chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She started acting fussy, sleep was disturbed june 3-5. She seemed fine until June 10th she had personality changes including lack of smiling. June 11th started involuntary head Bob in cluster of 5, June 12th another episode cluster of 7, June 13th another  episode cluster of 7-9. Went to hospitals after talking to Pediatrician. She was admitted and an eeg confirmed infantile spasms. She was advancing early with mile stones, healthy, the only change was vaccines.
Rash showed up on the patient's back 5 days after 2nd dose (April 30th).   Waited 5 days and it continued to spread so went to Urgent care.  Visual inspection is assumed to be Herpes Zoster (Shingles).  A swab was taken to be tested.  Submitted prescription for valacyclovir 1000mg 3 times a day for 7 days.
First does given 2/5/2021 no reactions except sore arm next day Second dose given 3/5/2021 Headache next day and on 3/7/2021 now have swollen knot on left side of neck, area around somewhat swollen as well.
chills, fever, fluttering heart, faintness, dipping BP, ill for 5 days
LOCALIZED SWELLING, REDNESS ON LEFT THIGH AND NON-STOP CRYING AND FUSSINESS. THIS OCCURED TO ANOTHER PATIENT SEEN THE SAME DAY. NEW LOT OF VACCINE GIVEN TO BOTH.
Estimated Due Date: 4/29/2021 Unknown pregnancy history   Patient states she started feeling nauseous and vomiting around 4am the day after vaccination. States she felt "dehydrated" and went to the ER (Hospital in town). No blood work performed in the ER per patient. Patient states she was given "anti-nausea" medication and IV fluids.  Diagnosed with dehydration, per patient. She started feeling better after treatment and was sent home. Patient states her vitals were normal in the ER. Patient followed up with her OB after her ER visit, and was encouraged to get her second Moderna vaccination. No history of allergies.
Nothing right away other than some tenderness at the injection site. Later that evening (about 11-12 hours later) I became very tired. Was able to sleep until about 3:00 a.m., at which point I woke up to changing temperatures from hot to cold, headache and muscle aches. Most of the aching is occurring in my legs and arms. The back of my thighs are the worst, then my valga, and lastly my biceps and triceps. The headache is mild.
Myalgia, Fever, Throat swelling Narrative:  Was seen in local urgent care clinic for throat swelling and given Decadron injection. Then later followed up the ENT and PCP. As of 1/19/21 symptoms resolved.
Came in today 09/18/20 and said his arm is still tingly and sore. Shot given 09/02
Day following: fatigue, body ache, headache Day 6-7: Severe swelling and redness at injection site, injection site very itchy
My shoulders and chest and neck started seizing up and causing great pain. Then I had a lot of trouble breathing. I am an avid hiker and I couldn?t hike because I couldn?t catch my breath. Also this happened after each vaccination shot. I also experienced extreme fatigue, Dizziness. And high blood pressure.
14th of jan i had a pain around my jaw got up the next day i started having water eyes, the right side of face started to droop. went to ER and was diagnosed with Belspaulsy. after that did a follow up appointment with neurology
The patient received three vaccinations on this date - FLUAD, BOOSTRIX and PREVNAR. We discussed and decided to inject all vaccines into the left arm, but we did notate where on the arm we injected each vaccine. The PREVNAR was L back, BOOSTRIX was L high and FLUAD was L front. The injections were completed on 9/29 and the patient came to the pharmacy today 10/06/17 to inquire about her reaction and which vaccine was placed where so she could have an idea which one caused the reaction. Her left arm had a raised red area, that was warm to touch. She said the area of redness had decreased. I advised her to seek medical attention if the redness did not decrease or appeared to get worse.
Intussusception diagnosed on 5/10 (15 days following the rota virus vaccine)
right arm  hurting continuously/can't lay down on his arm; right arm hurts where the shot went in/hurts down in his arm/right arm is hurting continuously; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (right arm  hurting continuously/can't lay down on his arm) and VACCINATION SITE PAIN (right arm hurts where the shot went in/hurts down in his arm/right arm is hurting continuously) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012620A) for COVID-19 vaccination.     Concomitant products included INFLUENZA VACCINE (FLU) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Nov-2021, the patient experienced VACCINATION SITE DISCOMFORT (right arm  hurting continuously/can't lay down on his arm) and VACCINATION SITE PAIN (right arm hurts where the shot went in/hurts down in his arm/right arm is hurting continuously). At the time of the report, VACCINATION SITE DISCOMFORT (right arm  hurting continuously/can't lay down on his arm) and VACCINATION SITE PAIN (right arm hurts where the shot went in/hurts down in his arm/right arm is hurting continuously) had not resolved.            Patient had no known drug or food allergies. No Treatment information was reported. No medical history was provided by the reporter. Patient had a flu shot on the same day of booster in the left arm, whereas booster shot was into the right arm. Reporter stated that his right arm was not hurting until 3 days after receiving the booster dose. The patient stated that his right arm was hurting where the Moderna shot went in his arm. He stated it hurts down in his arm and he was not able to lay down on his arm due to the arm pain. The patient mentioned his right arm was hurting continuously. Patient had done some work overhead reaching his right arm up in the air and he wonders if this was also a cause of his hurting arm.
Red ,swollen, hot, itchy lump at injection site within 30 minutes of injection (very similar to a wasp sting).  Arm continued to swell over next several days, ultimately occupying most of arm between shoulder and elbow.   Began to subside 10 days after injection after treating with ice packs, diphenhydramine (oral and topical), and cortizone cream
Initial report received from a health care professional on 09 November 2011. An 84-year-old male patient received an intramuscular right deltoid injection of FLUZONE, sanofi pasteur Inc. lot number UH477AB, on 27 October 2011. The patient had no known allergies, no illness at the time of vaccination, no other vaccines within 4 weeks of the FLUZONE and denied any adverse events following prior vaccinations. The patient's medical history included increased blood pressure, atrial fibrillation, osteoarthritis and hyperlipidemia. The patient's concomitant medications included albuterol, nitro as needed (prn) COUMADIN, ALDACTONE, K-DUR, ZOCOR, XANAX, SENOKOT and COLACE. On 27 October 2011 hours after the vaccination in the afternoon, the patient complained of feeling very weak and needed help in ambulating, became incontinent, had wheezing and was short of breath. The symptoms lasted a day or so and then completely resolved. The outcome was reported as recovered a day or so later. Documents held by sender: None.
This spontaneous report was received from a medical assistant and refers to a unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided.   On an unknown date, the patients were vaccinated with an improperly stored doses of PNEUMOVAX23 for prophylaxis (dose, route of administration, anatomical location, lot# and expiration date were not reported). Administered doses of PNEUMOVAX23 experienced an unknown temperature (out of range temperatures) for an unknown time, on an unknown date. There were multiple previous temperature excursions (dates, time and of the excursions were not reported). It was unknown if the digital data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA012038: US-009507513-1701USA009285: US-009507513-1701USA012035: US-009507513-1701USA012036:
Fever up to 105 deg, rash on left leg advised Motrin for fever, lukewarm baths for fever and Benadryl for rash. Symptoms started 10/15/06.
Pt was in observation area, went to operations table and told them she felt faint. Pt then passed out onto carpet. Onsite EMTs and charge nurse were called. Pt revived after 15-20 sec, was able to respond to questions. Pulse was taken - 62 bpm. Pt stated she had a history of passing out when receiving a needlestick but it had not happened in past two years. Pt was assisted to w/c and taken to observation area outside ballroom. VS were taken and were WNL (BP 120/70, HR 61, SpO2 99% RA, RR 16). Pt asked for water, stated she was feeling better. EMTs advised pt she could be transported to ED for further eval - pt refused. Pt denied any pain or soreness. After 15 min, VS were taken again, and again were WNL (BP 106/76, RR 16, HR 75 bpm, SpO2 99% RA). Pt left shortly after 2nd VS eval, stated she "felt fine," was advised to seek emergent help if sx resume, esp to pull over and call emergency number if she felt dizzy again while driving home. Pt stated understanding.
This case was reported by a healthcare professional and described the occurrence of muscle weakness right-sided in a 55-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). On 7 August 2009 the subject received 1st dose of Twinrix (1ml, unknown, right arm). On 7 August 2009, less than one day after vaccination with Twinrix, the subject experienced muscle weakness right-sided and radiating tingling down right arm to fingers. The subject's symptoms were only on the right side. At the time of reporting, the outcome of the radiating tingling down the arm to fingers was worse. The outcome of muscle was unknown. The healthcare professional considered the events were possibly related to vaccination with Twinrix. The healthcare professional called the CDC and was referred to GSK.
Low grade fever, headache, fatigue started in the evening on 8/24/16. Left arm red, swollen, headache, fatigue continued on 8/25/16. Headache, fatigue, left arm redness continued on 8/26/16.
Nausea, fever hours after vaccine was administered, continued until the next day but had decreased in intensity.
Swelling of hands and lower legs after first 2 vaccines prior to diagnosis of iga nephropathy. Admitted 2 weeks later for low sodium. After 7 mos course of prednisone putting iga into remission received 3rd vaccine and developed edema again. Placed on lasix 20 mg 1-2 x daily and was decreasing that when on 25th day developed 2 grand mal seizures within 18 hours of each other and low sodium of 123. Sodium was stable and in 130?s months prior to vaccine.
redness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No medical history information was reported.  Concurrent medical conditions included Blood pressure and Thyroid disorder.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced ERYTHEMA (redness). At the time of the report, ERYTHEMA (redness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were blood pressure meds and thyroid meds.  No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: event outcome updated and further consent denied
my face began to swell; my BP went to 198/120 plus 110/196/110 plus still at 110; I was unable to breath and chocking on my own fluids in my lungs; My lungs were chocking me; This is a spontaneous report from a contactable consumer (patient). A 41-years-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route of administration, administered in left arm on 30Jul2021 at 14:15 (Batch/Lot Number: FA7485) as a single dose for covid-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD), chronic myeloid leukaemia (CML) in remission and heart condition. Concomitant medications included topiramate, metoprolol and lisinopril; all taken for an unspecified indication from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient had not been tested for COVID-19. About thirty minutes after the injection at 16:00, the patient face began to swell, and her BP went to 198/120 plus 110. Then 2 hours later she was rushed to hospital and was unable to breath and chocking on her own fluids in her lungs. She arrived at hospital unable to breathe nor catch her breath. Her lungs were chocking her, and her BP was 196/110 plus still at 110. After entering emergency room (ER) they had no clue what to do and treated her as a covid patient. She needed a nebulizer and was told the ER doctor couldn't give it to her there and no beds were available. The doctor gave her pills without explaining and then kept treating her like she came in for covid. She had the worst reaction of her life and was treated horribly. The doctor did not give her discharge paperwork, nor did hospital follow up. It was not until she went yesterday to her GP and he even said the notes were missing information, also the doctor supposedly sent me with prescriptions which she never got. She encountered, all side effects of the shot. The adverse events resulted in emergency room/department or urgent care. The outcome of the events was recovered with sequel.  No follow up attempts are possible. No further information is expected.; Sender's Comments: Based on plausible dose-event temporal relationship likely hypersensitivity post-vaccination  the causal role of  bnt162b2 vaccine cannot be excluded for reported events. Underlying CMLL and chronic onstructive pulmonary disease are significant risk factors.  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
AGE-type symptoms beginning about 5 PM yesterday: chills, myalgias, dizzy, diarrhea, nausea. Symptoms continue today.
About 5 to 10 minutes after the shot I felt extremely lightheaded and then fainted.  When I came to about 10 seconds later, there was a public health official there rubbing my chest asking me if I knew where I was.  It took me a second to fully come to my senses but then I realized where I was and what had happened.  I was very pale, felt chills, was sweating, and it took effort to open my hands.  The EMTs ran a bunch of tests, my Blood pressure was low (I think the number I remember was 104/33), but the rest of the measurements like blood sugar or the number of ekg like tests they did all came back normal.  The EMTs in the field said they think it was a response to the vaccine.  After about 20 minutes of the EMTs monitoring me, my numbers came back up and I was feeling relatively normal.  I waited another 30 minutes before leaving just to make sure.  It has been almost a week and I haven't felt any symptoms close to that since then.
Shortly after receiving vaccine, patient began to experience shortness of breath and throat itching/tightness.
Pt noticed a "bump" and redness around site in shape of a rectangle also painful "size of a box of cigarettes" pt will put hot compresses on.
Patient presented to the ED for hypertensive emergency and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. On 6/6/2021 patient presented to the ED and was subsequently hospitalized for Acute arterial ischemic stroke, multifocal, multiple vascular territories.
Couldn't move; No appetite; Diarrhea; Shakes; Sweats; Fatigue; Headache; Threw up 4 times; Stomach was queezy; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Couldn't move), DECREASED APPETITE (No appetite), DIARRHOEA (Diarrhea), TREMOR (Shakes) and HYPERHIDROSIS (Sweats) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced MOBILITY DECREASED (Couldn't move), DECREASED APPETITE (No appetite), DIARRHOEA (Diarrhea), TREMOR (Shakes), HYPERHIDROSIS (Sweats), FATIGUE (Fatigue), HEADACHE (Headache), VOMITING (Threw up 4 times) and NAUSEA (Stomach was queezy). At the time of the report, MOBILITY DECREASED (Couldn't move), DECREASED APPETITE (No appetite), DIARRHOEA (Diarrhea), TREMOR (Shakes), HYPERHIDROSIS (Sweats), FATIGUE (Fatigue), HEADACHE (Headache), VOMITING (Threw up 4 times) and NAUSEA (Stomach was queezy) outcome was unknown.            This case was linked to US-MODERNATX, INC.-MOD-2021-092695 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-092695:Dose 1
03/26/2003: Telephone call from school nurse-Advised patients condition and reaction. On 03/21/2003: Patient received Hep B injection in school setting.  States after a few minutes "felt hot, lip began swelling".  Later went to visit relative for weekend when returned on 03/23/2003.  Lip very swollen, had sore on lip "like a cold sore", fever 102, complained of fatigue, advised mom to take child to doctor.
approx 4yrs p/vax pt devel chickenpox. @ time of rpt had no more than 30 lesions which were not classic either, it was hard to tell & MD tested for it
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: pt was lightheaded, felt warm, and had chills after vaccine w/in 15 min.-Mild, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Pt experienced sympotoms within the 15 min observation period.  Was monitored and vitals checked.  Pt was placed in a supine position with feet elevated until symptoms passed.
PT HERE FOR 2ND DOSE OF PFIZER. RN NOTICED PT RECD FIRST DOSE TO LEFT TRICEPT RATHER DELTOID, RESULTING A BRUISED. NO OTHER SYMPTOMS REPORTED FROM PT.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered to patients 18 hours after first vial puncture) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) 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, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered to patients 18 hours after first vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered to patients 18 hours after first vial puncture) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported by the reporter. No treatment information was reported by the reporter.
One episode of hematochezia 3 days after receiving 4 month-old immunizations, including 2nd Rotateq. 2nd Pediarix, 2nd Prevnar, and 2nd Hib vaccine. Stool culture and parasites negative. No recurrence of GI bleeding. Stool guaiac neg on exam
Patient had general malaise unknown cause. Onsite EMS was called vitals BP 224/100 99%O2  HR 93 Patient treated, transported by the EMS to the hospital.
Enlarged prostate; Difficult urination; lack of semen; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the arm right on 18Mar2021 at 09:30 (at the age of 47-year-old) as a dose 1, single for COVID-19 immunisation. The patient's medical history included penicillin allergy. The patient's concomitant medication included omeprazole (OMEPRAZOL). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, the patient experienced enlarged prostate, urination difficulty and lack of semen (semen volume low). No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events enlarged prostate, urination difficulty and lack of semen (semen volume low) were not recovered at the time of the report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained  Amendment: This follow-up report is being submitted to amend previously reported information: "The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care" Deleted from narrative since it not provided in source document.
I felt really funny after the vaccine. I picked up my girls and we went to eat. They told me I was very quiet. When we were going home they told me I was swerving, all over the road and they told me to stop, they would drive, I said no, i don't trust anyone with my car. We got home, I remember changing into my nightgown and was texting someone and I suddenly I stopped. After that I was unresponsive. I would not answer anyone, they said I looked pale and stared into the air. They called my children and they came and emergency personnel was called. I was taken to a hospital and they transferred me to another hospital. I stayed there for 3-4 days. After going home it took me some days to be able to walk without assistance. I wanted to say I had covid in May (1st time) and September (2nd time) . I still do not have taste or smell back from the covid. I can only eat 3 or 4 bites and then I am done.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Aug2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation. The patient's relevant medical history included: "VCD (Vocal Cord Dysfunction)" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Drug Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Nov2022) Positive; (04Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.