chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ADVERSELY AFFECTED BY THE JANSSEN COVID-19 VACCINE; This spontaneous report received from a consumer concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced adversely affected by the janssen covid-19 vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of adversely affected by the janssen covid-19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958633.
Received my shot, talked with the nurse for about a minute or two afterwards in the back and she informed me that i needed to wait 10-15 minutes before i left. i go to the waiting room and set my alarm for 10 minutes. i texted my mother i was done and leaving  to go back home soon and that my second appt was on May 11. she texted back, i responded once again that i will call her when i get home in just over an hour.  Since i had no idea what to expect if something "did go wrong", i picked up my packet of information i received prior to my shot and started browsing through. i saw the possible serious side effects column and started to go through the list. At the time, about 5-6 mins now afterwards of my shot, i had no difficulty breathing, i did have a little tingling in my tongue, i read "a fast heartbeat", and put my hand on my chest and asked myself, IS MY HEART GOING FASTER? i looked at the paper again and put my hand back on my chest, and that was the last thing i remember until i was brought back to conscious by the nurses and doctors. i was told the guy in the waiting room ran after i passed out. when i came back to they walked me into the back, i was dizzy and profusively sweating and was drenched from head to toe , shirt and pants were SOAKED in sweat, they took my vitals for the next 40 minutes (3 or 4 times) i dont remember it too clearly until i started coming back to. Blood pressure was up and down and i was white as a ghost, they gave me fluids and i hung out until i felt superbly better about 40 minutes later. Then on my drive home, i had to pull over again, because i was getting light headed and felt like i was going to vomit. made it home, 90 minutes later, took a baby aspirin and slept the rest of the afternoon for about 5/6 hours before waking back up to eat some dinner.
Information has been received from a physician and a medical assistant concerning an 18 month old female patient with a peanut allergy, who on 03-JAN-2008 was vaccinated intramuscularly into the left thigh with the second dose of PEDVAXHIB (Lot # 656518/0258U).  Concomitant therapy included intramuscular vaccination into the right thigh with the second dose of PREVNAR (Lot # B04190).  On 09-JAN-2008 at 12:14 pm, the patient experienced a pea size, (1 centimeter) rash on the face, leg, hands and groin area.  It was reported that the patient was also given a new food, yogurt with strawberries.  The reporter indicated a questionable allergy to strawberries.  The patient was diagnosed with urticaria.  Subsequently, the patient recovered.  No product quality complaint was involved.  Additional information is not expected.
This spontaneous report was received from a medical assistant concerning an unspecified number of patients of unknown age and gender. The pertinent medical history and concurrent conditions were not reported. On an unknown date (also reported as some doses were administered on 30-JUN-2016 and some doses were administered on unspecified dates), the unspecified patients were vaccinated with unspecified doses of MMR II (lot number L049314, expiration date: 03-DEc-2017; lot number L041455, expiration date: 22-OCT-2017; lot number L026551, expiration date: 16-JUL-2017; lot number L032044, expiration date: 24-AUG-2017) (dose, route and anatomical location of administration were not reported), which were improperly stored. Temperature excursions reported maximum temperature 51.3 F for 84 hours and minimum temperature 27.7 F for 314 hours. It was unknown if a digital data logger was involved. No adverse effects were reported and no product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
FEELING LAZY; BACKACHES; LEGS ACHE; HEADACHE; TIRED; BAD MUSCLE ACHE IN SHOULDER AND NECK; REDNESS AT INJECTION SITE; SWOLLEN INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 09:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced redness at injection site. On MAR-2021, the subject experienced swollen injection site. On 19-MAR-2021, the subject experienced feeling lazy. On 19-MAR-2021, the subject experienced backaches. On 19-MAR-2021, the subject experienced legs ache. On 19-MAR-2021, the subject experienced headache. On 19-MAR-2021, the subject experienced tired. On 19-MAR-2021, the subject experienced bad muscle ache in shoulder and neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, backaches, legs ache, and bad muscle ache in shoulder and neck, had not recovered from tired, redness at injection site, and swollen injection site, and the outcome of feeling lazy was not reported. This report was non-serious.
This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant therapy was not reported. The medical assistant reported that an unspecified number of doses of VAQTA (lot# M030598, expiration date: 13-OCT-2017, dose and route of administration were not reported) were administered to the patients on unknown dates following a temperature excursion of 32.9F for 22 hours and 17 minutes. No adverse effects were reported for any patients receiving doses. This is one of three reports received from the same source. Additional information has been requested.
Mother brought him to the pharmacy to ask about a swollen lump on the base of the left side of his neck.  I explained it was likely a swollen lymph node but to monitor it closely and seek medical attention if it worsened.
This is one case out of a cumulative total of 244 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 17 December 2014. These 244 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 16 December 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 3 year old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of DAPTACEL, on 25 October 2011, 20 December 2011, 14 February 2012 (lot numbers not reported), and 11 February 2013 (lot number C4310AA) (routes and sites of administration not reported). On 23 October 2014, the subject developed a cough and catarrhal illness. Paroxysmal cough was noted on 25 October 2014 with a whoop. The subject also experienced sleep disturbance. PCR result was not reported; chest x-ray findings were negative. Corrective treatments consisted of Azithromycin starting on 01 November 2014 for 5 days. The subject was not hospitalized. At the time of final contact on 21 November 2014 the subject's cough was still persisting. The duration of the cough was reported at that time as 29 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Fever 102.4 onset 2am. Followed by severe right side and abdominal pain radiating from Right hip up through shoulder and head.  Vomiting for 13 hours and syncope X2.
Sore arm at injection site muscle starting a few hours of injection on 1/16/21, resolved within 24 hours. As of 1/24 I noticed small lump and a hive like rash in the general vicinity of the injection site. Rash has grown since first noting merging two "hives" into one large one.
Right arm, shoulder, armpit and chest are swollen double their normal size. Painful to touch and very warm. Aching even without touch.   Ibuprofen/APAP used with little to no relief.
Twelve hours after my booster shot I developed fever, chills, aches, and severe headache, which lasted over twelve hours.  The second day I ached all over, but I felt better on day three.  At midnight on day 4 (Saturday) I had a leg vein open and bleed uncontrollably.  I had to use Blood Stop to stop the bleeding.  I saw my vein doctor the following Monday, and he injected the vein to shut it down.  That same week I developed a worsening of my arthritic knee--much more pain and loss of mobility.   It feels like burning nerve pain from my knee down to my ankle and up to my hip.  It hurts to even drive my car.  A few days after that I began having terrible tooth pain on the upper AND lower left side teeth.  Two of those top teeth already have root canals.  The lower teeth have repairs.  The pain slams my face and radiates to the front teeth.  I saw my dentist.  His X-rays did not show anything conclusive.  I saw the periodontist.  His X-rays didn't really show anything either.  I have a visit scheduled with my endodontist this week to evaluate the roots and try to determine where the pain is coming from.  The pain is debilitating.  I've begun Advil around the clock to keep it from becoming overwhelming.  I have no idea if any of this is related to the vaccine.  But it all came on within days of the shot.  As a nurse, I'm wondering if I've mounted an inflammatory response that is causing me all this pain.
Fever; It has not worsened but he cannot go to work; This is a spontaneous report from a Pfizer sponsored program (CEP ID: 159558). A contactable 53-year-old male consumer (patient) reported that: A 53-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EWO186), via an unspecified route of administration, administered in Deltoid Left (reported as left shoulder) on 13Jun2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation (reported as because everybody should take it). The patient's medical history and family medical history relevant to adverse event was reported as none. There were no concomitant medications. No prior vaccinations within 4 weeks. The patient previously received flu shot (unspecified manufacturer) on an unspecified date and experienced itches and fever (anytime when he has the flu shot he had a fever). On 14Jun2021, midnight around 01:00, the patient experienced fever and was suffering. It has not worsened but he cannot go to work. He can't make it to work. It was persisting and staying the same. The patient did not receive treatment and stated he was calling to get treatment for fever. The outcome of event fever was not recovered and the outcome of other event was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Fast Heart Rate lasted about 5 minutes after injection Light headed lasted about 15 minutes after injection  Dizzy lasted about 5 minutes after injection
This spontaneous report as received from a Registered Nurse refers to a 12 year old female patient. The nurse reported that the first in the series of GARDASIL (dose, lot number and expiration date were not provided) was administered to a patient of a year ago on an unspecified date (approximately in 2013) and the second dose of GARDASIL was administered on 10-OCT-2014 (dose, lot number and expiration date were not provided). No adverse effects were reported. The patient's outcome was not reported. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a 10 years old patient. The patient was inadvertently vaccinated with ZOSTAVAX instead of VARIVAX (Merck). No other co-suspects were reported. No concomitant medications were reported. No adverse effect is reported. Additional information has been requested.
This spontaneous report as received from a female registered pharmacist of unknown age with high blood pressure, sulfa allergy and erythromycin allergy reporting on herself. On 20-APR-2012, the pharmacist was vaccinated with a dose of ZOSTAVAX (Lot # not reported). Concomitant therapies included DIOVAN HCT and verapamil. The pharmacist reported that on 21-APR-2012, the day after vaccination with ZOSTAVAX, she developed shingles and lasted for about 10 days. The patient went to her physician for treatment. The patient was treated with VALTREX. There were no lab diagnosis or studies performed. The outcome of shingles was reported as recovered/resolved on approximately 30-APR-2012.  This is one of several reports received from the same source. Additional information has been requested.
It has been 8 weeks since the first shot; illness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It has been 8 weeks since the first shot) and ILLNESS (illness) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It has been 8 weeks since the first shot) and ILLNESS (illness). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It has been 8 weeks since the first shot) had resolved and ILLNESS (illness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were reported. No treatment was reported.
I woke up the next day with a bad headache; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration at left arm on 25Jan2021 15:45 at a single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. No allergies to medications, food or other products. The patient's concomitant medication included Multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient woke up the next day with a bad headache. The event started on 26Jan2021 at 08:00. There was no treatment received for the adverse event. The event was non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient recovered from the event in Jan2021.
Systemic: Exhaustion / Lethargy-Mild, Systemic: tingling all over. patient reported feeling better after about 20-30 minutes of watching/waiting.-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: tingling in extremities
it was rpt from pharmD concerning pt who exp severe local rxn which required unspecified medical intervention to prevent hosp
Prolonged SVT episodes with heart rate at 120bpm lasting 10 hours. accompanied by extreme chills and headache, dizzyness.  My normal resting heart rate is 54bpm.
Janssen COVID-19 Vaccine EUA: Vaccine recipient experienced dizziness and was monitored by medic for 30 minutes. There was no treatment given.
Pt stated her heart was racing and her throat was tingling. Lungs clear to auscultation. She stated that she took a Benadryl 25 mg by mouth 30 minutes prior to injection. Had her remove her mask. O2 sats remained 98% on room air, HR 120, B/P 88/70. HR dropped to 105  and B/P went up to 104/71 after a few minutes of deep breathing and drinking water. Ice applied to back of her neck.
No adverse event; incorrect product storage; This spontaneous report was received from an unspecified source via a physician, referring a patient of an unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies were not reported.  On 18-DEC-2020, the patient was vaccinated with an improperly stored dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) at a dose of 0.5 mL which had a valid lot # T007790 expiration date on 03-DEC-2021) for prophylaxis, however no adverse effects reported.   Administered dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) experienced the temperature excursion above 31.2 F for 430 minutes. Digital data logger was involved. There were no previous temperature excursions reported. No product to retrieve. No Product Quality Complaint reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T007790; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Information has been received from a social media user via a market research referring to a male patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose, strength and route were unknown). On an unknown date, the patient was inability to gain an erection within weeks of GARDASIL. The patient's parents were advised to open their hearts about a formerly taboo subject and help their child through times of the event. The outcome of the event was unknown. The reporter considered the event to be related to GARDASIL. This case is one of several cases received from the same reporter. Additional information has been requested.
Pt. received VARIVAX on Friday 5-7-10 Lt. thigh. Mom reported on Monday, that area was red and hard nodule was noted at the injection site. Pt came to office and site was viewed by Doctor.
07/24/2003: 10x8cm area of erythema with slight increased warmth with fluctulance.  No red streaks.  Good range of motion and caprefill.  07/28/2003: Redness receeded and 1x1cm induration evident.
mom called our office 1/30/2021 at 8:06pm stating that patient had limited movement to right arm and shoulder pain, that she received  MenB vaccine 1/28/2021.  Arthralgia  Returned to our office 2/1/2021, no bruising, swelling or redness to injection site.  We sent her to ortho,  Dr 2/1/2021. no  swelling or ecchymosis. mild diffuse tenderness around shoulder girdle and limited range of motion. he diagnosed her with right shoulder contusion, told her to take ibuprofen 800mg 3 times a day, heating pad and work on range of motion. he will see her again in 10 days if not better.
COVID-19; vaccination failure; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (COVID-19) and VACCINATION FAILURE (vaccination failure) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Ankylosing spondylitis.    No Medical History information was reported.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19) and VACCINATION FAILURE (vaccination failure). At the time of the report, COVID-19 (COVID-19) was resolving and VACCINATION FAILURE (vaccination failure) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable.; Sender's Comments: Very limited information regarding these events has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine.
This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. On 30-AUG-2017, the patients were vaccinated with improperly stored VARIVAX (lot # and expiration date were not reported), that was mixed with a properly stored sterile diluent. Administered doses of vaccines underwent a temperature excursion of 3.6 degrees Celsius, which lasted for 23 hours. There was no previous temperature excursion. A digital data logger was involved in recording the excursion. No adverse effects were reported. Product quality complaint was not involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA000849.
SOB, cough, watery eyes, wheezy, oral cyanosis. Rapid heart rate -> give 0.15 mg epinephrine admitted to ICU.
Moderna COVID-19 Vaccine EUA Soreness in arm around injection site for two days.
Information has been received from a certified medical assistant concerning a 29 year old female with insomnia and hypertension and no drug allergies who on 06-NOV-2007 was vaccinated IM with a 0.5 ml dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot # 653338/0216F). Concomitant therapy included lisinopril, hydrochlorothiazide and trazodone HCl. It was reported that the patient experienced arm pain after the vaccination. It was reported that the patient received this dose of vaccine because she had a low rubella antibody titer, after receiving measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) as a child. Unspecified medical attention was sought. No diagnostic laboratory test was undertaken. A product quality complaint was not involved. Additional information has been requested.
Unexplained death at age 6 weeks about 24 hrs after Hepatitis B #2 dose. Autopsy pending. 9/22/08-records receivd for DOS 8/15-/16/08-transferred after cardiopulmonary arrest and severe hypoxic-ischemic encephalopathy. Found unreponsive and pulseless on couch following nap. Received unresponsive with fixed and dilated pupils, hypothermic core temperature 32.6 rectally.  Coarse bilateral breath sounds. Intubated, mechanical ventilation. 1/12/09-Autopsy report received-COD Asphyxia. Undetermined cause.
On May 17 noticed some hearing loss in my right ear by May 18 lost most of my hearing out of my right ear. The extremely loud ringing prevents sleep and gives me headache   Went to MD and he referred me to ENT.  Dr. stated that this acute event happened due to a virus.  The only virus that I know I was exposed to was the J&J shot.  Dr. stated I should report this to VAERS