chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt rcv'd 3rd dose of vax and subsequently discovered she was pregnant. Pregancy & delivery were uneventful. Infant was dx w/ R eye congenital glaucoma & cataract. Hosp for surgical proceedures (at least 3). Cont in notes. Information has been received from a female consumer who on 13-APR-1999 was vaccinated with the third dose of MERUVAX II (second generation). The patient stated that she had been vaccinated with MERUVAX II (second generation) twice but there were no antibodies in the blood, so she decided to get revaccinated." At this time the patient was seeing a fertility specialist. She waited one month took the pregnancy test and it was negative. The patient subsequently found out that she was pregnant (LMP: 12-MAR-1999) and was attended to by a high risk obstetrician/gynecologist. On 14-JUN-1999 she was tested for immunity to rubella and found to be immune. On 15-DEC-1999 the patient delivered a baby boy. The pregnancy and birth were uneventful. A nurse performed an infant assessment and found out that the child's right eye did not respond to light. He was diagnosed with right eye congenital glaucoma and cataract. At the time of the report the child had already had three surgeries on his right eye. He was hospitalized for the surgical procedures. The ophthamologist who operated on the child stated that some tissue from the trabeculectomy may yet remain in the pathology department. She also stated that the cataract was a unilateral persistent hyperplastic primary vitreous cataract with no known etiology and not associated with congenital rubella syndrome. Additional information has been requested.
A few vesicle/lesions noted on trunk, legs, arms, face. Positive test result for varicella zoster.
PERIPHERAL NEUROPATHY 2/7/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Pt is a 49 y/o male who presented to facility for his yearly flu shot on 11/16/2012. He had received a flu shot in the previous year without incident. He presented to his PCP on 1/18/2013 with a chief complaint of visual field deficits and headache for the past 5 days. His PCP referred him to an emergent visit with the ophthalmology department. He was referred from there to the emergency department with concern for a neurological process versus an ophthalmologic one. In the ED he was extensively worked up for neurological processes and found to be negative for HIV, CMV, meningitis, MS and at this time was not experiencing nausea, vomiting, or gait disturbances. He also received a gadolinium-enhanced MRI at this time. The MRI revealed a hypodense lesion in posterior limb of the right internal capsule surrounded by slight edema, suspicious for glioma or possible cerebrovascular accident. He was admitted to the hospital for further management on 1/18 and was continually followed by neurology through to his discharge on 2/6. After further investigation it was also discovered that he had recently had symptoms consistent with an upper respiratory viral illness prior to the onset of his neurologic symptoms. The timeline of this illness is unclear per the notes but is described as "flu-like symptoms" and were present before the onset of his neurological symtoms. During his hospitalization he experienced progressive loss of his visual field as well as neurologic decompensation presenting as left-sided hemiplegia and facial droop as well as gait disturbance. On 1/25 the lesion was biopsied and he was started on dexamethasone. This biopsy revealed a demyelinating process and neurology determined that this was likely a tumefactive demyelinating lesion, more specifically acute disseminated encephalomyelitis (ADEM). This is an exceptionally rare side effect of vaccinations but it has been reported in the literature and has been associated with previous influenza vaccinations. Given the timeline of onset after administration of the vaccine, it is difficult to determine whether the vaccine or the possible viral illness was the cause of the ADEM. In correspondence between doctors it was stated that this could be related to the influenza vaccine given in November. Based on an assessment with the Naranjo scale this would be classified as a possible adverse event associated with the administration of the influenza vaccine. Pt was initially treated with dexamethasone but was switched over to a 5 day course of intravenous methylprednisolone after diagnosis of a demyelinating disorder. This was followed up with prednisone taper and aggressive physical therapy. He continues to improve per the notes and has progressed to being able to walk with a cane.
9 days after the vaccine I experienced sudden hearing loss in my right ear.  There is a marked difference between the left and right ear, and I am relying on my left ear to hear and function. I am reporting this 48 hours after the onset of the hearing loss. Treatment - prednisone, zyrtec, flonase. Outcome - treatment only began 24 hours ago, so it's too soon to tell.
He had a fever, and drainage in his ear. This lasted for a couple days and then we decided to take him to urgent care and they diagnosed him with an ear infection. They prescribed ofloxacin and amoxicillin. He started feeling better after taking the medication for 2 days.
This medically confirmed health authority report (initial receipt 27-OCT-2013) concerns a male patient. Every year, the patient received the flu shot (manufacturer and batch number not reported) and always developed a very  mild reaction. Outcome was not reported. Linked to 2014046391.
Spoke to husband 8am on 10/24/10. He described soreness erythema and some swelling at injection site which is normal. But he said she was having excruciating pain and could hardly move arm. I advise them to seek further medical attention. They did not see Dr 10/24/10 or 10/25/10.
The patient states she noticed a rash that itches less than 1 inch in diameter on her right forearm that she noticed today. Patient also states the injection site has red ring around it and the injection site feels hard.
Patient tested + for covid  6-28-22.  I do not have details of treatment given at that time.  He was admitted  to hospital on 7-18-22    with dyspnea and per dc summary reported to have had long COVID.  cxr showed mixed interstitial infiltrates with patchy consolidation  throughout both lungs.  IV zosym was started but later stopped in favor of rocephin, vanco and azithromycin. .  oxygen was titrated.  In ICU.  Elevated troponins felt to be from hypoxia and cardiology recommended outpt stress test.   Had acute kidney injury on chronic kidney disease.   Anemia - given packed RBC.  Ct of neck showed large soft tissue mass about the epiglottis.    Oncology consulted.  altered mental status as well with negative CT of head.    Steroids were stopped due to confusion.  He improved enough to be transferred to telemetry  and on 8/1/22 code blue was called, acls performed but patient expired 8-1-22. .  Blood cultures later showed esbl e coli that were collected 8/1/22.
Hives on trunk/arms with development of rhonchi on Resp. exam. Tx with PO BENADRYL & SQ Epi. Rash developed 5 min after vaccination with Resp sx onset approximately 30 min after vaccination.
Patient developed fatigue and headache within 24 hrs of receiving 1st vaccine, over the next several days she developed periorbital edema and cervical LAD.  6 days after vaccine she developed fever and chills and was febrile to 103.  She went to the ER and labs revealed pancytopenia.  She was admitted on the evening of 4/20 and was observed for 36 hrs.  Symptoms improved without antibiotics
Bruised left arm; Swollen left arm; Burning feeling down left arm; Hot left arm; Very tired/ Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruised left arm), PERIPHERAL SWELLING (Swollen left arm), BURNING SENSATION (Burning feeling down left arm), INJECTION SITE WARMTH (Hot left arm) and FATIGUE (Very tired/ Fatigued) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A and 088021A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021, the patient experienced CONTUSION (Bruised left arm), PERIPHERAL SWELLING (Swollen left arm), BURNING SENSATION (Burning feeling down left arm), INJECTION SITE WARMTH (Hot left arm) and FATIGUE (Very tired/ Fatigued). At the time of the report, CONTUSION (Bruised left arm), PERIPHERAL SWELLING (Swollen left arm), BURNING SENSATION (Burning feeling down left arm), INJECTION SITE WARMTH (Hot left arm) and FATIGUE (Very tired/ Fatigued) outcome was unknown.            Relevant concomitant medications includes antibiotics for UTI and severe sinus infections with double ear infections and take calcium  and vitamin D for my bones.  Treatment product information was not provided.   This case was linked to MOD-2021-297880 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Significant follow up received on 30-AUG-2021 and date of second dose of vaccine, concomitant medications and events has been updated.
DAPTACEL given to an 11 year old instead of the intended ADACEL with no adverse event; Initial information received on 03-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old male patient who was given daptacel [DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE] instead of the intended adacel with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 9V (YEAST) (GARDASIL 9) for Immunisation; MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Immunisation; and COVID-19 VACCINE (COVID-19 VACCINE) for Immunisation.  On 03-Aug-2022, the patient received a  dose of 0.5 ml of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5816AA, expiration date: 28-Feb-2023, via intramuscular route in the right thigh (Right Vastus Lateralis) as Immunization.   On 03-AUG-2022 the daptacel was given to an 11 year old instead of the intended adacel with no adverse event (wrong product administered) same day following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken not applicable.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome was Unknown for the event   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.
Initial and follow-up information has been received from a licensed practical nurse concerning a 17 year old white female with a history of depression who on 16-AUG-2007 was vaccinated intramuscularly into the right deltoid with a 0.5 ml first dose of Gardasil (Lot #655617/1447F). On 25-SEP-2007 the patient was treated for Menorrhagia and was given DARVOCET and CIPRO for a urinary tract infection (UTI). On 16-OCT-2007 the patient was vaccinated intramuscularly into the left deltoid with a second dose of Gardasil (Lot #658563/1063U). On 16-OCT-2007 the patient was given a pregnancy test prior to vaccination which was negative. On 30-OCT-2007, the patient requested a pregnancy test because she was 2 weeks late. This test was positive for pregnancy. A serum quantitative test was performed, results were 3528 and positive for pregnancy. The patient was placed on unspecified prenatal vitamins. The patient's last menstrual period was on 18-SEP-2007 and the estimated date for delivery was 24-JUN-2008. On 14-NOV-2007 the patient was placed on ZITHROMAX for treatment of bronchitis. On 26-NOV-2007 the patient was to have an appointment with the obstetrician (OB). At the time of the report the patient's outcome was unknown.  Follow up information was received, conerning a 17 year old female patient, who experienced anemia, psoitive Beta strep, yeast infecetion and UTI as complications during pregnancy. Concomitant therapy used during pregnancy included prenatal vitamins and iron. On 09-JUL-2008, the patient delivered a normal, healthy female baby weighed 8-2. 7 oz and length 21 inches.  Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of fever in a female subject of unspecified age who was vaccinated with Influenza vaccine trivalent (Flulaval, GlaxoSmithKline). On 15 September 2009 at 15:00 the subject received unspecified dose of Flulaval (.5mL, unknown right arm). On 15 September 2009, less one day after vaccination with Flulaval, the subject experienced fever and bone pain. Subject received Flulaval dose yesterday and developed 104 fever and aching bones last night. This is unresolved as of 17 September 2009. At the time of reporting events were unresolved.
PATIENT WAS GIVEN 1 DOSE OF MODERNA THAT HAD EXPIRED BY 2 DAYS. NO TEMPERATURE EXCURSIONS.
Pt stated he didn't feel good. slumped over and passed out. Ammonia smelling salts placed under pt. nose. pt twitches with Left arm jerking and Right head deviation. dusky coloring. eyes open and pupils dilated. Pt laid on floor. 911 called. Pt responsive after 30 seconds of above episode. Pt AOx3 Pulse and respiration WNL . EMS arrived appx 1015AM. VS retaken and WNL. EKG done and IV started by paramedics. Pt had nausea and small spit up and emesis at 10:25AM. Pt taken via EMS to Hospital at 10:30AM.
Patient presented to the emergency room at the hospital the day of admission with complaints of shortness of breath.  The patient was discovered to have an oxygen sat of 82% air. Initially the patient had improvement with supplemental oxygen in the ER. The patient did test positive for COVID-19.He was admitted to the critical care unit and initiated on IV antibiotics, dexamethasone, Remdesivir, the convalescent plasma as well as supplemental vitamin therapy.  The patient was noted to be bradycardic and Cardiology was consulted and followed along. The patient was initially stabilized on 100% non-rebreather and subsequently placed on Vapotherm at 85% Fi02. He was then placed on continuous BiPAP. He subsequently had to be intubated on the night of 08/06.  Patient expired on 09/02/2021.
redness on both sides of her neck; not that itchy but irritating; when touched, it is warm; feels rigid,like rough area on her neck; scattered little red bumps on her chest; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness on both sides of her neck), IRRITABILITY (not that itchy but irritating), SKIN WARM (when touched, it is warm), NUCHAL RIGIDITY (feels rigid,like rough area on her neck) and BLISTER (scattered little red bumps on her chest) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included FORMOTEROL FUMARATE (FORADIL) for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced ERYTHEMA (redness on both sides of her neck), IRRITABILITY (not that itchy but irritating), SKIN WARM (when touched, it is warm), NUCHAL RIGIDITY (feels rigid,like rough area on her neck) and BLISTER (scattered little red bumps on her chest). At the time of the report, ERYTHEMA (redness on both sides of her neck), IRRITABILITY (not that itchy but irritating), SKIN WARM (when touched, it is warm), NUCHAL RIGIDITY (feels rigid,like rough area on her neck) and BLISTER (scattered little red bumps on her chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided.
This spontaneous report was received from a Registered Nurse concerning an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II lot # L012479, the expiration date: 10-APR-2017, lot# M010426, the expiration date: 01-MAR-2018, Lot# M004063, the expiration date: 25-JAN-2018 and Lot# M007277, the expiration date: 09-FEB-2018 (dose and route were not provided) for prophylaxis. The nurse could not provide the lot and expiration for the properly stored sterile water diluent used to reconstitute the doses of M-M-R II) No adverse effects reported nor Product Quality Complaint involved (PQC). The call was made due to data logger with a temperature of 35°F during 45 minutes. There was no previous temperature excursion reported. This is one of several reports received from the same reporter. Additional information is not expected because the reporter refused additional contact.; Sender's Comments: US-009507513-1703USA009966: US-009507513-1704USA001679: US-009507513-1704USA001680:
Patient reports feeling stable immediately after receiving the Shingrix vaccine. She began to feel dizzy and fatigued when she went to bed and also began to shiver uncontrollably. She was able to fall asleep, but woke up several hours later and continued to feel dizzy. When she woke the following morning still feeling dizzy and shivering. She sat down to continue resting and lost consciousness. She woke up on the floor. She states she had a mild injury and soreness to the hip and shoulder. Shivering, fatigue, dizziness resolved slowly throughout the morning.
The patients arm swelled up in a large area with blistering in the middle of the swelled area.
Heart inflammation, ringing ear and numbness in feet , face hands  and gi flare up now as well
very bad rash; injection site red; Injection site sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (very bad rash), INJECTION SITE ERYTHEMA (injection site red) and INJECTION SITE PAIN (Injection site sore) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medically reported history).    On 09-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced INJECTION SITE RASH (very bad rash), INJECTION SITE ERYTHEMA (injection site red) and INJECTION SITE PAIN (Injection site sore). At the time of the report, INJECTION SITE RASH (very bad rash), INJECTION SITE ERYTHEMA (injection site red) and INJECTION SITE PAIN (Injection site sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included went to urgent care, they give her a steroid cream  Recoded events (Vaccination site rash, Vaccination site erythema and Vaccination site pain)
Muscle soreness like flu shot; This spontaneous case was reported by a pharmacist and describes the occurrence of MYALGIA (Muscle soreness like flu shot) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, HYDROCHLOROTHIAZIDE, TELMISARTAN (TELMISARTAN HCTZ), MONTELUKAST SODIUM (SINGULAIR), NIACIN and POTASSIUM for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced MYALGIA (Muscle soreness like flu shot). The patient was treated with PARACETAMOL (TYLENOL) for Prophylactic, at an unspecified dose and frequency. At the time of the report, MYALGIA (Muscle soreness like flu shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-333431.
Body aches and mild fever at 1030pm 5/8. Took OTC Dayquil. Continued like that with fever peaking at 102.3 on 5/9 at 5pm. Fever reduced to 100 at  8am on 5/10. Fever gone by 1pm on  5/10.
DTap/IPV #2 (had never been immunized before 08/01). Mom called next AM, temp 104 degree and advised Tylenol/motrin every 4 hours, increased fluids. 11/08/2001 Afebrile but large localized reaction from right shoulder to elbow, red, hot, indurated.
Patient in observation. Patient complaining of difficulty swallowing. Patient has hives on her chest, spreading to neck and face. Patient verbalizes feeling lightheaded and heart beating  fast.  911/EMS called. Vital signs, BP-177/88, HR-104, RR 21. Epinephrine 0.3mg administered into left upper thigh by EMT.  Vital signs, BP-118/77, HR-107. Patient stated she feels better and can breathe.  EMS arrived to scene. Patient refused EMS cared. Patient educated about adverse symptoms and advised to call 911 if symptoms reoccur and/or worsen. Patient signed AMA and released.
Would sure like some help with this. I have always been a very active person. I would bike on average 20 miles a day after work and on days off. Ever since 2 days after my flue shot I have never been the same. Every step I take is painful. It started in my right leg. At first a big knot and leg cramp like I've never had before in my life and my leg felt like a stretched rubber band oddly but pain would transfer around my leg and foot sometimes even making my foot half asleep. Within a week however the pain has settled to my very low back or the top part of my butt on both sides. I found it hard to believe that this pain was caused by the flu shot and have been waiting for it to go away. I take 4 advil now every mourning just to get to work or out of bed and some days it feels worse then others. I can't bike anymore without intense pain in what I believe is my siactic nerve there at the top of my butt. I'm worried it's going to immobilize me simply because it hurts to get up and walk. I move a lot slower because of the pain and people have noticed because I can't help but walk with a slight limp most the time. It's never gone away and I never experienced pain in this area prior to the flu shot. I'm not even about trying to get money or something for this, I want my mobility back. To boot, I've been scared to go see a doctor because of Corona virus although I think today I may finally go to urgent care about it