chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vision loss; Balance issues; Tingling in Extremities; Fatigue; Chills; A spontaneous report was received from a consumer concerning a 34-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vision loss, tingling in extremities, paraesthesia, balance issues, fatigue and chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received her first of two planned doses of mRNA-1273 (Lot number: unknown) on an unspecified date in Jan 2021 intramuscularly. On 12-Feb-2021, prior to the onset of the events, the patient received her second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of Covid-19 infection.   On 13 Feb 2021, Patient experiencedvision loss, tingling in extremities, paraesthesia, balance issues, fatigue and chills. Laboratory details included an increased white blood cell count..Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events. Therefore, action taken with the drug in response to the events is not applicable.  The outcomes of the events of vision loss, tingling in extremities, balance issues, fatigue, and chills were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.
Pt. broke out in hives on neck and legs and had facial swelling approximately 4 1/2 hours after receiving FluMist vaccine.
Fever of 101.5 Very sore arm (hurts too much to use) Rapid rising temp went from normal to 100 in an hour Muscle aches  Nausea Vomiting  Headache (migraine like)
Lt deltoid local reaction from Gardasil vaccine.  Area with swelling, warmth and redness and induration measuring 5 1/2"x 4 1/2".  Child c/o pain to Left deltoid, mom denies fever, temp= 99.1 tym.
8/11/21 - PT IS HERE AT HEALTH CLINIC would like to get a 3rd dose of MODERNA vaccine. At this moment, pt doesn't complains of any symptoms. Writer consulted w/ provider hotline, to check if pt needs to have another Moderna vaccine since the 1st and the 2nd dose is 8 days apart. Per hotline, did checked and double checked w/ the vaccine team and both stated "No". Do not give the 3rd Moderna vaccine. Hotline operator requested writer to fill out the VAERS as there is an vaccine errors. Information is below.  Covid-19 Provider Hotline
pt recv vax & in  MAY98 pt began to exp causalgia & myalgia;pt exp a burning sensation down rt arm;tx w/Darvocet, Catapres, narcotics, Cerebrex & Neurontin;most recent info recv 22MAR99 reports status of pt as permanently disabled;
injection site sore, left arm; and hours later she experienced wheezing; congestion getting better/Nasal congestion; Headache is better now but still remains.; Feels achy; Feels weak; now has diarrhea; Fever 101-104.5; threw up; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of adverse reaction (had a reaction to the Flu shot when patient was 11). Concurrent medical conditions included multiple allergies.   On 31st October 2022, the patient received the 1st dose of Fluarix Quadrivalent 2022-2023 season (intramuscular) and Fluarix Tetra Pre-Filled Syringe Device. On 31st October 2022, less than a day after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced vomiting and fever. On 2nd November 2022, the patient experienced diarrhea. On an unknown date, the patient experienced injection site pain, wheezing, nasal congestion, headache, pain and feelings of weakness. The patient was treated with benadryl allergy (nos) (Benadryl Allergy), epinephrine (Epi Pen) and paracetamol (Tylenol). On an unknown date, the outcome of the injection site pain was unknown and the outcome of the wheezing and nasal congestion were recovering/resolving and the outcome of the headache, diarrhea, pain and feelings of weakness were not recovered/not resolved and the outcome of the vomiting and fever were recovered/resolved.   It was unknown if the reporter considered the injection site pain, wheezing, nasal congestion, headache, vomiting, diarrhea, pain, feelings of weakness and fever to be related to Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device.   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: 02-NOV-2022 Reporters comment:  The reporter reported left arm a little sore at injection site and hours later she experienced wheezing. She took Benadryl ( allergies)  and carried an EPI Pen. The patient was still wheezing and congestion getting better. Headache was better now but still remained. She reported she threw up the night of vaccine and now had diarrhea. She felt achy and weak. On the date of reporting, she reported fever was 101 degree F which had been higher, with the highest temperature recorded hours after vaccine and fever was 104.5 degree F. She had been taking Tylenol for the fever and aches. No other information provided.  Consented to follow up.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/28/2022 PAIN DUE TO NEOPLASM J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/28/2022 NONTRAUMATIC ACUTE KIDNEY INJURY
Information has been received from a physician concerning a 12 month old male who on 29-AUG-2007, was vaccinated with MMR (lot #656428/0203U). Concomitant vaccines included Varivax (lot#655320/1009F) and HAVRIX (lot# AHAVB186AA). On 05-SEP-2007, the patient was hospitalized with a diagnosis of thrombotic thrombocytopenia purpura (TTP). During his hospitalization, he experienced a stroke affecting his left side, and blindness. He was hospitalized for one month, and on 09-OCT-2007, was to under go follow up in the office with his physician. No product complaint was reported. No further information was available. Thrombotic thrombocytopenic purpura (TTP) and stroke affecting his left side, and blindness were considered to be life threatening. Additional information has been requested. A lot check has been requested.
Dose 2 -14 hours after shot: Severe Vertigo; dizziness; fever; headache; body aches; nausea; vomiting; diarrhea; loss of balance; dehydration; debilitating; This is a spontaneous report from a contactable consumer(patient reported for herself). A 69-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, Formulation:Solution for Injection, Batch/Lot Number: EN6205 and Expiry date was not provided),via an unspecified route of administration, administered in Arm Left on 27Feb2021 (at the age of 69-year-old) as Dose 2, Single for Covid-19 immunization. Medical history included Hypothyroidism, Hypertension, Sleep Apnoea syndrome, Malignant melanoma and Endometrial cancer from an unknown date and unknown if ongoing. Concomitant medication(s) included Levothyroxine Sodium (SYNTHROID) 125 ug; hydrochlorothiazide (HYDROCHLOROTHIAZIDE) 25 mg and Ergocalciferol (VIT D [ERGOCALCIFEROL]) taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE; Formulation; Solution for Injection, Batch/Lot Number: EN6201 and Expiry date was not provided) via unspecified route of administration as Dose 1 Single on Left arm on 06Feb2021, (at 13:15) for COVID-19 immunization and experienced diarrhoea. The patient did not receive no other vaccine in four weeks and not have Covid prior vaccination. The patient was not tested Covid post vaccination. The patient experienced Dose 2 -14 hours after shot: Severe vertigo, Dizziness, Fever, Headache, Body Aches, Nausea, Vomiting, Diarrhea, Loss of balance, Dehydration and Debilitating on 28Feb2021 03:15. No treatment was received for the events. The events were assessed as Non serious. The outcome of all the events was recovering.    No follow up attempts are possible. No further information is expected
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration given as 7-May-2021. No relevant concomitant medications were reported.  No treatment information was provided.
Cannot run more than 1 block. Severe pain & tightness and starting to black out if attempting any longer. Still in effect currently.
He was given 0.2 mL of Pfizer adolescent/adult instead of Pfizer peds. There were no adverse events that have been reported
Information has been received from a physician concerning a 12 weeks old male patient who on 13-MAY-2010 was vaccinated by mistake with a dose of GARDASIL (lot # 663558/0819Y) 0.5mL, intramuscularly. Concomitant therapy included poliovirus vaccine and hepatitis B virus vaccine (unspecified) (manufacturer unknown). The mother of the patient stated that he was "spitting up a lot" a day or two days after getting the vaccine. Therapy with human papillomavirus vaccine was discontinued. The outcome of the patient was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Day 1- fever, chills, aches, dizziness, nausea, fatigue Day 2- aches, dizziness, nausea, fatigue Day 3- slight nausea, extreme fatigue* Day 4- slight nausea, extreme fatigue * Slept 20 out of 24 hours day 3-4 and still fatigued
Pt. came into ED with chest pain. Labs were done and pt. has an elevated troponin. Was diagnosed with NSTEMI and transferred to a hospital with a cath lab.
sore arm at injection area; Initial information received on 06-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an Adult patient who experienced sore arm at injection area (injection site pain), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  05-Feb-2021, the patient developed a non-serious sore arm at injection area (injection site pain) (unknown latency) following the administration of INFLUENZA VACCINE.  It was not reported if the patient received a corrective treatment.  The outcome of the event was not reported.  Information on batch will not be available.
Experienced pain in neck. Subsequently a large swollen nodule appeared on shoulder at base of neck on right side. Pain and stiffness going up neck.
EXTREMELY SICK FOR ALMOST THREE DAYS; HEADACHE FOR 6; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced extremely sick for almost three days, and headache for 6. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extremely sick for almost three days, and headache for 6. This report was non-serious.
Facial paralysis (05/31/2021, this lasted about 2 weeks), Lower back and leg pain (05/31/2021, this continues to this day), Headache/neck ache (06/11/2021, this continues to this day), Poor eye vision (06/11/2021, this lasted about 3 weeks), Arm pain and leg pain and hand tremors and body twitching and muscle weakness and limb numbness (06/15/2021, this continues to this day). I am being seen by my PCP, a neurologist, and a pain specialist. I am in constant pain and my hands and/or feet feel like they are asleep. I had to withdraw from an internship and leave my job as I am no longer to do either of them. I have not recovered from the adverse health events.
Rash developed on forehead; Nerve pain down leg; This case was reported by a other health professional via sales rep and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, 1 day after receiving Shingrix, the patient experienced rash and nerve pain. On an unknown date, the outcome of the rash and nerve pain were unknown.   It was unknown if the reporter considered the rash and nerve pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had rash developed on forehead and nerve pain down leg. The Rash and nerve pain persist. The patient had followed up with primary care physician and speculates event was related to vaccine administration.
Information has been received from a 62 year old male patient referring to himself. The patient's concurrent condition and medical history were not reported. On 21-MAR-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose and route were unknown). Concomitant therapies were not reported. On 22-MAR-2015, the patient developed a white bump and pain near the injection site of his ZOSTAVAX injection. The patient said the pain bothered him when he lied on his arm. No treatment was given for the adverse events. The patient sought for medical attention by physician visit. The outcome of the events was unknown. Additional information has been requested.
Breakthrough case admission after 2 vaccines Pfizer 7/15/21 LOt# EW0169 Pfizer 8/5/21 Lot# Ew0169
Had fever, chills, achy all over.  Next day at 10am he was fine.
Associate experienced intense red itchy non raised rash, covering the upper arm and post shoulder and some areas of chest.
extreme itching and 11/2 inches big redspot on arm. The itching is so severe and cannot relieved by over counter hrdrocortisone, it make me feel my heart starting beat irregularly
Some vaccine leaked out of the needle when the vaccinator removed the needle.  The vaccinator also reinjected the same needle into the patient's arm to administer the rest of the dose (did not inject all prior to removing).
pt recv vax 4MAR97 & devel lesions between toes;By 13MAR97 pt had lesions on arms & knees;the lesions were described itchy, clear, fluid-filled pustules;pt had 8 lesions on lt hand;10-12 lesions on rt hand;3 lesions on rt leg;2 lesions toe
tested positive for tuberculosis; This spontaneous case was reported by a consumer and describes the occurrence of TUBERCULOSIS (tested positive for tuberculosis) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 020B21A) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease since 1970. Concomitant products included MESALAZINE (MESALAMINE DELAYED RELEASE), SERTRALINE HYDROCHLORIDE (ZOLOFT P), MULTIVITAMIN [VITAMINS NOS], DIAZEPAM (VALIUM) and INFLIXIMAB (INFLECTRA [INFLIXIMAB]) for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TUBERCULOSIS (tested positive for tuberculosis) (seriousness criterion medically significant). At the time of the report, TUBERCULOSIS (tested positive for tuberculosis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: abnormal (abnormal) abnormal. On an unknown date, Mycobacterium tuberculosis complex test: positive (Positive) Positive.         Other concomitant medication included: Acycletere.  No treatment was reported.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Fur the event Tuberculosis the drug Inflectra (Infliximab)  is a co suspect for the event.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Fur the event Tuberculosis the drug Inflectra (Infliximab)  is a co suspect for the event.
Patient received second dose ofM-M-R II on 07/22/2019; bloating; head-cold; This spontaneous prospective pregnancy report was received from a 25-year-old female patient who was referring to herself. Her concurrent condition included psoriasis. Concomitant therapies included betamethasone. She had no drug allergies or reactions.      On 21-JUN-2019, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, (strength, exact dose, frequency, rout of administration, anatomical location, lot # and expiration date were not provided) and on 22-JUL-2019, she received the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, (strength, exact dose, frequency, rout of administration, anatomical location, lot # and expiration date were not provided) for indication reported as vaccination. The vaccines were dissolved in sterile diluent (DILUENT MRK INJ) (strength, dose, frequency, route of administration, lot # and expiration date were not reported) . On 20-JUL-2019 (reported as adverse event onset date), the patient experienced "normal" pregnancy symptoms including bloating as well as a head cold. On 04-AUG-2019 after having the pregnancy test, she found out that she was pregnant. The patient's last menstruation period (LMP) was on 07-JUL-2019, she believed the conception date was on 20-JUL-2019 and estimated due date (EDD) was calculated as 12-APR-2020. The patient was treated with amoxicillin for the head cold since an unknown date.  The pregnancy outcome was outcome pending.  The outcome of bloating and head cold was reported as not recovered. The causality assessment was not provided.
Uncontrollable shivers for about 20 min, with muscle spasms,  and the tempature of 92°F lasting for about 30-45min.
Information has been received from a physician concerning a 13 year old (also reported as 12 year old) female who on 17-JUN-1997 was vaccinated with the first dose of MMR II (route, site, dose and lot number not reported). On 14-OCT-2000 the patient was vaccinated with the second dose of MMR II (route, site, dose and lot number not reported). On 20-NOV-2009 the patient experienced mumps (thought the date diagnosed was reported as 23-NOV-2009). The patient had a fever of 102 and had L parotitis. On 23-NOV-2009 blood work was performed which revealed <1:10 IgM, 5.17 IgG, and serum amylase of 86. The outcome for mumps was not reported. No further information is available.
Patient was admitted to Hospital for pneumonia related to COVID-19. This is considered a breakthrough case.
Fever, redness, swelling and pain started at left arm injection site 1 day after vaccine was administered. Treated with 7 days of Augmentin for diagnosis of cellulitis.
Information has been received from a medical assistant concerning a female who was vaccinated with a dose of RECOMBIVAX HB (lot # not reported between 1993 and 1997. Subsequently the patient experienced hives from the vaccine. It was reported that no further information was provided from the caller as the vaccine was not given in this physician's office. As of 07-JAN-2009, the patient's outcome was unknown.
Dizzy; Headache/ sick headache; I have been in bed ever since/I can't turn my head or anything; it got worse today; Sick; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 63-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: unknown, Expiration Date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 27Jan2021 (age at vaccination was 63 years) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included anxiety. Concomitant medication included escitalopram oxalate (LEXAPRO) taken for anxiety. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: unknown, Expiration Date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was unknown) as 1ST DOSE, SINGLE for COVID-19 immunization. The consumer stated that she had been sick since yesterday. She was at work and got dizzy and had a headache. She took like for the headache, she had like a sick headache at night and she took Tylenol (Lot no: E2392V, Expiration date: 20/22) but it seemed like it got worse today. She had a second shot of the virus shot and she had been in bed ever since. She felt very dizzy. She couldn't turn her head or anything, so she went to urgent care and they told her to call them right away that they thought that might be it was an allergic reaction. (As consumer was sure, hence allergic reaction not captured as event). The consumer was informed about the role of Pfizer Drug Safety and also informed about Pfizer Medical Information department and provided with the website link as (Website provided). The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.