chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: COVID19, FLU4, COVID19
Symptoms: Brain scan abnormal, Cardiac disorder, Feeling hot, Laboratory test, Loss of control of legs
Clinical narrative: He had a Transient Ischemic Attack which lasted an hour and thirty minutes. He was rushed to the Medical Center  Hospital for evaluation and then sent to City for further evaluation. He woke up that Thursday morning feeling different and stated that he couldn't move his left arm and leg. We dialed 911 and he was rushed in the ambulance to the hospital where he had several test. They include an CAT scan, MRI, EKG, TEE, and other physical exams. Since the TIA I have been experiencing severe breathing issues, severe headaches, anxie issues and lack of sleep, heart problems, body aches from head to toe, and I'm taking several different medications. These medications include Apixaban, Amlodipine, Aspirin, Atorvastatin, Plavix, Amoxicillin, Docusate, and others. He has also had the Intelliheart monitors sent to our house and had to wear them for 30 days to rule out AFIb.  Before the the stoke, after retiring he worked out everyday, now he is limited to walking around the block 1 to 2 times a week.                                                                                                                                                                                                                                                                                                          Since having the Trans Ischemic Attack, he has been to the ER 6 times for symptoms related to the stroke, those symptoms include rapid heart rate, headaches, insomnia and anxiety, high blood pressure, numbness and tingling in his left shoulder and arm, plus burning sensations all throughout his head.  He has also experienced short term and long term memory loss.
Age: 53.0
Sex: M
Vaccine: COVID19, FLU4, COVID19
Symptoms: Magnetic resonance imaging head abnormal, Musculoskeletal disorder, Transient ischaemic attack
Clinical narrative: He had a Transient Ischemic Attack which lasted an hour and thirty minutes. He was rushed to the Medical Center  Hospital for evaluation and then sent to City for further evaluation. He woke up that Thursday morning feeling different and stated that he couldn't move his left arm and leg. We dialed 911 and he was rushed in the ambulance to the hospital where he had several test. They include an CAT scan, MRI, EKG, TEE, and other physical exams. Since the TIA I have been experiencing severe breathing issues, severe headaches, anxie issues and lack of sleep, heart problems, body aches from head to toe, and I'm taking several different medications. These medications include Apixaban, Amlodipine, Aspirin, Atorvastatin, Plavix, Amoxicillin, Docusate, and others. He has also had the Intelliheart monitors sent to our house and had to wear them for 30 days to rule out AFIb.  Before the the stoke, after retiring he worked out everyday, now he is limited to walking around the block 1 to 2 times a week.                                                                                                                                                                                                                                                                                                          Since having the Trans Ischemic Attack, he has been to the ER 6 times for symptoms related to the stroke, those symptoms include rapid heart rate, headaches, insomnia and anxiety, high blood pressure, numbness and tingling in his left shoulder and arm, plus burning sensations all throughout his head.  He has also experienced short term and long term memory loss.
Age: 53.0
Sex: M
Vaccine: COVID19, FLU4, COVID19
Symptoms: Amnesia, Anxiety, Burning sensation, Cardiac disorder, Cardiac monitoring
Clinical narrative: He had a Transient Ischemic Attack which lasted an hour and thirty minutes. He was rushed to the Medical Center  Hospital for evaluation and then sent to City for further evaluation. He woke up that Thursday morning feeling different and stated that he couldn't move his left arm and leg. We dialed 911 and he was rushed in the ambulance to the hospital where he had several test. They include an CAT scan, MRI, EKG, TEE, and other physical exams. Since the TIA I have been experiencing severe breathing issues, severe headaches, anxie issues and lack of sleep, heart problems, body aches from head to toe, and I'm taking several different medications. These medications include Apixaban, Amlodipine, Aspirin, Atorvastatin, Plavix, Amoxicillin, Docusate, and others. He has also had the Intelliheart monitors sent to our house and had to wear them for 30 days to rule out AFIb.  Before the the stoke, after retiring he worked out everyday, now he is limited to walking around the block 1 to 2 times a week.                                                                                                                                                                                                                                                                                                          Since having the Trans Ischemic Attack, he has been to the ER 6 times for symptoms related to the stroke, those symptoms include rapid heart rate, headaches, insomnia and anxiety, high blood pressure, numbness and tingling in his left shoulder and arm, plus burning sensations all throughout his head.  He has also experienced short term and long term memory loss.
Age: 53.0
Sex: M
Vaccine: COVID19, FLU4, COVID19
Symptoms: Computerised tomogram, Dyspnoea, Echocardiogram, Electrocardiogram, Feeling abnormal
Clinical narrative: He had a Transient Ischemic Attack which lasted an hour and thirty minutes. He was rushed to the Medical Center  Hospital for evaluation and then sent to City for further evaluation. He woke up that Thursday morning feeling different and stated that he couldn't move his left arm and leg. We dialed 911 and he was rushed in the ambulance to the hospital where he had several test. They include an CAT scan, MRI, EKG, TEE, and other physical exams. Since the TIA I have been experiencing severe breathing issues, severe headaches, anxie issues and lack of sleep, heart problems, body aches from head to toe, and I'm taking several different medications. These medications include Apixaban, Amlodipine, Aspirin, Atorvastatin, Plavix, Amoxicillin, Docusate, and others. He has also had the Intelliheart monitors sent to our house and had to wear them for 30 days to rule out AFIb.  Before the the stoke, after retiring he worked out everyday, now he is limited to walking around the block 1 to 2 times a week.                                                                                                                                                                                                                                                                                                          Since having the Trans Ischemic Attack, he has been to the ER 6 times for symptoms related to the stroke, those symptoms include rapid heart rate, headaches, insomnia and anxiety, high blood pressure, numbness and tingling in his left shoulder and arm, plus burning sensations all throughout his head.  He has also experienced short term and long term memory loss.
Age: 53.0
Sex: M
Vaccine: COVID19, FLU4, COVID19
Symptoms: Headache, Heart rate increased, Hypertension, Hypoaesthesia, Injection site hypoaesthesia
Clinical narrative: He had a Transient Ischemic Attack which lasted an hour and thirty minutes. He was rushed to the Medical Center  Hospital for evaluation and then sent to City for further evaluation. He woke up that Thursday morning feeling different and stated that he couldn't move his left arm and leg. We dialed 911 and he was rushed in the ambulance to the hospital where he had several test. They include an CAT scan, MRI, EKG, TEE, and other physical exams. Since the TIA I have been experiencing severe breathing issues, severe headaches, anxie issues and lack of sleep, heart problems, body aches from head to toe, and I'm taking several different medications. These medications include Apixaban, Amlodipine, Aspirin, Atorvastatin, Plavix, Amoxicillin, Docusate, and others. He has also had the Intelliheart monitors sent to our house and had to wear them for 30 days to rule out AFIb.  Before the the stoke, after retiring he worked out everyday, now he is limited to walking around the block 1 to 2 times a week.                                                                                                                                                                                                                                                                                                          Since having the Trans Ischemic Attack, he has been to the ER 6 times for symptoms related to the stroke, those symptoms include rapid heart rate, headaches, insomnia and anxiety, high blood pressure, numbness and tingling in his left shoulder and arm, plus burning sensations all throughout his head.  He has also experienced short term and long term memory loss.
Age: 53.0
Sex: M
Vaccine: COVID19, FLU4, COVID19
Symptoms: Injection site paraesthesia, Insomnia, Laboratory test, Loss of personal independence in daily activities, Magnetic resonance imaging
Clinical narrative: He had a Transient Ischemic Attack which lasted an hour and thirty minutes. He was rushed to the Medical Center  Hospital for evaluation and then sent to City for further evaluation. He woke up that Thursday morning feeling different and stated that he couldn't move his left arm and leg. We dialed 911 and he was rushed in the ambulance to the hospital where he had several test. They include an CAT scan, MRI, EKG, TEE, and other physical exams. Since the TIA I have been experiencing severe breathing issues, severe headaches, anxie issues and lack of sleep, heart problems, body aches from head to toe, and I'm taking several different medications. These medications include Apixaban, Amlodipine, Aspirin, Atorvastatin, Plavix, Amoxicillin, Docusate, and others. He has also had the Intelliheart monitors sent to our house and had to wear them for 30 days to rule out AFIb.  Before the the stoke, after retiring he worked out everyday, now he is limited to walking around the block 1 to 2 times a week.                                                                                                                                                                                                                                                                                                          Since having the Trans Ischemic Attack, he has been to the ER 6 times for symptoms related to the stroke, those symptoms include rapid heart rate, headaches, insomnia and anxiety, high blood pressure, numbness and tingling in his left shoulder and arm, plus burning sensations all throughout his head.  He has also experienced short term and long term memory loss.
Age: 53.0
Sex: M
Vaccine: COVID19, FLU4, COVID19
Symptoms: Musculoskeletal disorder, Neurological symptom, Pain, Paraesthesia, Sleep disorder
Clinical narrative: He had a Transient Ischemic Attack which lasted an hour and thirty minutes. He was rushed to the Medical Center  Hospital for evaluation and then sent to City for further evaluation. He woke up that Thursday morning feeling different and stated that he couldn't move his left arm and leg. We dialed 911 and he was rushed in the ambulance to the hospital where he had several test. They include an CAT scan, MRI, EKG, TEE, and other physical exams. Since the TIA I have been experiencing severe breathing issues, severe headaches, anxie issues and lack of sleep, heart problems, body aches from head to toe, and I'm taking several different medications. These medications include Apixaban, Amlodipine, Aspirin, Atorvastatin, Plavix, Amoxicillin, Docusate, and others. He has also had the Intelliheart monitors sent to our house and had to wear them for 30 days to rule out AFIb.  Before the the stoke, after retiring he worked out everyday, now he is limited to walking around the block 1 to 2 times a week.                                                                                                                                                                                                                                                                                                          Since having the Trans Ischemic Attack, he has been to the ER 6 times for symptoms related to the stroke, those symptoms include rapid heart rate, headaches, insomnia and anxiety, high blood pressure, numbness and tingling in his left shoulder and arm, plus burning sensations all throughout his head.  He has also experienced short term and long term memory loss.
Age: 53.0
Sex: M
Vaccine: COVID19, FLU4, COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: He had a Transient Ischemic Attack which lasted an hour and thirty minutes. He was rushed to the Medical Center  Hospital for evaluation and then sent to City for further evaluation. He woke up that Thursday morning feeling different and stated that he couldn't move his left arm and leg. We dialed 911 and he was rushed in the ambulance to the hospital where he had several test. They include an CAT scan, MRI, EKG, TEE, and other physical exams. Since the TIA I have been experiencing severe breathing issues, severe headaches, anxie issues and lack of sleep, heart problems, body aches from head to toe, and I'm taking several different medications. These medications include Apixaban, Amlodipine, Aspirin, Atorvastatin, Plavix, Amoxicillin, Docusate, and others. He has also had the Intelliheart monitors sent to our house and had to wear them for 30 days to rule out AFIb.  Before the the stoke, after retiring he worked out everyday, now he is limited to walking around the block 1 to 2 times a week.                                                                                                                                                                                                                                                                                                          Since having the Trans Ischemic Attack, he has been to the ER 6 times for symptoms related to the stroke, those symptoms include rapid heart rate, headaches, insomnia and anxiety, high blood pressure, numbness and tingling in his left shoulder and arm, plus burning sensations all throughout his head.  He has also experienced short term and long term memory loss.
Age: 30.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Arthralgia, Asthenia, Electric shock sensation, Immediate post-injection reaction, Joint range of motion decreased
Clinical narrative: Patient developed severe pain and weakness of left shoulder upon administration of a routine HPV vaccine. Pain has persisted for past two months with associated reduced ROM and difficulty using arm. She has been diagnosed with rotator cuff tendinopathy by Orthopedics and has completed PT. Pain has not meaningfully improved, PCP will obtain MRI for further evaluation.
Age: 30.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Pain
Clinical narrative: Patient developed severe pain and weakness of left shoulder upon administration of a routine HPV vaccine. Pain has persisted for past two months with associated reduced ROM and difficulty using arm. She has been diagnosed with rotator cuff tendinopathy by Orthopedics and has completed PT. Pain has not meaningfully improved, PCP will obtain MRI for further evaluation.
Age: 30.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Arthralgia, Injected limb mobility decreased, Muscular weakness, Tendon disorder
Clinical narrative: Patient developed severe pain and weakness of left shoulder upon administration of a routine HPV vaccine. Pain has persisted for past two months with associated reduced ROM and difficulty using arm. She has been diagnosed with rotator cuff tendinopathy by Orthopedics and has completed PT. Pain has not meaningfully improved, PCP will obtain MRI for further evaluation.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Patient had pap smear 8/2023 that showed HPV positive. It is unknown what strain of HPV from the pap; This spontaneous report was received from other health professional referring to a 30 year old non pregnant female patient.      The patient's pertinent current conditions, medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On an unknown date in 2009, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL)  intramuscular injection, administered intramuscularly (IM) as prophylaxis (strength, dose, frequency, lot # and expiration date were not provided). On an unknown date in 2010, she was vaccinated with the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL)  intramuscular injection, IM as prophylaxis (strength, dose, frequency, lot # and expiration date were not provided).    On an unspecified date in August 2023, a Papanicolaou test (also reported as pap smear) was performed and showed Human Papillomavirus (HPV) positive, it was unknown what was the strain of HPV; thus, on that date, she experienced human papilloma virus test positive. No treatment was giving regarding the event. At the time of this report, she had not recovered from the event.   The causal relationship between human papilloma virus test positive and quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) was not provided.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; TE with PROQUAD.; This spontaneous report was received from a medical assistant referring to a 12-month-old patient of unspecified gender. Information regarding the patient's medical history, concurrent conditions and concomitant therapies was not reported.   On 03-AUG-2023, the patient was administered an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) 0.5 milliliters (ml) (route of administration and anatomical site of vaccination were not reported; lot number W023865 has been verified to be valid, expiration date reported and established as 29-OCT-2023) for prophylaxis (product storage error).  No adverse effects were reported (no adverse event).
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Nurse reported VAQTA was administered after improper storage; unknown of VAQTA was prefilled syringe or vial, however it is known that it was a pediatric dose administered. The operator of the device was a healthcare professional. Requested follow up; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On an unknown date, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated(VAQTA) lot number X003791, expiration date 01-JUN-2024 (dose and route of administration) for prophylaxis (product storage error).   The onset date of the event was reported as 01-JUN-2024 that is similar to the expiration date of the vaccine.  The temperature excursion was of 51 degrees Fahrenheit for 1 hour. No previous excursion were detected.
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; HCBP calling to report AE for patient that received dose of expired PNEUMOVAX 23.  Vaccine expired on 8/18/2023.  Per memo, data supports dosing.  No additional AE or PQC.; This spontaneous report was received from Other Health Professional and refers to an 81-year-old male patient. The patient's medical, concurrent conditions and concomitant therapies were not reported.  On 30-AUG-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) injection, single dose, lot #U035117, expiration date: 18-AUG-2023 (strength, route of administration, and indication were not provided). No additional adverse event was reported.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 23-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose number unknown (booster), single (Lot number: unknown) at the age of 22 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Peppermint" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID-19 Treatment". This case was reported as non-serious. The patient treatment included Paxlovid from 31Aug2023 to 01Sep2023. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: maternal vaccine exposure with no reported adverse event; Initial information received on 31-Aug-2023 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves a 35-year-old female patient who was exposed to vaccine influenza quadrival A-B vaccine [Fluzone Quadrivalent] in context of maternal vaccine exposure with no reported adverse event.  Data regarding this pregnancy were received prospectively. The reported maternal vaccine exposure with no reported adverse event occurred at unknown gestation period.  The date of last menstrual period was not reported. The estimated due date is 31-Oct-2023. The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On 31-Aug-2023, the patient received an unknown dose of suspect influenza quadrival A-B vaccine suspension for injection (strength: unknown) (lot: UT8040NA, expiry date: Jun-2024) via intramuscular route in unknown administration site for prophylactic vaccination (immunization) and patient had maternal vaccine exposure with no reported adverse event (maternal exposure timing unspecified) (latency: same day).  It was unknown if any lab data/test results available.  Action taken with quadrivalent influenza vaccine (Fluzone Quadrivalent) was not applicable.  Outcome: Unknown.  Additionally, at time of reporting, the pregnancy was still ongoing.
Age: 64.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient received Prevnar 20 08/10/2023. Patient came back to clinic 08/14/2023 with the right arm red and swollen. Patinet was afebrile. Patient was counseled on the signs and symptoms to monitor, was given a cold compress for the arm, and was advised to take Tylenol for pain.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Choking sensation, Dizziness
Clinical narrative: The patient was administered Pneumovax 23 08/21/23. After 10 minutes, the patient noted dizziness, weakness, and a choking feeling. The patient received Benadryl and O2. MD and charge nurse were at the patient's bedside, and EMS was called. The patient's symptoms improved, and the patient declined to go to EMS to ED for further evaluation.
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Tinnitus
Clinical narrative: Developed tinnitus after my COVID vaccine administered on 04/01/2021. PFIZER EP6955 administered at clinic
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Decreased appetite, Gastrointestinal haemorrhage, Laboratory test normal, Lethargy
Clinical narrative: Presented with lethargy, dec appetite;  +Covid test; also dx with GI bleed  Labs: normal; Tx: antibiotics & PPI; remained on room air
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Presented with lethargy, dec appetite;  +Covid test; also dx with GI bleed  Labs: normal; Tx: antibiotics & PPI; remained on room air
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Atelectasis, C-reactive protein, Chest X-ray abnormal, Fatigue
Clinical narrative: Presented with AMS, fatigue; Labs:  D-dimer 0.59; CRP: 5.08; Ferritin: 178; CXR: mild atelectasis or infiltrates; Tx: Decadron, Remdesivir, Vit C, Vit D3, Lovenox, singulair, zinc,  Initially FiO2 @ 2 LPM, max dose was 4LPM; back to room air prior to d/c
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Fibrin D dimer, Lung infiltration, Mental status changes, Serum ferritin normal
Clinical narrative: Presented with AMS, fatigue; Labs:  D-dimer 0.59; CRP: 5.08; Ferritin: 178; CXR: mild atelectasis or infiltrates; Tx: Decadron, Remdesivir, Vit C, Vit D3, Lovenox, singulair, zinc,  Initially FiO2 @ 2 LPM, max dose was 4LPM; back to room air prior to d/c
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory distress syndrome, Anticoagulant therapy, Bradycardia, C-reactive protein increased, COVID-19
Clinical narrative: Presented to ED with SOB, hypoxia, cough x 5 days; + covid 4 days PTA; dx Covid PNA/ARDS; Labs: D-dimer 1.55; CRP 486: Ferritin: 1841; Chest CT: Covid 19 PNA groundglass opacities; TX: Rocephin, Decadron, Lovenox, 2/15 Tocilizumab x1 dose; HFO2 2/17 To ICU; dopamine, veletri neb added; 2/18 Bipap 2/19 bradycardia due to Covid; PPM inserted; 2/21 back to HFNC for O2; at 7LPM HFNC at discharge
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Cardiac pacemaker insertion, Computerised tomogram thorax abnormal, Cough, Dyspnoea
Clinical narrative: Presented to ED with SOB, hypoxia, cough x 5 days; + covid 4 days PTA; dx Covid PNA/ARDS; Labs: D-dimer 1.55; CRP 486: Ferritin: 1841; Chest CT: Covid 19 PNA groundglass opacities; TX: Rocephin, Decadron, Lovenox, 2/15 Tocilizumab x1 dose; HFO2 2/17 To ICU; dopamine, veletri neb added; 2/18 Bipap 2/19 bradycardia due to Covid; PPM inserted; 2/21 back to HFNC for O2; at 7LPM HFNC at discharge
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Fibrin D dimer, Hypoxia, Intensive care, Lung opacity, Positive airway pressure therapy
Clinical narrative: Presented to ED with SOB, hypoxia, cough x 5 days; + covid 4 days PTA; dx Covid PNA/ARDS; Labs: D-dimer 1.55; CRP 486: Ferritin: 1841; Chest CT: Covid 19 PNA groundglass opacities; TX: Rocephin, Decadron, Lovenox, 2/15 Tocilizumab x1 dose; HFO2 2/17 To ICU; dopamine, veletri neb added; 2/18 Bipap 2/19 bradycardia due to Covid; PPM inserted; 2/21 back to HFNC for O2; at 7LPM HFNC at discharge
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Serum ferritin increased
Clinical narrative: Presented to ED with SOB, hypoxia, cough x 5 days; + covid 4 days PTA; dx Covid PNA/ARDS; Labs: D-dimer 1.55; CRP 486: Ferritin: 1841; Chest CT: Covid 19 PNA groundglass opacities; TX: Rocephin, Decadron, Lovenox, 2/15 Tocilizumab x1 dose; HFO2 2/17 To ICU; dopamine, veletri neb added; 2/18 Bipap 2/19 bradycardia due to Covid; PPM inserted; 2/21 back to HFNC for O2; at 7LPM HFNC at discharge
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Hypophagia, Rash pruritic
Clinical narrative: Pruritic rash, decreased PO intake x 5+ days starting 14 days after MMRV vaccine. Symptomatic care, outcome pending.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, C-reactive protein, COVID-19, COVID-19 pneumonia, Chest X-ray normal
Clinical narrative: Presented to ED; SOB x10 days, N/V, productive cough; fever, fatigue; + covid at MD office PTA; - covid at hospital; DX: Covid PNA; thrombocytopenia & leukopenia (possible due to covid infection) Initially on 6L O2; CXR: clear; CT ith min nodular infiltrate in RUL; Labs: D-dimer: 8.53; CRP 2.22; Ferritin 895.61; TX: Lovenox, Decadron, Singulair, Zinc (not a candidate for remdesivir since no confirmed + covid test); remained on O2 via NC during stay and back to room air at time of d/c
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram thorax abnormal, Dyspnoea, Fatigue, Fibrin D dimer, Leukopenia
Clinical narrative: Presented to ED; SOB x10 days, N/V, productive cough; fever, fatigue; + covid at MD office PTA; - covid at hospital; DX: Covid PNA; thrombocytopenia & leukopenia (possible due to covid infection) Initially on 6L O2; CXR: clear; CT ith min nodular infiltrate in RUL; Labs: D-dimer: 8.53; CRP 2.22; Ferritin 895.61; TX: Lovenox, Decadron, Singulair, Zinc (not a candidate for remdesivir since no confirmed + covid test); remained on O2 via NC during stay and back to room air at time of d/c
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Lung infiltration, Nausea, Productive cough, Pulmonary mass, Pyrexia
Clinical narrative: Presented to ED; SOB x10 days, N/V, productive cough; fever, fatigue; + covid at MD office PTA; - covid at hospital; DX: Covid PNA; thrombocytopenia & leukopenia (possible due to covid infection) Initially on 6L O2; CXR: clear; CT ith min nodular infiltrate in RUL; Labs: D-dimer: 8.53; CRP 2.22; Ferritin 895.61; TX: Lovenox, Decadron, Singulair, Zinc (not a candidate for remdesivir since no confirmed + covid test); remained on O2 via NC during stay and back to room air at time of d/c
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Serum ferritin increased, Thrombocytopenia, Vomiting
Clinical narrative: Presented to ED; SOB x10 days, N/V, productive cough; fever, fatigue; + covid at MD office PTA; - covid at hospital; DX: Covid PNA; thrombocytopenia & leukopenia (possible due to covid infection) Initially on 6L O2; CXR: clear; CT ith min nodular infiltrate in RUL; Labs: D-dimer: 8.53; CRP 2.22; Ferritin 895.61; TX: Lovenox, Decadron, Singulair, Zinc (not a candidate for remdesivir since no confirmed + covid test); remained on O2 via NC during stay and back to room air at time of d/c
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Asthenia, C-reactive protein increased, COVID-19, COVID-19 pneumonia
Clinical narrative: Presented to ED with weakness, SOB, fever, cough; + covid ED CXR:  Reticular densities greater on the left concerning for elements of  pulmonary interstitial fibrosis.; DX Covid PNA  Labs: D-dmer: 1.12; CRP 13.03; Ferritin 2002; TX: Rocephin, Decadron, Remdesivir, Lovenox, Zinc; remained on FiO2 via NC during stay; discharged on 5LPM NC
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Cough, Dyspnoea, Fibrin D dimer, Lung disorder
Clinical narrative: Presented to ED with weakness, SOB, fever, cough; + covid ED CXR:  Reticular densities greater on the left concerning for elements of  pulmonary interstitial fibrosis.; DX Covid PNA  Labs: D-dmer: 1.12; CRP 13.03; Ferritin 2002; TX: Rocephin, Decadron, Remdesivir, Lovenox, Zinc; remained on FiO2 via NC during stay; discharged on 5LPM NC
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive, Serum ferritin increased
Clinical narrative: Presented to ED with weakness, SOB, fever, cough; + covid ED CXR:  Reticular densities greater on the left concerning for elements of  pulmonary interstitial fibrosis.; DX Covid PNA  Labs: D-dmer: 1.12; CRP 13.03; Ferritin 2002; TX: Rocephin, Decadron, Remdesivir, Lovenox, Zinc; remained on FiO2 via NC during stay; discharged on 5LPM NC
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Cough, Dyspnoea, Hypoxia, Myalgia
Clinical narrative: Presented c/o vomiting, fever, myalgia, shortness of breath and cough as well as fever.Dx: COVID-19 pneumonia. Patient was found to be hypoxic and he was placed on oxygen supply. Treated with IV antibiotics/steroids;  patient was offered tocilizumab as well as remdesivir but he declined both. Patient's symptoms improved gradually and we were able to wean of his oxygen to 2 L and he was discharged home on home oxygen and to continue steroid course at home.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Presented c/o vomiting, fever, myalgia, shortness of breath and cough as well as fever.Dx: COVID-19 pneumonia. Patient was found to be hypoxic and he was placed on oxygen supply. Treated with IV antibiotics/steroids;  patient was offered tocilizumab as well as remdesivir but he declined both. Patient's symptoms improved gradually and we were able to wean of his oxygen to 2 L and he was discharged home on home oxygen and to continue steroid course at home.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Axillary mass, Blood pressure increased, Dizziness, Feeling abnormal
Clinical narrative: Went to MD for routine appointment. They informed me I needed a DTAP shot. Got the shot in my left arm. Site pain a bit later that day. That evening, swelling at site, swollen lymph nodes, next day headache feeling awful, body aches. Neck and armpit lumps. Small lumps on my neck muscle. Went to Urgent Care 2 times with Dizziness, sweating, pain shooting down arm. Elevated BP both times. Still having residual effects from shot. Still have lumps in neck area on muscle. Antibiotics given, Ultram given, had to go back 2 times, had pretty severe pain in left side all the way down to the hip area. I still get intermittent pain down my arm, like pinching from the neck and my hand/arm doesn't grasp like it used to.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Flank pain, Headache, Hyperhidrosis, Injection site pain, Injection site swelling
Clinical narrative: Went to MD for routine appointment. They informed me I needed a DTAP shot. Got the shot in my left arm. Site pain a bit later that day. That evening, swelling at site, swollen lymph nodes, next day headache feeling awful, body aches. Neck and armpit lumps. Small lumps on my neck muscle. Went to Urgent Care 2 times with Dizziness, sweating, pain shooting down arm. Elevated BP both times. Still having residual effects from shot. Still have lumps in neck area on muscle. Antibiotics given, Ultram given, had to go back 2 times, had pretty severe pain in left side all the way down to the hip area. I still get intermittent pain down my arm, like pinching from the neck and my hand/arm doesn't grasp like it used to.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Laboratory test, Lymphadenopathy, Motor dysfunction, Muscle mass, Neck mass
Clinical narrative: Went to MD for routine appointment. They informed me I needed a DTAP shot. Got the shot in my left arm. Site pain a bit later that day. That evening, swelling at site, swollen lymph nodes, next day headache feeling awful, body aches. Neck and armpit lumps. Small lumps on my neck muscle. Went to Urgent Care 2 times with Dizziness, sweating, pain shooting down arm. Elevated BP both times. Still having residual effects from shot. Still have lumps in neck area on muscle. Antibiotics given, Ultram given, had to go back 2 times, had pretty severe pain in left side all the way down to the hip area. I still get intermittent pain down my arm, like pinching from the neck and my hand/arm doesn't grasp like it used to.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Pain, Pain in extremity
Clinical narrative: Went to MD for routine appointment. They informed me I needed a DTAP shot. Got the shot in my left arm. Site pain a bit later that day. That evening, swelling at site, swollen lymph nodes, next day headache feeling awful, body aches. Neck and armpit lumps. Small lumps on my neck muscle. Went to Urgent Care 2 times with Dizziness, sweating, pain shooting down arm. Elevated BP both times. Still having residual effects from shot. Still have lumps in neck area on muscle. Antibiotics given, Ultram given, had to go back 2 times, had pretty severe pain in left side all the way down to the hip area. I still get intermittent pain down my arm, like pinching from the neck and my hand/arm doesn't grasp like it used to.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Neuralgia, Pain
Clinical narrative: Nerve pain, L upper arm radiating from shoulder to elbow, limited mobility, intermittent, sharp shooting pain when raising arm from shoulder to elbow. No pain noted when moving left upper extremity from elbow to hand.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE; M-M-R II® (MEASLES/MUMPS/RUBELLA) Most Recent Temperature/ Temp Range ABOVE 47F (122.0F) for 13 hours 30 minutes and 0 seconds/ Most Recent Temperature/ VARIVAX® (VARICELLA VIRUS VAC, LIVE) Temp Range 122F/ (78F or warmer); Received transfer, who informed HCP stated she received late shipment on 8/7/2023 and should have been received on 8/6/2023 of VARIVAX and MMR II. Spoke with HCP who informed VARIVAX was given to 5patients. Additional AE on case 024518; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  Healthcare provider (HCP) stated she received late shipment on 07-AUG-2023 and should have been received on 06-AUG-2023 of varicella virus vaccine live (OKA/MERCK) (VARIVAX) (Product distribution issue). The vaccine had a temperature excursion due to late shipment. On 09-AUG-2023, the patient was vaccinated with an improperly storage varicella virus vaccine live (OKA/MERCK) (VARIVAX) subcutaneous injection, 0.5 milliliter/x1, valid lot #X010525, expiration date: 11-APR-2025, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). No additional adverse event was reported.
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP calling to report an expired dose of PEDVAX HIB was given to a patient. No side effects reported. HCP reports the vaccine has not had any temperature excursions. No additional information provided. Additional AE case filed, refer to case #0244908; This spontaneous report was received from a nurse and refers to a 2-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-AUG-2023, the patient started therapy with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5 ml, (lot # T037651, has been verified to be a valid lot number, expiration date: 20-JUL-2023), administered for prophylaxis (strength, and route of administration were not provided).  On 03-AUG-2023, HCP called to report an expired dose of PEDVAX HIB was given to a patient (Expired vaccine used). No side effects reported. HCP reports the vaccine has not had any temperature excursions. No additional information provided. No PQC.
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Nurse reported pediatric patient received adult dose of VAQTA. See additional AE cases 02457006 and 02457033/no PQC.; This spontaneous report was received from a registered nurse concerning an unknown gender and age of child patient. The patient's concurrent condition, medical history, and concomitant medications were not provided.  On 22-AUG-2023, the patient was vaccinated with 1 adult dose of hepatitis A vaccine, inactivated (VAQTA) (lot# X006701, expiry date was reported as 21-JUN-2024, but upon internal validation established as 06-APR-2024) intramuscular injection as prophylaxis (exact dose, route of administration and anatomical location not provided) (product administered to patient of inappropriate age).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2308USA008072: US-009507513-2308USA008381:
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: No AE; HCP called to report that a dose of PNUEMOVAX 23 was given to a patient after a TE that was not supported. No further AE information available. No PQC.     ?    Names of vaccines involved (including lot/exp) PNUEMOVAX 23 Lot: W007035 Exp: 10/20/202; Information has been received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 10-AUG-2023, the patient was vaccinated with and improper storage dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5ml/once, lot #W007035, expiration date: 20-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided).  The vaccine had a temperature excursion of 49.44 Fahrenheit (F), during a time frame of 75 hours and 35 minutes. It was confirmed that non previous temperature excursions occurred.
Sex: F
Vaccine: MMR
Symptoms: Laboratory test normal
Clinical narrative: now testing serologically negative for MMRII protection; This spontaneous report was received from office manager and refers to a 20-year-old female.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On 31-AUG-2023, the patient experienced serologically negative test for MMRII protection. At the time of reporting, the outcome of the event was not known.   The causal relationship between adverse event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No Symptoms reported. No further AE details.; Medical Assistant transferred from Specialist. HCP reports that a 2-week-old infant was given a dose of ROTATEQ. HCP reports that the dose was administered today 9/1/2023.; This spontaneous report has been received from a medical assistant, regarding a 2-weeks-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 01-SEP-2023, the patient was vaccinated with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, at a dose of 2 milliliters once as prophylaxis (lot number: X008011, which was determined to be valid, with an expiration date on 25-SEP-2024) (strength and route of administration were not reported) (Product administered to patient of inappropriate age).  No additional adverse event was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: I got both of mine painful but not as painful as the Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: I got both of mine painful but not as painful as the Shingles).  The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingrix.     It was unknown if the company considered the pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-AUG-2023 The case was received from the patient via interactive digital media. The patient received both her Shingrix vaccine which was painful. It was not as painful as Shingles. She stated that the people she knew had shingles were like it was so painful. The patient asked to get vaccinated.  The follow-up would not required per process
Sex: M
Vaccine: RSV
Symptoms: Asthenia, Chest pain, Dyspnoea, Fatigue
Clinical narrative: shortness of breath; Chest pain; Weakness; fatigue; This non-serious case was reported by a nurse via sales rep and described the occurrence of shortness of breath in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included emphysema and chronic obstructive pulmonary disease.   On 25-AUG-2023, the patient received Arexvy (unknown arm). In AUG-2023, 24 hrs after receiving Arexvy, the patient experienced shortness of breath (Verbatim: shortness of breath), chest pain (Verbatim: Chest pain), weakness (Verbatim: Weakness) and fatigue (Verbatim: fatigue).  The outcome of the shortness of breath, chest pain, weakness and fatigue were not reported.   It was unknown if the reporter considered the shortness of breath, chest pain, weakness and fatigue to be related to Arexvy.     It was unknown if the company considered the shortness of breath, chest pain, weakness and fatigue to be related to Arexvy.   Additional Information: GSK Receipt Date: 30-AUG-2023 It was reported that 24 hours after vaccine in arm at pharmacy, patient reported shortness of breath, chest pain, weakness and fatigue.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received her second  dose of Shingrix 1 month after 1st dose instead of 2 months; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included the patient was immunocompetent. Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   In MAR-2023, the patient received the 2nd dose of Shingrix. In MAR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: received her second  dose of Shingrix 1 month after 1st dose instead of 2 months).  The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 28-AUG-2023 The patient received her second dose of Shingrix 1 month after 1st dose instead of 2 months, which led to shortening of vaccination schedule. The reporter thought the patient received her doses in February and March of 2023 but not sure since they were not administered at her pharmacy. The reporter did not consent to follow up since she did not have additional details to share given the vaccines were administered at another pharmacy.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: a 63 years old male patient received an expired dose of Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number Z42G4, expiry date 26-AUG-2023) for prophylaxis.   On 28-AUG-2023, the patient received the 1st dose of Shingrix. On 28-AUG-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: a 63 years old male patient received an expired dose of Shingrix).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 28-AUG-2023 Medical Assistant reported that the patient received an expired dose of Shingrix, which led to expired vaccine used. The reporter consented to follow up (email provided).