chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a health care professional on 07 February 2011. A 52-year-old male patient received on 27 July 2005 a right deltoid injection (route not provided) of DECAVAC, lot number U1217AA. The patient had no medical history but takes an unknown blood pressure medication. He had no illness at the time of vaccination and had no other vaccinations within 4 weeks of the DECAVAC. The patient went to the hospital for treatment for his high blood pressure and received DECAVAC as a booster. Six months later, his whole body broke out and he had ringing in his ears. He was seen by a health care professional and a dermatologist. Today he continues to have severe psoriasis with rash, scales, psoriasis all over legs, back and stomach. The outcome was reported as unknown. Documents held by sender: None.
according to mom, pt had a t103.0, had convuls, stopped breathing & was rushed to ER;incident occurred about 12hrs p/vax;
PT RECEIVED VACCINE AND WAITED IN THE CLINIC WAITING ROOM FOR 15 MINUTES. AFTER LEAVING THE CLINIC THE PARENT OF THE CHILD RETURNED STATING HE THINKS HIS CHILD IS HAVING AN ALLERGIC REACTION DUE TO THE CHILD COMPLAING OF HIS NECK HURTING AND HE COULDNT PUT ON HIS SEALBELT. THE FATHER ALSO STATED HE EXPERIENCED SOME VOMITING IN THE CAR AND HE WAS VERY PALE.
Fever; chills; aches; rash; This is a spontaneous report from a contactable consumer (patient). A 23-years-old female non pregnant patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9265) dose 1, administered in Left arm on 29Jan2021 12:00 PM as single for covid-19 immunisation and bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6021), dose 2 via an unspecified route of administration, administered in Left arm on 20Feb2021 12:30 PM (at the age of 23-year-old) as single for covid-19 immunisation. Medical history included asthma and food allergy (Pineapple) from an unknown date and unknown if ongoing. Concomitant medications included escitalopram (ESCITALOPRAM), minocycline (MINOCYCLINE) and ethinylestradiol, etonogestrel (NUVARING) taken for an unspecified indication, start and stop date were not reported. Prior vaccinatopn patient was not has covid and Post vaccination covid test was not performed. On 21Feb2021, 06:00 AM the patient experienced fever, chills, aches and rash. No treatment was received. Outcome of the events were resolving.    Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 at 13:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6202), on 01Apr2021 as dose 2, single (Lot number: ER8734), in left arm, on 04Oct2021 as dose 3 (booster), single (Lot number: FF2588), in left arm and on 05May2022 as dose 4 (booster), single (Lot number: FM9992), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ROSUVASTATIN, start date: 20Sep2019, stop date: 15Dec2022. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a health care worker (office manager) refers to 3 unspecified patients of unknown demographics. No medical history was reported. The reporter stated that the 3 unspecified patients were administered RECOMBIVAX (lot# not reported) (dose, route and frequency unspecified) that was stored improperly. No concomitant medications were reported. Nurse was then placed on the line to answer additional questions regarding event. No adverse effects were reported. No further information was provided. This is one of the two reports received from the same reporter and linked to case. All telephone attempts to obtain follow up information have been unsuccessful. Follow up has been received from the office manager. The office manager stated this temperature excursion was supported and the vaccines were out of range for approximately 3 hours. The office manager was unable to provide patient identifiers and dates of administration at this time, but was able to provide lot numbers and expiration dates for RECOMBIVAX: lot# H014132, expire date 08-FEB-2015. Additional information has been requested.
local tenderness, redness, vertigo;subsided p/72hr;will cont w/series & premedicate;
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 23-FEB-2007, a healthcare provider at a city clinic administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 22-MAY-2017, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the his injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earning capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
2JAN92 devel redness & lump @ site of inject rt leg 13DEC91 w/in 24 hrs of inject; there was bruising & tenderness; no fever no other adverse sx; also low grade fever; 4DEC91 alert, fussy, t100 R;
On 12/04/2021 I experienced chest pain, and slight shortness of breath that began in the morning and increased in intensity throughout the day. I went to the local hospital ER at 05:00PM PST. I was evaluate at the ER for 6 hours while tests were being done, but I was not given a diagnosis, or any treatment for the pain. During the 6 hours I was at the ER the chest pain, slight shortness of breath began to subside. 24 hours after the onset of the symptoms I was fully recovered and able to resume normal activities. I have not experienced any lingering or recurrent symptoms.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced injection site pain and general body pain. On an unknown date, the outcome of the injection site pain and general body pain were recovered/resolved. The reporter considered the injection site pain and general body pain to be related to SHINGRIX. Additional details reported as follows: This case was not previously reported to anyone. The age at vaccination was not applicable for this report. Thar pharmacist stated that several patients reported experiencing body aches and injection site pain after getting SHINGRIX. The pharmacist stated that generally the symptoms started on the same day, usually later that evening, that they receive the injection. The pharmacist stated that most of the patient's symptoms resolved in 2 to 3 days. The pharmacist did not have specifics for this group of patients, but they were all adult patients.
Outside of the typical symptoms of:  Nausea, became lethargic as the day went on, arm sore, felt feverish, fell asleep 8pm earlier than usual.  When I awoke I had tremors, my feet hurt upon standing and were heavy to walk.  I felt as though something was weighting me down as I walk and was difficult and heavy to walk up stairs.  I had pain in my lower back that was more of a dull heavy ache upon standing that got better as I walked.  My eyes were dilatated and I felt faint.  I rested the entire day and returned to work on Monday, but felt exhausted and like I had to spend more time for concentration on my work and work slower than usual.  That lasted for about 10 days slowly getting better as time went on. after about day 8 the tremors had lessened were all but gone.  Now about 15 days out, I am not at full energy but close, pain in feet has lessened and lower back better, but not fully healed and no more tremors.
Redness, swelling, warmth, pain at injection site. Headache w/minor chills. BENADRYL and TYLENOL.
(R) arm swollen, tingling down arm and having hard time moving arm. 25mg BENADRYL PO - ice pack to arm. VS 100/66 72 98.2 99% RA - pt d/c home.
This spontaneous report as received from a medical assistant refers to a 17 year old patient of unknown gender. On 10-FEB-2014, the patient was administered a dose of GARDASIL (lot#, expiry date, dose, frequency, route and indication not reported) which went through an unsupported temperature excursion. No adverse effects reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Breakthrough COVID-19 case with symptom onset 8/17/2021:  Cough (new onset or worsening of chronic cough) and  Shortness of breath or difficulty breathing. Hospitalized from 8/24/2021-8/25/2021. Died 8/25/2021.
Myositis (L) leg - (L) Lower thigh - + staph aureus. S to all but PCN. 5/6/08-reecords received for DOS 4/7-4/11/08-DC DX: Left thigh myositis abscess. Six days prior to admission unable to straighten left leg, swelling noted in left thigh. Decreased oral intake and decreased urinary output. 4/2/08 diagnosed with Caffey's disease. Treated as outpatient. Admitted to another facility for ultrasound showed fluid collection. Surgical intervention debridement.
Immediate pain, constant burning in arm from shoulder to elbow. Cannot raise my arm above my head, cannot put arm all the way behind my back. Not sleeping well due to the pain & the burning.
BRUISING TO RIGHT ARM; LIGHT HEADEDNESS; COLD; GETS REALLY SLEEPY; RIGHT SIDE OF BACK HURTING; SLIGHT PAIN TO RIGHT ARM; HEADACHE; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included patient had no known allergies and the patient was not pregnant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 27-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-JUN-2021, the subject experienced bruising to right arm. On 28-JUN-2021, the subject experienced light headedness. On 28-JUN-2021, the subject experienced cold. On 28-JUN-2021, the subject experienced gets really sleepy. On 28-JUN-2021, the subject experienced right side of back hurting. On 28-JUN-2021, the subject experienced slight pain to right arm. On 28-JUN-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headedness, cold, gets really sleepy, and headache on 28-JUN-2021, and had not recovered from bruising to right arm, right side of back hurting, and slight pain to right arm. This report was non-serious.
fever of 100.5; chills; Arm was hurting very badly; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Arm was hurting very badly), PYREXIA (fever of 100.5) and CHILLS (chills) in an 81-year-old male patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 07-Sep-2022, the patient experienced PAIN IN EXTREMITY (Arm was hurting very badly). On 08-Sep-2022 at 5:00 AM, the patient experienced PYREXIA (fever of 100.5) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing from 08-Sep-2022 at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm was hurting very badly) and CHILLS (chills) outcome was unknown and PYREXIA (fever of 100.5) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Sep-2022, Body temperature: 100.5. On 08-Sep-2022, SARS-CoV-2 test: (Negative) Negative.         Patient received 4 doses of the Moderna COVID-19 vaccine by intramuscular injection on 6FEB2021 (lot number 023M20A), On 26MAR2021 (lot number 018B21A), On 29OCT2021 (lot number 014F21A), and  On 4APR2022 (lot number 048L21A).  No concomitant medications were reported.
This spontaneous report was received from a licensed practical nurse referring to multiple patients of unknown ages and genders. The patients historical condition, concomitant medications and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number R021078 and expirtion date 12-JUN-2021, and lot number  R021076 and expirtion date 11-JUN-2021; GARDASIL 9 lot number R023006 and expirtion date 06-MAY-2021,  lot number R025155 and expirtion date 23-MAY-2021, and lot number N026814 and expirtion date 15-JUL-2020;  RECOMBIVAX HB lot number R001529 and expirtion date 07-NOV-2020; and ROTATEQ lot number R015435 and expirtion date 17-APR-2020,  lot number R025733 and expirtion date 30-MAR-2020, and  lot number R017948 and expirtion date 03-MAY-2020; for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). The administered dose of the vaccines experienced a temperature above 47 °F to 53.1 °F for 1 hour, as recorded by a data logger. There was no adverse effect reported. There was not previous temperature. The outcome of product storage error and no adverse event was unknown.
Swelling, hives, itching, low grade fever, throat. Starting friday morning. Went to urgent care saturday afternoon.  Diagnosis with allergic reaction.  Prescribed prednisone and Zyrtec.
Most concerning is swollen lymph node under arm. It started right away and is still slightly swollen one week later. I also had pain injection say it, low-grade fever, a little flare of fibromyalgia, and really bad headache. The lymph node swelling was the most concerning however, and painful for several several days
Patient admitted 7/25/2021 for SOB, Vaccinated 4/7/2021, tested positive for covid 7/25/2021 Discharge home 8/8/2021  Description of event/reaction: Breakthrough COVID infection Date of Clinic Visit or Hospitalization: 7/25/2021 Reason for clinic visit or hospitalization: Respiratory failure COVID-19 positive test result: Yes or No; if Yes, date 7/25/2021 Plans to monitor (include medications if prescribed): In hopsital on O2, remdesivir, and dexamethasone.   History Of Present Illness Patient is a 57 y.o. male  with past medical history most significant for diabetes who presents to ED for shortness of breath. Patient reports she is getting exposed to someone who tested positive for COVID 2 weeks ago.  Since the exposure, patient has had constitutional symptoms in form of fevers chills and poor by mouth intake.  Of late, he has developed shortness of breath and cough with cough producing a yellow color sputum which continued to worsen prompting the hospital visit.  He has not had any concurrent GI symptoms.  Of note, patient did get COVID vaccine (unclear which kind but reports it was 1 dose only) in 04/2021  Review of Systems  Constitutional: Positive for activity change, chills, fatigue and fever.  Eyes: Negative.   Respiratory: Positive for cough and shortness of breath. Negative for wheezing.   Cardiovascular: Negative for chest pain.  Gastrointestinal: Negative for diarrhea, nausea and vomiting.  Genitourinary: Negative.   Musculoskeletal: Positive for myalgias.   Hypoxic respiratory failure 2/2 COVID PNA Symptom onset 13-14 days ago. NO signs of CHF. Troponin x 2 -ve -Start dexamethasone 6mg qday + remdesivir per protocol -Consider descalating antibiotics based on Procalcitonin. Currently on Azithromycin.  -ID for delta variant testing, vaccination failure  -Self Proning advised -Incentive spirometry  # Acute hypoxic respiratory failure 2/2 SARS-COV 2 viral PNA; improved - continue dexamethasone x 10 days - Completed remdesevir - Lab to ID if it is delta variant. Turnaround time is approx. 10 days. - Janssen Vaccine 1 dose taken on 04/07 PLAN: O2 weaned off and ambulatory pulse ox noted and doing well. Plan to discharge to home to resume prior regimen and to follow with PCP regarding his diabetes and cognitive decline.     # Suspect steroid induced psychosis; resolved # ? h/o TBI # Memory loss/amnesia Given acute psychosis and reported memory loss/amnesia we ordered an MRI of the brain with and without contrast. This was done after some delay and did not show any neurodegenerative process or any lesions (suggestive of covid related encephalitis) and he is discharged to home in stable condition. He is advised to follow up with his PCP regarding his neurocognitive decline (differential considerations include early onset dementia).  Treated with Remdesevir
Dizzy spells.  There have usually been other factors involved (extreme heat, exhaustion, alcohol) so I've not worried about it.  However, in the same time frame I have begun to have a constant ringing in the ears.  The dizzy spells are getting worse and today lost me a job.  I mentioned it to one of the doctors when he was treating me for a sprained wrist that I got when a dizzy spell caused me to fall down.  He blamed the ringing on me being exposed to loud noises.  He said the dizzy spells were from drinking and smoking.  This was the first time I'd ever seen this doctor and he gave me those diagnoses without any examination.
heart attack; grand mal seizure episodes "for the first time in over 2 years", he didn't remember the episode; he was freezing and was cold; throwing up profusely; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (heart attack) and GENERALISED TONIC-CLONIC SEIZURE (grand mal seizure episodes "for the first time in over 2 years", he didn't remember the episode) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by the reporter.  Concomitant products included LACOSAMIDE (VIMPAT) for Seizure.    On 21-Apr-2021 at 3:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 22-May-2021, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criteria hospitalization, disability, medically significant, life threatening and intervention required), GENERALISED TONIC-CLONIC SEIZURE (grand mal seizure episodes "for the first time in over 2 years", he didn't remember the episode) (seriousness criteria hospitalization, disability, medically significant, life threatening and intervention required), NASOPHARYNGITIS (he was freezing and was cold) and VOMITING (throwing up profusely). The patient was hospitalized on 22-May-2021 due to GENERALISED TONIC-CLONIC SEIZURE and MYOCARDIAL INFARCTION. At the time of the report, MYOCARDIAL INFARCTION (heart attack), GENERALISED TONIC-CLONIC SEIZURE (grand mal seizure episodes "for the last time in over 2 years", he didn't remember the episode), NASOPHARYNGITIS (he was freezing and was cold) and VOMITING (throwing up profusely) outcome was unknown.            Patient was admitted to hospital on 22-may-2021.patient lips were purple and had no pulse for 12 minutes, but was resuscitated.The hospital took out patient's breathing tube at  on 23May2021, and hospital staff stated he will remain there for a while.  Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Vomiting is  consistent with the known safety profile of the product.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Vomiting is  consistent with the known safety profile of the product.
I had medication controlled atrial fibrillation prior to the 2nd dose of the C19 vaccine. After the 2nd dose, my afib became increasingly unstable and I am now in afib 100% time! I also was sick for several days after getting the C19 vaccine. I did get Covid, but not until Feb 2023. I don't know if it is also related; however, my neuropathy, weakness in my legs is so bad now that I have a hard time even working part time; and have significant issues walking. I am on cymbalta for the neuropathy, and it has helped me relax too. I still have a hard time functioning, usually in bed 10-to-12 hours a day; and that was not the case in the past, not even in 2021. I did door-to-door sales in 2021; and could not imagine doing that much walking today.
Displaying inappropriate behavior, hyperactive, rolling on floor, acting as if she was intoxicated.
Patient registered and presented for Pfizer vaccine. Stated she had not received any other COVID-19 vaccine. Denies any allergies. She was vaccinated and observed for 15 minutes. Approximately 30 minutes later she reported nausea. She appeared flushed. Vital signs normal. She was observed for an additional 15 minutes. Nausea did not improve. Patient then stated she had lied about receiving COVID-19 vaccine. She stated she received 1 dose of Moderna  COVID-19 vaccine a few months ago but that she waited too long to get the second dose so she lied in order to get the Pfizer vaccine.  She was advised to go to the hospital if symptoms worsens.
No adverse reaction. Child was given MMR and MMRV and should have gotten MMR and Varicella. Parent was contacted and child was reported to be doing fine.  This was a vaccine administration error on my part.