chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician, a LPN and medical records concerning a 15 month old white/asian male pt with no allergies, no concurrent conditions and a Hx of fever who on 05/18/2004 was vaccinated SQ in the right thigh with a 1st dose of varicella virus vaccine live. Concomitant vaccination on 05/18/04 included; 1st SQ dose in LL of MMR vaccine, and a 3rd dose in the LL of Hep B virus vaccine + Hib conjugate vaccine. Other concomitant therapy included . There were no adverse events following prior vaccination. On 06/10/04, the pt presented to the medical office with thrombocytopenia. The pt had a petechial rash on the arms, legs, trunk, and buttocks. There were no signs or symptoms of illness or fever. Lab work revealed the following platelet counts: 06/10/04- 8, 06/11/04-11, 06/13/04-10, 06/17/04-19, 06/27/04-62 (reference range: 250-600). The physician confirmed the pt's platelets were extremely low. A probable Dx of ITP was made and an onset date on 06/10/04 was noted. The physician consulted with a hematologist and the recommendation was to just medically manage. The pt was not hospitalized and no Tx was initiated. The pt wore a helmet. Aside from his bruising, there was no obvious bleeding. The physician stated the pt experienced some type of immune thrombocytopenia, "presumably temporarily associated to the vaccine. however there was no way to assess this. Subsequently in approximately 07/2004 the pt completely recovered on his own and was clinically normal with platelets up to the 200's. The physician did not feel the pt's experience me the definition of other medical event, however felt this was a "major" adverse response. A product quality complaint was not involved, additional information has been requested.
01/26/11 - 0.1 cc tetanus toxoid given instead of PPD 01/26/11 - developed itching at site of injection 01/27/11 - itchy and red - 01/28/11 - same 01/31/11 - less erythema, 2mm induration.
Hardness and itchiness around the site. Tender to the touch. Redness about 1.5 inch in diameter around the site, hardness and redness area are the same size.
Glucose what 171; Arm is very painful; Chills and was shaking; This spontaneous case was reported by a consumer and describes the occurrence of HYPERGLYCAEMIA (Glucose what 171), TREMOR (Chills and was shaking) and VACCINATION SITE PAIN (Arm is very painful) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy (Cipro allergy), Diabetes mellitus, Hypertension and Ocular myasthenia. Concomitant products included LISINOPRIL, METFORMIN, LINAGLIPTIN (TRADJENTA), INSULIN, ALPRAZOLAM (XANAX), ATORVASTATIN, FLUVOXAMINE and POTASSIUM for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TREMOR (Chills and was shaking). On 09-Feb-2021, the patient experienced HYPERGLYCAEMIA (Glucose what 171) and VACCINATION SITE PAIN (Arm is very painful). At the time of the report, HYPERGLYCAEMIA (Glucose what 171), TREMOR (Chills and was shaking) and VACCINATION SITE PAIN (Arm is very painful) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided
Information has been received form a physician concerning a 12 month old patient who was vaccinated with a dose of VARIVAX (Oka/Merck) (lot number, injection site and route not reported). Within 24 hours the patient developed severe neutropenia and a high fever. Unspecified medical attention was sought. Additional information has been requested.
received the DTap-IPV portion of PENTACEL in the office on 05MAY2022 without reconstituting with the Hib portion with no reported adverse event; Initial information received on 06-May-2022 regarding an unsolicited valid  non-serious case received a other health professional.  This case involves a 4 months old male patient who received the dtap-ipv portion of pentacel in the office on 05-May-2022 without reconstituting with the hib portion with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ).  On 05-May-2022, the patient received 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE  (lot : UJ593AA and  expiry date: 18-Dec-2022 for powder vial; lot: U7054AA and expiry date: 18-Dec-2022 for liquid vial) via intramuscular route for immunization.  It was reported that the patient received the dtap-ipv portion of pentacel in the office on 05-May-2022 without reconstituting with the hib portion with no reported adverse event (product preparation issue) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (received the DTap-IPV portion of PENTACEL in the office on 05MAY2022 without reconstituting with the Hib portion with no reported adverse event).  Outcome: unknown   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.
Patient is experiencing muscle soreness, constant ache from shoulder to elbow for 2 weeks. Took Tylenol but it doesn't help.
Dizziness, lightheadedness, nausea, heart palpitations, shortness of breath, can?t drive  (4/16 to present), can?t work (4/16 to present)
This is a spontaneous report from a contactable physician. This physician reported similar events for 2 patients. This is 1st of 2 reports (male and female). This physician reported for male patient that: A male patient of an unspecified age and ethnicity received TRUMENBA at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date after receiving TRUMENBA the patient experienced syncope events/fainted and, fell on his face. He was transported to the ER where he received follow-up care. The outcome of the events was unknown. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available. Linked Report(s): US-PFIZER INC-2016497611 same reporter/drug, different patient/event; US-PFIZER INC-2016497611 same reporter/drug, different patient/event.
The patient wanted to go to the restroom after getting the vaccine.  He said he felt a little nauseous and had a slight headache but felt ok to walk to the bathroom.  After returning from the bathroom, the patient informed he gotten a little dizzy in the bathroom and passed out.  His head was bleeding. Patient informed his head was hurting at hit sit, feeling nauseous, vision a bit blurry and did throw up a bit. He was able to state his name, address, DOB, and was cognizant.  There was no signs of SOB or allergic reaction.  The EMS was called and it was detected his BP was a little low. Patient did feel a little better but it was advised to go to the hospital to make sure he did not have a concussion.  Patient was then escorted by EMS to the hospital.
Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date; No adverse event; Administered the vaccine after the 30 day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date) and NO ADVERSE EVENT (No adverse event) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date).    No concomitant medication was reported by reporter. Total 35 vials were affected. Vial was initially stored in refrigerator on 4-Jun-2022 and did not undergo temperature excursion.  Patient got half dose. No treatment medication was reported by reporter.
Seen in office on 4/26/10, patient had rash.  Started on 4/23 & spread all over body.  Temperature 100 on 4/23 & 4/24 & itching & pulling on ear.  Dx: Viral Exanthem & MMR rash.
Two days after vaccine, patient's urine started turning dark and he became jaundiced. Jaundice got slightly better by Monday 2/8/2021
First episode occurred three weeks after she had the first shot of Gardasil and the second episode also occured about three weeks after she had the second shot of Gardasil. She was diagnosed with a grand mal seizure. Patient was seen in the ER on Sept 8, 2007 for her first episode. Patient was then seen in our office on Sept 10, 2007 and referred to Neurology. Patient was then seen in our office again on Nov 27, 2007 and wanted the doctor to report to vaccine manufacturer about the possible adverse reaction to the vaccine. The patient is very convinced that there is an association between the Gardasil vaccine and seizures.
Headache, left deltoid tenderness, dizziness, elevated temperature 100.4 - 103 degrees over 6 hour period 2/2/11 other symptoms started this am. Immunizations given 1430 2/1/11. Rest, fluids PO, alternation TYLENOL and Ibuprofen for temperature, monitoring for rash, stiff neck & HA.
Got my first CV vaccine yesterday AM at 11:30. For those of you in town, Medicine is running an amazingly efficient site at the theater (I was in and out in 20 minutes).  So after the vaccine, I felt 100% ok. Walked over to store to pick up a few things, then headed to the subway to go home. I remember going down the stairs to the subway station, and then I remember nothing until I was unlocking the front door of my house. After that the next thing I remember is waking up on my couch ~6PM. I was feeling totally confused. I picked up my phone and saw that I messaged one of my besties to let her know that I received my first dose ? I have no recollection of sending the message. I also noticed that my hair was wet, which was weird. I went upstairs to my bathroom saw evidence that I had taken a bath with some of the bath salts I had bought at store?.no memory of that either. I went to bed ~8 and woke up at 9:30 this AM. I?m not at all looking forward to my second dose.
Baby had cold symptoms, cough, congestion, a little vomiting. My son came home at 7:20 p.m. On 5/10 to babysitter advising baby was napping from 6 p.m. Patient was face down on bed. My son laid next to him and put his hand on his back and he noticed he wasn't breathing right. He lifted him and turned him over and his one side of face and mouth was drooping and his right arm and leg kept jolting. No left side movement at all. 911 was immeidately called. CT scan showed bleeding on brain. Three hours later transferred by ambulance to Hospital (not airlifted) was put on respirator at Medical Center. Got to another hospital had another CT scan, bleed was worse underwent neurosurgery and brains was hemorrhaging too bad. Neurosurgeons said bleed was too bad and injuries were consistent with shaken baby syndrome. Patient had no brain activity or breathing capacity at all. Passed away on 5/13 at 10:30 a.m. Initial Autopsy was inconclusive. Undergoing more tests. Patient on 5/5 had PVC (Pneumococcal Vaccine and Varicella Vaccine). It is being treated as a homicide by Prosecutor's office. A local chiropractor told us about a link with vaccines and brain injuries similar to shaken baby. We wanted to report this since he did get these two recent injections. Awaiting second autopsy. They said brain and eyes were sent to specialist around the country.
This case was reported by a healthcare professional (nurse) and described the occurrence of fatigue in a 43-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 16 October 2013 the subject received a dose of FLULAVAL (.5 ml, unknown route, left arm). On an unspecified date the subject received unspecified dose of influenza vaccine unspecified (unknown details). On an unknown date, less than one day after vaccination with influenza vaccine unspecified, the subject experienced fatigue, headache, cough and itching. At the time of reporting the events were resolved. Per the nurse, "the [subject] has had same symptoms in the past with other flu vaccine; however, they usually go away within a week of the vaccine being given" and "never lasted this long." The subject was treated with TYLENOL and ADVIL. On 16 October 2013, less than one day after vaccination with FLULAVAL, the subject experienced fatigue, headache, cough and itching. At the time of reporting the events were unresolved.
Patient says that 1-2 days after first shot he had a fever of 103 degrees F for another 1-2 days. Resolved after Tylenol OTC.
Collapsed; head injury from hitting the corner of the cabinet; dizzy; Lumbar contusion; she didn't feel so good; A spontaneous report was received from a consumer concerning a 75 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced syncope, collapsed (syncope), head injury from hitting the corner of the cabinet (head injury), didn't feel so good (feeling abnormal), dizzy, and lumber contusion (bone contusion).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 19 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 007M20A) via unknown route for prophylaxis of COVID-19 infection. On 18 March 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 040A21A) via unknown route for prophylaxis of COVID-19 infection.  On 20 March 2021, she was dizzy and passed out  and ended up on the floor unconscious and was taken to the ER in an ambulance. The patient had a CT scan done and was diagnosed with syncope, head injury from hitting the corner of the cabinet and lumbar contusion.No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.   At the time of this report, the outcome of the event syncope, collapsed (syncope), head injury from hitting the corner of the cabinet , didn't feel so good were not reported. The events dizzy and lumber contusion  were not recovered.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Information has been received from an MD concerning a 1 month old male who was vaccinated with a second dose of Hep B. Subsequently, the pt experienced induration after the second dose. The reaction occurred within 5 minutes and subsided within 10-15 minutes. The induration was 3 inches in diameter. The pt sought unspecified medical treatment. Subsequently, the pt recovered from induration.  No further information is available.
Severe eczema flare up on neck   (For vaccine 1, which was 20 days earlier, I also had an eczema  flare up on my ears)
Immunizations given 05/12/2004 afternoon 05/13/04, mom noticed red lump at both injection sites. Child had been restless and irritable through the night. But does not seem bothered today. Areas are indurated and warm but not tender to touch.  No prescription needed.
Pt states at about 3 hours after receiving the flu shot, pt started to feel achy, shaking, teeth grindind and nausea and her 2 fingers were numb. next day she states that she didn't have appetite and felt lathergic. after that she states she was fine and no issues.
Pt recv vax on 11/2/98; on 11/4/98 pt exp right neck discomfort; 11/7 right facial weakness; dx=Bell's Palsy
A child was given an adult dose of Havrix; A child was given an adult dose of Havrix; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 2-year-old male patient who received HAV (Havrix adult) (batch number KM72C, expiry date unknown) for prophylaxis.   On 19th August 2021, the patient received Havrix adult. On 19th August 2021, unknown after receiving Havrix adult, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.  Additional details were provided as follows: The pediatric patient was given an adult version of Havrix, which led to overdose and adult product administered to the child. The reporter consented to follow up.
When it started and wake up  the room is spinning from Vertigo. I called Physical Therapy office and made appointment. I   sometimes have Positional Vertigo that's caused by little crystals in my ear canal. When this happens they do a maneuver to get the crystals out of my ear to regain balance. When I went this time the crystals had changed so they had to perform a different maneuver. We also did some balance exercises to try to regain my equilibrium. It helped for about 1 week, then went twice and still had some off balance. Have been going to the PT once or twice a week for follow ups. Still experiencing this, sometimes stronger than other days.
Her symptoms were congestion, watery eyes, runny nose and loss of taste and smell and lasted about a week.
This spontaneous report as received from a Certified Medical Assistant refers to a 85 year old female patient. In 2006 the patient was vaccinated with ZOSTAVAX. Dose number, lot number, expiry date, route of administration and anatomical location of the vaccination were not reported. Concomitant therapies included a LIPITOR, metoprolol, XANAX and FLONASE. On 05-MAR-2014 the patient experienced shingles at which date the patient visited the office of the reporting medical assistant. The patient was treated with VALTREX and gabapentin for the event. The outcome of shingles was reported as not recovered/not resolved. Additional information has been requested.
This spontaneous report was received from a licensed practical nurse referring to unknown number of patients of unknown age and gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with unknown number of doses of improperly stored PNEUMOVAX 23 injection (strength, dose and route of administration were not reported) (lot # M041686, expiration date: 20-MAY-2018), GARDASIL 9 (strength, dose and route of administration were not reported) (lot # N013276, expiration date: 21-JAN-2020 and lot # M043731, expiration date: 22-JUN-2019) and LIQUID PEDVAXHIB (strength, dose and route of administration were not reported) (lot # M046133, expiration date: 26-SEP-2019 and lot # M006710, expiration date: 06-DEC-2018) for prophylaxis (product storage error). The vaccines were stored in 53.4 degrees Fahrenheit (F) for 24 hours and 20 F for 2 weeks. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No other information was available. There was no product quality complaint (PQC) reported. This is a non-valid case due to lack of patient identifiers.
Patient stated he was not feeling well at 1 minute or so after shot. I came out to help him and he was seated in a chair and passed out. I caught him as he fell and laid him on the ground. At that point my tech called 911 and I went to went to get  an epi pen as he was breathing. He came to before I could grab an epi pen and he was sitting up. I helped him to a chair and he was having chills. My tech went to get a jacket and we gave him some water and a candy bar. He also had some orange juice before the EMTs arrived. He refused the ambulance ride and we helped him into his moms pickup truck and advised him to be seen by a doctor and talk to his MD before another shot. The patient stated he had never passed out after a shot before.
vaccine brand=Pfizer / BioNTech, COVID 19 Treatment; vaccine brand=Pfizer / BioNTech, COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: GABAPENTIN. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "vaccine brand=Pfizer / BioNTech, COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: The patient have received other medications in two weeks. Anti viral details. Product: COVID 19 Treatment, treatment start date: 29Apr2022, treatment stop date: 04May2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Shortly after the first dose I noticed that I was becoming hypomania  but thought it was normal. After the second dose it started getting worse. I started talking fast, confused, moody, anger, overreacting, excessive spending, unable to stick to task. I am extremely sensitive to steroids and the reaction was very similar.  I am bipolar type 2 and rarely struggle with managing hypomania. I've been under psychiatric care for 33 years and manage my condition very well. I've always been able to get hypomania under control within 2 weeks. This was something different.