chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Day 1: About 5 hours after receiving a pneumonia vaccine, I woke up with excruciating pain in the injection site- left arm-. Any form of movement sent a wave of nausea over me. I could not move the arm without screaming or crying. Taking Ibuprofen was the only thing that brought a form of relief. Had to miss a whole day of work. Day 2: Arm not nearly as sore, but skin around the injection site is red and splotchy, the skin is hot to the touch, and there seem to be lumps under the skin. Day 3: Pain nearly gone in the arm, but redness has grown worse and arm is still hot to touch.
received their second dose, dose was expired; This case was reported by a nurse via sales rep and described the occurrence of expired vaccine used in a 79-year-old patient who received Hepatitis A vaccine for prophylaxis.   Previously administered products included Hepatitis A vaccine (received 1st dose on 21st December 2021).   On 21st June 2022, the patient received the 2nd dose of Hepatitis A vaccine. On 21st June 2022, unknown after receiving Hepatitis A vaccine, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 27-JUN-2022 Reporter's Comments: The patient received their second dose of Hepatitis A vaccine; however, the dose was expired. No systemic or local reactogenicities were reported at the time of reporting. Additional Supportive Information: The patient received Hepatitis A vaccine which was expired which led to expired vaccine used. This case had been linked with case US2018117623, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2018117623:Same reporter
10/5/23 woke up with numbness from injection site down to left arm & epigastric pain.  Seen in employee health clinic. 10/9/23  Reports she woke up with above s/s continuing along with numbness up in to left side of face.   Dr. sent employee directly to ED where lab work and CT head were completed.   Labs & CT negative; no significant findings. 10/10 Employee health clinic symptoms remain the same but reports numbness to left shoulder has improved some.   Schedulke appointment with Dr. neurology and MRI brain ordered. & scheduled for 10/18/23.
pt recv vax;seemed fine, mom said she gave apap q 4 hr;29mar95, pt pale, shaking; to er; T 103-104 for 5 days;
10/24/01-Patient experienced tremors which were more severe on the right side of his body. He also had a headache and his eyes were involuntary cross-eyed.  10/26/2001-The neurologist did a lumbar puncture and a WBC. (See results below) 10/27/01- All symptoms were resolved.
Administration of the Rotarix Diluent Alone; inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Rota (Rotarix lyophilized formulation) (batch number KB7FJ, expiry date 19-SEP-2024) for prophylaxis.   On 25-OCT-2023, the patient received Rotarix lyophilized formulation. On 25-OCT-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate preparation of medication (Verbatim: Administration of the Rotarix Diluent Alone) and inappropriate dose of vaccine administered (Verbatim: inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were 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: GSK Receipt Date: 02-NOV-2023 Clinic Supervisor reported that 6 kids received Rotarix diluent alone with our mixing it which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up via email. This case is 1 out of 6 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2023152363:Different patient US-GSK-US2023152373:Different patient US-GSK-US2023152365:Different patient US-GSK-US2023152370:Different patient US-GSK-US2023152371:Different patient
PATIENT RECIEVED VACCINE 6/3/2021 IN THE AFTERNOON S/P LACERATION TO LEFT HAND. PATIENT  REFUSED VACCINE 2 DAYS BEFORE DURING INITIAL  VISIT TO ANOTHER LOCATION. 6/3/2021 IN THE LATER AFTERNOON PATIENT STATED TO WIFE EYE FEELS FUNNY. 6/4/2021 9AM PATIENT STATED EYE AND MOUTH NOT FEELING RIGHT NOT WORKING PROPERLY. PATIENT WENT FOR JOG AROUND 1700HRS FELT UNSTEADY ON HIS FEET. 6/5/2021 PATIENT DIAGNOSIS WITH BELL'S PALSY. POSSIBLE VACCINE REACTION.
Patient with spinal muscular atrophy.  Wheelchair bound, very abnormal habitus.  She developed chest pain and then back pain 1 minute after IM vaccination; then became unresponsive.  Initially unable to feel pulse.  Responded to lying down and conservative care.  Back to normal in about 10 minutes.
Redness increased/swelling increased; Swelling increased and was about egg shaped size; Little bit of itchiness at the injection site; Redness at the vaccination site; Some swelling at the vaccination site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at the vaccination site), VACCINATION SITE SWELLING (Some swelling at the vaccination site), VACCINATION SITE PRURITUS (Little bit of itchiness at the injection site), CONDITION AGGRAVATED (Redness increased/swelling increased) and VACCINATION SITE SWELLING (Swelling increased and was about egg shaped size) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lymph node excision and Lumpectomy. Concurrent medical conditions included Penicillin allergy and Seasonal allergy.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the vaccination site) and VACCINATION SITE SWELLING (Some swelling at the vaccination site). On 06-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Little bit of itchiness at the injection site). On 09-Jan-2021, the patient experienced CONDITION AGGRAVATED (Redness increased/swelling increased) and VACCINATION SITE SWELLING (Swelling increased and was about egg shaped size). On 08-Jan-2021, VACCINATION SITE PRURITUS (Little bit of itchiness at the injection site) had resolved. On 14-Jan-2021, VACCINATION SITE ERYTHEMA (Redness at the vaccination site), VACCINATION SITE SWELLING (Some swelling at the vaccination site), CONDITION AGGRAVATED (Redness increased/swelling increased) and VACCINATION SITE SWELLING (Swelling increased and was about egg shaped size) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
RECEIVED LESS THAN 0.5ML OF VACCINE AS A BOOSTER DOSE (0.3ML); OFF LABEL USE; This spontaneous report received from a health care professional concerned an 18 year old  female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient previously received covid-19 vaccine from unspecified manufacturer (form of admin, route of admin, and batch number were not reported), 1 in total, dose was not reported (dose number in series was 1), for prophylactic vaccination. The reporter does not reported any adverse events following vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: 11-APR-2022) dose was not reported, (dose number in series was 2), 1 total administered on 01-DEC-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 01-DEC-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the reporter mentioned that patient received less than 0.5 Milliliter (mL) of the vaccine as a booster dose approximately around 0.3mL of dose (vaccine under dose and off label use) (both events dose number in series was 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5ml of vaccine as a booster dose (0.3ml) and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210684, 20211209912, 20211210067, 20211209775, 20211209874, 20211209874, 20211209880, 20211209884, 20211210107, 20211210112, 20211210112, 20211210141, 20211210143, 20211210159, 20211210165, 20211210180, 20211210197, 20211210334, 20211210350, 20211210385, 20211210408, 20211210409, 20211210585, 20211210590, 20211210662, 20211210733, 20211210824, 20211212082, 20211212088, 20211209551, 20211210160, 20211210549, 20211210610, 20211210555, 20211210133, 20211209816, 20211209782, 20211209551, 20211209775, 20211209782, 20211209798, 20211209798, 20211209816, 20211209874, 20211209884, 20211210107 and 20211210588.
Bell?s Palsy- right side of face paralyzed with severe ear pain and loss of taste.  Doctor prescribed Prednisone 10 mg and Valacyclovir 1g
this is 1 of 2 who devel an inj site rxn 24hr p/vax;
Medical assistant calls to report a temperature excursion that occurred on November 9, 2020 / The products were administered; No other information given at this time.; This spontaneous report was received from a medical assistant, referring to an unknown number of patients of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 09-NOV-2021, the following vaccines experienced temperature excursion, and then on unknown dates, they were administered to unspecified number of patients: measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (formulations, strengths, doses, vaccination schemes frequency, routes of administration and anatomical sites of vaccination were not reported; lot numbers S007811, S029457 and S005248, expiration dates reported and validated as 14-MAR-2021, 19-SEP-2021 and 20-FEB-2021, respectively to each lot number), hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)  (formulations, strengths, doses, vaccination schemes frequency, routes of administration and anatomical sites of vaccination were not reported; lot numbers 1621929 and R025729, which has been verified to be valid, expiration dates reported and validated as 06-DEC-2021 and 18-JUN-2021, correspondingly to each lot number), haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (formulation, strength, dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported; lot number R014263, which has been verified to valid, expiration date reported as 26-JAN-2021, but upon internal review it was established as 26-MAR-2021), and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe (PFS)  (strengths, doses, vaccination schemes frequency, routes of administration and anatomical sites of vaccination were not reported;(lot numbers S005856, S029542 and T020638, which has been verified to valid, expiration date reported and validated as 03-DEC-2020, 10-JUN-2021 and 26-FEB-2022, respectively to each lot number), all the vaccines were administered as prophylaxis. The vaccines administered experienced a temperature excursion above 47 degrees Fahrenheit (F) for a time frame of 3 hours. There was a previous temperature excursion above 47 F (47.4 F) for 1 hour and 20 minutes, 47 F (46.7 F) for 50 minutes and 47 F (47.6 F) for 40 minutes, as recorded by a data logger. No additional adverse events were reported. At the reporting time, some of the lot numbers had expired, but were not expired at the time of the administration, neither the lot numbers had expired at the time of the report.    This case has been considered non-valid due to the lack of patients' identifiers.
Early January I noticed tingling in hands and feet on and off during the day more significant when laying down, two weeks later late January developed lumps on interior on legs very hard and painful, showed them to my orthopedic doctor, sent for ultrasound to. check for blood clouts results were negative, Vein doctor ordered another ultrasound which came out negative.  The orthopedic doctor asked for MRI, was prescribed antibiotics and pensione, completed antibiotics, injected each site with pensione lumps reduced.  Tested positive for covid, experiencing breathing difficulties.  10 days of stronger antibiotics and pensione to treat respiratory infection.  Hands and feet began to appear gray dark blue color.
Patient received Zostavax at a Pharmacy, prescribed by me.  Vaccination was given in the left upper arm on 02/14/2007.  On 02/21/2007 patient noticed burning discomfort on left buttock and a day later notice a cluster of red blisters which spread to the inner left thigh.  He saw me on 02/26/2007 and his exam revealed what looked like a typical herpes zoster rash on the left buttock and left inner thigh.  The lesions were cultured for herpes zoster [result still pending] and he was given Valtrex 1 gram 3 times daily for 1 week and Vicodin for pain.  Patient also informed me that he had forgotten to tell me when I went over all of his medications before prescribing the Zostavax, that he was using a sinus rinse daily, given by another physician, that contained triamcinolone in it.  This reaction is reported to Merck. This is in follow-up to report (s) previously submitted on 3/14/2007. Information has been received from a pharmacist cnocerning a 72 year old male who on 14-FEB-2007 was vaccinated SC with a dose of ZOSTAVAX (Oka/Merck) (lot # 656606/0033U). Concomitant therapy included LASIX, COUMADIN, CELEBREX and clonazepam 0.5 mg. On 17-FEB-2007, the patient developed a rash on his back which was circular and was two to three inches wide. The patient was diagnosed with shingles and prescribed VALTREX and VICODIN. Additional information was received from a physician who reported that the patient's symptoms started on 21-FEB-2007 (originally reported as 17-FEB-2007) and lesions appeared on 22-FEB-2007. The patient was seen in the office on 26-FEB-2007. Samples of the lesions from the left thigh were obtained in a viral culture media and were sent to a laboratory. The patient told the physician that his ear, nose, and throat specialist ordered a sinus rinse of triamcinolone and he had been taking that for about a month. A product quality complaint was not involved. The patient was enrolled in the VZVIP program: the Varicella Zoster Virus Identification Program enables biological samples to be analyzed by PCR to identify if VZV is present and if it is present to identify whether it is associated with the wild-type VZV strain or with the OKA/Merck vaccine VZV strain. The specimen arrived in the laboratory on 01-MAR-2007. No VZV DNA was amplified and no B-globin DNA was amplified. The PCR analysis results were inadequate to process. Additional information has been requested.
Covid arm which enlarged; Big red rash at injection site; Sore and tender to the touch; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Covid arm which enlarged), INJECTION SITE RASH (Big red rash at injection site) and AXILLARY PAIN (Sore and tender to the touch) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PERIPHERAL SWELLING (Covid arm which enlarged), INJECTION SITE RASH (Big red rash at injection site) and AXILLARY PAIN (Sore and tender to the touch). At the time of the report, PERIPHERAL SWELLING (Covid arm which enlarged), INJECTION SITE RASH (Big red rash at injection site) and AXILLARY PAIN (Sore and tender to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reports treating big red rash at injection site with ICE.
@ 12 pm chills, headache, very tired and weak, arm pain at injection site symptoms  lasted till 10 pm 3/13/21 then on 3/14 when I woke up @ 9am my armpit was bothering me on my right side.
Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 16-MAR-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K014798 (expiration date 12-MAR-2016, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
The child came home from school with a large golf ball sized red, warm and raised spot where the vaccine was given. Child also had a headache after the last shot that started that evening and went until the next day.
Headache, Fever, c/o tingling left fingers and hand,left lymph node in air pit swollen,fatigue,injection site sore,reddness,warmth and swelling Narrative:
Patient reports hives, facial, lip and nose edema, and chest pressure. Took allergy med and Tylenol and all resolved today except for some nose edema. Of note she has had dermal fillers in her face and nose 6 years ago,
A spontaneous, non-serious report of administration of FluMist six days apart was received from a registered nurse concerning a male child (age unknown). Medical history and concomitant medications were not reported. On 23-Sep-2009, the patient received FluMist at a physician office. Six days later, on 29-Sep-2009, the patient received another dose of FluMist at school. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. All follow-up attempts have been completed per company SOP's.  No further information is available. 19-Feb-2010.
Patient developed rash and also lymphadenopathy, supraclavicular after injection with 2nd dose of moderna covid vaccine
vaccination to patient with improperly stored vaccine; This spontaneous report as received from a nurse refers to a currently 4-month-old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not reported.  On an unknown date, the patient was vaccinated with improperly stored vaccine rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number and expiration date were unknown, strength and frequency were not reported) 0.5 milliliter (ml) orally for prophylaxis. The vaccine was stored under 28 Fahrenheit (F), 33.9 F and 50.2 F for 7 hours and 10 minutes. It was reported that there was no previous temperature excursion. The event was found supported after the vaccination. The digital data logger was not involved.   This was one of six reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA009426: US-009507513-2009USA009674: US-009507513-2009USA009446: US-009507513-2009USA009550: US-009507513-2009USA009631:
This spontaneous report as received from a physician refers to a 79 years old female patient. The patient was vaccinated with a dose of live ZOSTAVAX (lot number unspecified)on 06-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient went to the physician;s office with a case of shingles. No treatment was given for the events. The outcome of shingles was not recovered/not resolved. The relatedness for shingles was unknown for live ZOSTAVAX. Additional information has been requested.
First 30 minutes sore throat, hoarse, evening hrs raised red rash on arm of injection. Next 2 days after gathered red rash on entire body. Next 2 wks. shingles in entire left side of body then rash at that side of spine. This has happened for last 3 yrs after flu shot. Must have activated shingles shot May 3 yrs. earlier given to me.
EMPLOYEE REPORTS HE AWAKENED ON 10.04.2016 WITH JOINT PAIN, BY EVENING HE HAD WEAKNESS, DIZZINESS, CHILLS/CLAMMY, PALPATATIONS, NIGHT SWEATS.  10.05.2016 CALLED OFF FROM WORK DUE TO SYMPTOMS.
From initial information received on 4/16/03 from a nurse regarding an adverse event occurring in the US, it was reported that a 20 year old female patient received her first dose of IMOVAX RABIES, lot number T0133, given IM in the deltoid on the evening of 4/9/03. Within half an hour after the vaccination, the patient developed tightness in her throat, a rash on her legs and hands and complained of having a fever, a headache and feeling nausea. The recovery status of this patient was not reported.
Negative COVID test; nausea; passed out; chest pain; shortness of breath; Tested positive for COVID; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (passed out) in a 77-year-old male patient who received mRNA-1273  for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart disease, unspecified and Atherosclerosis (blockage of artery was noted.). Concurrent medical conditions included Drug therapy (patient was on heart medications) and Drug therapy (patient was on antibiotic). Concomitant products included ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]), CLOPIDOGREL BISULFATE (PLAVIX) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273  (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced SYNCOPE (passed out) (seriousness criterion medically significant), CHEST PAIN (chest pain), DYSPNOEA (shortness of breath), SARS-COV-2 TEST POSITIVE (Tested positive for COVID) and NAUSEA (nausea). On an unknown date, the patient experienced SARS-COV-2 TEST NEGATIVE (Negative COVID test). At the time of the report, SYNCOPE (passed out), CHEST PAIN (chest pain), DYSPNOEA (shortness of breath), SARS-COV-2 TEST POSITIVE (Tested positive for COVID), SARS-COV-2 TEST NEGATIVE (Negative COVID test) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, SARS-CoV-2 test: positive Positive. On 14-Apr-2021, SARS-CoV-2 test: negative Negative.     The action taken with mRNA-1273 (Unknown Route) was unknown.       This case concerns a 77-year-old male with a serious unexpected event of syncope, and nonserious unexpected chest pain, dyspnea, and expected nausea. SARS-CoV-2 test positive.  Treatment with Regeneron antibodies. Event onset 19 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 77-year-old male with a serious unexpected event of syncope, and nonserious unexpected chest pain, dyspnea, and expected nausea. SARS-CoV-2 test positive.  Treatment with Regeneron antibodies. Event onset 19 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.