INIT ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/13/2023 L5 VERTEBRAL OTHER TYPE FX, INIT ACUTE PULMONARY EMBOLISM 3/23/2023 LYMPHOMA UNSPECIFIED TYPE, UNSPECIFIED SITE HYPOTENSION 3/23/2023 LYMPHOMA UNSPECIFIED TYPE, UNSPECIFIED SITE ACUTE RESPIRATORY FAILURE 4/10/2023 LYMPHOMA UNSPECIFIED TYPE, UNSPECIFIED SITE ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/13/2023 LYMPHOMA UNSPECIFIED TYPE, UNSPECIFIED SITE ACUTE PULMONARY EMBOLISM 3/23/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOTENSION 3/23/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE  ACUTE RESPIRATORY FAILURE 4/10/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/13/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient has reported no adverse effects. Vaccine was punctured 2 days before use. Punctured on a Friday and administered on a Sunday.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Obstructive sleep apnoea syndrome, Osteoarthritis
Clinical narrative: OBSTRUCTIVE SLEEP APNEA 5/2/2023 OSTEOARTHRITIS OF RIGHT KNEE
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Delirium, Obstructive sleep apnoea syndrome
Clinical narrative: G47.33 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 5/2/2023 CONFUSION G47.33 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 5/2/2023 DELIRIUM
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Diarrhoea, Fatigue, Feeling abnormal
Clinical narrative: In January 2023 I noticed I was very tired.  I was very worn out.  I was nauseous and vomiting and also had diarrhea.  I had body aches, too.  On or about January 13th, I went to the doctor and tested positive for COVID-19 and was given antibodies.  I felt better after a couple of days.  After that, I began to feel bad again and I tested positive for the flu.  I still have a nagging cough that I cannot seem to get rid of as well as a bit of COVID-19 brain.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza virus test positive, Nausea, Pain, SARS-CoV-2 test positive, Vomiting
Clinical narrative: In January 2023 I noticed I was very tired.  I was very worn out.  I was nauseous and vomiting and also had diarrhea.  I had body aches, too.  On or about January 13th, I went to the doctor and tested positive for COVID-19 and was given antibodies.  I felt better after a couple of days.  After that, I began to feel bad again and I tested positive for the flu.  I still have a nagging cough that I cannot seem to get rid of as well as a bit of COVID-19 brain.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchial hyperreactivity, Hypertension, Hypoxia
Clinical narrative: R09.02 HYPOXIA 3/25/2023 HTN (HYPERTENSION) R09.02 HYPOXIA 3/25/2023 REACTIVE AIRWAY DISEASE, UNSPECIFIED
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Benign prostatic hyperplasia, Hypotension
Clinical narrative: I95.9 HYPOTENSION 3/27/2023 BPH (BENIGN PROSTATIC HYPERPLASIA)
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Acute coronary syndrome, Acute myocardial infarction
Clinical narrative: ACUTE NON ST ELEVATION MI 4/16/2023 ACUTE NON ST ELEVATION MI ACUTE NON ST ELEVATION MI 4/16/2023 ACUTE NON ST ELEVATION MI CAD (CORONARY ARTERY DISEASE) WO ANGINA
Age: 59.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Injection site reaction
Clinical narrative: site reaction on left arm symptoms started 2 days after vaccine administration date
Age: 59.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Dizziness, Feeling hot, Headache, Pain, Rash
Clinical narrative: site reaction on left arm symptoms started 2 days after vaccine administration date
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Neuropathy peripheral
Clinical narrative: NEUROPATHY 4/19/2023 ACUTE NON ST ELEVATION MI ACUTE NON ST ELEVATION MI 4/21/2023 ACUTE NON ST ELEVATION MI NEUROPATHY 4/19/2023 ACUTE NON ST ELEVATION MI ACUTE NON ST ELEVATION MI 4/21/2023 ACUTE NON ST ELEVATION MI
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Asthma, Condition aggravated, Hypoxia
Clinical narrative: J96.00 ACUTE RESPIRATORY FAILURE 4/5/2023 ASTHMA, UNSPECIFIED W ACUTE EXACERBATION R09.02 HYPOXIA 4/5/2023 ASTHMA, UNSPECIFIED W ACUTE EXACERBATION
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Craniocerebral injury, Fall, Hypotension, Intensive care
Clinical narrative: Hypo tension, fall causing a with traumatic Brian injury
Age: 4.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, Underdose
Clinical narrative: The wrong bivalent vaccine and dose were given. The patient was contacted by their PCP, instructed to come back in and received the correct bivalent vaccine per guidelines.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, Myalgia
Clinical narrative: delays in my period; muscular pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Lot number: EW0151) at the age of 36 years intramuscular, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MENSTRUATION DELAYED (non-serious) with onset Apr2021, outcome "unknown", described as "delays in my period"; MYALGIA (non-serious) with onset Apr2021, outcome "unknown", described as "muscular pains".  Additional information: Vaccination Facility Type: Workplace Clinic, Vaccine was not Administered at Military Facility. No Relevant Tests, No Specific Relevant Test for Thromboembolic Events with Thrombocytopenia. Since the first dose of the vaccine, patient started having delays in her period. The fists delays were of 1 or 2 weeks. After the second dose, the delays increased to months. For that reason, patient decided not to administer any more vaccines on herself. Currently, patient had 5 months without my period. It was regular and now patient have this problem. Regarding the muscular pains, they are really strong. she can't sleep well due to them. The biggest one is on the back.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, Poor quality product administered
Clinical narrative: finger flange was broken; No additional AEs were reported; finger flange was broken / an unspecified patient was administered with the syringe and possibly received less than the recommended dose but she was not sure.; an unspecified patient was administered with the syringe and possibly received less than the recommended dose but she was not sure.; This spontaneous report was received from an office manager regarding a patient of an unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 01-MAY-2023, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) prefilled syringe, product quantity 1, lot #X004813, expiration date: 28-JUL-2024, administered as prophylaxis (strength, dosage regimen, and route of administration were not provided). It was reported that it was possible that the finger flange was broken while the nurse was administering the vaccine (Poor quality product administered) and that the patient possibly received less than the recommended dose (Incorrect dose administered). Product Quality Complaint (PQC) was filed. The syringe was broken into 2 o more pieces and the syringe tray was intact and undamaged on receipt. It was not difficult trying to attach the syringe needle to the syringe, the syringe tip cap was attached properly prior to use, the product was administered, and the cellophane cover of the syringe tray was intact and completely sealed. On 12-MAY-2023, it was reported that the product was returned. No adverse events were reported.  This is one of two cases received from the same reporter.  This is a Non-valid case due to lack of patient's identifiers. ; Sender's Comments:  US-009507513-2305USA001992:
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reported TE for VARIVAX that was administered to one patient. TE Filed. No symptoms reported. No consent to contact HCP, caller stated that they were instructed by their supervisor to not contact patient's HCP until the TE wa; This spontaneous report was received from a pharmacy technician an refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 08-JUN-2023, the patient was vaccinated with an improperly storage varicella virus vaccine live (OKA/MERCK) (VARIVAX) 0.5 milliliter, lot #W022605, expiration date: 17-JUL-2024, administered for prophylaxis (frequency, strength, anatomical location, and route of administration were not provided); which was diluted with sterile diluent (dose, frequency, strength, lot #, expiry date, and route of administration were not provided). Temperature excursion occurred at -13.9 C for 25 minutes and 13 seconds. No prior temperature excursion was reported. No symptoms were reported. No additional information or adverse events were reported.
Age: 11.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; inadvertently administered to an 11-year old patient.; This spontaneous report was received from a nurse referring to an 11-year-old patient of unspecified gender. Information regarding the patient's medical history, concurrent conditions and concomitant therapies was not provided.  On 19-JUN-2023, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 milliliters (ml) as prophylaxis (route of administration and anatomical site of vaccination were not reported; lot number W028534 has been verified to be valid, expiration date reported and established as 10-MAY-2025) (product administered to patient of inappropriate age). No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: Blood test abnormal, Genital lesion, Varicella virus test positive
Clinical narrative: VZV case/ positive specimens; Genital lesion; This spontaneous report was received from a healthcare professional referring to a 5-year-old patient of unspecified gender. Information regarding the patient's medical history, concurrent conditions and concomitant therapies was not provided.  On an unspecified date in June 2023, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, route of administration, anatomical site of vaccination, lot number and expiration date were not reported) as prophylaxis.   On an unspecified date in June 2023, the patient experienced a genital lesion, which resulted positive for varicella zoster virus on 16-JUN-2023 (varicella virus test positive).  On 18-JUN-2023, the patient underwent a blood test which also resulted positive for varicella zoster virus. At the time of reporting, the outcome of the events was unknown.  The causal relationship between the events and varicella virus vaccine live (Oka/Merck) (VARIVAX) was not reported.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse outcomes or side effect were reported or observed by the patients who received the administered doses by an experienced HCP; HCP (nurse) called for VARIVAX (lot: W031813 expiration: 10/05/2024) that occurred on 05/11/2023 but she was not made aware until today (06/26/2023).  The product was stored at 10.8F for 8 hours, 23 minutes and 0 seconds with; This spontaneous report was received from a nurse and refers to a 12-month-old patient. No information on patient's medical history, current conditions and concomitant medications was provided.      On 13-JUN-2023 the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # W031813 and expiration date 05-OCT-2024, 0.5 milliliter for prophylaxis (dose number, route and site of administration was not provided) (product storage error and no adverse event). The product was stored at 10.8 degrees Fahrenheit (F) for 8 hours, 23 minutes and 0 seconds with a supported temperature excursion stability evaluation.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse outcomes or side effect were reported or observed by the patients who received the administered doses by an experienced HCP; HCP (nurse) called to report VARIVAX (lot: W031813 expiration: 10/05/2024) that occurred on 05/11/2023 but she was not made aware until today (06/26/2023).  The product was stored at 10.8F for 8 hours, 23 minutes and 0 seconds with; This spontaneous report was received from a nurse and refers to a 4-year-old female patient. No information on patient's medical history, current conditions and concomitant medications was provided.      On 12-JUN-2023 the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # W031813 and expiration date 05-OCT-2024, 0.5 milliliter for prophylaxis (dose number, route and site of administration was not provided) (product storage error and no adverse event). The product was stored at 10.8 degrees Fahrenheit (F) for 8 hours, 23 minutes and 0 seconds with a supported temperature excursion stability evaluation.
Sex: U
Vaccine: HPV9, PNC15, PNC15, PNC15
Symptoms: Product storage error
Clinical narrative: HCP called to report temperature excursion on GARDASIL 9 and VAXNEUVANCE; No additional AE/PQC; This spontaneous report was received from a nurse referring to multiple unspecified patients. The patients' information regarding concurrent conditions, medical history, and concomitant medications was not provided.   On an unspecified date, a call was received stating that a temperature excursion (Product storage error) had occurred; but the dates of vaccination were unknown. It was reported that among the vaccines included were HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot number valid, reported as W028573, expiration date 06-JAN-2025), pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) (lot number valid, reported as W027275, expiration date 09-JUL-2024; W039033 and W036242, expiration date for both 01-OCT-2024); (doses, routes of administrations and anatomical locations, were not provided) all for prophylaxis.  The vaccines presented a temperature excursion, at a temperature of 31.5 degrees Fahrenheit (F) for a timeframe of 2 hours and 45 minutes. There was no previous temperature excursion. There were no product quality complaints and no adverse events reported. ; Sender Comments: Keywords :
Sex: U
Vaccine: RV5
Symptoms: Accidental underdose, Vomiting
Clinical narrative: the baby threw up and could not take any additional doses; when the vaccine was administered, the baby threw up; This spontaneous report was received from a medical assistant and refers to an infant patient of unknown gender. The patient had existing issue with swallowing. No information on patient's medical history and current conditions was provided.      On an unknown date the patient was vaccinated with first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis (exact dose, route of administration, lot# and expiration date were not provided) (accidental underdose).         On an unknown date the patient experienced vomiting. The outcome of vomiting was unknown. Action taken with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) regarding the event was not applicable.  The causality between rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and the event was not provided.
Sex: U
Vaccine: RV5
Symptoms: Accidental overdose, Vomiting
Clinical narrative: the baby threw up; when the vaccine was administered, the baby threw up; This spontaneous report as received from Other Health Professional (HCP), referring to an infant patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 27-JUN-2023, the patient was administered with first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (orally, exact dose, lot #, expiration date and anatomical location were not provided) for prophylaxis.  On 27-JUN-2023, when the vaccine was administered, the baby threw up (Accidental underdose). The outcome of the event of vomiting was unknown. Action taken with suspect vaccine regarding the events was not applicable.  The causal relationship between the event of vomiting and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not provided.
Sex: M
Vaccine: HPV9
Symptoms: Exposure via skin contact, No adverse event, Underdose
Clinical narrative: No Adverse Event; the liquid dripped down his arm; is afraid he did not get the whole dose; This spontaneous report was received from a consumer refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 27-JUN-2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis.   On 27-JUN-2023, the patient experienced exposure via skin contact and underdose. It was reported that the liquid dripped down on patient arm, and he was afraid he did not get the whole dose. No additional adverse event reported (no adverse event).
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Viral titre
Clinical narrative: No additional AE reported; Received PROQUAD instead of PRIORIX; Overdose; This spontaneous report was received from Other and refers to a 23-years-old female.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 23-JUN-2023, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); and  varicella virus vaccine live (oka/merck) (VARIVAX) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date (before the appointment), patient had titers done for MMR and Varicella. Varicella titer was low less than 135 (needed a booster), Rubella and Measles were normal, Mumps were low, needed a booster. On 23-JUN-2023, the patient received PROQUAD instead of PRIORIX, the patient experienced Overdose. No additional AE reported. No PQC reported.
Sex: U
Vaccine: TYP
Symptoms: Urinary tract infection
Clinical narrative: UTI; A spontaneous report was received from a patient of unknown age and gender on 06MAY2023 who developed "UTI" (PT: Urinary tract infection) following the administration of Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunization.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that the patient received two doses of Vivotif vaccine following which the patient developed urinary tract infection and started antibiotic treatment. Reportedly, the Vivotif was stopped.  The outcome of the reported event was unknown, at the time of this report.   The action taken with Vivotif with respect to the reported event was drug withdrawn.   No additional information was reported.  Company comment: It was reported that a consumer developed UTI (urinary tract infection) following the administration of two doses of Vivotif. In response to this, Vivotif was discontinued and was started with antibiotic treatment. Further information regarding the event is limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of urinary tract infection is assessed as possible with Vivotif.; Sender's Comments: It was reported that a consumer developed UTI (urinary tract infection) following the administration of two doses of Vivotif. In response to this, Vivotif was discontinued and was started with antibiotic treatment. Further information regarding the event is limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of urinary tract infection is assessed as possible with Vivotif.
Sex: U
Vaccine: TYP
Symptoms: Vomiting
Clinical narrative: Threw up within 45 minutes of Vivotif administration; A spontaneous report was received from a pharmacy intern on 15MAY2023 regarding a patient of unknown age and gender who threw up within 45 minutes of Vivotif (typhoid vaccine live oral Ty21A; lot number: unknown) administration (PT: Vomiting) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  On an unknown date, the patient received a dose of Vivotif and within 45 minutes of administration, the patient threw up.   The outcome of the reported event was unknown, at the time of this report.  The action taken with Vivotif with respect to the reported event was unknown.  No additional information was reported.  Company comment: A patient took Vivotif for immunisation and it was reported that the patient threw up within 45 minutes of Vivotif (vomiting). Considering the case information, the role of Vivotif cannot be ruled out, and the causality of vomiting is assessed as possible. The case is considered non serious as per medical assessment.; Sender's Comments: A patient took Vivotif for immunisation and it was reported that the patient threw up within 45 minutes of Vivotif (vomiting). Considering the case information, the role of Vivotif cannot be ruled out, and the causality of vomiting is assessed as possible. The case is considered non serious as per medical assessment.
Sex: F
Vaccine: TYP
Symptoms: Adverse event
Clinical narrative: Cannot handle the side effects; A spontaneous case was received from a registered nurse on 17MAY2023 regarding a female patient of unknown age who "cannot handle the side effects" (PT: Adverse event) following the administration of oral Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that the patient administered two doses of oral typhoid and was not able to handle the side effects. Therefore, the patient would not be finishing the series of vaccination.  The outcome of the reported event was unknown at the time of this report.  The action taken with the Vivotif with respect to the event was drug withdrawn.  No additional information was provided.  Company comment: It was reported that a consumer took Vivotif for immunisation and could not handle the side effects (adverse event). Further information regarding the event is limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of adverse event is assessed as possible. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer took Vivotif for immunisation and could not handle the side effects (adverse event). Further information regarding the event is limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of adverse event is assessed as possible. The case is considered non serious as per medical assessment.
Sex: F
Vaccine: TYP
Symptoms: No adverse event, Product packaging issue
Clinical narrative: Vivotif capsules internal packing had a line, and it was partially open; A spontaneous report was received from a pharmacist on 19MAY2023 regarding a female patient of an unknown age who found that the "Vivotif capsules internal packing had a line, and it was partially open" (PT: Product packaging issue) prior to the administration of Vivotif (Typhoid vaccine live oral Ty21A) capsules (lot number: 3003832, expiry date: 29FEB2024) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  On 10MAY2023 at 09:16 PM, the patient received her Vivotif capsules pack from pharmacy. Reportedly, the capsules internal packing had a line, and it was partially open. Additionally, the patient would be traveling next month, so vaccination course was not yet started.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: Vivotif capsules internal packing had a line, and it was partially open (product packaging issue). Considering the nature of event, the causality of product packaging issue is assessed as not applicable with Vivotif. The case is considered non-serious as per medical assessment. No follow-up is required as there was no administration to consumer and no associated adverse events. Quality assurance is aware of the product complaint.; Sender's Comments: Vivotif capsules internal packing had a line, and it was partially open (product packaging issue). Considering the nature of event, the causality of product packaging issue is assessed as not applicable with Vivotif. The case is considered non-serious as per medical assessment. No follow-up is required as there was no administration to consumer and no associated adverse events. Quality assurance is aware of the product complaint.