chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pee has change its color, it is like bloodier, darker and reddish; Dizziness; Did not have any appetite; Itchiness in different part of their body at different moments (feet, legs, chest, back); Throat is closing some times, like when one gets the flu; Tired; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHROMATURIA (Pee has change its color, it is like bloodier, darker and reddish), DIZZINESS (Dizziness), DECREASED APPETITE (Did not have any appetite), PRURITUS (Itchiness in different part of their body at different moments (feet, legs, chest, back)) and OROPHARYNGEAL DISCOMFORT (Throat is closing some times, like when one gets the flu) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHROMATURIA (Pee has change its color, it is like bloodier, darker and reddish), DIZZINESS (Dizziness), DECREASED APPETITE (Did not have any appetite), PRURITUS (Itchiness in different part of their body at different moments (feet, legs, chest, back)), OROPHARYNGEAL DISCOMFORT (Throat is closing some times, like when one gets the flu), FATIGUE (Tired) and HEADACHE (Headache). At the time of the report, CHROMATURIA (Pee has change its color, it is like bloodier, darker and reddish), DIZZINESS (Dizziness), DECREASED APPETITE (Did not have any appetite), PRURITUS (Itchiness in different part of their body at different moments (feet, legs, chest, back)), OROPHARYNGEAL DISCOMFORT (Throat is closing some times, like when one gets the flu), FATIGUE (Tired) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication and treatment information were not reported.   This case was linked to MOD-2021-054925 (E2B Linked Report).; Sender's Comments:  MOD-2021-054925:Same reporter; Primary reporter case
Chills; Sneezing; head cold; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), SNEEZING (Sneezing) and NASOPHARYNGITIS (head cold) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included MELOXICAM, ATORVASTATIN, HYDROCHLOROTHIAZIDE, AMLODIPINE and FLUOXETINE for an unknown indication.   On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced SNEEZING (Sneezing) and NASOPHARYNGITIS (head cold). On 04-Mar-2021, the patient experienced CHILLS (Chills). The patient was treated with PARACETAMOL (TYNELOL) for Fever, at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), SNEEZING (Sneezing) and NASOPHARYNGITIS (head cold) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Vaccines were given on 1/17/2018, patient came in on 1/19/2018- Doctors note- 24hrs after started with hives, swollen feet, seems itchy, fever starting yesterday, 2 episodes of vomiting , no respiratory distress no mouth swelling.
Patient reported that her left arm is in pain and can barely left it... she has chills and feels very short winded... also very tired
She reports that 1 week ago today she received her third Covid vaccine.  She reports after this she has had progressive fatigue, shortness of breath and dyspnea on exertion.  States she has difficulty even walking between rooms at home now.  Today felt might want to worsen so called family to take her to her doctor's office, on the way she reports she had a syncopal episode while sitting in the car.  Currently while in the doctor's office sitting she had syncope for a few seconds and then complained of significant shortness of breath.
Patient is pregnant and got the first dose of the Moderna vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 12-Apr-2022. On 27-Sep-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY. On 27-Sep-2021, MATERNAL EXPOSURE DURING PREGNANCY had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   ? No treatment information was provided.; Sender's Comments: This report concerns a 36 year old female subject with no relevant medical history, who experienced the unexpected event of vaccine exposure during pregnancy. The patient received the first dose of vaccine at unknown weeks of gestation. The benefit-risk relationship of Spikevax is not affected by this report.
Fever, hives on the stomach that spread to legs and arms.  Gave ibuprofen for fever and Benadryl for hives as recommended by her pediatrician. She ran a fever through the night and on 10/24 the hives were worse. She was taken to an urgent care center where she was prescribed a steroid medication to treat the hives. Her fever was as high as 103 at some points. She was also diagnosed with a possible urinary tract infection and was given an antibiotic. She was given ibuprofen every six hours to control the fever. On 10/24 her fever returned to normal temperature and the hives seem to be improving. 10/28/09:  Urgent Care Records received for date of service 10/23/09.Dx:  Acute otitis media/ROM/LOM/BOM, Allergy unspecified, not elsewhere classified, URI.  Urinary Tract Infection. Assessment:  Presents with cough, chills, fever, headache, runny nose, lymphadenopathy, hives, Right TM-full, red, purulent.  Prescribed Zithromax, Benadryl.
Significant pain at injection site; muscular pain; nausea; general malaise; fever; joint pain; gastrointestinal distress; fatigue; brain fog
Developed a dry, red rash that I was told was eczema within 48 hours of the vaccine
Initial information received on 12-Mar-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves 3 patients who experienced received vaccines TRUMENBA, PREVNAR 13, FLUZONE QUADRIVALENT and PENTACEL because there was a temperature excursion which reached 29 degrees Fahrenheit for 1 hour. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation. On an unknown date, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ061AAA via unknown route in the left thigh. On 21-Dec-2018, the patient received a  dose of suspect PREVNAR 13 not produced by Sanofi Pasteur lot X35262 via unknown route. On an unknown date, the patient received a  dose of suspect TRUMENBA not produced by Sanofi Pasteur lot number not reported via unknown route. On an unknown date, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6315RA via unknown route in the left thigh. It was a case of actual medication error due to incorrect product storage. No adverse events have been reported. 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 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.
rapid, uneven heart rate, fever, slept for 2 full days, couldn't stand up for any length of time. aches and pains, wobbled around for 2 more days.  Arm swollen, bright red,painful.  No other reactions with the other 2 shots. Just the one on Oct 22nd
Months after the vaccine i developed chest tightness, shortness of breath without exertion. High heart rates at rest. By august I was diagnosed with DVT and multiple bilateral PE?s
Deltoid muscle pain. 0 skin changes. Pain continues after 1 month from Immunization
Pt was given both DTaP-IPV and Varicella in the right leg, mother could not tell me specifically where the reaction was from.
This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 28-MAY-2013, the patient was vaccinated with a dose of VAQTA, (lot # H010659, expiry date MAR-2015), which was exposed to 31 degree Fahrenheit. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
L arm pain Friday. Vesicles Saturday. Puss drained Saturday-Sunday. Treated with clindamycin.
I had pain in my arm the day of the shot, and felt fine until Wednesday. On Monday I began taking magnesium and moringa pills once daily as supplements and took them consistently over the course of the week. On Wednesday, i woke up with extreme muscle soreness in my neck and shoulders and joints including my wrists. I had a headache and loss of appetite. I took Tylenol but felt feverish and the pain persisted so i slept all day except to walk my dog at 7am, 2pm and 8pm. I followed that schedule every day and the pain intensified on Thursday. As it got worse I started taking DayQuil and NyQuil as directed but was still getting worse. On Friday I began to have mucus buildup and phlegm and developed a cough and continued the DayQuil and NyQuil course. On Saturday the symptoms persisted but i was able to function by Saturday night with manageable symptoms as long as the DayQuil was working. On Sunday my symptoms had significantly decreased and I felt better but was unable to taste or smell anything. I stopped taking the DayQuil and NyQuil Sunday and my only symptoms were the loss of taste, smell, and I still sound congested when I talk. It is now Monday and I can?t smell, taste, and I sound congested/ raspy.
Exhaustion.  Slept 12 hours then could barely sit up for next 12 hours.  Pain at injection site. Chills for the following day.  Raised red bump at injection sire for the last week.
on 15Apr2019 a dose of Fluzone Quad pediatric prefilled 0.25ml was given and on 26 Apr another dose of the Fluzone Quad pediatric 0.25ml was given by mistake,  No AE symptoms; Initial information received on 26-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 10 months old female patient who was vaccinated with a 0.25 ml first dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] on 15-Apr-2019 and a 0.25 ml second dose of same vaccine on  26-Apr-2019 (lot UT6315SA and Exp. Date 30-JUN-2019) via intramuscular route in the left thigh(reported as left leg).  The patient's past medical treatment included Flurex on 23-JAN-2019 vaccinated with 0.5 ml dose and concomitant medications were not given.  It was an actual medication error case due to extra dose administered.  No AE symptoms occurred.  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 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.  List of documents held by sender: none.
Severe pain at site when injection given. Pain constant, swollen -> pain/continues. 2 months given cortisone shot into subacromial space. MRI in 5 mons - SLAP tear. Surgery - pt 3/week -> adhesions - manipulation.
herpes keratitis; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not provided. In or around 21-SEP-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dose, frequency, injection anatomical location or route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), she suffered sudden blurry vision, pain in left eye and inflammation of the cornea in her left eye and was diagnosed with herpes keratitis (herpes ophthalmic). As a direct and proximate result of the defective zoster vaccine live (ZOSTAVAX), her symptoms had resulted in physical limitations not present prior to using the vaccine. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome for herpes ophthalmic was not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The herpes ophthalmic was considered a disabling event by the reporter.  Upon internal review, the herpes ophthalmic was considered a medically significant event.
Patient has history of passing out. 2-3 min after Pfizer shot patient started to feel hot and was pale.  A volunteer doctor assisted to sit down on floor. Has syncope episode after seated on ground. Use ammonia capsule . Pulse was intact throughout. Airway as cleared of gum in mouth. Loss of consciousness for 15 sec. Then alert able to call mother who was in the parking lot. 911 EMS called and arrived. Cool compress applied. Ems arrived. Patient felt better. Vital by Ems Glu 80  BP 120/80. Patient was able to drink water. MD instructed mother to clear with PCP or Cardiologist to clear before getting 2nd shot.  Mother declined EMS transport. MD walked patient to car.
Pt developed a large lump upper left arm, progressing to rash on her neck, torso, and facial flushing; no difficulty swallowing or changes in breathing.  She returned to the clinic on 3/5/15, where she received Depo Medrol, prednisone oral, Pepcid, and Alavert.  She worsened on Friday evening, and went to the ED, with a fever of 100.4, and HTN 200's/high 100's.  She received adrenaline.  She continued to have symptoms over the weekend, although lessening.  She has returned to work, and continues to improve.
her SED rate went from 30 to 130; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 22Jun2021 as dose 1, single and received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 12Jul2021, as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient had a blood test done before she received the vaccine. On an unspecified date of 2021, patient had another blood test done after she received the vaccine, and her erythrocyte sedimentation rate (SED) went from 30 to 130. Patient questioned that, has this happened before and was informed that there was no information regarding a change in lab results with the Pfizer Covid-19 vaccine, Survey offered. The outcome of the event was unknown.   Information about lot/batch number has been requested.
I received my second dose of Moderna vaccine on 3/24/2021 and approximately one week later I experienced sudden loss of hearing in my right ear. A diagnosis of sudden severe sensorineural hearing loss was confirmed by both audiologist and MD ENT specialist. Hearing aid is no longer of benefit and treatment plan includes a future unilateral cochlear implant for my right ear.
This spontaneous report as received from a pharmacist refers to a 59 year old male patient with no drug reactions/allergies. On 14-JUN-2013 the patient was vaccinated with ZOSTAVAX 19400 PFU (lot # J000436, exp. date 10-APR-2010) (dose and route were not reported). Concomitant therapies included lisinopril (manufacturer unknown), metoprolol, pravastatin sodium and PRILOSEC. Pharmacist reported the patient stated that ever since he received ZOSTAVAX and got bit by a mosquito, the mosquito bites swelled up extremely large and got red, hard and warm to the touch. Pharmacist mentioned this happened where ever the patient got a mosquito bite and was not isolated to any one area on the patient's body. Patient was treated with BENADRYL and hydrocortisone (unspecified). Patient sought the pharmacist. The outcome of the events was reported as not recovered/not resolved. The relationship between the ZOSTAVAX and the events was not reported. Additional information has been requested.
Fever 102, headache, dizziness, nausea, vomiting, body aches, fatigue, chills.
This is a spontaneous report from a contactable consumer or other non-healthcare professional, reported for herself. A 23-year-old female patient received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), at the age of 23, via an unspecified route of administration, on Oct 6, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient previously received the first and second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route, on an unspecified date, single dose, for COVID-19 immunization. Patient got her booster dose yesterday and experienced headache, fever, nausea, fatigue, diarrhea, chills and sweat Oct 2021. Her side effects are really bad. She wondered what she should do with her symptoms or if she should go to doctor or wait. Report related to a study or program: no. The outcome of the events reported unknown. Follow-up attempts completed. No further information expected.
This spontaneous report as received from a pharmacists refers to a patient of unknown age and unknown gender. Medical history and current conditions not reported. On 12-MAY-2014 the patient was inadvertently vaccinated with PNEUMOVAX 23 (strength, lot number and dose number were unspecified) which expired on 09-Mar-2014. No concomitant therapies were reported. No adverse effects reported. The outcome of the event was unknown. Additional information has been requested.
Patient admitted to the facility twice for AMS, March 6th-14th 2022 and April 2nd-22nd 2022. The first of these hospitalization is summarized as follows: His recent history is notable for an admission to the neurology service in March 2022 for altered mental status, weakness and left arm shaking. His hospital course was notable for a detected R posterior cerebral lesion, c/f encephalitis vs late subacute infarct. An LP was performed, which ruled out infectious causes but was possibly concerning for an autoimmune etiology (with mildly elevated protein, miledly elevatead WBC, and elevated Serum QIG IgA), indicated for continued workup. He was started on IVIG on 3/14 out of concern for autoimmune encephalitis but only completed a two day course. Rheumatology was e-consulted and felt that his +ANA IFA screen 1/160 was unlikely to be due to an autoimmune process given abscence of other autoimmune findings. His hospital course at that time was also complicated by focal epilepsy, which was felt to be provoked in the setting of aspiration pneumonia.  Second hospitalization is summarized as follows: Differential includes sequelae of status epilepticus, autoimmune/paraneoplastic encephalitis,cns primary maligancy and MELAS. MELAS would be rare in this age group, however there are case reports of onset in the 6th and 7th decade of life. While MELAS is unlikely to be unimodal, the patient does have an older R temporoparietal infarct present on MRI in 6/21. Hypermetabolism on PET was initially thought to be less consistent with MELAS, given that hypometabolism on PET is a more typical finding. However, this hypermetabolism on PET may be better explained by ongoing seizure activity, which is a less common, but known, complication of MELAS. More also, he also came with gram negative bacteremia and UTI (Probably due to BPH VS prostate cancer)  which could have contributed to his altered mental status. AMS wise, he continues to have difficulties with following commands, comprehending and some repitition.Note here that the patient word finding difficulties were present since 2021. Mainly, he has non fluent aphasia, not able to name, read, or comprehend.  His writing is intact. MRI repeat shows improvement. We discussed the case with Dr. at facility and Dr, who have all come to agree that the pattern of findings on MRI are more concerning of MELAS than infection/inflammatory.  Neurology team wanted to repeat LP to send ENC2, lactate and pyruvate, however, the patient was not able to tolerate the first LP. Since the clinical picture seems to head towards MELAS, we decided to go ahead and order genetic testing and send ENS2. Please note that Lab was not authorizing to send to Lab, wanted ENS2 send to quest. Lab has more test on the  panel than quest. Another ddx still included Hashimoto and encephalitis. Anti tpo, repeat TFTs, Anti thyroglobin were all negative. Repeat PET scan now shows hypometabolism in the right parietal, occipital and posterior temporal love. There is an intense focal hypermetabolism in left mesial posterior temporal lobe.
her mother is now experiencing bradycardia; This case was reported by a consumer via call center representative and described the occurrence of bradycardia in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th August 2022, the patient received the 1st dose of Shingrix. In August 2022, less than a week after receiving Shingrix, the patient experienced bradycardia (serious criteria GSK medically significant). On an unknown date, the outcome of the bradycardia was not recovered/not resolved.   It was unknown if the reporter considered the bradycardia to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-AUG-2022 Reporter's comments: The case was reported by patient's daughter. The reporter stated that her mother had the first dose of Shingrix on 17th August 2022 and her mother had now experienced bradycardia and she was scheduled for a pacemaker placement. The reporter had limited information about the pharmacy and Healthcare Professional (HCP) contact information. The daughter gave the consent to contact to herself and to the consumer.