chrisvoncsefalvay/vaers-outcomes huggingface dataset:
21 yo male states he had reaction to 1st covid vaccine. Within 2 hours of vaccination developed rash on chest and SOB. Never sought care.  Sent to allergy for possible med exemption. Allergy did exemption 11/16/21 after shared decision making but 2/14/21 allergy note says patient decided to get J&J vaccine off post.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 as dose 4 (booster), single (Lot number: GJ3Z76) at the age of 33 years, in left arm 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 07Sep2023 to 11Sep2023.
PRETTY BIG HEADACHE; NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced pretty big headache, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pretty big headache and nausea was not reported. This report was non-serious.
pt recv vax 19APR95 & 3-4 days later pt exp a cough & cold sx;pt was seen by MD for green phlegm;MD prescribed unspecified ATB & erythromycin;
PT VERBALLY STATES HE RECEIVED PRIME AND BOOSTER DOSE OF MODERNA COVID 19 IN DALLAS WITH LAST DOSE ADMINSITERED ON OR ABOUT 03-28-2021. PT TESTED POSITIVE FOR COVID 19 DISEASE 08-11-2021 PCR AND IgG POSITIVE.
Pt vaxed 12MAY92 woke up 14MAY92 w/red, swollen lt upper shoulder, midway down to elbow; area swollen, red,  warm; sensitive to touch; advise mom to apply warm, wet cloth today; follow by cool cloth tomorrow;
fever(low grade)noted on Monday (6-25) cranky with temp 100.4-101.4 on Wed. x 4-5 loose stools noted since Monday, bloody specks noted in stools on Wed, worsened on Thurs AM (6/28) stooled X 12 throughout evening, MD eval on 6/28
felt like if I was going to pass out; whole body started feeling warm all over from my legs up to my head; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported) via an unspecified route of administration administered in the Left Arm on 25Mar2021 12:45 as a single dose for COVID-19 immunization. Medical history included gastritis. The patient was not pregnant at the time of vaccination. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine and no other medications received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. On 25Mar2021, within minutes after the vaccine, the patient's whole body started feeling warm all over from her legs up to her head and she felt like as if she was going to pass out. After 15 minutes it went away completely. No treatment was given in response to the events. The outcome of the events was recovered on 25Mar2021. The patient has not been tested for COVID-19 since vaccination. The reporter assessed the events as non-serious.   Information about lot/batch number has been requested.
Itchy tongue. Post menopausal bleeding.  I have itchy tongue since vaccine for 5 months diagnosed today with thrush. Have autoimmune disease and started 3 days after injection
A report has been received from a Health Professional concerning a 3 year old, male subject, who had been receiving FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 26-Dec-2013. The health professional reported that they inadvertently administered expired FLUMIST which started on 26-Dec-2013. The outcome of the event of EXPIRED FLUMIST ADMINISTERED is unknown. The report was considered to be non-serious.
Itching began after first dose on 05/17/2021 and then rash began after 2nd dose on 06/07/2021, rash and bumps are on upper arms, bumps are prevalent  on back and other parts of body
pt recvd 1 dose of Engerix-B 10JUL92 exp chest tightness & SOB; seen by MD; cxr nl; wheezing detected; treated for bronchitis; dx was bronchospasm;
Employee C/O pain, redness, swelling, itching,  and heat to vaccination site. Employee applied ice to area, and store bought allergy medication for the itch.
This case was reported by a pharmacist and described the occurrence of elevated liver function test in a subject of unspecified age and gender who was vaccinated with hepatitis A vaccine inactivated (Havrix) for prophylaxis. On an unspecified date in either 2000 or 2001, the subject received a dose of Havrix, (dose number and lot number not provided. At an unspecified time after vaccination with Havrix, on an unspecified date in either 2000 or 2001, the subject was hospitalised for 5 days. The outcome of the events was not reported. Report received via manufacturer.
Fatigue; headache; This is a spontaneous report from a contactable other hcp via a sales representative. A patient of unspecified age and gender received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that after the first dose, the patient felt fatigue and headache immediately following the dose, but it resolved in about 1/2 day. Outcome of the events was recovered.  Information about lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Red, warm area around injection site, about 3 inches in diameter that did not resolve when an ice pack was used.  No systemic fever or chills, redness elsewhere.
Small balls on feet; This is a spontaneous report from a contactable consumer (patient). A 80-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN0164, Expiration date and NDC number was unknown), via an unspecified route of administration, administered in left arm on 07Jun2021 as dose 1, single (at the age of 80-years-old) for COVID-19 immunisation. Medical history included deep vein thrombosis (DVT), thrombosis right leg (had this twice when she was 50-55 years of age) from an unknown date and unknown if ongoing. The patient had not received any other products/concomitant medications. Patient had no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient's family medical history relevant to adverse event was not reported. On 07Jun2021, patient had a reaction to it and stated that she doesn't know how to explain it, but it was like small balls on her feet. Duration of the event was 6 days and then symptom passed. Patient denied any medications, labs, testing, or treatments relevant to event. Patient had no emergency room and physician office visit for the event. The outcome of the event was recovered on 13Jun2021.
C/o muscle aches, calf cramps, (B) feet numbness, cough, nausea, diarrhea, all began after #2 vaccine. No problems with #1 vaccine  Tx antiemetic, H2 blocker, anti histamine, Tylenol push fluids
swelling and redness of arm to elbow Pain at injection sight headache fatigue nausea
Patient booked an appointment and requested the booster shot of the Janssen vaccine.  However, the wrong vaccine was administered.  Patient was given the booster dose (0.25ml) of Moderna.   No adverse reaction was observed after the shot during the patient's stay in the pharmacy.
He had a high fever 4 days after getting the vaccines on 11/26/2008.  He was not as alert as he usually was, he had diarrhea, acted as though he didn't know how to suck a bottle, swelled, 1 week before he died I took him to the hospital on 12/20/2008 for wheezing, hard time breathing, fever, coughing severely. They said it was a respiratory infection.  I had taken him to the hospital and doctors office for the same reasons numerous times prior to that last visit. They kept telling me there was nothing wrong with him, but I knew there was. He died 12/27/2008. 7/14/09-autopsy report received-COD-positional asphyxia.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 1:49 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 1:44 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Batch number 019B21A underwent temperature excursion on 27-Mar-2021 with temperature 35 degrees Fahrenheit at 09:00 and 10:00 am. Total 20 vials were moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021.  Batch number 014M20A underwent temperature excursion on 27-Feb-2021 with temperature 35 degrees Fahrenheit at 01:00 PM. Total 20 vials were moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.   This case was linked to MOD-2022-566976 (Patient Link).
Complained of itching eyes and wheezing. No rash. Noted with diffuse expiratory wheezing.  Given Benadryl and Solumedrol with resolution of symptoms. O2 sat 98%.
Two days post vax, this pt eyes began tearing and became red, irritated, and "wrinkled."
Woke up and turned over in bed  to the left side and the room was moving in a circle/spinning.  Turned back over on the right and it was still spinning, but to a lesser extent.  This subsided after a few minutes, but my head felt weird the rest of the day, not quite a headache, but maybe slight pressure.  The next morning, the same thing happened, but then felt dizzy/lightheaded the rest of the day.  Had chills.  Minor temp at 99.1.  Very fatigued.  Symptoms began to improve on 4/10/2021 with feeling 98% back to normal on Monday 4/12/2021.  Still feel a bit off.
had the vaccines / now have shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via (Shingrix interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included gingival operation (4 weeks ago). Previously administered products included anesthesia (4 weeks ago).   On an unknown date, the patient received Shingrix and Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had very intensive and intrusive oral (gum) surgery that involved lots of anesthesia 4 weeks ago. The patient stated he/she had Shingles vaccines and had shingles under right arm close to the arm pit. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
aches and pain; fever; lingering headache; lingering nausea; This spontaneous case was reported by a patient and describes the occurrence of PAIN (aches and pain), PYREXIA (fever), HEADACHE (lingering headache) and NAUSEA (lingering nausea) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu vaccine in September 2021. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Asplenia (15 years ago), Idiopathic thrombocytopenic purpura and Immunocompromised.    On 12-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Sep-2022, the patient experienced PAIN (aches and pain), PYREXIA (fever), HEADACHE (lingering headache) and NAUSEA (lingering nausea). On 13-Sep-2022, PAIN (aches and pain) and PYREXIA (fever) had resolved. At the time of the report, HEADACHE (lingering headache) and NAUSEA (lingering nausea) had not resolved.            Concomitant products were not reported.  It was reported that patient did not have any allergies to medications, food and other products.  Patient received Moderna 1st dose on 06-Jan-2021, lot number - 012L20, 2nd dose on 02-Feb-2021, lot number - 010M20A, 1st booster dose on 19-Aug-2021, lot number - 049E21A, 2nd booster dose on 28-Mar-2022, lot number - 066K21A. The event did not cause the patient to seek medical care. The symptoms are still lingering.  Treatment medications were not reported.   This case was linked to MOD-2022-647031 (Patient Link).
Information has been received from a lawyer regarding a case in litigation concerning a male (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. In 2016, the patient was treated at a medical facility for a blistering vesicular outbreak, which was diagnosed as 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 significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Woke up half body numb, numbess went away and then I started feeling nausea. I started to vomit several times. I had a migraine headache. I went to the hospital everything checked out perfectly fine with me. They gave me medicine for the headache and xofran . This continued for a month. I was in and out of the hospital. One time was really bad my face was droopy and i couldnt think and my speech was slowed and I couldn't spell. They thought I was having a stroke and 30 minutes later I was back to normal.  Over time things for better and now I'm only getting minor headaches.
Client report receiving second COVID vaccine on 05/08/21 at 10:00 am and having an adverse reaction of hives on Monday 05/10/21 about 02:00 am.  Client received first COVID vaccine on 04/10/21 without an adverse reaction.  This adverse reaction from the second vaccine consist of hives on his buttock, armpits, back of head, back and front of legs.  The hives are itchy in a couple of spots.  They are not painful or tender.  No other symptoms.  Client has taken Benadryl, at this time but is not sure how helpful it has been as of yet.
Day after 2d COVID-19 vaccine (5/16/21) had approx 16 hours of feeling extremely weak, fatigued, brain feeling fuzzy, fever. Then fine.  On June 18, I was fine and then started to feel similar fuzzy brain; within 5 minutes identical feelings from day after 2d shot hit full force and worse; felt on verge of blacking out, couldn?t look left or right without spots, extremely weak, went to bed; completely better within approx 20 hours like nothing happened.  July 13, same experience; started feeling fuzzy, symptoms hit full force within 5 minutes: extremely weak, headache, dizziness, fuzzy brain, slight nausea, fever, light painful to eyes, went to bed - 16 hours later totally fine again.  Not sure if these episodes are related, but I?ve never before experienced this quick hit, run over by bus, then completely fine again 16-20 hours later except day after 2d dose. So it seems very strange that I would feel that way again one day each month since then.
patients have been administered doses while the temperature excursion assessment was ongoing; patients have been administered doses while the temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing) in a 47-year-old female 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, reporter reiterates that because the facility was unable to download the digital data logger and reporter also stated that they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State. Reporter did not stated that no adverse reactions were reported by any Patient.   No treatment medication was provided.
11 days after receiving influenza vaccine in the L deltoid and varivax in the L upper arm he had a fever of 100-102, swelling and tenderness of the arm, and some groin tenderness.  No skin lesions developed.  Tenderness was around the varivax site.  It improved with motrin and lasted about 2 days.  No other treatment given.
day after 2nd injection increased fatigue, arm soreness and shortness of breath overnight requiring rescue inhaler. Fatigue and general malaise continued x 7 days with intermittent shortness of breath requiring use of rescue inhaler. (Prior to vaccine inhaler used 3/year post vaccine requiring inhaler 2x per day). Increased post nasal drip with shortness of breath at night 02-03am each night and head congestion ear fullness during day requiring rest increased benadryl and decongestant use.