chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse event; the patient was inadvertently administered a dose of VAQTA that was expired; This spontaneous report was received from a pharmacy technician referring to a 37 years old patient with unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided.     On 08-JUL-2020, the patient was inadvertently administered a dose of hepatitis a vaccine, inactivated (VAQTA) (strength, dose and route were unknown; lot # S007265, expiration date 07-JUL-2020) for prophylaxis (expired product administered). No additional adverse event. The outcome of the events was unknown. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:  manufacturercountry:  devicelotnumber: S007265; expirationdate: 07-JUL-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
Patient was treated at hospital on the following dates: 5/7/07, 5/9/07, 10/26/07, 12/09/07, 02/05/08, 03/12/08, 04/16/08, 04/17/08, 05/08/08, 10/19/08, 11/18/08/04/01/09, 05/18/09, 05/27/09, 05/28/09 through 5/31/09, 09/03/09 9/17/09, 09/20/09, 09/23/09, 10/19/09, 10/23/09, 10/26/09 through 10/28/09, 11/17/09, 11/23/09, 11/24/09,  12/14/09, and 12/25/09 for medical issues relating to adverse reaction to the Gardasil vaccine.  She was also treated by multiple physicians on the following dates: 04/17/07, 05/16/07, 06/29/07, 10/08/08, 10/15/08, 11/13/08, 01/28/09, 02/11/09, 04/02/09, 05/12/09, 05/28/09, 06/02/09, 06/10/09, 07/02/09, 07/28/09, 08/12/09, 09/14/09, 09/21/09, 09/25/09 by two separate physicians, 10/09/09, 10/12/09, 10/19/09, 11/09/09, 11/16/09, 11/17/09, 11/23/09, 11/30/09, 12/02/09, 12/11/09, 12/14/09, and 01/01/10.  Patient was seen and treated for the following ongoing medical issues:  Fibromyalgia, environmental allergic reactions, hoarseness, coughing, shortness of breath, difficulty/pain when swallowing, continued throat pain, dizziness, repeated severe headaches, light headed, chills, overheated, excessive night sweating, lethargic, sleeping for entire day without waking rested, confusion/short term memory issues, seizures, sharp chest pains, racing heart, muscle/joint aches, hives on trunk/arms/shoulders, ringing in ears, severe depression, twisted/spastic colon, acid reflux, heartburn, weight gain. 1/4/2010 GI consult records for 9/14/2009, patient with chronic but progressively worse abdominal pain of ? etiology, increased fatigue, non-specific chest pain, change in bowel movements, alternating constipation and diarrhea, cold sweats and SOB with exertion, weakness with sensation of knees giving away
On 17-AUG-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # R004689; expiration date: 29-NOV-2020 or lot # R006689; expiration date: 29-NOV-2020) (dose and route of administration were not reported) for prophylaxis, which had a temperature excursion of 47 degrees F to 77 degrees F (56F) for 15 days on unspecified dates. There were no previous temperature excursions and no digital data logger involved in recording the temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Sender's Comments: US-009507513-1808USA012996; US-009507513-1809USA006251; US-009507513-1809USA006252; US-009507513-1809USA006253; US-009507513-1809USA006254; US-009507513-1809USA006255; US-009507513-1809USA006256; US-009507513-1809USA006258; US-009507513-1809USA006259; US-009507513-1809USA006260; US-009507513-1809USA006261; US-009507513-1809USA006262; US-009507513-1809USA006263.
Patient reported being dizzy and passed out.  Emergency services were called and emergency room doctor determined that dizziness and fall was not result of influenza vaccine.
EXTREME VERTIGO, HIGH FEVERS, SYNCOPE, BODY ACHES, CHILLS, MEMORY LOSS
Covid symptoms started 01/25/2022. I was at work and had this bad charlie horse like feeling in head with intense muscle pain in my brain and in my forehead, nasal bridge, and eyebrow. It felt like stroke symptoms and it was a very intense cramping in part of my brain and I didn't think it was normal. It went away after 10 minutes and so I went back to work and my speech was getting slow and my reaction time and body movements were slow. I was conscious but my whole head and thinking and my conscious self kind of slowed down so I realized this is something more. I went home sick for the day and went home and that following Friday I did a zoom call with my PCP and was diagnosed with Covid-19. I was slow with long Covid-19 symptoms for 2-3 days but it kind of just went in my system, damaged it, then left. It wasn't a breakthrough case for a few days there. No lingering effects. I had just taken the doses of Adderall that day and I had just taken the 2nd dose when all of that happened and my PCP that diagnosed me said that it was an attack on the nervous system and Adderall stimulated it so if I didn't have the ADHD medicine I would've collapsed most likely. I was in the ER last week for stomach bug as well but I can't confirm if it was Covid-19 related and they think it could've been food poisoning. I had blood in stool and IBS symptoms. Local ER location.
Starting the night of the injection, my left arm gets numb from my elbow to my fingertips. Only my ring and pinky finger are affected.  The color and temp of the fingers are normal, but it feels like the circulation is cut off. If I get up and work it for about a half-hour it is completely normal (and stays so throughout the day). This wakes me up 3-4 times a night and continues to this day >3 weeks later.  I started Zeposia medication a few days before this shot. I didn't have this effect with my 2nd shot in my other arm.  I did use an ax to chop wood for 4 hours 2 days before the shot, and my arm was sore from that before the injection. It's possible this is unrelated to the shot altogether, and I did something to trigger some sort of carpal tunnel with the ax. I plan on discussing with my Dr at some point.
5 minutes post vax, the pt began scratching left arm and pt developed a baseball sized area of erythema. Given Benadryl to relieve symptoms.
Husband called 10/1/12 & said patient had a swollen & red right arm that redness reached down to her elbow. Husband said he will call her physician & see if she should be seen. He said the reaction was from the pneumonia vaccine.
I was alerted on 3.11.21 by the patient's wife that patient had passed away the night after having received the vaccine. The wife informed me that she did not wake up the next morning.
about 45 minutes following vaccine administration patient got sore throat and felt like throat was swelling. Throat swelling lasted 10 minutes, soreness lasted 4 hours.
Woke up with a rash on my face this morning; This case was reported by a consumer via interactive digital media and described the occurrence of rash on face in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th June 2021, the patient received Shingrix. On 14th June 2021, 7 days after receiving Shingrix, the patient experienced rash on face. On an unknown date, the outcome of the rash on face was unknown.   It was unknown if the reporter considered the rash on face to be related to Shingrix.  Additional details was reported as follows: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient woke up with a rash on my face this morning (on the day of reporting). The follow up would not possible as no contact details were available.
Employee received #2 Pfizer on 3/18/21 at 3pm. At 8pm she describes experiencing vague chest pain that she attributed to musculoskeletal pain. She took Tylenol and drank fluids, went to bed. The next am, she woke up with worsening chest tightness and diffuse back pain. At approximately 1-2 pm she experienced SOB, labored breathing, and a "weird" chest discomfort "like something was sitting on her chest." She called 911, was evaluated by paramedics, VSS, BP 120s-130s, O2 sat 100%. They did not transport her to ED. She took Tylenol and drank fluids and reportedly felt "much better" by 4pm
This spontaneous report as received from a registered nurse refers to a 9 months old patient of unknown gender. On 23-JUN-2014 the patient was vaccinated with liquid PEDVAXHIB (lot # J016185, expiry date: 02-OCT-2016, dose and route of administration were not reported) that was exposed to temperatures out of range (multiple excursion over a 24 hour period totaling 5 hours below 36F, including three cycles below 28F, have occurred on unspecified date, reported as prior to the morning 23-JUN-2014) that were not supported by Merck's stability data. No adverse effects were reported. This is one of several linked reports received from the same reporter. Additional information has been requested.
Fever 102.1, chills, severe muscles/joint pain, headache, nausea, sensitivity to light,  weakness.  Medication did not relieve symptoms for  22 hours. After 24 hours symptoms are fading.
First vaccine lot # 013L20A left arm  on 1/18/2021 at 6pm Second vaccine lot # 023M20A left arm 2/25/2021 at 6pm  Rash developed to left arm Saturday 2/27/21 with scattered areas to right forearm, bilateral thighs and right hamstring.
Patchy hives developed within 36 hours, spread to entire body within 60 hours. Saw doctor at 48 hours and again at 72 hours post vax. Received, following second visit, Methylprednisolone, 4mg dose pack. Fever peaked at 103.5 at 120 hours post vax. Still recovering.
This spontaneous report was received from nurse refers to a 26 or less patients of unknown age and gender. Medical history was not reported. The nurse informed that on an unknown date the patients were vaccinated with RECOMBIVAX HB (lot number, expiration date, dosage and route were not reported), that were improperly stored. The nurse stated she knew that RECOMBIVAX HB was one of the vaccines that was administered. Also informed she was still gathering information on how many clients were vaccinated with improperly stored vaccines. No adverse effects were reported. Additional information has been requested.
Pt recv vax on 1/21/99; on same day pt exp red, pain, heat at vax site w/ swollen arm; tx=Prednisone
3 days after 1st dose of moderna began to have mild generalized pruritis and "prickly heat" rash after showers. Has persisted since 1/24. No anaphylaxis.
Information has been received from a physician concerning a female who was vaccinated on an unspecified date with GARDASIL (lot # not provided). Concomitant therapy included DEPO-PROVERA. Subsequently the patient experienced extreme drowsiness within an hour after receiving GARDASIL. The patient's outcome was not reported. Additional information has been requested.
Migraine; Shortness of breath; This spontaneous case was reported by a pharmacist and describes the occurrence of MIGRAINE (Migraine) and DYSPNOEA (Shortness of breath) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced MIGRAINE (Migraine) and DYSPNOEA (Shortness of breath). In February 2021, MIGRAINE (Migraine) and DYSPNOEA (Shortness of breath) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Initial presentation appeared to be a splotchy rash on sides of abdomen from armpit to hip bone. Ultimately was diagnosed with atopic dermatitis after a biopsy. Met with dermatology and allergy/immunology for testing, treatment and follow up. Condition has continued to present, and has worsened overtime. The rash/symptoms have appeared on my legs, shoulders, back, and now around my eyes. It is being treated with topical creams and I have changed my laundry detergent, body soap, and moisturizer. All of my products are fragrance and dye free.  The allergy patch testing was non-conclusive. Despite the condition continuing to worsen, my providers can't pinpoint why it started when it did. I had never been diagnosed with eczema prior to this emergence, which coincided with my first COVID vaccine.
Patient felt hot, naseau, lost feeling in her hands, dizzy about 10min post injection.  She had her blood pressure taken which was normal and was given diphenhydramine 25mg tab and water.  After about 5-10 min the patient was feeling better.
Information has been received from a RN concerning a pt who on 29Sep95 was vaccinated with a dose of varicella virus vaccine live (lot 609290/0434B). Subsequently, on 16Jun01, the pt developed chickenpox. The pt was not seen in the office. The reporter also indicated that 30 other pts were vaccinated with varicella virus vaccine live and developed chickenpox (WAES0409USA00600, WAES0409USA01045, WAES0409USA01046, WAES0409USA01047, WAES0409USA01048, WAES0409USA01049, WAES0409USA01050, WAES0409USA01051, WAES0409USA01052, WAES0409USA01053, WAES0409USA01054, WAES0409USA01055, WAES0409USA01056, WAES0409USA01057, WAES0409USA01058, WAES0409USA01059, WAES0409USA01060, WAES0409USA01061, WAES0409USA01062, WAES0409USA01063, WAES0409USA01064, WAES0409USA01066, WAES0409USA01067, WAES0409USA01068, WAES0409USA01069, WAES0409USA01070, WAES0409USA01071, WAES0409USA01072, WAES0409USA01073, WAES0409USA01074). No further information is expected.
Flu like symptoms; Blood pressure decreased; Chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), BLOOD PRESSURE DECREASED (Blood pressure decreased), CHILLS (Chills) and HEADACHE (headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), BLOOD PRESSURE DECREASED (Blood pressure decreased), CHILLS (Chills) and HEADACHE (headache). The patient was treated with ASCORBIC ACID, CYANOCOBALAMIN, FERRIC PYROPHOSPHATE, FOLIC ACID (SEDEROM) at a dose of 500 milligram. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), BLOOD PRESSURE DECREASED (Blood pressure decreased), CHILLS (Chills) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: decreased (Low) decreased.         No concomitant medications reported. Action taken for Moderna COVID-19 Vaccine was not applicable.
34 yo male is calling to report symptoms of itching, loss of appetite, change in voice, fatigue, nausea, headache and fever that started 24 hours after first Pfizer vaccination on 4/30/21. He reports taking Nyquil at night with minimal improvement.  He reports symptoms have changed over the last two weeks and progressed to different symptoms. He did a rapid covid test last week that was negative. He did this at a travel location and did not see a provider.
inappropriate reconstitution technique; patient was administered a dose of Shingrix adjuvant without reconstituting with the antigen vial; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27-OCT-2023, the patient received Shingrix. On 27-OCT-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: inappropriate reconstitution technique) and inappropriate dose of vaccine administered (Verbatim: patient was administered a dose of Shingrix adjuvant without reconstituting with the antigen vial). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 27-OCT-2023 The state department of health regional consultant reported a site reached out to them regarding a patient that was administered a dose of Shingrix adjuvant without reconstituting with the antigen vial, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The dose was given today, on the date of reporting.  The reporter did not have/declined to provide any further details. The reporter did not consent to follow-up.
The pt experienced a maculo-vesicular rash scattered all over the body which started as few patches on chest and toes and gradually spreading in 2 days. Rashes crested and dried after 7 days. No associated fever.
Slight fever treated with children's Tylenol.  He immediately stopped passing stools and his stools became hard and black.  He stopped smiling and started crying after no previous "colic" behaviors.  He started staring out into space and stopped moving or noticing things in front of him.
EMPLOYEE STATES SHE STARTED TO DEVELOP HIVES ON HER LEFT HIP AROUND 7 PM 26 AUG 2021. SHE STATES HIVES THEN STARTED DEVELOPING ON HER RIGHT THIGH DESCENDING DOWN HER RIGHT LEG. EMPLOYEE (PT) STATES SHE THEN DEVELOPED HIVES ALL OVER HER BODY MINUS THE LEFT DELTOID AREA WHERE TD VACCINE WAS ADMINISTERED. DENIES SHORTNESS OF BREATH OR DIFFICULTY BREATHING. STATES SHE TOOK OTC BENADRYL AND BEGAN TO NOTICE IMPROVEMENT IN SYMPTOMS.
Preoperative screening COVID-19 PCR detected  pt procedure  to donate kidney surgery postponed.
Moderna Covid-19 Vaccine EUA I noticed a rash on the front of my body .  It gradually spread to my back, neck and now is on my face.  The rash is dark pink and splotchy, warm and slightly raised .
No adverse event, pt was give Peds dose of DTAP .5ml - pt was to receive TDAP .5ml
Headache, Myalgia, fatigue, chills, body aches Narrative:
Patient states are after Prevnar13 got progressivly inflamed, hot and painful. Patient went to PCP on 11/13/2015, who said that the Prevnar was leaking out of muscle tissue into subcutaneos tissue.  Patient was treated with Bactrim DS antibiotic and Prednisone.
3 days p/vax pt was taken for a f/u CT Scan which showed a new massive subdural hematoma resulting in craniotomy & death;
PATIENT STATES THAT SHE RECEIVED HER 1ST MODERNA COVID VACCINE ON 14 MAY IN HER LEFT ARM AND STATES INITIALLY SHE JUST HAD A SORE ARM.  SHE STATES ON 16 MAY SHE HAD NECK AND LEFT SHOULDER PAIN, AND THEN ON 17 MAY SHE STATES SHE HAD NECK, LEFT SHOULDER PAIN, AND STATES SHE WAS UNABLE TO MOVE HER LEFT ARM AND HAD HAND SWELLING IN HER LEFT HAND AND WAS SEEN AT THE FACILITY ON THAT DATE.  SHE WAS TREATED WITH A TORADOL INJECTION AND WAS ALSO GIVEN IBUPROFEN 800 MG AND FLEXERIL.  PATIENT STATES NO IMPROVEMENT WITH TREATMENT AND WAS SEEN AGAIN AT THE FACILITY ON 19 MAY AND SHE WAS GIVEN ANOTHER TORADOL INJECTION AND WAS STARTED ON A 3 DAY COURSE OF PREDNISONE.  TODAY IS DAY 2 OF PREDNISONE COURSE AND HAS NOT TAKEN HER 2ND DAY DOSE YET.  PATIENT STATES NO CHANGES IN HER SYMPTOMS AFTER TREATMENT YESTERDAY.  SHE HAS HAD DIFFICULTY SLEEPING DUE TO INCREASED PAIN IN HER NECK.  SHE STATES SHE HAS NUMBNESS/TINGLING/WEAKNESS INTO LEFT ARM AND HAND/FINGERS (THUMB/INDEX/MIDDLE/RING FINGERS). PATIENT STATES HER LEFT SHOULDER AND ARM FEELS 'WEAK AND HEAVY '.  PT HAVING DIFFICULTY MOVING HER NECK DUE TO PAIN.  PATIENT STATES SHE'S ALSO TRIED ICE PACKS, SOAKING IN HOT TAB, SHE GOT A MASSAGE YESTERDAY AND STATES SHE FELT BETTER FOR ABOUT ONE HOUR AND THEN HER SYMPTOMS RETURNED.  PATIENT DOES HAVE PREVIOUS HISTORY IN 2019 OF CERVICALGIA AND STATES THAT SHE HAS BEEN TOLD THAT SHE HAS 'HARD TRAPEZIUS MUSCLES 'AND HAS HAD DRY NEEDLING WITH PHYSICAL THERAPY IN 2019.  PATIENT STATES SHE DID NOT HAVE ANY NECK SYMPTOMS PRIOR TO HER VACCINE.
It started to affect my speech. It is slowing down. It is quite involved; Mobility problem; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MOBILITY DECREASED (non-serious) with onset 2022, outcome "unknown", described as "Mobility problem"; SPEECH DISORDER (non-serious), outcome "unknown", described as "It started to affect my speech. It is slowing down. It is quite involved". The events "mobility problem" and "it started to affect my speech. it is slowing down. it is quite involved" were evaluated at the physician office visit.  Additional information: The patient did not like what has happened to her. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About 9-10 hours after receiving vaccine at 8:15am - chills, body aches, and headache. Fever peaked at 101.4 around 8-9 pm. Tylenol was able to reduce fever. Woke up twice in the middle of the night dripping in sweat. Next morning (3/14) all symptoms were gone.
Hives on left arm (where injection was given) within 4 hours of injection. Injection was given in tandem with flu shot.
First dose of rotavirus started and client was over 14 weeks of age.  No abnormal side effects noted.  Client is still under the age of 8 months.
Patient came to the pharmacy to get COVID vaccination. After the vaccination he felt a bit anxious and slipped. He recovered in less than a minute and felt good after it. We took care of him. We observed him for more than 30 minutes. He felt really well after that minute. It was not a adverse reaction to the medication. He said he felt anxious with flu shot as well
Expired Kinrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number PX27D, expiry date 17th January 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th January 2023, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 28th January 2023, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-JAN-2023 Reporter's Comments: HCP stated that an expired dose of Kinrix was administered to a patient. The reporter consented to follow up via postal. Additional Supportive Information: The patient received Kinrix, which was already expired.