chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fall; This is a spontaneous report from a contactable consumer (patient's daughter). A 100-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL9261) via an unspecified route of administration in left arm on 22Jan2021 at single dose for COVID-19 immunisation. There were no relevant medical history or concomitant medications (it was also reported that the patient was on a lot of different medications). The patient experienced fall on 16Feb2021. The patient was then "hospitalized for a fall" and might not be attend her second vaccination appointment. Her second dose was scheduled on 24Feb2021. The hospitalization had nothing to do with vaccine. The outcome of event was not recovered.
Patient complaining of pain in the upper arm, through shoulder and neck at left arm where FLUZONE ID was administered. (Pain described as tingling/burning). Patient complaining of pain since 1/22 - until today ratio of pain "1 - 10" is "7" Her arm hurts every time she move it.
No additional  adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 16-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S025258 and expiration date 05-NOV-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Office Visit 3/15/2021   with, PA-C  COVID-19 Dx Follow-up Reason for Visit Progress Notes , PA-C Encounter Date: 3/15/2021 Cosigned by: DO at 3/20/2021  6:25 PM Expand AllCollapse All      Assessment/Plan        Problem List Items Addressed This Visit    None   Visit Diagnoses    COVID-19    -  Primary Unfortunately, patient does not meet criteria for monoclonal antibody infusion therapy as he is 10 days from start of symptoms.  At this time I have sent in a prescription for Tessalon Perles and a ProAir inhaler for him to use with increased cough or shortness of breath.   You tested positive for COVID-19 today.  Discussed recommendation for self-isolation from others at home.  You should try to stay in the specific sick room and use a separate bathroom if possible, even if you are feeling better.  You can be around others 10 days after your symptoms first appeared, and you have had 24 hours without fever without the use of fever reducing medications, and other symptoms of COVID-19 are improving.  If you do come into contact with others at home, you should stay six feet away and wear a mask.     Please follow good handwashing hygiene: wash your hands with warm water and soap for 20 seconds, or when hand washing is not available, use an alcohol based hand sanitizer that is at least 60% alcohol. Please stay well hydrated and rest. May use tylenol for fever, chills, or pain. You may also use hot tea with lemon and honey to soothe your cough and salt water gargles for any sore throat.     If you develop difficulty breathing, persistent pain or pressure in your chest, have any confusion, difficulty staying awake, please call us or go to the ED.      Relevant Medications   albuterol HFA (PROAIR HFA) 90 mcg/actuation inhaler   benzonatate (TESSALON) 200 mg capsule   Other Relevant Orders   POCT COVID-19 Antigen (Completed)   Pulse oximetry (Completed)        SUBJECTIVE   PT 72 y.o. male who presents for a sick visit with concern for possible COVID 19.  Reports onset of symptoms started 10 days ago. Information was obtained from PATIENT.  Reports some dry cough, mild shortness of breath, occasional headache, increased fatigue, loss of taste and smell, decreased appetite, congestion, rhinorrhea. Reports loose stool. Denies wheezing, fever, chills, myalgias, sore throat, ear pain, n/v. He was exposed to an individual who was exposed to someone with COVID. He had his flu shot and his first dose of the COVID-19 vaccination.    Review of Systems  Constitutional: Positive for fatigue. Negative for chills and fever.  HENT: Positive for congestion and rhinorrhea. Negative for ear pain and sore throat.   Respiratory: Positive for cough and shortness of breath. Negative for wheezing.   Gastrointestinal: Positive for diarrhea. Negative for nausea and vomiting.  Neurological: Positive for headaches.
I woke up with my arm itchy, red, and warm around the injection site. The total red region is approximately 2 inches in diameter.
Pt experienced several covid like symptoms; fever (TMAX 100.5), cough, body aches, and lastly a raised lace like rash.  Unsure if symptoms are from the vaccine or other viral infection.   Pt reports negative covid test on 4/22/2021
Pt. received vaccine (FLUZONE HD) on 10/11/16, pt. had itching almost immediately following and bruised the next day. On 10/13/16, began to welt and called primary physician who in turn sent her urgent care. Diagnosed as cellulitis and given ABX. (Pt called me 10/15 to let us know).
A short while after receiving the vaccine I began seeing "wavy lines" on the right side of spreadsheets, a few weeks later it became difficult to read small print and numbers.  I contacted my ophthalmologist and he referred me to a retinal specialist who injected medication into my eyes.  I believe the medication was Eylea.
Incident Description:  Patient was unintentionally injected with 0.25 ml of air by agency nurse. Patient did receive 0.25 ml of Moderna immediately afterwards in response.
No further AE.; Medical assistant calls to report PNEUMOVAX 23 lot#u035117  8/18/2023 administered after expiration date.  See AE case.  No further AE.  No PQC.  MIR request case; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 07-SEP-2023, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, one time, lot #u035117, expiration date: 18-AUG-2023, administered for prophylaxis (strength, and route of administration were not provided).  On 07-SEP-2023, medical assistant called to report PNEUMOVAX 23  was administered after expiration date. See AE case.  No further AE. No PQC. MIR request case.
Vaccinated 9-12-2009 @ 3:15PM. Sat 9/12 patient reports "he slept lousy". Sun 9/13 didn't feel right. Kind of a sore throat. Mon - Wed 9/14-9/16 sniffles, coughing. Sneezing no temp. Not phlegm. "Tightness in chest" sweating off +/on.
My left arm developed a rash at the antecubital site which spread upward to my shoulder. It appeared on my right arm, within two hours, same location. It continued to spread down to my wrists and remains today, 1/26/21. The rash is red with small pruritus bumps. On 1/21/21, it appeared on my throat.
This spontaneous case, initially received from other non-health professional (consumer) via Agency (Reference number: 18P-163-2321310-00) on 21-May-2018, concerning a 54-year-old, adult female patient. The patient was non-smoker and abstained from alcohol. The patient's historical drug included: TEGRETOL for an unknown indication. The patient's current condition included: hypertension. The patient was allergic to sulfa manifested by rash, TEGRETOL allergy manifested by rash, opioids and derivatives allergy manifested by rash. Concomitant medication included: Clonidine for hypertension. On an unspecified date in Nov-2016, the patient was administered with non-company suspect drug CREON (Pancreatin, 36000-unit, capsule) (3 capsules daily with meals and 1 capsule with snacks via oral route) for idiopathic pancreatic insufficiency. On 04-Oct-2017, the patient was administered with FLUVIRIN (route of administration: reported as injection, dose, anatomical location, batch number, expiry date: not reported). On an unspecified date in 2017, reported as two weeks later, the patient experienced numbness in her extremities that eventually worsened to her whole body. On 20-Dec-2017, after 2 months 17 days of vaccination, the patient was hospitalized for the symptoms and was diagnosed with chronic inflammatory demyelinating polyneuropathy. On an unspecified date in Dec-2017, lumbar puncture and nerve conduction study was done, results of which confirmed chronic inflammatory demyelinating polyneuropathy. The patient received plasmapheresis and intravenous globulin treatment during the hospitalization. On 25-Dec-2017, the patient was discharged from the hospital. The patient's numbness symptoms continued and was hospitalized from 09-Jan-2018 to 23-Jan-2018 for the same symptoms and was given a walker and cane for ambulation. However, the patient's symptoms did not improve and was re-hospitalized from 15-Feb-2018 to 08-Mar-2018 and received another plasmapheresis and intravenous immune globulin treatment. Later, the patient was transferred to another hospital for the final week of hospitalization. The patient's routine follow-up with physician noticed that her right leg was swollen. On an unspecified date, the patient was hospitalized. On 10-Apr-2018, after 6 months 7 days of vaccination, the patient's ultrasound of leg was performed which showed thrombosis in leg (final diagnosis). The patient was prescribed with ELIQUIS due to blood clot. No additional treatment for the blood clot was planned at that time. It was reported that, the patient was treated with Gabapentin, immune globulin, prednisone and ELIQUIS. At the time of this report, the patient had not yet recovered from the event inflammatory demyelinating polyradiculoneuropathy and was still recovering from the event thrombosis leg. The reporter considered the case as serious due to hospitalization and medically significant. The reporter considered the causality of the events as not related   [Due to memory limitations, the remainder of this text could not be compared.]  lated with suspect product CREON and related to suspect vaccine.
Parents purchased vaccine from the Pharmacy. A family member administered the vaccine, which was expired. The expiration date was 19 Jan 18. Health Department was noticed by School Nurse that they received a child's vaccine on a hand written note and were told the family member had administered the vaccine at home. She wanted to know if it was acceptable. The father also provided the school with a picture of the empty vial. The information was sent to agency. It was noted and verified that the vaccine was expired. The agency recommended that child be revaccinated in 8 weeks and that the local HD submit a VAERS report.
PT. developed asymmetrical dysesthesia and paresthesia in both arms with difficulty breathing at times as well as verbal dyspraxia which also was transient, rigid gait-seen at local ER, CT of head normal, all labs drawn WNL, neurology consult assessed as hypersensitivity reaction. Of note, PT. Had tonic arm movements when eliciting patella reflex, however, no LP has been performed to date.
My Acupuncturist discovered swollen lymph nodes during my exam. It was located on the right side. Acupuncturist sent me to the internist who referred me to an ENT. He examined and was concerned so he decided to do a watch and wait after x-rays. I went for 3 check ups with my ENT and they gave me the all clear. The ENT indicated it could be a calcified lymph node.
Red induration  on Left deltoid area. Measures about 24x12 area. Patient able to move extremities. Recommended local measurement to local reaction. No treatment needed.
She could barely eat on Sunday; Early morning on Sunday, she woke up 6 to 7 times and had severe diarrhea/ She had diarrhea again on Sunday night to Monday morning; Early morning on Sunday, she woke up 6 to 7 times and had vomiting; Patient started with cold and chills next day morning; Patient started with cold and chills next day morning; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Patient started with cold and chills next day morning), DECREASED APPETITE (She could barely eat on Sunday), DIARRHOEA (Early morning on Sunday, she woke up 6 to 7 times and had severe diarrhea/ She had diarrhea again on Sunday night to Monday morning), CHILLS (Patient started with cold and chills next day morning) and VOMITING (Early morning on Sunday, she woke up 6 to 7 times and had vomiting) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.   On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 ml. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced NASOPHARYNGITIS (Patient started with cold and chills next day morning) and CHILLS (Patient started with cold and chills next day morning). On 28-Mar-2021, the patient experienced DECREASED APPETITE (She could barely eat on Sunday), DIARRHOEA (Early morning on Sunday, she woke up 6 to 7 times and had severe diarrhea/ She had diarrhea again on Sunday night to Monday morning) and VOMITING (Early morning on Sunday, she woke up 6 to 7 times and had vomiting). At the time of the report, NASOPHARYNGITIS (Patient started with cold and chills next day morning), DECREASED APPETITE (She could barely eat on Sunday), DIARRHOEA (Early morning on Sunday, she woke up 6 to 7 times and had severe diarrhea/ She had diarrhea again on Sunday night to Monday morning), CHILLS (Patient started with cold and chills next day morning) and VOMITING (Early morning on Sunday, she woke up 6 to 7 times and had vomiting) outcome was unknown.            Relevant concomitant medications also included statin. No treatment information was provided(none).
Stiffness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single.), administration date: 16Mar2021, for Covid-19 Immunization. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious) with onset 2021, outcome "unknown", described as "Stiffness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional Information: Two weeks after the second dose, around the 14th or 15th day, he became very stiff in his legs and then it traveled up to hips briefly and then in his shoulders for a longer period of time. He just wanted someone to know about this and he heard of two women that had the same problem.
Breakthrough case admission after 3 vaccines  Pfizer 1/22/21 Lot# El9261;  Pfizer 3/3/21 Lot# EL9267;  Pfizer 11/18/21 Lot# 33030BD
Nausea, vomiting, dizziness, weakness, tender at injection site. Occurred after administration of 2nd Anthrax vaccine. Other roommates bad similar symptoms.
Pt vax w/ DTP;  exp 2 seizures for 1 min, 1-10 min in ambulance & resp.  Temp 99F on adm.  Tx w/ APAP
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 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); "Dysthymia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: Codeine", notes: known allergies: Codeine, Keflex; Keflex, reaction(s): "known allergies: Keflex", notes: known allergies: Keflex. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical information: The consumer started Paxlovid on 25May2022 for treatment of COVID-19 and stopped on 30May2022. Finished course of Paxlovid 5 days ago. Felt mostly back to normal yesterday but this morning had severe fatigue, mild headache, mild productive cough. Consumer had underlying asthma which was also slightly triggered.   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 available reported information, the causal association between the events drug ineffective and covid-19 and the suspect drug BNT162B2 cannot be excluded.
lyophilized component of pentacel being reconstituted with sterile water, rather than with the liquid component of the pentacelvaccine with no reported adverse event; Initial information received on 22-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 months old female patient to whom, while giving DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lyophilized component being reconstituted with sterile water, rather than with the liquid component of the pentacelvaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included WATER FOR INJECTION (STERILE WATER); PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; and HEPATITIS B VACCINE (VACCINE, HEPATITIS B) for Immunisation.  On 17-Aug-2022, the patient received 0.5ml, dose: 3 of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (formulation, strength: unknown) lot U7013AB, (expiry date:15-Oct-2022) via intramuscular route in the left vastus lateralis (left thigh) for iimmunisation.  On 17-Aug-2022 (latency: same day), the patient had a non-serious event "lyophilized component of pentacel being reconstituted with sterile water, rather than with the liquid component of the pentacelvaccine with no reported adverse event" (product preparation error).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
sharp pain in her right ear especially when she swallows; nerve pain in the left side of her body; sharp pain in the left side of her jaw /couldn't eat on her left side because of this pressure and pain; sharp pain in the left side of her jaw and ear; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN JAW (sharp pain in the left side of her jaw /couldn't eat on her left side because of this pressure and pain), EAR PAIN (sharp pain in the left side of her jaw and ear), NEURALGIA (nerve pain in the left side of her body) and EAR PAIN (sharp pain in her right ear especially when she swallows) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 19-Mar-2021, the patient experienced PAIN IN JAW (sharp pain in the left side of her jaw /couldn't eat on her left side because of this pressure and pain) and EAR PAIN (sharp pain in the left side of her jaw and ear). On 20-Mar-2021, the patient experienced NEURALGIA (nerve pain in the left side of her body). On 22-Mar-2021, the patient experienced EAR PAIN (sharp pain in her right ear especially when she swallows). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 22-Mar-2021, PAIN IN JAW (sharp pain in the left side of her jaw /couldn't eat on her left side because of this pressure and pain), EAR PAIN (sharp pain in the left side of her jaw and ear) and NEURALGIA (nerve pain in the left side of her body) had resolved. At the time of the report, EAR PAIN (sharp pain in her right ear especially when she swallows) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   There was no concomitant list.
Second shot given 20 days after first one; A spontaneous report was received from a client manager at group home concerning a 26 year-old-male, who received second dose of vaccination 20 days after the first dose.   The patient's medical history was not reported. Concomitant medications were not reported.  On 29 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Batch number: Unknown) via an unknown route for prophylaxis of COVID-19 infection.  On 18 Feb 2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Batch number: Unknown) via an unknown route for prophylaxis of COVID-19 infection. The patient was given second shot 20 days after the first one.  Laboratory tests was not reported.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events is not applicable as the individual received both the doses.  The outcome of the event inappropriate schedule of vaccination is resolved on 18-FEB-2021.; Reporter's Comments: This case concerns a 26-year-old male patient who received their second of two planned doses of mRNA-1273 (Lot unknown), reporting Inappropriate schedule of product administration without any associated adverse events.
Numbness and pain have become worse in my feet and calf areas of both feet. pain in abdomen (liver, stomach and spleen). Cramping in lower right abdomen at the end of urination.  I'm having IBS symptoms. Severe migraine headaches. I have a small lump and pain in the right side of my neck. My anxiety and depression have become worse. Occasional Dizziness and loss of memory.
patient received 1st Moderna dose on 4/30/21.  The next morning on 5/1 he felt pain on his left leg.  He waited to see if would get better or worse.  On the afternoon at an unknown time, his leg had gotten worse.  He had severe pain on his left leg; it was painful to the touch; it was swollen and was hard as a rock.  He called 911.  He was taken to  Hospital.  Pt wanted me to report that he did not receive any treatment for his blood clot.  He received a Lidocaine patch on his knee and was given a prescription for Voltaren Gel.  (he was expecting to receive TPA to dissolve the clot like a few times before when he had blood clots but this particular time he did not)