chrisvoncsefalvay/vaers-outcomes huggingface dataset:
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    190 patients (9 different lot numbers) received a vaccine past the beyond used by date.  It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration.  No concomitant medication was reported.  No treatment medication was reported.  This case pertains to the 10th patient of the total 190 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:CASE
On 2nd day: Very bad headache, almost fainted, took Tylenol (6/day of 500mg), drank fluids, blood pressure low. Better on day3, only slight headache. On 9th day: felt soreness in right calf muscle, no swelling or redness.  Thought it was due to low physical activity. No stamina.  Tire very easily and get sweaty upon little extertion On 10th day: felt sharp jabbing pain in chest when taking deep breath or yawning. No actual shortness of breath. On 11th day (today): decided to start taking full strength aspirin in case it is a blood clot.  Took 1 in a.m. 1 in p.m.
Woke up am 2/17 with burning-itching rash on my midrift.  By 2/26 it had spread &  was clearly nasty enough to go to doctors - diagnosed with Shingles . [ Had only taken the old shingles vaccine - moved/changed doctors, never realized there was a new better one to take now.]  Did not realize I should report it to you til saw Dr  this week, she instructed my to report it.
It was reported that a 2 month old female received a Tripedia, an ACTHIB and an IPOl vaccination on 02/22/00. Reportedly on 02/23/00, a knot formation developed at the injection site of the right thigh. From mailed follow up correspondence received on 06/19/01, it was stated that the patient recovered from this expereince. Additional patient, vaccine, resaponsible physician and vaccine administrator informatioin was provided. "No further information available regarding this patient or this case." This case is closed.
Slight headache, feeling extreme tiredness fairly suddenly, saying ?I feel  like I could pass out? and then passing out. Slight movement of mouth for air, some drooling.
pt recvd initial vax 9OCT84 & another dose 25JAN91 & had mumps titer done 23MAY91 IgM 0.22; IgG 3.65 seen 19MAY94 w/ rt parotid gland swelling dx mumps;
Swollen arm, redness, rash; continues headaches, loss of taste, chest pain, fatigue, joint pain, back pain, abdominal pain, loss of appetite.  Due to my Raynaud's; I experienced 5 Raynaud's attacks which were long and painful. Usually I have one every 4 - 5 months.
Syncope. Vasovagal episode, felt lightheaded. Loss of consciousness < 10 seconds while sitting. Prior history of vasovagal episodes with needles. Vital signs within normal limits.
2d Dose of vaccine received Feb 22 - Monday.  On Wed evening around 10:15 my arm started itching.  Next day - Thurs after getting out of the shower I noticed a bright red blotch on my arm just below my injection, but not itching.  Next day Fri, it was still bright red and a little larger.  Sunday morning it was still there and still bright red.  I measured the area and it was about 2 1/2 inches long and a little over 1 inch wide. as of Sunday night I still have the rash it doesn't seem as bright but it has spread a little more in length and width.
Pt called a week later and complained of arm aches/pains and that she couldn't get out of bed for 1 day after shot.
A non-serious report of administration of expired FluMist has been received from a nurse concerning a nine-year-old female. Neither medical history nor concomitant medications were provided. The patient received FluMist on 12-Mar-2008. The FluMist had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FluMist from the Vaccines For Children Program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. The patient had no adverse events at the time the report was received, neither as of 18-Apr-2008 when the office was contacted for follow-up information. The event has resolved. It was not whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow-up information received 18-Apr-2008 and incorporated into the narrative: no adverse event occurred. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006659; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.
Documented at 837am and was jerking motion and incoherent x 30 seconds. nausea w/emesis followed. Pt treated with Zofran IV, 200 cc NS. Blood glucose checked and was 226. Dr. was notified. Pt was stable on discharge and was discharged to home. Patient admitted next day with diagnosis of Pneumonia.  MD not sure if any correlation.  Patient already had existing issues with multiple recent hospitalizations.
nurse pull the syringe out and the liquid flow out.; a lot of blood came out after administration; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's mother) reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 15Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included autism spectrum disorder, muscle tightness. The patient's concomitant medications were not reported. The consumer called in to ask about the amount of vaccine administered for the first dose and if it is the same for the second dose. She mentioned that her son with autism and tight muscle, got the first dose of the vaccine today (15Apr2021). She was worried if all of the dose was administered because she saw the nurse pull the syringe out and the liquid flow out. She also mentioned that a lot of blood came out after administration that they had to wipe with a cotton ball and that the needle used was big unlike when they got their first dose. She wanted to know if there was an antibody test to check if the vaccine was properly administered.  The outcome of events was unknown.    No follow up attempts are possible, information about lot/batch number cannot be obtained.
HEADACHE; DIARRHEA; SWEATING; NAUSEA; CHILLS; FATIGUE; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included dust allergy, mite allergy, and pollen allergy, and other pre-existing medical conditions included patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with amoxicillin/clavulanic acid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 to Left Deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced fatigue. On 07-MAR-2021, the subject experienced nausea. On 07-MAR-2021, the subject experienced headache. On 07-MAR-2021, the subject experienced diarrhea. On 07-MAR-2021, the subject experienced sweating. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and headache on 07-MAR-2021, was recovering from fatigue, and had not recovered from nausea, diarrhea, and sweating. This report was non-serious.
rash on my hands that is continuing to spread and worsen; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on my hands that is continuing to spread and worsen) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 experienced RASH (rash on my hands that is continuing to spread and worsen). At the time of the report, RASH (rash on my hands that is continuing to spread and worsen) outcome was unknown.            No concomitant medication was reported. No treatment was reported.
pain, swelling & redness appeared @ inject site a few hrs p/administration of vax;
rash feels warm to the touch; big bullseye rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (rash feels warm to the touch) and VACCINATION SITE RASH (big bullseye rash at injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (rash feels warm to the touch) and VACCINATION SITE RASH (big bullseye rash at injection site). At the time of the report, VACCINATION SITE WARMTH (rash feels warm to the touch) and VACCINATION SITE RASH (big bullseye rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant history was not reported. The treatment history was not provided. Patient also reported events like  "does not hurt", "is in her left arm".   This case was linked to MOD-2021-298374 (Patient Link).
Localized Reaction R upper arm circular erythemic rash with multiple small vesicles within erythemic area; are measured 4 cmx4cm in diameter. Pt experienced this reaction on Saturday morning 9/25 after receiving vaccines on Friday 9/24/21.   See attached Pt. was prescribed Prednisolone  15mg/5ml  oral solution 6.5ml's BID x 5days  & instructed to take childrens Benadryl  12.5 chewable tablet  every 6 hours PRN. Pt also advised  to apply  cold compress to reaction site. Discussed if  cold compress does Not help may use warm compress  3-4 times daily.  Mither and Grandmother verbalized understanding of tc plan  & was advised to follow up in office with Dr. if symptoms persist, no improvement.
brain fog; Tiredness; Spike in blood pressure/High very high Blood pressure, needed treatment to bring down 210 over 109.; immediately ringing in ears; Facial stiffness; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm (reported as left shoulder) on 29Mar2021 09:30 (Batch/Lot Number: ER8730) (at the age of 57-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid-19 prior to vaccination and has not been tested for covid-19 since the vaccination. The patient had no relevant medical history and no known allergies. There were no concomitant medications. On 30Mar2021, the patient experienced spike in blood pressure, immediately ringing in ears, and facial stiffness. On 31Mar2021, the patient experienced brain fog and tiredness. It was further reported that after tracking O2, blood pressure, heart rate and exercise for one and half years with all being under normal, the patient almost immediately had ringing in ear, facial stiffness, high very high blood pressure, needed treatment to bring down 210 over 109 (blood pressure medicine). The events spike in blood pressure, had ringing in ear, and facial stiffness were considered as serious important medical event. The events spike in blood pressure, brain fog and tiredness resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood pressure measurement: normal in 2020, blood pressure measurement: needed treatment to bring down 210 over 109 in 2021, heart rate: normal in 2020, oxygen saturation: normal in 2020, and physical examination: good (released for sports) on 30Sep2020. Therapeutic measures were taken as a result of all events. The patient received the second dose of bnt162b2 administered in left shoulder on 19Apr2021 09:30 (Batch/Lot number: EW0153). The patient was recovering from spike in blood pressure, immediately ringing in ears, and facial stiffness while outcome of brain fog and tiredness was not yet recovered.  Follow-up attempts are completed. No further information is expected.
My mom had high d dimer she had stroke they gave her heparin she had more stroke and stomach bleed
This spontaneous report as received from an other health professional refers to a patient of unknown age. On an unknown date, adult patient was vaccinated with RECOMBIVAX HB of strength 5 Microgram/0.5Milliliter pediatric vaccine (dose, route and frequency were not provided). No concomitant medications were reported. No adverse effect reported. Outcome was unknown and causality was assessed as not related. Additional information is not expected.
Peripheral angio-edema (swelling); Pruitus (itching); Shortness of breath.
3 year old consumer getting a partial dose of Fluzone Quadrivalent; Initial information received on 17-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 3 years old male patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and reported that 3 year old consumer getting a partial dose of Fluzone Quadrivalent (accidental underdose).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 15-Sep-2019, the patient received a dose of suspect 0.5 ml INFLUENZA QUADRIVAL A-B VACCINE lot UJ243AD and expiry date: 30-Jun-2020 via intramuscular route in the left deltoid.  It was a case of actual medication error due to accidental underdose.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none
had bleeding pretty bad on the injection site; injection site bruising; pain on the injection site and tenderness; Initial information received on 30-Sep-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 72 years old female patient who had bleeding pretty bad on the injection site, injection site bruising and pain on the injection site and tenderness while receiving vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Sep-2022, the patient received a  dose of 0.5 ml of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (formulation, strength: unknown) lot number not reported via intramuscular route in the left arm as Immunization.Batch/lot number requested.The patient did not used the product for the first time.  On an unknown date in 2022, the patient had bleeding pretty bad on the injection site (injection site haemorrhage) injection site bruising and pain on the injection site and tenderness (injection site pain) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Patient called to inquire if she gets completed immunity or if the FLUBLOK administered to her was effective as she mentioned she did not get the expected effects of the vaccine when it was administered previously such as pain on the injection site and tenderness. Patient mentioned she thiought that the person who administered the vaccine does not know what she was doing as she had bleeding pretty bad on the injection site as well as bruising that was still present after 2 weeks of vaccine immunization which she did not have previously. Patient said that she was not even asked to stay after the vaccination and was asked to leave as soon as possible. Patient was concerned that she did not get the immunity she should get from the vaccine given. Patient also said that she thought that they need to change the needle to a pediatric needle as she was only 100 pounds.   Action taken was not applicable.  Corrective treatment for the events: None   At time of reporting, the outcome was unknown for all.
angioedema; swelling of lips; numbness in tongue and mouth; This is a spontaneous report from a contactable other hcp.  A 56-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular on 16Mar2021 09:30 (Batch/Lot Number: EP7534) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient was not pregnant. No Known allergies. The patient took other medications (many, none new) in two weeks. The patient experienced angioedema, swelling of lips, numbness in tongue and mouth on 16Mar2021. The AEs resulted in Doctor or other healthcare professional office/clinic visit. The patient received zyrtec and allegra and epi pen for prn use. No covid tested post vaccination. The outcome of the events was recovering.  No follow-up attempts possible. No further information expected.; Sender's Comments: Based on the compatible temporal association and the product's known safety profile,  there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the event angioedema. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Not long after leaving,  I began feeling stiffness in  the back of neck, similar to what I would  feel  prior to a migraine coming on.   By the time  I had arrived at the house my head was pounding.   I was feeling  a dizzying  migraine.  I have not had one of those in a  while.  It was also accompanied with lite nausea.  I had a cup of coffee when I came home and went to bed.  I was feeling so bad I had to get up  and take a Sumatriptan and another cup of coffee.  I laid back down for a few more hours.  I awakened later,  used the restroom  and was feeling much better than before.   Although my arm and shoulder is sore at the injection site,  I?m feeling much better.
01:15 am on 03/16/2021:  Began with chills, muscle aches, headache, body temperature 95.7F.  Rapidly developed fever at highest 101.1F.  The swing in body temperature occurred within 20 minutes.  Continued .  Temperature upon awakening at 08:15 am on 03/16/2021 was 99.1F.  Occasional chills and low grade fever continued through that Tuesday.  I mostly stayed in bed.  Developed soreness and heat around the injection site.  I slept through until 2:00 pm. Wednesday afternoon and had considerable dizziness on arising.   At 3:00 pm on Wednesday, I had a sudden  nosebleed, my first ever.  Bleeding was under control in about 30 minutes.  This was my first ever nosebleed.  At night when retiring to bed my gums bled with brushing...unusual.
ACUTE GASTROENTERITIS; A spontaneous report has been received from a consumer. The report concerns a female patient of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v), via nasal route, on an unknown date.     No malfunction has been reported for FLUMIST QUADRIVALENT.    On an unknown date, the patient experienced acute gastroenteritis (preferred term: Gastroenteritis).     The outcome of the event was unknown.    The event was considered non-serious.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Product Role: Suspect
Flushed, low fever, hands shaking, continuous nausea, muscle aches, spacing out, decreased appetite (now no appetite), sleep twitches, sleeplessness (no sleep), stomach pain for 5 months and ongoing. Since 11/01, been to doctor 15 times and he is now on meds to help bring him up, meds for nausea and meds for sleep.
Fever 102.5 and above 9pm over 24 hours  Body aches all over SAA ongoing
About a week after injection, arm felt warm, just below injection area.  Rash appeared on most of upper arm and red, hot sore lump noticed(about 1.5 inches by 2 inches). Within 2 days,  red spot on arm doubled in size. Area is tender to touch and surface skin is itchy.
I seen the doctor the day before and had joint pain. I was having problem picking things up. Her neck was tight.  Got the booster on Tuesday and it kicked her butt. Had joint pain, achy skin, hurt all over, fatigue, fever, and even muscle pain. Trying to raise the right arm it really hurt especially lifting. Really tight from neck to lower truck. Still going to physical therapy.
Pain in all fingertips with red sunburn-like appearance, white on some tips, generalized joint pain,  shingles-like rash on back.  Increased gabapentin to 300 mg daily for 7 days; keep hands warm and do warm water soaks to ease pain, labs drawn, will f/u in one week if s/s have not improved.
24 hours after vaccine administration pt broke out in full body rash/hives. Pt took ZYRTEC and rash resolved without problems.