chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presents with ? SUICIDAL     pt intoxicated and tried to hang herself on the shower curtain rod. boyfriend called 911. pt states this was a suicide attempt        HPI:   This is a 41y.o. female with significant past medical history of polysubstance abuse that presented to the hospital with chief complaint of suicide attempt. The patient apparently tried to hang herself on the shower curtain rod after reportedly drinking 1 liter of Captain Morgan's rum. She was found on the ground by her boyfriend whom reports she was 'blue in the face." On examination she is resting in bed in no acute distress. She denies any fever, chills, chest pain/pressure, palpitations, shortness of breath, abdominal pain, nausea, vomiting, diarrhea, constipation, or urinary complaints. She denies any illicit drug use or ingestion of toxins.    In the ED, patient mildly hypertensive, afebrile, stable SPO2 99% on room air. CBC, BMP, coags, UA unremarkable. Ethanol level 410. UDS negative. COVID positive. CT head and CTA neck unremarkable for injury. Admitted for further evaluation and management with psychiatry consultation. Suicide precautions implemented in ED.    Pt seen and examined only by the attending physician. NP only responsible for chart review in an effort to limit exposure given the current pandemic and patient's COVID positive status.    ROS:   Constitutional:  Denies fatigue, fever or chills.  Eyes:  Denies change in visual acuity, diplopia or pain. HENT:  Denies nasal congestion, sore throat or tinnitus. Respiratory:  Denies cough,difficulty in breathing or shortness of breath.  Cardiovascular:  Denies chest pain, palpitations or edema.  GI:  Denies abdominal pain, nausea, vomiting, constipation or diarrhea.  GU:  Denies dysuria, urinary frequency or hematuria. Musculoskeletal:  Denies back pain, atrophy, spasticity or joint pain.  Hematologic:  Denies anemia, bleeding, or bruising. Integument:  Denies rash or lesions. Neurologic:  Denies headache, focal weakness, seizure or stroke. Endocrine:  Denies temperature intolerance, polyuria, or polydipsia.   Psychiatric:  Denies irritability, +depression +anxiety. +suicide attempt
Aches, slight fever, fatigue, feeling ill.  Lasted about 1 18/2 days.
This spontaneous report has been received from a registered nurse referring to a 12 month old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not reported. On 20-JUL-2017, the patient was inadvertently administered a dose of both PROQUAD (dose, route, lot# and expiration date were not reported) and VARIVAX (dose, route, lot# and expiration date were not reported) for prophylaxis (Accidental overdose), which was reconstituted with sterile diluent. No adverse effects were reported.
From initial information received on 5/4/04 from the patient's daughter regarding an adverse event occurring in the USA, it was reported that a 73 year old female patient received a dose of FLUZONE, administered in the deltoid on the first week of December 2003. The lot number and route of administration were not reported. Two to three weeks later, the patient began tripping, which occurred three times, and developed short term memory loss. The patient resides overseas but was visiting USA at the end of November 2003. She returned overseas at the beginning of March 2004, and is currently hospitalized due to a brain infection. Reportedly, the patient was treated with Solu-Medrol. The patient's recovery status was not reported.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 21-NOV-2018 the patient was vaccinated with properly stored but expired dose of M-M-R II (therapy type rHA) (lot # M045394 with expiry date of 14-NOV-2018) for prophylaxis. No adverse effects reported. No product quality complaint was filed.
Pain in injection site 3 hours later which continue to increase to severe. Fever, chills, muscle and joint/ body aches, headache which increased to severe. Fatigue, unable to sleep for a period of time.
No additional AE; 2x Doses of GARDASIL 4, 10 years ago; This spontaneous report was received from certified medical assistant who was reporting on herself via company representative.  On an unknown dates in October 2011, the patient received two doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis (inappropriate schedule of vaccine administered). The reporter inquired if the patient should receive a single dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) to complete a series of 3 doses. There was no additional adverse event reported.
left arm weakness; injection site feels hard after the second dose; This is a spontaneous report from a contactable consumer (patient) and contactable physician.  A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration at arm left in Jan2021 at single dose for COVID-19 immunization.  The patient medical history included diabetes from Nov2020 and ongoing. The patient's concomitant medication included glipizide from Nov2020 at 2.5 mg twice daily and metformin at 500 mg twice a day, both for diabetes. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1686) via an unspecified route of administration on 03Jan2021 at 16:00 single dose for COVID-19 immunization and experienced left shoulder felt heavy, pain, felt really weak, appetite lost and "energy level was through the roof".  The patient experienced injection site feels hard on 24Jan2021, left arm weakness on 25Jan2021 with outcome.  The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 24Jan2021.  The patient outcome of injection site feels hard was not recovered and the outcome of left arm weakness was unknown.
devel flu like sx i.e. h/a, achiness on Thursday;arm swelled from area of shot down & around the inner arm;devel red welts on underside very sore
pt recvd vax & 1wk post vax pt exp bell's palsy;pt was also exp a viral infect;MD believes that assoc between pt's bell's palsy & vax is coincidental
Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 73-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 23Feb2021 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was not reported whether the patient received any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 05Feb2021 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. On 24Feb2021, the patient experienced headache. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headache was unknown at the time of this report.   No follow-up attempts are possible,  information about lot/batch number cannot be obtained. No further information is expected.
Fever rectal 104.2, tachycardia, hypoxia started 1/27/21. SpO2 82% on room air. Supplemental O2 was required. COVID-19 and influenza negative. Resolved 1/28/2021.
General unwell feeling,  shivering, likely fever, muscle aches and extreme tiredness.  Went to sleep and after 10 hours sleep, felt much better.  (I took 2 Tylenol before going to sleep.)  I still feel very tired.
"About 10 to 15 minutes after the vaccine, I started itching on my eyelids and neck.  The nurse gave me Benadryl and it went away.  My eye lids got scabby, but it could have been from scratching them"
I started to get the chills around dinner time, then when I went to bed, I experienced severe chills, perfuse sweating, bad headache and intense arm pain at the site of the injection.  The symptoms lasted all night and were improved in the morning but not fully resolved.
Redness, tenderness, palp. thickness at site R upper arm about 1.5 cm.  Sx still present 6 days after injection.
Headache, Myalgia, chills Narrative:  symptoms lasted 24 hours  Other Relevant History:
08/31/11 (next morning) approximately 24 hours later: coughing and issues with voice. 09/01/11 complete loss of voice (laryngitis) for almost 4 days.
A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00592591) and transmitted to Sanofi on 07-May-2021.  This case involves a 12-year-old female patient who received an expired 0.5 mL dose of  DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot C5577AA and expiry date: 20-Feb-2021) via an intramuscular route in the deltoid for prophylactic vaccination on 07-May-2021 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for prophylactic vaccination and ALTHAEA OFFICINALIS ROOT, CINNAMOMUM CAMPHORA ESSENTIAL OIL, CITRUS AURANTIUM OIL, EUCALYPTUS GLOBULUS LEAF ESSENTIAL OIL, MENTHA X PIPERITA ESSENTIAL OIL (GARDISIL).  The medical assistant (MA) would like to know the efficacy of ADACEL past the expiration date.  This was a case of actual medication error due to expired vaccine used (latency same day).  At the time of reporting, no 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 holders compliance with the requirements set out in 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.
I had a sore arm for a day after my first vaccine and it went away. Eight days later a slightly raised, hot to touch, red and very itchy rash appeared on the arm near where I got my shot. The rash lasted about 36 hours and then vanished completely.
Fever of 101.5-101.9 took tylenol did not reduce until 6pm 2/6/21. Headache consistent throughout the day of 2/6/21 Fatigue all day 2/6/21
PATIENT CALLED PHARMACY TO REPORT THAT SHE HAS HAD A FLARE UP OF SHINGLES POST VACCINE. HAS HAD SHINGLES IN THE PAST.
On June 6, 2021 shortly after tne vaccine was administered, my head began to hurt, the pain at the top and mostly at the back down to the nape area were severe.  the pain continues for days into weeks, I was in bed for most of those days.  The pain got progressively worse each week.  On friday june 18, 2021, i went to the hospital as the paiin became unbearable.  A MRI was done, the results were all negative.  I was given pain meds.  On the morning of July 28, at about 5:45am I passed out at home. End up at the hospital.  My headaches continues to become progressively worse, follow by memory lost, unalbe to focus, weakness in my hands and feet. passout  6/times and end up at the hospital 4/of the 6.
I received the Moderna COVID-19 booster on 9/7/2022. On 10/24/2022, I woke up at night with a sore throat. I felt a wave of fatigue and had a slight fever. On 10/25/2022, I developed respiratory symptoms that included stuffy nose, phlegm in the throat, clogged ears, an earache in the right ear. I had difficulty hearing, and listening is a key necessity for my job, as I am a psychologist. Not only that, but I also have pre-existing tinnitus, and it was exacerbated by the symptoms I developed. I took a home antigen test on 10/27/2022 and got a negative result. I was also given a flu test by my doctor, which also yielded a negative result. The doctor then prescribed me an antibiotic cough suppressant, which I ended up not taking. Instead, on the10/28/2022, I contacted my PCP, who prescribed ciprofloxacin. From then on, I took the ciprofloxacin with MUCINEX to treat my symptoms. Altogether, I was sick for 3 1/2 weeks. It was 4 weeks before I got my hearing back and felt fine again. Thankfully, I have the option of working remotely, so I didn't miss too much work during my illness.
Sudden numbness in leg 5:20pm. Went to emergency room via ambulance. Did a CT scan, found blood clot in upper leg. Sent via ambulance to  Hospital had Surgery at 10pm to remove clot and save leg.
Information has been received from a nurse practitioner referring to unspecified multiple patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored VARIVAX (lot # L001333, expiration date 13-JAN-2017; lot # L011085, expiration date 01-APR-2017; lot # L020003, expiration date 02-JUN-2017) (dose and route were not reported). The defrost cycles of vaccine temperature of -14 Celsius degrees occurred 6 days in October 2015, and -13 degrees Celsius for 5 days in September 2015. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
No adverse event; A patient received an expired dose of pneumovax23; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.     On 30-MAR-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # R012497, with expiration date of 08-JAN-2020, 5 milligram (strength, frequency, route, and anatomical location were not provided) for prophylaxis. No adverse effects were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress: ; manufacturercity:; manufacturerstate: ; manufacturercountry: ; devicelotnumber: R012497; expirationdate: 08-JAN-2020; deviceage and unit: 0 ; operatorofdevice: Medical Assistant; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
14:08, pt presenting with complaint of "lips feel like they are swelling", pt has history of medication allergies &  adverse reaction to lidocaine; per EMS S.O., 2-Benadryl-25 mg tables were given.  Pt was asked to stay another 30 minutes after taking the Benadryl.
I've been in bed for two days; It literally feels like my brain is splitting in two; I had 102.3°F; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (I've been in bed for two days), FEELING ABNORMAL (It literally feels like my brain is splitting in two) and PYREXIA (I had 102.3°F) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine. Concomitant products included SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for Migraine, GABAPENTIN, LEVETIRACETAM, TAMSULOSIN, TOPIRAMATE, CELECOXIB and CHLORZOXAZONE for an unknown indication.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Aug-2021, the patient experienced BEDRIDDEN (I've been in bed for two days), FEELING ABNORMAL (It literally feels like my brain is splitting in two) and PYREXIA (I had 102.3°F). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. On 17-Aug-2021, BEDRIDDEN (I've been in bed for two days) had resolved. At the time of the report, FEELING ABNORMAL (It literally feels like my brain is splitting in two) and PYREXIA (I had 102.3°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Aug-2021, Body temperature: 102.3°f (High) 102.3°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter mentioned that he had seen to a neurologist.
had swelling, aching and intense burning on arm from the flu shot; Initial information was received on 30-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient).  This case involves a 76 years old female patient who was diagnosed with fibromyalgia with the symptom had swelling, aching and intense burning on arm from the flu shot (vaccination site inflammation), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patients medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.  On 29-Sep-2020, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via unknown route in the right deltoid for prophylactic vaccination.  On 30-Sep-2020, the patient diagnosed with a non-serious with fibromyalgia with the symptom had swelling, aching and intense burning on arm from the flu shot (vaccination site inflammation) one day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Case details: Caller stated that she had the flu shot yesterday and she had swelling, aching and intense burning and has been using ice on and off consistently and states it scared her because she has never had this reaction. States her husband went at the same time and did not have any problems. Reporter contacted a pharmacist from another drug store who told her the burning may be the Fluad but caller looked on information and she did receive the Fluzone High Dose but no lot number was available. She stated that since she has been diagnosed with Fibromyalgia she has had to ice her arm for two weeks due to swelling from the flu shot.  Details of laboratory data were not reported.  Ice was used on and off consistently as a corrective treatment.  The outcome was unknown for the events of fibromyalgia and vaccination site inflammation.  There will be no information available on the batch number for this case
8 year old patient was given the adult dose. Patient's parents were immediately notified and warn of possible systemic/localized adverse effects. Parents denied any adverse effects. Parents informed no additional Hep A immunization needed since this was patient's second Hep A dose.
I did not give the vaccine.  Patient came here for treatment 12 days after vaccine was given because she still has a red/hard area on her arm where the vaccine was given.
Patient received the influenza vaccine.  Approximately 15 minutes following the vaccine administration the patient became diaphoretic, clammy, and short of breath.  He reported that his 'throat was closing' and having difficulty breathing.  Epinephrine 1:1000 was immediately administered and the patient was transported to the emergency room.    In the emergency department the patient was found to have tracheal wheezing, resp rate 28-30 bpm, and Sat of 100% on room air.  Patient had an IV started and was given diphenhydramine 25 mg IVP, famotidine 20 mg PO, methylprednisolone 125 mg IVP.  He was observed for the next 2 1/2 hours without further treatment or complaints.  He was discharged home with a Medrol dose pack.   The patient has not returned for a follow-up appointment with his primary care physician yet.
Patient slept 4 hours more than Normal. Woke up with paiN iN hips, knees shoulders and muscles as well as a headache
subdural hematoma; brain bleed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (COMIRNATY), as dose number known, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUBDURAL HAEMATOMA (medically significant), outcome "unknown", described as "subdural hematoma"; CEREBRAL HAEMORRHAGE (medically significant), outcome "unknown", described as "brain bleed".  Clinical course : Caller (48 years old when he had subdural hematoma), 49 years old now) calling for Pfizer covid vaccine wanted to know if  subdural hematoma has been reported with the vaccine. He was worried as he has subdural hematoma but he did not hit his head. He stated the doctor told him its not the vaccine what caused it, he might have hit his head and he forget about it. He stated it happened 6 months after taking the covid vaccine. He rides bike 30-40 km and nothing happened to him before. But now 6 month later of getting the vaccine he has brain bleed. He stated he was very suspicious of the vaccine and will not be taking any other dose. He need to have the blood grained from the head. He stated his childhood friend, same age and received the Pfizer covid Vaccine experienced the same subdural haematoma / brain bleed. He also did not hit his head. Reporter stated, "So last year in April reporter took the Pfizer vaccine and after like three week reporter did the second shot and then in October reporter had something called subdural hematoma in my head which was like bleed in the brain, the doctor told me you hit your head or something like that but reporter could not remember reporter hit my head. reporter have been thinking the vaccine (Pfizer COVID-19 Vaccine) could be the problem but nine months after, reporter did surgery they believe reporter have in my head to take the blood and things like that and that had risk to die basically and reporter did not hear that somebody had this situation right but like a month ago my close friend had the same issue and he had the Pfizer vaccine (Pfizer COVID-19 Vaccine) as well. So my call was here to ask you do you heard some situation like this? Can you confirm this was a Pfizer because now reporter am worried can reporter have again something like that because me and my friend, the guys was my childhood friend and he was very close to my age. reporter am like 49 he was like 48 may be and he had the same problem, both of us and we both get the Pfizer and we both do not remember we hit our head and subdural hematoma usually come when you hit your head or make car accident or something like that."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201037906 Same product and event, different patient;
A medical supplier reported a pt received vaccine and subsequently developed a bad injection site reaction characterized by redness and swelling.
Within 24 hours of flu and shingles shot, experienced two episodes of fainting within a 5 minute period.
my left thigh mostly in back. charley horse, still bad after 7 days. tried heat and cold treatments. bad pain
Pt tested positive for COVID on 2/15/21. She passed away on 02/23/21. Not listed as COVID death on death certificate.