chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woke up with burning urination feeling " up all night . Went to urgent care at 8:00a,m. Urinalysis revealed blood in urine and UTI . More results to follow . Will be put on antibiotics .
COVID test result: Positive; COVID test result: Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: Er8730), in left arm, on 31Jul2021 as dose 2, single (Lot number: Er8731), in left arm and on 29Nov2021 as dose 3 (booster), single (Lot number: Ff2593) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Jun2022, outcome "unknown" and all described as "COVID test result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jun2022) Positive.
Disseminated varicella, rash, hypotension, Hospitalized 45 days treated with Acyclovir, Foscarnet, as well as Tobramycin and vancomycin and cuspofungim for septic episodes.  Verified AE onset date (box 11) as 10/10/2006 (not 2007). 03/06/2007 Extensive MR received for a 45 day hospitalization for disseminated varicella following vaccination.  The child was also experiencing a septic-like episode with poor color, poor perfusion and low blood pressure on the day of admission. PE: Listless with weak cry, perfusion improved from earlier with BP of 110s/70s. However peripheral perfusion remains poor with cap refill of 7-8 seconds. Intraoral varicella lesions with oral candidiasis on her tongue and buccal mucosa. Intra-auditory canal varicella lesions. Diffuse scattered varicella lesions which appear to have a mild superinfection.  GJ tube insertion has mild erythema. Liver and spleen enlarged. Otherwise, the child appears ill, but exam is grossly non-focal. She was admitted to the PICU and treated with Tobramycin, Vancomycin, Acyclovir, Foscarnet, and Caspofungin. Pain control was also initiated with a ketamine and benzodiazapine drip. She initially responded to the Acyclovir but began developing new lesions again on 11/08/2006.  Hypertension developed early on in the hospitalization without known cause, and treated with multiple anti-hypertensives. She was discharged after 45 days with frequent F/U in the heme/onc clinic with occasional varicella eruptions.  Chemotherapy was resumed on 2/1/07. Assessment:  Disseminated varicella, status post vaccination in an immunocompromised host.  Langerhans cell histiocytosis.  Chemotherapy-currently on hold.  Malnutrition, requiring gastrostomy tube feeds. Hypertension of unknown etiology.  History of developmental delay.  Narcotic and benzodiazapine wean.  History of gram (-) spectrum beta lactamase blood cultures.  Stable hepatosplenomegaly.
Lungs inflammation/it's swelling all around the heart; Arm swelled up; High fever; Not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONITIS (Lungs inflammation/it's swelling all around the heart), PERIPHERAL SWELLING (Arm swelled up), PYREXIA (High fever) and EXTRA DOSE ADMINISTERED (Not immunocompromised) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Sep-2021, the patient experienced PNEUMONITIS (Lungs inflammation/it's swelling all around the heart), PERIPHERAL SWELLING (Arm swelled up), PYREXIA (High fever) and EXTRA DOSE ADMINISTERED (Not immunocompromised). On 22-Sep-2021, EXTRA DOSE ADMINISTERED (Not immunocompromised) had resolved. At the time of the report, PNEUMONITIS (Lungs inflammation/it's swelling all around the heart) and PERIPHERAL SWELLING (Arm swelled up) outcome was unknown and PYREXIA (High fever) had resolved.            No concomitant medications were provided. No treatment medications were reported. The patient had high fever last only one day arm swelled up and lungs inflammation. The doctor thought it was pneumonia, but the fever went away after one day, it was swelling all around the heart.   This case was linked to MOD-2021-331716 (Patient Link).
Fever (100.4 F); chills; fatigue; nausea; general malaise; This is a spontaneous report from a contactable Consumer. This consumer reported for a 16-year-old male patient that.  A 16-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0186), dose 2 intramuscular, administered in Arm Left on 11Jun2021 17:00 as (Age at the time of vaccination 16-years) DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0186),dose 1, intramuscular, administered in Arm Left on 21May2021 at 06:00 pm for COVID-19 immunization. Patient did not receive any other vaccine in four weeks. No covid prior vaccination. No Known allergies ware reported. Other medications in two weeks included Multivitamins. The patient experienced fever (100.4 f), chills, fatigue, nausea, and general malaise on 12Jun2021 10:00. Patient received treatment with Ibuprofen 200 mg (2 tablets) for events. The patient underwent lab tests and procedures which included body temperature: 100.4 fahrenheit on 12Jun2021. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Injected 0.5mL of air instead of vaccine; Sore arm and pain; A spontaneous report was received from a nurse concerning an 81-year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and resulted in the following events injected 0.5mL of air instead of vaccine, sore arm and pain.  No relevant medical history and concomitant medications were reported.  On 21-Jan-2021, prior to the onset of events, the patient received their first of two planned doses of MRNA-1273 (lot number 029L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 21-Jan-2021, the patient was injected with 0.5mL of air instead of vaccine and was evaluated, where she complained about sore arm and pain. No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the event, injected 0.5mL of air instead of vaccine was considered to be resolved on 21-Jan-2021. The outcome of the event, sore arm and pain was unknown.; Reporter's Comments: This case concerns a 81-year-old, female patient. This report refers to a case of Product administration error for mRNA-1273 (lot number 029L20A), when 0.5 ml of air was injected instead of vaccine. The adverse event of pain in arm is associated with this case of product administration error.
muscle aches; upset stomach; headache; tiredness; in bed all day today; This case was reported by a consumer via call center representative and described the occurrence of myalgia in a 67-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th February 2020, the patient received the 2nd dose of Shingrix. On 20th February 2020, 1 days after receiving Shingrix, the patient experienced myalgia, upset stomach, headache, tiredness and bedridden. On an unknown date, the outcome of the myalgia, upset stomach, headache, tiredness and bedridden were not recovered/not resolved.   It was unknown if the reporter considered the myalgia, upset stomach, headache, tiredness and bedridden to be related to Shingrix.  Additional details were provided as follows: The pateint had shingles vaccine on the day before reporting and had in bed all day on the day of repoting with muscle aches, upset stomach, headache and tiredness.  The reporter inquired how long did the symptoms usually last.
He woke up panicked; Vision loss; Visual disturbances; Difficulty breathing; This is a spontaneous report from a contactable consumer. A 67-years-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 31Mar2021 as a single dose for COVID-19 immunization. Medical history included: heart attack a few years ago and takes maintenance drugs for the heart condition and asthmatic and takes medication but the medications come and go depending on how he is physically. Concomitant medications were not reported. This case was from the same reporter; this case is for the husband. On 2Apr2021 he experienced difficulty breathing and they did not know if it was attributed to the vaccine but he did not have any breathing issues until he got the vaccine but it was a general feeling of something was different but did not think it was severe until the vision thing. Reporter stated there is no medication her husband takes that is related directly to the episode he experienced. On 5Apr2021, he woke up from being asleep, asked if the TV was on (which it was) because he could hear it, but could not see it. His symptoms have also resolved. He had no history of anything like that happening previously with the first dose pfizer covid vaccine. Hi wife stated that he experienced visual disturbances since then, with no prior history of vision impairment. The outcome of the events could not see, Visual disturbances was recovered; the outcome of Difficulty breathing was not recovered; the outcome of the event He woke up panicked was unknown.   Information on the lot/batch number has been requested.
Information has been received from a physician concerning a female who was vaccinated with a first dose of GARDASIL (route and lot# not provided) was one day late on getting her menstrual cycle. She might be pregnant (to be determined by office). Physician did not want to provide more information yet. He might call back. The patient had an appointment with the physician (date unknown). The patient's outcome unknown. No product quality complaint was involved. No further information is available.
Pt recv vax 22MAY96 & 4JUN96 pt exp rash w/11 or 12 pox; No vesicles were noted;No further details were provided;
pt recv vax;pharmacist reported that pt devel total body rash consisting of large bumps w/ red rings around the base & itching on 11aug94;
a few days later started feeling as if my ears filled with water a day or two later hissing in my left ear and is still there but today 4/14 at 12 noon i experienced a bad vertigo room spinning very fast.I am concerned because i have a appt. on 4/17 for my second dose.Will someone get back to me soon.
Significant swelling, heat, redness, pain to r arm. Fever with temp max of 102, headache and body aches that have required use of Tylenol and ibuprofen for more than 24 hours to keep managed
Information has been received from a registered nurse concerning her daughter, a 14 year old female, who in 2006 was vaccinated with varicella virus vaccine live (Oka/Merck). In 2006 the patient developed a lump on her neck shortly after receiving her vaccination with varicella virus vaccine live (Oka/Merck), which her mother reported "eventually fully recovered". There was no product quality complaint. Additional information has been requested.
Patient was out of date range for Moderna Correct by 1 month later given Pfizer 5yr-11yr. Mother did not record any adverse reaction.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 5:05 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 3:57 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 77.83 for dose administered on 02-Mar-2021 and 77.91 for dose administered on 30-Mar-2021. No concomitant medications were reported. Batch number 014M20A underwent temperature excursion on 02-Mar-2021 with temperature 36 degrees Fahrenheit from 09:00 AM to 03:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 02-Mar-2021. Batch number 019B21A underwent temperature excursion on 30-Mar-2021 with temperature 33 degrees Fahrenheit at 09:00 AM This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 30-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Rt arm -felt heavy and soreness - still feels heavy and sore after 28 days. Had slight fever/aching 2-3 after vaccine administered. Educated pt re: live virus vaccine. Pt advised f/u with PMD for evaluation.
1st dose / 24Aug2020 /  little pain in the injection site.; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix and had experienced only little pain in the injection site. The reporter consented to follow up. For tolerance after 2nd dose refer case US2020AMR220342.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR220342:same patient (2nd dose)
Developed shingles L facial  (V- 1 nerve root) few days after ZOSTAVAX.
Case number PHEH2014US010437 is an initial spontaneous report from the pharmacist received on 21 May 2014, with a follow up received from nurse on 17 Jun 2014. This report refers to a 19-year-old female patient. She was inadvertently vaccinated with an expired MENVEO (batch number: A11081) intramuscularly on 19 May 2014. No adverse event reported following this medication error (expired vaccine used). The reporter stated that she does not belong to their practice. She used to be their patient many years ago, but was no longer their patient and they have no records of her. So they cannot provide any additional information. Follow-up received form nurse on 17 Jun 2014: Updated reporter comment.
Information has been received from a registered nurse concerning an approximately 51 year old male who may have been vaccinated as a child with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) and varicella virus vaccine live (VARIVAX) and had low titers. The nurse did not have any additional information on the patient's vaccination history or what titers were low. The patient was applying to school. No problems were reported. No other information available. No further information available.
Injection site reactions (severe pain, redness), fever, chills, severe arm swelling and arm heaviness. All signs/symptoms lasted approximately 5 days, which then later lead to skin peeling.
Gave the flu shot on the right arm and in an instant it turned red and then it turned blue.
Information has been received from a medical assistant concerning a 78 year old retired female with hypertension, hypercholesterolemia, COPD, and a sulfa allergy who on 8/3/05 at 9:30am was vaccianted IM in the left arm with a first 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 647661/0055R). There was no illness at the time of vaccination. Subsequently the pt experienced burning at site of injection and pain at site of injection. Follow up information received from a medical assistant indicated that on 8/3/05 at approx 6:00PM, the pt developed pain, edema and warm to touch in the left upper arm. She was advised to use Benadryl every l4 hours PRN, Tylenol every 4 hours PRN, and cold compresses. Additional follow up information received from a medical assistant indicated that the pt recovered. No additional information is expected.
Fever; Chills; Fatigue; Headaches; Muscle pain; Joint pain; Soreness on his arm/Tenderness on his arm; Tightness on his arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY, MUSCLE TIGHTNESS, PYREXIA, CHILLS, and FATIGUE in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic. Concomitant products included ESCITALOPRAM, ROSUVASTATIN, INSULIN, VITAMINS, and AMLODIPINE for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY and MUSCLE TIGHTNESS. On 10-Mar-2021, the patient experienced PYREXIA, CHILLS, FATIGUE, HEADACHE, MYALGIA, and ARTHRALGIA. On 11-Mar-2021, PYREXIA had resolved. On 13-Mar-2021, CHILLS, FATIGUE, HEADACHE, MYALGIA, and ARTHRALGIA had resolved. On 14-Mar-2021, PAIN IN EXTREMITY and MUSCLE TIGHTNESS had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included Blood thinner. Treatment information were not provided.   This case was linked to MOD-2021-070009.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow-up information received on 19-may-2021 contains non-significant information. Sender's Comments: MOD-2021-070009: 2nd dose.
Excessive Sweating after the Second Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Excessive Sweating after the Second Vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On an unknown date, the patient received second 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 HYPERHIDROSIS (Excessive Sweating after the Second Vaccine). At the time of the report, HYPERHIDROSIS (Excessive Sweating after the Second Vaccine) outcome was unknown.            No relevant concomitant medications were reported  No treatment information was provided.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 27-OCT-2012 18:26, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. 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.
Information has been received from a nurse practitioner concerning a 24 year old female who on 15-AUG-2007 was vaccinated with her first dose of Gardasil.  There was no concomitant medication.  On 25-AUG-2007 the patient called the office and reported that she had a rash at the injection site and then it got progressively worse and spread to her stomach and face.  She took BENADRYL to help the rash.  Additional information has been requested.
9OCT98 c/o fine red non itchy rash on chest & shoulders & 1wk T989 c/o body aches, knee & rt wrist pain x several days;