chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inappropriate reconstitution technique; Wrong solution used in drug reconstitution; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo at an unknown dose. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and wrong solution used in drug reconstitution. On an unknown date, the outcome of the inappropriate preparation of medication and wrong solution used in drug reconstitution were unknown.  Additional details were received as follows: The age at vaccination was not reported. In a separate clinic on another day, it was noted that an HCP had given a patient Menveo with menA reconstituted with sterile water, not the menCWY diluent provided. Through researching this HCP's previous vaccine administrations, it was determined that between 8th August 2019 and 28th October 2019, the Health care professional had vaccinated with Menveo prepared incorrectly men A reconstituted with sterile water, which led to inappropriate preparation of medication and wrong solution used in drug reconstitution. These patients were then re-vaccinated with Menveo. This case 1 of 22 cases reported by the same reporter.
I broke out in a rash from my breasts up to my face. I sent my doctor a picture and started to feel like I could not keep anything down and started to have bowl movements that were incontrollable. The rash lasted about three or four days and I've been tired ever since; however, we had a COVID-19 exposure in our house.
nausea; headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for herself that. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 13Feb2021 13:30 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN SINGLE for covid-19 immunization.  The patient medical history and concomitant medications were not reported. on an unspecified date the patient experienced nausea and headache. She wanted to know what to do, and Potential AE realized after call. The event outcome was Unknown.  Follow-up attempts completed. No further information expected.
Began with weakness in extremities around 7:00PM. By 9:00 PM lost feeling in legs. This lasted for about 12 hours to one day.
This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (lot number, route, dosage and injection site were not known) in June 2012. No other co-suspects were reported. No concomitant medications were reported. The patient has been experiencing headaches and a "wacky menstrual cycle" ever since one GARDASIL injection was administered. The patient was not recovered at the time of report. The patient had visited the physician's office for medical attention. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with the dose of GARDASIL, injection in gluteus muscle, intramuscularly (strength, dose, lot number and expiration date not provided). No adverse effect was reported. The outcome of event was unknown. Additional information has been requested.
Mother called 12/12/02 stating child had right deltoid (site of flu shot) swollen  1.5 in to 2 in wheal, red + raised. Area raised-size small apple. Mother gave Benadryl at hs 12/11/02 applied cool compresses to area, giving Tylenol prn for pain.
At 5:30 pm, I gave pt. Influenza vaccine, after about 5 minutes pt. started walking and fainted and hitting her head on floor. Pt. was out for about 10-15 seconds. We checked B/P, pulse, glucose, all was WNL. Pt. had a bump on back of head, put ice pack. Pt. to f/u in 1 day.
strange feeling in my throat; Shaking; I felt like a fever was coming on/temp of 102; fatigue; extremely sore arm; This is a spontaneous report from a contactable nurse, who is also the patient. This 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899) via an unspecified route of administration in the left arm on 17Dec2020 at 09:00 at single dose for COVID-19 immunisation. Vaccination facility type: workplace clinic. The patient did not receive other vaccines in four weeks. Relevant medical history included asthma, hypothyroidism, seasonal allergy, allergy to pine nuts and almonds and past drug history included allergy to levofloxacin (LEVAQUIN). Concomitant medications included ethinylestradiol/norethisterone acetate (LOESTRIN), levothyroxine sodium (SYNTHROID), fluticasone furoate (VERAMYST), levocetirizine dihydrochloride (XYZAL) and montelukast sodium (SINGULAIR). On 17Dec2020, within a few minutes of receiving the vaccine, the patient noticed a strange feeling in her throat. The patient stated that it was difficult to describe, but only lasted a minute or so. That night (17Dec2020), as she was getting ready for bed, she felt like a fever was coming on, but she checked her temperature and it was 97.6 (her normal temperature). She woke up around midnight shaking, with a temperature of 102. She took ibuprofen and it came down to 100.8 before she fell back asleep. In the morning, her temperature was down to 98.5 and she did not experience any additional fevers. The only other symptoms she experienced were fatigue and an extremely sore arm. These lasted about two days. The patient recovered from the events strange feeling in her throat on 17Dec2020 and she recovered from the fever on 18Dec2020; the patient recovered from the other events in Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient was tested for COVID-19 with a nasal swab on 31Dec2020 which was negative.
patient described a headache starting 4 hours after vaccination. At around 7pm that night fever, sweats, extreme chills and nausea began in addition the the headache. Patient stated these symptoms lasted for about 48 hours.
I had an eye rental tear in July 2022. On January 6th, 2023, at about 3:00AM I experienced chest pressure and twisting.  About 3 hours later I drove myself to the emergency room.  I had echocardiogram, stress test.  They admitted me for 5 days to Medical Center and Transported to Hospital.  They found blockages.  They placed stents implants to reverse the blockages.
Pt rec'd Bexsero as initial dose.  Second in series administered was Trumenba.  Products are not interchangeable and have different  dosing schedules.  Situation evaluated and patient was administered second dose of Bexsero.  Dates admin - Bexsero  4/30/22, Trumenba 07/07/22, Bexsero 08/19/22.  Patient had no adverse reactions to vaccines.  He did have some soreness in his arm as can be expected with IM delivery.
I had body aches, and I also became very fatigue. I ran a fever at 102 . I also lost my taste and smell. Two days later I test positive for COVID. A couple days later I recovered my taste from smell , but I am still having lingering affects with my taste and smell.
pt recvd vax; 3feb96 blotchy rash; 5feb96 joint (serve) pain;
APPROXIMATELY WITHIN 5 -10 MINS OF IMMUNIZATION - PATIENT FELT LIKE HE WAS HAVING AN ANXIETY ATTACK.  HE WAS HYPERVENTILATING, SHAKING, AND FLUSHED FACE.  911 WAS CALLED. PARAMEDICS ARRIVED AND TOOK HIM TO A HOSPITAL
Infant developed a rash starting on face and spreading down body, then arms and legs. Had MMR 3/8/20 Rash was itchy. Low grade fever pink macular eruptions over body Eruptions are more confluent on face and upper chest, with scratch marks * Rash started on 3/18/2020 televisit done 3/19/2020 toddler visited clinic 3/20/2020 - Pt had been on amoxicillin for bilateral otitis media course completed on 3/19/2020. Eruptions continued to spread after amoxicillin was complete. Advised parent that eruptions mostly likely vaccine reaction with Rubella like rash. The rash will be self-limiting. Televisit done on 3/30/20 - Eruptions resolved.
none adverse reaction or side effects experienced; patient vaccinated with 23-valent pneumococcal vaccines on 01-JUN-2012 and 06-OCT-2013; This initial spontaneous report has been received from a lawyer, via a Plaintiff Fact Sheet from a case in litigation for zoster vaccine live (ZOSTAVAX) (original legal case MARRS # 1901USA000773), concerning a 67-year-old male patient (pt), a non-smoker. On 01-JUN-2012, the pt was vaccinated at a pharmacy with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. On 06-OCT-2013, the pt was vaccinated at a pharmacy with another dose of polyvalent (23-valent) (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiration date were not provided) (inappropriate schedule of vaccine administered). Adverse reaction or side effects experienced with regard to the suspect vaccines' administration were reported as none.  This is one of two reports concerning the same patient.; Sender's Comments:  US-009507513-1901USA000773:
FEVER; This spontaneous report received from a patient . The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, start therapy date was not reported for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021 03:15, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 303 F, and COVID-19 (NR: not provided) Positive. Treatment medications (dates unspecified) included: Oxycodone/Paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
pt recvd vax & 1 month later pt devel HIB meningitis; Anti-PRP antibody titer was 0.00 ug/ml @ the onset of the HIB infect; however the convalescent anti-PRP antibody titer was 0.72 ug/ml; dx w/pneum men, prog to septic shock & death
Approximately 10 hours after the injection feeling in right ear was lost. No feeling in ear since 2/4/21
Woke up with a headache. Have had headaches each day since the vaccine. They come and go. Also, my tinitus has intensified to the point that it is constantly noticeable. Previously, it was very mild and did not effect my day.
Narrative:  Patient developed symptoms within 3 days of 2nd COVID-19 vaccination that by day 10 resulted in hospitalization and diagnosis of unprovoked bilateral pulmonary emboli, with resultant recurrent hospitalizations over the next 2 months for progressive right and now left heart failure and worsening RV/LV systolic function.
Approximately 90 minutes after vaccination, patient reports noticing 1 hive  on left cheek, then within another hour developed hives on face, neck, back, and progressed to chest. Then patient reports tingling and itchiness on lips and in an around her mouth. At this point the patient took benadyl (diphenhydramine) OTC 25mg tablets. Hives resolved post-benadyl within 60 minutes and continued itchiness on skin until next morning. All symptoms/hives/itchiness resolved by next morning.
12 hrs after: Fever, Chills, ear aches, body aches and really sore muscles in back and neck. Can?t move my left arm at all, too painful.  Next day, sore muscles, joints, nausea, exhaustion, headache.
NUMBNESS IN FEET AND HANDS; TINGLING IN NERVES; CHILLS; This spontaneous report received from a physician concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. Batch number was not reported and has been requested.  On an unspecified date, the subject experienced numbness in feet and hands, tingling in nerves, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, numbness in feet and hands and tingling in nerves was not reported. This report was non-serious. This case, from the same reporter is linked to 20210710727.
About 10 AM I was feeling lightheaded and then passed out.  My breathing had stopped so my granddaughter called 911.  The medics had to perform CPR and also give me an injection of epinephrine.  X-rays showed a saddleback embolism at the junction of two heart veins.
Myalgia, Arthralgia, NauseaVomiting,  fatigue, sight/sound sensitivity, chills Narrative:
I was congested,  had a cough and I felt like I had a fever. I had body aches - mostly on my right arm where I had second dose. I did a telehealth visit. He diagnosed me with another respiratory infection - two packs of antibiotics - I can't remember what they were called. Those helped to resolve symptoms - I was out of work for 10 days. About day 7 when I felt so much better. I had another recent (last month)respiratory thing - I let it run its course - congested, cough, fever etc - I attributed it to allergies - those symptoms just resolved last week after a good 20 days. My parents had gone to Mexico and they brought back some antibiotics - one was Tamiflu - and I took it. It did take 20 days to resolve.
Patient was vaccinated on 10/13/20 she came back on 11/17/20 and stated that her arm still hurts a lot and that she cannot sleep because of the pain. She stated that she experienced fever for some days after the injection, went to her doctor was told to use Tylenol which she did and the went away after some days but the pain is still very severe
Fever 101.5, chills, headache, muscle aches and diarrhea-1/13/21. Fever 100.7 headache, muscle aches 1/14/21. Abd pain 1/16, 1/17 ER admission- abdominal pain 1/18. Discharge home. Rash and abd pain 1/19
Immediatley following the shot I felt extremely tired and irritable.  After the 1st shot I had weakness in my legs and general fatigue.  I also had extreme thirst lasting about 1 month, heart palpitations which have not subsided.  After the second shot I had the same symptoms and in addition to those above I have  general shortness of breath and extreme burning in my muscles with exercise.  I am a competitive swimmer and this burning feels like what one would call lactic acid build up,  this is occuring without extreme exercise as when I would normally feel  during a hard swimming set.  I have not taken the 3 rd shot and will fight not to!  It was a requirement for school.
No adverse effects reported; improperly stored doses of VARIVAX and PROQUAD; This spontaneous report was received from an administrator referring to patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 28-MAR-2019 or 31-MAR-2019 or 02-APR-2019 or 03-APR-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) with lot# R023736 with expiration date on 20-AUG-2020 or measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot numbers R008697 and R000551, for prophylaxis (dose and routes of administration). The administered doses of the vaccines experienced temperature excursion -12.85 degrees Celsius for 15 minutes. There was no adverse effect reported.  This call was because of a data logger and there was not previous temperature excursion.   No product quality complaint was involved.   Lot number R008697 and R000551 are invalid lot numbers for  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) .  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1904USA004741:Original Case : 1904USA003556 US-009507513-1904USA004742:Original Case : 1904USA003556 US-009507513-1904USA003556:Original Case : 1904USA003556 US-009507513-1904USA004744:Original Case : 1904USA003556 US-009507513-1904USA004739:Original Case : 1904USA003556 US-009507513-1904USA004740:Original Case : 1904USA003556
This case was reported by a healthcare professional and described the occurrence of injection site redness in a 60-year-old female subject who was vaccinated with INFLUENZA vaccine (manufacturer unspecified) and FLULAVAL (GlaxoSmithKline).  Concurrent medical conditions included lactose intolerance and neck pain.  Concurrent medications included SYNTHROID.  In early October 2008, on a day around 09:00 or 10:00, the subject received a dose of FLULAVAL at 0.5 ml in the left arm.  Immediately after vaccination with FLULAVAL, the subject experienced injection site pain that radiated down her arm to her wrist.  As a result of the pain, the subject also had difficulty sleeping and was unable to knit.  The subject also experienced neck pain exacerbation.  The healthcare professional considered the events were disabling.  At the time of reporting the events were worse with the exception of pain radiating down the arm for which the outcome was not specified.  The healthcare professional considered the events were possibly related to vaccination with FLULAVAL, again with the exception of pain radiating down the arm which was not specified.  It was additionally mentioned that the subject experience injection site redness and injection site swelling following an unknown flu vaccination two years prior (2006).  The outcome of the events was not reported.
At the time of injection, it was extremely painful and it looked like it was too high on the arm.  My arm has been sore at the injection site for 10 days now. Sometimes I feel tingling and a cold feeling in my arm.  Range of motion is not limited but the pain is lingering and not subsiding. Pain is about 3/10.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 06-SEP-2017 the patient was vaccinated with M-M-R II lot # M045392 for prophylaxis. Other suspect therapies included VARIVAX. Concomitant therapies included sterile diluent. On 06-SEP-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. Sender's Comments: US-009507513-1709USA003131.
Twenty-four hours after receiving DTaP, Hib, Prevnar, IPV patient developed erythema multiforme.
pt devel painful, swollen, indurated deltoid muscle @ site of inj p/DTAP;
I had a nagging dry cough. When I would take a deep breath, it would trigger a cough. It never produced any expectorant. I was more pronounced when sitting in my recliner. I presented itself less when I was sitting upright. There was also a wheeze that went along with. I used saline rinses, Afrin nose spray and gargled with hot salt water. Nothing seemed to work. The doctor listened to it and indicated that I was suffering from fatigue, cough and shortness of breath. I was also experiencing headaches. She completed a chest x-ray and CT scan. She indicated that a shadow showed up showing patchy area of atelectasis or scarring bilaterally. Asymptomatic prominent in the right hilum when compared to the left. A CT scan was done and there was no pneumonia. I sucked in a dose of chlorine gas as a teenager which caused me issues with breathing for a couple of weeks to they contributed the scarring to the event that happened. I was treated with prednisone and an antibiotic. The cough went away and then returned. I still have the cough but it is not as bad.
site of administration on tight; stiffness on my tight for a week; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness on my tight for a week) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (site of administration on tight) 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 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness on my tight for a week). On 19-Nov-2021, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (site of administration on tight). In November 2021, MUSCULOSKELETAL STIFFNESS (stiffness on my tight for a week) had resolved. On 19-Nov-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (site of administration on tight) had resolved.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
At 0900 this morning my face next to the right side of my mouth started itching. I immediately felt it swell. I looked in the mirror and could see the left lower part of my face (lower cheek by the edge of my mouth) swell and my right upper lip started to swell. I took a Benadryl (25mg oral tablet) and my roommate drove me to the Emergency Room. That area of my face continued to swell and impacted my lower lip as well. My lips were numb and tingling and I could feel my cheek swell more inside my mouth as it was touching my teeth. I was monitored (vital signs and pulse ox) for 90 minutes and received 20 mg of pepcid oral tablet and 10 mg dexamethasone oral tablet- both 1x only.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age. 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 administration not reported, batch number: 1805029, expiry: Unknown) frequency one total, dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  The patient reported that since 15-APR-2021, she had head cold with congestion and runny nose. On 18-APR-2021, the patient experienced suspected clinical vaccination failure and suspected covid-19 infection. Laboratory data included: Covid-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection and outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality compliant: 90000177213.; Sender's Comments: V0:20210444534-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
a fine papular reddened rash over trunk & upper arms bilat devel 1 wk p/2nd Hep B vax;
After medication was given patient informed staff she was allergic to "pertussis" After 10 mintues patient felt SOB and became pale.  She was tachy and Hypertensive at the time vitals were taken. Small rash formed on patient chest. She was given 25mg of Benedryl with 20mg Orally Pepcid. She continued to feel more SOB and c/o chest tightness and began to cough more frequently. {atient then given 1mg of Epi IM. After epi was given per protocol patient was tx to local emergency room
01/12/22 presents to ED for "nausea, emesis, diarrhea, fatigue". PMHx of "type I DM, hypertension"
Unusually strong flu symptoms: fever, chills, body aches, nausea, and cough lasting approximately 12 hours.  I normally have mild flu symptoms after vaccination, but this was the most severe reaction I have had.
Became flush and clammy 2-3 times. Recovered after 30 minutes of observation