chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial case received on 02 November 2014 from a consumer who is the parent, via a news source on the internet. The following is verbatim from the report: "A woman says her daughter became paralyzed after getting a routine flu shot. (The mother) says her child was happy and healthy until getting the flu shot just before the Thanksgiving Day holiday last year. Three days later, however, her daughter could not move or talk, (the mother) said. The child is now a bedridden 10-year-old diagnosed with a rare viral infection of the brain called Acute Disseminated Encephalomyelitis, or ADEM. (The mother) believed what happened is directly tied to the flu shot. "The doctors won't confirm it or deny it," the mother told the news source Sunday. "Her father and I are certain, due to all of our research, that this was what caused (the patient's) condition. She was a happy, healthy, running and playing 9-year-old then this happened." (The mother) added: "There was no underlying condition. I mean so many tests at the hospital to try and find something else that could have caused it and they could not find anything." Patient's father has to carry her to get around. "It can just appear out of the blue or after maybe a surgical procedure," (A physician) told the news media. (The physician) is a physician at a hospital where he is director of infectious diseases. He told the station Friday a flu shot can cause the illness, but he does not recommend not getting the flu shot. "If I get the flu I'm more likely to get ADEM than from the flu vaccine," (The physician) said, adding that recovery is possible. (The mother) said parents need to educate themselves about the flu vaccine. "Be informed and make an informed decision with you doctor's guidance," she said. The patient outcome is unknown. Documents held by sender: None.
Pt (PREGNANT) recv vax on 11/13/97; in 12/97 pt exp no drug effect.
I have had flu like symptoms since about one day  after the injection.  Very fatigued, chill, lethargic, runny nose, coughing, sneezing, reduced appetite.  Other vaccines did not produce these efffects.
soreness at injection site; burning of the lips; A spontaneous report was received from a consumer concerning a 84-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events soreness at injection site/vaccination site pain, burning of the lips/ oral discomfort.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) soreness at injection site, burning of the lips.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), soreness at injection site, burning of the lips was unknown.
administered 0.3 ml instead of the recommended 0.5 ml dose; A spontaneous report was received from a Pharmacist (a PharmD) concerning seven patient (reporter was not sure about the number) (ages and genders unknown) who received Moderna's COVID-19 vaccine (mRNA-1273) and were administered 0.3 ml instead of the recommended 0.5ml dose (accidental underdose).  No medical histories were provided.  Concomitant product use was not provided.  On unspecified dates, the patients received doses of mRNA-1273 (lot number: 031M20A) intramuscularly for prophylaxis of COVID-19 infection.  The reporter, who was calling on behalf of another pharmacist, stated that one "intern" administered 0.3 ml instead of the recommended 0.5ml dose of Moderna vaccine to seven patients (the reporter was not sure about the number of patients).   Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event was considered resolved.; Reporter's Comments: This report refers to a case of accidental underdose for mRNA-1273 (lot # 031M20A) with no associated AEs reported.
Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient was flushed with rash. Seemed to be anxious. Was given chewable benadryl and symptoms improved shortly after.
pressure type pain in upper mid chest area; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (pressure type pain in upper mid chest area) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (pressure type pain in upper mid chest area). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, CHEST DISCOMFORT (pressure type pain in upper mid chest area) outcome was unknown.            No Concomitant Medications taken were provided.
Redness & minor swelling at injection site (ZOSTAVAX). No fever or pain. Patient taking BENADRYL at night.
Patient was given a  booster dose of Pfizer vaccine while the patient was under the age of 18 and within 6 months  since last dose.
Injected in left deltoid - patient reports deltoid hurting when bending arm back and slightly when raise above head.
After receiving his first dose of Pfizer Covid vaccine was standing while mother was asking a few questions and as they were about to walk over to the observation area, he passed out and fell.  He hit his head on the corner of a metal plate.  Pt may have been "out" for ~30 sec and came to immediately and was A+Ox3.  All his vital signs were stable (BP 118/66, HR 86, O2 100).  Mother was present and the ambulance was called at 10:23.  Mother denies past history of fainting with IZs, denies remarkable mhx.  Paramedics arrived by 10:28 and per mom's request was taken to ED.
facial flushing, light-headed, and mild shortness of breath (which patient attributes to generalized anxiety disorder).  Given Benadryl 12.5 mg.
Approximately 16 hours later fever, chills, body aches etc. Adverse reaction: Passed out on floor, sweating, dizzy
Pt had Pneumococcal 23 and Fluad given on 10/15/19 in separate arms. For the next 24 hours Pt had 4 episodes of emesis and a headache. Pt did bland diet and fluids and was fine after 24 hours. No other reactions noted.
Got symptoms worse and longer lasting than her own; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (Got symptoms worse and longer lasting than her own) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Got symptoms worse and longer lasting than her own). At the time of the report, VACCINATION COMPLICATION (Got symptoms worse and longer lasting than her own) outcome was unknown.        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.   No concomitant medications are provided. No treatment medications are provided.
On January 27, 2021 this 40-year-old female the patient received her second dose of the Moderna Covid vaccine on her right deltoid. On January 27, 2021 in the evening the patient reported pain at the injection site, the patient was then treated with Acetaminophen 650 mg. On January 28, 2021 the patient continued to complain of pain on her right arm, Acetaminophen 650 mg was given. On January 29, 2021 the patient reported pain, redness and swelling to her right shoulder due to the covid-19 vaccine, Acetaminophen 650 mg and an ice pack were provided. On January 29, 2021 the patients' provider accessed the patient, the patient reported "feeling achy and stated my arm hurts, I think it's gone down."
Pt recvd 2nd dose of MMR on 08NOV90; Approx 15 min following vax exp acute swelling & reddening of eyes & face assoc w/rhinitis; tx Epi & DPH & sx resolved;
GAVE PATIENT PFIZER COVID 19 MONOVALENT BOOSTER SHOT INSTEAD OF THE PFIZER COVID 19 BIVALENT SHOT
Patient present to clinic on 6/12/19 with complaints of progressing rash for 4 days. Week prior (6/4/19) patient with fevers 100-101 degrees F.  SKin appeared normal with sl rashes noted papular and raised about 0.5-1mm around and older lesions crusting on the posterior trunk and individual about 5-8 and newer lesions are more vesicular, dew drop on a rose petal with erythematous base that is broader by about 4mm or so.  Symptomatic treatment recommended.
Hardness; Itchiness; Swelling at injection site; Redness; pain became worse; Pain in arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (Hardness), CONDITION AGGRAVATED (pain became worse), VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE PAIN (Pain in arm at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021A2114) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain in arm at injection site). On 02-Mar-2021, the patient experienced CONDITION AGGRAVATED (pain became worse). On 03-Mar-2021, the patient experienced INDURATION (Hardness), VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, INDURATION (Hardness), CONDITION AGGRAVATED (pain became worse), VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE PAIN (Pain in arm at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.     Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Contact information was Updated.
On July 7, 2022 my throat felt a little scratchy, then the next morning I woke up with stuffy nose, yellow drainage and irritated throat. I took a home test which was positive. I called my doctor on 07/09/2022 and was prescribed Paxlovid. I started taking medication on 07/09/2022. Today I am still having irritated throat, productive and non-productive coughing and runny nose.
The mother noticed spots on the left hip below the diaper. Clusters appeared on the left thigh about two to three inches above the knee. Mother said he had a runny nose and runny eyes with a fever that that was low grade prior to the cluster. She said they scabbed over and the child did not appear to have any itching or irritation from the clusters.
Complete loss of speech language (had been cooing, babbling, talking- had been saying "ma & hi") Only grunted until 27 mos old and then started talking again with severe articulation problems
2:30 am uncontrollable shaking, chills,  lasted 3 hours.  All next day fever 102, body aches, fatigue, nausea, last 20 hours.
Admit for acute on chronic resp fx d/t COVID PNA and COPD. Hx CHF. tx w/abx, steroids, zinc, singulair and resp care. DC'd to rehab.
headache; Left arm sore; This is a spontaneous report from a contactable consumer (patient)  This 61-year-old male consumer received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from Lot# EL3247 at left arm on 26Jan2021 11:00 at SINGLE DOSE for covid-19 immunisation . Facility where the most recent COVID-19 vaccine was administered:Workplace clinic. the patient  didn't receive any other vaccines within 4 weeks prior to the COVID vaccine.Medical history :none.  Concomitant medication included atorvastatin calcium (LIPITOR ) bupropion hydrochloride (WELLBUTRIN), acetylsalicylic acid (ASPIRIN) 81 mg.The patient experienced left arm sore and minor headache on 27Jan2021 06:00 .No treatment received.Events reported as non serious.Outcome of the event was recovering.No Prior to vaccination, was the patient diagnosed with COVID-19 .Since the vaccination, The patient hadn't  been tested for COVID-19
Patient  was inadvertently given vaccine and vaccine not indicated for her age.  Patient doing well with no adverse reactions.
Patient was given the 12+ Pfizer Vaccine, when he is in the 5-12 Pfizer Vaccine age range. Patient did not experience any adverse side effects, but management was immediately notified, staff meeting was held, patient's family was notified, and this report was filed.
Within 5 minutes after the injection I could feel my tongue swell up. My throat did not close. My vision become blurred. When I got home at 4:30 I got a sudden onset of an intense headache in the front of my head by my forehead and by my temples. The back of my neck is sore and so if my arm st the injection site
This spontaneous report as received from a registered nurse (R.N.) refers to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates (before expiration dates), the patients were vaccinated with improperly stored VARIVAX (lot # 0661AE, expiration date 28-MAR-2014; lot # H013398, expiration date 10-JUL-2014; lot # reported as 1910AA, expiration date 05-DEC-2013; lot # H017879, expiration date 27-SEP-2014; route and dose were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
The Next Day had flu like symptons Muscle/Joint pain Legs/knees & hips and Buttocks - The pain has cause spasms that are severe/ painful to walk when It flares up - Hurts to sit down sometimes I feel like my life has changed My life changed the Next Day After vaccination It's hard to sit down/walk without pain. Spasms can BE so severe I'm In tears I can't Bend or Stoop at times/Always been Independent / I'm limited to what I do. No Housework / If I drop anything I can't Bend or Stoop without Being in pain. Limited to things I do now Inflammation & Numbness At times Lab tests Ran on All Muscles & More Referred to Neurologist
Have had a consistent tight feeling in my head after having a headache 9 days after my first dose.
Severe pain by deltoid muscle past 5 days. Had pain after flu vaccine and has gotten worse.
PER PATIENT: PT STATES SHE HAD ITCHING ALL OVER HER BODY, RINGING IN EARS, AND A LUMP THAT FORMED AT THE INJECTION SITE. PT TOOK BENADRYL AND ICED THE AREA OF THE INJECTION. BY THE NEXT DAY, REACTION HAS IMPROVED.
Patient presented to the vaccine van for follow-up dose of COVID-19 vaccine. Her first dose was done in March of 2021 (the time she received J&J). She was approached by RN who asked her if she was immunocompromised where the patient stated she had autoimmune disease (Hashimoto's). She was registered and given the immunocompromised dose of 0.5cc Moderna instead of the 0.25mL dose she should have received. She reported not feeling well after shot.
Reported on 11/1/2020. Patient reports redness, swelling, hardness, and burning at site of injection. She is taking ibuprofen, applying heat and cold, and will contact PCP.
Extreme fever  extrem chills extreme  trembling and puking. All lasting for over 12 hour. Joint pain so severe could not stand or walk in an upright position. Extreme haedache and head ache continues daily
Immunizing  technician went to deliver dose, but as syringe entered arm the vaccine just ran out of the syringe down the arm instead of going in. Pharmacist came in after and delivered full dose.
Temp 101, bodyaches, nose bleed from both nose, sleep non-stop nearly 20 hours straight the next day, got better by 3rd day but this time not fast like the first time, took a couple more days to feel normal.
I had several different side effects, such as back pain, chills, shivering, cough, diarrhea, general body discomfort, headaches, mild fever, muscle aches, sore throat, stuffy nose, loss of appetite, tingling, vision changes, unusual hoarseness, itching, muscle weakness, decreased movement or sensation in the arm or shoulder, difficulty breathing. The name of the product is called, FLUZONE multidose vial (influenza virus vaccine).
Patient stated that she got a stiff neck the day after the immunization and believes it was caused by the immunization. She said she was getting better the next day but not fully recovered yet.
Information has been received from a registered nurse concerning an outbreak of chickenpox in a child, between the ages of kindergarten to 4th grade, who had been vaccinated subcutaneously with a first dose of 0.5 mL varicella virus vaccine live (Oka/Merck). Subsequently, the child developed chickenpox. The child may have 50 lesions or more. Additional information is not expected. This is one of several reports received from the same source.
Admitted to a hospital ( ICU for 7 seven days); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of HOSPITALISATION (Admitted to a hospital ( ICU for 7 seven days)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (Admitted to a hospital ( ICU for 7 seven days)) (seriousness criterion hospitalization). At the time of the report, HOSPITALISATION (Admitted to a hospital ( ICU for 7 seven days)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication use was provided by the reporter.  No treatment of events was reported.  Company comment: Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
in the days following the injection, I had a bruise at the injection site and started having body aches and fatigue that worsened over the course of serveral days. I went to my PCP for my annual physical and my CBC blood work showed below normal WBC count. This is unusual as my WBC count had been fine a month and a half ago when I had minor foot surgery. Two weeks after the findings, I had another CBC done and it had gone back into the normal range. At four weeks post vaccination, I still have a bruise and soreness at the injection site.
Patient was injected and immediately lost consciousness. That lasted about 10 seconds. Patient woke up with no recollection of what happened.  911 was called and here within minutes.
hepatocellular pattern of liver injury; This is a literature report for:  A 61 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. There were no liver disease history.   The following information was reported: LIVER INJURY (medically significant), outcome "recovering", described as "hepatocellular pattern of liver injury". The patient underwent the following laboratory tests and procedures: alanine aminotransferase: 1735 IU/l; antinuclear antibody: 1:320; biopsy: ++/+++, portal no interface hepatitis, notes: Inflammation severity, location; mixed infiltrate, notes: Cellular pattern of inflammation; none, neutrophilic peri-cholangitis, notes: Cholestasisd and bile duct features; blood alkaline phosphatase: 287 IU/l; blood bilirubin: 1.5 mg/dl; blood immunoglobulin g: negative; blood immunoglobulin m: negative; SARS-CoV-2 test: negative; imaging procedure: hepatic steatosis; international normalised ratio: 1.1; serology test: negative; varicella virus test: negative; viral load: 78. Therapeutic measures Oral prednisone were taken as a result of liver injury. Timing of pattern presentation of injury was 42 days in relation to first dose of vaccine. The author acknowledged that this series of patients with hepatic injury following mRNA-based COVID-19 vaccination contains retrospective and observational data without adjudication. Thus, this report is not structured to evaluate potential causality. Drug induced liver injury is not readily implicated in this patient series, although it cannot be wholly excluded. The author also considered unlikely direct hepatotoxicity from SARS-CoV-2 mRNA vaccines, noting the strong safety profile for delivery of lipid nanoparticle mRNA vaccines to human tissues. Rather, vaccine-induced immune-mediated hepatitis is a known phenomenon, and other autoimmune events (e.g., AIH, ITP) have been reported following COVID-19 vaccination. It is plausible that a similar mechanism is occurring here, whereby the host immune response directed against the COVID-19 spike protein triggers an aberrant, autoimmune-like hepatic condition in predisposed individuals.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a possible causal relation between the event liver injury and the administration of the vaccine cannot be excluded. 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, and Investigators, as appropriate.,Linked Report(s) : 202101834329 Same article/drug/event and different patient
No adverse effects were reported in the patient; a patient received a vaccine following a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, as well as drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot number and expiration date were not reported).         On 25-OCT-2019, it was detected the temperature excursion was lowest below 36 degrees Fahrenheit (F)/ 2 degrees Celsius (35 F) for a time frame of 430 minutes, and no had the previous temperature excursion (product storage error). It was reported that not call was due to data logger. No adverse effect were reported in the patient.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA000822: US-009507513-1911USA000826:
5 1/2hr post vax devel high fever (hot per mom) stomachache, eyes hurt & were sensitive to light, no rash, no problems breathing;MD dx as severe local rxn;parent advised not to cont hep b series unless pt in high risk situation;