chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Quadracel was given but it leaked and that led to the patient receiving less than the recommended dose/NO AE; Quadracel was given but it leaked due to syringe issue and that led to the patient receiving less than the recommended dose/NO AE; Initial information was received on 16-Jul-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves a patient of an unknown demographics who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL], but it leaked and that led to the patient receiving less than the recommended dose.  Medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to vaccine underdose.  It was also the case of syringe leak.  A dose of Quadracel was given and then it experienced a syringe issue, there was leakage that led to the patient receiving less than the recommended dose.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directiveand Module VI of the 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.  There will be no information available on the batch number in this case.
In the week after each of my vaccinations, I experienced gout attacks.   I have had gout attacks prior to the vaccinations for years (two to five flareups a year) and I take Allopurinol.   To experience flareups this close to each other is not the norm but it could be just my body.
pt recvd vax 15JUN94 & that nite c/o h/a & pain @ site-local react inc reaching 6x7 size w/pain & redness by 17JUN94;
pulse was high; little flutters; Blood pressure was a little bit high; felt uncomfortable; covid rash; pain; swelling; This spontaneous case was reported by a consumer and describes the occurrence of RASH (covid rash), PAIN (pain), SWELLING (swelling), HEART RATE INCREASED (pulse was high) and ATRIAL FLUTTER (little flutters) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pneumonia. Concurrent medical conditions included Cystitis (interstitial cystitis). Concomitant products included OXYCODONE HYDROCHLORIDE (OXYCONTIN) for Chronic back pain, HYDROCODONE, TIZANIDINE, LOVASTATIN, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL + HIDROCLOROTIAZIDA), GABAPENTIN and PENTOSAN POLYSULFATE SODIUM (ELMIRON) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced RASH (covid rash), PAIN (pain) and SWELLING (swelling). On an unknown date, the patient experienced HEART RATE INCREASED (pulse was high), ATRIAL FLUTTER (little flutters), HYPERTENSION (Blood pressure was a little bit high) and DISCOMFORT (felt uncomfortable). At the time of the report, RASH (covid rash), PAIN (pain), SWELLING (swelling), HEART RATE INCREASED (pulse was high), ATRIAL FLUTTER (little flutters), HYPERTENSION (Blood pressure was a little bit high) and DISCOMFORT (felt uncomfortable) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: abnormal High. On an unknown date, Heart rate: abnormal High.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment reported.   This case was linked to MOD-2021-049975 (Patient Link).
patient was inadvertently administered a dose of MenQuadfi that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees F with no reported adverse event; Initial information received on 15-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a meningococcal a-c-y-w135 (t conj) vaccine [menquadfi] where 16 years old female patient  was inadvertently administered a dose of menquadfi that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees f with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included influenza vaccine inact split 4v (fluzone quadrivalent) for Immunisation.  On 08-Feb-2023, the patient received a 0.5 ml of suspect meningococcal a-c-y-w135 (t conj) vaccine  Solution for injection lot U7594AC (strength and expiry date not reported)  via intramuscular route in the left deltoid for immunization where patient was inadvertently administered a dose of menquadfi that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees f with no reported adverse event (poor quality product administered) (same day: latency). Vaccines that had undergone temperature excursion down to 30 degrees F for 3 hours and 15 minutes, due to a refrigerator malfunction  Action taken: not applicable.  Outcome:  Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.; Sender's Comments:  US-SA-2023SA056272:01493882
Information has been received from a registered nurse concerning a 64 year old female patient with no known drug allergies, neuropathy and depression who on 25-MAY-2010 was vaccinated IM with a 0.5 ml first dose of PNEUMOVAX 23 (lot number 665402/1339Y, expiration date 22-MAY-2011) in the left deltoid. Concomitant therapy included LEXAPRO and NEURONTIN. The nurse reported that on 25-MAY-2010 the patient's site of injection became very red, swollen and painful after administration of the first dose of PNEUMOVAX 23. No laboratory tests were performed. At the time of the report the patient's outcome was unknown. The patient sought medical attention via telephone. Follow up information has been received from a registered nurse who reported that the 64 year old patient (also reported as 65 year old) with polycythaemia vera and osteopenia was vaccinated in the deltoid with the first dose of PNEUMOVAX 23. The nurse reported that in the night of 25-MAY-2010 the patient's arm was red, painful and swollen. On 03-JUN-2010 the patient recovered. The patient did not seek medical attention. No further information is expected.
Information has been received from a health professional concerning a 5 year old male who on 2/28/02 was vaccinated with a 2nd dose of MMRII (lot 639137/1082L). The 1st dose was given on 3/11/98. Concomitant vaccination on 2/28/02 included a dose of poliovirus vaccine and diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid. At the child's well visit, the day of vaccination, it was reported that the pt had been coughing for the past 2 weeks and his mother was treating him with diphenhydramine hydrochloride (Benadryl) and quaifenesin (Robitussin). On this visit, the pt had his urine dipped, which was normal with no ketones or no glucose; he was afebrile and his visit was recorded as a normal exam. On 3/2/02, the pt's mother reported to the physician's office that the pt developed swollen eyes and a pocket of fluid under his left eye and was pale and listless. The physician documented questionable Mono or questionable nephrotic disease. The pt was seen in the office to be evaluated. He had no weight loss but a history of wetting the bed for the past 2-3 weeks. From the office, the pt was admitted to the hospital with the chief complaint of periorbital swelling/early nephrotic syndrome or kidney disease. The plan was to follow his blood sugars every 2 hours and with each void to check his urine for ketones and sugar. The results of blood sugars and urine dips were all normal. The physician's clinical impression was that the child might be on a slope of a normal pancreas or insulin dependent diabetes. The pt was discharged from the hospital on 3/3/02 with instructions for his mother to continue to dip his urine for ketones and sugar at home. The parents requested for him to be seen by a Pediatric Endocrinologist for follow-up. It was reported that the physician did not feel that this adverse event was related to the MMRII. The nurse reported that another pt (WAES0204USA00284) had a similar experience following exposure to MMRII. Additional information has been requested. The follow up states the pt recovered from glycosuria and ketonuria on 3/3/02.
Chest pain, heart palpitations, fatigue started on July 22nd and ongoing, no improvement
This spontaneous report as received from a physician refers to two female teenager patients of unknown age. The reporting physician stated that he read an article (the physician did not recall reference) about two female teenagers who, on an unknown date, have experienced serious adverse event (unspecified) following vaccination with GARDASIL (dose, dose number, route, anatomical location, lot #, expiration date were not reported) administered. The outcome of event was not provided. The relatedness between the event and the therapy with GARDASIL was not provided. Additional information is not expected, as no follow up was available.
First dose received mRNA Moderna vaccine 2 months ago and received Janssen today.  No ASE noted, client tolerated well.
Day after shot complained of itching, burning.  Mom noted large swollen area that night.  I see area 4 1/2" long by 4" at widest tapering to 3" at bottom.  Area raised, hot on posteria left upper arm.  Patient given Tylenol and aloe cream for itching.
This is a spontaneous report from 2 contactable consumers or other non-healthcare professionals (one of the consumer is patient). A 12-year-old male patient received the 1st dose of BNT162B2 (Comirnaty; solution for injection; batch/lot# ER8733, expiry date: unknown), at the age of 12, intramuscularly, via unspecified route of administration, left arm, on May 18, 2021, at 08:00, single dose, for COVID-19 immunization. Medical history included food allergies: walnuts, pecans, sesame; and environmental allergies from an unknown date and unknown if ongoing. The patient's other medical history: none. The patient has not received any other vaccine within 4 weeks. The patient has not been diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID post vaccination. Concomitant medications included D3 and folic acid for an unspecified indication, start and stop date not reported (other medications in two weeks). On May 23, 2021, patient experienced increased heartrate (a few days later) and frequently resting (laying down) at 115-100. No treatment received for the events. The outcome of the events unknown. Follow-up attempts completed. No further information expected.
Oct 21, 2016, nurse called to spoke to RPH that HS. Patient got a flu shot the day before and developed a distal (not localized) swelling at wrist area. Warm to touch/red, no fever, the redness started the night of the flu shot and was more so the next day, the nurse contacted the doctor. Pt was ok (contact him on 10/14 and 10/25).
pt recv vax & presented w/marked urticaria 23JUL PM; initially was w/o orthostasis or resp sx, & was placed on DPH & pred; 24 hr later pt re presented w/worsening urticarial sx & orthostatic hypotension;
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939893) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Sore arm). At the time of the report, MYALGIA (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment information was reported by reporter.   This case was linked to MOD-2021-313350 (Patient Link).
Pt with H/O epilepsy had several large grand mal seizures within hours of H1N1 shot and seasonal flu. 11/18/09 Medical records received for date 11/9/09. Pt. parent called to MD office stating pt had both flu vax x1wk prior. Pt now experiencing seizures daily. Pt has h/o seizures but parent states these seizures are different. Parent took pt to ER seizure med levels taken and per parent WNL.   .
This is a spontaneous report from a contactable consumer (patient). A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 17Feb2021 11:45 (Lot Number: EL9264) (at the age of 63-years old) as dose 1, single for covid-19 immunisation. Medical history included hepatitis b, psoriasis, hypothyroidism. Patient had no allergies to food. Concomitant medications included apremilast; entecavir; levothyroxine sodium, all taken for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks of vaccination. The patient did not have covid-19 prior to vaccination and was not tested for covid-19 post vaccination. On 20Feb2021 15:15, the patient experienced chest pain, nausea, cold sweat and dizziness. The events resulted in emergency room/department or urgent care visit. The patient did not receive any treatment for the adverse events. The outcome of the events was recovering.  Follow-up (17May2021): Follow-up attempts were completed. No further information expected.
I had gotten my period two weeks prior and my cycle is pretty regularly 28 days.   Was surprised to get it again 14 days later.
Mild reaction to Td vaccine given to (L) arm, 2 cm x 2 cm, pink  raised arm (L) deltoid area. Ibuprofen prn, BENADRYL prn.
Fever for 12 hours with migraine.  Once recovered had problems with controlling blood sugars where the medication was not as effective and causing problems with blood sugar that was being controlled having problems with controlling the levels and increased dosages only  providing mild help.
This spontaneous report as received from a health care worker (also reported as medical assistant) refers to an unspecified number of patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. Since 12-OCT-2015, the patients were vaccinated with improperly stored GARDASIL (lot # K011562, expiration date 08-APR-2017, dose and route not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Severe diarrhea started within 24 hours of vaccination. Watery stools approx 10-12/day lasted about 5 days. Started on pedialyte and soy formula. Resolved with nuetranafer. Stool rota enzyme neg. day 5.
Starting the evening of the 2nd injection, I became extremely weak with general muscle and overall joint pain?inability to concentrate . Nausea and poor appetite  all lasting from onset until 9/13/2021.
About 4 hours after the shot I developed a burst blood vessel on the index finger (midway)of my right hand, which left a painful purple subcutaneous mark.
This spontaneous report was received from a nurse practitioner, referring to multiple unspecified patients of unknown age and gender. Information about current condition, concomitant medication and medical history were not provided. On unspecified dates, unspecified patients were vaccinated with unspecified number of doses of improperly stored PEDVAXHIB (lot# reported as N003536 with expiration date 02-NOV-2019; M046133 with expiration date 26-SEP-2019; concentration, dose, route and frequency were unknown) for prophylaxis. No adverse effects were reported. The vaccines were stored at 47 degrees Fahrenheit (F) to 77F (51F) for 1 hour 20 minutes, and 32F to 35F (34F) for 3 hours and 46 minutes. There was no previous temperature excursion. The data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA009417: US-009507513-1707USA009615.
About 20 minutes after administration patient came back to pharmacy complaining of tightness in throat, flushing, and tingling on tongue.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age. Pertinent medical history and drug reactions/allergies were not reported. On 12-AUG-2014, the patient was vaccinated with (Oka-Merck) PROQUAD (Lot#J000141, Expiration date 04-JUL-2014) (dose and route were not reported). Concomitant medication was not reported. No adverse effect reported. Additional information has been requested.
This spontaneous report as received from a nurse refers to a 6 month old patient of an unknown gender. On 15-JAN-2015, the patient was vaccinated with improperly stored, oral, ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
I suddenly became very ill with a respiratory infection. Symptoms include coughing, fevers, chills, sweats, body aches, and a rash.
The patient received her Janssen Covid19 vaccine with no problems during administration. Following administration, approximately 2 minutes after, the patient began to feel lightheaded and dizzy. She proceeded to vomit and continue feeling this way for the next 15 minutes.
Patient reported on 10/18/2009, 11 days after the date of vaccination that she's been having chills & SOB since the day 1. Starting 10/16/2009, she's been having chest pain along with chills & SOB. Patient was instructed to take some BENADRYL and visit urgent care ASAP.
This spontaneous report as received from nurse practitioner refers to unspecified number of patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was not reported. On an unknown date unspecified number of patients were vaccinated with improperly stored (incorrect product storage) GARDASIL (0.5 ml, once) (lot number unspecified), intramuscular. Concomitant medications were not reported. The reporter state that the unspecified patients received doses of GARDASIL between 10-AUG-2014 and 24-JAN-2015. No adverse effects (no adverse event) were reported. The outcome of the events was unknown. The causality of the events with GARDASIL was not reported. This case is linked to #1502USA001952 via same reporter ling. Additional information has been requested.
Employee  received the Covid 19 vaccine around 4pm on 1/15/21. Employee waited 15 minutes then returned to the floor her shift.  Around 5:15 employee felt dizzy and has slight headache and stomachache. Employee passed out and hit head on floor and was not breathing. RN Charge at time called code blue and started compressions and gave employee O2. 911 was called, paramedics arrived and transferred via ambulance .
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 9:06 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 9:06 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the fridge on 29-Sep-2021 or 05-Oct-2021, moved to clinic on 27-Oct-2021 and proposed beyond use date was 29-Oct-2021 or 04-Nov-2021 respectively.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit.  On 22-Oct-2021, at 08:00 A.M, 09:00 A.M and at 10:00 A.M. the temperature recorded was 32 degree Fahrenheit that has been reached by the vial.  On the date of administration, at 09:00 A.M., the temperature recorded was 29 degree Fahrenheit and at 10:00 A.M., the temperature recorded was 32 degree Fahrenheit that has been reached by the vial.  Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).