chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # R016638, expiration date 28-JAN-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of -2.94 degrees Celsius for one hour. Data logger was involved. There were multiple previous excursions below 0 degrees Celsius reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1811USA001858: US-009507513-1811USA001977: US-009507513-1811USA001976.
This spontaneous report as received from health department Alert of 01-APR-2014, refers to a 2 year old patient. On an unknown date the patient experienced measles. The patient was vaccinate with the first dose of measles, mumps, and rubella virus vaccine, (manufacturer unknown) (lot #, dose and route not reported) before exposure. The outcome of measles was unknown. Total 25 measles cases were reported in the Alert. Six cases had been hospitalized. Five cases (including this case, other four cases was captured in MARRS 1404USA006359) were confirmed as vaccinated with MMR vaccine before. It was not reported which cases among the 25 cases the 6 cases hospitalized cases refer to. Additional information has been requested.
Patient was admitted to the hospital with COVID infection on 10/25/21. Patient was fully vaccinated with Pfizer COVID vaccine (on 2/11/21 lot #EM9810 and  1/21/21 lot #EL3249). A FLUVID test indicates that patient did test positive for COVID on 10/25/21. Per provider notes, patient reported that 10 /25/21 was approximately day 9 of illness for her. Patient reported increased oxygen requirement (uses oxygen at home),muscle aches, fatigue, cough, and diarrhea. At the time of this report, patient is still admitted to the hospital for treatment of COVID infection, and it is not know when patient will be able to discharge.
Patient was sitting in chair when she passed out and fell on her face. She was convulsing (head and upper part of body) which ceased after approx. 10 seconds. At that time the patient became conscious. An ambulance arrived to assess patient. She was transported to the hospital for an extremely low heart rate.
07/25/02 Grandmother called Health Dept and states "She had a seizure today at about 11am." 07/26/02 called pt's home to check on pt and grandmother reports that pt had a second seizure at 11pm last night.
On 02/11/2023 my daughter received her Covid-19 vaccine. On 03/11/2023 my daughter started complain of sore throat with a low grade fever. After reaching out to her doctor she was diagnosed with strep throat. Doctor prescribed amoxicillin. Symptoms last about a week.
Information has been received from a nurse practitioner concerning a 38 year old pregnant female with allergy to DEMEROL and a history of gastric bypass in 1996 who on 31-OCT-2008 at 08:40 was vaccinated IM into deltoid with the second dose of RECOMBIVAX HB (lot# 660461/0401X). There was no concomitant medication. Dose 1 was administered at a different facility and the date that dose 1 was administered was unspecified. Dose 2 was given as 2 combined pediatric doses of RECOMBIVAX HB. As of 18-DEC-2008, the patient was 7 and 1/2 months pregnant (estimated LMP was 18-MAY-2008 and EDD was 22-FEB-2009). No symptoms reported. The patient sought medical attention in the office. Follow-up information received from a licensed practical nurse indicated that the patient was a female with sun damaged skin who received her first dose of (previously reported by the nurse practitioner as second dose) of RECOMIVAX HB (lot# 66041/0401X) IM into the left deltoid on 31-OCT-2008. Concomitant vaccine included FLUZONE, (lot # UT2882FA) IM into the right deltoid as 2 combined pediatric doses during the same visit. The patient did not seek medical attention (previously reported by the nurse practitioner as sought medical attention). The nurse practitioner's office had not seen patient since injection given on 31-OCT-2008 and could not provide any information regarding the outcome of the pregnancy. Follow-up information has been received from a healthcare professional who reported that the patient had 2 previous pregnancies and 1 live birth. No birth defect but a miscarriage or stillbirth occurred 5-6 weeks from last menstrual period during previous pregnancies.  It was reported that the date of LMP was 01-APR-2008. On 31-OCT-2008, 30 weeks after the LMP, the patient went to her primary care physician (PCP) for a flu shot and was given the RECOMIVAX HB instead in error (patient was pregnant at that time). During pregnancy, the patient took FLINSTONES MULTIVITAMINS and 2 doses of injection RHOGAM. No prescription drug was taken. The patient had no infections/illnesses during pregnancy. Ultrasounds were performed (results unknown) on 11-MAY-2008 (5 weeks 5 days from LMP), 27-JUN-2008 (12 weeks 3 days from LMP), 27-AUG-2008 (21 weeks 1 day from LMP) and 10-DEC-2008 (36 weeks 1 day from LMP). A nuchal translucency (results unknown) was performed on 27-JUN-2008 (12 weeks 3 days from LMP). An amniocentesis (results unknown) was performed on 26-AUG-2008 (21 weeks from LMP). On 30-DEC-2008, 39 weeks after the LMP, the patient delivered a normal, healthy female baby weighing 8 pounds 7 ounces with no congenital anomalies. Additional information is not expected.
Pt became pale, started shaking all over about 2 hrs p/immun; felt warm; t103 R; mom called MD who advised 2nd dose of APAP; shaking episode lasted about 10 mins; pt exp sz 12NOV91 5PM;
Chills started around 11:00 PM.  Extreme chills and fever through the night.  105.4F.
cough; muscle pains; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 21Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose: 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: COUGH (non-serious) with onset 2021, outcome "not recovered", described as "cough"; MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "muscle pains"; PYREXIA (non-serious) with onset 2021, outcome "recovered" (27Dec2021), described as "fever".  Additional Information: The patient received booster dose of Pfizer Covid vaccine 21Dec2021, developed a cough, muscle pains, and fever. Stated that symptoms are what was given in the paper. Fever was resolved as of 27Dec2021, and the patient was "feeling better" but coughing continues. Further would like to know if he should get a Covid test. Potential AE recognized after caller disconnected. Transmitting potential duplicate AE.  The lot number for bnt162b2 was not provided and will be requested during follow up.
A spontaneous report has been received from a Health Professional concerning a 30 year old, female subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 28-OCT-2014. On 28-OCT-2014 the pregnant woman received FLUMIST Quadrivalent and delivered baby on Nov 5, 2014. The outcome of the event of pregnancy and delivered is unknown. The report was considered to be non-serious by the reporter.
Vaccine received in am, noted red swollen and itchy hive on entire body late that?s afternoon
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 to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 22-FEB-2016, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In April 2016, the patient was treated by a healthcare provider 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 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 earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Information has been received from a physician concerning an approximately 90 year old female who in approximately 1997, 6 or 7 years ago, was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the patient developed a severe injection site reaction which required hospitalization. At the time of this report, the outcome was unknown. The reporting physician felt that the patient's injection site reaction was an other medical event (OMIC). No additional information is expected.
Patient presented to Facility with sudden onset headache and falls.  CT head large right cerebellar intraparenchymal hemorrhage with surrounding edema resulting in mass effect as well as 4mm right to leftward midline shift.   Platelets, Vitamin K and Plasma given.  Patient quickly had decreased level of consciousness.  Stat Head CT showed increased ICH, increased mass effect with new hemorrhage in R cerebellum, upward transtentorial herniation and obstructive hydrocephalus.  Patient intubated and taken to emergent OR for suboccipital craniotomy and External Ventricular Device placement. Post-op assessment was poor.  Stat CT showed hemorrhage on EVD track.  On 6/8 patient had MRI that showed upward transtentorial and downward foramen magnum herniation.  Goals of Care meeting was held on 6/9.  Patient will be terminally extubated 6/13/2022.
Pt received vaccine and was directed to mandatory waiting area by pharmacist, shortly after pt started having lightheadedness due to anxiety. This only lasted 5 minutes in length and after the 15 minutes, pt was back to normal mental status.
1040 The patient received the COVID vaccine. At 1055 the patient began to complain of a dry scratchy throat. Zyrtec 20 mg given per MD. Patient monitored for another 45 minutes.  Patient reported feeling better. Symptoms resolved. Discharged home per MD
Initial and follow-up information has been received from a physician concerning a 13 year old female with multiple medical problems who on 06-JUL-2007 was vaccinated with PNEUMOVAX (lot # unknown) injection.  On an unspecified date the patient developed cellulitis after the vaccine.  The physician reported that the patient experienced symptoms 48 hours after the injection was given.  Medical attention was sought.  No further information was provided.  At the time of reporting the patient had recovered.  Follow-up information was received from the physician and stated that this is not a case of cellulitis.  Additional information is not expected.  This is one of two reports from the same source.
This is an instance of breakthrough COVID-19 disease after which death occurred.   The individual was vaccinated with the Moderna product on 01/28/2021, 02/25/2021, and 10/28/2021. The first two doses were administered at the facility specified above, but the third dose administered on 10/28/2021 was administered at a different location: a pharmacy. The individual also received a flu vaccine on 10/28/2021.   The individual presented to emergency department on 02/07/2022 with primary complaints of general weakness and visual hallucinations which had been going on for approx. 2 weeks. The individual was admitted to hospital due to the combination of complex medical conditions and these concerns. They tested positive for COVID-19 on 02/07/2022. The individual seemed to have minimal COVID-19 symptoms, with occasional cough and minimal oxygen needs until 02/14/2022, when their conditions suddenly worsened and they became hypoxic unexpectedly. The individual was transitioned to comfort care only and died on 02/15/2022.
L arm (site of injection) and L back rash. Onset 1 wk after injection. Present now for 1 week.
1/2 - 1/4 developed chills, nausea which is par for the course 1/5 continued with same symptoms and then developed hives, back, arms, legs, ankles and feet 1/5 directed to:  given prednisone 50mg, bendryl 50mg and zyrtec 10 mg in ED and then given script for Prednisone 50mg 1 tablet daily for 5 days, zrytec 10 mg, 1 tablet daily and benadryl 50 mg every 6  hours as needed
PRONOUNCED PAIN @ INJECTIONS SITE TRAVELING DOWN ARM. HEADACH AND BODY ACHES. NAUSEAS. TOOK ADVIL FOR PAIN, PEPTO AT NIGHT (1/12) AND MORNING (1/13)
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information was received from a Medical assistant on 02-JUL-2015 concerning a patient of unknown age and gender who on 21-APR-2015, the patient was vaccinated with a dose of ROTATEQ lot # K011663 (expiration date, dose, route and site of administration were not reported) that was exposed to temperatures outside of the recommended range. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Headache, Myalgia, Nausea Vomiting, chills Narrative:
I developed an ITP flare after receiving vaccine and my blood platelets dropped to as low as 7000.; I developed an ITP flare after receiving vaccine and my blood platelets dropped to as low as 7000.; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient (not pregnant) received second dose of bnt162b2 (Pfizer, Batch/Lot number was not reported), via an unspecified route of administration on 15Jan2021 as single dose for covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took aspirin (e.c.) and developed allergies (known allergies Aspirin and related products), first dose of bnt162b2 in left arm on 29Dec2020 for covid-19 immunization. The patient developed an ITP (immune thrombocytopenia) flare after receiving vaccine and her blood platelets dropped to as low as 7000 on 22Feb2021. The patient underwent lab tests and procedures which included platelet count: platelets dropped to as low as 7000 on 22Feb2021, nasal swab: negative on an unspecified date. Therapeutic measures (Steroids) were taken as a result of events. No other vaccine in four weeks. No other medications in two weeks. The event resulted in doctor or other healthcare professional office/clinic visit. No covid prior vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The outcome of events was resolving.  Information on the lot/batch number has been requested.
Presented to Drs office on 5/23/21 with R leg swelling x 2 weeks duration. Has previous hx of DVTs related to Factor V Leiden. No additional information available about dx or treatment duration.
Missed a period (menstruation cycle) the following month but returned twice as heavy the month after
5/11/2021   Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, she experienced an adverse reaction with the following symptoms:  dizziness, nausea and leg cramps, dyspnea, sweating.   Assessment : Time of assessment Alert and oriented and skin dry.   Actions taken:  Vitals sign taken  VAERS form obtained and completed by RN.  At 1029 VS- BP-168/98, P- 60, O2- 97 %, given water and crackers, at 1044 VS- P- 58, O2- 98%, complains of feeling anxious, and dyspnea, 1046 feeling better, no dizziness or cramping, 1050- patient reports breathing better, complains of feeling hot and cold with chills, O2- 97-98%, P- 54=55. 1103- denies all S&S, Vs - BP_ 146/83, P- 59, O2- 99%.       Medications administered: Loratadine (Claritin) 10 mg  by mouth. Time: 1036. Administered by RN.   Disposition: Reports no further symptoms of adverse reaction after observation for 60 minutes. Discharged home.     Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 5/11/2021  9:57 AM 0.3 mL 2/25/2020 Intramuscular   Manufacturer: Pfizer, Inc   Lot: EW0182
No additional AE; Caller reported that PROQUAD that experience a temperature excursion was administered.; This spontaneous report has been received from a pharmacist concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 14-DEC-2022, the patient was vaccinated with an improper stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot # W024972, has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live [rHA] [PROQUAD], expiration date reported and upon internal validation established as 05-FEB-2024) for prophylaxis (dose, anatomical location and route of administration were not reported). The vaccine suffered a temperature excursion (temperature -14 up to -10 Celsius degrees (-11.11C) for 17 hours and 45 minutes) (Product storage error).  No additional adverse event was reported.
Received GARDASIL 6/14/11; that evening he developed sensation "legs aren't helping me" during baseball game and parents noted awkward running gait; seen 6/17/11 in office and though he feels somewhat improved with normal stand mother still feels he runs differently.
TINGLING IN FACE, HANDS, AREA TOWARDS EARS, THROAT AND FINGERS; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: latex allergy, certain food allergy, abstain from alcohol, non smoker, high cholesterol, and irregular heart beat, and other pre-existing medical conditions included: Since childhood patient gets scared when everything gets dark and she was unable to breathe. The patient had not drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, and expiry: 21-DEC-2021) dose was not reported, 1 total administered on 24-SEP-2021 in left arm for prophylactic vaccination. Concomitant medications included atenolol/hydrochlorothiazide, and simvastatin.  On 24-SEP-2021, around 3 PM she felt the sensation in fingers and hands. The tingling started in lower face on the right side then moved to the left. It started right under her chin area towards ears and moved down to throat(Paraesthesia).Treatment medications (dates unspecified) included: epinephrine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tingling in face, hands, area towards ears, throat and fingers. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210951778-covid-19 vaccine ad26.cov2.s - tingling in face, hands, area towards ears, throat and fingers.This event(s) is labeled per Safety Information and is therefore considered potentially related.
Redness on Rt thigh, with blistering and looks blue. Spreading as well. Dx Cellulitis of thigh. Treated with Amoxicillin-Pot Clavulanate 600-42.9 mg/5mL. Pt to take 3ml BID x 10 days.
pt recv vax & pt exp serum sickness, nephritis & hosp for 10 days;
shoulder warm; shoulder swollen; Extra dose administered; swollen lymph node under arm; Shoulder sore; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (shoulder warm), SWELLING (shoulder swollen), EXTRA DOSE ADMINISTERED (Extra dose administered), LYMPHADENOPATHY (swollen lymph node under arm) and ARTHRALGIA (Shoulder sore) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN WARM (shoulder warm), SWELLING (shoulder swollen), EXTRA DOSE ADMINISTERED (Extra dose administered), LYMPHADENOPATHY (swollen lymph node under arm) and ARTHRALGIA (Shoulder sore). At the time of the report, SKIN WARM (shoulder warm), SWELLING (shoulder swollen), LYMPHADENOPATHY (swollen lymph node under arm) and ARTHRALGIA (Shoulder sore) outcome was unknown and EXTRA DOSE ADMINISTERED (Extra dose administered) had resolved.            Patient is taking steroids. No treatment medications were reported   This case was linked to MOD-2021-294169 (Patient Link).
Flu shot 10/13/05 had red rash with itching from above knees to head, arms, thighs and chest.  Saw Dr. 11/30/05 was treated wing methylprednisolone 4 mg packet for 7 days.  and Zyrtec 10mg 1x day for 10 days.  rash still present no difficulty breathing.  To follow up with Dr again or dermatologist.
Tingling, weakness, and numbness in lower left leg from knee down. Lasted approximately 12 hours. With movement, there was shooting, burning pain throughout lower left leg from knee down. Weakness was perceived in leg for approximately six hours. No injury to precipitate incident.
Pt vaccinated with DTP/OPV experienced unusal high pitched cry, hypersensitivity to stimulation.
A report has been received from a Health Professional. The report concerning to multiple patients of unknown gender, who had been receiving Nasal FLUMIST Quadrivalent (Intranasal), 0.2 Millilitres. FLUMIST (Intranasal) started on an unknown date. The patient experienced vaccine exposed to temp excursions. No data on the stability of the product after a temperature excursion on Jan4 to 32F and Jan15 to 32F. The outcome of the event of vaccine exposed to temp excursions is unknown. The report was considered to be non-serious by the company physician.