chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On 20-AUG-2014, patients were vaccinated with a dose of PEDVAXHIB (lot number K004541, Expiry date 04-DEC-2016, dose and route were not reported) that was improperly stored at 48F for 39 minutes. Concomitant medications were not reported.  No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
A hard knot appeared at the injection site the day of the injection and the arm was sore but not red for 1-3 days. On day 4-6 the injection site became itchy on day 8 the patient reported that the sight became very red and swollen and ached. The span of redness was 10-11 inches
Information has been received from a physician concerning a 31 year old female who in 2002 was vaccinated with first and second doses of varicella virus vaccine live (Oka/Merck) which were given one month apart. Subsequently the patient's IGG antibody test was negative. Unspecified medical attention was sought. There was no product quality complaint involved.  Additional information has been requested.
but had a slight headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "but had a slight headache".  Additional Information: Patient stated that after the first dose had a little stronger side effects compared to what everyone was telling her. Patient did not have a fever but had a slight headache but it was minimum and went away in 10 hours and did not have it the next day.
Pt reported severe chills and all over body aches/shooting pains beginning about 12 hrs after vaccine given & lasting about 24 hrs.
This non-serious initial spontaneous case, was received from a Pharmacist on 23-Oct-2017, concerning an elderly female patient of 68 years. On 30-Aug-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left Deltoid, batch number: 178301, expiry date: Apr-2018). On an unspecified date (between 02-Sep-2017 to 03-Sep-2017), the patient developed "indention" (like a hole) on her arm where injection was given. She had a dimple greater than a quarter dollar coin in the site of the indentation. She went to her physician and he said he had never seen a reaction to a flu vaccine like that and no treatment was recommended for the same. Patient also mentioned that the physician had confirmed the described reaction was from the flu shot. On an unknown date, the patient also experienced headache since she got the vaccine and never had headaches before. It was reported that the patient still had a scar. The indentation had not gone, and the patient kept visiting to the pharmacy to seek advice. The reporter stated that the patient did not receive any treatment measures for the events. At the time of this report, the patient had not yet recovered from the event. The reporter assessed the event as non-serious. Follow up received from the reporter on 14-Nov-2017: Updated age of the patient, added event headache and reporter's comment. Accordingly, updated narrative.
HAD EXTREME STOMACH CRAMPS FOR MANY HOURS WITH SOME NAUSEA FOLLOWD BY FEELING VERY COLD WITH EXTREME CHILLS, HOT SKIN, AND LATER EXREME SHAKING ALL HAPPENED IN THE EVENING WOKE IN THE MORNING W/HEADACHE NOTE HUSBAND RECEIVED SAME VACCINE AT SAME TIME WITHOUT REACTIONS
pt exp t106 & given APAP; temp remains 106 R given tepid bath; temp remains 106;
Swollen arm at injection site. After day 8, itching, warmth, and redness started at injection site. Rash grew bigger. Malaise. Treated for cellulitis.
had 1st dose of covid vaccine. After vaccine had gotten covid; had 1st dose of covid vaccine. After vaccine had gotten covid; This is a spontaneous report from Pfizer-sponsored program, from a non-contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (lot number and expiry date: unknown) as dose 1, single, for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On unspecified date, after the first vaccine, the patient experienced Covid. Patient wanted to know if he can get the 2nd dose. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a consumer concerning her daughter who in August 2007, was vaccinated with her first dose of Gardasil vaccine. The patient experienced dizziness and nausea right after receiving the first 0.5 mL dose. She recovered 10 to 15 minutes after it started. On 22-OCT-2007 the patient received her second dose of Gardasil vaccine. On 28-OCT-2007  the patient developed swelling at the injection site. It was painful to the touch but it is not red and does not look infected. The swelling has gone down since it started. The patient's outcome is unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2007. Information has been received from a consumer concerning her daughter who in August 2007, was vaccinated with her first dose of GARDASIL vaccine. The patient experienced dizziness and nausea right after receiving the first 0.5 mL dose. She recovered 10 to 15 minutes after it started. On 22-OCT-2007 the patient received her second dose of GARDASIL vaccine (lot# 659435/1265U). On 29-OCT-2007 the patient developed swelling at the injection site an on 30-OCT-2007 slight redness. It was painful to the touch but it is not red and does not look infected. The swelling has gone down since it started. The patient has recovered. The doctor feels the dizziness was not related to the shot. Additional information has been requested.
past 36 days since receiving first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (past 36 days since receiving first dose) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (past 36 days since receiving first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (past 36 days since receiving first dose) had resolved. Not Provided          No treatment or concomitant medication were reported
Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.
Reddish Wheal at injection site; Itching at injection site; Tender at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Tender at injection site), VACCINATION SITE ERYTHEMA (Reddish Wheal at injection site) and VACCINATION SITE PRURITUS (Itching at injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concomitant products included METFORMIN, LOSARTAN, HYDROCHLOROTHIAZIDE and ALLERGY MEDICATION for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 16-Mar-2021, the patient experienced VACCINATION SITE PAIN (Tender at injection site). On 18-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Reddish Wheal at injection site) and VACCINATION SITE PRURITUS (Itching at injection site). At the time of the report, VACCINATION SITE PAIN (Tender at injection site), VACCINATION SITE ERYTHEMA (Reddish Wheal at injection site) and VACCINATION SITE PRURITUS (Itching at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Acute allergic reaction with erythema, diffuse rash on face and upper torso. BP-stable; no wheezing, (+) SOB and chest tightness.
Patient has had redness and inflammation in arm of vaccination when receiving a flu shot once in the past.  This was a few years ago, and did not happen with repeat flu vaccine.  Patient was vaccinated on 11/3/22 in the afternoon.  She noticed swelling beginning on 11/4/22 while showering.  Redness in arm went down past her elbow and almost to her wrist.  She did not have pain, but mentioned that the redness almost looked like a rash.  First time I spoke with patient after the vaccination on 11/3/22 was on 11/8/22, redness and slight swelling was 98% better according to patient.   Redness and swelling improved without intervention.
1/7/21 @ 16:25 Dizziness, headache, nausea. Epinephrine administered
Diarrhea..... ongoing Hives on injected arm....ongoing Nausea....first 4 days after injection No treatment done as of yet
Day after visit for vaccine receipt started with rash and seen in clinic by me following day (2/23/17) and diagnosed with erythema multiforme.
Fever up to 102.2 for 3 days and scant flesh colored rash on cheeks.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CAD" (unspecified if ongoing), notes: Other medical history: CAD; "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Continued to test positive for a week and a half; (2022) Negative, notes: Got negative test after about 2 1/2 weeks total; (Aug2022) Positive, notes: Now again symptomatic and positive for COVID about three weeks later. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID treatment was reported as yes. Other medication in 2 weeks reported as Yes. Antiviral product for COVID 19 Started on date 23Aug2022 and stop date given as 28Aug2022. Other medication in 2 weeks product reported as Atorvastatin. Rebound COVID. Finished Paxlovid course. Got mild rebound in symptoms. Patient had no Known allergies  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 7JAN98 & 2 or 3 more pox were noted;pt recovered;
some one tell me its create complication like elergic reation; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (some one tell me its create complication like elergic reation) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (some one tell me its create complication like elergic reation). At the time of the report, HYPERSENSITIVITY (some one tell me its create complication like elergic reation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided Treatment information was not provided
This initial spontaneous report was received from a physician referring to a 8 week-old female infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 01-SEP-2015 at 10:24 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received.
This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 22-JUN-2016, the patient received the first dose of ROTATEQ vial (lot # M005733 with an expiry date of 01-OCT-2017 and dose not reported) and then the second dose of vaccine on 19-JUL-2016 (lot # M005733 with an expiry date of 01-OCT-2017 and dose not reported) orally (inappropriate schedule of drug administration). No adverse event was reported. There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
No additional AE's; temperature excursion on GARDASIL 9; This spontaneous report was received from a nurse prescriber and refers to a 18-year-old male patient. There was no information about the patients concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 26-APR-2021, the patients were vaccinated with improperly stored doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # S031287, expiration date 08-APR-2022 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine was stored in the temperature of 0.18 degrees Celsius for 3 hours and in temperature of 8.69 degrees Celsius for 30 minutes. Data logger was involved. There were no previous excursions 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 Sharp & Dohme Corp.; devicelotnumber: S031287; expirationdate: 08-APR-2022; 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
Fever ranging from 99.3 to 101.6 so far. Body aches, joint pain, chills, fatigue
In the afternoon I felt disabled and I couldn't walk and my MS started 5-10 years ago but I've never had that before until suddenly after booster vaccine. It was about 1-2 hours after booster vaccine. I went to walking and I noticed I could not walk. It lasted all day and the next day I had an appointment with my Doctor and I told him about it and he said that I was okay.  It gradually became better after a couple of days and I did not take any medication, only went to the infusion center for my MS. This is still ongoing.
After being vaccinated patient became pale and diaphoretic while sitting in chair, patient fainted and was unconscious for approxmiately 60 seconds.  Patient's feet were elevated, cold compress was applied to the back of his neck and he was given small sips of orange juice.  Patient remained in recovery position for approximately 10 minutes and was able to sit and then stand without dizziness, ambulated out of immunization clinic without problems.
Headache, Nausea, Lethargy as expected.  But then EXTREME joint pain, EXTREME muscle pain (not aches) unrelieved by Ibuprofen. Tramadol was needed every 6 hrs PRN.  Swelling under armpit, not in armpit, lateral to left breast. Hard & warm to touch. Also, currently being monitored for symptoms of cellulitis under injection site. Red, swelling, itching & hot to touch.
Month long diarrhea and excessive vomiting after every meal (he is exclusively breastfed).
Patient received vaccine and sat in monitoring area and fainted about 1 -2 minutes after receiving vaccine.  She became alert quickly but stayed on the floor resting and she was given cold water.  She reported feeling ok; however, an ambulance was called because when asked is she wanted an ambulance she said she was unsure.  She walked out of the store under her own power but took the ambulance to a nearby hospital as a precaution.
spinning feeling upon rapid movements or rising up; dizziness; vertigo; tired and achy; tired and achy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS POSTURAL (spinning feeling upon rapid movements or rising up), DIZZINESS (dizziness), VERTIGO (vertigo), FATIGUE (tired and achy) and MYALGIA (tired and achy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concurrent medical conditions included Multiple sclerosis. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for Attention deficit disorder, GLATIRAMER ACETATE (COPAXONE) for Multiple sclerosis, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) and FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000).   On 06-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced FATIGUE (tired and achy) and MYALGIA (tired and achy). On 11-Apr-2021, the patient experienced DIZZINESS POSTURAL (spinning feeling upon rapid movements or rising up), DIZZINESS (dizziness) and VERTIGO (vertigo). At the time of the report, DIZZINESS POSTURAL (spinning feeling upon rapid movements or rising up), DIZZINESS (dizziness), VERTIGO (vertigo), FATIGUE (tired and achy) and MYALGIA (tired and achy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information provided.
Pt stated he had never received Flu shot injection. Denied allergies to eggs ant themerisol. Explained potential side effects. Pt received shot, stayed with me for 15 minutes then went back to desk. Returned 10 min. later with c/o feeling "jittery" and sweaty and might pass out. BP and pulse taken 152/90 and 60 pulse stayed with pt. Took BP and pulse again 140/82 pulse 64.
Itching behind knee caps, both legs, ribs under armpits, whole back itching and redness all over body and got really bad itchy when he got home but it went away after a few hours with no treatment.
Extreme chills, headache, runny eyes.  Uncontrollable shaking for 4 hours (until 2 am 12/18/13).  Had an electric blanket turned on to 9 for 4 hours.
shivering; soreness at injection site; warm feeling; tired; headache; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st August 2019, the patient received the 2nd dose of Shingrix. On 21st August 2019, less than a day after receiving Shingrix, the patient experienced shivering, injection site pain, feeling of warmth, tiredness and headache. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the shivering, injection site pain, feeling of warmth, tiredness and headache were unknown.   It was unknown if the reporter considered the shivering, injection site pain, feeling of warmth, tiredness and headache to be related to Shingrix.  Additional details were provided as follows: The patient received vaccine and she had soreness at the injection site. Later the patient experienced shivering, warm feeling but without fever, tiredness and a headache. The patient had taken tylenol and she was feeling better. The reporter consented to follow up.
Yesterday - nausea (thought I was going to have to run out of a meeting), right arm pain, chest heaviness, fingers numb, metallic taste in my mouth... before the metallic taste I thought maybe I was having a heart attack, then I remembered that earlier in the day I received a flu vaccine. Today - hurts to move fingers, especially thumb and into palm of hand - everything else the same except no metallic taste this is day 2 - symptoms should be resolving. They are not. Nausea has returned.
No adverse event occured but patient needed a tetanus vaccine as a result of an injury and the patient had receive a covid vaccine on 3/23/21
my throat starting getting tight and was dry; my throat starting getting tight and was dry; This is a spontaneous report from a contactable consumer (patient). A 69-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EP7533, expiration date was not reported), via an unspecified route of administration, administered in right arm on 11Apr2021 13:15 (at the age of 69-years-old) as dose 2, single for covid-19 immunization. The patient medical history was not reported. Concomitant medications included omeprazole (20 mg), escitalopram (10 mg), simvastatin (40 mg). Other medications patient received in two weeks included omeprazole 20mg, escitalopram 10 mg, simvastatin 40mg. The patient historical vaccine included first dose of BNT162B2 (Lot number: EN6207, expiration date was not reported), via an unspecified route of administration, administered in right arm on 14Mar2021 01:00pm (at the age of 69-years-old) as dose 1, single for covid-19 immunization. Patient did not receive other vaccine in four weeks. The patient does not have any allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that on 11Apr2021 01:15 PM, on second shot - Within 10 minutes her throat starting getting tight and was dry. EMS checked her heart rate and listened to her heart. She waited an additional 30 minutes before they had her leave. Symptoms stayed for about 3 hours and went away. The patient underwent lab tests and procedures which included heart rate: unknown results on an unspecified date. No treatment was received for the adverse event. The outcome of the events was recovered on an unspecified date of 2021.  No follow-up attempts are possible. No further information is expected.