chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received flu shot at clinic in building.  The following day her daughter called the housing manager to report that the patient has dementia  and receives all her vaccines at the Program.  She stated that the patient had received her flu vaccine at the Program prior to the one received at the flu clinc held in the building. Daughter did not report any adverse events.
Administered 0.5cc influenza vaccine to client on Left deltoid on 12/11/06. On 12/13/06 reports tenderness, redness and warmth at injection site. Denies any itching and other symptoms. Noted light color of redness on Left deltoid about 2x3 inches. No swelling or drainage. Negative for any other reactions.
Patient complained of a lot of pain and stiffness in her hands and legs. She said it started the day after the vaccines and lasted about 3 days. She said it finally went away on its own.
This spontaneous report as received from a physician via a company representative refers to a 41-year-old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. On 31-OCT-2016, at the pharmacy, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (lot # L012042, and expiration date 18-NOV-2016; route of administration was not reported). On the same day, the patient was vaccinated with influenza virus vaccine (unspecified) (dose and route of administration were not reported). It was unspecified in which arm the patient received PNEUMOVAX 23 and in which influenza virus vaccine (unspecified). Concomitant therapy was not reported. On an unknown date in 2016, after the vaccinations, the patient developed cellulitis around the injection site. She sought medical attention, spoke with the physician, and on an unknown date in 2016, she was hospitalized to treat the cellulitis. It was unspecified in which hospital the patient was treated and for how long. The outcome of the event was not reported. The relatedness between the event and PNEUMOVAX 23 was not reported. Additional information has been requested.
A non serious spontaneous report of runny nose, congestion, headache, chills, fever, vomiting and diarrhea has been received from a consumer/ mother concerning her four-year-old son, subsequent to FluMist. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. The patient's medical history included birth at 37 weeks, tonsillectomy and adenoidectomy at 22 months and a urinary tract infection in April-2009. On 28-Aug-2009, prior FluMist vaccination, the patient had mild nasal congestion. He was not taking any concomitant medications and did not receive any other vaccines on the day FluMist was administered. The patient's brother experienced high fever and lethargy after receiving his first dose of DTAP at two-months-old and did not  experience any reactions after subsequent doses of Diphtheria and Tetanus Toxoid, pediatrics (DT) only. The patient received his first dose of FluMist on 28-Aug-2009 at 2:00.pm. On 30-Aug-2009, the patient awoke with nasal congestion and a runny nose. As the day went on he developed a headache, chills and fever. His mother treated him with Children's Acetaminophen. On 31-Aug-2009, his mother reported that he seemed better. She called her pediatrician's office and spoke to the "head nurse" about the events. During that call, the nurse informed her that the events were most likely related to the FluMist vaccination. On the evening of 31-Aug-2009, her son developed a fever, diarrhea and vomiting. His temperature was 101.3 degrees Fahrenheit. She treated him with Children's Ibuprofen. On 01-Sep-2009, his mother again called the pediatrician's office and spoke with the same nurses regarding the fever, diarrhea and vomiting he experienced on 31-Aug-2009. During the call on 01-Sep-2009, the nurse informed the patient's mother reported that her other children received FluMist the same day and did not experience any "reactions" and have not been sick. She added that she, her husband, his siblings and visiting grandparents who were around the patient did not get sick. The mother indicated she did not think she would have FluMist administered again. The events resolved.  Additional information was received on 14-Oct-2009 from the physician's office and incorportated into the narratives included confirmation that no other vaccinations were provided on the day FLUMIST was administered or within four weeks prior and that the patient was not taking any concomitant medications.
First off? the first injection gave me the sorest arm I?ve ever experienced on the 2nd day. By the 3rd day soreness had pretty much gone.  Secondly, the second injection gave me the same sore arm the 2nd day but the bloodshot eyes was a new one. My eyes burned the following day causing the red eyes and I felt weak.  By the 3rd day I was good.  We power walked Saturday morning and did our thing and Sunday Morning.  Sunday night I went to bed and  around 2am I awoke to pain in my abdomen with nausea and an instant feeling of needing to run to the bathroom because I knew I was going to have diarrhea. My body felt it needed to expel a foreign invader. As I sat on the pot, the pain that began running through my veins and body was like no other. My body didn?t know  which hole to violently expel it thru. The consensus was through the anus.  I thought I was done with the first bought, so I got up off the pot and washed my hands when all of a sudden a pain coursed through my healthy body and said sit yourself down now or you won?t make it.  A violent expelling occurred again. Goodness gracious what did I do to deserve such violence from my wretched body at 2:20am. I was done. Got up, washed my hands?did so for 20 seconds and looked at myself in the  mirror.  I was instantly nauseous. I left the bathroom and grabbed my things and decided to go downstairs.  I approached the stairs and instantly felt the need to poo again. Made it to my bathroom downstairs and the pain surged through my body again.  For the next few hours I experienced the same thing and the chills that ran through my body and pain was difficult to say the least. I had 5 blankets on top of me and I still couldn?t keep warm.  Yes, I had a fever 101.5. No I did not take any Tylenol or Ibuprofen. I finally fell asleep around 5:45am. Laid on the couch all day. Ate tomato basil soup around 2pm and a salad around 6pm. Thankfully I?m feeling better but my stomach is still a little queasy. All good but it was awful for sure. Just so you know, I?m a healthy woman and I don?t take pharmaceutical prescriptions.
This case was reported by a consumer and described the occurrence of death in a 2-month-old male patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. The reporter is the sister of the patient. A physician or other health care professional has not verified this report. On an unspecified date, the patient received a dose of Infanrix (dose number not specified). At an unspecified time following the administration of Infanrix, on an unspecified date, the patient died. The cause of death was not provided. It is unknown whether an autopsy was performed.
Rash at injection site.  Patient reported the rash was warm, red and itching.
This case was reported by a healthcare professional and described the occurrence of injection site tenderness in a 41-year-old female subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline).  There were no concurrent medications.  On 13 April 2009 at 11:46 the subject received unspecified dose of BOOSTRIX (.5 ml, unknown, left arm).  On 13 April 2009, less than one day after vaccination with BOOSTRIX, the subject experienced injection site tenderness, erythema and local reaction at injection site.  The subject sought medical attention by visiting the nurse on duty at the clinic.  At the time of reporting the outcome of the events was unspecified.  Follow up received from reporting healthcare professional on 22 May 2009:  BOOSTRIX was administered intramuscularly.  The onset of the events was reported as 16 April 2009, 3 days after vaccination with BOOSTRIX.  The events were resolved on 19 May 2009.
Lightheadedness within 5 minutes; weakness of muscles; rapid heart rate; This is a spontaneous report from a contactable  other HCP reporting for herself.  A 28-years-old female patient received the first dose of  bnt162b2 (BNT162B2) vaccine , intramuscular on 25Jan2021 09:00 at single dose  for Covid-19 immunisation .  The patient medical history and concomitant medicatons were not reported.  The patient previously took amoxicillin and experienced drug hypersensitivity.  The patient experienced lightheadedness, weakness of muscles and rapid heart rate  on 25Jan2021 09:15 with outcome of recovering. The patient was treated in Emergency Room with steroids and anxiety medications.  Information on the lot/batch number has been requested.
Information regarding PREVNAR 13 was received from a healthcare professional regarding a 3-year-old female patient who experienced ring around injection site. At 3 years of age, the patient received a dose in Jun-2010. The patient experienced ring around injection site in Jun-2010. The patient recovered. No additional information was available at the time of this report.
Development of erythematous papular rash starting one day after vaccine.  Rash began on head and spread down body.  Rash still present 12 days later, though papules are fading to more flesh tone.  No additional symptoms.
FLU LIKE SYMPTOMS; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported.  The patient's concurrent conditions included non alcohol user, non smoker, and drug allergy, and other pre-existing medical conditions included no drug abuse or illicit usage reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042a21a, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced fever. On an unspecified date, the subject experienced flu like symptoms, chills, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, headache, chills, and flu like symptoms. This report was non-serious.
With this booster I'm having trouble breathing again that's relieved with an inhaler, this isn't normal for me. Usually only need it around tanoak pollen or if I'm recovering from severe flu, neither of which are the case now.   Aside from being tired and soreness at the injection site I've got no other symptoms.   With the second dose it affected me so bad I had severe burning in my lungs and couldn't go for a hike without being out of breath for a good six weeks, it impacted my job. This is something my body only seems to do with this vaccine or severe illness. I've never had any issue with other vaccines. Why?
Patient reported that three previous times after receiving season flu vaccine, she developed accelerated heartrate and shortness of breath, but that it had been four years since that last happened. We instructed to remain her for 30 minutes after the shot rather than 15. About 10 minutes after receiving the COVID injection, she developed increased hearth rate and shortness of breath. She reported she also felt nauseous. We removed her face mask and had her lie on her side on the floor. We called 911 and remained with her until the ambulance left. She looked less pale and was feeling somewhat better by the time the ambulance arrived, but   Patient returned later in the morning, looking and feeling fine. She told us that the ER assessment was that it was not an allergic reaction to the vaccine, but rather something in the vaccine that triggers her increased heartrate. She told us that when this happens, it compounds her anxiety, and she attributes what happened to being as much a panic attack as a physical reaction. She also told us that due to her agoraphobia, she feels anxious in unfamiliar surroundings. She had never been to our pharmacy before.
Developed hives on face and legs starting 12/16/2021 morning. No severe symptoms. Hives on and off after food intake. No known previous allergies. No suspect of any food allergies (as there has been no change in food-type).
pain, swelling, redness, local fever @ site;lt upper arm itching;started w/pain p/giving shot getting worse w/itching by end of day;redness & swelling appeared next day;tx w/heat/cold packs, Ibuprofen for pain, DPH;shoulder to elbow;
Hospitalization 9/17/22-9/22/22 Fall, weakness, hypoxia, PNA, tachycardia, cough,
104 fever. Chills. Extreme body pain.   Pain and numbness in lower legs for weeks after.
bronchitis; post herpetic neuralgia; herpes zoster; Information has been received from a lawyer and a consumer regarding a case in litigation referring to a patient (pt) of unknown age or gender. The pt's concurrent conditions, medical history and concomitant medications were not reported. On an unspecified date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, anatomical location, lot number and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after being vaccinated, the pt suffered multiple outbreaks of herpes zoster, post herpetic neuralgia and bronchitis. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of the pt's use of the defective zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to using the company's product. The pt also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of company's conduct, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the claimed events was not recovered, and causal relationship was reported as related to zoster vaccine live (ZOSTAVAX).  The reporter considered bronchitis, post herpetic neuralgia and herpes zoster to be disabling events.
6-11yr bivalent vaccine was given to elderly patient; Nausea- couldn't get out of bed; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (6-11yr bivalent vaccine was given to elderly patient) and NAUSEA (Nausea- couldn't get out of bed) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 017B22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.    On 23-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (6-11yr bivalent vaccine was given to elderly patient) and NAUSEA (Nausea- couldn't get out of bed). At the time of the report, WRONG PRODUCT ADMINISTERED (6-11yr bivalent vaccine was given to elderly patient) outcome was unknown and NAUSEA (Nausea- couldn't get out of bed) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided. No treatment medications was provided. Patient received 1st dose, lot number was 018B221, 2nd dose with lot number was 048B21A.   This case was linked to US-MODERNATX, INC.-MOD-2023-719184 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719184:wife case
Right arm - from injection site to below elbow red, hot itchy.  color has lessened to pik and no longer hot, but sill 4 x6 inch pink are.a
given an extra Hib dose and IPV 1 year early with no reported adverse event; given an extra Hib dose and IPV 1 year early with no reported adverse event; Initial information received on 09-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 years old male patient who was given an extra HIB dose and IPV 1 year early with no reported adverse event , and it involved vaccines HIB and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  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) for Immunisation.  On 08-Aug-2022, the patient received 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, with an unknown formulation and strength, once, ( lot: UJ620AAA  ; expiry date: 07-Dec-2022) via intramuscular route in the left thigh for immunization and also received an unknown dose of suspect HIB not produced by Sanofi Pasteur , with an unknown formulation and strength , (lot number and expiry date: not reported) in unknown administration site for immunization.  It was reported that the doctor ordered Dtap, hib and Prevnar13 but the patient was administered PENTACEL and ACTHIB, which means the patient got an extra hib dose as well as the 4th IPV dose before age 4  On 08-Aug-2022 the patient was given an extra Hib dose and IPV 1 year early with no reported adverse event (inappropriate schedule of product administration) (extra dose administered) (latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE and following the administration of HIB. The patient turned 3 , a day after administration.  Action taken : not applicable.  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.
Initial information received on 23 November 2009 from an affiliate; the initial reporter was a consumer. A female adult patient reported that she experienced an anaphylactic reaction after receiving an INFLUENZA VACCINE (lot number and manufacturer were not reported) in 1969 (also reported as 20-25 years ago). Her blood pressure dropped to 60/40 and as a result required EPINEPHRINE and BENADRYL. The patient recovered from the event. She reported a medical history of diabetes, 3 leaky heart valves, high blood pressure, kidney cancer, a solitary kidney and a history of egg, milk, wheat, and multiple drug allergies including PENICILLIN. However, it was not specified whether these conditions existed at the time of the event. No further information was provided. List of Documents held by Sender: none.
Patient received IPV, Pneomovac, Hib and DTaP vaccines on 9/15/08.  that night developed increased fussiness and some vomiting, occassionally projectile.  .  Patient seen on 9/16/08 for evaluation.  No rashes, erythema or skin changes.  Injection sites okay
Patient noticed when she woke up the next day that the arm was sore and red.  The redness spread into two different splotches over the course of the week and remained painful to the touch.
Pt States she Rec'd Hep A in RD 4/23/2006. Had local redness for x 2 days, then arm began to be painful when she raised her arm. Unable to carry her child, unable to get a job.
Patient received his vaccination then sat in the waiting area for his post-vaccination waiting period with his son. Within the next ten minutes  became dizzy then fell out of the chair onto the floor where he struck his nose and eye area on the floor. Patient lost consciousness for about 30 seconds then woke up. Patient had profuse bleeding from the nose and dizziness for 15 minutes.  We had patient sit on the floor and press towels to his head to stop the bleeding. We gave an instant cold pack to patient. We called 911 and requested medical assistance due to the amount of bleeding that patient was experiencing. EMS arrived and took charge of the scene. EMS providers attempted to help the patient to his feet and he fell again. EMS decided to transport the patient to the hospital for further evaluation.
Aug93 Pt recv 1 dose vax. 04Feb98 Pt exp varicella-like rash w/approx 40 lesions.
This spontaneous case reported by an other healthcare professional, describes the occurrence of COVID-19 in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient developed COVID-19. At the time of the report, COVID-19 outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. The patient received two shots of the Moderna vaccine then later contracted COVID-19. Sender's comments: This is a spontaneous case concerning a female patient, of unknown age, with no reported medical history, who experienced the unexpected event of COVID-19. The patient received 2 doses of COVID-19 with unknown dose interval. The event COVID-19 exact occurrence unknown but stated the event occurred after 2 doses of mRNA-1273 vaccine administration. No reported treatment information. The outcome of the event COVID-19 unknown. The benefit-risk relationship of mRNA-1273 vaccine not affected by this report.
Some time after the first vaccine I noticed "white noise" in my left ear and I assumed it would go away over time (it didn't).  The ringing/white noise is constant and seems to be only in my left ear.  I visited the doctor where they conducted several hearing tests over a 6 month period.  There is some hearing loss in the left ear compared to my right ear. Did not have tinnitus previously. Diagnosis:  Tinnitus Next step: MRI/CT scan