chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: er8737), in left arm, on 23Apr2021 as dose 2, single (Lot number: ew0161), in right arm and on 27Dec2021 as dose 3 (booster), single (Lot number: 33130ba) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Demerol, reaction(s): "Known allergies: Demerol"; Topamax, reaction(s): "Known allergies: Topamax". The following information was reported: VACCINATION FAILURE (medically significant) with onset 19Aug2022, outcome "unknown", COVID-19 (medically significant) with onset 19Aug2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Aug2022) Negative, notes: I started feeling unwell the last couple of days after testing negative on 14Aug22 and 15Aug22; (15Aug2022) Negative, notes: I started feeling unwell the last couple of days after testing negative on 14Aug22 and 15Aug22; (19Aug2022) Positive, notes: I just took another home test today 19Aug22 and it is positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information:  Patient did not receive any other medications in 2 weeks. Patient had COVID rebound. She started feeling unwell the last couple of days after testing negative on 14Aug22 and 15Aug22. She just took another home test today 19Aug22 and it was positive.  No follow-up attempts are possible. No further information is expected.  Follow-up (23Aug2022): Follow-up attempts are completed. No further information is expected.
Pt reports yellow discharge from right eye after getting vaccine. Eye secretes discharge daily after getting vaccine on 06/12/2021.
Great big round red spot the size of her fist; Itching at injection site; Soreness at the injection site; Firmness at the injection site; A spontaneous report was received from a consumer, concerning a female patient of 79 Years, who received Moderna's COVID-19 vaccine and experienced Soreness at the injection site,Firmness at the injection site, Itching at injection site,Great big round red spot the size of her fist.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 15 Jan 2021 , prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch number 011J20A) via intramuscularly in her left arm for COVID-19 infection prophylaxis. On 24 Jan 2021, the patient experienced itching at injection site and on 25 Jan 2021 the patient reported a great big round red spot the size of her fist.  The patient was treated with warm compress and a calming cream.   Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event was  considered to be not resolved at the time of this report.
edema w/urticaria to lt arm & neck p/left clinic;returned to clinic 2 days later & mom stated child is having rxn to vax;
FATIGUE Narrative: THIS IS A 57 YEAR OLD WITH A RECENT REACTION FROM COVID 19 PFIZER VACCINE. RN REPORTED PT EXPERIENCED FATIGUE/HEADACHE X 2 DAYS. SELF LIMITING REACTION
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 03-JUL-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) lot # L000454 expiry date: 06-JAN-2017 (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient reported tingling in the throat about 10 minutes after the vaccination.  The doctor examined the throat.  Patient's symptoms resolved prior to leaving our office.
hospitalization for IVF, on RA so no remdesivir or dexamethasone
SHORTNESS OF BREATH; TROUBLE SLEEPING; This spontaneous report received from a patient concerned a 51 year old male. 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: 1808609, expiry: 09/JUN/2021) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced shortness of breath. On 09-APR-2021, the subject experienced trouble sleeping. Laboratory data (dates unspecified) included: CT scan (NR: not provided) Signs of Pneumonia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath, and trouble sleeping. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
accidently administered to a 5 year old patient instead of the correct vaccine intended (name not reported.); accidently administered to a 5 year old patient; This spontaneous report was received from a vaccine coordinator from HCP office and refers to a 5-year-old male patient. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 21-JAN-2021, the patient was accidently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection, 0.5 milliliter (ml) intramuscularly (IM) x 1 dose, lot # S020255, expiration date: 09-DEC-2021 (dose number and anatomical location were not reported) for prophylaxis instead of the correct vaccine intended (name of vaccine was not reported) (wrong product administered and product administered to patient of inappropriate age).  It was confirmed, that the vaccine administered to the patient has never experienced a temperature excursion. No other details given.  The patient did not seek medical attention and there was no treatment given for the event. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S020255; expirationdate: 09-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
I had my period on 4/9 at the time of vaccine and have it again as of 4/23 which was only 14 days later and this has never happened before. I thought it was worth reporting
Moderna COVID-19 Vaccine EUA. Severe swelling and redness of injection site one week post-vaccination- approx. 12 cm diameter firm, severely inflamed area at site of injection on right  upper arm with severe pain in right axillary region; five day duration of inflamed lesion with slow resolution; pain still present.
dizziness and hot flash x 20 minutes on 6/20/21. fatigue on 6/21/21. no treatment other than fluids and rest.
arm pain; experienced slight arm discomfort that latest about a day and a half after the second; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (experienced slight arm discomfort that latest about a day and a half after the second) and VACCINATION SITE PAIN (arm pain) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE DISCOMFORT (experienced slight arm discomfort that latest about a day and a half after the second). On an unknown date, the patient experienced VACCINATION SITE PAIN (arm pain). At the time of the report, VACCINATION SITE DISCOMFORT (experienced slight arm discomfort that latest about a day and a half after the second) had resolved and VACCINATION SITE PAIN (arm pain) outcome was unknown.            The patient had no known drug or food allergies. The patient experienced slight arm discomfort that last about a day and a half after the second dose. No concomitant drug was reported. No treatment drug was reported.   This case was linked to MOD-2021-428648, MOD-2021-428660 (Patient Link).
A VERY MILD HEADACHE SINCE THE FIRST SHOT; 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, and batch number were not reported) 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 a very mild headache since the first shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from a very mild headache since the first shot. This report was non-serious.
Information has been received from a physician concerning a 27 month old pat who on 08/12/1999 was vaccinated with a dose of varicella virus vaccine live. On 12/01/2001 the pt experienced breakthrough varicella. There were less than 50 lesions. Unspecified medical attnetion was sought but there was  no tx or hospitalization. The pt recovered . No product quality complaint was involved. This is one pt out of 40 reported. Thirty nine other cases (WAES 0407USA01446 and 0409USA01855 through 0409USA01881 and 0409USA01883 through 0409USA01893) experienced breakthrough varicella after vaccination with varicella virus vaccine live. Additonal information is not expected.
Numbing in lower extremities. Time of course was at 5:45pm on Saturday July 10,2021. Symptoms relieved within 2 hours.
I had a breakthrough of COVID. I experience of nasal congestion, fatigue, and bad cough.
Heart palpitations, dizziness, ringing ears, major pressure in head, blurred vision, light headed, menstrual cycle not due but came and lasted 2 and a half weeks.
Red rash on the injected arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Red rash on the injected arm) 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 22-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced VACCINATION SITE RASH (Red rash on the injected arm). At the time of the report, VACCINATION SITE RASH (Red rash on the injected arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported.   No treatment medications were reported.
breaking out in hives; hurt all over; This spontaneous case was reported by a physician and describes the occurrence of PAIN (hurt all over) and URTICARIA (breaking out in hives) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 043120A) for COVID-19 vaccination.     Concomitant products included METFORMIN for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (hurt all over). On 07-Mar-2021, the patient experienced URTICARIA (breaking out in hives). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PAIN (hurt all over) and URTICARIA (breaking out in hives) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication also include: Thyroid medication, BP medication, Depression medication and cholesterol medication.
Few days after the shot, redness increased in size, and lower part of reaction had swelling (swelling started around week 2), and started itching. The increase in intensity occurred for approximately 2 weeks then started to decrease. By 5/7/18 (when patient reported reaction), appearance of the outline of the reaction is still visible. size of outline (4 inches by 2.5 inches).
On 4/16/00, the pt received his 1st dose of Lymerix and within the 1st hour, post vax, the pt experienced right arm numbness for 15 hours, arm soreness for 24 hours and tingling in the arm for 6 hours. The events resolved after 24 hours. On 5/19/00, the pt received his 2nd dose of Lymerix and within 18 hours, he experienced nausea, vomiting, diarrhea, dizziness and some arm soreness. It was noted that the pt was sick for 3 days. The most recent information received on 5/26/00, reports the outcome of the events as resolved.
Large itchy circular red spot around injection site; I believe it?s ?covid arm,? but it?s been almost two weeks and I still have it. It?s not impacting my daily functioning, it?s just very odd.
Per patient's mother: Approximately 1 hour after vaccines patient broke out with hives, itching and swelling to left eye and lips. Vaccines administered were Tdap and MENACTRA to right deltoid, and GARDASIL #1 to left deltoid.
Severe headache starting at 5AM the next morning; followed by muscle weakness, inability to move, walk, sit up, loss of bladder control. On 10/29 I am able to sit up and walk but still have a severe headache.
10/26/2021  The patient presents with Possible stroke x50 min ago. Per EMS, pt had left sided weakness and facial droop, pt was also reported that she was puffing her cheeks. Pt BG reading was >700. Pt only responded to her name with some nodding noted by EMS. HPI limited due to physical impairment and Stroke alert was activated on arrival to emergency department.  During her non-contrast head CT patient had a full body seizure.  Patient was brought back to the emergency department for sedation..  The onset was 50  minutes ago.  The course/duration of symptoms is: Location: left. The character of symptoms is weakness.
Narrative:  COVID infection following COVID vaccine series 12/28/2020, Pfizer, dose #1 01/19/2021 Pfizer, dose #2 08/23 pt cc: myalgias, rhinorrhea, congestion, exposure: unknown 08/24 COVID swab, result: detected 08/24 SARS-COV-2 Variant Sequencing result: pending
Diarrhea for about 12 hours; took imodium and it went away; went to get co-vid testing because I had to work the next day. Covid test was negative.
I felt fine when I went to bed Saturday (Aug14th) evening. I did not wake up until midmorning Tuesday,  Aug 17th.  When I woke,  I felt nauseous,  dizzy. I experienced sweats, no fever.
right eye iritis/herpes simplex iritis/right eye uveitis; right posterior vitreous detachment; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On or around 20-MAY-2014 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date in 2014 (reported as shortly after the vaccination), the patient suffered severe eye pain and eye redness. Patient was diagnosed with right eye iritis, right eye uveitis, right posterior vitreous detachment and herpes simplex iritis (viral iritis and posterior vitreous detachment). As a result of vaccine live(ZOSTAVAX), the patient suffered serious, progressive, severe, 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. He also suffered medical expenses, the loss of accumulations and other economic and non-economic damages. The outcome of viral uveitis and vitreous detachment was considered as not recovered. The reporter considered the events to be disable and related to Zoster Vaccine Live(ZOSTAVAX).  Upon internal review, viral iritis and posterior vitreous detachment were determined to be medically significant.
Miscarried at 6 weeks; Vaccine exposure during pregnancy; A spontaneous  report was received from a healthcare professional concerning a 32 year old female patients who received Moderna's  Covid 19 vaccine(mRNA1273) and experienced vaccine exposure during pregnancy and miscarried at 6 weeks.  The patient's medical history was not provided. Concomitant product use was not provided.    The patient received second of two planned dose of mRNA-1273  for prophylaxis of Covid 19 infection approximately 2.5 weeks before the miscarriage.  The patient experienced vaccine exposure during pregnancy and miscarried at 6 weeks, approximately 2.5 after receiving her second dose of Moderna vaccine.  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 outcome of the event, miscarriage spontaneous  was considered as unknown. The outcome for the event of Vaccine exposure during pregnancy was recovered/resolved.; Reporter's Comments: This case concerns a 32 year old, female subject, who experienced a spontaneous abortion and drug exposure during  pregnancy. The patient experienced vaccine exposure during pregnancy and miscarried at 6 weeks, approximately 2.5 after receiving her second dose of mRNA-1273. Very limited information has been provided at this time. Further information has been requested.
Pt E-mailed the EHN on 5/21/07, stating that she had a rash all over her face and was wondering if it was a reaction from the HBV that was given on 5/15/07 at 3pm. EHN called pt at school on 5/21/07. She stated that on Friday she looked worse. The rash was on her face and neck and her eyes were swollen. On Friday she went to patient first and they prescribed Hydroxizine HCL. She did not go into work on Friday. She said that the medicine made her extremely tired. She took 2 doses on Friday, and quit taking it because of how she felt. On Saturday she stated it was worse and only slightly itchy. She said she also felt sick, and has not had an appetite. On Sunday she thought it was getting better, but after she was out in the sun, it looked worse again. Today (Monday 5/21/07) she stated it looked better today, but it was still there. Pt said the doctor at patient first said it should be gone by Saturday. The EHN informed the employee that she needed to leave work and go back to patient first, since the rash was still present. She would need clearance from a doctor to return to work tomorrow. I explained that we need to make sure the rash is not contagious since she works with kids at the school. EHN asked Pt to f/u with the EHN today or tomorrow before before coming back to work, and to fax me her doctor's note. EHN will notify DR and will send an adverse reaction form to VAERS.
This spontaneous report was received from a medical assistant and refers to a 15 month old patient of unknown gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 25-OCT-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L042267, expiration date 27-OCT-2017; site, dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as no further information is available.
Pt recvd series of 3 Hep B vax doses & it was determined that pt did not respond; 2 booster doses of Engerix-B were given MAY91 & JUN91 respectively;
3X6 irritation on right upper arm onset post tetanus shot. Will use Benadryl prn. This per MD.
palpitations; chest pain; high heart rate; This is a spontaneous report from a contactable other HCP. This Other HCP (patient) reported for herself that a 38-years-old female (Non-pregnant) patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: EL3248), (at the age of 38-years-old) via intramuscular route of administration in right arm on 01Feb2021 at 15:15 as dose 1, single for COVID-19 immunisation. Vaccine was facilitated in hospital. The patient's medical history and concomitant medications were not reported. She had no known allergies. Neither other vaccine in four weeks nor other medications in two weeks were received by patient. On 01Feb2021 at 15:15, the patient experienced palpitations, chest pain and high heart rate. Patient visited emergency room and physician office due to events. Neither prior vaccination nor post vaccination, patient tested for covid. The patient did not received treatment for adverse event. The outcome of the adverse events was unknown.
Complaints of left arm pain, redness and swelling to immediate care center 11/02/02. Treatment with Allegra and antibiotic.
I had muscle soreness, severe headache, chills, a fever that came and went for 12+ hours.  I would go from normal temperature of around 98 to 101 or so and back within a matter of 20 minutes.  Additionally, random parts of my body would get very hot at times.  About 2 hours after the side effects started, I became nauseous and threw up.  I was unable to eat for nearly 24 hours.  It seems that the fever and most side effects subsided through the 2nd night after vaccination.
Without fail every time he gets the flu shot and got the flu; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 07-Dec-2020. This case involves a patient of unknown demographics reported without fail every time he gets the flu shot and got the flu (influenza), while the patient received Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site;   On an unknown date, the patient reported without fail every time he gets the flu shot and got the flu (influenza) unknown period of time after the administration of influenza vaccine.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Patient states about 5 hours after receiving the vaccine she had a very sore arm and had difficulty lifting her arm.