chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever 103.8 later on day of vaccine. About 48 hr after shot developed cyanotic apneic episode. Seen at ED then transferred for obs at another hospital. 2 subsequent episodes. Hospitalized x5d. Negative EEG, MRI. No further spells. 11/18/2009 MR for 8/16-8/18/2009, patient with c/o's fever, vomiting, diarrhea, loss of consciousness, unresponsive.  DC DX ALTE
Initial report received via search of the literature on 16 April 2013. This case contains information for 1 of 22 patients whose clinical data were provided. Information regarding the other 21 patients is captured in case numbers: 2013-05188, 2013-005251, 2013-005252, 2013-005254 to 2013-005263, 2013-05268, 2013-05269, 2011-03827, 2006-03086, 1995-00668, 2006-03230, 1995-00224 and 2003-02926. From the published article, the authors reviewed charts of patients who had been hospitalized with Guillain-Barre Syndrome (GBS) from 1995 through 2006. Using a case-centered design, they compared the odds of vaccination in the 6 and 10 weeks prior to onset of GBS to the odds of vaccination during the same time intervals in all vaccinated individuals in the entire hospital population. While cases of GBS had been reported following a wide range of vaccines, a clear association had only been established with the 1976 H1N1 inactivated influenza vaccine. The authors confirmed 415 cases of which only 25 had received any vaccine in the six weeks prior to GBS onset. Vaccines received included TIV, 23-valent polysaccharide pneumococcal vaccine, tetanus-diphtheria combination vaccines, Hepatitis A and Hepatitis B. The large retrospective study did not find any association between influenza vaccine or any other vaccine and the development of GBS within 6 weeks following vaccination. According to the authors, the risk of GBS following any vaccine, including influenza vaccines, was extremely low. Regarding this case which involved a 81-year-old male patient had received I-TYPHOID VACCINE, manufacturer unknown, and HEPATITIS A vaccine, other manufacturer, (lot numbers, routes, sites and dates of administration not reported); and nine days later reported the onset of GBS. No further information was provided. Outcomes were not reported. Documents held by sender: none.
Extra dose administered; first dose on 5/30/2017 / second dose on 5/20/2020 / third dose /(6/9/2021); This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA396A, expiry date 31st August 2021) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (received 1st dose of Menveo on 30th May 2017). Concomitant products included Hepatitis A vaccine and GARDASIL.   On 9th June 2021, the patient received the 3rd dose of Menveo. On 20th May 2020, the patient received the 2nd dose of Menveo. On 20th May 2020, not applicable after receiving Menveo and Hepatitis A vaccine and unknown after receiving Menveo, the patient experienced extra dose administered. On 9th June 2021, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and extra dose administered were unknown.  Additional details were provided as follows: The reporter was a physician assistant. The patient received 2nd and 3rd dose of Menveo, which led to extra dose administered and also received Gardasil and Hepatitis A vaccine along with 3rd dose of Menveo. The reporter consented to follow up. The reported batch number AMBA396A was not found in sales data sheet, hence was updated to AMVA396A.
This spontaneous report was received from a 62 year old female nurse with asthma and allergy to sulphonamides (reported as sulpha), referring to herself. On 21-NOV-2013, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU (dose, route and lot not provided). Concomitant therapy included CRESTOR. Ten days after vaccination, approximately on 01-DEC-2013, the patient developed severe pain on her scalp area, with redness, and a feeling of burning. The patient went to her dermatologist who prescribed her FAMVIR, which the patient took for 7 days. The pain returned after stopping FAMVIR; the patient saw another dermatologist and was put on clobetasol propionate on 18-DEC-2013. At the time of the report, the outcome of the adverse events was unknown. No lab diagnostics studies were performed. The causality was not provided. Additional information has been requested.
Redness at site and rash. Went to ED. Patient was diagnosed with cellulitis but per MD d/t break in skin and not from vaccine. Started on cephalexin.
This is a spontaneous report from contactable nurse. This nurse reported for five patients with the same lot number of PREVNAR 13 given on the same date. This is the 5th of 5 reports. A 83-year-old female patient of an unspecified ethnicity received PREVNAR 13 (lot # L62074, exp. date Nov2016) intramuscular at 0.5 ml, single in left deltoid on 09Jun2015. The patient did not receive other vaccines. The patient medical history was not reported. The reporter did not know of any illness at time of vaccination. The patient's concomitant medications were not reported. The reporter did not believe the patient was given any other vaccines within four weeks of this vaccination. On an unspecified date, the patient experienced cellulitis and redness. The patient called the office and returned for an office visit to see the doctor for the occurred events 4 days after the vaccination. The patient was not hospitalized for the event. The patient received KEFLEX for the events. The outcome of the events was unknown.
First dose received in January 2020, and she has not received her 2nd dose of Gardasil 9 yet; No adverse event; Information has been received from a female patient of unknown age, reporting on herself. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On an unspecified date, in January 2020, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), dose 1, (dosage information, lot #, expiration date, route, and anatomical location were not provided) for prophylaxis.  It was reported, that at the time of the report, the patient had not received her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) yet (Inappropriate schedule of product administration). No adverse event was reported.; Sender's Comments:  US-009507513-2202USA005968:
Patient returned saying he "felt funny." Had blurred vision and problems focusing eyes. Had headache and couldn't catch breath. No swelling of throat/tongue. Called 911. They did pulse ox (>99) and gave O2. Then transported patient.
Bells Palsy; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jan2021 16:00 (Lot number: EL0142) 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, intramuscular in the left arm, Batch/Lot number: EJ1685, administration time: 16:00), administration date: 26Dec2020, for COVID-19 Immunization. The following information was reported: BELL'S PALSY (medically significant) with onset Mar2021, outcome "unknown", described as "Bell's Palsy".; Sender's Comments: Based on the available reported information, the causal association between the event Bell's palsy, and the suspect drug BNT162B2 cannot be excluded considering drug-event temporal association. 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.
patient received  1.0 ml  of Fluzone Quadrivalenton, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA297927, 2019SA317307, 2019SA317358, 2019SA317359, 2019SA317360, 2019SA317361, 2019SA317362, 2019SA317363, 2019SA317364, 2019SA317365, 2019SA317366, 2019SA317367, 2019SA317368, 2019SA317369, 2019SA317370, 2019SA317372, 2019SA317373, 2019SA317374, 2019SA317375, 2019SA317376 (same reporter).  This case involves a 64 years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as left) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   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.
pt recvd vax on 18oct94;had no pain w/ inject but that noc, began having aching pain in axillary area;pain cont x 2wks;pain now goes from shoulder to just above Lt elbow;c/o hurting when lift an object or if raises arm above head;
Half an hour after administration, felt numbness in the mouth and difficulty swallowing and rash. Treatment-Benadryl, steroids (oral)
Approximately 24 hours after my 2nd dose I awoke with severe joint pain in my left pointer finger.  This issue has now become persistent and is worse when my I am outside and my hand is cold.
In November my right leg swelled to about 3 times the size of my left.  I went into the doctor after about the 3rd day and had blood work done along with an ultrasound.  They did not find a DVT and blood work came back fine leg eventually went to normal.  Around the same time I started getting discoloration in my feet and ankles.  I started wearing compression socks and elevating my feet at night to help with circulation now a day after my 33rd birthday I noticed the discoloration has spread up my legs and looks a purplish color with light tan around it.  I stopped eating salt when this first. began as well as switched to only drinking water and green tea.  I am a contractor so I do strenuous work also go to the gym 3-5 times a week to maintain as healthy of a lifestyle as possible. I don't understand why I am still having issues.
Got 1st shot of Pfizer at unknown location on 4/29/2021. Received a Jansen shot on 7/06/2021
Missed period/ delayed menstrual cycle for 3 months. one long 20 day period/ menstruation.  Also development on new nosebleeds.
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Headache-Medium, Systemic: Hypertension-Medium, Systemic: Hyperventilation-Medium
Patient tested positive for covid-19 after first dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient tested positive for covid-19 after first dose of the vaccine) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced COVID-19 (Patient tested positive for covid-19 after first dose of the vaccine). At the time of the report, COVID-19 (Patient tested positive for covid-19 after first dose of the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient got contact with people with COVID-19 after the vaccination.  No relevant concomitant medications were reported. No treatment information was reported.; Sender's Comments: Based on the natural history of COVID-19, and the established information about the mRNA-1273 vaccine, a causal association between the event and the product use is assessed as unlikely.
Received vaccine and having a reaction to it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Received vaccine and having a reaction to it) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Received vaccine and having a reaction to it). At the time of the report, VACCINATION SITE REACTION (Received vaccine and having a reaction to it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment or concomitant medications were reported. No treatment information was reported.
Pt was administered the flu shot at a flu clinic and experienced syncope and vomiting blood within 5 minutes.
Redness to right arm, warm to touch, mild swelling, denies pain. Received treatment, antibiotic for 5 days. Arm is better.
Discharge Provider: MD Primary Care Provider at Discharge: MD  Admission Date: 5/5/2023 Discharge Date: 5/7/2023  PRESENTING PROBLEM: Weakness [R53.1] Generalized weakness [R53.1] Laceration of scalp without foreign body, initial encounter [S01.01XA] Fall from standing, initial encounter [W19.XXXA] COVID-19 virus infection [U07.1]   HOSPITAL COURSE: Patient is a 87 y.o. male who presented to the emergency department with complaints of weakness.  Patient has a past medical history including hypertension, coronary artery disease, stage 3 chronic kidney disease, anemia of chronic disease, glaucoma, and OSA. Patient states that for the past week, he has had increasing weakness, cough, as sustained a fall.  He states that he is too weak to care for himself independently or navigate stairs at home without difficulty.  He presented to the emergency department for evaluation.  In the emergency department, patient was hypertensive and tachypneic, however, other vital signs were stable.  He did not require supplemental oxygen.  Complete blood count revealed anemia, which is chronic for this patient.  CMP was unremarkable.  Troponin was stable at 17. COVID-19 was positive.  EKG showed normal sinus rhythm with a right bundle-branch block.  CT of the head showed no acute intracranial abnormality.  Chest x-ray shows no acute cardiopulmonary disease.  Suspect generalized weakness secondary to COVID-19.  Patient has been admitted for further evaluation and management of generalized weakness secondary to COVID-19.   The patient improved overnight. He did have a 20 second episode around 6 am on 5/6 that was seizure like. MRI with and without contrast was negative for any acute findings. Neurology reviewed and felt low suspicion for seizure. He was referred to the neurology clinic for outpatient 2 hour EEG and review. PT and OT evaluated the patient and did not feel he needed home services, though there was continued concern because of the amount of stairs in the home. He was unable to try stairs in the hospital due to isolation precautions, so HHC PT will follow up outpatient to monitor and help with progress in the home.    He was discharged home in stable condition on prior medications with HHC PT and RN. He is recommended to follow up with PCP for suture removal from left scalp laceration, and has been referred to neurology for follow up appointment and EEG.   Active Issues Requiring Follow-up Issue: Sutures left scalp laceration Recommended follow-up provider/specialty: PCP What is needed: suture removal and evaluation of healing.
Numb face for ~2 hours.  Heart fluttering.  Right calf pain.
Within 5 minutes I had blurred vision, foggy brain and dizziness.  This lasted about an hour, and after that I was fine.  It seemed to come on fast, and then leave just as fast.
Patient reported to ED with complaints of tightness in throat, hoarse voice and difficulty swallowing.  No rash or urticaria.  NO wheezing on exam Given Epinephrine 0.3 mg IM with prompt resolution of symptoms subjectively and objectively noted clearing of voice changes Also given IV Solumedrol, Pepcid and Benadryl
Red sores/ bumps on torso and upper arms began to appear a few days after shot, and have multiplied since then.
After about 12 hours of 2nd dose vaccination (Thursday) , I stared feeling chills, sever headache and then high fever up to 101, whole body burning feeling and body ache, upset stomach. Took Tylenol (500 mg) which helped to get fever down. Could not sleep whole night and diarrhea started -(three times). Next day (Friday), headache, body ache, diarrhea (four times) was still there, but no more fever, I was feeling very week . Third day (Saturday), I still have headache, body ache, upset stomach, sore (dry)  throat, weakness, dull tongue, dizzy and nausea.  ,
This spontaneous report as received from a physician via company representative, refers to a 84 year old female patient. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, lot# and route of administered was not reported) and PREVNAR. On an unknown date the patient experienced "local reaction which was not specified" and swelling in her feet. The patient did not seek medical attention. On an unknown date the patient passed away. Relatedness between therapy and adverse event was not reported. Additional information is not expected, physician refused to contact to him.
Arm so painful it was immobilized.  Rash spreading into armpit like fingers; General feeling of unwell, very tired, nausea, chills, sweats, 104 degree fever.
Headache for several days. Feeling of malaise/depression.  The headache started Monday and response to ibuprofen but comes back every morning shortly after waking up. Have not had any recent issues with depression but began to feel depressed Monday and increasingly so throughout the week.
Caller's neighbor was so sick; Could barely walk; Has not received second dose of the Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 81 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Lot number: Unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart Condition" (unspecified if ongoing), notes: Kind of has a heart condition (Thinks this began about 12 years, ago. Caller's neighbour had a heart attack and a stent put in.; "Covid-19", start date: Oct2020 (unspecified if ongoing), notes: Tested positive and was sick with Covid before her first dose of Pfizer Covid Vaccine. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "Caller's neighbor was so sick"; GAIT INABILITY (non-serious) with onset 2021, outcome "unknown", described as "Could barely walk"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious) with onset 2021, outcome "unknown", described as "Has not received second dose of the Vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient was hospitalized for 6 weeks and was not sure was going to make it. Caller clarifies this hospitalization took place prior to the first dose Pfizer Covid Vaccination.  This hospitalization was in Oct2020 or middle of Nov2020.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Arm hurt very little after first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm hurt very little after first shot) in an adult male patient 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 first 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 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 VACCINATION SITE PAIN (Arm hurt very little after first shot). At the time of the report, VACCINATION SITE PAIN (Arm hurt very little after first shot) outcome was unknown.            Concomitant product information was not provided. Treatment information was not provided. It was reported that Moderna shots were a breeze unlike patient rabies shot.
Fatigue, headache, muscle pain, joint pain, chills, nausea, and fever (101) approximately 8 hours after the vaccine and lasting 48 hours.   Dizziness and Weakness 3/17 from 6 am to 3pm Shortness of breath and fast heart rate on 3/17 from 12am-1am, and 3/18 from 11pm - 12pm; resolved with rest.
neuropathy of both legs few hours after shot - it went away after 12 hours few days after the shot I start to have occassional pins and needles in little finger on left arm (the injected arm)
Tingling in the back of my throat; tingling in the back of my throat and tongue; Slight numbness in the effective area; a flushed feeling; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP 6955), via an unspecified route of administration in the left arm on 23Mar2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received unspecified medications for an unknown indication since unknown dates within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Mar2021, approximately 20 minutes after the vaccination, the patient experienced tingling in the back of her throat and tongue, a flushed feeling and slight numbness in the effective area. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events tingling in the back of her throat and tongue, a flushed feeling and slight numbness in the effective area. The clinical outcomes of the events tingling in the back of her throat, tingling tongue, a flushed feeling and slight numbness in the effective area were recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Client reported experiencing pain on the left side of his chest starting 5-6 days after his second dose. Client described pain as 4/10, pulsating, and constant for 20 minute intervals. Client described pain being triggered after eating. Client maintained that pain was resolved after taking over the counter 1200mg omega-3 supplements. Client did not seek medical care after receiving 2nd dose.