chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Nasal congestion, Sinus congestion
Clinical narrative: Nasal sinus clog; Nasal congestion; This spontaneous case was received on 05-Jan-2024 from other healthcare professional via Communications (reference number: SEQW24-00076) and concerned a patient of unreported age and gender.  The patient's medical history and concomitant medications were not reported. Reportedly, the patient had taken flu shots in the past years.  On an unspecified date, the patient was vaccinated with Influenza vaccine (influenza vaccine, dose, route of administration and anatomical location: not reported) for prevention of influenza virus. The batch number was not reported.   On an unspecified date, an unknown amount of time after receiving Influenza vaccine, the patient had reaction in the form of nasal sinus clog and congestion.   The outcome of the events of 'sinus congestion' and 'nasal congestion' was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A patient of unreported age and gender experienced sinus congestion and nasal congestion an unknown amount of time after being vaccinated with Influenza vaccine. The patient's medical history as well as relevant laboratory and diagnostic findings were not reported. Due to unclear temporal relationship and lack of above-mentioned information, causality for the events including sinus congestion and nasal congestion is unassessable.; Sender's Comments: A patient of unreported age and gender experienced sinus congestion and nasal congestion an unknown amount of time after being vaccinated with Influenza vaccine. The patient's medical history as well as relevant laboratory and diagnostic findings were not reported. Due to unclear temporal relationship and lack of above-mentioned information, causality for the events including sinus congestion and nasal congestion is unassessable.
Age: 54.0
Sex: F
Vaccine: FLUC3
Symptoms: Asthenia, Walking aid user
Clinical narrative: Started feeling weak / she was still weak for the reaction, and was using a walker; This spontaneous case was received on 08-Jan-2024 from other healthcare professional (nurse) (reference number: SEQW24-00098) and concerned a 54-year-old female patient.  The patient's concurrent conditions included multiple allergies, hypothyroidism, bipolar disroder, hypertension, depression, type 2 diabetes mellitus, seasonal allergies, hypokalemia, muscle weakness, asthma, and constipation. The patient's procedures included gastric bypass. The patient's concomitant medications included losartan, fluticasone, Ventolin (salbutamol), azelastine, mometasone, Singulair (montelukast), Ozempic (semaglutide), metformin, levocetirizine, potassium, vitamin D, calcium, multivitamin, magnesium, lamotrigine, lurasidone, vitamin C, Aspirin (acetylsalicylic acid), Epipen (epinephrine), esterase and persulphate. The patient's historical vaccines included influenza vaccines received on unspecified dates (batch numbers: not reported), for unreported indication.  On 26-Dec-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 mL, route of administration, and anatomical location: not reported) for active immunization against influenza disease. The batch number was reported as 370661 and the expiry date was 30-Jun-2024.  On the same date, after receiving the Flucelvax Quadrivalent the patient started feeling weak.   On 02-Jan-2024, seven days after receiving the Flucelvax Quadrivalent, the patient called again and stated that she still felt weak and had been using a walker. No treatment measures were associated with the event.  At the time of the initial reporting, the patient had not recovered from the event.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 54-year-old female patient started feeling weak on the same day after being vaccinated with Flucelvax Quadrivalent. The patient's concurrent conditions hypothyroidism, hypertension, depression, muscle weakness, and asthma. Nevertheless, causality for asthenia is assessed as possibly related based on chronological plausibility.; Sender's Comments: A 54-year-old female patient started feeling weak on the same day after being vaccinated with Flucelvax Quadrivalent. The patient's concurrent conditions hypothyroidism, hypertension, depression, muscle weakness, and asthma. Nevertheless, causality for asthenia is assessed as possibly related based on chronological plausibility.
Age: 1.08
Sex: U
Vaccine: UNK, VARCEL
Symptoms: Product storage error
Clinical narrative: no adverse event; data logger became dislodged and stopped tracking data during the time frame reported; This spontaneous report as received from certified medical assistant refers to a 13 month old patient. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided.   Temperature excursion was form 05-JAN-2024 through 07-JAN-2024.  On 09-JAN-2024, the patient was vaccinated with an improperly stored dose of  varicella virus vaccine live (oka/merck)(VARIVAX) lot # X006982,expiration date: 07-MAR-2025, dose: 0.5 milliliter ( dose number, route of administration was not reported) and included sterile diluent (dose, route of administration, lot number and expiration date were not reported) for prophylaxis.  The caller stated that the cord from the data logger became dislodged and stopped tracking data during the time frame reported. The caller was unaware of the issue until today (10-JAN-2024) and was unable to provide the data necessary to perform a stability evaluation due to insufficient data.  The administered dose of the vaccine experienced a temperature excursion minus 2 degrees Fahrenheit for 72 hours. There was no adverse effect reported. No product quality complaint was involved.  This is one of several reports received from the same reporter (reported as a total of 5 patients received doses of the vaccines during and after the potential excursion).; Sender's Comments:  US-009507513-2401USA006022: US-009507513-2401USA005959: US-009507513-2401USA005730: US-009507513-2401USA006056:
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No adverse event; HCP calling to report accidentally administering second dose of VARIVAX vaccine to adult patient vaccine prior to 4-week interval. Caller stated patient received first dose of VARIVAX on 9/26/2023 and received second dose on 10/19/2023. Permission to; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-SEP-2023, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #X017484, expiration date: 25-JUN-2025, and on 19-OCT-2023, received the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) accidentally for prophylaxis (strength, and route of administration were not provided) (inappropriate schedule of product administration).
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Acute kidney injury, Blood creatine phosphokinase increased, Blood creatinine increased, Cardiac arrest, Dialysis
Clinical narrative: Patient developed rhabdomyolysis with AKI leading to dialysis.  Hospital course complicated by cardiac arrest with return of pulses.  I can not comment on the specifics on the RSV vaccine other than the date that it occurred.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Rhabdomyolysis
Clinical narrative: Patient developed rhabdomyolysis with AKI leading to dialysis.  Hospital course complicated by cardiac arrest with return of pulses.  I can not comment on the specifics on the RSV vaccine other than the date that it occurred.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antibody test, Asthenia, Blood pressure increased, Blood test abnormal, Cardiovascular symptom
Clinical narrative: On the evening of November 15, I first noticed a sensation of heaviness/weakness in my left arm, as I reached for a jug in my refrigerator.  I did not think it was serious, and went to bed without any other symptoms.  The next morning (Nov 16), I woke up with an extremely heavy left arm, and elevated blood pressure.  I went to urgent care for some initial testing on cardiac symptoms - CT and EKG were clean, but by that time, I had lost mobility and strength all the way up and down my left side, and was unable to stand up.  I was transported by ambulance to the hospital, where MRI's led to diagnosis by a neurologist of transverse myelitis, caused by a lesion on my cervical spine at C4/C5.  I was treated with high dose IV steroids for 5 days, and subsequent physical therapy.  Further bloodwork revealed that I have a (previously undiagnosed and asymptomatic) antibody disorder called MOGAD (myelin oligodendrocyte glycoprotein antibody disorder).  My neurologist has indicated that the vaccine likely triggered activation of this disorder, manifested in transverse myelitis.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram normal, Condition aggravated, Dysstasia, Electrocardiogram normal, Limb discomfort
Clinical narrative: On the evening of November 15, I first noticed a sensation of heaviness/weakness in my left arm, as I reached for a jug in my refrigerator.  I did not think it was serious, and went to bed without any other symptoms.  The next morning (Nov 16), I woke up with an extremely heavy left arm, and elevated blood pressure.  I went to urgent care for some initial testing on cardiac symptoms - CT and EKG were clean, but by that time, I had lost mobility and strength all the way up and down my left side, and was unable to stand up.  I was transported by ambulance to the hospital, where MRI's led to diagnosis by a neurologist of transverse myelitis, caused by a lesion on my cervical spine at C4/C5.  I was treated with high dose IV steroids for 5 days, and subsequent physical therapy.  Further bloodwork revealed that I have a (previously undiagnosed and asymptomatic) antibody disorder called MOGAD (myelin oligodendrocyte glycoprotein antibody disorder).  My neurologist has indicated that the vaccine likely triggered activation of this disorder, manifested in transverse myelitis.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging spinal abnormal, Mobility decreased, Muscular weakness, Myelin oligodendrocyte glycoprotein antibody-associated disease, Myelitis transverse
Clinical narrative: On the evening of November 15, I first noticed a sensation of heaviness/weakness in my left arm, as I reached for a jug in my refrigerator.  I did not think it was serious, and went to bed without any other symptoms.  The next morning (Nov 16), I woke up with an extremely heavy left arm, and elevated blood pressure.  I went to urgent care for some initial testing on cardiac symptoms - CT and EKG were clean, but by that time, I had lost mobility and strength all the way up and down my left side, and was unable to stand up.  I was transported by ambulance to the hospital, where MRI's led to diagnosis by a neurologist of transverse myelitis, caused by a lesion on my cervical spine at C4/C5.  I was treated with high dose IV steroids for 5 days, and subsequent physical therapy.  Further bloodwork revealed that I have a (previously undiagnosed and asymptomatic) antibody disorder called MOGAD (myelin oligodendrocyte glycoprotein antibody disorder).  My neurologist has indicated that the vaccine likely triggered activation of this disorder, manifested in transverse myelitis.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Spinal disorder
Clinical narrative: On the evening of November 15, I first noticed a sensation of heaviness/weakness in my left arm, as I reached for a jug in my refrigerator.  I did not think it was serious, and went to bed without any other symptoms.  The next morning (Nov 16), I woke up with an extremely heavy left arm, and elevated blood pressure.  I went to urgent care for some initial testing on cardiac symptoms - CT and EKG were clean, but by that time, I had lost mobility and strength all the way up and down my left side, and was unable to stand up.  I was transported by ambulance to the hospital, where MRI's led to diagnosis by a neurologist of transverse myelitis, caused by a lesion on my cervical spine at C4/C5.  I was treated with high dose IV steroids for 5 days, and subsequent physical therapy.  Further bloodwork revealed that I have a (previously undiagnosed and asymptomatic) antibody disorder called MOGAD (myelin oligodendrocyte glycoprotein antibody disorder).  My neurologist has indicated that the vaccine likely triggered activation of this disorder, manifested in transverse myelitis.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Myelitis transverse
Clinical narrative: On the evening of November 15, I first noticed a sensation of heaviness/weakness in my left arm, as I reached for a jug in my refrigerator.  I did not think it was serious, and went to bed without any other symptoms.  The next morning (Nov 16), I woke up with an extremely heavy left arm, and elevated blood pressure.  I went to urgent care for some initial testing on cardiac symptoms - CT and EKG were clean, but by that time, I had lost mobility and strength all the way up and down my left side, and was unable to stand up.  I was transported by ambulance to the hospital, where MRI's led to diagnosis by a neurologist of transverse myelitis, caused by a lesion on my cervical spine at C4/C5.  I was treated with high dose IV steroids for 5 days, and subsequent physical therapy.  Further bloodwork revealed that I have a (previously undiagnosed and asymptomatic) antibody disorder called MOGAD (myelin oligodendrocyte glycoprotein antibody disorder).  My neurologist has indicated that the vaccine likely triggered activation of this disorder, manifested in transverse myelitis.
Sex: M
Vaccine: PNC20
Symptoms: Drug ineffective, Laboratory test, Pneumonia
Clinical narrative: Limited information receivedJust that patient is in hospital with Pneumonia; Limited information receivedJust that patient is in hospital with Pneumonia; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  A male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), PNEUMONIA (hospitalization, medically significant), outcome "unknown" and all described as "Limited information receivedJust that patient is in hospital with Pneumonia". The patient underwent the following laboratory tests and procedures: Tests: Unknown results. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: RSV
Symptoms: Rash, Rash pruritic, Skin burning sensation
Clinical narrative: Itchy burning rash on stomach; Itchy burning rash on stomach; This is a spontaneous report received from a Physician from a sales representative.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: RASH PRURITIC (non-serious), RASH (non-serious), outcome "unknown" and all described as "Itchy burning rash on stomach". Therapeutic measures were taken as a result of rash pruritic, rash. Additional information: Patient got an RSV shot and developed an itchy burning rash on stomach that lasted about 4 weeks. Doctor was unsure which RSV shot it was and may have not been Abrysvo. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: RSV
Symptoms: Drug ineffective, Respiratory syncytial virus infection, Respiratory syncytial virus test positive
Clinical narrative: 2 patients positive RSV post RSV vaccine.; 2 patients positive RSV post RSV vaccine.; This is a spontaneous report received from a Physician from a sales representative.  A male patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), RESPIRATORY SYNCYTIAL VIRUS INFECTION (medically significant), outcome "unknown" and all described as "2 patients positive RSV post RSV vaccine.". The patient underwent the following laboratory tests and procedures: Respiratory syncytial virus test: Positive, notes: positive RSV. It was unknown if therapeutic measures were taken as a result of drug ineffective, respiratory syncytial virus infection. Clinical course: 2 patients (husband and wife) positive RSV post RSV vaccine.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is subject to many other factors. The association between the event lack of effect (RSV infection) with RSV VACCINE PROT.SUBUNIT PREF 2V can not be fully excluded.,Linked Report(s) : US-PFIZER INC-202400010119 same reporter/drug/event, different patient.;
Sex: U
Vaccine: PNC20, PNC20
Symptoms: Rash
Clinical narrative: broke out with a skin rash; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Prevnar 13, administration date: 2014, for Immunization, reaction(s): "without any reaction"; Pfizer covid vaccine (Dose 1), administration date: 2021, for Covid-19 Immunization, reaction(s): "without any reaction"; Pfizer covid vaccine (Dose 2), administration date: 2021, for Covid-19 Immunization, reaction(s): "without any reaction". The following information was reported: RASH (non-serious), 36 hrs after the suspect product(s) administration, outcome "unknown", described as "broke out with a skin rash". Additional information: patient have never had a reaction to any vaccine in the past.   The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: U
Vaccine: PNC20, PNC20
Symptoms: Pruritus, Rash
Clinical narrative: broke out with a skin rash; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Prevnar 13, administration date: 2014, for Immunization, reaction(s): "without any reaction"; Pfizer covid vaccine (Dose 1), administration date: 2021, for Covid-19 Immunization, reaction(s): "without any reaction"; Pfizer covid vaccine (Dose 2), administration date: 2021, for Covid-19 Immunization, reaction(s): "without any reaction". The following information was reported: RASH (non-serious), 36 hrs after the suspect product(s) administration, outcome "unknown", described as "broke out with a skin rash". Additional information: patient have never had a reaction to any vaccine in the past.   The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Herpes zoster, Joint swelling, Rash
Clinical narrative: patient stated that 3 days after the immz, she developed severe pain and swelling in her shoulder (almost like bursitis); she also developed a rash from her breast to the shoulder; she did see the MD and they stated she developed shingles
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Bronchoscopy, Computerised tomogram thorax, Differential white blood cell count, Eosinophilia, Eosinophilic pneumonia
Clinical narrative: Developed Eosinophilic pneumonia and eosinophilia,
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Pulmonary function test
Clinical narrative: Developed Eosinophilic pneumonia and eosinophilia,
Age: 25.0
Sex: M
Vaccine: RAB
Symptoms: Malaise, Nasal congestion, Productive cough, Pyrexia, Respiratory tract congestion
Clinical narrative: Three hours after receiving vaccine donor developed a fever. Approx 48 hours later donor developed chest and nasal congest ion, a productive cough, and malaise. These symptoms lasted for one week. Donor has  been asymptomatic for four days.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Accidentally administered a dose even though she got the updated version in September
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Visual field defect, Visual impairment
Clinical narrative: Patient described a loss of peripheral vision in both eyes, the loss was temporary and improved with time. Contacted her primary care physician, was instructed to not receive the second dose of the series. No further medical treatment was needed.
Age: 86.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Bladder catheterisation, Bladder operation, Cardiogenic shock, Deep vein thrombosis
Clinical narrative: Patient received his 5th dose of COVID vaccine on 7/20/2023.  He had no provoking factors in terms of long travels, prolonged immobilization, malignancy or major surgery.  On 7/29/2023, he presented with weakness and was found to have a large saddle pulmonary embolus with RLE DVT.  He developed obstructive and cardiogenic shock and was placed on three pressors for BP support.  He was given TPA for thrombolysis and had an IVC filter placed.  Subsequently he developed gross hematuria with clots requiring urologic intervention for clot evacuation as well as multiple units of blood transfusions.  He also required embolization of prostatic artery and R kidney artery.  He repeatedly failed voiding trial and became foley dependent.  On 8/26, he was finally discharged to home after a 28 days of hospital stay.
Age: 86.0
Sex: M
Vaccine: COVID19-2
Symptoms: Haematuria, Obstructive shock, Prostatic artery embolisation, Pulmonary embolism, Renal artery embolisation
Clinical narrative: Patient received his 5th dose of COVID vaccine on 7/20/2023.  He had no provoking factors in terms of long travels, prolonged immobilization, malignancy or major surgery.  On 7/29/2023, he presented with weakness and was found to have a large saddle pulmonary embolus with RLE DVT.  He developed obstructive and cardiogenic shock and was placed on three pressors for BP support.  He was given TPA for thrombolysis and had an IVC filter placed.  Subsequently he developed gross hematuria with clots requiring urologic intervention for clot evacuation as well as multiple units of blood transfusions.  He also required embolization of prostatic artery and R kidney artery.  He repeatedly failed voiding trial and became foley dependent.  On 8/26, he was finally discharged to home after a 28 days of hospital stay.
Age: 86.0
Sex: M
Vaccine: COVID19-2
Symptoms: Thrombolysis, Thrombosis, Transfusion, Trial of void, Vena cava filter insertion
Clinical narrative: Patient received his 5th dose of COVID vaccine on 7/20/2023.  He had no provoking factors in terms of long travels, prolonged immobilization, malignancy or major surgery.  On 7/29/2023, he presented with weakness and was found to have a large saddle pulmonary embolus with RLE DVT.  He developed obstructive and cardiogenic shock and was placed on three pressors for BP support.  He was given TPA for thrombolysis and had an IVC filter placed.  Subsequently he developed gross hematuria with clots requiring urologic intervention for clot evacuation as well as multiple units of blood transfusions.  He also required embolization of prostatic artery and R kidney artery.  He repeatedly failed voiding trial and became foley dependent.  On 8/26, he was finally discharged to home after a 28 days of hospital stay.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Fall, Malaise
Clinical narrative: Patient came to the Pharmacy today5:30pm and reported that on 1/12/2024, a day after receiving both AREXVY and FLUZONE HD QUADRIVALENT Vaccines she felt so sick that she fell and was rushed to the ER .  She also said she pent 4 days in the hospital and was discharged today. She believes her illness was as a result of receiving both vaccines at the same time.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebellar stroke, Ischaemic stroke
Clinical narrative: Patient received his 5th COVID vaccine dose on 11/29/2023.  He had no risk factors for CVA - no history of tobacco, ETOH, diabetes, hypertension, hyperlipidemia, heart disease, obesity or sedentary lifestyle.  He exercised regularly and had seen his doctor recently with a clean bill of health.  On 1/3/2024, patient presented to hospital with R cerebellar ischemic stroke.  He was given TNK and started on ASA and Atorvastatin.  Patient was hospitalized for two days and was discharged to home on 1/5.
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: COVID vaccine for ages 12+years administered, instead of vaccine intended for 5 years- 11 years. Pt showed no signs of distress.  No treatment needed.
Age: 60.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Bronchoscopy abnormal, Chemotherapy, Death, Endotracheal intubation, Imaging procedure abnormal
Clinical narrative: Patient received his flu shot and 7th dose of COVID vaccine on 10/11/2023.  He had underlying diagnosis of lung cancer.  On 10/16/2023, he presented to the hospital with hypoxic respiratory failure with lung opacities on imaging consistent with diffuse pneumonitis.  He was intubated and initial bronchoscopy result was negative for infection.  Patient was given empiric antibiotics, steroids and a trial of chemo.  He had prolonged intubation and eventually developed ventilator associated pneumonia and required tracheostomy placement.  Patient's cancer progressed and he developed brain metastasis.  Given the overall poor prognosis with no good assurance of quality of life, family opted for comfort care and he passed away on 11/23, after 38 days in the hospital.
Age: 60.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Lung cancer metastatic, Lung opacity, Metastases to central nervous system, Pneumonia, Pneumonitis
Clinical narrative: Patient received his flu shot and 7th dose of COVID vaccine on 10/11/2023.  He had underlying diagnosis of lung cancer.  On 10/16/2023, he presented to the hospital with hypoxic respiratory failure with lung opacities on imaging consistent with diffuse pneumonitis.  He was intubated and initial bronchoscopy result was negative for infection.  Patient was given empiric antibiotics, steroids and a trial of chemo.  He had prolonged intubation and eventually developed ventilator associated pneumonia and required tracheostomy placement.  Patient's cancer progressed and he developed brain metastasis.  Given the overall poor prognosis with no good assurance of quality of life, family opted for comfort care and he passed away on 11/23, after 38 days in the hospital.
Age: 60.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Respiratory failure, Tracheostomy
Clinical narrative: Patient received his flu shot and 7th dose of COVID vaccine on 10/11/2023.  He had underlying diagnosis of lung cancer.  On 10/16/2023, he presented to the hospital with hypoxic respiratory failure with lung opacities on imaging consistent with diffuse pneumonitis.  He was intubated and initial bronchoscopy result was negative for infection.  Patient was given empiric antibiotics, steroids and a trial of chemo.  He had prolonged intubation and eventually developed ventilator associated pneumonia and required tracheostomy placement.  Patient's cancer progressed and he developed brain metastasis.  Given the overall poor prognosis with no good assurance of quality of life, family opted for comfort care and he passed away on 11/23, after 38 days in the hospital.
Age: 51.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated with 2 boosters
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated with 2 boosters
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Blood culture, Central venous catheterisation, Computerised tomogram head, Confusional state
Clinical narrative: HSV encephalitis Diagnosed 11/1 via LP with no known prior history of HSV infection  Severe confusion and high fevers admitted to hospital 10/23-11/3. Treated with IV acyclovir for 3 week course via PICC line. Residual aphasia to this date 1/15/24. Symptoms started  10/21/23 with lethargy and fatigue which worsened to aphasia and High fevers of 103F.  Hospitalized 10/23/23
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Differential white blood cell count, Electroencephalogram, Fatigue, Full blood count, Herpes simplex encephalitis
Clinical narrative: HSV encephalitis Diagnosed 11/1 via LP with no known prior history of HSV infection  Severe confusion and high fevers admitted to hospital 10/23-11/3. Treated with IV acyclovir for 3 week course via PICC line. Residual aphasia to this date 1/15/24. Symptoms started  10/21/23 with lethargy and fatigue which worsened to aphasia and High fevers of 103F.  Hospitalized 10/23/23
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Lumbar puncture abnormal, Magnetic resonance imaging head, Pyrexia
Clinical narrative: HSV encephalitis Diagnosed 11/1 via LP with no known prior history of HSV infection  Severe confusion and high fevers admitted to hospital 10/23-11/3. Treated with IV acyclovir for 3 week course via PICC line. Residual aphasia to this date 1/15/24. Symptoms started  10/21/23 with lethargy and fatigue which worsened to aphasia and High fevers of 103F.  Hospitalized 10/23/23
Age: 72.0
Sex: F
Vaccine: FLU4, RSV, VARZOS
Symptoms: Wrong product administered
Clinical narrative: PATIENT STATES SHE WAS GIVEN WRONG VACCINE DID NOT ASK FOR AREXVY
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest X-ray, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: I received a  vaccination at Pharmacy on December 14, 2023, with some reservation since the pharmacist who administered the vaccination informed me that she had, in fact, discarded most of the vaccine in October since the people were not coming out to get the vaccination. However, I decided to go on with the vaccination in spite of this information.  On the evening of December 14, around 7:30 p.m., I  began to experience heat flush and ensuing fatigue after being vaccinated around 3;30 p.m. earlier that day.  However, that night I continued to feel fatigued with tremendous body aches which kept me awake most of the night.  The next day, I experienced a pounding headache on one side of  my head, along with the fatigue and boy aches.  I assumed that this was normal after reading about the side effects.  However,  this problem only got worse.  I began to experience intense pain in the center of my back, and extreme heart palpitations, which a month later make me feel as if I'm going to pass out.  I hurt so bad and was rushed to the hospital at 2:30 am  on December 19, 2023.  I have been to the doctor's office twice and still feel awful.  Please help me!
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush, Pain, Palpitations, Sleep disorder
Clinical narrative: I received a  vaccination at Pharmacy on December 14, 2023, with some reservation since the pharmacist who administered the vaccination informed me that she had, in fact, discarded most of the vaccine in October since the people were not coming out to get the vaccination. However, I decided to go on with the vaccination in spite of this information.  On the evening of December 14, around 7:30 p.m., I  began to experience heat flush and ensuing fatigue after being vaccinated around 3;30 p.m. earlier that day.  However, that night I continued to feel fatigued with tremendous body aches which kept me awake most of the night.  The next day, I experienced a pounding headache on one side of  my head, along with the fatigue and boy aches.  I assumed that this was normal after reading about the side effects.  However,  this problem only got worse.  I began to experience intense pain in the center of my back, and extreme heart palpitations, which a month later make me feel as if I'm going to pass out.  I hurt so bad and was rushed to the hospital at 2:30 am  on December 19, 2023.  I have been to the doctor's office twice and still feel awful.  Please help me!
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Sleep disorder, Tachycardia
Clinical narrative: Five days after receiving the vaccine, patient woke up at 4 pm and could not go back to sleep. Patient had palpitation and tachycardia. Patient had to go to urgent care and then ER. The symptoms lasted for 12 hours or longer.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Headache, Respiratory syncytial virus infection
Clinical narrative: Patient had two doses of RSV vaccination, first 9/18/23 with her annual flu shot and requested and received  another RSV immunization 10/27/23. Patient complained of headache after RSV injection which lasted 3-4 months after immunization. Patient stated she had RSV infection 1/2023.
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP reported VAQTA was administered post expiry; confirmed product was stored according to PI. No additional AE/no PQC.; This spontaneous report was received from a nurse referring a patient of unknown age. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.     On 29-DEC-2023, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) for prophylaxis (expired product administered) (strength, dose, frequency, route of administration, anatomical location and expiration date were not provided).   No  adverse event reported.   Lot number W01819 is an invalid lot number for hepatitis a vaccine, inactivated (VAQTA).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC.; inadvertent administration of expired VAQTA to a patient; This spontaneous report has been received from a nurse prescriber and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 10-JAN-2024, the patient was inadvertently vaccinated with expired hepatitis a vaccine, inactivated(VAQTA) intramuscular injection (lot # W028824 verified to be a valid lot number, expiration date 07-JAN-2024; dose, dose number, route and strength not provided) for prophylaxis, by a health professional (Expired product administered). There is no additional adverse event reported (No adverse event).
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I developed a full body rash with raised wheals that caused irritation. I went to the emergency department shortly after and was given benadryl and weeklong course dexamethasone. The symptoms subsided while on the medication but returned after the medication finished. I subsequently went to the Emergency Department again and given the same treatment with same results. I then made an appointment to an allergy specialist which gave me levocetrizine 5mg daily. I had to take and taper off of this medication a number of times until about 1 year and a half later when my body stopped having an allergic reaction to whatever it was reacting to
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional ae; inadvertently administered today, 12/18/2023, after its labeled expiry date of 12/10/2023; This spontaneous report was received from a physician assistant referring to a 2-month-old patient of unknown gender. Information about the patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions/allergies were not reported.  On 18-DEC-2023, the patient was inadvertently vaccinated with first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (2ml, lot #1912561, expiration date: 10-DEC-2023, administered orally for prophylaxis (strength was not provided) (expired product administered). The reporter reported the vaccine had not had any previous temperature excursions. No additional adverse event (AE) (no AE).
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms or additional details provided. No other AE and no PQC; HBP calling to report the administration of an expired dose of a PNEUMOVAX 23 SYRINGE to a patient on 01/10/2024.; This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender.  The patient's pertinent medical history, previous drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  0n 10-JAN-2024, the patient was vaccinated with an expired dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (expired product administered) (lot number W019533 has been determined to be valid, expiration date reported and validated as 30-SEP-2023), administered for prophylaxis (strength, dosage regimen, vaccination scheme, anatomical site of administration and route of administration were not provided). No symptoms, additional details or adverse events were provided for this patient.
Sex: M
Vaccine: VARZOS
Symptoms: Ear pain, Facial pain, Feeling hot, Myalgia, Odynophagia
Clinical narrative: right ear pain; feels hot; his hair hurts to touch it; right side of his face hurts; his throat hurts to swallow; he felt feverish; and had muscle aches; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose of shingrix received on an unknown date for tolerance refer case US2024AMR005309).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular, unknown arm) .5 ml. On 30-DEC-2023, 18 months after receiving Shingrix, the patient experienced ear pain (Verbatim: right ear pain), feeling hot (Verbatim: feels hot), scalp pain (Verbatim: his hair hurts to touch it), facial pain (Verbatim: right side of his face hurts) and throat pain (Verbatim: his throat hurts to swallow). On an unknown date, the patient experienced fever (Verbatim: he felt feverish) and muscle pain (Verbatim: and had muscle aches). Rechallenge with Shingrix was positive. The outcome of the fever and muscle pain were resolved (duration 1 day) and the outcome of the ear pain, feeling hot, scalp pain, facial pain and throat pain were not resolved.   It was unknown if the reporter considered the fever, muscle pain, ear pain, feeling hot, scalp pain, facial pain and throat pain to be related to Shingrix.     It was unknown if the company considered the fever, muscle pain, ear pain, feeling hot, scalp pain, facial pain and throat pain to be related to Shingrix.   Additional Information: GSK receipt date: 08-JAN-2024 The patient self reported this case. The patient received shingrix vaccine about 18 months ago. The patient felt feverish and had muscle aches the day he received both 1st and 2nd dose. The patient reported that, the symptoms resolved the next day. The patient reported, about 10 days ago his right ear hurted and felt hot, his hair hurted to touch it, the right side of his face hurted and his throat hurted to swallow. The patient thought he my had a case of shingles. The patient did not consented to follow up. This case was linked with US2024AMR005309 same patient 1st dose.; Sender's Comments:  US-GSK-US2024AMR005309:1st dose case
Sex: M
Vaccine: VARZOS
Symptoms: Pain of skin, Pyrexia
Clinical narrative: right ear pain; feels hot; his hair hurts to touch it; right side of his face hurts; his throat hurts to swallow; he felt feverish; and had muscle aches; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose of shingrix received on an unknown date for tolerance refer case US2024AMR005309).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular, unknown arm) .5 ml. On 30-DEC-2023, 18 months after receiving Shingrix, the patient experienced ear pain (Verbatim: right ear pain), feeling hot (Verbatim: feels hot), scalp pain (Verbatim: his hair hurts to touch it), facial pain (Verbatim: right side of his face hurts) and throat pain (Verbatim: his throat hurts to swallow). On an unknown date, the patient experienced fever (Verbatim: he felt feverish) and muscle pain (Verbatim: and had muscle aches). Rechallenge with Shingrix was positive. The outcome of the fever and muscle pain were resolved (duration 1 day) and the outcome of the ear pain, feeling hot, scalp pain, facial pain and throat pain were not resolved.   It was unknown if the reporter considered the fever, muscle pain, ear pain, feeling hot, scalp pain, facial pain and throat pain to be related to Shingrix.     It was unknown if the company considered the fever, muscle pain, ear pain, feeling hot, scalp pain, facial pain and throat pain to be related to Shingrix.   Additional Information: GSK receipt date: 08-JAN-2024 The patient self reported this case. The patient received shingrix vaccine about 18 months ago. The patient felt feverish and had muscle aches the day he received both 1st and 2nd dose. The patient reported that, the symptoms resolved the next day. The patient reported, about 10 days ago his right ear hurted and felt hot, his hair hurted to touch it, the right side of his face hurted and his throat hurted to swallow. The patient thought he my had a case of shingles. The patient did not consented to follow up. This case was linked with US2024AMR005309 same patient 1st dose.; Sender's Comments:  US-GSK-US2024AMR005309:1st dose case
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: dose of Shingrix was administered with sterile diluent; wrong diluent used; This non-serious case was reported by a consumer via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 09-JAN-2024, the patient received Shingrix. On 09-JAN-2024, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: dose of Shingrix was administered with sterile diluent) and inappropriate dose of vaccine administered (Verbatim: wrong diluent used). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 09-JAN-2024 The GlaxoSmithKline sales representative requested for information about how a client (patient) should proceed after a dose of Shingrix was administered with sterile diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not yet received her 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on 2020 received 1st dose.).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: not yet received her 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 12-JAN-2024 A reporter reported that a patient received her first Shingrix dose in 2020, just before the Covid lockdown and had not yet received her 2nd dose till the time of reporting. Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination. The reporter requesting consent to follow up.
Age: 0.58
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: refrigerator door being accidentally left open/high of 8.9C out of range for 40 minutes with no adverse event; administered post excursion with no adverse event; Initial information was received on 09-Jan-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2024SA014574.  This case involves a 7 months old female patient to whom IPV (VERO) [Ipol] was administered when refrigerator door being accidentally left open/high of 8.9c out of range for 40 minutes with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal vaccine for Prophylactic vaccination.  On 14-Dec-2023, the patient received a 0.5 ml, once of suspect IPV (VERO) (Suspension for injection) (lot V1B902M, expiry date: 02-Jun-2024, strength: standard) via intramuscular route in right thigh for Immunisation (poor quality product administered) (Latency: same day).  On an unknown date the patient developed a non-serious refrigerator door being accidentally left open/high of 8.9c out of range for 40 minutes with no adverse event (product storage error).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: Accidental dose increase; This non-serious case was reported by a other health professional via patient support programs and described the occurrence of accidental overdose in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced accidental overdose (Verbatim: Accidental dose increase). The outcome of the accidental overdose was unknown.   Additional Information: GSK receipt date: 10-JAN-2024 The patient accidental received increase dose of Shingrix which led to accidental overdose. The reporter consented to follow up.