chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report has been received from a Physician concerning a 6 year old male subject, who had been receiving FLUMIST QUADRIVALENT.  FLUMIST QUADRIVALENT started on 23-OCT-2014. The patient experienced fever, chills, cough and headache which started on 25-OCT-2014. At the time of reporting the event of fever, chills, cough and headache was ongoing. The report was considered to be non-serious.
Pt recv vax on 9/22/98; on 9/24/98 pt exp chicken pox lesions
sore arm; fever; wanted to sleep all the time; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4557823.  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 14Dec2021 (Batch/Lot number: unknown) at the age of 63 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, MANUFACTURER UNKNOWN), for COVID-19 Immunization.The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 14Dec2021, outcome "unknown", described as "sore arm"; PYREXIA (non-serious) with onset 14Dec2021, outcome "unknown", described as "fever"; SOMNOLENCE (non-serious) with onset 14Dec2021, outcome "unknown", described as "wanted to sleep all the time".  We have no further information regarding the reported event(s) described above. Any additional material information received will be forwarded to you in accordance. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
p/vax pt devel an inj site rxn characterized by tenderness, swelling, warmth & erythema;2 days p/vax pt extended to elbow;pt recovered;
I received the Eli Lilly monoclonal antibody infusion on Feb.  12 after testing positive for COVID-19 on Feb.  10. I received the Pfizer vaccine on Feb. 5, and had muscle aches, chills and a cough. I passed out at home on the 10th, cut my forehead, and had to receive stitches. That is when I tested positive for COVID-19. I continued to by symptomatic and opted for the monoclonal infusion. About 5 hours after I received the infusion, I became completely disoriented. I was unable to stand and did know where I was. My wife summoned an ambulance, and I was taken by ambulance to a local hospital. I received fluids intravenously. I was released from the emergency room about 6 hours later.
no other adverse event; Improperly stored product administered; This spontaneous report has been received from an office manager and refers to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.  On 20-FEB-2021, the improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 1 dose, lot # s011532 with expiration date 01-DEC-2021 (route of administration, exact dose and frequency were unknown) was administered to a patient (product storage error). The vaccine was stored at -2.7 Celsius degrees for 11 hours and 52 minutes. There was no previous temperature excursions. Digital data logger was involved. No other adverse events were reported. 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; devicelotnumber: s011532; expirationdate: 01-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
Patient was administered booster dose of Moderna Vaccine 4 days prior to the recommended 180 days
Pt was inadvertently given Tdap instead of Hep A vaccine. Pt was also given PEDIARIX.
Fever 102 degrees for 2 days 8th and 9th. Loss of appetite, redness, tenderness, chills, joint pain, hot from Wed 7th to Sat 10th.
Injection site arm is swollen, red, hot bubbly red rash around the site, hot itches.  Taking Tylenol.
Shortness of breath, heart palpitations, feeling of overwhelming anxiety, panic attacks  These events started on June 19, 2021 and reached a peak on June 27, 2021 when I was hospitalized following a panic attack that caused me to faint.
FEELING FULL IN BOTH EARS; HISSING SOUND IN THE LEFT EAR; This spontaneous report received from a patient concerned a 49 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 20-MAR-2021, the subject experienced feeling full in both ears. On 20-MAR-2021, the subject experienced hissing sound in the left ear. On 15-APR-2021, treatment medications included: bioflavonoids nos/vitamins nos. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling full in both ears, and hissing sound in the left ear. This report was non-serious.
Urticaria-2 cm wheals at site of each injection & below each site. L/arm very sore & painful to raise. MD recommended no repeat of these vaccines in the future.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 26-JAN-2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 30-JAN-2016, the patient was treated at a hospital (not specified whether admitted; therefore, considered Emergency Room visit until follow-up is received) for a blistering vesicular outbreak which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Hot, painful, itchy hives Facial swelling Hand swelling Feet swelling Severe chest pains, feels like heart attack, can't breathe  Severe symptoms lasted three months+ Symptoms continue to present, mitigated with antihistamines and cryotherapy treatments
Patient received a FLUCELVAX vaccine after it had been exposed to below freezing temperatures. She did not experince any ADR, but we questioned whether or not she should be revaccinated. She received a new vaccine from her PCP per recommendation of CDC and Agency.
Pain and warmth at injection site on left arm, numbness of extremity on same side as injection 10 min after administration, monitored in ER x 2 hours.
2 3/4" x 2" long red area & achey; warm/cold spells, OTC antiinflammatory; return if does not improve or go to pvt MD;
Grew to a rash; Injection site became swollen; Itchy; arm was sore to touch; A spontaneous report was received from a consumer who was an 68-year-old, female patient who experienced sore to touch, injection site became swollen, itchy and grew to a rash.  The patient's medical history was not provided. No concomitant medications were reported.  On 31 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 01 Jan 2021, the patient experienced sore to touch. No treatment information was included.   On 07 Jan 2021, the patient reported that the injection site became swollen and itchy.   On 08 Jan 2021, the patient developed a rash. The treatment for the event included caladryl.  Action taken with mRNA-1273 in response to the events was not provided.  The event, sore to touch, was considered resolved on 02 Jan 2021.  The outcome for the events, injection site became swollen and itchy was unknown.  The outcome for the event, grew to a rash was not resolved.; Reporter's Comments: This case concerns a 68-year-old female who experienced nonserious expected events of pain in extremity, injection site swelling, injection site pruritus, injection site rash.  Event onset occurred 2 days after the first dose of mRNA-1273. Treatment included caladryl. Event outcomes unknown. Based on 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.
Toxic effects of Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of TOXICITY TO VARIOUS AGENTS (Toxic effects of Moderna vaccine) in a 26-year-old male patient 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 TOXICITY TO VARIOUS AGENTS (Toxic effects of Moderna vaccine) (seriousness criterion death). The reported cause of death was toxic effects of moderna vaccine. It is unknown if an autopsy was performed.            No relevant concomitant medications were reported.  No treatment information was provided.  Company comment: Very limited information regarding this event has been provided at this time. Critical details including medical history, concomitant medication, date of vaccine administration and the event term, and cause of death is required for further assessment.; Sender's Comments: Very limited information regarding this event has been provided at this time. Critical details including medical history, concomitant medication, date of vaccine administration and the event term, and cause of death is required for further assessment.; Reported Cause(s) of Death: Toxic effects of Moderna vaccine
Pfizer COVID-19 shot was injected in my right arm on 3/9/2021. Five days later on 03/15/21 around 5am, my right eye was very sore and red, stinging/itching. The soreness continued on 3/16 and 3/17.  My eye started to swell on 3/18 and continued to swell through 3/20. Started in the right corner of my eye. On 3/21 as I write this event, my right eye is still swollen. I have pictures of the swollen eye. I have a history of eye swelling from childhood thru adulthood after taking certain known medications(Aspirin, NSAIDS, penicillin, codeine, Feldene, steroids. There may be others that I am unaware of. Today 3/21 is the 4th day of swelling,
pt recv vax 13FEB97 & 12MAY97 pt exp chickenpox w/greater than 50 spots, mild case;
Low Grade Fever; Lower Back Pain; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number 29RD5, expiry date 16th April 2022) for prophylaxis.   On 10th December 2019, the patient received Shingrix (intramuscular) .5 ml. On 10th December 2019, less than a day after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced fever and low back pain. The patient was treated with ibuprofen. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the low back pain was not recovered/not resolved.   It was unknown if the reporter considered the fever and low back pain to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix in the right deltoid and the same day the patient developed a low grade fever and lower back pain.  The pharmacist reported the fever resolved, but the patient still has lower back pain.  The pharmacist believes the patient takes ibuprofen to decrease pain, but the ibuprofen only takes the edge off not providing full relief.  The pharmacist reported the patient tried to go a day without any pain reliever unsuccessfully.
Can not stand up with out feeling like I'm gonna pass out.; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 66 years of age), dose 2 via an unspecified route of administration, administered in Arm Left on 09Mar2021 11:00 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included known allergies to sulfa drugs and bladder infection. The patient's concomitant medications included medications for her bladder infection. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE first dose on 16Feb2021 11:00 AM in the left arm (at 66 years of age) for Covid-19 immunization. The patient was not pregnant. The patient had no other vaccine in four weeks prior to covid vaccine. She had not had Covid-19 prior vaccination and she had not been tested for Covid post vaccination. It was reported that the patient cannot stand up without feeling like she's gonna pass out on 10Mar2021 at 12:00 AM. The outcome of the event was recovering and no treatment received for the event.  Information on the lot/batch number has been requested.
11/7/2013 Pt described to have rashes on her chest, itchy and pustules. the day after the shot (10/18). It was on an off for 1 week. We have ruled out all other factors. Benadryl and ketonazole were helping to relief her rashes.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Dec2020 as dose 1, single (Lot number: EL1284), in left arm, on 18Jan2021 as dose 2, single (Lot number: EL3248), in left arm, on 24Sep2021 as dose 3 (booster), single (Lot number: 301458A), in left arm and on 06Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Atrial septal aneurysm" (unspecified if ongoing), notes: Atrial septal aneurysm; "intermittent atrial fibrillation" (unspecified if ongoing), notes: intermittent atrial fibrillation; "premalignant ovarian tumor" (unspecified if ongoing), notes: premalignant ovarian tumor. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jul2022) Positive. Therapeutic measures were taken as a result of covid-19 which include Paxlovid from 30Jun2022 to 05Jul2022.  Clinical course: The patient had no known allergies. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events
Developed localized pain, redness and body aches approximatley 12- hours after receiving Td Vaccine. Seen in hospital ED where employed. 2.5cm area around site of injuection right deltoid
My top and bottom lips developed blisters on Friday afternoon and by Saturday they began to weep. They them became crusty and swollen. Over the next few days they continued to weep. They stopped weeping and were crusty, and then the crust came off on the Wednesday after it began. My lips were still sore and sensitive, but were back to normal about 10 days later. Doctor prescribed an antiviral (vircyclovir) for cold sore but I don't think it was a cold sore. I actually did develop a cold sore on my bottom lip 2 weeks after the initial lip issue.
Temperature 99.6F (axillary); red rash at site and on feet and chest (maculo-papular);  hot, hard, lump at site. Vomited x 2, last PM.
serious heart problem; high blood pressure; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: Not reported, Expiry date: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced serious heart problem and high blood pressure. It was reported that the patient was referred to her physician for treatment recommendations. The patient underwent lab tests and procedures on an unspecified date which included blood pressure measurement increased. The outcome of the events was unknown.  The lot number for the vaccine, was not provided and would be requested during follow up.
Pain in opposite arm vaccine given  Had pain 3 days after second dose waited 3 weeks went to orthopedic doctor who diagnosed me with subacute lymphangitis. Still experiencing pain every day
Pain in the left Arm; Fever; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 50 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 28Oct2021 16:00 (Batch/Lot number: unknown) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm right, administration date 28Oct2021 (Batch/Lot number: unknown) as dose number unknown, single. The patient's relevant medical history was not reported. Concomitant medication(s) included: LIPITOR; TRILIPIX; CABERGOLINE. Past drug history included: Known allergies; codeine, reaction(s): "Known Allergies; Codeine", notes: Known Allergies; Codeine. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 13:00, Route of Administration: Intramuscular), administration date: 22Mar2021, when the patient was 49 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM, Route of Administration: Intramuscular), administration date: 16Apr2021, when the patient was 49 years old, for COVID-19 immunization.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 28Oct2021 22:00, outcome "not recovered", described as "Pain in the left Arm"; PYREXIA (non-serious) with onset 28Oct2021 22:00, outcome "not recovered", described as "Fever". Therapeutic measures were not taken as a result of pain in extremity, pyrexia.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sore swollen spot at injection site, very warm to the touch. Pain and tenderness under arm near armpit on same arm as injection site.
12/2/21 Pt has had several months hx of right sided abdominal pain, she just saw urologist b/c hx of abnormal renal US. A CT of abdomen came back normal. Specialist ruled out a renal cause of the abdominal pain. She has issues with constipation, she has BM every 2-3 days and hard stools. Has been on stool softeners in the past but not currently. Last BM was 2 days ago.  - She missed school yesterday b/c she developed sore throat, headache and fever of 101.8. No cough but has nasal congestion. Has been cases of COVID in the school. Review of Systems  Constitutional: Positive for fever.  HENT: Positive for congestion and sore throat.   Respiratory: Negative for cough.   Review of Systems  enitourinary: Negative for decreased urine volume.  Neurological: Positive for headaches.
10/26 Evening, low grade fever 100.5 Tylenol. 10/27 afternoon, very hot after getting up from nap. Temperature unk. At 4:30 PM, child was given Tylenol, milk, juice with water, removed clothes. At 5:05 PM, febrile seizure occurred, unresponsive, trouble breathing, called 911. At 5:40 PM, child was given valium by EMT to "get him out of 30 minute seizure. 5:50 arrived at hospital, temperature was 102.2. Physician stated to observe development over next 2 months and will refer to pediatric neurologist if needed. 10/30 physician noted measles spots on chest and stomach.
I had the shingles shot about 2-3 days after the shingles rash broke out; This case was reported by a consumer via  interactive digital media and described the occurrence of off label use in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (shingles rash broke out).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.  Additional details were provided as follows: The case was reported by the patient for herself/himself The age at vaccination was not reported. The patient received Shingles vaccine about 2 to 3 days after the shingles rash broke out, which led to off label use. The patient reported that without vaccine shingles can reappear again, usually in some other nerve group. No other information was reported.
This case was reported by a physician and described the occurrence of a male subject aged between 60 and 69 years old testing hepatitis b antibody negative following vaccination with a complete series of Engerix B for prophylaxis.  On 2 March 2007 the subject completed his three dose series of Engerix B (unknown).  The 3rd dose was given, 20mcg in the deltoid of each arm.  At an unspecified time after completion of the Engerix B series, the subject was tested on 05 March 2007 and found to be positive for surface antigens.  The subject was tested again on 10 March 2007 and was negative for surface antigens.
pt administered 13JUL92 DTP/HIB pt had fever 102.5 was sent to hosp w/meningitis type reaction discharged in 2 days w/probable vax rxn mom states;
Continuing pain, inflammation in muscle, unable to raise arm above shoulder, unresolved with corticosteroids.
A report has been received from a Health Professional concerning a 4 year old, male patient. The relevant history and concomitant disease of the patient were not reported. It was reported that the patient was on no concomitant medications. The patient had been receiving nasal FLUMIST started on 23-Dec-2008. The reporter stated that after FLUMIST administration patient contracted Flu A which started on 24-Jan-2013 and which was tested positive on 24-Jan-2013. It was reported that the patient was treated with TAMIFLU and reporter said the patient had not been seen since then, she presumed the flu had resolved. The outcome of the event of Flu A was unknown. The reporter assessed the event of Flu A to be non serious. Summary of follow-up information received 26-Feb-2013 from health professional. Form completed date updated. Expiry date for drug added. Title added for primary reporter. Narrative updated with reporter's comment. Corrected report 08-Mar-2013: Lab value corrected.
Nausea, vomiting, periorbital edema, edema at administration site.