chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore throat; Head congestion; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient had the first Covid vaccine shot on Tuesday and the patient have got like head congestion and drainage and kind of a sore throat on an unknown date in Jan2021. The patient wanted to know should the patient went get a Covid test. The patient also stated that "Is it possible that I still got Covid". The outcome of the events was unknown.
Exactly 9 days after the 1st vaccine developed painful welts and hives all over body.; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 29Mar2021 at 16:15 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included multiple sclerosis and sleep apnea. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included natalizumab (TYSABRI), duloxetine hydrochloride (CYMBALTA), amitriptyline (MANUFACTURER UNKNOWN), baclofen (MANUFACTURER UNKNOWN), cyanocobalamin (VIT B12) and "D"; all from unknown dates for unspecified indications and unknown if ongoing. The patient previously took COPAXONE and experienced an allergy. The patient previously took TYLENOL and experienced hives (which usually lasted for an hour). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 07Apr2021 at 12:00, exactly 9 days after the first vaccine, the patient developed painful welts and hives all over the body. Even after one week of them not have gone away, the patient went to the primary care doctor who confirmed that it was hives. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with a 10 days course of prednisone taper pack. The clinical outcome of the event's painful welts and hives all over body was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Narrative: observed for 1 hour, gradually improved, normal glucose and EKG; he has known history of vasovagal reaction with near syncope. No prior syncope. Other Relevant History:
severe eczema after receiving the first dose / eczema all over her body, the back of legs, shoulders, arms.; can't move her right hand; making more sick; crying; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (severe eczema after receiving the first dose / eczema all over her body, the back of legs, shoulders, arms.), MOBILITY DECREASED (can't move her right hand), ILLNESS (making more sick) and CRYING (crying) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination.     Concurrent medical conditions included Eczema (prone to eczema her whole life.).    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ECZEMA (severe eczema after receiving the first dose / eczema all over her body, the back of legs, shoulders, arms.), MOBILITY DECREASED (can't move her right hand), ILLNESS (making more sick) and CRYING (crying). At the time of the report, ECZEMA (severe eczema after receiving the first dose / eczema all over her body, the back of legs, shoulders, arms.) had not resolved and MOBILITY DECREASED (can't move her right hand), ILLNESS (making more sick) and CRYING (crying) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment information was reported. Patient reported that in april after seeing her doctor she was able to get it under control and it all went away.
Body aches; Sever muscle ache; Fatigue; Joint pain; Mild fever; Chills; Sweats; Severe Headache; Aches in arms and legs; Nausea; Vomiting; This is a spontaneous report from a contactable consumer (patient). A 23-years-old non pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 intramuscular, administered in Arm Right (deltoid) on 21Jun2021 11:15 (at the age of 23-years-old) (Batch/Lot Number: EW0196) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included PTSD (Posttraumatic stress disorder) from an unknown date and unknown if ongoing, ongoing depression and ADHD (Attention deficit hyperactivity disorder). Concomitant medication included fluoxetine hydrochloride (PROZAC) taken for depression from Jan2019 and ongoing, dexamfetamine sulfate (DEXEDRINE) taken for an unspecified indication, start and stop date were not reported and lisdexamfetamine mesilate (VYVANSE) taken for ADHD from Nov2020 and ongoing. Patient previously took first dose of bnt162b2 (Lot number: EW0191) administered in Arm Right (deltoid) on 01Jan2021 11:00 AM (at the age of 23-years-old), intramuscular for covid-19 immunisation. Patient did not have pregnancy at time of vaccination. On 21Jun2021 20:00, the patient experienced chills, sweats, severe headache, aches in arms and legs, nausea and vomiting. On 21Jun2021 23:15, the patient experienced mild fever, severe muscle ache, fatigue, joint pain. On 22Jun2021 12:30, the patient experienced body aches. Patient received no treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient did not underwent for any prior vaccination and relevant tests. Seriousness of events were reported as non serious by reporter. Outcome of events chills, sweats, severe headache, aches in arms and legs, nausea, vomiting were recovering while outcome of events mild fever, sever muscle ache, fatigue, body aches and joint pain were unknown.   Follow-up attempts are completed. No further information is expected.
Healthy 2 month old received RotaTeq on 1/22/07.  Within 48 hours developed frequent diarrhea (bloody), screaming, weight loss of 1/2 pound and was admitted to hospital with BUN 80.Diagnosed with hyponatremic dehydration.  2/15/07 Received medical records from hospital which reveal patient experienced repeat hospitalizations on 1/25-1/29/07 for cough/fever/vomiting/diarrhea.  IS was ruled out at that time.   Readmitted on 1/30-2/3/07 for decreased appetite despite slight weight gain overnight.  Liver & kidney function deteriorated.  MD unsure if due to rotateq vax.  Consults by peds GI & developmental team.  FINAL DX: Acute renal failure secondary to volume depletion
Vaccinated Weds 4/28/21.  Started shortly thereafter with fever Tm 102 F, chills, headache.  Starting Thursday with fatigue and metallic taste in his mouth. He has no appetite and reports not eating x 4 days.  He has had fever and headache persistent since vaccination.  He has not slept x 4 days since vaccination, he reports his mind is racing.    He had a syncopal episode x3 night of 5/2/21 back to back.  Right before syncope he did not feel lightheaded or dizzy, chest pain, palpitations.  He had LOC lasting less than a minute in total.
Patient called at 5:30 she explained she received the flu shot on 10/21/2020, she had concerns about injection site pain and redness. I explained to her that it could be a common side effect. She later explained that the injection site is now like a rash and has went from a quarter size to now the size of her palm. She explained that she will be going in to see the doctor. She was concerned of a possible allergic reaction to the vaccine.   Followed up, patient went to a clinic to be seen, was told it was an allergic reaction to the vaccine and was given Benadryl and zofran. Rash has gone down and patient is now feeling fine.
I am currently 19 weeks pregnant. My due date is around 10/21. I had my second dose of the Covid 19 vaccine yesterday 5/19/21 at 10:05 am.  I had it administered on the right arm and I left right after. I got a call from the pharmacist right when I left,  stating that he didn?t believe I got the vaccine, either that it was empty to begin with or that it broke open. He said that he came to this conclusion because he didn?t feel any resistance when he gave me the shot. I went back in after ending the phone call and he administered another full  dose of 0.3ML into the same right arm.
Patients received the Moderna COVID 19 vaccine after temperature excursion; Patients received the Moderna COVID 19 vaccine after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna COVID 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna COVID 19 vaccine after temperature excursion) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 20-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna COVID 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna COVID 19 vaccine after temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna COVID 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna COVID 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  HCP reported that the facility where she works, there had been temperature excursions with freezer. It had been happening for weeks since April 2022  The batch numbers were reported as 065K21A and 045L21A.  The storage condition at the time of the excursion was reported as frozen storage.  The temperatures excursion range was reported as maximum 30 Fahrenheit degrees and minimum minus18.9 Fahrenheit degrees The vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute.  The vails were stored in frozen state.Visual inspection did not noted any vaccine state change.  No treatment information was provided.   This case was linked to MOD-2022-591989 (Patient Link).
Temperature; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (Temperature) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BODY TEMPERATURE INCREASED (Temperature). At the time of the report, BODY TEMPERATURE INCREASED (Temperature) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant list is provided. No treatment is provided.  Company Comment: This is an invalid case due to no identifiable patient. Also, very limited information regarding the event has been provided at this time.; Sender's Comments: This is an invalid case due to no identifiable patient. Also, very limited information regarding the event has been provided at this time.
chills, fever of 101.6, fatigue, body aches, sensitive to sound and light, headache, loss of appetite lasting about 24 hours
Patient described and intense burning and itching  that radiated down the whole arm. Symptoms began approximately 24 hours after injection and occurred mainly in the evening. Symptoms where treated by patient's physician with Gabapentin and resolved in about 12 days.
24 hours after the injection my arm at the injection site swelled up to about the size of a large orange, site was red and burning and there is still a round discolored area about the size of a half dollar at the site - not improving and vaccine was on 12/23/15.
As I was awaiting my 30 minute monitoring I began to itch all over my body. I began to get hives on my face, arms, legs, and stomach. I felt ill and could not stop itching.
Fever and chills lasting approximately 12 hours. Generalized pain, primarily in back and neck, lasting over one week. Fatigue lasting one week.
This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiration date were not reported). On an unknown date, the patient developed a grapefruit size case of shingles at the ZOSTAVAX injection site. The outcome of the event was unknown. Relatedness between the event and the therapy with ZOSTAVAX was not reported. Additional information has been requested.
Information has been received from a registered nurse concerning a 4 year old male patient who in approximately 2005 was vaccinated with the first dose of VARIVAX (Lot not reported). The patient received the second dose of VARIVAX (Lot not reported) on 28-JAN-2009. After the second dose of VARIVAX was given, the father's patient reported that the child did have chickenpox "last year" (2008). Additional information has been requested.
Patient received Pfizer vaccines on 1/20/21, 2/10/21 Tested positive for COVID-19 by PCR on 5/24/21 Had previous COVID infection in November 2020. h/o Stem Cell Transplant, DM, morbid obesity, multiple myeloma Patient is asymptomatic.
Covid Bilvalent 5-11 vaccine was given as first dose of COVID vaccine. Monovalent version should have been given. No adverse reactions in office. Pt was monitored for 15 minutes.
patient states she has pain and swelling in the axilla region of the arm she got her shot in.  It developed 2 days after the vaccine was given.
1st dose of pfizer vaccine was given to patient on 07/07/2021. We found out on 07/09/2021 vaccine was stored outside the recommended 31 day expiration window. We reached out to pt on 07/15/21 to get the 2nd dose again. She will return to pharmacy on 07/12 to take the 1st dose again.
VACCINE REACTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine reaction was not reported. This report was non-serious.
Patient experienced a mild, shingles rash on his forehead and left eyelid four days post vaccination. Rash was reported to his primary care, confirmed as shingles, and resolved quickly.
infant was given an Adacel vaccine instead of a Hepatitis vaccine in error / no AE; 3 hours old patient administered Adacel vaccine / no AE; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 3 hours old patient who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of HEPATITIS VACCINES  (lot number and Expiry date unknown) via unknown route in unknown administration site, on 18-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to wrong vaccine administered and Inappropriate age at vaccine administration.  It was reported that The patient will be in the hospital for 48 hours per standard protocol and will be monitored. lot/exp: UTR The physician is not linked to the same system as the hospital where the patient was born. 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 holder's compliance with the requirements set out in Directive and Module VI of the 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.  Information on the batch number was requested.
95 y.o female with history of a fib not on anticoagulation, CAD, HTN, HLD, IFG, and CKD who presents with generalized weakness. Patient has perhaps mild cognitive impairment at baseline, but is able to provide reasonable history at admission. She lives at home alone in generally functions well.  It seems that she has developed generalized weakness in the past few days. This has been progressive to the point that she was unable to get up out of chairs or in the bathroom today, even despite assistance from family members.  Has had a mild nonproductive cough in the past few days but denies shortness of breath. Denies fevers, chills, or any localizing symptoms of infection including dysuria.  Due to her weakness, she was brought to the ED today for evaluation. There, vitals were stable without hypoxia. Labs were significant for normal electrolytes, creatinine 1.2 (baseline), WBC 6.2. Urinalysis revealed bacteriuria, but as above patient was asymptomatic. COVID testing returned positive. Chest x-ray was clear. As patient is unable to care for herself at home, she has been admitted to the medicine team for further care.
Pt. states the injection site became red, swollen and warm to touch. She also verbalized she had flu like symtoms.
contracted Covid in early Aug2021; contracted Covid in early Aug2021; currently pregnant; This is a spontaneous report from a contactable consumer (patient). A 28-year-old (currently pregnant) female patient received bnt162b2 (BNT162B2), in Jan2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  The patient medical history and the medications were not reported.  The patient was vaccinated in Jan2021 and contracted Covid in early Aug2021. She was planning on getting her booster vaccine. The patient was pregnant. The outcome was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This spontaneous report as received from a other health professional (Registered nurse) refers to a patient of unknown age. Current conditions and medical history was not reported. On an unknown date, the patient was vaccinated with GARDASIL for an unknown indication (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On an unknown date the patient was administered improperly stored dose of GARDASIL. No adverse effect reported. Product quality complaint was not reported. Additional information has been requested.
76 year old male with chronic bladder outlet obstruction, HTN, BPH, presented to ER with AKI. Found to have suspected UTI as wll as COVID +. Admitted to hospital medicine. Urology, nephro, ID (Infectious diseases) consulted. ID recommended no treatment of COVID as he was relatively asymptomatic. Completed short course IV rocephin. Entresto was held on admission. Renal function improved. nephro cleared him to resume entresto at dc. Urology placed foley cath and recommended he keep this in til he follows up with them in clinic. He worked with PTOT (Physical Therapy & Occupational Therapy). Plan home w home care at dc. To return to ER should admission symptoms reoccur. Cleared for dc home on 10/4. To follow up with pcp and all consultants at dc. Discharged home in stable
Patient received shot and immediately bent over and complained of pain. When asked if he was ok he said he was anxious.  He was instructed to stay seated and when ready to go out front of pharmacy.  About 2 minutes later he walks out front of pharmacy and sits down.  A couple minutes later he faints.  I grabbed ice pack and as soon as I got to him he came to.  I gave him ice pack and laid him down for a bit.
Pt recvd vax & exp acute hepatitis; pt devel jaundice, nausea, malaise, elevated alanine aminotransferase, elevated aspartate aminotransferase & was pos for hepatitis B surface antigens;
Client had diarrhea, vomiting and abdominal cramping starting 2 days after vaccination. 4 episodes, then fatigue for 2 days after the vaccine. Had chills, but no know fever.
Right arm pain increasing since vaccine was given 10/10 pain on 6/2, seen in office 6/3/16 pain was 7/10, then worsened now with tingling to arm.
This spontaneous report as received from a physician refers to a 80 years old female patient. The patient was vaccinated SQ with a dose of ZOSTAVAX. On 28-AUG-2012 the patient experienced shingles. VALTREX was given for adverse event. The patient visited the office to seek medical attention. The outcome of shingles was unknown. Additional information has been requested.
Nausea, fatigue, body aches, severe headache.  I couldn't move without risk of vomiting for 25 hours.
Swollen lympnode left axillary  Taking tylenol and ibuprofen for pain relief
vasovagal syncope, patient fainted shortly after vaccination (about 5 minutes after); patient regained consciousness almost immediately; pt told to lie down and given fluids; pt vomited afterwards; pt recovered after; EMT came to check on patient
pt recvd vax 1MAY92 & 10MAY rash over face & upper body plus t105 ax; 11MAY t101; body still covered w/fine like rash; pt still covered w/rash plus sx of fifth's disease; pt fussy;
4/1/2021: SEVERE LEG PAIN, PRESENTED TO HOSPITAL ER AND WAS FOUND TO HAVE ACUTE DEEP VENOUS THROMBOSIS LEFT LOWER EXTREMITY.  4/4/2021: SEVERE SHORTNESS OF BREATH, SQUEAD WAS CALLED AND HE WAS TAKEN TO HOSPITAL ER WHERE HE WAS FOUND TO HAVE BILATERAL PULMONARY EMBOLISM
12-24h after vaccine administration developed swelling and redness of distal thigh/just above knee - improved at time of visit/exam (R) leg 9 in, (L) leg 9 1/2 in. Tx cold compress, Ibuprofen x about 2 qh.
Tremors; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Tremors) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No medical information history was reported.  Concomitant products included GABAPENTIN, MINOXIDIL, EZETIMIBE and ATORVASTATIN for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced TREMOR (Tremors). At the time of the report, TREMOR (Tremors) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was taken by the patient for the event.
pt recv vax 11MAR96 & w/in 1hr post vax pt exp soreness & numbness in vaccinated arm;pt also reported that arm turned sl red around the vax site;pt recovered w/in 48hr;