chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: blood clot on his first booster shot; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team, Program ID: (159558). The reporter is the patient.  A male patient received BNT162b2 (COMIRNATY), in Aug2021 as dose 3 (booster), 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:2, Lot /batch no: unknown, my first two doses of the vaccine were Pfizer mild reactions), for COVID-19 immunization; Bnt162b2 (dose:1, Lot /batch no: unknown, my first two doses of the vaccine were Pfizer mild reactions), for COVID-19 immunization. The following information was reported: THROMBOSIS (medically significant), outcome "recovered", described as "blood clot on his first booster shot". Therapeutic measures were taken as a result of thrombosis. Clinical course: Caller is a physician but also a patient in this particular situation, question regarding Pfizer-BioNTech COVID-19 Vaccine. The patient was treated with Eliquis, it totally resolved. The patient was asymptomatic and his question was before the patient gets his second booster he was little bit hesitant because of development of that clot so he wanted to know if data shows if there is a higher incidence of developing clot if you had a clot from that vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of thrombosis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Infection, Myocarditis, Pulmonary oedema
Clinical narrative: patient passed away, patient had lymphocytic myocarditis; infection; lungs were full of fluid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 17-year-old male patient received BNT162b2 (BNT162B2), in Jun2021 as dose 1, single (Batch/Lot number: unknown) at the age of 17 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INFECTION (death, hospitalization) with onset 30Oct2021, outcome "fatal"; PULMONARY OEDEMA (death, hospitalization, medically significant) with onset 30Oct2021, outcome "fatal", described as "lungs were full of fluid"; MYOCARDITIS (death, hospitalization, medically significant) with onset 30Oct2021, outcome "fatal", described as "patient passed away, patient had lymphocytic myocarditis". The events "patient passed away, patient had lymphocytic myocarditis", "infection" and "lungs were full of fluid" required emergency room visit. Therapeutic measures were taken as a result of myocarditis. The patient date of death was 30Oct2021. Reported cause of death: "patient passed away, patient had lymphocytic myocarditis", "infection", "lungs were full of fluid".  Clinical course: Patient passed away 30Oct2021, patient got the vaccine, but the adverse event could be nothing to do with the vaccine. Patient took the vaccine in Jun2021. Patient was just hanging with buddies at a soccer game, patient just collapsed, just died right there, EMT rushed patient to hospital and tried 42 minutes of CPR, nothing happened. Once autopsy was done, the patient definitely had myocarditis, and think it was lymphocytic myocarditis.Think patient had an infection in his body which traveled to patient's heart. Patient's lungs were full of fluid, caller was told that patient's lungs being full of fluid could be the 42 minutes of CPR. Patient had an infection somewhere in the body. Patient didn't go back for a booster shot, just followed the initial guidelines for pediatrics. Confirmed patient only received 1 dose total of the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient's Medical History and Relevant Tests were none.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: patient passed away, patient had lymphocytic myocarditis; infection; lungs were full of fluid
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Temperature, decreased appetite, diarrhea
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Decreased appetite, Diarrhoea, SARS-CoV-2 test positive
Clinical narrative: Temperature, decreased appetite, diarrhea
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diplopia, Dizziness, Feeling abnormal, Gait disturbance, Headache
Clinical narrative: Severe headache, scalp pain, dizziness, double vision, neuropathy, muscle weakness, imbalance, brain fog, vision loss, blurry vision, eye pain, ptosis, shortness of breath.  General symptoms consistent with autoimmune syndromes, GCA, myasthenia gravis, etc.  Treatment: high dose prednisone (60 mg) knocked down headache and scalp pain, all other symptoms have remained and worsened.  Other medications had no effect: pyridostigmine, 4-aminopyridine.  I am presently receiving tocilizumab IV but no effect so far.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Immunisation, Interchange of vaccine products, Malaise, Muscular weakness, Myasthenia gravis
Clinical narrative: Severe headache, scalp pain, dizziness, double vision, neuropathy, muscle weakness, imbalance, brain fog, vision loss, blurry vision, eye pain, ptosis, shortness of breath.  General symptoms consistent with autoimmune syndromes, GCA, myasthenia gravis, etc.  Treatment: high dose prednisone (60 mg) knocked down headache and scalp pain, all other symptoms have remained and worsened.  Other medications had no effect: pyridostigmine, 4-aminopyridine.  I am presently receiving tocilizumab IV but no effect so far.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Neck pain, Off label use, SARS-CoV-2 test, Vision blurred
Clinical narrative: Severe headache, scalp pain, dizziness, double vision, neuropathy, muscle weakness, imbalance, brain fog, vision loss, blurry vision, eye pain, ptosis, shortness of breath.  General symptoms consistent with autoimmune syndromes, GCA, myasthenia gravis, etc.  Treatment: high dose prednisone (60 mg) knocked down headache and scalp pain, all other symptoms have remained and worsened.  Other medications had no effect: pyridostigmine, 4-aminopyridine.  I am presently receiving tocilizumab IV but no effect so far.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Weight decreased
Clinical narrative: Severe headache, scalp pain, dizziness, double vision, neuropathy, muscle weakness, imbalance, brain fog, vision loss, blurry vision, eye pain, ptosis, shortness of breath.  General symptoms consistent with autoimmune syndromes, GCA, myasthenia gravis, etc.  Treatment: high dose prednisone (60 mg) knocked down headache and scalp pain, all other symptoms have remained and worsened.  Other medications had no effect: pyridostigmine, 4-aminopyridine.  I am presently receiving tocilizumab IV but no effect so far.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Antinuclear antibody, Antinuclear antibody negative, Balance disorder, Biopsy
Clinical narrative: Severe headache, scalp pain, dizziness, double vision, neuropathy, muscle weakness, imbalance, brain fog, vision loss, blurry vision, eye pain, ptosis, shortness of breath.  General symptoms consistent with autoimmune syndromes, GCA, myasthenia gravis, etc.  Treatment: high dose prednisone (60 mg) knocked down headache and scalp pain, all other symptoms have remained and worsened.  Other medications had no effect: pyridostigmine, 4-aminopyridine.  I am presently receiving tocilizumab IV but no effect so far.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blindness, Blood thyroid stimulating hormone normal, Borrelia test negative, C-reactive protein increased, Computerised tomogram head
Clinical narrative: Severe headache, scalp pain, dizziness, double vision, neuropathy, muscle weakness, imbalance, brain fog, vision loss, blurry vision, eye pain, ptosis, shortness of breath.  General symptoms consistent with autoimmune syndromes, GCA, myasthenia gravis, etc.  Treatment: high dose prednisone (60 mg) knocked down headache and scalp pain, all other symptoms have remained and worsened.  Other medications had no effect: pyridostigmine, 4-aminopyridine.  I am presently receiving tocilizumab IV but no effect so far.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diplopia, Dizziness, Dyspnoea, Electromyogram, Eye pain
Clinical narrative: Severe headache, scalp pain, dizziness, double vision, neuropathy, muscle weakness, imbalance, brain fog, vision loss, blurry vision, eye pain, ptosis, shortness of breath.  General symptoms consistent with autoimmune syndromes, GCA, myasthenia gravis, etc.  Treatment: high dose prednisone (60 mg) knocked down headache and scalp pain, all other symptoms have remained and worsened.  Other medications had no effect: pyridostigmine, 4-aminopyridine.  I am presently receiving tocilizumab IV but no effect so far.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eyelid ptosis, Feeling abnormal, Glomerular filtration rate normal, HLA-B*27 assay, Headache
Clinical narrative: Severe headache, scalp pain, dizziness, double vision, neuropathy, muscle weakness, imbalance, brain fog, vision loss, blurry vision, eye pain, ptosis, shortness of breath.  General symptoms consistent with autoimmune syndromes, GCA, myasthenia gravis, etc.  Treatment: high dose prednisone (60 mg) knocked down headache and scalp pain, all other symptoms have remained and worsened.  Other medications had no effect: pyridostigmine, 4-aminopyridine.  I am presently receiving tocilizumab IV but no effect so far.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Imaging procedure, Interleukin level increased, Laboratory test, Magnetic resonance imaging head, Muscular weakness
Clinical narrative: Severe headache, scalp pain, dizziness, double vision, neuropathy, muscle weakness, imbalance, brain fog, vision loss, blurry vision, eye pain, ptosis, shortness of breath.  General symptoms consistent with autoimmune syndromes, GCA, myasthenia gravis, etc.  Treatment: high dose prednisone (60 mg) knocked down headache and scalp pain, all other symptoms have remained and worsened.  Other medications had no effect: pyridostigmine, 4-aminopyridine.  I am presently receiving tocilizumab IV but no effect so far.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nerve conduction studies, Neuropathy peripheral, Pain of skin, Positron emission tomogram, Red blood cell sedimentation rate increased
Clinical narrative: Severe headache, scalp pain, dizziness, double vision, neuropathy, muscle weakness, imbalance, brain fog, vision loss, blurry vision, eye pain, ptosis, shortness of breath.  General symptoms consistent with autoimmune syndromes, GCA, myasthenia gravis, etc.  Treatment: high dose prednisone (60 mg) knocked down headache and scalp pain, all other symptoms have remained and worsened.  Other medications had no effect: pyridostigmine, 4-aminopyridine.  I am presently receiving tocilizumab IV but no effect so far.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Thyroxine free normal, Thyroxine normal, Tri-iodothyronine free normal, Vision blurred
Clinical narrative: Severe headache, scalp pain, dizziness, double vision, neuropathy, muscle weakness, imbalance, brain fog, vision loss, blurry vision, eye pain, ptosis, shortness of breath.  General symptoms consistent with autoimmune syndromes, GCA, myasthenia gravis, etc.  Treatment: high dose prednisone (60 mg) knocked down headache and scalp pain, all other symptoms have remained and worsened.  Other medications had no effect: pyridostigmine, 4-aminopyridine.  I am presently receiving tocilizumab IV but no effect so far.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Inappropriate schedule of product administration, Joint range of motion decreased, Magnetic resonance imaging, Neck pain
Clinical narrative: Shoulder pain in left arm; range of motion debility.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Nervous system disorder, Pain in extremity, Paraesthesia, Periarthritis, Radial nerve palsy
Clinical narrative: Shoulder pain in left arm; range of motion debility.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Spondylitis, Vaccination complication, Vaccination site pain, X-ray, X-ray limb
Clinical narrative: Shoulder pain in left arm; range of motion debility.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Electromyogram, Injected limb mobility decreased, Magnetic resonance imaging
Clinical narrative: Shoulder pain in left arm; range of motion debility.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Shoulder pain in left arm; range of motion debility.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Periarthritis
Clinical narrative: Shoulder pain in left arm; range of motion debility.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia
Clinical narrative: Shoulder pain in left arm; range of motion debility.
Age: 57.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Tinnitus
Clinical narrative: Ringing in the ears (tinnitus) and loss of hearing - 24/7 ever since the Moderna booster.   Infrequent bouts of dizziness also have occurred.
Age: 57.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Deafness, Dizziness, Immunisation reaction, Tinnitus
Clinical narrative: Ringing in the ears (tinnitus) and loss of hearing - 24/7 ever since the Moderna booster.   Infrequent bouts of dizziness also have occurred.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Exposure to SARS-CoV-2, Hyperhidrosis, Malaise, Pain
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Sep2021 at 19:30 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 12Apr2022 at 12:30 as dose 4 (booster), single (Lot number: F34989) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ALLERFEX, start date: May2018; LOSARTAN, start date: Dec2021; MONTELUKAST SODIUM, start date: Jul2022; PREDNISONE, start date: 05Jul2022, stop date: 09Jul2022; SYNTHROID, start date: Dec2006. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: Blood cholesterol: (unspecified date) high; SARS-CoV-2 test: (05Jul2022) Positive, notes: After testing positive for Covid 05Jul2022; (15Jul2022) Negative, notes: By 15Jul2022 I tested negative for Covid and had no symptoms; (23Jul2022) Positive, notes: I had symptoms of Covid again and tested positive on 23Jul2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. After testing positive for Covid 05Jul2022 I started Paxlovid from 05Jul2022 - 09Jul2022. By 15Jul2022 I tested negative for Covid and had no symptoms. On 22Jul2022 I had symptoms of Covid again and tested positive on 23Jul2022.  The information on the batch/lot number for BNT162B2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Respiration abnormal, Respiratory tract congestion, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Sep2021 at 19:30 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 12Apr2022 at 12:30 as dose 4 (booster), single (Lot number: F34989) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ALLERFEX, start date: May2018; LOSARTAN, start date: Dec2021; MONTELUKAST SODIUM, start date: Jul2022; PREDNISONE, start date: 05Jul2022, stop date: 09Jul2022; SYNTHROID, start date: Dec2006. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: Blood cholesterol: (unspecified date) high; SARS-CoV-2 test: (05Jul2022) Positive, notes: After testing positive for Covid 05Jul2022; (15Jul2022) Negative, notes: By 15Jul2022 I tested negative for Covid and had no symptoms; (23Jul2022) Positive, notes: I had symptoms of Covid again and tested positive on 23Jul2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. After testing positive for Covid 05Jul2022 I started Paxlovid from 05Jul2022 - 09Jul2022. By 15Jul2022 I tested negative for Covid and had no symptoms. On 22Jul2022 I had symptoms of Covid again and tested positive on 23Jul2022.  The information on the batch/lot number for BNT162B2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood cholesterol, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Sep2021 at 19:30 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 12Apr2022 at 12:30 as dose 4 (booster), single (Lot number: F34989) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ALLERFEX, start date: May2018; LOSARTAN, start date: Dec2021; MONTELUKAST SODIUM, start date: Jul2022; PREDNISONE, start date: 05Jul2022, stop date: 09Jul2022; SYNTHROID, start date: Dec2006. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: Blood cholesterol: (unspecified date) high; SARS-CoV-2 test: (05Jul2022) Positive, notes: After testing positive for Covid 05Jul2022; (15Jul2022) Negative, notes: By 15Jul2022 I tested negative for Covid and had no symptoms; (23Jul2022) Positive, notes: I had symptoms of Covid again and tested positive on 23Jul2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. After testing positive for Covid 05Jul2022 I started Paxlovid from 05Jul2022 - 09Jul2022. By 15Jul2022 I tested negative for Covid and had no symptoms. On 22Jul2022 I had symptoms of Covid again and tested positive on 23Jul2022.  The information on the batch/lot number for BNT162B2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Decreased appetite, Dizziness, Dyspnoea
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 60-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: FN2908), in left arm for covid-19 immunization. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; LANTUS taken for diabetes mellitus. Vaccination history included: Covid-19 vaccine (Dose: 1st, Manufacturer: Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose: 2nd , Manufacturer: Unknown), for Covid-19 immunization. The following information was reported: COUGH (non-serious), outcome "not recovered", described as "I did coughy breathing"; HEART RATE INCREASED (non-serious), outcome "not recovered", described as "fast heart beat"; DIZZINESS (non-serious), outcome "not recovered"; ASTHENIA (non-serious), outcome "not recovered", described as "Weakness"; HEADACHE (non-serious), outcome "not recovered"; NAUSEA (non-serious), outcome "not recovered"; MYALGIA (non-serious), outcome "not recovered", described as "muscle pain it just goes"; ARTHRALGIA (non-serious), outcome "not recovered", described as "Joint pain". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Reported that, patient got shot yesterday (unspecified date) and need to report all the side effects. Stated that, Immediately 10 minutes after getting the shot he did cough breathing, fast heart beat, dizziness and weakness, headache, muscle pain it just goes, joint pain, nausea and it wasn't fine. Therapy details were reported as, Patient's doctor suggested, he guess to drink lots of water and wait it out, so not active treatment. Patient just doing like doctor told him waiting for everything to go away.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Heart rate increased, Myalgia, Nausea
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 60-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: FN2908), in left arm for covid-19 immunization. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; LANTUS taken for diabetes mellitus. Vaccination history included: Covid-19 vaccine (Dose: 1st, Manufacturer: Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose: 2nd , Manufacturer: Unknown), for Covid-19 immunization. The following information was reported: COUGH (non-serious), outcome "not recovered", described as "I did coughy breathing"; HEART RATE INCREASED (non-serious), outcome "not recovered", described as "fast heart beat"; DIZZINESS (non-serious), outcome "not recovered"; ASTHENIA (non-serious), outcome "not recovered", described as "Weakness"; HEADACHE (non-serious), outcome "not recovered"; NAUSEA (non-serious), outcome "not recovered"; MYALGIA (non-serious), outcome "not recovered", described as "muscle pain it just goes"; ARTHRALGIA (non-serious), outcome "not recovered", described as "Joint pain". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Reported that, patient got shot yesterday (unspecified date) and need to report all the side effects. Stated that, Immediately 10 minutes after getting the shot he did cough breathing, fast heart beat, dizziness and weakness, headache, muscle pain it just goes, joint pain, nausea and it wasn't fine. Therapy details were reported as, Patient's doctor suggested, he guess to drink lots of water and wait it out, so not active treatment. Patient just doing like doctor told him waiting for everything to go away.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 60-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: FN2908), in left arm for covid-19 immunization. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; LANTUS taken for diabetes mellitus. Vaccination history included: Covid-19 vaccine (Dose: 1st, Manufacturer: Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose: 2nd , Manufacturer: Unknown), for Covid-19 immunization. The following information was reported: COUGH (non-serious), outcome "not recovered", described as "I did coughy breathing"; HEART RATE INCREASED (non-serious), outcome "not recovered", described as "fast heart beat"; DIZZINESS (non-serious), outcome "not recovered"; ASTHENIA (non-serious), outcome "not recovered", described as "Weakness"; HEADACHE (non-serious), outcome "not recovered"; NAUSEA (non-serious), outcome "not recovered"; MYALGIA (non-serious), outcome "not recovered", described as "muscle pain it just goes"; ARTHRALGIA (non-serious), outcome "not recovered", described as "Joint pain". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Reported that, patient got shot yesterday (unspecified date) and need to report all the side effects. Stated that, Immediately 10 minutes after getting the shot he did cough breathing, fast heart beat, dizziness and weakness, headache, muscle pain it just goes, joint pain, nausea and it wasn't fine. Therapy details were reported as, Patient's doctor suggested, he guess to drink lots of water and wait it out, so not active treatment. Patient just doing like doctor told him waiting for everything to go away.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Cough, Dizziness, Headache
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 60-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: FN2908), in left arm for covid-19 immunization. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; LANTUS taken for diabetes mellitus. Vaccination history included: Covid-19 vaccine (Dose: 1st, Manufacturer: Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose: 2nd , Manufacturer: Unknown), for Covid-19 immunization. The following information was reported: COUGH (non-serious), outcome "not recovered", described as "I did coughy breathing"; HEART RATE INCREASED (non-serious), outcome "not recovered", described as "fast heart beat"; DIZZINESS (non-serious), outcome "not recovered"; ASTHENIA (non-serious), outcome "not recovered", described as "Weakness"; HEADACHE (non-serious), outcome "not recovered"; NAUSEA (non-serious), outcome "not recovered"; MYALGIA (non-serious), outcome "not recovered", described as "muscle pain it just goes"; ARTHRALGIA (non-serious), outcome "not recovered", described as "Joint pain". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Reported that, patient got shot yesterday (unspecified date) and need to report all the side effects. Stated that, Immediately 10 minutes after getting the shot he did cough breathing, fast heart beat, dizziness and weakness, headache, muscle pain it just goes, joint pain, nausea and it wasn't fine. Therapy details were reported as, Patient's doctor suggested, he guess to drink lots of water and wait it out, so not active treatment. Patient just doing like doctor told him waiting for everything to go away.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Heart rate increased, Myalgia, Nausea
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 60-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: FN2908), in left arm for covid-19 immunization. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; LANTUS taken for diabetes mellitus. Vaccination history included: Covid-19 vaccine (Dose: 1st, Manufacturer: Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose: 2nd , Manufacturer: Unknown), for Covid-19 immunization. The following information was reported: COUGH (non-serious), outcome "not recovered", described as "I did coughy breathing"; HEART RATE INCREASED (non-serious), outcome "not recovered", described as "fast heart beat"; DIZZINESS (non-serious), outcome "not recovered"; ASTHENIA (non-serious), outcome "not recovered", described as "Weakness"; HEADACHE (non-serious), outcome "not recovered"; NAUSEA (non-serious), outcome "not recovered"; MYALGIA (non-serious), outcome "not recovered", described as "muscle pain it just goes"; ARTHRALGIA (non-serious), outcome "not recovered", described as "Joint pain". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Reported that, patient got shot yesterday (unspecified date) and need to report all the side effects. Stated that, Immediately 10 minutes after getting the shot he did cough breathing, fast heart beat, dizziness and weakness, headache, muscle pain it just goes, joint pain, nausea and it wasn't fine. Therapy details were reported as, Patient's doctor suggested, he guess to drink lots of water and wait it out, so not active treatment. Patient just doing like doctor told him waiting for everything to go away.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Product storage error
Clinical narrative: administered exposed vaccines, 52 Fahrenheit; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) (batch number 7P2PS, expiry date 2nd June 2023), (batch number 75B29, expiry date 24th August 2023) and (batch number 24LA3, expiry date 7th July 2023) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 7P2PS, expiry date 2nd June 2023), (batch number 75B29, expiry date 24th August 2023) and (batch number 24LA3, expiry date 7th July 2023) for prophylaxis.   On 1st July 2022, the patient received the 2nd dose of Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On 31st March 2022, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 20-Jul-2022 Reporter's comment: The medical assistant called in to check stability of vaccines exposed on 29th March 2022, as Shingrix and Boostrix, 52 Fahrenheit for 3 months. The reporter reported that 20 patients were administered the exposed vaccines, 15 patients were administered the Shingrix and 5 patients were administered Boostrix. The reporter stated that Boostrix details were unknown. The reporter was unable to provide any additional details. The reporter did not consent to follow-up. Additional supportive information: The patient received a dose of Shingrix which was exposed at 52 Fahrenheit for 3 months, which led to incorrect storage of drug. This is 1 out of 20 linked cases, reported by same reporter. As it was not clear from which Lot which patient received the vaccine, therefore conservatively all the Lot details were coded in sub tab of product details.; Sender's Comments:  US-GSK-US2022AMR109267:same report, other patient US-GSK-US2022AMR109268:same report, other patient US-GSK-US2022AMR109269:same report, other patient US-GSK-US2022AMR109270:same report, other patient US-GSK-US2022AMR109271:same report, other patient US-GSK-US2022AMR109272:same report, other patient US-GSK-US2022AMR109273:same report, other patient US-GSK-US2022AMR109274:same report, other patient US-GSK-US2022AMR109275:same report, other patient US-GSK-US2022AMR109276:same report, other patient US-GSK-US2022AMR109265:same report, other patient US-GSK-US2022AMR109264:same report, other patient US-GSK-US2022AMR109263:same report, other patient US-GSK-US2022AMR109262:same report, other patient US-GSK-US2022AMR109266:same report, other patient US-GSK-US2022AMR109278:same report, other patient US-GSK-US2022AMR109279:same report, other patient US-GSK-US2022AMR109280:same report, other patient US-GSK-US2022AMR109281:same report, other patient
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 20Jan2021 at 17:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 10Feb2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 28Sep2021 at 11:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 01May2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Unknown Results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient received the treatment for COVID-19 with Paxlovid from 08Jul2022 to12Jul2022. The patient did not receive any other medication in 2weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 20Jan2021 at 17:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 10Feb2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 28Sep2021 at 11:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 01May2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Unknown Results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient received the treatment for COVID-19 with Paxlovid from 08Jul2022 to12Jul2022. The patient did not receive any other medication in 2weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Ageusia, Bell's palsy, Blood test normal, Corneal abrasion, Eye irritation
Clinical narrative: Systemic: Bell's Palsy-Medium, Additional Details: patient lost sense of taste 24 to 48 hrs after vaccine. 7 days later noticed eye irritation. Day 8 unable to control left eye and mouth is frozen.
Age: 49.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Laboratory test normal, Pain, Pyrexia
Clinical narrative: Systemic: Bell's Palsy-Medium, Additional Details: patient lost sense of taste 24 to 48 hrs after vaccine. 7 days later noticed eye irritation. Day 8 unable to control left eye and mouth is frozen.
Age: 49.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Ageusia, Bell's palsy, Eye disorder, Eye irritation, Mobility decreased
Clinical narrative: Systemic: Bell's Palsy-Medium, Additional Details: patient lost sense of taste 24 to 48 hrs after vaccine. 7 days later noticed eye irritation. Day 8 unable to control left eye and mouth is frozen.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Cardiac failure congestive, Chest X-ray abnormal, Dyspnoea, Dyspnoea exertional
Clinical narrative: Patient admitted to Hospital 1/17/2022 with shortness of breath. Patient was positive for COVID-19 infection. She rapidly worsened during stay and developed acute on chronic hypoxic respiratory failure. She initially required transition on 1/ 19/2022 and then was transferred to the ICU on 1/21/2022. She was transitioned to BiPAP. She was evaluated by pulmonology and infectious disease. Patient had an elevated D-dimer and CTA of the chest was performed without evidence of pulmonary embolism. D-dimer was trending upward to greater than 20. She was treated with therapeutic Lovenox dosing was initiated. She was initially started on dexamethasone and transition to high-dose methyl prednisone 60 mg every 6 hours. She was also started on remdesivir and vitamin C/E by infectious disease. Patient was vaccinated with Pfizer vaccine x2 in March 2021. She was transitioned to DNR/DNI and then eventually comfort measures; her family was in agreement. Comfort measures were provided. Patient died on 1/23/2022 of acute on chronic respiratory failure and covid pneumonia at 15:47 with her family present.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Intensive care, Positive airway pressure therapy, SARS-CoV-2 test positive
Clinical narrative: Patient admitted to Hospital 1/17/2022 with shortness of breath. Patient was positive for COVID-19 infection. She rapidly worsened during stay and developed acute on chronic hypoxic respiratory failure. She initially required transition on 1/ 19/2022 and then was transferred to the ICU on 1/21/2022. She was transitioned to BiPAP. She was evaluated by pulmonology and infectious disease. Patient had an elevated D-dimer and CTA of the chest was performed without evidence of pulmonary embolism. D-dimer was trending upward to greater than 20. She was treated with therapeutic Lovenox dosing was initiated. She was initially started on dexamethasone and transition to high-dose methyl prednisone 60 mg every 6 hours. She was also started on remdesivir and vitamin C/E by infectious disease. Patient was vaccinated with Pfizer vaccine x2 in March 2021. She was transitioned to DNR/DNI and then eventually comfort measures; her family was in agreement. Comfort measures were provided. Patient died on 1/23/2022 of acute on chronic respiratory failure and covid pneumonia at 15:47 with her family present.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute respiratory failure, Angiogram pulmonary normal, Anticoagulant therapy, COVID-19, COVID-19 pneumonia
Clinical narrative: Patient admitted to Hospital 1/17/2022 with shortness of breath. Patient was positive for COVID-19 infection. She rapidly worsened during stay and developed acute on chronic hypoxic respiratory failure. She initially required transition on 1/ 19/2022 and then was transferred to the ICU on 1/21/2022. She was transitioned to BiPAP. She was evaluated by pulmonology and infectious disease. Patient had an elevated D-dimer and CTA of the chest was performed without evidence of pulmonary embolism. D-dimer was trending upward to greater than 20. She was treated with therapeutic Lovenox dosing was initiated. She was initially started on dexamethasone and transition to high-dose methyl prednisone 60 mg every 6 hours. She was also started on remdesivir and vitamin C/E by infectious disease. Patient was vaccinated with Pfizer vaccine x2 in March 2021. She was transitioned to DNR/DNI and then eventually comfort measures; her family was in agreement. Comfort measures were provided. Patient died on 1/23/2022 of acute on chronic respiratory failure and covid pneumonia at 15:47 with her family present.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray, Death, Dyspnoea, Electrocardiogram, Fibrin D dimer increased
Clinical narrative: Patient admitted to Hospital 1/17/2022 with shortness of breath. Patient was positive for COVID-19 infection. She rapidly worsened during stay and developed acute on chronic hypoxic respiratory failure. She initially required transition on 1/ 19/2022 and then was transferred to the ICU on 1/21/2022. She was transitioned to BiPAP. She was evaluated by pulmonology and infectious disease. Patient had an elevated D-dimer and CTA of the chest was performed without evidence of pulmonary embolism. D-dimer was trending upward to greater than 20. She was treated with therapeutic Lovenox dosing was initiated. She was initially started on dexamethasone and transition to high-dose methyl prednisone 60 mg every 6 hours. She was also started on remdesivir and vitamin C/E by infectious disease. Patient was vaccinated with Pfizer vaccine x2 in March 2021. She was transitioned to DNR/DNI and then eventually comfort measures; her family was in agreement. Comfort measures were provided. Patient died on 1/23/2022 of acute on chronic respiratory failure and covid pneumonia at 15:47 with her family present.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: General physical health deterioration, Intensive care, Laboratory test, Positive airway pressure therapy, Respiratory failure
Clinical narrative: Patient admitted to Hospital 1/17/2022 with shortness of breath. Patient was positive for COVID-19 infection. She rapidly worsened during stay and developed acute on chronic hypoxic respiratory failure. She initially required transition on 1/ 19/2022 and then was transferred to the ICU on 1/21/2022. She was transitioned to BiPAP. She was evaluated by pulmonology and infectious disease. Patient had an elevated D-dimer and CTA of the chest was performed without evidence of pulmonary embolism. D-dimer was trending upward to greater than 20. She was treated with therapeutic Lovenox dosing was initiated. She was initially started on dexamethasone and transition to high-dose methyl prednisone 60 mg every 6 hours. She was also started on remdesivir and vitamin C/E by infectious disease. Patient was vaccinated with Pfizer vaccine x2 in March 2021. She was transitioned to DNR/DNI and then eventually comfort measures; her family was in agreement. Comfort measures were provided. Patient died on 1/23/2022 of acute on chronic respiratory failure and covid pneumonia at 15:47 with her family present.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient admitted to Hospital 1/17/2022 with shortness of breath. Patient was positive for COVID-19 infection. She rapidly worsened during stay and developed acute on chronic hypoxic respiratory failure. She initially required transition on 1/ 19/2022 and then was transferred to the ICU on 1/21/2022. She was transitioned to BiPAP. She was evaluated by pulmonology and infectious disease. Patient had an elevated D-dimer and CTA of the chest was performed without evidence of pulmonary embolism. D-dimer was trending upward to greater than 20. She was treated with therapeutic Lovenox dosing was initiated. She was initially started on dexamethasone and transition to high-dose methyl prednisone 60 mg every 6 hours. She was also started on remdesivir and vitamin C/E by infectious disease. Patient was vaccinated with Pfizer vaccine x2 in March 2021. She was transitioned to DNR/DNI and then eventually comfort measures; her family was in agreement. Comfort measures were provided. Patient died on 1/23/2022 of acute on chronic respiratory failure and covid pneumonia at 15:47 with her family present.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Lower respiratory tract congestion, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: sire throat, runny nose, chest congestion, cough
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: sire throat, runny nose, chest congestion, cough
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Headache, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Headache, inability to stay awake, chills and fever.  Treated with Paxlovid.  Lasted about 5 days.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Headache, inability to stay awake, chills and fever.  Treated with Paxlovid.  Lasted about 5 days.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Rash
Clinical narrative: Extremely nauseated/though she was going to throw up; She had a rash all over; This spontaneous case was reported by a patient and describes the occurrence of RASH (She had a rash all over) and NAUSEA (Extremely nauseated/though she was going to throw up) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059a22a, 048c21a, 036a21a and 031m20a) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2022, the patient experienced RASH (She had a rash all over). On 25-Jul-2022, the patient experienced NAUSEA (Extremely nauseated/though she was going to throw up). At the time of the report, RASH (She had a rash all over) and NAUSEA (Extremely nauseated/though she was going to throw up) had resolved.            Patient had no allergies to medications, food and other products. Concomitant medication included Statins. Patient used  a pill that you put under your tongue and a spray to treat nausea.   This case was linked to MOD-2022-614661 (Patient Link).