chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Phlebitis Narrative: Reports vaccine reaction, recieved Moderna #1 dose on 12/23/20 and #2 dose on 1/20/21. No prior report and employee endorses she has not reported this adverse reaction previously. Employee states saw pmd recently for r le pain and low grade fever of 100 for 5 d, was diagnosed with superficial venous thrombosis in great saphenous vein of r le from knee to ankle, ultrasound rle did not show dvt per her report, no report available.Covid tested Mon 8/23 and was neg. Reports one wk ago fever and redness began to RLE at from r knee to ankle medially . Her PMD recommended to take xarelto, then to measure for compression stocking to wear while doing stationary work and in bed. MD reports noticing her symptoms began in month of march/2021. Denies palpitation chest pain after vaccine. Reports in March of 2021 she experienced drythema in the r foot and having had leg cramps for 3-5 d. duration that resolved without treatment. MD reports sc of redness to dorsum of foot and leg cramps alternating to the left then the right lower extremities intermittently the past 5-6 months, the symptoms would resolve with nsaid. Pain is in bilateral legs, cramping 5/10 Took up hormones up to  2-3 yrs ago. Estrogen for 3 yrs. PMH: Denies h/o DVT, PE or CVA, not HTN, denies PVD, smoking history or trauma to lower extremities Active Outpatient Medications (including Supplies): Xarelto started 8/28/21
Patient received vaccine on 8/29/21 at around 4:45pm.  The next morning around 9am patient had trouble standing/walking, dropped to his knees and felt weak.  An ambulance was called and he was transported to hospital emergency dept.  Sometime after he arrived hives developed over his body.  He did not experience swelling in his face or throat.  He spent approximately 5 hours there.
Fever 103, chills couldn?t get warm, throwing up, headache, skin sensitive to the touch, dehydrated
This spontaneous report as received from a nurse refers to multiple patients of unknown demographics. The reporter stated that the patients received improperly stored RECOMBIVAX HB (lot number/expiry date unknown) on unknown dates (incorrect product storage). No adverse effects reported. The outcome was unknown. Excursion information for the vaccine: High temperature: 30 Minutes at 11.2 degree Celsius. Lowest temperature cumulative: 3 Hours and 17 Minutes at 0.4 degree Celsius. It was confirmed that the vaccines that were incorrectly stored were administered. There were no previous temperature excursions. Data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
COVID+ s/p 2 doses Pfizer - received monoclonal antibodies for treatment
This spontaneous report as received from an officer manager referring to a currently 4 year old female patient. No information was provided regarding the patient's medical history and concurrent conditions. The patient's concomitant medications included sterile diluent (MERCK STERILE DILUENT).  On 14-APR-2018, the patient was vaccinated with an improperly stored dose of VARIVAX (dose and anatomical location and route of administration were not reported)  lot # M046004, expiration date: 18-NOV-2018 indicated for prophylaxis. The vaccine had not had any previous temperature excursions as recorded by a data logger. On an unknown date, VARIVAX had temperature excursions of   -14C to -10C  for a time frame of 7 minutes which was called by a data logger. There were no adverse effects reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1805USA000841: US-009507513-1805USA000922: US-009507513-1805USA000923: US-009507513-1805USA000928: US-009507513-1805USA000925: US-009507513-1805USA000926: US-009507513-1805USA000927: US-009507513-1805USA000921:
Certain foods/drinks/tastes now taste like metal. So far the specific tastes are: hazelnut, peppermint, and Gatorade. There are others that I can?t pin point as the cause of the taste.  I got COVID in February and lost my taste and smell for around a month.
On April 4, 2021, my mother, was diagnosed with a cerebral venous sinus thrombosis (CVST).  I figured I would report this, as I am seeing more and more reports about the vaccines tied to this rare brain blood clot:   "Moderna?s rival mRNA shot has been linked to five CVST cases out of 4 million vaccinated." "More than a dozen countries worldwide temporarily stopped administering the Oxford-AstraZeneca COVID vaccine, notes the Association of American Physicians and Surgeons (AAPS), because of deaths from blood clotting disorders, with either clots or excessive bleeding. Some patients experienced the extremely rare event of clots in the veins that drain blood from the brain (venous sinus thrombosis)."
she gave a 6-year-old child a dose of TYPHIM SQ instead of IM with no reported adverse event; Initial information received on 30-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 years old male child patient who has been given a dose of typhim sq instead of im with no reported adverse event after receiving vaccine typhoid vi polysaccharide vaccine [Typhim Vi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Nov-2022, the patient received suspect typhoid vi polysaccharide vaccine solution for injection (batch number: V1A331M) at a dose of 0.5 ML 1X  via subcutaneous route (expiry date, frequency: unknown)  in unknown administration site for Immunization.  On an unknown date the patient diagnosed with a non-serious event of she gave a 6-year-old child a dose of typhim sq instead of im with no reported adverse event (incorrect route of product administration) (unknown latency) following the administration of typhoid vi polysaccharide vaccine.  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
30 year old female complains of facial skin rash and pruiritis after AVA and Typhoid vaccines. Symptoms: Swelling, Rash, focal, Pruritus.
sore arm; Initial information received on 16-Jan-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves an adult patient of an unknown gender who experienced sore arm (pain in extremity), while the patient received vaccine INFLUENZA VACCINE.  The patient did not have medical history, concomitant disease, or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medication was reported.  On an unknown date, the patient received dose of suspect INFLUENZA VACCINE (strength and formulation unknown) (lot number and expiry date unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date (latency unknown) after the administration of suspect therapy, the patient experienced sore arm (pain in extremity).  No laboratory data was reported.  It was unknown if the patient received a corrective treatment.  At the time of report, the outcome of the event was unknown.  There would be no information regarding batch number for the case.
Information was received from the father of a female patient, age unknown. On unknown dates, the patient was vaccinated with GARDASIL (dosage and route of administration not provided). The patient experienced severe erythema after her first dose of GARDASIL, and less severe erythema after her second dose of GARDASIL. The third dose of GARDASIL has not yet been administered. The outcome of the severe erythema and less severe erythema was not provided. Additional information is not expected.
This spontaneous report as received from a physician via a field representative refers to a pediatric male patient of unknown age. The patient concurrent condition, medical history, drug reactions/allergies and concomitant condition were not reported. On an unknown date in April 2018 the patient was vaccinated with GARDASIL 9 (dose, frequency, lot #, expiry date and route were not reported) for prophylaxis. On an unknown date in April 2018 the patient had an unspecified seizure that included unspecified tremors in the car, on the way home after administration of GARDASIL 9. The physician also reported the patient returned to the office after the seizure on the same unspecified date. The outcome of the event seizure was reported as recovered. The relatedness of the events to seizure to the therapy with GARDASIL 9 was unknown. No product quality complaint was involved. Upon internal review, the event seizure was determined to be medically significant.
This is a spontaneous report received from a contactable consumer or other non-HCP. An 81-year-old male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), for COVID-19 immunisation. The patient experienced  fatigue (feeling tired, and woke up still tired today), onset Mar 25, 2021, with outcome of not recovered; and malaise (feeling unwell), onset Mar 25, 2021, with outcome of unknown. Additional information: Patient cancelled a dental appointment because he felt unwell. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
This child received a 4th DTaP approximately at 9 AM on 04/17/2001. Gave her Motrin requirement because she tended to run a fever after DTaP. Did not continue Motrin on Wednesday. AM 04/18/01. The baby sitter reported an episode of whole body jerking on Wednesday in the AM. They lasted about 2 minutes. The grandmother observed same thing about 5 PM on 04/18/01. Temp was 102.5 at that time. Not checked again after that. Nothing else noted since.
Headache everyday all day  starting 3-7 days after injection. Some days the intensity level is higher than others.
could not move right arm swilling on the whole arm pain in shoulder ,neck, and chest. prednisone for 7 days bendriyle at night and a prednisone shot
Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized on 11/06/2008 for left fem artery reocclusion. Vaccination took place on 1/09/2008. According to the physician, the relationship is 'None'. We would be happy to forward the Study's SAE reporting form upon request. 3/11/09-records received for DSO 9/25-9/26/08-DC DX:Bilateral fem-pop artery in-stent restenosis with disabling claudication. Bilateral lower extremity claudication andovascular intervention.
received first dose of Havrix and the vaccine had expired on September 30th 2022; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 40-year-old female patient who received HAV (Havrix 1440 adult) (batch number 7ya99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th October 2022, the patient received the 1st dose of Havrix 1440 adult and Havrix Pre-Filled Syringe Device. On 7th October 2022, unknown after receiving Havrix 1440 adult and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-Oct-2022 Reporter's comment: The pharmacist reported that the patient received the first dose of Havrix vaccine which had been expired on 30th September 2022.  The consent to follow up was granted.  The vaccine administration facility was the same as primary reporter. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used.
15OCT98 7PM flu sx fever, achy, chills, h/a, rash on cheek subsided 17OCT98 & new sx appeared;c/o chest tightness & feeling like someone was sitting on chest;adm for observation & tests 17OCT98 3PM;
Information regarding PREVNAR was received from a pharmacist regarding a 15-month-old patient who experienced fever of 103.9 degrees.  The patient received the fourth dose on 06-May-2008.  The patient experienced fever of 103.9 degrees on 06-May-2008.  The patient's fever "went down" after patient was given an unspecified antipyretic.  The outcome was resolving and no additional information was available at the time of this report.
Fairly rapid onset after second injection of muscle and joint pain, joint swelling, still present to date.
cold; back pain; swollen throat; runny nose; pounding head; Initial information received on 10-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 64 years old female patient who experienced cold (Nasopharyngitis), back pain (back pain), swollen throat (Pharyngeal swelling), runny nose (Rhinorrhoea) and pounding head (headache), while she received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past vaccination(s) included imovax rabies with The patient receive the full pre-exposure series 30 years ago. The patient's past medical history, medical treatment(s) and family history were not provided.  On 06-Dec-2019, the patient received a single dose of suspect RABIES (HDC) VACCINE lot number not reported via unknown route in unknown administration site. On 09-Dec-2019 she also received a second  dose of the same vaccine  with an unknown batch number via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious cold (nasopharyngitis), back pain, swollen throat (pharyngeal swelling), runny nose (rhinorrhoea) and pounding head (headache) (Unknown latency) following the administration of RABIES (HDC) VACCINE.  Other relevant tests were not reported.  Final diagnosis was pounding head, runny nose, swollen throat, back pain and cold.  It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for cold, as Unknown for back pain, as Unknown for pounding head, as Unknown for swollen throat and as Unknown for runny nose.
very tired, right arm, hand & fingers tingling, dizziness, coughing, trouble breathing, asthmatic cough, chest hurt
pt had been crying during inj appeared to be breath holding;pt took 2 deep breaths p/mom blew gently in face then pt eyes became fixed & body became stiff;MD notified;
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of MMR II (dose and lot # not reported) after the vaccine was exposed to temperatures outside of recommended condition. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
positive for COVID; sore arm; loss appetite; achy body; trouble breathing; fever; chills; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), SARS-COV-2 TEST POSITIVE (positive for COVID), PAIN IN EXTREMITY (sore arm), DECREASED APPETITE (loss appetite) and PAIN (achy body) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN IN EXTREMITY (sore arm), DECREASED APPETITE (loss appetite), PAIN (achy body), DYSPNOEA (trouble breathing), PYREXIA (fever) and CHILLS (chills). On 02-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (positive for COVID). On 11-Feb-2021, INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN IN EXTREMITY (sore arm), DECREASED APPETITE (loss appetite), PAIN (achy body), DYSPNOEA (trouble breathing), PYREXIA (fever) and CHILLS (chills) had resolved. At the time of the report, SARS-COV-2 TEST POSITIVE (positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   relevant concomitant medications were vitamins or herbal supplements Treatment details included, Acetaminophen, Dextromethorphan, Doxylamine, and Pseudoephedrine, naproxen and paracetamol.   This case was linked to MOD21-028110 (E2B Linked Report).; Sender's Comments:  MOD21-028110:Wife case
Vaccine was given on the 13th and on Thursday June 15th the patient had significant swelling in the left deltoid. The patient had limited mobility in the left shoulder/arm until Saturday the 17th.  No redness or warmth during that time frame.  Parent gave Ibuprofen and iced area. Today parent states there is still a quarter size lump in the deltoid, no pain.
severe gas; diarrhea; This is a spontaneous report from a contactable consumer (patient).    A 76-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EL9264), via an unspecified route of administration, in Arm Left on 09Feb2021 as single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient experienced severe gas and diarrhea on 13Feb2021 with outcome of not recovered. The patient reported that severe gas started on 13Feb2021. It would last about an hour and then she would go to the bathroom and have diarrhea. Severe gas and diarrhea have been intermittent, and they continued throughout. The patient received the second dose on 02Mar2021 (Lot EN6205) in left arm and about 4 days later she had the same gas effect. The patient mentioned her stomach swelled and had loud gas which was shocking to her. She continues to state that she was basically a vegetarian that ate well and did not normally have diarrhea issues.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021269680 same patient, different dose/AE
Patient fainted while sitting - proceeding to stand from a pediatric exam table and landed on her head and face on the floor and hit her head on a bench.  She was bleeding from her mouth and her braces perforated her lips and she suffered facial abrasions.  Immediately after landing her upper body was spasming or jerking.  Patient has scarring to her lip and chin.
bilateral cellulitis elbows; rosacea face; throbbing from elbows to wrists with forced exertion; This is a spontaneous report from a non-contactable consumer. A 61-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: EE0151), dose 2 via an unspecified route of administration, administered in arm on an unspecified date (at the age of 61-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included hypertension (HBP), gastrooesophageal reflux disease (GERD), vertigo positional (BPPV) and meniscus injury (torn meniscus R knee) from an unknown date and unknown if ongoing. Historical vaccine included: first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: ER8733) as dose 1, single on 21Mar2021 for COVID-19 immunization. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), hydrochlorothiazide, losartan potassium (LOSARTAN HCT), omeprazole (OMEPRAZOLE), diphenhydramine hydrochloride (BENADRYL) and vit d [vitamin d nos] (VIT D [VITAMIN D NOS]) taken for an unspecified indication, start and stop date were not reported received other medications in two weeks. The patient previously took z-pak, lorabid and sulfonamide (Known allergies- Sulfa, z-pack, Lorabid) experienced drug hypersensitivity. The patient experienced food allergy (Known allergies: tangerines). The patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No COVID prior vaccination. The patient experienced bilateral cellulitis elbows, rosacea face, throbbing from elbows to wrists with forced exertion (i.e. coughing, sneezing, bowel movement, etc.). Adverse event resulted in Doctor or other health care professional office/clinic visit. Treatment received for the adverse events include Antibiotic for cellulitis, skin creams for rosacea. No COVID tested post vaccination. The outcome of the events were recovering.  No follow-up attempts are possible. No further information is expected.
Within hours, an unusually large skin reaction/weal. Approximately 10 days later, developed pulsatile tinnitus, distortions in hearing. Within month, saw ENT specialist, had MRI, confirmed hearing loss in left ear compared to previous hearing studies with same doctor.
Client received Covid19 vaccine first dose from Moderna on 1/18/21.  I inadvertently gave her second dose on 2/15/21 from Pfizer.  Client reported  no adverse reaction and no harm done.
This spontaneous report as received from a registered nurse refers to a currently 12 year old patient (gender was not reported). Information regarding drug reactions or allergies and medical history was not reported. The nurse reported that the patient received the first two doses of RECOMBIVAX HB 5mcg/0.5ml in 2002 and 2003 (exact dates not reported). The third dose of RECOMBIVAX HB 10 mcg/1ml was administered on 10-FEB-2015 (intramuscular, 1ml, anatomical location, lot#, expiration date were not reported). Concomitant therapies were not reported. No adverse effect was reported. Additional information has been requested.
Between Aug90 + Nov90 pt vax w/ hepta B from expired lot. No adverse exp.
Pt recvd 1st dose of Engerix B & exp inc lymphocytes 57 days post vax "not close enough to the time of vax administration to infer that it was a rxn from the vax;
Redness and warmth to admin area. Raised area 4 cm by 4 cm to admin area. Tenderness to area also to (R) axilla pt had been taking ibuprofen for general pain.
Started with a little tickle in my throat; that progressed to some coughing. That caused a sore throat. I had sinus drainage, runny nose, and sneezing. I had basic allergy type symptoms. I did not have a fever. It turned into general hoarseness - it was affecting my voice. Upper respiratory congestion - typical textbook sinusitis symptoms. COVID-19 tests - on the 19th and 20th of October. I just took over the counter - my doctor advised me to take cough medicine - Dalsin cough medicine - day and night; Aspirin and I used Flonase to get the inflammation in my nasal passages down a little. I took Dayquil to get it under control. No antibiotics and nothing from physician. I had televisit with my doctor and this was the protocol they advised. I still have the symptoms today. Every day they are getting a little better. At night-time I get a little hoarser and have a little more coughing. I haven't had to over the counter medicine for four or five days and the symptoms are manageable. I have taken Zyrtec, though lately, because I take that when I change environments due to allergies.