chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient 2: was non-immune to VZV, despite receiving 2 doses previously as per the  recommended vaccine schedule at 1 and 4 years of age; none of the patients developed symptoms of vaccine related viral illness; This literature marketed report has been received from the authors of the published article, titled as stated below referring  a 16 year old female patient. The patient's concurrent conditions included 22q11.2 deletion, cardiomyopathy and chronic heart failure. Information regarding the patient's pertinent medical history and concomitant medications was not provided by the authors.  On an unspecified date, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (manufacturer unknown) for prophylaxis (strength, dose, route of administration, frequency, lot number and expiration date were not provided).  On an unspecified date, the patient was going to underwent on an orthotopic heart transplantation (OTH) for her cardiomyopathy and heart failure. Her pre-transplant infectious diseases evaluation was unremarkable, however her serology testing revealed that she was immune to measles but not immune for varicella zoster virus (VZV) despite being vaccinated previously (vaccination failure) as per the recommended vaccine schedule at 1 and 4 years of age. She therefore received a third dose of varicella virus vaccine live (Oka/Merck) (manufacturer unknown) and seven days later she underwent to her OTH surgery. It was reported that the patient did not develop any symptoms of vaccine related viral illness.   At the time of reporting, the outcome of vaccination failure was unknown.   The causal relationship between the vaccination with varicella virus vaccine live (Oka/Merck) (manufacturer unknown) and vaccination failure was considered to be related.   This is one of three reports received from the same literature (2107USA005480, 2107USA005481 and 2107USA002514); Sender's Comments:  US-009507513-2107USA002514:
Onset began Thursday evening rapid heart rate and increased blood pressure. Headache and chills. unable to do housework for 2 days.
This spontaneous report as received from a medical assistant refers to one unspecified patient of unknown age. Medical history, concurrent conditions and concomitant medications were not reported. On 07-MAY-2015, the patient was vaccinated with an improperly stored dose of VAQTA (dose, frequency and route of administration were not provided). No adverse events were reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. No further information was provided. This is one of two reports received from the same reporter. Additional information has been requested.
Severe head tremors; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEAD TITUBATION (Severe head tremors) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included SIMVASTATIN for Cholesterol, OMEPRAZOLE for GERD, VALSARTAN for Hypertension, MELOXICAM for Pain.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced HEAD TITUBATION (Severe head tremors). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 12-Mar-2021, HEAD TITUBATION (Severe head tremors) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-114552 (Patient Link).
Onset of fever 1 hour after hepatitis B vaccination, intermittent with high of 102 degrees for 48 hours. Now with urticaria on 10/17/01 visit.
Death Narrative:  Patient has been admitted to a home hospice program since approximately 11/12/20 with an initial terminal diagnosis of dysphagia which was later changed in February 2021 to vascular dementia. Patient with significant past medical history of several CVA's which led to aphasia and vascular dementia.
Diarrhea, racing heart, shortness of breath day after injection onset of symptoms. Symptoms come and go intermittent symptoms.
This spontaneous report as received from a nurse and refers to a currently 8 year old male patient. There was no information regarding the patient's medical history, concomitant medication drug reactions and allergies provided. On 02-SEP-2015, the patient was vaccinated with ZOSTAVAX, subcutaneously for prophylaxis (lot # L011535, expiration date: 03-JUL-2016) instead of VARIVAX. The vaccine was reconstituted with sterile diluent. There was no adverse effect reported.
Tingling and numbness in left pinky and ring finger of vaccinated arm.  After 2 months, it is no longer constant, now it comes and goes, and is worse on some days than other days.
got Covid after getting the first booster and the primary series of the Moderna covid19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got Covid after getting the first booster and the primary series of the Moderna covid19 vaccine.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (got Covid after getting the first booster and the primary series of the Moderna covid19 vaccine.). At the time of the report, COVID-19 (got Covid after getting the first booster and the primary series of the Moderna covid19 vaccine.) outcome was unknown.            It was reported as the age was over 50 years.  No concomitant information was reported. No treatment information was provided.  Company comment: This spontaneous case concerns a patient of over 50-years-old with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 which occurred in context to the third dose of mRNA-1273 vaccine in covid-19 vaccination series. Latency cannot be assessed since vaccination date was not disclosed. It was reported as got Covid after getting the first booster and the primary series of the Moderna covid19 vaccine with outcome was unknown. The Clinical course, Concomitant medication, treatment details were not provided, and the events outcome was unknown.  Ongoing COVID-19 Pandemia remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a patient of over 50-years-old with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 which occurred in context to the third dose of mRNA-1273 vaccine in covid-19 vaccination series. Latency cannot be assessed since vaccination date was not disclosed. It was reported as got Covid after getting the first booster and the primary series of the Moderna covid19 vaccine with outcome was unknown. The Clinical course, Concomitant medication, treatment details were not provided, and the events outcome was unknown.  Ongoing COVID-19 Pandemia remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.
Chills, Headache, skin is sensitive to touch, nauseated, fever, aches
Slightly blurred vision after the 2nd dose.   It is saturday April 10 now and my right eyelid is a bit red and puffy. I?ve taken Allegra each day since the 7th and using a cold compress now and it seems to help
Information has been received from a nurse concerning a female patient who was vaccinated with a 0.5 ml dose of Gardasil. Subsequently the patient experienced fainting. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. This is one of several reports received from the same source. Additional information has been requested.
Headache, Myalgia, Fever, Diarrhea, Chills Narrative:
Patient is a 71 y.o. female with a history of CAD,NSVTand OSA who presented to ED with subacute viral syndrome and generalized weakness with Left more than right found to have CTA H/N nonacute, COVID + thus transferred 7/31/2023 for further neuro eval.    1. Transient neurological symptoms: Suspect related to viral syndrome. CTA H/N without LVO, CVA. Initially planned MRI - however with rapid  clinical improvement  per discussion with neurology cancelled MRI. Neurology recommended PCP follow up.  2. COVID Infection: Present on admit, symptomatic 7/26/23 with dyspnea and cough. Initially required 2-3 L O2, but was weaned off and discontinued steroids and remdesevir 3. CAD: S/p LAD and PDA dissection in 2014. Followed w/ Dr. Previously on ASA. Myalgias with statin.  4. OSA: NPPV at bedtime.
Increased anxiety, leading to hospitalization. Hearing voices, from 5/25 - present. Shortness of breathe. Headaches. Brain fog and general confusion. Treatments included anti depressant Lexapro 10mg. Hydroxyzine 50mg 4 times daily. Abilify, 1mg daily.
Pt reports that sight of injection was sore, but after a few hours started getting a bruise around injection site. Over the weekend the patient's entire arm appears to be bruised and he reports that blood is pooling at lower part of arm by the elbow. Instructed patient to visit the doctors office as soon as possible and/or go to emergency room.
Light rash behind left ear; This spontaneous case was reported by a patient and describes the occurrence of RASH (Light rash behind left ear) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Light rash behind left ear). At the time of the report, RASH (Light rash behind left ear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's medical history was not provided. No relevant concomitant medications were reported.  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
patient fainted after the administered dose; fall and hit head as part of fainting coded; fall and hit head as part of fainting coded; This spontaneous report was received from a nurse via a company representative referring to a female patient of unknown age. Information about medical history, concurrent conditions and concomitant therapies was unknown.    On an unknown date (reported as within last few months), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dosage detail, strength, lot # and expiration date were not reported) intramuscular for prophylaxis. The patient fainted after the administered dose and was observed in the office after fainting, treatment for fainting was not specified. It was also reported that the patient might fall and hit head as part of fainting, office did call 9-1-1 and patient was taken to unspecified medical facility (not believed to be a hospital) for unspecified treatment and release (it was unsure if patient actually experienced fall and heat injure at the time of this report, capture it conservatively). It was unknown if any laboratory tests were performed for the events. The outcome of faint was reported as recovered. The outcome of fall and head injure was not provided. Causality assessment was not provided.  Upon internal review, faint was determined to be medically significant.  This is one of two reports received from the same reporter (linked case # US-009507513-1910USA008773).; Sender's Comments:  US-009507513-1910USA008773:
4/25/13 at 4:45 PM Pt. came in for PPD reading and mentioned to us that she had gotten reaction to vaccine in her (L) deltoid. There is a wheal with erythema about 20mm x 18mm. Dr. advised cold compress 3x's a day for about 10 minutes and a Rx for BENADRYL given.
fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) had not resolved. Not Provided    Action taken with mRNA-1273 in response to the event was not applicable. Concomitant information was not provided. No treatment information was provided.
Employee had c/o nausea with emesis after injection by another nurse earlier that day.  He was told to check with this nurse before leaving his shift.  He did.  feel better, but did state that during his last series, years ago, that he had a "seizure".  Informed mgmt.
Anaphylactic reaction: 1. Suddenly couldn't swallow but was eating & so I choked 2. Briefly lost consciousness while choking, woke up on floor 3. Tingling/numb feet/hands 4. 120 heart rate 5. Throat closing, tongue swelling, couldn't breathe without struggling or talk properly & afraid of swallowing tongue 6. After 20 minutes of the above I developed 5 minute long convulsions with hands/feet/eyes/head uncontrollable & firing off constantly (kicking, mangling held objects, snapping head around). Could not talk at all during these 7. Downtime between convulsions where I could barely think other than to say I was dying 8. Convulsion waves went on for about an hour before subsiding 9. Extreme nausea, fear of suffocating if I were to vomit 10. Abdominal/chest pain, "something feels very wrong" 11. 1 hour later I finally recovered on my own 12. Extreme physical exhaustion afterwards 13. Throat feels weird the next day but otherwise no recurring symptoms
Patient was lying down during administration of Twinrix #2 because she stated that she gets nauseous. After vaccine given patient was still lying down and drinking juice. When she left after reassuring the RN she was alright, she left the clinic and entered the waiting room and proceeded to fall straight back and hit the floor, passing out. Medical attention was given promptly by Dr. and the paramedics were called who transported patient to the ER. She called and talked to the supervising Public Health Nurse on 6-23-2008 and told her that she had been hospitalized for 2 days in the ICU. 7/11/08-records received for DOS 6/20-6/21/08-DX: Left occipital skull fracture. Presented to ED after a fall and striking head after vasovagal response. Neck pain, nausea and emesis.
Day after 2nd dose got coughing; wheezing; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 24Feb2021 (at the age of 68-years-old) (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included no (reported other medical history was no). The patient was not pregnant at the time of the events. The patient has no known allergies. The patient's concomitant medications were not reported. The patient did not receive other vaccine in four weeks and did not receive other medications in two weeks. The patient did not have COVID prior to vaccination and had not been tested for COVID post-vaccination. The patient previously took the first dose of BNT162B2 administered in the left arm on 03Feb2021 at 13:30 for COVID-19 immunisation. On 25Feb2021 at 6:00, the patient experienced coughing and wheezing. No treatment was received for the events. It was reported that the patient was still having the same coughing and wheezing a week later. The outcome of the events was not recovered/not resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a pharmacist via sales rep and described the occurrence of pain in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The reporting pharmacist was the concerned patient. The sales representative reported the information to medical information. The age at vaccination was not reported. The healthcare professional did not want to speak further to medical information at the time regarding the adverse event. No further information was reported regarding the event.
headache; migraine; sensation of bilateral eye pressure; severe nausea; photophobia; low blood pressure at 90/62; This is a spontaneous report from a contactable other hcp.   A 47-years-old female Non-Pregnant patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 10Feb202116:00 (Batch/Lot Number: EL9265) as dose 1 single for covid-19 immunisation. Medical history included glaucoma, bilateral high eye pressures (early glaucoma- treated with Vyzulta), hypersensitivity. Concomitant medication(s) included latanoprost (VYZULTA). Patient had key lime allergy. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was reported that, the patient experienced headache, migraine, sensation of bilateral eye pressure, severe nausea, photophobia, low blood pressure at 90/62 on 11Feb2021 05:00 with outcome of recovered. The patient underwent lab tests and procedures which included blood pressure measurement: 90/62 on. Therapeutic measures were taken Advil 600mg and Tylenol 1000 mg total as a result of headache (headache), migraine (migraine), sensation of bilateral eye pressure (ocular discomfort), severe nausea (nausea), photophobia (photophobia), low blood pressure at 90/62 (hypotension).  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
local reaction right shoulder red; swollen mild tender nonfluctuant; Mild induration; local inflammatory reaction. Follow up 2-8-08 mom states decreased swelling no redness
A dose of PENTACEL administered to a patient, but did not reconstitute no AE;Initial information regarding an unsolicited valid non-serious case was received from a nurse via consumer/non-health care professional via Medical Information (Reference number- 00807298) and transmitted to Sanofi on 11-Oct-2021.   This case involves a patient (unknown demographics) who was received a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] administered to a patient but did not reconstitute (product preparation issue).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot UJ544AB, expiry 07-Aug-2022) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate reconstitution technique (latency same day).  It was reported "Nurse states they administered a dose of PENTACEL to a patient but did not reconstitute before administering. Nurse states the Diphtheria and tetanus toxoids and acellular pertussis- Inactivated Poliovirus Vaccine (DTaP-IPV) portion was administered but not the Haemophilus influenzae type b (Hib). states that she is just trying to request the proper diluent, the 0.4% sodium chloride (NaCl) saline solution for the Hib component. She was referred to the Pentacel Reconstitution Video."  No other adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Second dose of MCV4 administered to 18 y.o. female. Patient had first dose at age 11 (2007) and reported no adverse side effects. Patient stood up approx 5 minutes after administering MCV4 into left deltoid. Within 1-2 minutes of standing, patient stated that she didn't feel well. She then became pale and lost consciousness. Patient eased to the ground by NP and mother. Patient regained consciousness after being placed in lying position with legs elevated. On assessment after event pt was alert and oriented, bp 110/70, hr 70's, sp02 98%. Lungs sounds clear to auscultation, hearts sounds RRR, pupils round and reactive to light. No edema present to mouth, lips, tongue and no hives noted. Approx after 15-20 minutes of lying down, moved patient into sitting position and provided patient with orange juice. Patient tolerated sitting for about 10 minutes (bp 107/80 in sitting position. She then began to c/o lightheadedness and nausea, placed back into lying position. Ambulance called d/t pt recurrent symptoms of lightheadedness and unable to tolerate position changes. Spoke with mother on 7/8/14 regarding incident and pt prognosis. She stated that EMS administered fluids on route to the hospital. At the ED they did an EKG which was negative, monitored patient and sent her home within a few hours. Mother further stated that the daughter did not eat much that day and was anxious about getting a vaccine. Has hx of fainting in the past.
Embolic stroke involving left middle cerebral artery; Impaired mobility and ADLs; Stroke