chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ENLARGED LYMPH NODE IN ARMPIT, ENLARGED LYMPH NODE NECK; FLU-LIKE SYMPTOMS; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 11-MAR-2021 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 11-MAR-2021, the subject experienced flu-like symptoms. On 13-MAR-2021, the subject experienced enlarged lymph node in armpit, enlarged lymph node neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms on 16-MAR-2021, and had not recovered from enlarged lymph node in armpit, enlarged lymph node neck. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Chest pain x 1 day ; improving on Motrin Myopericarditis; Troponin elevated in the 20's; Normal echocardiogram and ECG shows non-specific mild ST elevation Anti-Spike > 50.000 at the time of admission (02/05/2022) RVP negative
tested for covid and came back positive; feels kinda weak; started feeling sick; coughing; feel bad; not very good appetite,; fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested for covid and came back positive), ASTHENIA (feels kinda weak), MALAISE (started feeling sick), COUGH (coughing) and FEELING ABNORMAL (feel bad) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter. .  Concomitant products included GABAPENTIN, METFORMIN HYDROCHLORIDE, AMLODIPINE, METOPROLOL and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced ASTHENIA (feels kinda weak), MALAISE (started feeling sick), COUGH (coughing), FEELING ABNORMAL (feel bad), DECREASED APPETITE (not very good appetite,) and PYREXIA (fever). On 19-Feb-2021, the patient experienced COVID-19 (tested for covid and came back positive). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN (MUCINEX DM) ongoing since an unknown date at a dose of UNK, bid; PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and GUAIFENESIN at an unspecified dose and frequency. At the time of the report, COVID-19 (tested for covid and came back positive), ASTHENIA (feels kinda weak), MALAISE (started feeling sick), COUGH (coughing), FEELING ABNORMAL (feel bad), DECREASED APPETITE (not very good appetite,) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Body temperature: 102 °F (High) fluctuated to 100°F. On 19-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
they had a temperature excursion for the vaccines Menactra, Pentacel asshipment of vaccine that was too long in transit; Initial information received on 25-Jun-2019 regarding an unsolicited valid non-serious case received from a consumer (Office Staff).  This case involves a two months old male patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ065AA and Exp. Date 16-Oct-2020) via unknown route in the left thigh, on 25-Jun-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 incorrect product storage. Menactra also had a temperature excursion but was not administered to the patient.  It was reported that they had a temperature excursion for the following vaccines Menactra, Pentacel. Caller stated she did not check the temp because she thought it was delivered at a normal delivery time. Caller stater Pentacel was administered this morning.  It was unknown whether the patient had any adverse reactions.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  Information on the batch number was requested for Menactra.  List of documents held by sender: none.
minor joint aches lasting aprox 12 hrs. chills. fever of 3 degrees above norm w sensitive skin
This is the second of the 2 vaccines. Both times, the next day, I felt fatigued, sweaty, blood pressure drop to the point of lying down with feet up for about 30 min. Today, I'm still feeling very tired and lethargic.
Fever (high of 102 for 2 days), chills, body aches, rash on arm, chest pain (in mornings for 2 hours), coughing
Patient was under the age of 18 and should not have been given the vaccine.  No adverse effects noted during administration or the observation period.
4JUN93 taken to ER w/from 105-106 & diarrhea treated w/medication & pedialyte; stayed in ER;
This spontaneous report as received from a registered nurse concerning her male cousin. The patient's pertinent medical history, drug reactions/allergies were not provided. In October 1966, the patient was vaccinated with a dose of M-M-R II (dose, route, lot # and expiration date were not provided). (To note that M-M-R II was not approved until 22-APR-1971). It was reported patient developed a fever after getting a dose of M-M-R II in October 1966. The patient recovered from fever on unkonwn date. The relatedness between the event and suspect therapy was not provided. Additional information is not expected since no follow up information can be obtained.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a five-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 07-Dec-2011, the patient received expired FLUMIST. The product expired on 20-Nov-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Pt. received Varicella vax on 3/11/2011 and developed suspicious varicella lesions acutely 4.20.2011 - pruritic, pink, papular lesions, few vesicles - clustered pelvic region.
Per mom, asthma symptoms since the intranasal influenza vaccine was administered. Symptoms were intermittent but cough was fairly consistent since the vaccine was given.
administered expired doses; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number G3Z3N, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 30th September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra 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 was provided as follows: The age at vaccination was not reported. The patient received vaccine which was already expired on 30th June 2021. This is 1 of the 5 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR207378:same reporter US-GLAXOSMITHKLINE-US2021206979:same reporter US-GLAXOSMITHKLINE-US2021AMR207380:same reporter US-GLAXOSMITHKLINE-US2021AMR207377:same reporter
Vaccine itself was fine. Some muscle soreness at injection site. But 24 hours after receiving the shot, I developed a fever of 102°. Fever of 100° or more (with Tylenol) lasted for 36 hours.
Serious headache starting Friday (4/9) evening and lasting through Sunday (4/11) morning.  Woke up Saturday am (4/10) with temperature of 101.6 - fever was gone by 8 am.  Overall did not fee well Friday (4/9) through Sunday (4/11). Slept on and off.  Charley horse in right leg Sunday afternoon, which is rare for me.  Woke up Sunday (4/11) with pain in left arm.
Patient describes rash, swelling, and tenderness at site of injection within the day after vaccination. Rash spread from injection site down approximately 2/3 of the way to the elbow. Patient also noticed some small bumps/pustules within the borders of the rash a couple of days after vaccination. Patient presented to pharmacy one week after vaccination, at which point rash was only slightly visible and swelling gone.
Chills, Headache, Body Aches, Fatigue occurred around 5PM.  Fever (103) began around 7:30PM.
PATIENT REFERS DIZZINESS, PERSPIRATION AND PALENESS.LASTED FOR 20 MINUTES. RECOVERED AFTER LAYING DOWN.
This spontaneous report as received from a nurse refers to unspecified patients of unknown age. Since 25-JUL-2014, the patients were vaccinated with PNEUMOVAX23 (lot #, expiration date, route, frequency and dose were unknown) which had been improperly stored. No adverse effects were reported. This one of several reports from the same reporter. Additional information has been requested.
Parathesia in arms and hands, feet numb,heaviness in arms and legs, extreme fatigue
Information has been received from a physician concerning a 28 year old female with no medical history or drug allergies who on 28-JAN-2008 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot # 659439/1267U) and on 07-APR-2008 was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL (lot # 658558/1061U).  There was no concomitant medication.  On 07-APR-2008 the patient experienced pain at the injection site.  The patient had constant soreness and pain without redness or bruise.  The patient got worse when she moved her arm over her head.  At the time of this report, the patient's pain at the injection site persisted.  The patient was seen by the physician.  The patient did not have any symptoms when she received her first dose of GARDASIL (lot  # 659439/1267U).  No product quality complaint was involved.  Additional information has been requested.  Additional information was received from a registered nurse who administered the second dose of vaccine for the patient. According to the reporter, the patient had intermittent pain in the left arm for several months after the injection on 07-APR-2008. Erythema or edema was not reported. Laboratory test were performed (CPK, LDH, xray) but no results were reported. On an unspecified date, the patient recovered from the event. It was stated "The patient chose to continue series of requested third dose in left arm".  No further information is available.
Patient is an 83 yr old female with medical history significant for afib on eliquis (renally dosed), CAD, HTN, chronic hypoxemic respiratory failure on 2L NC at home, HLD, CKD3, Carotid artery dz, fibromyalgia, anxiety/depression, dementia, and frequent falls. She had recent L LE cellulitis and an ulcer in left lower extremity. She was also recently hospitalized here from 1/5/22- 1/12/22 for AFib with RVR and left intertrochanteric hip fracture, (the latter) which was treated with a left IT nail on January 6th by Dr. She had been ambulating well until about a week and half ago. She does not remember any specific fall but has been having difficulty with pain in the L leg and groin. X-rays in ED demonst demonstrate failure of IT nail. Also of note, during the most recent hospital stay her home Diltiazem dose was increased, and she was started on metoprolol as well. She was discharged for SNF. On 1/28/22 performed routine surveillance COVID testing on her (she was asymptomatic), and she was COVID positive. Since about 1/30/22 staff noted her to have decreased PO intake and increased confusion including hallucinations. They also started her on Dexamethasone. Patient denies chest pain, palpitations, shortness of breath, headache, chills, diarrhea, vomiting, and dysuria. Hospitalist is asked to admit the patient namely because of AKI (superimposed on CKD) and failure of IT nail. Dr. with orthopedic surgery was consulted by ED physician for the latter.  PT IS INPATIENT AT THIS TIME
Significant localized reaction to DT shot with 6cm indurated, erythema, L/arm & 2cm at injection site, continues to be bothersome.
A report has been received from a Health Professional concerning a subject of unknown gender, who had been receiving FLUMIST quadrivalent, (intranasal), 0.2 Millilitres. FLUMIST quadrivalent, (intranasal) started on an unknown date. The patient experienced refrigerator where they stored the vaccine went out of range for 1 hour and 48 minutes with the lowest temperature reading of 33.8 degrees Fahrenheit. FLUMIST quadrivalent, (intranasal) was continued. The outcome of the event of refrigerator where they stored the vaccine went out of range for 1 hour and 46 minutes with the lowest temperature reading of 33.8 degrees Fahrenheit is unknown. The report was considered to be non-serious by the company physician.
I am having swelling under the arm; It is in my left arm where I got the shot, it is kind of sore; Where I had the shot in my left arm, there is swelling underneath my arm; It is underneath my armpit; I am having swelling under the arm; It is in my left arm where I got the shot, it is kind of sore; Where I had the shot in my left arm, there is swelling underneath my arm; It is underneath my armpit; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0177, NDC number, UPC number and Expiration date are unknown), via an unspecified route of administration, administered in Left arm on 11Jun2021 as unknown, single dose for covid-19 immunisation. Medical history included Blood pressure from unspecified date. Concomitant medications included Vitamin D (VITAMIN D NOS) taken for an unspecified indication on an unspecified date and unspecified blood pressure medicine, on an unspecified date. It was reported that patient was calling regarding a side effect that is not written on the paper. The patient had several of them and had shot on Friday and just noticed having swelling under the arm, it is in left arm where patient got the shot, it is kind of sore and where patient had the shot in left arm, there was swelling underneath arm on an unspecified date in Jun2021. The patient wanted to report it and also wanted to know if it was normal, the swelling and the " Consumer stated, "Not my hand, my arm where the shot was and also underneath my arm." It was reported that the patient did not take any medication for adverse events. Reporter seriousness for adverse events was unspecified. The outcome of events was unknown.
A legal complaint was received from an attorney alleging that a male child received series of Tripedia, ActHIB, and Recombivax-HB vaccines as well as Hib-TITER vaccine from 12/2/98 through 11/14/00 and subsequently "suffered devastating injuries through mercury toxicity and associated complications and sequelae and the aggravation of other condition directly through exposure, via IM injection of mercury" in the "thimerosal-containing vaccinations." According to the legal complaint, the child "was born a perfectly normal, healthy boy whose APGAR scores at birth were well within the normal range." It is alleged that at approximately 12 months of age, the child "was neurologically devastated by the accumulation of mercury in his body, having been exposed via IM vaccinations, and suddently regressed developmentally, losing milestones of neurological development previously achieved, specifically including, but not limited to becoming withdrawn, unresponsive to his environment, engaging in repetitive behavior and the loss of language skills." According to the legal complaint, the child "suffered severe and permanent injuries" and "sustained and will sustain in the future a mental, intellectual, developmental and neurological incapacity and associated learning disabilities, affect disorders and impairments." Vaccination information contained in the legal complaint indicated that the child received Tripedia, ActHIB, HibTITER, and Recombivax-HB vaccines beyond 12 months of age.
Pt. was seen at Dr office. The provider called and stated that she think the patient may have had an adverse reaction to immunizations that I gave. She stated the pt. (L) leg was red, itching, with swelling and the size on the site was 10 x 12cm. She prescribed him BENADRYL/ibu/and told mom to apply ice.
Case number PHEH2013US016985, is an initial spontaneous report received from a nurse on 08 Aug 2013. This report refers to an 11 year old male patient. His medical history and concomitant medication was not reported. He was vaccinated with MENVEO (batch number: M12113) 0.5 ml intramuscularly into left arm on an unknown date. Concomitantly he also received hepatitis A vaccine (manufacturer and batch number: unknown) into left arm. The patient reported sore arm and did not feel right the next day. Two days later, when called back, it was reported that he was taken to emergency room for trouble breathing and local reaction in left arm. Outcome of the events, seriousness and causality assessment was not reported.
Fever, seizures, slur of speech, weakness & fatigue, inability to stand  during seizures, hot flashes
PHN received phone call from client on 10/11/2021 stating that she received her first dose of Pfizer vaccine on 09/04/2021 and that about two days later she began with a hive-like rash on her bilateral legs beginning at the knee and extending to the feet and on bilateral arms beginning at the elbow and extending to the hands. Client reports that over the next few days the rash progressed and spread up toward the trunk of her body. About 8 days after receiving the vaccine she had this hive-like rash covering her entire body. Client reports that the rash was hot to the touch, burned, and itched. Client reports she was seen on 9/10/2021 where she was prescribed 4 days of prednisone and topical triamcinolone cream. Client reports no symptom improvement so she went to a specialist on 9/13/21. Client reports they ran tests and biopsy's which did not show cause for the rash. Client was treated with a longer course of prednisone, topical betamethasone, and hydroxyzine. Client reports the dermatologist told her the rash was from the vaccine, and that she could call the government agency. PHN referred client to her PCP to determine course of action for 2nd dose of vaccine. Client verbalized understanding. Client reports rash improvement, but still experiencing hives on her trunk to date.
This spontaneous prospective pregnancy report has been received from a physician referring to a female patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with the first dose of VARIVAX (route, strength, dose, batch/lot # and expiration date were not reported) for prophylaxis of varicella virus. The patient became pregnant with last menstrual period (LMP) of 20-AUG-2018 and estimated date of delivery(EDD) of 27-SEP-2019 (reported the patient was 8 weeks pregnant at the time of this report). The pregnancy outcome was pending. On 03-SEP-2018, the patient was vaccinated with the second dose of VARIVAX (route, dose, batch/lot # and expiration date were not reported), and she was unknown she had been 2 weeks pregnant at the time of administration (vaccine exposure during pregnancy). At the reporting time, the outcome of the event was unknown.
3" diameter red area;warm to touch;sl firm arm; tenderness;cellulitis lt deltoid;tx;
Initial information received on 20-Mar-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 18 months old male patient received 0.5 ml fourth dose of QUADRACEL lot C5497AA, expiry date- 17-Jul-2020 via unknown route in the right thigh on 19-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration. There were no symptoms. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. Documents held by the sender: none.
pt recv vax; devel limpness, urticaria & elev T; to MD who dx rxn to meds, not to pertussis or MMR; put on DPH for inc T;
Pt initally presented to hospital on 10/20-10/26/08 with gait instability, garbled speech and Left sided weakness.  Pt was re-admitted to hospital on 11/20-11/23/08 with worsening weakness, increasingly garbled speech and severe gait instability.  Pt. transferred to hospital on 11/23/08 for a brain biopsy.  Brain Biopsy revealed demyelination consistent with progresive multifocal Leukoencephalopathy.  Pt's neurological status deteriorated until pt expired on 12/11/08.  11/22/2008 MR received for multiple admissions beginning ~10/20/2008.  Pt expired 12/11/08 with COD Progressive Multifocal Leukoencephalopathy. Pt presented to local hospital 10/20-26/08 with respiratory distress and admitted for COPD exacerbation and CHF. Also having sx of L sided weakness attributed to possible TIA. Pt d/c but developed increasing L-sided weakness and hemineglect and readmitted 11/10/08 with D/C DX: Immunogenic encephalitis s/p vaccination, Diabetes with hyperglycemia on steroids, COPD. Pt was acting confused with abnormal behavior c/w encephalitis. Started on antiviral and steroids w/o improvement. Pt continued to progress with worsening psychomotor retardation. Pt transferred to rehab for several days and admitted agian 11/19/08 for brain biopsy. D/C DX: Infiltrative bilateral frontal lobe process, extending into the brain stem, possible postvaccinal encephalomyelitis.  COPD, Dyslipidemia.  Basilar artery stenosis, HTN, DM, DVT risk, morbid obesity. Brain bx (+) for JC virus which lead to dx of PML. Pt with decreasing LOC.  Transferred to hospice care. Pt expired 12/11/2008. 2/5/09 Death Cert received.  COD:  Progressive Multifocal Leukoencephalopathy.