chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ACUTE DVT OF BILAT PERONEAL VEINS 4/20/2021 ATHEROSCLEROSIS OF AORTA ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/20/2021 ATHEROSCLEROSIS OF AORTA HYPOVOLEMIC SHOCK 4/20/2021 ATHEROSCLEROSIS OF AORTA SHOCK, UNSPECIFIED 4/11/2021 ATHEROSCLEROSIS OF AORTA ACUTE DVT OF BILAT PERONEAL VEINS 4/20/2021 AORTIC VALVE STENOSIS ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/20/2021 AORTIC VALVE STENOSIS HYPOVOLEMIC SHOCK 4/20/2021 AORTIC VALVE STENOSIS SHOCK, UNSPECIFIED 4/11/2021 AORTIC VALVE STENOSIS ACUTE DVT OF BILAT PERONEAL VEINS 4/20/2021 AORTIC VALVE STENOSIS ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/20/2021 AORTIC VALVE STENOSIS HYPOVOLEMIC SHOCK 4/20/2021 AORTIC VALVE STENOSIS SHOCK, UNSPECIFIED 4/11/2021 AORTIC VALVE STENOSIS ACUTE DVT OF BILAT PERONEAL VEINS 4/20/2021 AORTIC VALVE STENOSIS ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/20/2021 AORTIC VALVE STENOSIS HYPOVOLEMIC SHOCK 4/20/2021 AORTIC VALVE STENOSIS SHOCK, UNSPECIFIED 4/11/2021 AORTIC VALVE STENOSIS ACUTE DVT OF BILAT PERONEAL VEINS 4/20/2021 NONTRAUMATIC ACUTE KIDNEY INJURY ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/20/2021 NONTRAUMATIC ACUTE KIDNEY INJURY HYPOVOLEMIC SHOCK 4/20/2021 NONTRAUMATIC ACUTE KIDNEY INJURY SHOCK, UNSPECIFIED 4/11/2021 NONTRAUMATIC ACUTE KIDNEY INJURY ACUTE DVT OF BILAT PERONEAL VEINS 4/20/2021 AORTIC VALVE STENOSIS ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/20/2021 AORTIC VALVE STENOSIS HYPOVOLEMIC SHOCK 4/20/2021 AORTIC VALVE STENOSIS SHOCK, UNSPECIFIED 4/11/2021 AORTIC VALVE STENOSIS
paralysis; Initial information was received on 10-Oct-2020 regarding an unsolicited valid serious social media case received from a consumer/ non-healthcare professional via public post on the Sanofi flu shot campaign via social media.  This case involves two patients of an unknown demographics who suffered with paralysis, when they received INFLUENZA VACCINE.  The patients medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.  On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patients suffered with serious paralysis (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death.  Case details: Reporter did not provided the product name, but since this was a public post on the Sanofi flu shot campaign, the Race for 200M it was assumed that the consumer was referring to the Sanofi flu vaccine. Reporter Commented that does company ever heard of French polio, one of the side effects of the flu shots, he/she  know of two people that got it and suffered paralysis and death. Wake up sheep.  Details of laboratory data were not reported.   It was not reported if the patient received a corrective treatment (before death).  It was unknown if an autopsy was done. The cause of death was captured as paralysis.  Information on the batch number was requested.; Sender's Comments: A case was reported from Social Media, which involves two patients of unknown demographics who suffered with paralysis and death following the administration of INFLUENZA VACCINE (unknown manufacturer). The time to onset was unknown. Additional information of past medical treatments, concomitant therapies, past vaccination and tolerance, allergic history, concurrent conditions, laboratory data and autopsy results are needed for complete assessment of the case. Based upon the reported information the role of the suspect product cannot be assessed. Missing data needed for further assessment of the case.; Reported Cause(s) of Death: paralysis
sight problems; 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 VISUAL IMPAIRMENT (sight problems) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 020B21A) for COVID-19 vaccination.     The patient's past medical history included Thrombosis (Patients had blood clot that affected their retina and they can hardly see with that eye).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VISUAL IMPAIRMENT (sight problems). At the time of the report, VISUAL IMPAIRMENT (sight problems) outcome was unknown.            Patient reported, saw online that other people had sight problems after getting the vaccine. Concomitant product use was not provided by the reporter.   No treatment information was provided.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no previous temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 8-week-old patient of unknown gender. On 03-APR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N020352 (expiration date 10-APR-2020). On 18-JUN-2018, the patient was vaccinated with the next dose of improperly stored LIQUID PEDVAXHIB lot number N031492, expiration date: 02-MAY-2018. This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
pt devel sever itching over entire body approx 1hr or less p/vax;got little relief from oral DPH;sent home;pt devel rash later same day;RN reported visible scratches on pt 3 days later when pt had uncontrollable itching;
FEVER, SWELLING AND REDNESS AT INJECTION SITE (LEFT ARM), BASEBALL SIZE LUMP AT INJECTION SITE. STILL RECOVERING.
Initial information has been received from a physician via company representative refers to a 12 month old male patient with no drug reactions or allergies and no pertinent medical history. On 19-MAR-2014 the patient was vaccinated with dose of PROQUAD (thimerosal free) lot # J014235 expiration date 07-MAY-2015 dose and therapy route was not reported. There was no concomitant medication reported. On 29-MAR-2014 (ten days after vaccination) the patient had an adverse reaction to PROQUAD (Merck). The patient experienced diarrhea and viral like rash on the abdomen area. On approximately 01-APR-2014 (on day's 13 and 14 after vaccination) a zoster-like rash that was about the size of a half dollar appeared in the injection site.  The patient sought medical attention, saw the physician and none lab diagnostic studies was performed. The outcome of viral like rash on the abdomen area and the child had diarrhea was reported as recovered on approximately 01-APR-2014. The outcome of zoster like rash that was about the size of half dollar, was unknown. Unspecified antibiotic treatment for the adverse events was given. Additional information has been requested.
Patient presented to clinic two days after receiving vaccine reporting erythematous rash that is painful adjacent to the site where she received a PPSV 23 vaccination. She says the muscle "biceps" and her axilla feels sore and that the raised red rash developed within 24 hours of the immunization. It is not pruritic and does not seem to be spreading rather in fact seems to be improving. She has no mouth, tongue or lip swelling. She has no dyspnea or fevers. She is otherwise feeling fine. Right anterolateral arm with a 3.5 x 4" patch of erythematous confluent papules with raised edges. These do not feel fluctuant and they're minimally tender to palpation.  There is no significant warmth. She is able to move her arm at the elbow and shoulder without discomfort. She has no axillary lymphadenopathy.
Raised red circular rash that is extremely itchy and sore and is 2" by 3" in size. Started after injection about 2 hours later, got itchy and sore for 4-5 days.  Started to get better and then got worse on 7th day  post injection.  Being treated with Benadryl tablets by mouth and ice packs.  Severe enough to wake me from sleep and keep me awake.
Per office note 1/13/20: Patient has a history of sensory processing disorder.  She was previously followed by occupational therapy but was discharge in January of 2019. Her mother reports her sensory issues have been exacerbated since November of 2019 and worsened significantly in the past week.     Last Wednesday she went to school.  When she got home she had a meltdown.  Every day since that day she has had meltdowns with more severity.  She will throw things, hitting mom, screaming.  Mom used to try to ignore the behavior or walk away--3 hour meltdown Thursday which prompted ER visit. Mom has since tried staying with her instead of ignoring the behavior and the meltdowns don't last as long.  The meltdown ends with her going back to normal behavior.  She does not appear tired and doesn't go to sleep.  At the first ER visit she was given benadryl.  At the second ER visit she was started on risperdone.  Her mother really doesn't want her on regular medication until she has further medical and psychiatric evaluation.    Examples of things that have set her off the past few days: clothes--won't wear regular clothes because of things itching or they have germs.   She has been scrubbing her hands and feet with water to the point they are rough and dry/cracked. She won't go in her room due to fear of germs. She even went to grandmother's house due to fear of germs in her own home (no sick contacts at home). Food issues: has always been picky but has been more restrictive recently.  She will not say why she will no longer eat certain things. She has not had much to eat in the past 5 days.  Urine output has also been less--one day in the past 5 she only had uop x 2 in 24 hours.  Drinking a little better past few days.  After this visit, symptoms progressed such that she had severe phobia of germs.  she would not get dressed, would only sit in certain rooms of the house, and had food refusal.  the patient underwent laboratory evaluation and imaging and was referred to OT and psychiatry
Full body aches/soreness began ~24 hours after injection and lasted for 30 hours.  Significant fatigue began ~24 hours after injection and lasted for 36 hours Headache began at the same time and lasted 12 hours. Treated with ibuprofen.
Redness, swelling and itching at injection site approx. 8 inch x 5 inch area. Patient says it started itching and red 3 days ago (3 days after injection).  Has not put any topicals or taken anything for reaction- recommended treatment today with topical hydrocortisone for itching, ice to area. Monitor for improvement and consider treatment for possible cellulitis.
Case number PHEH2012US007096 is an initial spontaneous report received from a nurse on 22 Mar 2012 with the follow-up received on 30 Apr 2012. This report refers to an 11-years-old female patient. Her medical history, past drugs, current conditions and concomitant medications was unspecified. It was reported that this patient received only the MenCWY-135 liquid component of MENVEO (batch number: not specified) intramuscularly on to unspecified site without reconstituting the Men A lyophilized conjugate vaccine component on 22 Mar 2012. The patient will return to clinic to receive full-dose of MENVEO. No adverse event was reported following this drug administration error. Follow-up received from nurse on 30 Apr 2012: Updated patient demographics (age, gender, date of birth, height and weight).
I have never seen a vein in my upper arm before. I noted in mirror on 6/14/2021 a single blue vein leading from the injection site up over my shoulder. The vein crossed my collarbone and branched out horizontally into many smaller  veins. The color was light blue. The veins were not above my skin, but flush.  By afternoon they disappeared.
No adverse events reported at time of vaccine.  Death reported on 1-24-2023.  Patient expired on 1-9-2023.
5 days later she started having weakness in her legs.  Then passed out, complained of a headache that was sharp on the left side of her head that lasted a few minutes, then started ticing all over her body and still hasn't stopped.
Sx began on 9/18/02 pm with severe pain in deltoid, 9/19/02 swelling 1-2+ with pain entire arm.
SEVERE ITCHING, PROGRESSION OF MACULAR, RED RASH TO AXILLA, NECK, SCALP, TRUNK AND LEGS, UPPER ARMS.
pt exp a rash w/about 50 scattered lesions;pt devel lesions on lt side of neck, then face/trunk/limbs;dx OM;mo noted productive cough, fever 102.0, dec activity & dec PO intake;to ER, dx: pneumonia & hosp;MD noted possible varicella pneumon
After a week from shot, developed itchy rash and red pimples on legs. Spread to torso, shoulders and back. Unable to sleep at night. Lasted for over 2 weeks; thank God is finally subsiding. Not a happy person!
After the vaccine was given pt "passed out" in the exam room, mom witnessed it. ARNP evaluated him afterwards, no further treatment needed. Pt was observed x 20 min in exam room.
Received flu vaccine. Flu dx chills, body aches, cough, congestion, fatigue, fever, headache, runny nose.
No additional AEs; HBP with responsibility for vaccine storage calling to report a temperature excursion. Product administered.; This spontaneous report was received from an administrator referring to a patient (unknown age and gender). The patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.  On 11-APR-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1x dose, lot #W025273, expiration date: 10-AUG-2024, administered for prophylaxis (strength, anatomical location and route of administration were not provided) that underwent a temperature excursion at temperature of -10C for 59 minutes (Product storage error). There was no previous temperature excursion. No additional AEs (No adverse event).
Fever over 101 Chills Body aches Skin pain Migraine Body shakes Vomiting Extreme fatigue Eye pain
This spontaneous report as received on 02-MAR-2017 from a female healthcare worker (Not further specified if a healthcare professional), refers to 10 patients (age and gender not reported) who received unspecified doses in VARIVAX (Lot number M033905, expiration date 20-JUL-2018) immunization series that were improperly stored.  The site and route of VARIVAX administration were not reported.  The vaccinations occurred between 22-FEB-2017 and 01-MAR-2017. The vaccines were exposed to temperature of 18.5F (Fahrenheit) for a time frame of 5.3 hours.  There were no previous temperature excursions reported. The temperature excursion was recorded by a data logger. The patients' pertinent medical history, concomitant medications and drug allergies were not reported. It was further specified that on 22-FEB-2017, this patient (age and gender not reported) received administration of VARIVAX. No adverse effects were reported. There was no product quality complaint involved. No further information was provided. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA001788: US-009507513-1703USA001788: US-009507513-1703USA003630: US-009507513-1703USA003631: US-009507513-1703USA003633: US-009507513-1703USA003638: US-009507513-1703USA003634: US-009507513-1703USA003635: US-009507513-1703USA003632: US-009507513-1703USA003636: US-009507513-1703USA003637:
PT had left arm redness, swelling, and pain after receiving injections. Reported to pharmacist 5pm the next day. Pain was relieved by Aleve.
she suffered High Tempeature (106°F), Headache, Pain in wrists, knees, clavicles, Muscle pain, bones pain, Joints, and in both jaws
SMOOTHER AND CLEARER SKIN; INCREASED SENSITIVITY IN FINGERS AND TOES; HEARING INCREASED; INCREASED COORDINATION IN HANDS, FINGERS, ARMS; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's past medical history included completely Paralysed, and concurrent conditions included Guillain-barre syndrome. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date, the subject experienced smoother and clearer skin, increased sensitivity in fingers and toes, hearing increased, and increased coordination in hands, fingers, arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the smoother and clearer skin, increased sensitivity in fingers and toes, hearing increased and increased coordination in hands, fingers, arms was not reported. This report was non-serious.
My arm became sore and swollen that evening after the vaccine and I ran a very high fever.
She got her vaccine, about 5-7 hours later her heart started pounding and pounding, and her BP went up.  She waited for it to go away, but then called them and her medication was changed on 4/5/21.  The problems then continued and her doctor did an EKG and it came out with the 1st degree AV block, which she has had since 2003.  She was taken off the Propranolol and started on Metoprolol titrate and dealing with the different dosages of those medicines, nothing really worked.  It did get a little better, but she could not take the dose they wanted her to as it made her feel like she was going to pass out and had to go on a lower dose.  Nobody would commit that it was due to the vaccine, so it was OK to get the next booster, which she got on 11/9/21.  Again, about 5-7 hours after that vaccine the same thing happened again, her heart started pounding and her BP was up.  She went to the ER and then got in touch with the doctors again and they could not say it was from the vaccine or not, and had medicine changed.  She does not remember if there was another EKG done or not.  She has not gotten any more vaccines since the one on 11/9/21.  She has pretty much been at a standstill with her condition, but no better.  She has days where it is a lot worse, and it has gotten worse recently as she is trying different medications again.  She did a 24 hour Holter monitor, then a 28 day Holter monitor, EKG's, echocardiogram.  They are trying to figure out what is going on with her.    She has tried to get a referral to a cardiologist, and this doctor she has now did refer her to a cardiologist.  She was then sent for the 2-week Holter monitor and had to stop her Metoprolol for 2 weeks.  Those 2 weeks were horrible on her.  If she would walk up to go up steps her heart would start off pounding.  Those results showed a muscle flutter (she does not agree with that).  She had 189 incidents that were recorded over the 2 week period.  Every-time she exerts herself her heart starts pounding.  She is now trying to get  help and cannot see cardiology due to the muscle flutter report, but nothing better.    If they can't commit to saying it's from the vaccine, then how 5-7 hours later did she have this happen to her.  It continued and then got her 2nd booster which made it worse.  Around 2003 she had high BP but never had a history of any heart issues.
17JUN next day rt leg swelled, reddened & c/o warm w/fever suggested cold compress & APAP;18JUN mom called again appointment made w/MD;noted lump r/t area where needle inserted;
My dad ended up with GBS from the flu shot; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The case was reported for the patient's father. The age at vaccination was not reported. The patient ended up with guillain barre syndrome (GBS) after receiving flu vaccine and never experienced again.