chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID-19 symptoms returned 5 days after completion of paxlovid - including: tachycardia, coughing, rhinirrhea, fatigue, night sweats. COVID 19 Treatment, brand Paxlovid treatment start date 13Jul2022, treatment stop date 17Jul2022 indication Treatment of COVID-19. no other medication in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient experienced anaphylactic reaction which includes fainting, sudden increase in secretions from eyes and nose, weakness, numbness in upper extremity (fingertips) agitation, flushing dizziness, feeling something wrong, and extreme headache. The patient was treated with epipen and pharmacist called 911 and advised patient to go to the hospital. Patient recovered in approximately 30 minutes but refused to go to the hospital and called in a ride by the husband.
Patient was in a hurry to receive her vaccination and was pressuring me to proceed quickly.  I reviewed her chart, discussed her second dose with her, and prepared for the IM injection.   Unfortunately, do to her instance that I proceed quickly, I became distracted and did not wipe her arm with an alcohol swab prior to the injection.   The patient then reminded me that I forgot to wipe her arm and she was concerned about suntan lotion was introduced into her body.   I apologized for my mistake and informed her that I did not anticipate an adverse reaction but encouraged her to watch for signs of infection.
On Day 5 after the Fluzone Quadrivalent  vaccination, our son developed a high fever (greater than 103) and significant Malaise.  He became uninterested in all activities, even things that normally excite him.  All he wanted to do was sit/lay down and stare ahead.  At multiple points he was just sitting, staring, & drooling.   On day 6 after the vaccination (and 24 hours after symptoms) I took him back to the Doctor.  (12/16/2018).  The doctor recorded his fever as 103.8 & observed that he looked sick.  They tested him for influenza.  The in office nose swab test came back negative.  The doctor recommended children's Motrin or ibuprofen and to bring him back if the fever lasted more than 3-4 days. The high fever continued for 4 more days (total of 5 days) and remained above 103 deg F whenever the ibuprofen wore off.  With Ibuprogen it would lower to a 101-102 degree fever, but he always had a fever for 5 days.  At night our son would have outburts of unconsolable crying and toss and turn and hit his head against the wall. I called the dr again on Day 7 (2 days after sickness started) however they still recommended to wait out the fever.   After 5 days of  fever &  feeling very unwell, he began to return to normal temp and behavior.
Shortly after receiving flu shot started having face itching and tingling lips.  Evaluated in employee health @ 12:30 PM. Denied SOB, wheezing, throat tightness, change in voice or rash. Physical exam WNL. Patient given Benadryl 50mg PO and instructed to report to ER with worsening sxs.
pt recv vax 4FEB98 & same day pt exp arthralgia w/pain in both shoulders;pt also exp dermatitis on arms consisting of rash w/papules that were .5mm to 5mm in size;the papules were light in color. This is a follow-up to report (s) previously submitted on 03/01/1999. Informaiton has been received from a registered nurse concerning a 12 year old female with a history of an ear infection one week prior to vaccination who on 02-DEC-1997 and 02-JAN-1998 was vaccianted IM with the first and second doses of RECOMBIVAX vaccine. Concomitant vaccines on 02-JAN-1998 includes diphteria + tetanus toxoids vaccine. On the same day as vaccination, the patient experienced arthralgia wiith pain in both shoulders. On approximately 06-JAN-1998 the patient experienced a rash on the arms with papules .5 mm to 5 mm in size. The papules were light in color. She was seen in a physician's office on 05-FEB-1998. She also had otitis media at the time of the office visit. The rash began to worsen on approximately 11-FEB-1998. The patient was initially administered and antifungal cream, but it was inefective. On 18-FEB-1998 the rash was "all over" the arms, legs, and back. The papules had become confluent into plaques. Subsequently, the patient revcovered. No further information is available.
Covid vaccine caused AFIB which caused blood clots to form and break off and cause 8 strokes ! Very scary event  could have killed my father !
headache, chills, fatigure, muscle aches, injection site warm to touch Narrative: Took Motrin and Tylenol. Patient had COVID and recovered 12/17/2020
Patient received PNEUMOVAX injection into left deltoid on 1/11/11 - has had swelling, redness and pain.
Information has been received from a medical assistant referring to a patient of unknown age and gender. Concurrent condition and medical history of the patient were not reported. On 01-JUN-2016 the patient was vaccinated with a dose of improperly stored ROTATEQ orally (lot # L039298, expiration date: 27-JUN-2017) (dose unspecified) and a dose of improperly stored PEDVAXHIB (lot # L042258, expiration date: 18-AUG-2018 (dose and route unspecified). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Chills, muscle and body aches, stuffy nose, headache, fever. Lasted for 4 hours. Today, April 6, I noted swelling and redness at the injection site.
swollen hands; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP), Program ID:   A 74-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Forgetfullness" (unspecified if ongoing); "rheumatoid arthritis" (unspecified if ongoing), notes: reports generally agree to generally its been hard to cope with rheumatoid arthritis; "Stroke", start date: 2016 (unspecified if ongoing), notes: 3 strokes(2016/2017/2018); "Stroke", start date: 2017 (unspecified if ongoing), notes: 3 strokes(2016/2017/2018); "Stroke", start date: 2018 (unspecified if ongoing), notes: 3 strokes(2016/2017/2018); "ruptured intestines", start date: 2017 (unspecified if ongoing), notes: ruptured intestines resulting in a stoma/2017); "stoma", start date: 2017 (unspecified if ongoing), notes: ruptured intestines resulting in a stoma/2017). The patient's concomitant medications were not reported. Past drug history included: Xeljanz xr for rheumatoid arthritis. Vaccination history included: Covid-19 vaccine (Primary immunization completed, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swollen hands".  Additional information: Reporter stated that COVID booster received a few months ago (date not provided) told to hold Xeljanz XR for 4-5 days (dates not provided) with adverse effects of swollen hands reported during hold.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
pt recvd vax 4APR & 5 days later recvd Celestone for asthma & exp GI distress w/breathing diff;episodes occur p/meals & sxs unlike asthma episodes;ER visit-meds rx includes oral Pred/Librium
Swelling, bruising, local rash @ inject site; Past rxn w/DTP
Pt was given low dose Moderna Vaccine. Pt is only 11 years old and 8 months.
Large redden area behind left triceps. With welping radiating on inner portion of arm. Arm redness 3 1/2in x 4in hard warm to touch. VS=97.5- 117/80-82-18
Flushing,  started about 5h after vaccination, lasts a few minutes, has occurred daily .  Fatigue/aches, started ~48h after vaccination, usually occurs in the afternoon, enough for me to need a nap, has occurred daily.
the patient received the 0.25ml of Fluarix earlier this season; the patient received the 0.25ml of Fluarix earlier this season; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 76-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Flu vaccine (on an unknown date had adverse reactions after the flu vaccine in the past (brand name not reported, details of adverse reactions unknown).).   On 5th October 2022, the patient received Fluarix Quadrivalent 2022-2023 season .25 ml and Fluarix Tetra Pre-Filled Syringe Device. On 5th October 2022, unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced underdose and off label use. On an unknown date, the outcome of the underdose and off label use were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022AMR143111   Additional Information: GSK receipt date: 05-OCT-2022 Reporters comment:  The reporter reported that patient received two 0.25ml doses of the Flu vaccine every season.  The reporter said that the patient received the 0.25ml of Fluarix earlier that season did not know if prefilled syringe or multidose vial and wanted to know if the patient could receive another 0.25ml from the Fluarix QIV prefilled syringe as a second dose for this season.  Follow-up declined Agent had selected as Vaccine involved on this case Fluarix QIV season 21-22" because there are no other option for this current season The reporter did not consent to follow-up. Additional Supportive information: The patient received the 0.25ml of Fluarix which led to Underdose and off label use; Sender's Comments:  US-GSK-US2022AMR143111:Same reporter - invalid case
immediate itching at site, itching generalized, hives, face very red, no respiratory distress, Solumedrol 125mg IVP, Benadryl 50mg IVP at 09:01am Pepcid 20mg IVPB over 15 minutes at 09:20 am on 12/29/2020. Prescriptions included prednisone 20mg times 5 days, Benadryl 50mg every 6 hours for 24 hours and epi pen as needed. Epi pen not used.
pt recv vax & p/vax exp a gen maculopapular itchy rash (arms, legs, abd);pt was seen in ER & tx w/zyrtec;rash resolved;
I am a 48 year old Female been in Menopause for 3years ( no cycle for 24plus months), 4 days after receiving  the vaccine I have now started to have stomach cramps an light bleeding as if I  were on my period. I have not had any symptoms of this in three years. After my first shot day 14 i had very tender breasts , That has since subsided and now i am dealing with bleeding. would love to know how many other women are going thru this
Asthma; Fever; Cough; Sore; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Asthma), PYREXIA (Fever), COUGH (Cough) and PAIN (Sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history 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 ASTHMA (Asthma), PYREXIA (Fever), COUGH (Cough) and PAIN (Sore). At the time of the report, ASTHMA (Asthma), PYREXIA (Fever), COUGH (Cough) and PAIN (Sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient received 2nd COVID-19 Booster and 1st dose of Shingrix concurrently.  The following day the patient experienced a blister in his mouth, on his nose, and near his eye - all on the right side of his face.  Blisters/pain appear to be resolving and patient is monitoring.
Decreased WBC count; This spontaneous case was reported by a consumer and describes the occurrence of WHITE BLOOD CELL COUNT DECREASED (Decreased WBC count) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 036B21A) for COVID-19 vaccination.     The patient's past medical history included White blood cell count high (high white blood cell count of 65,000 before receiving the vaccine). Concurrent medical conditions included Chronic lymphocytic leukemia.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced WHITE BLOOD CELL COUNT DECREASED (Decreased WBC count) (seriousness criterion medically significant). At the time of the report, WHITE BLOOD CELL COUNT DECREASED (Decreased WBC count) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: 44000 (Inconclusive) 1-2 weeks after getting the 1st dose and 36000 (Inconclusive) 1-2 weeks after getting the 2nd dose.         Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This patient had a flu shot on 10/30/00 AM. He went to see the eye doctor 11/01/00 for another reason, but noted right eyelid drooping. Two weeks after, complained of tingling from both arms and legs and facial weakness. Two weeks after, hospitalized under telemetry x4 days due to complaints of weakness from both the upper and lower extremities with right weaker than left, tachycardia, and palpitation.
I did not have an adverse reaction to the vaccine. In 02/2023, I became very sick with a viral respiratory illness. I went to an urgent care center, and they wanted me to go to emergency room because I was having chest pain. Concurrently, I had a bacterial infection. I was ultimately diagnosed with Hepatitis A. At this time, I am not taking any medication for Hepatitis, and I am being watched.
Severe headache, burning headache sensation, fatigue, chill, fever, very loud hick ups, feels like about to vomit, no appetite, dizziness.
8x10 cm erythema and warmth left deltoid. Temperature max: 101F.
Back of (L) arm, red, bruised, swollen painful. Could not move. Missed 2 days of work. Swelling extended to her (L) armpit and back. Had picture on her cell phone.
Patient with edema in muscle where T-dap shot administered. 3.5 cm length/3.0 cm wide.
One day  after shot,   hives broke out on left arm, left shoulder, left torso, left thigh. Raised, red, very itchy.  Also had delayed hypersensitivity rash/ hives  Day 9 after first Moderna dose previously reported.
This spontaneous report has been received from a 55 year old female patient, who was also a nurse and who was reporting on herself, via a company representative. No information regarding the patient's medical history or concurrent conditions was provided. On 03-FEB-2016, the patient was vaccinated with a dose of M-M-R II injection (dose, route of administration, lot# and expiry date were not reported). The patient had no concomitant therapies. On an unknown date in February 2016, reported as last couple of days, the patient experienced a tension headache "in the back of her neck". The patent did not seek medical attention and no treatment was given for the event. The outcome of the event was reported as recovering. The relatedness between M-M-R II and the event was not provided. Additional information is not expected as no contact details were provided.
Post injection, employee c/o pain and tingling. Upon evaluation site was warm and swollen. Site iced for a few minutes. Employee was offered outside treatment and declined. Employee was informed if symptoms persisted or worsened to let manager or medical staff know.
BlurredVision, Dizziness, Headache, Fever, INCREASE IN FATIGUE, HEADACE LASTED>10 DAYS - Narrative:
1) fever , and chills, sweats for 24hours (started few hours after the vaccine) 2) passed out around 3 am next day when woke up from sleep, Wanted to drink water in kitchen but she felt weak, instead got up to use the bath room to urinate, felt weak, mild dizzy, she made to urinate and when got up after urinate, she fainted. She passed out. Not remember the episode. She woke up (think after short period) looking at ceiling and thinking where she was. Next day, woke up with whole clothes wet from sweating.  Denies CP, SOB, diff breath, ting, numb, weak over part of body. 3) had diarrhea for 10 days before this shot. 3 times per day, nausea +, watery, no mucus , blood. No v, Tried Immodium. No BM since 2/2.   Likely syncope fr vasovagal vs hypotension fr diarrhea.
First inj (with the lot they temp pulled in ca) only had injection site reaction (redness, indirection, tender). Second injection had the common side effects as listed, but had a similar rash/induration about 2-3 inches BELOW the actual injection site
Patient received vaccine. Patient in monitoring area and started complaining of not feeling well and becoming nauseated. Rapid Response called. VS taken and doctors arrived. Determined patient did not need further treatment and just to monitor patient for another 15 minutes before patient left. Patient alert and talking, and states she is feeling better.
Initial unsolicited report received from a health care professional (physician's assistant) on 21 April 2016. This case involves a (age and gender not reported) patient who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient went into shock. Laboratory investigation and corrective treatment were not reported. The outcome of event was not reported. Upon internal review, the company decided to consider the event serious because of important medical event shock. List of documents held by sender: none.; Sender's Comments: Shock is unlisted with the role of the vaccine. This case is very poorly documented to assess the role of the vaccine. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Initially, sore arm at injection site lasting for 2 days.  On day 8 (Sunday), area near injection site became swollen and itchy and continue for 2 days.  Patient had to use cortisone cream for itch and take antihistamine.
On day 2 after the vaccine I awoke to a redness in my left arm and it was very itchie.  This is day 3 and I still have the redness and itch.
This is a spontaneous report obtained from a contactable consumer that reported on behalf of her 20-year-old daughter. A 20-year-old female patient received, on 12Jan2016, at 12:00, the first dose of TRUMENBA at 0.5 ml, single dose. The patient received the product at the doctor's office (did not have the lot, expiration and NDC). Relevant medical history and concomitant medications were unknown. On 12Jan2016, at 13:30, the patient experienced severe chills. Patient's doctor has been notified. The patient was treated with ADVIL. Chills worsened and the patient did not recover from the event at time of this report. Follow-up (18FEB2016): Follow-up attempts are completed. No further information is expected.