chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Increase in tinnitus levels; harder to hear people talk than before; Very very distracting; This is a spontaneous report from a contactable consumer. A 72-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm on 01Mar2021 14:15 as 1st dose single (at the age of 72-years-old) for COVID-19 immunization. Vaccination facility type was reported as Other. Patient did not receive any other vaccine in four weeks. Patient did not receive any prior COVID vaccination. Patient was not tested for COVID post vaccination. Patient medical history included CLL, stenosis of spine, occasional SVT, previously mild tinnitus, some hearing loss and had known allergies to Aspirin, Ginger, NSAIDs. The concomitant medications were not reported. On 03Mar2021, patient experienced increase in tinnitus levels, which is very distracting now, when in silence, harder to hear people talk than before. First noticed that a few days later. It has not gone away. The outcome of the event was not recovered.    No follow-up attempts are possible; information about lot/batch number cannot been obtained.
slight headache; son received the vaccine at the age of 16; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (son received the vaccine at the age of 16) and HEADACHE (slight headache) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (son received the vaccine at the age of 16). On an unknown date, the patient experienced HEADACHE (slight headache). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (son received the vaccine at the age of 16) and HEADACHE (slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment or concomitant medication were reported.  The reporter wanted to know if it was ok for the patient to be under the age of 18.
Child crying, eyes rolled back, went limp,  responded immediately to mother saying name, mother picked up and child cried, observed by medical assistant, LPN, and mother.
This is a non-serious spontaneous case, initially received from other health professional on 13-Nov-2018, concerning a male patient of an unspecified age. On 10-Nov-2018, the patient was administered FLUCELVAX QIVc (dose: 0.1 ml, route of administration: subdermal, anatomical location forearm, batch number: 252227 and expiry date: 31-May-2019). It was reported that the patient was accidently administered FLUCELVAX QIVc instead of tuberculin injection. On the same day after vaccination, the patient developed a discoloration. The outcome of the event was not reported. The reporter assessed this case as non-serious.
aware of 6 cases of Bell's Palsy by the companies making these vaccines; This is a spontaneous report from a contactable other HCP. This Other HCP reported similar events for 6 patients. This report is for 3rd of 6 patient. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunization.  The patient medical history and concomitant medications were not reported. The reporter reported since the use of modified RNA in covid vaccines, he/she had aware of 6 cases of Bell's Palsy by the companies making these vaccines since an unknown date. The outcome of the event was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Based on a compatible temporal relationship, causality between event Bell's Palsy and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021007605 Different patient, same drug/event.
Patient experienced "something wrong with her throat", life side of neck and face were numb, left eye was dropping, tongue felt thick. Patient was referred to the ER but was not seen in the ER.   Symptoms resolved overnight.
This spontaneous report was received from a consumer refers to himself as a 65 year old male patient. The patient pertinent medical history included high blood pressure. On 17-JAN-2014, the patient was vaccinated with ZOSTAVAX (dose, route, and frequency were not reported) 1 time vaccine. On an unknown date in January 2014 (also reported as end of January 2014) the patient experienced hoarse. The outcome of the event was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Recently now has ataxia with migraines, also now has substernal squeezing chest pain (random, non-constant, and non-radiating) which lasts several hours, whole body shakes for a few minutes, depression, and suicidal ideation. This is her second hospitalization within the past two weeks.
This study case was received from the investigator in a trial on 27 March 2013. A male subject (age and birth date not reported) with no relevant past medical history, developed mild chest pressure and bundle branch block, considered mild in severity, three days after he received an injection of ACAM2000, SP Biologics Co., (lot number, route, site and side not reported) on 13 March 2013. On 16 March 2013, three days post vaccination, the subject experienced mild chest pressure one time while supine. On 19 March 2013, Troponin I result was reported as normal, less than (<) 0.10 ng/mL. On 20 March 2013, electrocardiogram (ECG) was reported as abnormal with finding of Right Bundle Branch Block (RBBB). The subject was referred for care. According to reporter, no further information was expected to follow; reporting only because abnormal ECG, but could represent myopericarditis. The subject did not take any medications to treat the adverse event. The chest pressure was considered resolved on 16 March 2013 and the bundle branch block was not resolved. The patient's outcome was reported as not recovered, referred for care. According to the investigator, the events of chest pressure and bundle branch block were considered other important medical events and possibly related to the trial product. Documents held by sender: Medical Records.
I was 11weeks and 2 days pregnant at time of injection. EDD 08/15/2021.  The day after my vaccine, I had fever, chills, bodyaches, headache and fatigue. The following day,  I woke up with a rash just on my face. It is not itchy or painful.
NEAR-SYNCOPAL EPISODE PT FELT LIGHT HEADED, WEAK  VITALS: 90/PALP RESP. RATE: 20 REG PULSE: 110 REG
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 04-SEP-2014, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD lot # K006770, expiry date: 07-NOV-2015 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient had a syncope event shortly after receiving Janssen Covid vaccine. Patient put feet up and laid back for additional 10 minutes after initial 15 minute observation. BP and Pulse were not significant (176/79 and 79). Patient recovered after 25 minutes and went home.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 46-year-old male patient received BNT162b2 (BNT162B2), on 22Dec2021 at 16:00 as dose 3 (booster), single (Lot number: FE3590) at the age of 46 years, in right 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jul2022) faint line; (28Jul2022) faint line got darker; (29Jul2022) line is darker. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid, treatment start date=22Jul2022, treatment stop date=27Jul2022.  No follow-up attempts are possible. No further information is expected.
HEMORRHAGIC STROKE; This spontaneous report received from a lawyer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-MAR-2021 (Within 24 hours after vaccination), the patient experienced a stroke and was hospitalized. On 13-MAR-2021, the patient was transferred to another hospital where she was diagnosed with a haemorrhagic stroke. Currently, the patient was admitted as inpatient rehabilitation center.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hemorrhagic stroke was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: Medical Assessment Comment not required per standard operations procedure for legal case
still got flu; Initial information received on 16-Dec-2022 regarding an unsolicited valid Social media non-serious case received from a consumer/non-health care professional.  This case involves an unknown age and unknown gender patient who  still got flu after receiving vaccine Influenza Vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation, strength, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient still got flu (influenza) (latency: unknown) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  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 spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE DISCOLOURATION (injection site is dark pink), SWELLING FACE (facial swelling), EYE SWELLING (Underneath her right eye is swollen), PRURITUS (itchiness on neck) and INJECTION SITE MASS (injection site is a knot) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011JZOA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced INJECTION SITE DISCOLOURATION (injection site is dark pink), SWELLING FACE (facial swelling), EYE SWELLING (Underneath her right eye is swollen), RASH (face rash) and RASH (rash on neck). In February 2021, the patient experienced PRURITUS (itchiness on neck), INJECTION SITE MASS (injection site is a knot) and PRURITUS (itchiness under and on her ears). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) for Itch, at an unspecified dose and frequency. On 10-Mar-2021, SWELLING FACE (facial swelling), EYE SWELLING (Underneath her right eye is swollen), RASH (face rash) and RASH (rash on neck) had resolved. At the time of the report, INJECTION SITE DISCOLOURATION (injection site is dark pink), PRURITUS (itchiness on neck), INJECTION SITE MASS (injection site is a knot) and PRURITUS (itchiness under and on her ears) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment drugs include: cream. No concomitant drugs were reported.   This case was linked to MOD-2021-091400 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Updated contact information, patient demographics and the events start date, stop date and outcome of the events ( Swelling eye, Rash on neck, Face rash) from unknown to recovered. Added the second dose details such as vaccine information events and outcome of events and treatment details.
Headache, Myalgia, BODY ACHES, CHILLS, MIGRAINE FOR 4 DAYS, SYMPTOMS RESOLVED BUT NOW HAS CONGESTION Narrative:
swelling in lymph node located under left armpit; pain in lymph node located under left armpit; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swelling in lymph node located under left armpit) and LYMPH NODE PAIN (pain in lymph node located under left armpit) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 LYMPHADENOPATHY (swelling in lymph node located under left armpit) and LYMPH NODE PAIN (pain in lymph node located under left armpit). At the time of the report, LYMPHADENOPATHY (swelling in lymph node located under left armpit) and LYMPH NODE PAIN (pain in lymph node located under left armpit) outcome was unknown. Not Provided          No concomitant medication was reported. The treatment information was unknown. Patient got booster on Monday in my left shoulder.
Starting the next day after his vaccine he started having issues with dizziness.  It happened several times on the day after the vaccine, and today as well.  He said that today he was so dizzy that he actually lost his balance and fell down.  He is still occasionally dizzy, not constant, but worried about driving and being alone
Breakthrough case admission after 2 vaccines Moderna Lot# 037C21A;  Moderna 6/22/21 Lot# 049C21A
I started taking Protonix in place of the lansoprazole since last ER visit. I felt fine the first day and then I had some mild congestion and then I had some nausea again and I had still had some of the Zofran from previous ER visit and the nausea progressed again and I didn't know if it was my appendix or gallbladder or what was going on and I didn't know why I was having this again. I went back to the hospital on 09/15 and I went to the ER and they took all kinds of tests again and they did an ultrasound and it turned out I had biliary sludge around the area of the gallbladder and they had sent a surgeon over to see me and he asked me a bunch of questions and felt my stomach and he said that my gallbladder did not have to come out. They treated me for the nausea once again and they got it under control, and I was released with Protonix delayed release and they sent the Protonix to the CVS as well as more Zofran. Since then I have spoken with my gastroenterology doctor over the phone and she called in much more Zofran than the ER gave me and I'm still taking that as I need it and I had an endoscopy and colonoscopy done and I was supposed to get results today but I have to wait until Monday. They found a couple of polyps. The endoscopy and colonoscopy were done on 10/01/2021. Sometimes I am fine and sometimes I am not but this is still ongoing. Mainly nausea and congestion.
fever 7 days after vaccine administered.  The fever lasted 2 days, going as high as 104.  Patient developed a rash over most of her body.  She won,t eat or drink much.  Patient has episodes of uncontrolable screaming.  She is very uncomfortable and irritable.  She hasn't slept mor than 4 hours at a time for the past 4 days. Patient had been sleeping through the night since she was an infant.  When she wakes up she is very disoriented and seems to be dilarious or halusinating.  She points at things and asks for them when there is nothing there.
Dizziness Severe headache Nausea Fatigue Persistent insomnia  Symptoms started within minutes of vaccine administering and only deteriorated in subsequent days with no improvement to date (17 days)
Generalized pain with movement. Body aches, chills, hives - everywhere except face but mostly on arms and feet, itching.
patient did not come for their second dose; Case reference number US-BN-2021-000027 is a spontaneous case report initially received from nurse practitioner on 21-JAN-2021, and concerns a male patient.  The patient's medical history was not provided.  The patient's concomitant medication details were not provided  In middle of Dec of an unknown year (second week of December as reported), the patient started therapy with RabaVert  (Inactivated Rabies Virus Vaccine, Batch no.ARBA731B) at unknown dose for pre-exposure prophylaxis. After receiving the first dose, the patient did not come for their second dose and it has been a month and a half. (missed dose)  At the time of this report it was not known whether the patient developed any adverse event.  No further information was provided.; Reporter's Comments: Product dose omission issue is listed by convention. Reportedly, the patient did not come for the second dose of RabaVert, which is considered as product dose omission. Reported event is not related to RabaVert , but to human action.; Sender's Comments: Product dose omission issue is listed by convention. Reportedly, the patient did not come for the second dose of RabaVert, which is considered as product dose omission. Reported event is not related to RabaVert , but to human action.
Unclear if patient loss consciousness. Directly following vaccination, patient was speaking to her mother and setting timer on her phone when she fell back on exam table. I heard patients head hit the wall next to her as she fell back. Mother by her side at time and she did respond to mother speaking at this time. Vitals: SpO2 97%, B/P 97/60, HR 63   Patient alert and speaking at this time. States she "feels okay", color good, vitals remain stable.  Mother reports that following HPV vaccine the patient did feel dizzy but did not pass out. Patient remained for 30 min observation while examined by a RN.
A non-serious report of expired FluMist administered was received from a nurse concerning a six-year-old female patient. No medical or drug history was reported. The patient received a booster dose of FluMist on 01-Jan-2008. The patient received her first dose of FluMist on 28-Nov-2007 without any reports of adverse events. The product had an expiration date of 27-Dec-2007. The patient was administered expired FluMist. At the time of the report, no adverse events were reported from this error. Information is being sought for the follow-up with the reporter regarding the outcome of this patient. The reporter did not provided a causality assessment. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Heaviness on both legs after dose 1. Heaviness on both legs persisted after dose 2 Difficulty walking and lower body and upper body tremor and spasm Increased Migraine Hips, waist, lower back pain-Difficulty setting for long period of time Development right leg paralysis and foot drop Extreme leg weakness, unable to stand, drive: Loss of motor function on both legs Confirmed CIDP-Chronic Inflammatory demyelinating Polyneuropathy diagnosis  Current treatment: Gamunex-C loading (5days) and Maintanance dose(1 dose every 3weeks) Physical therapy
This spontaneous report as received from a nurse refers to a 14-month-old male patient of unknown age. The patient's medical history, concurrent conditions, and concomitant drugs were not provided. On 20-JUL-2018, the patient was vaccinated with the first dose of M-M-R II 0.5 mL (lot# and expiration date were not reported), subcutaneously, for prophylaxis. Other suspect therapies included sterile diluent (lot# and expiration date were unknown by the reporter). On approximately 31-JUL-2018 (reported as: 11 days after vaccination), the patient developed a full body rash. Subsequently, he went to the emergency room and the physician (unspecified) stated that the patient had a viral rash. He was not admitted to the hospital. The patient was given treatment for the event (details unspecified). It was reported that the rash lasted for 6 days (however, the patient's current status was unknown by the reporter). Lab diagnostics were not performed. The reporter did not provide the causality assessment between M-M-R II, sterile diluent, and the full body viral rash.
got pretty sick/sickest I've ever been in my life; couldn't get out of bed to take my temperature; high fever of 101.5; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got pretty sick/sickest I've ever been in my life), MOBILITY DECREASED (couldn't get out of bed to take my temperature) and PYREXIA (high fever of 101.5) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (got pretty sick/sickest I've ever been in my life), MOBILITY DECREASED (couldn't get out of bed to take my temperature) and PYREXIA (high fever of 101.5). At the time of the report, ILLNESS (got pretty sick/sickest I've ever been in my life), MOBILITY DECREASED (couldn't get out of bed to take my temperature) and PYREXIA (high fever of 101.5) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  No concomitant medications reported. No treatment medications reported.   This case was linked to MOD-2021-397033 (Patient Link).
Normal pregnancy, due date was June 1, 2019. Shortly after  being vaccinated I experienced premature rupture of membranes resulting in the pre-mature deliver of my child. My water broke on 4/19/2019. My child was born weighing only 4lbs 4oz even though he was originally thought to be 34 weeks gestation. After an evaluation they realized he?d stopped growing around the time of my injection.
pt recv vax & 1 day later exp a patchy pruritic red rash on trunk, & muscle & joint aching;sx resolved w/o tx p/5 days;pt recv 2nd dose of vax 25OCT96 w/o event;