chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse practitioner concerning a 35 year old Caucasian female with no known drug allergies and a history of endometrial ablation who on 20-Nov-2000 was vaccinated IM in the left deltoid with a second dose of Hepatitis b vaccine recombinant (yeast) (lot #635523/0635K). There was no illness at the time of vaccination. Concomitant medications include acetaminophen + propoxyphene napsylate (Darvocet) It was noted that on 17-Oct-2000, the patient received a first dose of Hepatitis b vaccine recombinant (yeast) (lot # 636198/0678k) On 22-NOV-2000, the patient experienced finite macular papular rash on her arms and legs and joint pain that "incapacitated her for a week". The patient experienced occasional "tingling of skin of arms and legs" but no itching. a titer was drawn in October 2000 and the patient was positive for measles and rubella. The attending physician ordered acetaminophen (Tylenol) or aspirin for her condition. The patient's condition has subsided. It was reported that the patient has recovered  No further information is expected.
pt recv vax 29AUG96 & w/in 24hr pt devel an urticaria type rash approx 11.5 cm x 8 cm in diameter over lt deltoid & upper arm;did not have any significant pain;no diff breathing;no SOB or palpitations;pt placed on DPH;
Nausea; Diarrhea; Hot flashes; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number and Expiration date: unknown), via an unspecified route of administration in 2021, as first dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced nausea on an unspecified date in May2021 and diarrhea, hot flashes on an unspecified date in 2021, about three weeks after the vaccination. It was reported that the patient was wondering, if anybody experiencing symptoms from the shot the first dose of the shot about three weeks after like nausea and diarrhea, hot flashes or the people are facing only in the first week. The outcome of the events was unknown. All the events were reported as non-serious.  Information about lot/batch number has been requested.
Administered Typhoid VI vaccine 1 year early.  No adverse reaction reported by patient.
Developed a stye on right eye; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737), via an unspecified route of administration in the arm left on 15Apr2021(at the age of 41-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the arm left on 25Mar2021(at the age of 41-year-old), as a single dose for COVID-19 immunisation. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Apr2021, the patient developed a stye on right eye after receiving the second vaccine. The patient never had a stye before. The clinical outcome of the event stye on right eye was not recovered.   No follow-up attempts are needed. No further information is expected.
continues cough, heavy body pain ,shortness of breath, dizziness, low blood pressure, high heart rate, pain full boils on body, sore throat,
Narrative:  COVID infection following COVID vaccine series 03/10, Pfizer, dose #1 04/02, Pfizer, dose #2 08/20 pt cc:no sx exposure: unknown 08/28 COVID swab, result: detected 08/28 CXR Impression: No acute cardiopulmonary process. 08/28 pt admit to ED cc: check dx: COVID-19 LOS: 1 day
Temp 100.9. Pink blanching macular rash started on face and spread to chest. + occipital nodes 11 days post MMR/Varivax vaccines.
PAINFUL ARM; WEAKNESS OF ARM; FELT LIKE HIT BY TRUCK; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced felt like hit by truck. On an unspecified date, the subject experienced painful arm, and weakness of arm. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like hit by truck, and the outcome of painful arm and weakness of arm was not reported. This report was non-serious.
Started to have sore throat, headache, night sweats, dry cough and fever. Took a home COVID-19 test and it was negative. Went to urgent care and was told to take chloraseptic throat lozenge's; DELSYM cough syrup; vitamins; PEDIALYTE; and rest. Had severe headache. Took another home COVID-19 test and was positive. Was told by urgent care Dr. to reach back out if tested positive for COVID-19 was prescribed PAXLOVID. Took full course and left a metallic taste in my mouth and diarrhea. Am left with a raspy voice, brain fog, fatigue and still have a hard time concentrating. Took about a month to stop having the dry cough. Saw PCP and was told that I probably have long COVID.
Report received by the mother of the patient on 03-Nov-2009. The patient, a 5-year old male received seasonal flu shot 5 months ago (??-Jun-2009) and developed cough and wheezing that same day. The symptoms lasted for about 1 week. The patient received H1N1 and experienced similar symptoms the same day which lasted about one week. The patient was also on concomitant VIVAGLOBIN for 5 months. The mother stated the MD is not aware of these reactions. Upon follow-up conversation with the mother (10-Dec-2009): Her son was vaccinated at the pediatrician's office and she provided the contact information. She confirmed her son received vaccination for both the seasonal flu and two doses of H1N1 at this office. The mother stated the purpose of her original call was not to report AEs to the vaccinations, but to request information about contraindications for vaccination since her son is on VIVAGLOBIN. We do not know if these were CSL products, and are awaiting information from the pediatrician's office. See related case 2009021784 (H1N1). The company assessed the event causality as unassessable in relation to the suspect drug, H1N1, as time to onset and date of administration were not known. Information derived from this AE report does not change the safety profile of the product.
This spontaneous report was received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were not specified. On unspecified dates, the patients were vaccinated with improperly stored ROTATEQ (lot # M019691 with expiry date 02-NOV-2017 and lot # L026076 with expiry date 25-MAY-2017, dose, strength, dose number, vaccination site, route not provided). The temperature excursions were reported as 1.6 C for 39 minutes on 09-AUG-2016, 0.6 C for 1 hour 40 minutes on 10-AUG-2016, 1.5 C for 55 minutes on 11-AUG-2016, 1.5 C for 1 hour 7 minutes on 28-AUG-2016. No adverse effect were reported. Product quality complain (PQC) was not involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
mouth, lips swollen w/in 4hr;throat getting dry;NKDA;has food allergies to eggplant & rubara;lips swell;had seafood salad for lunch;
Redness, warmth and swelling starting at injection site (right deltoid) and extending down forearm to elbow.
Vomiting that night with stomach pain, fever, achy-- for 48 hours, then upper left lip swelled approx 30 hours later, this lasted 24 hours. Appetite did not return until the third day.
uncontrollable crying several hr last 3 1/2hr;cry-sleep, crying;could not comfort by holding, walking etc;had lump @ site of shot which persisted p/pain subsided;
PT C/O TINGLING IN FINGERS, NUMBNESS IN THROAT, ANXIETY, AND SHAKING. BP 138/91 HR 72 SpO2 100% PT WAS GIVEN SOME CRACKERS. VS STABLE. MOTHER WITH PT. PT INSTRUCTED TO DIAL 911 OR GO TO THE NEAREST ER IF ANY CONCERNS OCCURRED ON THEIR WAY HOME. PT VERBALIZED UNDERSTANDING. PT WAS MONITORED FOR A LITTLE LONGER. PT LEFT AT 10:10 AM WITH NO SIGNS OF DISTRESS.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ERYTHEMA (arm red/redness size of a soccer), PERIPHERAL SWELLING (arm swollen), INFLAMMATION (arm inflamed) and SKIN WARM (arm hot to touch) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M2019) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included ADALIMUMAB, FOLIC ACID, CYANOCOBALAMIN (VITAMIN B 12), LEVOTHYROXINE, DULOXETINE, CITALOPRAM, POTASSIUM CHLORIDE, GLIMEPIRIDE, METFORMIN, METOPROLOL and CLONIDINE for an unknown indication. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), ERYTHEMA (arm red/redness size of a soccer), PERIPHERAL SWELLING (arm swollen), INFLAMMATION (arm inflamed) and SKIN WARM (arm hot to touch). At the time of the report, PAIN IN EXTREMITY (sore arm), ERYTHEMA (arm red/redness size of a soccer), PERIPHERAL SWELLING (arm swollen), INFLAMMATION (arm inflamed) and SKIN WARM (arm hot to touch) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment details included Benadryl and ice.
Patient was given flu vaccine on or about January 31, 2018. Onset of Guillain-Barré Syndrome (GBS) on or around March 5th. Symptoms included lethargy, diarrhea, vomiting and extreme lower extremity weakness that lasted approximately 10 days. Pt was admitted to hospital and treated with fluids.
Narrative:  patient received no treatment for ADR, just came back to clinic to show had redness and wanted it documented
died in the hospital; collapsed during practice; Initial information received on 27-Jan-2022 regarding an unsolicited valid social media serious case received from a consumer/non-hcp.  This case involves a patient of unknown demographics who died in the hospital and collapsed during practice while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE (formulation, strength, route: unknown) produced by unknown manufacturer lot number not reported in unknown administration site for flu.  On an unknown date the patient collapsed during practice (syncope) and died in the hospital (death) (unknown latency) following the administration of INFLUENZA VACCINE.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (collapsed during practice, died in the hospital).  At time of reporting, the outcome was Unknown for the event collapsed during practice and was Fatal for the event died in the hospital. It is unknown if an autopsy was done. The cause of death was reported as unknown. Seriousness criteria- Medically significant for all ( hospitalization , life threatening, fatal for death); Sender's Comments: Sanofi company comment for dated 04-Feb-2022: This case involves a patient of unknown demographics who died in the hospital and collapsed during practice while receiving vaccine INFLUENZA VACCINE..Based upon the reported information, the role of a vaccine cannot be assessed Further information regarding time to onset, cause of death, death date, autopsy results, concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case; Reported Cause(s) of Death: unknown cause of death
17 year old patient got vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient got vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient got vaccine). On 26-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient got vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant product details was not reported. Treatment details was not reported .   This case was linked to MOD-2021-068453 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow-up information received on 16 Jun 2021 contains non-significant information - Reporter Address and Patient demographic details were updated. On 19-Jul-2021: Follow-up information received on 19 Jul 2021 contains non-significant information, Patient confirms there were no other adverse event.
Tachycardia (HR 138 at rest) approximately 10 mins after receiving vaccine
This spontaneous report was received from a Registered nurse regarding a 16 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Patient received first Shingles dose 8-10 weeks prior. For 2nd dose, by evening and early next morning arm was a little more tender and sore than after 1st dose. Then left arm became more sore and developed tenderness in armpit--from armpit radiating to pectoral muscle. On next day felt malaise and took it easy but late that day had 100.9 fever; it was gone by the next morning. By 5/29 developed sore on lower lip on left side (the size of a nickel); area was initially swollen with lot of pressure, and very uncomfortable. Next day felt sore developing inside mouth even on the roof of mouth and gums were irritated. Patient tried to manage the sore are by putting peroxide and keeping it moist so it would not crack. During scheduled dental cleaning dentist confirmed that there were no nuclei on the blisters, no bleeding but there was inflammation, irritation and tenderness. Patient went back to pharmacist who suggested follow-up with doctor. Called doctor on 6/4 and they will call manufacturer; doctor  did not recommend a course of action yet. On 6/3, lymph node under jaw in right side tender and inflamed. Today tenderness under armpit subsided and only has residual tender spots. Patient notes that he has not had sores since he was a teenager.
Had slight sore arm then headache for 2 days not received by medication. At day 3 my arm was very sore and got worse every day to the point I couldn?t even lift my arm more then half way  i have also had a lump at injection site since vaccine was administered. On day 8 i could now lift my arm without pain but the lump in my arm had tripled in size and was now very itchy.
Varicella ordered, MMR drawn up in error but not given. Both vaccines stored in freezer.
My left arm started hurting where I got the shot but I thought nothing of it.  Within a week it became quite severe so I couldn't dress properly.  Pain radiates down my arm and up into my shoulder.  Went to the doctor 10/29/09 and he said arm is inflamed.  No treatment prescribed except ibuprofen for discomfort.
Patient states she had a lot of pain in arm, felt ill and arm was swollen, red and itchy. By the time she reported it (6 days after administration) she says she feels better but arm still red and swollen.
About a week after my vaccine, I had swelling and pain in the arm that I got the shot in. It was a little warm, red, swollen and it was painful. It was an area the size of my hand on my left arm. It encompassed the area of the shot. I visited a doctor who advised Tylenol and massage to help my arm. It lasted another five days. I got second dose 02/04/2021 032L20A in the other arm and it was sore for a few days but not like the previous shot.
Severe frontal, forehead, developed headache rapidly (headache) & I rarely have a headache, extreme tiredness, lightheaded, red & pain in eyes, weakness. Still am bothered by headache.
Pt. noticed redness, swelling of injection site within 4 hrs after receiving injection. Redness & swelling became worse over next 3 days, spreading down to elbow. Pt noticed cluster of blisters late Friday evening, located just under injection site, about 2-3 inches of area covered with tiny blisters. Pt began taking BENADRYL on Saturday, which slowly took redness, swelling down. Monday in office, blisters were crusted over.
Arm is swollen and puffy, extends length of arm, not painful at injection site, painful on arm,  swollen feels hot, used naproxen to treat twice, used iced, for day of and day after, and used ibuprofen .
The patient did not have any adverse reactions during the 15 minute observation, nor any reported the day of the vaccine.  Between his COVID diagnosis and the second vaccine, he had serval documented complaints of nausea, dizziness, body aches.  The patient had a virtual visit on 1/21/2021 for dizziness, nausea and fever.  At this time, these symptoms had been persistent for one month according to his medical records.  Patient later presented to the Urgent Care for with a fever of 103.1, rigors, nausea and cough. Patient admitted to hospital for sepsis.
The day that I received the vaccine, my arm started hurting. The pain grew over the next several days. It's been months and I still have pain in the arm that I received the vaccine. The doctor prescribed me medication, but I am still experiencing pain.
Patient had a brief fainting spell immediately after all the vaccines had been administered, along with complaints of nausea and extreme diaphoresis. EMS called to come to facility to assess patient. EMS found patient to have a blood sugar in the 70's after drinking 6.75 ounces of juice approximately 20 minutes prior. EMS administered IV Dextrose to patient, with immediate verbal response from patient "I feel much better". Patient left facility with parents AAO X 3, with no complaints,
the night of: nausea & vomiting, fever the next day: fever, body aches, decreased appetite, sensitivity to light, head felt foggy, tired 6 days after: full body rash in the form of a bunch of little dots appeared
Patient had vaccine given at her senior living apartment  by staff.  She reported to her PCP today that she has upper back and neck pain, left arm pain, and headache.  This started one week after the vaccination.  She has had to use biofreeze, ice packs, and Tylenol to treat the discomfort.  She did state that it is slowly letting up.
We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) 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 EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. No treatment medications were reported.
Valve stenosis from minor to moderate/severe; Chills; This spontaneous case was reported by a nurse and describes the occurrence of AORTIC VALVE STENOSIS (Valve stenosis from minor to moderate/severe) and CHILLS (Chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Patient had many allergies to medicines and products but did not specify which ones.), Stenosis aortic valve (Patient had a cardiac aortic valve stenosis prior vaccination and After vaccination she went to her Doctor and noticed that it went from minor to moderate/severe condition. Doctor said it happens with age and did not attribute it to vaccine.) and Thyroid disorder (She had a thyroid condition prior vaccination.). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and PRAVASTATIN for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-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 AORTIC VALVE STENOSIS (Valve stenosis from minor to moderate/severe) and CHILLS (Chills). At the time of the report, AORTIC VALVE STENOSIS (Valve stenosis from minor to moderate/severe) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered AORTIC VALVE STENOSIS (Valve stenosis from minor to moderate/severe) to be not related. No further causality assessment was provided for CHILLS (Chills).    Treatment information was not provided.   This case was linked to MOD-2022-536287.
Generalized tonic clonic seizure x 3, lasting 1-3 minutes within same day of getting DTaP, IPV, Hib, Prevnar, Rotateq vaccines.  06/09/2008 MR received for ER visit 4/30/08 with DX: Complex Febrile Seizure vs reaction to DTaP vaccination. MRs also received for DOS 5/9-12/2008 with D/ C DX:  Seizure, abnormal EEG and 5/20-21/2008 with D/C DX: Idiopathic Epilepsy. Pt 1st presented to local hospital with report of 2 generalized tonic clonic seizures at home 1 day s/p vax. Pt had 3rd GTC seizure in ER.  All lasted 1-3 minutes. Transfered to current facility for W/U which was (-). D/C home. Seen again 5/9/08 with 1 min tonic-clonic seizure with much slower return to baseline. 2nd seizure in ER with L eye deviation. Postictal at time of exam.  Neuro consult.  Started on Keppra. Seen again 5/20/08 for increased seizure activity despite meds. Dose Increased and D/C.