chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Pyrexia, Sinus congestion, Sinus pain, Upper-airway cough syndrome
Clinical narrative: About 5-6 hours after the injection on Thursday, I first noticed some aching and  fatigue.  Soon, that same evening, I noticed I was getting some cold symptoms, including stuffy sinuses, slight headache, and a bit of a sore throat. Not having a fever,  I managed to go to work the next day, Friday, but had a lot of post nasal mucus and felt tired and weak with again a slight headache from sinus pressure. Over the weekend my symptoms have gotten worse, with much thicker mucus.  It's now Sunday night, and I have a slight fever and feel chilled. My sinus congestion has not alleviated, and I have sinus pain in my face , head, and ears. I have not had any coughing.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: pain, redness, and swelling at injection site that is getting larger in area with time
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site pain, Pain, Sleep disorder
Clinical narrative: 1. Facial numbness on the right side  2. At the site of the injection (mid upper of the left shoulder): muscle pain, at night time is throbbing and cannot sleep on that side  -pain comes and goes but mostly present  -she has done nothing and taken no medication to relieve it at this time  -there are no visible marking s or rashes at the site of the injection
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Lethargy
Clinical narrative: patient stated that she has been lethargic/tired and has no appetite since receiving the Comirnaty 12+ COVID-19 vaccination
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Thrombosis
Clinical narrative: G3P1, 38 yo with prenatal care. All serologies negative. No pregnancy complications. Normal ultrasounds. EDD 2/14/2024. Received monovalent Moderna vaccine and developed a blood clot in the leg two days later. Currently monitoring. Received the Covid vaccine beginning in 2020 and a booster every year since. This is my first known reaction to the vaccine since.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal discomfort, Neuralgia
Clinical narrative: vaccine administered 10/18/23, pt reports vaccine administered very far forward, nearly to arm pit.  Pt reports increasing joint/nerve discomfort on 10/19/23 and for several weeks after.  Reported to pharmacy on 11/12/23.  Pt states pain is resolving at this point
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure, Transient ischaemic attack
Clinical narrative: Seizure or TIA
Age: 39.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Discomfort, Erythema, Scar
Clinical narrative: Old smallpox? s scar in left arm got red and a bit uncomfortable.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: One day after my vaccination, I have bounding,  fast heart rate of 102-106 BPM.  It's more than 24 hours now since I was vaccinated.
Age: 39.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site nodule, Injection site pain, Injection site swelling, Sleep disorder
Clinical narrative: Pt received vaccine in left deltoid IM, and reports still having swelling in arm with nodule at site of injection causing pain and difficulties sleeping. Pt will contact her physician to see if further medical care is needed.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Spikevax vaccine for patients 12 years old and above administered to 10 year old patient instead of age appropriate covid-19 vaccine.
Age: 61.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Left arm - 11/11/23  had a  2 inch area around injection site swollen with warm rash . Took Benadryl  that evening.  11/12/23 woke up with the slightly improved condition due to the Benadryl the night before. Throughout the day the rash, swelling and heat increased.  Now have a 3 inch swollen rash  going down the arm from the injection site, toward the hand.  I am taking Benadryl again tonight.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Injection site swelling
Clinical narrative: Fatigue, muscle aches, headache, swelling at thr injextion site, chills, and sweating.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Fatigue, muscle aches, headache, swelling at thr injextion site, chills, and sweating.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Headache, Oropharyngeal pain, Productive cough
Clinical narrative: Nov 10- headache  Nov 11- sore throat, headache, cough, phlegm Nov 12- Sore throat, cough, headache, fever, phlegm (+ positive antigen at home test)
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Nov 10- headache  Nov 11- sore throat, headache, cough, phlegm Nov 12- Sore throat, cough, headache, fever, phlegm (+ positive antigen at home test)
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Acinetobacter test positive, Acute respiratory failure, Akinesia, Angiogram pulmonary abnormal, Bladder mass
Clinical narrative: BRIEF OVERVIEW: Admission Date: 8/31/2023 Discharge Date: Sep 21, 2023 Discharge Disposition:  skilled nursing facility   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute respiratory failure with hypoxia (HCC) [J96.01]   HOSPITAL COURSE: Patient is a 68 y.o. female with a past medical history including COPD without baseline O2 need, IgG lambda multiple myeloma currently undergoing treatment, coronary artery disease, achalasia s/p botox, essential hypertension, anxiety, and depression who was admitted 8/31/2023 for acute on chronic hypoxic,hypercapnic respiratory failure secondary to Covid-19 pneumonia.   Patient presented to ED after she was noted to be diaphoretic and hypoxic during an outpatient infusion appointment. On arrival she required 4L NC supplemental oxygen. Work up was notable for Covid-19 + PCR and uptrending troponin. CTA thorax demonstrated bilateral pneumonia with underlying severe emphysema. She as transferred to another hospital for cardiology consult and further care.    During admission, patient intermittently required HFNC for respiratory support. Bipap was attempted for increased respiratory acidosis, but she did not tolerate this. She received Remdesivir and IV solumedrol. Sputum culture was positive for Acinetobacter pittii, which was concerning for an aspiration pneumonia based on the patient's chronic dysphagia, so she also received a 7 day course on Unasyn. Pulmonology was consulted and assisted with her management. Her respiratory status slowly improved to needing 2L NC at rest and 3L with ambulation. Expect a prolonged recovery due to the severity of her underlying emphysema.   Cardiology was consulted due to the elevated troponins on admission. Echocardiogram demonstrated LVEF 33% with akinesis of the basal inferior wall and mild dilation of the left ventricle. She was started on Coreg and Losartan for medical management. Cardiology recommended further outpatient work-up with cardiac MRI/ repeat echo.    SLP was consulted during the admission, as well. They completed an FEES that demonstrated mild risk for aspiration and suggested continued regular diet with thin liquids to supplement PEG tube feeds.    She developed leukopenia. B12 levels were checked and WNL. Revlimid held for neutropenia discussed with oncologist to resume 9/26.   PT and OT were consulted and recommended SAR on discharge and SAR requested 20 day respiratory isolation with severity of illness. Daughter at bedside for transportation and all questions answered.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Cellulitis, Device intolerance, Echocardiogram abnormal
Clinical narrative: BRIEF OVERVIEW: Admission Date: 8/31/2023 Discharge Date: Sep 21, 2023 Discharge Disposition:  skilled nursing facility   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute respiratory failure with hypoxia (HCC) [J96.01]   HOSPITAL COURSE: Patient is a 68 y.o. female with a past medical history including COPD without baseline O2 need, IgG lambda multiple myeloma currently undergoing treatment, coronary artery disease, achalasia s/p botox, essential hypertension, anxiety, and depression who was admitted 8/31/2023 for acute on chronic hypoxic,hypercapnic respiratory failure secondary to Covid-19 pneumonia.   Patient presented to ED after she was noted to be diaphoretic and hypoxic during an outpatient infusion appointment. On arrival she required 4L NC supplemental oxygen. Work up was notable for Covid-19 + PCR and uptrending troponin. CTA thorax demonstrated bilateral pneumonia with underlying severe emphysema. She as transferred to another hospital for cardiology consult and further care.    During admission, patient intermittently required HFNC for respiratory support. Bipap was attempted for increased respiratory acidosis, but she did not tolerate this. She received Remdesivir and IV solumedrol. Sputum culture was positive for Acinetobacter pittii, which was concerning for an aspiration pneumonia based on the patient's chronic dysphagia, so she also received a 7 day course on Unasyn. Pulmonology was consulted and assisted with her management. Her respiratory status slowly improved to needing 2L NC at rest and 3L with ambulation. Expect a prolonged recovery due to the severity of her underlying emphysema.   Cardiology was consulted due to the elevated troponins on admission. Echocardiogram demonstrated LVEF 33% with akinesis of the basal inferior wall and mild dilation of the left ventricle. She was started on Coreg and Losartan for medical management. Cardiology recommended further outpatient work-up with cardiac MRI/ repeat echo.    SLP was consulted during the admission, as well. They completed an FEES that demonstrated mild risk for aspiration and suggested continued regular diet with thin liquids to supplement PEG tube feeds.    She developed leukopenia. B12 levels were checked and WNL. Revlimid held for neutropenia discussed with oncologist to resume 9/26.   PT and OT were consulted and recommended SAR on discharge and SAR requested 20 day respiratory isolation with severity of illness. Daughter at bedside for transportation and all questions answered.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Ejection fraction decreased, Emphysema, Endoscopic swallowing evaluation abnormal, Gastrostomy, Hyperhidrosis
Clinical narrative: BRIEF OVERVIEW: Admission Date: 8/31/2023 Discharge Date: Sep 21, 2023 Discharge Disposition:  skilled nursing facility   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute respiratory failure with hypoxia (HCC) [J96.01]   HOSPITAL COURSE: Patient is a 68 y.o. female with a past medical history including COPD without baseline O2 need, IgG lambda multiple myeloma currently undergoing treatment, coronary artery disease, achalasia s/p botox, essential hypertension, anxiety, and depression who was admitted 8/31/2023 for acute on chronic hypoxic,hypercapnic respiratory failure secondary to Covid-19 pneumonia.   Patient presented to ED after she was noted to be diaphoretic and hypoxic during an outpatient infusion appointment. On arrival she required 4L NC supplemental oxygen. Work up was notable for Covid-19 + PCR and uptrending troponin. CTA thorax demonstrated bilateral pneumonia with underlying severe emphysema. She as transferred to another hospital for cardiology consult and further care.    During admission, patient intermittently required HFNC for respiratory support. Bipap was attempted for increased respiratory acidosis, but she did not tolerate this. She received Remdesivir and IV solumedrol. Sputum culture was positive for Acinetobacter pittii, which was concerning for an aspiration pneumonia based on the patient's chronic dysphagia, so she also received a 7 day course on Unasyn. Pulmonology was consulted and assisted with her management. Her respiratory status slowly improved to needing 2L NC at rest and 3L with ambulation. Expect a prolonged recovery due to the severity of her underlying emphysema.   Cardiology was consulted due to the elevated troponins on admission. Echocardiogram demonstrated LVEF 33% with akinesis of the basal inferior wall and mild dilation of the left ventricle. She was started on Coreg and Losartan for medical management. Cardiology recommended further outpatient work-up with cardiac MRI/ repeat echo.    SLP was consulted during the admission, as well. They completed an FEES that demonstrated mild risk for aspiration and suggested continued regular diet with thin liquids to supplement PEG tube feeds.    She developed leukopenia. B12 levels were checked and WNL. Revlimid held for neutropenia discussed with oncologist to resume 9/26.   PT and OT were consulted and recommended SAR on discharge and SAR requested 20 day respiratory isolation with severity of illness. Daughter at bedside for transportation and all questions answered.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia, Infusion, Left ventricular dilatation, Leukopenia, Neutropenia
Clinical narrative: BRIEF OVERVIEW: Admission Date: 8/31/2023 Discharge Date: Sep 21, 2023 Discharge Disposition:  skilled nursing facility   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute respiratory failure with hypoxia (HCC) [J96.01]   HOSPITAL COURSE: Patient is a 68 y.o. female with a past medical history including COPD without baseline O2 need, IgG lambda multiple myeloma currently undergoing treatment, coronary artery disease, achalasia s/p botox, essential hypertension, anxiety, and depression who was admitted 8/31/2023 for acute on chronic hypoxic,hypercapnic respiratory failure secondary to Covid-19 pneumonia.   Patient presented to ED after she was noted to be diaphoretic and hypoxic during an outpatient infusion appointment. On arrival she required 4L NC supplemental oxygen. Work up was notable for Covid-19 + PCR and uptrending troponin. CTA thorax demonstrated bilateral pneumonia with underlying severe emphysema. She as transferred to another hospital for cardiology consult and further care.    During admission, patient intermittently required HFNC for respiratory support. Bipap was attempted for increased respiratory acidosis, but she did not tolerate this. She received Remdesivir and IV solumedrol. Sputum culture was positive for Acinetobacter pittii, which was concerning for an aspiration pneumonia based on the patient's chronic dysphagia, so she also received a 7 day course on Unasyn. Pulmonology was consulted and assisted with her management. Her respiratory status slowly improved to needing 2L NC at rest and 3L with ambulation. Expect a prolonged recovery due to the severity of her underlying emphysema.   Cardiology was consulted due to the elevated troponins on admission. Echocardiogram demonstrated LVEF 33% with akinesis of the basal inferior wall and mild dilation of the left ventricle. She was started on Coreg and Losartan for medical management. Cardiology recommended further outpatient work-up with cardiac MRI/ repeat echo.    SLP was consulted during the admission, as well. They completed an FEES that demonstrated mild risk for aspiration and suggested continued regular diet with thin liquids to supplement PEG tube feeds.    She developed leukopenia. B12 levels were checked and WNL. Revlimid held for neutropenia discussed with oncologist to resume 9/26.   PT and OT were consulted and recommended SAR on discharge and SAR requested 20 day respiratory isolation with severity of illness. Daughter at bedside for transportation and all questions answered.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia, Positive airway pressure therapy, Respiratory acidosis, Respiratory failure, SARS-CoV-2 test positive
Clinical narrative: BRIEF OVERVIEW: Admission Date: 8/31/2023 Discharge Date: Sep 21, 2023 Discharge Disposition:  skilled nursing facility   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute respiratory failure with hypoxia (HCC) [J96.01]   HOSPITAL COURSE: Patient is a 68 y.o. female with a past medical history including COPD without baseline O2 need, IgG lambda multiple myeloma currently undergoing treatment, coronary artery disease, achalasia s/p botox, essential hypertension, anxiety, and depression who was admitted 8/31/2023 for acute on chronic hypoxic,hypercapnic respiratory failure secondary to Covid-19 pneumonia.   Patient presented to ED after she was noted to be diaphoretic and hypoxic during an outpatient infusion appointment. On arrival she required 4L NC supplemental oxygen. Work up was notable for Covid-19 + PCR and uptrending troponin. CTA thorax demonstrated bilateral pneumonia with underlying severe emphysema. She as transferred to another hospital for cardiology consult and further care.    During admission, patient intermittently required HFNC for respiratory support. Bipap was attempted for increased respiratory acidosis, but she did not tolerate this. She received Remdesivir and IV solumedrol. Sputum culture was positive for Acinetobacter pittii, which was concerning for an aspiration pneumonia based on the patient's chronic dysphagia, so she also received a 7 day course on Unasyn. Pulmonology was consulted and assisted with her management. Her respiratory status slowly improved to needing 2L NC at rest and 3L with ambulation. Expect a prolonged recovery due to the severity of her underlying emphysema.   Cardiology was consulted due to the elevated troponins on admission. Echocardiogram demonstrated LVEF 33% with akinesis of the basal inferior wall and mild dilation of the left ventricle. She was started on Coreg and Losartan for medical management. Cardiology recommended further outpatient work-up with cardiac MRI/ repeat echo.    SLP was consulted during the admission, as well. They completed an FEES that demonstrated mild risk for aspiration and suggested continued regular diet with thin liquids to supplement PEG tube feeds.    She developed leukopenia. B12 levels were checked and WNL. Revlimid held for neutropenia discussed with oncologist to resume 9/26.   PT and OT were consulted and recommended SAR on discharge and SAR requested 20 day respiratory isolation with severity of illness. Daughter at bedside for transportation and all questions answered.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Sputum culture positive, Troponin increased, Vitamin B12 normal
Clinical narrative: BRIEF OVERVIEW: Admission Date: 8/31/2023 Discharge Date: Sep 21, 2023 Discharge Disposition:  skilled nursing facility   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute respiratory failure with hypoxia (HCC) [J96.01]   HOSPITAL COURSE: Patient is a 68 y.o. female with a past medical history including COPD without baseline O2 need, IgG lambda multiple myeloma currently undergoing treatment, coronary artery disease, achalasia s/p botox, essential hypertension, anxiety, and depression who was admitted 8/31/2023 for acute on chronic hypoxic,hypercapnic respiratory failure secondary to Covid-19 pneumonia.   Patient presented to ED after she was noted to be diaphoretic and hypoxic during an outpatient infusion appointment. On arrival she required 4L NC supplemental oxygen. Work up was notable for Covid-19 + PCR and uptrending troponin. CTA thorax demonstrated bilateral pneumonia with underlying severe emphysema. She as transferred to another hospital for cardiology consult and further care.    During admission, patient intermittently required HFNC for respiratory support. Bipap was attempted for increased respiratory acidosis, but she did not tolerate this. She received Remdesivir and IV solumedrol. Sputum culture was positive for Acinetobacter pittii, which was concerning for an aspiration pneumonia based on the patient's chronic dysphagia, so she also received a 7 day course on Unasyn. Pulmonology was consulted and assisted with her management. Her respiratory status slowly improved to needing 2L NC at rest and 3L with ambulation. Expect a prolonged recovery due to the severity of her underlying emphysema.   Cardiology was consulted due to the elevated troponins on admission. Echocardiogram demonstrated LVEF 33% with akinesis of the basal inferior wall and mild dilation of the left ventricle. She was started on Coreg and Losartan for medical management. Cardiology recommended further outpatient work-up with cardiac MRI/ repeat echo.    SLP was consulted during the admission, as well. They completed an FEES that demonstrated mild risk for aspiration and suggested continued regular diet with thin liquids to supplement PEG tube feeds.    She developed leukopenia. B12 levels were checked and WNL. Revlimid held for neutropenia discussed with oncologist to resume 9/26.   PT and OT were consulted and recommended SAR on discharge and SAR requested 20 day respiratory isolation with severity of illness. Daughter at bedside for transportation and all questions answered.
Sex: F
Vaccine: RSV, RSV
Symptoms: Body temperature increased, Influenza like illness, Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: Feeling weak; swollen glands in neck; Arm is still red; swollen arm; arm hot to touch; migraine; This non-serious case was reported by a consumer and described the occurrence of migraine in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included migraine.   On an unknown date, the patient received Arexvy. On 29-OCT-2023, an unknown time after receiving Arexvy, the patient experienced migraine (Verbatim: migraine). On an unknown date, the patient experienced feelings of weakness (Verbatim: Feeling weak), lymphadenopathy cervical (Verbatim: swollen glands in neck), erythema (Verbatim: Arm is still red), swelling arm (Verbatim: swollen arm) and feeling hot (Verbatim: arm hot to touch). The patient was treated with sumatriptan, paracetamol (Tylenol), cetirizine hydrochloride (Zyrtec) and non-drug therapy (Ice Pack (No Medication)). The outcome of the migraine was not reported and the outcome of the feelings of weakness, lymphadenopathy cervical, erythema, swelling arm and feeling hot were not resolved.   It was unknown if the reporter considered the migraine, feelings of weakness, lymphadenopathy cervical, erythema, swelling arm and feeling hot to be related to Arexvy.  It was unknown if the company considered the migraine, feelings of weakness, lymphadenopathy cervical, erythema, swelling arm and feeling hot to be related to Arexvy.   Additional Information: GSK Receipt Date: 31-Oct-2023  The reporter stated that the patient's name was entered wrong (possibly by patient) in web AE. The patient stated her symptoms had not resolved and that she also had a migraine the day before and the day of reporting. She used Sumatriptan for a history of migraines. She also mentioned about taking Tylenol, Zyrtec and icing left arm. She was feeling weak and possible swollen glands in neck. Her arm was still red, swollen and hot to touch. The reporter consented to follow up.
Sex: F
Vaccine: RSV, RSV
Symptoms: Asthenia, Condition aggravated, Erythema, Lymphadenopathy, Migraine
Clinical narrative: Feeling weak; swollen glands in neck; Arm is still red; swollen arm; arm hot to touch; migraine; This non-serious case was reported by a consumer and described the occurrence of migraine in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included migraine.   On an unknown date, the patient received Arexvy. On 29-OCT-2023, an unknown time after receiving Arexvy, the patient experienced migraine (Verbatim: migraine). On an unknown date, the patient experienced feelings of weakness (Verbatim: Feeling weak), lymphadenopathy cervical (Verbatim: swollen glands in neck), erythema (Verbatim: Arm is still red), swelling arm (Verbatim: swollen arm) and feeling hot (Verbatim: arm hot to touch). The patient was treated with sumatriptan, paracetamol (Tylenol), cetirizine hydrochloride (Zyrtec) and non-drug therapy (Ice Pack (No Medication)). The outcome of the migraine was not reported and the outcome of the feelings of weakness, lymphadenopathy cervical, erythema, swelling arm and feeling hot were not resolved.   It was unknown if the reporter considered the migraine, feelings of weakness, lymphadenopathy cervical, erythema, swelling arm and feeling hot to be related to Arexvy.  It was unknown if the company considered the migraine, feelings of weakness, lymphadenopathy cervical, erythema, swelling arm and feeling hot to be related to Arexvy.   Additional Information: GSK Receipt Date: 31-Oct-2023  The reporter stated that the patient's name was entered wrong (possibly by patient) in web AE. The patient stated her symptoms had not resolved and that she also had a migraine the day before and the day of reporting. She used Sumatriptan for a history of migraines. She also mentioned about taking Tylenol, Zyrtec and icing left arm. She was feeling weak and possible swollen glands in neck. Her arm was still red, swollen and hot to touch. The reporter consented to follow up.
Sex: F
Vaccine: RSV, RSV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Feeling weak; swollen glands in neck; Arm is still red; swollen arm; arm hot to touch; migraine; This non-serious case was reported by a consumer and described the occurrence of migraine in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included migraine.   On an unknown date, the patient received Arexvy. On 29-OCT-2023, an unknown time after receiving Arexvy, the patient experienced migraine (Verbatim: migraine). On an unknown date, the patient experienced feelings of weakness (Verbatim: Feeling weak), lymphadenopathy cervical (Verbatim: swollen glands in neck), erythema (Verbatim: Arm is still red), swelling arm (Verbatim: swollen arm) and feeling hot (Verbatim: arm hot to touch). The patient was treated with sumatriptan, paracetamol (Tylenol), cetirizine hydrochloride (Zyrtec) and non-drug therapy (Ice Pack (No Medication)). The outcome of the migraine was not reported and the outcome of the feelings of weakness, lymphadenopathy cervical, erythema, swelling arm and feeling hot were not resolved.   It was unknown if the reporter considered the migraine, feelings of weakness, lymphadenopathy cervical, erythema, swelling arm and feeling hot to be related to Arexvy.  It was unknown if the company considered the migraine, feelings of weakness, lymphadenopathy cervical, erythema, swelling arm and feeling hot to be related to Arexvy.   Additional Information: GSK Receipt Date: 31-Oct-2023  The reporter stated that the patient's name was entered wrong (possibly by patient) in web AE. The patient stated her symptoms had not resolved and that she also had a migraine the day before and the day of reporting. She used Sumatriptan for a history of migraines. She also mentioned about taking Tylenol, Zyrtec and icing left arm. She was feeling weak and possible swollen glands in neck. Her arm was still red, swollen and hot to touch. The reporter consented to follow up.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no adverse event; improperly stored VARIVAX was administered to patient; This spontaneous report as received from an office manager refers to a patient of unknown age and gender. On 26-JUL-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # W039294 exp date 11-DEC-2024) (dose and route not reported). The temperature excursion was 17.4 °F for a time frame of 2 hours. There was no previous temperature excursion.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: additional dose of Boostrix on 01Nov2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 15-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number NR5DX, expiry date 02-FEB-2026) for prophylaxis.   Previously administered products included Menactra (On 27th July 2020, received a dose) and Boostrix (On 5th May 2023, received a dose, batch number: 34FR4, expiry date: 23-SEP-2024). Concomitant products included MENVEO.   On 01-NOV-2023, the patient received Boostrix. On 01-NOV-2023, an unknown time after receiving Boostrix and an unknown time after receiving MENVEO, the patient experienced drug dose administration interval too short (Verbatim: additional dose of Boostrix on 01Nov2023). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 1-NOV-2023  A nurse reported a patient received a dose of Menactra on 27th July 2020 and a dose of Menveo 01st November 2023.  The patient also received a dose of Boostrix on 05th May 2023 and an additional dose of Boostrix on 01st November 2023. The reporter consented to follow up. The patient received another dose of Boostrix earlier than recommended schedule, which led to shortening of vaccine schedule.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: inadvertently reconstituted the Menveo lyophilized component with a sterile diluent; inadvertently reconstituted the Menveo lyophilized component with a sterile diluent; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA928A, expiry date 31-MAR-2025) for prophylaxis.   On 30-OCT-2023, the patient received Menveo. On 30-OCT-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: inadvertently reconstituted the Menveo lyophilized component with a sterile diluent) and inappropriate dose of vaccine administered (Verbatim: inadvertently reconstituted the Menveo lyophilized component with a sterile diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 2-NOV-2023  A License Practical Nurse reported they inadvertently reconstituted the Menveo lyophilized component with a sterile diluent and administered it to a patient. The nurse asked about how to proceed. The reporter did not consent to follow-up. The patient received a dose of Menveo vaccine wrongfully reconstituted, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Haematuria
Clinical narrative: Gross hematuria; This spontaneous case was reported by a patient and describes the occurrence of HAEMATURIA (Gross hematuria) in a 61-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 06-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced HAEMATURIA (Gross hematuria). At the time of the report, HAEMATURIA (Gross hematuria) was resolving.            Concomitant medication was not provided. Patient experienced gross hematuria; bleeding started 6 days post vaccination. Very heavy bleeding with blood clots which lasted for 8 hours. Primary care verified as no UTI. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-027514 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-027514:Same reporter, different product
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Alanine aminotransferase, Alanine aminotransferase increased, Aspartate aminotransferase, Aspartate aminotransferase increased, Fatigue
Clinical narrative: her liver enzymes, specifically her ALT and AST, were elevated 3 times higher than normal; her liver enzymes, specifically her ALT and AST, were elevated 3 times higher than normal; feeling tired; having pain/feeling like it was coming from the inside out; This is a spontaneous report received from a non-contactable reporter (consumer) from Medical Information Team, Program ID. The reporter is the patient.  A 61-year-old female patient received BNT162B2 OMI XBB.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in arm for COVID-19 immunization; influenza vaccine (FLU [INFLUENZA VACCINE]), as dose number unknown, single (Batch/Lot number: unknown), in arm for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALANINE AMINOTRANSFERASE INCREASED (medically significant), ASPARTATE AMINOTRANSFERASE INCREASED (medically significant), outcome "unknown" and all described as "her liver enzymes, specifically her ALT and AST, were elevated 3 times higher than normal"; FATIGUE (non-serious), outcome "unknown", described as "feeling tired"; PAIN (non-serious), outcome "unknown", described as "having pain/feeling like it was coming from the inside out".  Clinical course: The reporter considered events as non-serious. The patient was calling in for the side effect of the COVID-19 shot. She got her flu shot and COVID-19 shot at the same time on two different arms. "Was that possible that it was from the shot?" The reporter reported being administered COMIRNATY in one arm and the flu vaccine in the other arm on the same day/visit. Afterwards, the caller experienced feeling tired and having pain. The pain was further described as "feeling like it was coming from the inside out". The patient had lab work done 2 to 3 days after the COMIRNATY and flu vaccinations and her liver enzymes, specifically her ALT and AST, were elevated 3 times higher than normal. When probed to clarify the name of the other vaccine other than the COMIRNATY vaccine: Transferring agent stated, "She only got a total of two vaccines. The first, she got COMIRNATY in one arm and then in the other arm she got flu vaccine. I don't know the brand of the flu vaccine. So, she got the COMIRNATY and the flu vaccine at the same time, but they were in different arms. Yes, same day, that's correct".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Pain
Clinical narrative: her liver enzymes, specifically her ALT and AST, were elevated 3 times higher than normal; her liver enzymes, specifically her ALT and AST, were elevated 3 times higher than normal; feeling tired; having pain/feeling like it was coming from the inside out; This is a spontaneous report received from a non-contactable reporter (consumer) from Medical Information Team, Program ID. The reporter is the patient.  A 61-year-old female patient received BNT162B2 OMI XBB.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in arm for COVID-19 immunization; influenza vaccine (FLU [INFLUENZA VACCINE]), as dose number unknown, single (Batch/Lot number: unknown), in arm for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALANINE AMINOTRANSFERASE INCREASED (medically significant), ASPARTATE AMINOTRANSFERASE INCREASED (medically significant), outcome "unknown" and all described as "her liver enzymes, specifically her ALT and AST, were elevated 3 times higher than normal"; FATIGUE (non-serious), outcome "unknown", described as "feeling tired"; PAIN (non-serious), outcome "unknown", described as "having pain/feeling like it was coming from the inside out".  Clinical course: The reporter considered events as non-serious. The patient was calling in for the side effect of the COVID-19 shot. She got her flu shot and COVID-19 shot at the same time on two different arms. "Was that possible that it was from the shot?" The reporter reported being administered COMIRNATY in one arm and the flu vaccine in the other arm on the same day/visit. Afterwards, the caller experienced feeling tired and having pain. The pain was further described as "feeling like it was coming from the inside out". The patient had lab work done 2 to 3 days after the COMIRNATY and flu vaccinations and her liver enzymes, specifically her ALT and AST, were elevated 3 times higher than normal. When probed to clarify the name of the other vaccine other than the COMIRNATY vaccine: Transferring agent stated, "She only got a total of two vaccines. The first, she got COMIRNATY in one arm and then in the other arm she got flu vaccine. I don't know the brand of the flu vaccine. So, she got the COMIRNATY and the flu vaccine at the same time, but they were in different arms. Yes, same day, that's correct".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Caller has had 6 Pfizer Covid ...his doctor told him to take Paxlovid anyway; Caller has had 6 Pfizer Covid ...his doctor told him to take Paxlovid anyway; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 5 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 1, SINGLE), administration date: Aug2020, for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller has had 6 Pfizer Covid ...his doctor told him to take Paxlovid anyway". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Caller stated that had 6 Pfizer Covid 19 since Aug2020.  He wants to "thank your company for actually keeping me healthy." He states that without his vaccines "my infection earlier this week might have been a nasty activity." He states he had a mild cough and that was it. Not even a fever. He successfully completed the 5 day program and he feels great. "I just feel wonderful today."  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Exostosis, Illness, Musculoskeletal discomfort, Pain
Clinical narrative: bone spurs; breaking my shoulders; body aches; I did get sick n felt like dying; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  An adult patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXOSTOSIS (medically significant), outcome "unknown", described as "bone spurs"; ILLNESS (non-serious), outcome "recovered", described as "I did get sick n felt like dying"; MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "unknown", described as "breaking my shoulders"; PAIN (non-serious), outcome "unknown", described as "body aches". Therapeutic measures were taken as a result of exostosis. Clinical course: The patient mentioned that Pfizer was the best shot to take during COVID. But for the patient, the side effects was breaking his/her shoulders. He/She was told by the doctor that he/she have to get steroid injections in the back for bone spurs. He/ She will remind Pfizer when he/she have taken all even the booster. The patient did get sick and felt like dying but had beaten it and it only lasted for 5 days. Patient was thankful. Now, he/she was noticing the times, months and days that patient's body aches. He/She doesn't know what to do.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: "vaccine" for Covid-19 if it doesn't work?; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant), outcome "unknown", described as ""vaccine" for Covid-19 if it doesn't work?". Clinical course: Why would I take your stupid (Abusive word) "vaccine" for Covid-19 if it doesn't work? Quit marketing your (Abusive word).  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Typhim Vi vaccine that was administered to a patient with no adverse event; Initial information received  on 02-Nov-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who received expired Typhoid Vi Polysaccharide Vaccine [Typhim Vi] vaccine, with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in 2023, the patient received a dose of suspect expired Typhoid Vi Polysaccharide Vaccine, solution for injection (lot number: not reported, expiry date: 28-Oct-2023) via unknown route in unknown administration site for immunization), with no adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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.
Age: 1.33
Sex: M
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient received his first dose (28-sep) but received the second dose on (11-oct) before the 28 days with no reported adverse event; Initial information was received on 02-Nov-2023 and live follow up received on same date both were processed together regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 16 months old male patient who received his first dose (28-sep) of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] but received the second dose on (11-oct) before the 28 days with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications included ELASOMERAN (MODERNA COVID-19 VACCINE) for COVID-19 immunisation.  On 28-Sep-2023 the patient received first dose 0.5 ml, total (1x) of suspect INFLUENZA QUADRIVAL A-B VACCINE, Suspension for injection (strength, lot and expiry date: unknown) via intramuscular   route in unknown administration site for prophylactic vaccination (immunization).  On 11-Oct-2023, the patient received a dose 2  dose.  On 11-OCT-2023 the patient developed a non-serious patient received his first dose (28-sep) but received the second dose on (11-oct) before the 28 days with no reported adverse event (product administered to patient of inappropriate age) (latency same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown   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.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: experiencing itching after administration of the vaccine and for days since; Initial information received on 06-Nov-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 68 years old female patient who experienced itching after administration of the influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] and for days since.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 01-Nov-2023, the patient received 0.7 ml  dose once of suspect influenza quadrival A-B high dose HV vaccine (lot U81628A: Expiry date: 30-Jun-2024; Formulation, strength: not reported)  via intramuscular route in the left arm for Immunization.  On 01-Nov-2023 on same day the patient was experiencing itching after administration of the vaccine and for days since (pruritus).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome : Unknown.
Age: 24.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Dizziness, Dysstasia, Injection site vesicles
Clinical narrative: dizziness, enough to prevent standing up mild blistering around injeciton site
Age: 26.0
Sex: M
Vaccine: UNK
Symptoms: Deafness unilateral, Sudden hearing loss
Clinical narrative: Sudden hearing loss in right side ear,  prednisolone 60mg pre day Nothing got better still cant hear
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient who got his first dose of Shingrix in 2018 and never completed the series; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose of shingrix received in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient who got his first dose of Shingrix in 2018 and never completed the series). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 03-NOV-2023 The pharmacy intern reported that a patient never completed the series.  The patient now requesting to finish the series. The Vaccine Administration Facility was the same as Primary Reporter. Chat abruptly disconnected, on callback to  reporter, she had no other patient details. Follow-up was ok to any pharmacist at the pharmacy address in health care professional details. The reporter consented to follow up. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.