chrisvoncsefalvay/vaers-outcomes huggingface dataset:
neuromyelitis and paralysis / her "spinal fluid looked white"; the virus attacked her spine; Caller confirmed that she did not receive a dose of the vaccine, but caller administered the vaccine to a patient and "maybe did not wash hands good enough,"; Caller confirmed that she did not receive a dose of the vaccine, but caller administered the vaccine to a patient and "maybe did not wash hands good enough,"; This spontaneous report was received from a 66 years old female patient, who was referring to herself. The patient's concurrent conditions included high blood pressure, sjogren's syndrome and several unspecified allergies. Her concomitant medications included unspecified blood pressure medicine.  On an unknown date in January 2012, the reporter was administering to an unknown patient the dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (dose, frequency, route of administration, lot# and expiration date were not reported). The reporter confirmed that she did not receive a dose of the vaccine, but "maybe did not wash hands good enough". On an unknown date in January 2012, she experienced neuromyelitis and paralysis, her "spinal fluid looked white" and the virus attacked her spine. The patient was hospitalized due to the events in February 2012 for approximately one week and again in September 2012 for approximately 10 days. On an unknown date, unspecified blood work, antibodies testing and magnetic resonance imaging (MRI) of spine were performed but no results were provided. She received plasmapheresis and physical therapy as a treatment. The outcome of the events was reported as mostly recovered/resolved on an unknown date in March 2013. The causality assessment between the events and the suspect therapy was not provided.  Upon internal review, the events of neuromyelitis and paralysis, her "spinal fluid looked white" and the virus attacked her spine were determined to be medically significant.
improperly stored GARDASIL 9 was administered to patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.     On 23-NOV-2020, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast ) (GARDASIL 9) (lot # 1637651 with expiration date 09-JUN-2022; dose and route were not provided) for prophylaxis (product storage error). The vaccine was exposed to temperature excursions of below 36 degrees Fahrenheit (26.2F) for 35 hours. There was no previous temperature excursion. A "data logger" was involved. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637651; expirationdate: 09-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Shortly after getting the vaccine I started to have fatigue and body aches which last 48hours. The night of 11/22/2021 around 12am I noticed tenderness in my right armpit and assumed it was lymph node swelling. When I woke at 9am, my armpit was so painful I could barely get dressed, there was a red rash that was hot and raw, with painful aching around the armpit and in the muscles. I applied hydrocortisone to treat and medicated body powder with corn starch.
Two days after the patient received her second SHINGRIX shot, she noticed a red, itchy, blister like rash on the inside of her right arm. She came into the pharmacy the next day so that we could take a look at it. The patient had no fever, rash was itchy but not painful, and the patient said it looked better than it did yesterday. I told the patient to use hydrocortisone for the itchiness and to monitor the rash. If the rash gets worse, see a doctor.
No issues at times of both injections - after second injection, 6 days later had beginnings of shingles and at 9 days after injection definately knew I had shingles - shingles were on the left back quadrant of head
Patient complained of arm hurting - was not able to lift above head the morning after receiving PNE shot.
15 Year old patient presenting chest pain 4 days after de 2nd dose of the COVID-19 Vaccine.  Patient had to be hospitalize, elevated troponin levels, electrocardiogram with normal functions, mild FR, trace MR, thickened pericardium. Normal function Cardiac MRI. Pericardium effusion.
pt recvd Typhoid vax & devel an inject site reaction characterized by heat, swelling, & itching;
Shoulder pain when lifting arm. Pain is limiting mobility and seems to be getting worse each day. Took 400mg Ibuprofen for pain this morning with minimal affect. Some pain in muscle where vaccine received.
No adverse effects reported; received improperly stored VARIVAX; This spontaneous report was received from a medical assistant referring to six unspecified patients of unknown age and gender. Their medical history, concurrent conditions and drug reactions/allergies were not reported. Concomitant medication included sterile diluent. Since 14-MAR-2019, it was reported that these six patients were vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), lot # R011805 and expiry date: 23-APR-2020, lot # R023503 and expiry date 16-AUG-2020 for prophylaxis (strength, dose, unit, route, anatomical location were not reported). The vaccine was reconstituted with properly stored sterile diluent. The administered doses of the vaccines experienced temperature excursion from above 6 degree Fahrenheit (F) to 14 degree F (7.5 degree F) for five minutes. No previous temperature excursion was reported. The call was due to digital data logger. No adverse effects were reported. No product quality complaint (PQC) was involved.  Follow up information was received from a lead medical assistant refers to 12 month old patient of unknwon gender on 21-NOV-2019. On 02-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R023503 and expiry date 16-AUG-2020 (product storage error).  This is one of several reports received from the same reporter.
Injection given (L) deltoid on 9/10/2012 pt was seen 9/13/2012 w/ redness, pain, & warmth below area of injection - Dx 451.82; given Rx for Ibuprofen 600 mg every 8 hrs as needed for pain & swelling.
Pt was given Pfizer bivalent booster 0.3mL(age12 and above), pt is 9 yr and 9mos old.  Will follow-up with pt regarding adverse events
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of an unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose # and route not specified) for the long-term prevenion of shingles and zoster-related conditions. Subsequent on an unknown date, the patient was treated for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
pt recv vax 1 1/2 wk post vax & devel feelings of hot & cold, malaise, t101.5 & visual changes;no tx was given;sx resolved;
no adverse event; an unspecified patient received a dose of expired VAQTA; This spontaneous report was received from a Medical assistant via office manager, and refers to a 24 year old female patient. the patient's concurrent conditions, pertinent medical history, drug allergies or reactions were not provided.  On 03-NOV-2020, the patient was vaccinated with an expire dose of hepatitis a vaccine, inactivated (VAQTA) which had a lot # S017741 with expiration date on 26-AUG-2020, (route of administration and anatomical rout of administration were not reported) for prophylaxis.  The hepatitis a vaccine, inactivated (VAQTA) was stored at the appropriate storage condition, specified in the product label through the date of administration. However, no adverse events were reported.  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S017741; expirationdate: 26-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
admitted to shady grove hospital for ITP(immune mediated thrombocytopenia) plts were 1 on admission have not responded to typical ITP therapies, platelets still 4 today after 4 days in hospital workup shows ITP no other risk factors or history of itp or autoimmunity
.Please see the following determination; Doses Administered from 4.6.2021 to 5.21.2021:Based on the information you have provided and the lack of temperature data, we are not able to conduct an analysis or guarantee the doses administered between 4/6/2021 and 5/21/2021 provided the necessary protection against a COVID-19 infection. Please continue with the original plan of action on revaccination and completing a VAERS Reports on the all clients you have identified.
The patient is currently comatose admitted into the ICU at Hospital.  He received the RSV vaccine being in a normal state of health at his local pharmacy October 8, 2023.  He came to the office for routine labs on October 9, 2023 and at that time labs were within acceptable limits aside from a minimal lymphopenia.  He coursed with fatigue, shortness of breath and confusion and was hospitalized with a sodium of 121, fluctuating levels of consciousness that progressed over the past week to an obtunded state.  He is currently admitted at the ICU of Hospital.  Blood cultures have been within normal limits.  He has had a chest CT to screen for pulmonary embolism that has been unremarkable.  He has also had a CT scan of the abdomen and pelvis which has been unremarkable.  His labs have coursed with improvement of the sodium by administration of hypertonic saline solution.  His hemogram has coarse with leukopenia, anemia and thrombocytopenia and his platelets are currently 25,000.  His baseline is a normal white blood cell count, normal hemoglobin and normal platelets.  Pulse therapy with 1000 mg of steroid IV once daily has been performed for the past 3 days and the patient is now coursing with rhabdomyolysis and acute renal failure.  The plan is to intubate him later today.  MRI of the brain with and without contrast has shown no significant abnormality.  Lumbar puncture has not been performed because of the patient's low platelets.
Chills Aches & Pain No Energy No interest in food Started 20 hours after shot, lasted 18 hours
Red, inflamed spots and blotches on arms.  Worsening inflammation of spider bites on neck/ upper chest area. Sensation of being in a "fog" mentally.
Moderate fever 12hrs after receiving dose Fever of 101.4 18hrs after dose Headache, body aches, chills, loss of appetite 18hrs after dose Tylenol given ever 8hrs after 18hrs Fever reduced to 100 24hrs after onset of fever All symptoms resolved by 36hrs after onset of symptoms  No issues reported after 36hrs
Sore arm; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) and HEADACHE (Headaches) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm) and HEADACHE (Headaches). At the time of the report, VACCINATION SITE PAIN (Sore arm) and HEADACHE (Headaches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Immediately upon injection, patient went limp, then entered into a seizure, eyes rolling back, body convulsing, mouth clamped down on lower lip, unresponsive, arms rigid, hands near chin, and lips as pale as the rest of her face except for instant bruising in the corners where she bit. This lasted 10 to 20 seconds. Then, she was very angry, and very thirsty, and mildly disoriented.
Skin: 2.5-in x 3-in circular area of erythema on left deltoid, warm to the touch, minimal tenderness, no induration.          Assessment    1. Local skin infection  2. Skin inflammation  3. Adverse effect of influenza vaccine, initial encounter            Plan     1. Skin inflammation 2. Local skin infection 3. Adverse reaction to influenza vaccine, initial encounter - Inflammatory reaction vs infection due to flu vaccine - Advised mom to mark the area with a pen/marker and monitor for worsening - If no improvement or if redness spreads over the next 1-2 days, start antibiotics - cephalexin (KEFLEX) 250 mg/5 mL suspension; Take 8.5 mLs (425 mg per dose) by mouth 2 (two) times daily for 7 days.  Dispense: 119 mL; Refill: 0
Patient is a 11 y.o. male vaccinated against COVID with COVID exposure ~ 1 month ago presenting with fevers, conjunctivitis, vomiting and diarrhea, cough, rash, elevated inflammatory markers, and nucleocapsid antibody positivity for SARS-CoV-2. Clinical picture consistent with MIS-C and he is now s/p IVIG. He remains febrile, but reports improvement of GI symptoms, conjunctivitis, and resolution of rash. Remains admitted for monitoring.
This is a 36-year-old patient who received his first anthrax vaccination on April 17, 2003. On that day he also had a PPD placed. He reports that experienced immediate burning at the site but this soon resolved. He also developed a small lump at the site as well as an aching sensation. These symptoms continued for several weeks. When he received his second anthrax vaccination on July 7, 2003, he reports that he had identical symptoms, immediate burning that quickly resolved, a lump and an aching sensation that lasted for at least three weeks. Upon receiving his third anthrax vaccination, on July 23, 2003, the lump at the site remained for about 3 weeks again. Again, the ache in his upper arm developed; however, this time it persisted. He reports that both arms have a persistent dull ache on a daily basis that he rates a 2/10 in intensity. At times the sensation is throbbing. The sensation is greater in the right arm and at times wakes him from sleep. When he lifts objects over his head, this intensity increases to 6-7/10, quickly resolving when the lifting is stopped. He denies any weakness in his arms.  He also experienced a headache following each anthrax vaccination, however, denies that these were particularly bothersome. He did not use medications for relief of these symptoms.
15 minutes after vaccination, increased HR, SOB, swelling in tongue and mouth, numbness to all extremities and hives to trunk. HR 150's, BP 170's/100's. In ED given epinephrine, SOLU-MEDROL, BENADRYL and ZANTAC. Still on prednisone taper and having residual symptoms.  Medical records recieved for DOS 10/31/09- 11/1/09. Final DX: Anaphylactic reaction to the H1N1 influenza vaccine  Upper chest rash, tachycardia and SOB 30 min s/p vaccine. Faintness. Mild swelling around eyes.  Sx reoccurred intermittently and worsened once with Benadryl.  Episodes preceded by L forearm and hand, then tachycardia and tingling extrems. PE DTR 1/4 arms, 2/4 legs. Flexor plantar responses. EKG abn. Steroid therapy.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions or pertinent medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot# N013268, expiration date 25-OCT-2018 (dose and route of administration were not reported). Concomitant therapies included sterile diluent. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 6 to 14 degrees Fahrenheit for 54 minutes. There was no previous temperature excursion. Digital data logger was involved. The outcome of the event was not reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA004753: US-009507513-1709USA008502: US-009507513-1709USA008504.
BLACKED OUT UNCONSCIOUS IMMEDIATELY AFTER THE SHOT; SHOOTING PAIN IN HEART; This spontaneous report received from a patient via social media via a company representative concerned a 38 year old female. The patient's height, and weight were not reported. Patient was healthy. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported,1 total, therapy start date was not reported for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient was blacked out unconscious immediately after the vaccination with shooting pain in heart. Patient was taken to the emergency room. Patient had elevated troponin levels. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blacked out unconscious immediately after the shot and shooting pain in heart was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210827757-covid-19 vaccine ad26.cov2.s-blacked out unconscious immediately after the shot and shooting pain in heart. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
tender @ inject site; erythema below inject site on lat aspect upper arm; inc warmth other are of redness;
Patient received their second dose of Pfizer 3 days earlier than the grace period of 4 days before and any time after 10/21/21. Patient was in their second week of the waiting period between the first and second dose and the patient came to get their vaccine. The dates on the vaccine card were not carefully read and seen by the vaccinator and thus the vaccine was given too early.
12:45 patient received vaccine 12:55 patient felt "fullness" on one side of her throat then "fullness" on the other side as well; dizziness and nausea 13:50 EMS administered benadryl 50mg 14:10 patient felt no improvement, and was transported to Hospital
Fever, chills, muscle aches, runny nose, sore throat, headache, fatigue, cough, nausea, and diarrhea
administered with the booster dose 28 days after the 2nd dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Nov-2021 and was forwarded to Moderna on 01-Nov-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered with the booster dose 28 days after the 2nd dose) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered with the booster dose 28 days after the 2nd dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered with the booster dose 28 days after the 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.
This spontaneous report was received from a physician via company representative refers to a 19 year old female patient. Approximately on an unknown date in 2011, the patient was vaccinated with a dose of GARDASIL, (lot number, expiration date and route was not reported). No concomitant medications were reported. It was reported that the patient was getting headaches and discontinued GARDASIL series before completing the series. The outcome of headache was reported as not recovered. The patient sought medical attention (saw doctor and neurologist). Additional information is not expected.
Systemic reaction with rash on back and arms. Headache and lymphadenopathy.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) 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.   No concomitant and treatment medications were reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments.
A 24 year old female with no medical conditions received the 2nd dose of Anthrax vaccine on 01/21/2001.  The patient was not ill at the time of the vaccination was taking no concomitant medications at the time of the event.  The patient experienced a local reaction to the 1st dose of Anthrax vaccine. On 01/22/2001, 24 hours after the immunization, the patient noted a rash consisting of tiny red dots on the inside of the thighs and groin, behind the knees, under the arms and breasts, and in the bend of the elbows.  The areas were very itchy; scratching did not exacerbate the examination on 02/03/2001.  The patient did not initially take medication to treat the rash.  Benadryl was subsequently prescribed on 02/03/2001.  The patient also noted a full felling over the left ovary for several days.  The start of her menses coincided with relief of this pain.  The outcome of this events is unknown at this time.
Approx 10 days p/receiving vax @ clinic, child noted to have fever 100.6, s.t., cough, achy joints, & rash on abd. Mom will have child seen by pvt MD to r/o viral illness;