chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Neurological symptom, SARS-CoV-2 test positive, Vasogenic cerebral oedema
Clinical narrative: no known PMHx who presented on 1/31/22 with stroke like symptoms - left sided weakness, poor gait. Pt was found to have an acute, large Right temporal lobe intracranial hemorrhage, confirmed per admission CT/CTA head and neck. His blood pressure was high 205/105 and his UDS was positive for amphetamine. NSG evaluated the patient - no surgery recommended. He was on mannitol for vasogenic edema, Keppra for seizure ppx. Repeat CT head was stable and now he is off keppra. He was sent to LTACH with trach collar: Covid positive Patient infected earlier last month on 1/8 No sx prior to current hospitalization  Patient is immunized  Off isolation per infection prevention
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris
Clinical narrative: I20.8 STABLE ANGINA 4/10/2023 STABLE ANGINA
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure acute, Hypervolaemia, Left ventricular failure, Pulmonary hypertension, Transient ischaemic attack
Clinical narrative: G45.9 TRANSIENT CEREBRAL ISCHEMIA 4/12/2023 DIASTOLIC HEART FAILURE, ACUTE ON CHRONIC G45.9 TRANSIENT CEREBRAL ISCHEMIA 4/12/2023 HYPERVOLEMIA G45.9 TRANSIENT CEREBRAL ISCHEMIA 4/12/2023 PULMONARY HTN
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Acute respiratory failure, Hypertension
Clinical narrative: J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/27/2023 HTN (HYPERTENSION) J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/27/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: Interchange of vaccine products
Clinical narrative: Pt had recvd 2 monovalent Pfizer vaccines in 7/2022. They came to clinic for bivalent booster. Moderna is the only brand in stock so it was given. States dose is invalid bc of different brand used in this age group. States it is a vaccine error but is considered valid and does not to be repeated.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19 pneumonia, Creatinine renal clearance decreased, Nephropathy, Rectal haemorrhage
Clinical narrative: COVID pnuemonia; acute hypoxemic repsiraoty failure; rectal bleed; no tx for COVID given due to renal discfunction, From a covid standpoint she did not need any treatments. She was placed on antibiotics and steroids only due to her creatinine clearance less than 30. Remdesevir was held due to renal dysfunction. She did well with not requiring oxygen. She was placed on 10 days of steroids per ID recommendations.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Myocarditis
Clinical narrative: ACUTE NON ST ELEVATION MI MYOCARDITIS
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chronic kidney disease, Dyspnoea, Mental status changes, Pyrexia
Clinical narrative: SOB, fever, slight AMS.  COVID no hypoxemia. CKD. Gental hydration, trated for UTI . dc'd on keflex for UTI and guafenesin
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: SOB, fever, slight AMS.  COVID no hypoxemia. CKD. Gental hydration, trated for UTI . dc'd on keflex for UTI and guafenesin
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Adult failure to thrive, Asthenia, COVID-19, Fall
Clinical narrative: Patient had 1 episode of falling at home secondary to generalized weakness.  Patient will be admitted to the hospital for  COVID positive, adult failure to thrive and Acute Kidney Injury.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient had 1 episode of falling at home secondary to generalized weakness.  Patient will be admitted to the hospital for  COVID positive, adult failure to thrive and Acute Kidney Injury.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dyspnoea, Myalgia, Nausea
Clinical narrative: cough, SOB, myalgias, nausea. body aches, fever, hypoxemic resp faliure secondary to COVID. treated with dexamethasone, zinc and O2. home on RA. no remdisivir given
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Respiratory failure
Clinical narrative: cough, SOB, myalgias, nausea. body aches, fever, hypoxemic resp faliure secondary to COVID. treated with dexamethasone, zinc and O2. home on RA. no remdisivir given
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Ankle fracture, Ankle operation, Arthropathy, Elbow operation, Escherichia infection
Clinical narrative: hospitalized with e coli , blood clots, inability to move, not functional mental and physical broke  left ankle  i was unstable and hips and knees lost control was in hospital for 4 months and then dislocated right elbow and have had 4surgeries and got infectious disease twice
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Gait disturbance, Infection, Joint dislocation, Mental impairment
Clinical narrative: hospitalized with e coli , blood clots, inability to move, not functional mental and physical broke  left ankle  i was unstable and hips and knees lost control was in hospital for 4 months and then dislocated right elbow and have had 4surgeries and got infectious disease twice
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Surgery, Thrombosis
Clinical narrative: hospitalized with e coli , blood clots, inability to move, not functional mental and physical broke  left ankle  i was unstable and hips and knees lost control was in hospital for 4 months and then dislocated right elbow and have had 4surgeries and got infectious disease twice
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infection
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: Minor was accidentally given a 2nd dose of vaccines first dose was given on 8/9/23.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia
Clinical narrative: HYPOXIA
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: pt states tingling sensation in legs started a week after the vaccine.  he still has those symptoms today. pt will contact his doctor
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Symptom recurrence
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/6/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Biopsy bone abnormal, COVID-19 pneumonia, Hypoxia, Lethargy
Clinical narrative: admitted with lower back pain x 2 weeks. recent biopsy consistent with myeloma. Pt became hypoxemic and letharrgic during admit with increasing O2 requirements. COVID +; pneumonia; rec'd dexamethasone, laxix administered.  transferred to hospice.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Plasma cell myeloma, SARS-CoV-2 test positive
Clinical narrative: admitted with lower back pain x 2 weeks. recent biopsy consistent with myeloma. Pt became hypoxemic and letharrgic during admit with increasing O2 requirements. COVID +; pneumonia; rec'd dexamethasone, laxix administered.  transferred to hospice.
Age: 42.0
Sex: U
Vaccine: IPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: MInor received 2nd dose by mistake and 1 dose was recevied on 8.9.23
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Myocarditis
Clinical narrative: Patient has significant pain in the chest and was diagnosed by physician with myocarditis.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Computerised tomogram, Diarrhoea, Dysarthria, Pain
Clinical narrative: 101.6 temperature on day after vaccine with body aches, diarrhea and vomiting Slurred speech, aggressive tremors 4 days after shot administered (Continuing) Symptoms indicative of stroke and seizures
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor, Urine analysis, Vomiting
Clinical narrative: 101.6 temperature on day after vaccine with body aches, diarrhea and vomiting Slurred speech, aggressive tremors 4 days after shot administered (Continuing) Symptoms indicative of stroke and seizures
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient previously had a Tdap shot in 2019. The provider advised to give Tdap at 8/16/2023 visit, but after administering the vaccine saw that the patient should not have gotten that vaccine until a later date. No adverse reaction happened and patient and parent were advised it was given early, but that it would not harm the patient.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Hypoxia
Clinical narrative: ACUTE ST ELEVATION MI, UNSPECIFIED ACUTE NON ST ELEVATION MI HYPOXEMIA
Age: 16.0
Sex: F
Vaccine: MMR
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: none
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infection
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fall, Haemoglobin decreased, Open reduction of fracture, SARS-CoV-2 test positive
Clinical narrative: ground level fall - admit for ORIF, had preop +COVID, 3L O2, denies SOB or other COVID symptoms. hgb 5.4 - blood transfusion; transfer to rehab; no meds given for Covid
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Transfusion
Clinical narrative: ground level fall - admit for ORIF, had preop +COVID, 3L O2, denies SOB or other COVID symptoms. hgb 5.4 - blood transfusion; transfer to rehab; no meds given for Covid
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, Underdose
Clinical narrative: On 6/15/2023, The 5 year old patient came in with his mom to receive his 1st dose of moderna vaccine. Recommended to start the series with the Moderna Dark Blue/Gray Label 0.25ml for Dose 1.  Instead the patient was given Moderna Dark Pink cap 0.2ml for dose 1.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: The patient states she had a line coming from the injection site that spread to a red, hot, tender area larger than her palm. The patient states it hurts and had continued to spread since administration.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: ACUTE PULMONARY EMBOLISM
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Chest tube insertion, Confusional state, Dyspnoea, Hypoxia
Clinical narrative: SOB, confusion, lethargy; COVID Pneumonia; hypoxia, lt side pneumothorax with chest tube placement; inpt hospice; treatment - fluids, abx, O2, dexamethasone, 1 dose tocilizumab. not a canadite for remdisivir; high flow O2 + NRB
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pneumothorax
Clinical narrative: SOB, confusion, lethargy; COVID Pneumonia; hypoxia, lt side pneumothorax with chest tube placement; inpt hospice; treatment - fluids, abx, O2, dexamethasone, 1 dose tocilizumab. not a canadite for remdisivir; high flow O2 + NRB
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Chronic kidney disease, Cough, Dyspnoea, Fatigue
Clinical narrative: Cough, congestion, fatigue, SOB. COVID Pneumonia; BIPAP due to O2 sats in 60s in route, changed to 4-7 L NC; treatment - dexamethasone, remdisivir, baricitinib, Zinc and Vit C. 2/5 worsening CKD stage 3. stop Losarten, O2 increased to 15L.  transferring to LTAC
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Positive airway pressure therapy, Respiratory tract congestion
Clinical narrative: Cough, congestion, fatigue, SOB. COVID Pneumonia; BIPAP due to O2 sats in 60s in route, changed to 4-7 L NC; treatment - dexamethasone, remdisivir, baricitinib, Zinc and Vit C. 2/5 worsening CKD stage 3. stop Losarten, O2 increased to 15L.  transferring to LTAC
Age: 7.0
Sex: M
Vaccine: MMR, TDAP, VARCEL
Symptoms: Unevaluable event
Clinical narrative: On Saturday, 8/19/2023, the vaccinating LVN did not remember which vaccine she administered in the client's left deltoid. The client did not appear to exhibit signs or symptoms.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Ischaemic stroke, Transient ischaemic attack
Clinical narrative: TRANSIENT CEREBRAL ISCHEMIA ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Symptom recurrence
Clinical narrative: ACUTE NON ST ELEVATION MI 1/29/2023 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated with 3 boosters
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: PERIPHERAL NEUROPATHY
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: ACUTE DVT OF LEFT CALF MUSCULAR VEIN
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalized with covid; fully vaccinated
Age: 1.33
Sex: M
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Disorientation, Irritability, Musculoskeletal stiffness, Pyrexia, Unresponsive to stimuli
Clinical narrative: Patient's mother reported that patient had received second dose of Vaxelis on 08/11/2023. That evening, around 8 pm, patient developed a fever of 101.9 F. His parents put him to bed and co-slept with him to monitor him. Patient's mom went to check on him at 0100 and found he was "stiff as a board" and was not responding. She started screaming for help and had her phone ready to call 911 when he finally came to. Per father, patient was not responding for about 1-2 minutes and they were unsure if he was breathing or not. They did not call 911 or bring him to the hospital. The next day he was fussy and somewhat disoriented. Patient's mom spoke with an MD online provider who thought he may have been in REM sleep during the episode. Patient's mother disagrees with that assessment and states after the first dose of Vaxelis he had been very lethargic. Patient's primary care provider is unsure this event was related to the vaccination.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Hospitalized with covid; fully vaccinated
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Epilepsy, Symptom recurrence
Clinical narrative: EPILEPSY, UNSPECIFIED 5/12/2022,  6/21/2022,  9/11/2022,  9/21/2022,  1/23/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 44.0
Sex: F
Vaccine: VARCEL
Symptoms: Eye pain, Herpes zoster, Pruritus
Clinical narrative: On 08/17/2023 Employee noticed that she was having pain above L eye brow/temple. she went to urgent care where Employee  states that the provider diagnosed her with Shingles. Lesion started 08/18 slightly itchy and now states that it is painful. 7 days of treatment x3 times daily.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalized with covid; fully vaccinated with 1 booster
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: NEUROPATHY
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, SARS-CoV-2 test positive, Vomiting
Clinical narrative: Hospitalized with covid; fully vaccinated
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral artery occlusion, Cerebrovascular accident, Ischaemic stroke
Clinical narrative: ACUTE STROKE DUE TO OCCLUSION OF RIGHT CEREBELLAR ARTERY ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site hypoaesthesia, Injection site pain
Clinical narrative: The patient has had pain and numbness in the arm where she was vaccinated, she is currently in physical therapy because she cannot fully utilize her arm.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Chronic respiratory failure, Respiratory failure
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalized with covid; fully vaccinated
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Vaccine was adminsted 5 days after the BUD--contacted Moderna and the lot was still viable. Reporting the error.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalized with covid; fully vaccinated with booster
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Chills, Dizziness, Dyspepsia
Clinical narrative: by 8pm the night of my injection I was developing symptoms. I had pain, swelling, redness and rash at the injection site.  I had swelling at the injection site the size of a tennis ball. It was hot to touch. I had a rash about 2 inches wide that went 5inches down my arm from the injection site.  I had a severe headache, I felt like my head was going to explode. I was taking large amounts of tylenol and ibuprofen but they had very little effect on the headache. My right eye was painful, it hurt. I had chills, shivering, sweats. Fever of 101.2 to 101.5 that would come and go. I was dizzy. My entire body hurt. It felt like someone had just beat the crap out of my from head to toe. My legs were weak. My stomach was on fire. I had nausea, sometimes tried to vomit but didn't. Gagging I guess.  I spent the next 3 days in bed after getting this shot. I spent the next 4 days after that still getting over the effects of it before I actually started to feel better from all of this. If I had know this would happen I would have never gotten this shot.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye pain, Formication, Head discomfort, Headache, Herpes zoster
Clinical narrative: by 8pm the night of my injection I was developing symptoms. I had pain, swelling, redness and rash at the injection site.  I had swelling at the injection site the size of a tennis ball. It was hot to touch. I had a rash about 2 inches wide that went 5inches down my arm from the injection site.  I had a severe headache, I felt like my head was going to explode. I was taking large amounts of tylenol and ibuprofen but they had very little effect on the headache. My right eye was painful, it hurt. I had chills, shivering, sweats. Fever of 101.2 to 101.5 that would come and go. I was dizzy. My entire body hurt. It felt like someone had just beat the crap out of my from head to toe. My legs were weak. My stomach was on fire. I had nausea, sometimes tried to vomit but didn't. Gagging I guess.  I spent the next 3 days in bed after getting this shot. I spent the next 4 days after that still getting over the effects of it before I actually started to feel better from all of this. If I had know this would happen I would have never gotten this shot.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Injection site pain, Injection site rash, Injection site reaction, Injection site swelling
Clinical narrative: by 8pm the night of my injection I was developing symptoms. I had pain, swelling, redness and rash at the injection site.  I had swelling at the injection site the size of a tennis ball. It was hot to touch. I had a rash about 2 inches wide that went 5inches down my arm from the injection site.  I had a severe headache, I felt like my head was going to explode. I was taking large amounts of tylenol and ibuprofen but they had very little effect on the headache. My right eye was painful, it hurt. I had chills, shivering, sweats. Fever of 101.2 to 101.5 that would come and go. I was dizzy. My entire body hurt. It felt like someone had just beat the crap out of my from head to toe. My legs were weak. My stomach was on fire. I had nausea, sometimes tried to vomit but didn't. Gagging I guess.  I spent the next 3 days in bed after getting this shot. I spent the next 4 days after that still getting over the effects of it before I actually started to feel better from all of this. If I had know this would happen I would have never gotten this shot.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Muscular weakness, Nausea, Pain, Pyrexia
Clinical narrative: by 8pm the night of my injection I was developing symptoms. I had pain, swelling, redness and rash at the injection site.  I had swelling at the injection site the size of a tennis ball. It was hot to touch. I had a rash about 2 inches wide that went 5inches down my arm from the injection site.  I had a severe headache, I felt like my head was going to explode. I was taking large amounts of tylenol and ibuprofen but they had very little effect on the headache. My right eye was painful, it hurt. I had chills, shivering, sweats. Fever of 101.2 to 101.5 that would come and go. I was dizzy. My entire body hurt. It felt like someone had just beat the crap out of my from head to toe. My legs were weak. My stomach was on fire. I had nausea, sometimes tried to vomit but didn't. Gagging I guess.  I spent the next 3 days in bed after getting this shot. I spent the next 4 days after that still getting over the effects of it before I actually started to feel better from all of this. If I had know this would happen I would have never gotten this shot.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: by 8pm the night of my injection I was developing symptoms. I had pain, swelling, redness and rash at the injection site.  I had swelling at the injection site the size of a tennis ball. It was hot to touch. I had a rash about 2 inches wide that went 5inches down my arm from the injection site.  I had a severe headache, I felt like my head was going to explode. I was taking large amounts of tylenol and ibuprofen but they had very little effect on the headache. My right eye was painful, it hurt. I had chills, shivering, sweats. Fever of 101.2 to 101.5 that would come and go. I was dizzy. My entire body hurt. It felt like someone had just beat the crap out of my from head to toe. My legs were weak. My stomach was on fire. I had nausea, sometimes tried to vomit but didn't. Gagging I guess.  I spent the next 3 days in bed after getting this shot. I spent the next 4 days after that still getting over the effects of it before I actually started to feel better from all of this. If I had know this would happen I would have never gotten this shot.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia
Clinical narrative: HYPOXIA
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Blood glucose increased, Diarrhoea, Dizziness, Fatigue, Headache
Clinical narrative: Dizziness, headache, on 6/29/2023-lips numb, high glucose, high blood pressure, diarrhea, light headed, tired,
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Hypertension, Hypoaesthesia oral
Clinical narrative: Dizziness, headache, on 6/29/2023-lips numb, high glucose, high blood pressure, diarrhea, light headed, tired,
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Hypersensitivity, Loss of consciousness, Mydriasis, Skin warm, Urinary incontinence
Clinical narrative: Patient was given shot, and shortly after patients father states he is having a allergic reaction. Patient was unconscious with eyes very dilated and ended up urinated. Patient was warm to touch when felt.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Polymerase chain reaction positive
Clinical narrative: hospitalization
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: ADULT OBSTRUCTIVE SLEEP APNEA, MODERATE
Age: 82.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Pain, Rash erythematous
Clinical narrative: Red Rash and sore per patient
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infection
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Choking sensation, Depressed level of consciousness, Dyspnoea, Hypoxia, Lip oedema
Clinical narrative: 15 minutes after administration of the vaccines, patient with sudden shortness of breath and choking sensation, complaint of itchy mouth. On exam with poor aeration of lungs, diffuse wheezing, retractions, tachypnea, hypoxia to 90% RA, tachycardia, profuse watery discharge from mouth and nose, periorbital and lower lip edema, followed by decreased level of consciousness.  Patient treated with albuterol and albuterol/ipratropium nebs, oral dexamethasone, IM epinephrine, cetirizine, and famotidine.  Symptoms fully resolved after these medications.  patient then transported to local emergency department via ambulance for further monitoring
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Lung disorder, Oral discharge, Oral pruritus, Periorbital oedema, Rhinorrhoea
Clinical narrative: 15 minutes after administration of the vaccines, patient with sudden shortness of breath and choking sensation, complaint of itchy mouth. On exam with poor aeration of lungs, diffuse wheezing, retractions, tachypnea, hypoxia to 90% RA, tachycardia, profuse watery discharge from mouth and nose, periorbital and lower lip edema, followed by decreased level of consciousness.  Patient treated with albuterol and albuterol/ipratropium nebs, oral dexamethasone, IM epinephrine, cetirizine, and famotidine.  Symptoms fully resolved after these medications.  patient then transported to local emergency department via ambulance for further monitoring
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Tachycardia, Tachypnoea, Use of accessory respiratory muscles, Wheezing
Clinical narrative: 15 minutes after administration of the vaccines, patient with sudden shortness of breath and choking sensation, complaint of itchy mouth. On exam with poor aeration of lungs, diffuse wheezing, retractions, tachypnea, hypoxia to 90% RA, tachycardia, profuse watery discharge from mouth and nose, periorbital and lower lip edema, followed by decreased level of consciousness.  Patient treated with albuterol and albuterol/ipratropium nebs, oral dexamethasone, IM epinephrine, cetirizine, and famotidine.  Symptoms fully resolved after these medications.  patient then transported to local emergency department via ambulance for further monitoring
Age: 26.0
Sex: F
Vaccine: VARZOS
Symptoms: Exposure during pregnancy
Clinical narrative: patient is currently 37 weeks pregnant with anticipated delivery of 9/11/23.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Amnesia, Cyanosis, Electrocardiogram, Electroencephalogram, Magnetic resonance imaging head
Clinical narrative: Patient had a seizure of semiology of blank stare with blue lips and non-responsive. After it resolved, she could not remember anything and was sleepy for approximately one hour. No jerking movements or incontinence reported.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Neurological examination, Seizure, Somnolence, Staring, Unresponsive to stimuli
Clinical narrative: Patient had a seizure of semiology of blank stare with blue lips and non-responsive. After it resolved, she could not remember anything and was sleepy for approximately one hour. No jerking movements or incontinence reported.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid 19 Breakthrough Infection
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal pain, Crying, Dyskinesia, Enema administration, Infant irritability
Clinical narrative: Patient had increased fussiness and abdominal pain with significantly increased crying and leg raising. He came to the emergency department at the Hospital, where he had a KUB (showed increased stool burden), ultrasound (showed target sign with small bowel to small bowel intussusception, but couldn't rule out ileocolonic), and a fluoroscopic intussusception reduction enema which revealed that there was no intussusception, so presumably it self resolved.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Intussusception, Small intestinal intussusception reduction, Ultrasound abdomen abnormal, Urinary tract imaging abnormal, X-ray
Clinical narrative: Patient had increased fussiness and abdominal pain with significantly increased crying and leg raising. He came to the emergency department at the Hospital, where he had a KUB (showed increased stool burden), ultrasound (showed target sign with small bowel to small bowel intussusception, but couldn't rule out ileocolonic), and a fluoroscopic intussusception reduction enema which revealed that there was no intussusception, so presumably it self resolved.
Age: 1.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Lethargy, Loss of personal independence in daily activities, Movement disorder, Pyrexia, Speech disorder developmental
Clinical narrative: The parents say she had fever, lethargy, lack of physical movement and activity, delayed speech development
Age: 46.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Cough, Immediate post-injection reaction, Sensation of foreign body
Clinical narrative: Patient requested Hepatitis B and Varicella Vaccine for travel purposes. Requested vaccines be administered in Right Arm, due to recent TD vaccine administered in Left Arm. Immediately after injection, patient complained of "something in throat" and was observed coughing. No swelling of tongue or lips, or respiratory distress noted. EMT was called at approximately 11:10 am and arrived at approximately at 11:20 am. EMT assessed client, BP 153/93, HR 69 BPM. EMT advised to be transported to ER, patient declined, stated her throat felt better and cough stopped.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Arthralgia, Full blood count, Malaise, Myalgia, Pyrexia
Clinical narrative: GENERAL MALAISE, MYALGIA, ARTHRALGIA, FEVER
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope, Tremor
Clinical narrative: Shaking and syncope.  Evalated legs, gave crackers and juice, stabilized patient.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Eyelid rash, Headache, Myalgia, Neck pain
Clinical narrative: Patient had chicken pox as a child and shingles in her 20's.  Received Shingrix vaccination on 8/15 and had normal side effects, such as sore arm and headache for first 48 hours.  After 48 hours, developed deep nerve pain in left side of head and neck in and beneath the skin, earache, muscle pain followed by raised red, lumpy, painful rash on neck, under hair on left side of scalp, around and inside ear canal.  Essentially, reactivation of shingles within 48 hours of vaccination.  Rash continues to spread at 6 days post vaccination, but has not developed typical shingles blisters.  No part of the rash extends past the midline.  I will see my primary physician tomorrow.  This possible side-effect was not discussed in any literature, was not disclosed by primary physician, was not disclosed by pharmacist.   Shingrix 50 mcg/0.5 ml Inj; 58169-0823-11 I hope one of these numbers is the "lot number."  Primary physician's office said pharmacist should report unusual adverse reaction; pharmacist said primary physican would report.  So I, the patient, have reported to the best of my ability.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Pain in extremity, Rash, Rash erythematous, Rash papular
Clinical narrative: Patient had chicken pox as a child and shingles in her 20's.  Received Shingrix vaccination on 8/15 and had normal side effects, such as sore arm and headache for first 48 hours.  After 48 hours, developed deep nerve pain in left side of head and neck in and beneath the skin, earache, muscle pain followed by raised red, lumpy, painful rash on neck, under hair on left side of scalp, around and inside ear canal.  Essentially, reactivation of shingles within 48 hours of vaccination.  Rash continues to spread at 6 days post vaccination, but has not developed typical shingles blisters.  No part of the rash extends past the midline.  I will see my primary physician tomorrow.  This possible side-effect was not discussed in any literature, was not disclosed by primary physician, was not disclosed by pharmacist.   Shingrix 50 mcg/0.5 ml Inj; 58169-0823-11 I hope one of these numbers is the "lot number."  Primary physician's office said pharmacist should report unusual adverse reaction; pharmacist said primary physican would report.  So I, the patient, have reported to the best of my ability.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient was administered an expired dose of COVID-19 vaccine after the unfrozen date.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient was administered an expired dose of COVID-19 vaccine after the unfrozen date.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Breast pain, Dyspnoea, Pain
Clinical narrative: Patient reported pain on left side that made deep inhalations difficult. Pain started below breast and radiated towards the back. The pain began the day after receiving the second Shingrix dose. The pain was most intense on that day, and has slowly improved. She is still in some pain 3 days later, but can take deep breaths more easliy/comfortably.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient was administered an expired dose of COVID-19 vaccine after the unfrozen date.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient was administered an expired dose of COVID-19 vaccine after the unfrozen date.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient was administered an expired dose of COVID-19 vaccine after the unfrozen date.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient was administered an expired dose of COVID-19 vaccine after the unfrozen date.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Administered the TDAP shot to the patient and he was fine when he left the room. He went shopping in the warehouse and then fainted and blacked out.  He laid down on the floor with a pillow on his head. We called 911 and there were plenty of employees monitoring him along with our Asst General Mgr,. Paramedics arrived and  monitored his vitals such a BP and temperature and the child was ok and was not brought into the ambulance as was released. The paramedics escorted the mom to their car and they were told to take the child to the hospital.
Age: 52.0
Sex: F
Vaccine: HPV9
Symptoms: Myalgia, Product preparation error
Clinical narrative: she received the vaccine 20-JUL-2023 and had a minor muscle ache after but is fine now.; HCP states the product was not white prior to administration and she read in the PI taht it states you must shake the vaccine and it should turn white prior to administration; This spontaneous report was received from a 52-year-old female physician patient regarding herself. There was no information about patient's concurrent conditions or pertinent medical history.  Concomitant therapies included levothyroxine sodium(SYNTHROID).     On 20-JUL-2023, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly (dose, anatomical location, lot number and expiration date were not reported) "just to be safe" (prophylaxis).  The patient inquire if she should be revaccinated, or if the vaccine was still viable since she did not see anyone shake the vial of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) prior to administration. The patient stated that the product was not white prior to administration, and she read in the PI that it stated you must shake the vaccine and it should turn white prior to administration (product use issue). On 20-JUL-2023, the patient had a minor muscle ache (myalgia). No sought medical attention or treatment was given to the patient.   At the time of the report, the patient had recovered from the event on an unknow date in July 2023 (described as she was fine now). The patient requested the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) from a doctor and ordered it and received it from a doctor in a walk-in OB/GYN clinic that she did not know the name of the healthcare professional.  The relatedness between the event of myalgia and therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms reported.; inadvertent administration of expired PROQUAD to a patient; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 08-FEB-2022, the patient was vaccinated an expired dose of with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot number T027114, expiration date 07-FEB-2022, 0.5 milliliter (route of administration not reported) for prophylaxis that was diluted with sterile diluent(MERCK STERILE DILUENT) (expired product administered). No adverse event was reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, No adverse event
Clinical narrative: No additional AE; HCP called regarding PROQUAD. Caller reports that PROQUAD was inadvertently administered at the same time as VARIVAX. HCP denies patient reported signs/symptoms of adverse effects. Permission to contact HCP was given. No additional AE/PQC.; This spontaneous report was received from a nurse and referred to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 27-JUL-2023, the patient was inadvertently administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) injection, (2nd dose, lot #W034211, expiration date: 24-APR-2024, (strength and route of administration were not provided) for prophylaxis at the same time as varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, dose description, lot #, expiry date, and route of administration were not provided) for prophylaxis (Accidental overdose).  The reporter denied the patient reported signs/symptoms of adverse effects. No additional adverse event (AE).
Age: 15.0
Sex: M
Vaccine: HPV4, HPV9
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: missed their 3rd dose of GARDASIL; The patient did not know if they received GARDASIL or GARDASIL 9 for the first 2 doses; No other AE; This spontaneous report was received from a pharmacist referring to a 30-year-old male patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On an unknown date, when the patient was 15, he was vaccinated with either quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route of administration, lot number and expiration date not reported) for prophylaxis, the patient did not remember exactly with one (product name confusion), and now, the patient reported missing his third dose (product dose omission issue). No adverse event was reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: HCP called to report inadvertent administration of expired GARDASIL 9 to a patient. Vaccine expired on 08/08/2023 and was administered on 08/14/2023. No additional AE/PQC.; HCP called to report inadvertent administration of expired GARDASIL 9 to a patient. Vaccine expired on 08/08/2023 and was administered on 08/14/2023. No additional AE/PQC.; This spontaneous report was received from a nurse and referred to a 12-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-AUG-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (expiration date: 08-AUG-2023), administered intramuscularly for prophylaxis (strength, dose, and lot # were not provided).  The nurse reported this inadvertent administration of expired vaccine (Expired product administered). No additional adverse event or product quality complaints (No adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: HBP called to report inadvertent administration of VARIVAX after a temperature excursion. Limited patient demographics provided. See AE case #02451226 and #02451228. No additional AE/PQC.   ?    Names of vaccines involved (including lot/exp): VARIV; HBP called to report inadvertent administration of VARIVAX after a temperature excursion. Limited patient demographics provided. See AE case #02451226 and #02451228. No additional AE/PQC.   ?    Names of vaccines involved (including lot/exp): VARIV; This spontaneous report was received from a other reporter referring to a patient of unknown age and gender. The patient's pertinent medical history, drug allergies or reactions, and concomitant medications were unknown by the reporter.  On 14-AUG-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), for prophylaxis (formulation, dose, route of administration, vaccination scheme frequency, and anatomical location were not reported; valid lot number W016747 with and expiration date reported as 23-MAY-2024 but upon internal validation established as 23-APR-2024). The administered dose of the vaccine experienced a temperature excursion of 7.3 degrees Fahrenheit for 30 minutes. It was not mentioned if this information was recorded by a data logger or not. There was no adverse effect reported.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AEs; Nurse reported that a historical medical record showed that more than a decade ago a 38 years old adult patient might have received a pediatric dose of possibly RECOMBIVAX HB back on 9/17/2009.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.      On 17-SEP-2009, the patient was vaccinated with child dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot # 1689x and expiration date 28-AUG-2011, 0.5 milliliter for prophylaxis (dose number, route and site of administration were not provided) (product administered to patient of inappropriate age and no adverse event).
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain upper, Intentional dose omission
Clinical narrative: Stomach aches; Stopped Vivotif after taking the 2nd dose and did not take further doses; A spontaneous report was received from nurse on 11JUL2023 regarding 14-year-old male patient who experienced "stomach aches" (PT: Abdominal pain upper) and "stopped Vivotif after taking the 2nd dose and did not take further doses" (PT: Intentional dose omission). The patient took 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.   On 05JUL2023, Wednesday, the patient took the first dose of Vivotif and experienced stomach aches. On 07JUL2023, Friday, the patient took the second dose of Vivotif and again reported stomach aches. Reportedly, the patient stopped Vivotif after taking the second dose and did not take further doses. The outcome of the event "stomach aches" was unknown while it was not applicable for "stopped Vivotif after taking the 2nd dose and did not take further doses".  The action taken with Vivotif with respect to the event "stomach aches" was drug withdrawn while it was not applicable for the event "stopped Vivotif after taking the 2nd dose and did not take further doses".  No additional information was reported.  Company comment: It was reported that a consumer received Vivotif and she developed stomach aches (abdominal pain upper) and "stopped Vivotif after taking the 2nd dose and did not take further doses (intentional dose omission). Further information regarding event is limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of abdominal pain upper is assessed as possible. The causality of intentional dose omission is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer received Vivotif and she developed stomach aches (abdominal pain upper) and "stopped Vivotif after taking the 2nd dose and did not take further doses (intentional dose omission). Further information regarding event is limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of abdominal pain upper is assessed as possible. The causality of intentional dose omission is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: F
Vaccine: TYP
Symptoms: Product dose omission issue, Vomiting
Clinical narrative: Vomited and saw the second pill of Vivotif in the vomit; Vomited and saw the second pill of Vivotif in the vomit; A spontaneous report was received from a nurse on 25JUL2023 regarding a female patient of unknown age who "vomited and saw the second pill of Vivotif in the vomit" (PT: Product dose omission issue and PT: Vomiting). The patient took oral Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that shortly after receiving the second dose of Vivotif the patient vomited and saw the pill in the vomit. Reportedly, the patient was scheduled to receive the third dose today (at the time of report).  The outcome of the event "vomited and saw the second pill of Vivotif in the vomit" (PT: Product dose omission issue) was not applicable while it was unknown for "(PT: Vomiting)".  The action taken with Vivotif with respect to the event "vomited and saw the second pill of Vivotif in the vomit" (PT: Product dose omission issue) was not applicable while it was unknown with respect to "(PT: Vomiting)".  No additional information was reported.  Company comment: It was reported that shortly after receiving the second dose of Vivotif, a female patient of unknown age vomited and saw the second pill of Vivotif in the vomit (product dose omission issue and vomiting). Considering the case information, the role of Vivotif cannot be ruled out and the causality of vomiting is assessed as possible. Furthermore, the causality of product dose omission issue is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that shortly after receiving the second dose of Vivotif, a female patient of unknown age vomited and saw the second pill of Vivotif in the vomit (product dose omission issue and vomiting). Considering the case information, the role of Vivotif cannot be ruled out and the causality of vomiting is assessed as possible. Furthermore, the causality of product dose omission issue is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: U
Vaccine: COVID19
Symptoms: Uterine cancer
Clinical narrative: STAGE 3 UTERINE CANCER; This spontaneous report received from a consumer via another pharmaceutical company (Pfizer Inc.) concerned a patient of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported,1 total was administered on unspecified date for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced stage 3 uterine cancer. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stage 3 uterine cancer was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230830921- stage 3 uterine cancer. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.