chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative: 75 y.o. male Patient received dose #1 of Moderna COVID vaccine (Lot #011A21A, exp 8/16/21) on 3/3/21 and dose #2 of Moderna COVID vaccine (Lot # 018B21A, exp 9/16/21) on 3/30/21. PMH includes ESRD via left AV fistula MWF dialysis, CAD x2 (no PCI, on plavix), and DM. Patient presented to hospital on 4/10/21 with acute onset of right sided weakness and slurred speech. Found to have large left subdural hemorrhage. Treated with craniotomy and evacuation. Post-op he developed a new intraparenchymal hemorrhage. Family elected comfort measures and patient died on 4/12. Reaction classified as severe as death occurred following vaccination.
Red, hot, round area of about 3-5cm in diameter with a 2.5cm (diameter) area of induration in the right deltoid area.
Within 48 hours post Typhoid vaccine administration the patient developed lymphadenopathy one side - R axilla and R cervical. The nodes were painful - child did not attend school. By day 3 the nodes were improving. No systemic SXS. No fever
Developed throbbing under arm pit; Night sweat; Got sick like I had the virus again; Sore arm; Fever; Knot under arm; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Developed throbbing under arm pit), NIGHT SWEATS (Night sweat), SUSPECTED COVID-19 (Got sick like I had the virus again), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2020.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced AXILLARY PAIN (Developed throbbing under arm pit), NIGHT SWEATS (Night sweat), SUSPECTED COVID-19 (Got sick like I had the virus again), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever) and LYMPHADENOPATHY (Knot under arm). At the time of the report, AXILLARY PAIN (Developed throbbing under arm pit), NIGHT SWEATS (Night sweat), SUSPECTED COVID-19 (Got sick like I had the virus again), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever) and LYMPHADENOPATHY (Knot under arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided. No relevant concomitant medications were reported. Treatment details included Tylenol.
Arm swelled up  and I got a rash around the injection site 8 days after receiving the shot. My arm had stopped hurting 3 days after the shot, but started hurting again on the same day that it swelled up. I took Tylenol and Ibuprofen and iced it multiple times a day. The swelling and pain went down after about 4 days.
PATIENT PRESENTS WITH 4 DIME SIZE RED MARKS, ALMOST WELT LIKE ON VACCINATION FOREARM AND RIGHT ABOVE ELBOW AND STATES THEY ITCH ON AND OFF. ADVISED PT TO TRY SOME HYDROCORTISONE CREAM AND FOLLOW UP WITH MD IF NEEDED
Pt had flu shot and cholesterol finger stick. Went to massage chair and reportedly passed out while getting massage. Pt cool and clammy skin, face and lips pale. Checked BP and HR, client sweating and slow to respond. Gave 0.5ml sq epi 1:1000 to right arm. Pt reported feeling better. First responders arrived. Pt denied ER visit. 10/28/03 15:00 feels fine, no c/o. 17:22 BP 164/92 88-22. 17:27 122/76 80. 17:30 126/76 pt drinking soda, feeling better. 17:50 HR 104 after epi. 18:00 132/84 108 eating snack. 18:30 132/162 108 feeling better, spouse to pick up.
I administered  Pfizer dose 2 to a patient at 1:35 pm on 5/16/2021 . Prior to administration, I asked if the patient tolerated the 1st shot and patient reported that everything was fine with the 1st shot. So I proceeded with the shot.  In about 10 minutes after I administered the shot, she reported feeling that her throat is tingling and afraid it might close up. I used Epipen and called 911. 911 arrived within 5 minutes.  I contacted the patient at 5 pm to check how she was doing and she reported doing fine, she was home.
Pfeizer COVID-19 VACCINE EXPIRES 12/31/2022 BUT WAS GIVEN 01/09/2023
12 hrs post injection awoke with shaking chills with fever eventually 102. 2 more episodes of lesser chills in next 12 hrs, with gradual decrease in fever over 24 hrs to low grade 99. Had severe body aches/joint pains during this time which also slowly improved.
Face, Eye, Tongue Swelling; Face, Eye, Tongue Swelling; Face, Eye, Tongue Swelling; Extreme arm pain (injection arm) swollen arm, including site of injection; Extreme arm pain (injection arm) swollen arm, including site of injection; Extreme arm pain (injection arm) swollen arm, including site of injection; Extreme arm pain (injection arm) swollen arm, including site of injection; Headache; Chills; Sore throat; coughing; Right side of neck (lymph nodes) swollen with trap area; Shoulder pain; Pain in bicep area; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 29Apr2021 at 08:15 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included obsessive-compulsive disorder (OCD), major depression, attention deficit hyperactivity disorder (ADHD) and fruit allergy to fresh pineapple with reaction as swollen tongue. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fluvoxamine maleate (LUVOX), aripiprazole (ABILIFY), lamotrigine (MANUFACTURER UNKNOWN), amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL) and fish oil (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. On 29Apr2021 at 14:45, the patient experienced face, eye, tongue swelling, extreme arm pain (injection arm) swollen arm, including site of injection, headache, chills, sore throat, coughing, shoulder pain, pain in bicep area and right side of neck (lymph nodes) swollen along with trap area. Therapeutic measures were not taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events face, eye, tongue swelling, extreme arm pain (injection arm) swollen arm, including site of injection, headache, chills, sore throat, coughing, shoulder pain, pain in bicep area and right side of neck (lymph nodes) swollen along with trap area were not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
11/29/2022 I started having cold like symptoms and  difficulties breathing. After testing positive for Covid-19 I was prescribed Paxlovid. Symptoms lasted 2 weeks.
Information has been received from a literature article concerning a 29 year old female patient developed uveitis, following administration of GARDASIL. The patient had as a pre-existing conditions Behcets and pericarditis. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17 (range 12-29). The median time from vaccination to onset of ADRs was 30 days (range 0-476); time to onset was unknown in 1 case; the time to onset in this case was of 30 days from vaccination. There was one reported rechallenged of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 cases and included 3 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. The ocular findings of papilledema and papillitis may be confounded by pre-existing conditions (sarcoidosis, cat scratch disease and Behcet's disease) known to affect the optic nerve in 3 case reports. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccine and uveitis was "possible". Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports from the same literature source. Additional information has been requested.
sore throat, followed by headache and right ear pain. Nausea and fever of 101.0 on March 8th, in addition to previous symptoms. In the emergency department on March 11th with complete right facial droop consistent with Bell's palsy; this has persisted as of today, also with evidence of right serous otitis media
Developed Blood clot in right leg; This is a spontaneous report from a contactable consumer or other non-HCP (patient wife). This is the 2nd case out of 2 cases.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VAC-CINE, Solution for injection, Batch/Lot number: Unknown, Expiry Date: Unknown) via an unspecified route of administration on 13Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown, Expiry Date: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single COVID-19 immunization. The patient developed blood clot in right leg last Friday on 15Oct2021. The report is not related to a study. Patient wanted to know whether the Pfizer is having any reports of Blood clot from the Pfizer Covid Vaccine. The clinical outcome of the event blood clot in right leg was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101383426 same reporter/drug/AE, different patient
about a wk p/shot pt has weakness & fever & chills now lasting 3 wks; if pt stays in & resting pt is OK If pt up & active  pt is ill; lasted 3 months MD could find no cause;
None.  Patient should have gotten TDAP instead but DTAP can be used as booster for Tetanus.
It was reported that within several hours, post vax, a 4 month old female pt, developed vocal payalysis that lasted 3-5 days. From additional information received on 9/30/99, additional pt information was provided. From additional information received on 10/6/99, it was reported that the pt recovered from this experience.
Incidentally diagnosed. He has no symptoms and is not on oxygen. He is high-risk given heart disease and new cancer, which made him a good candidate for MAbs, which he received during admission. He has had transient desaturations overnight, which appears to be related to undiagnosed OSA with possible COPD. Remained in quarantine (no walks in the hall) for at least 10 days post first positive test.
Fever/chills,  abdominal cramping, diarrhea,  body aches. Started at 930pm & lasted 2 days
Information has been received from a Registered Nurse (R.N.) concerning a female patient in "early 20s" who was vaccinated with a first dose of Gardasil. The reporter reported that "patient fainted immediately after receiving her second dose of Gardasil." The patient sought unspecified medical attention and recovered. Additional information has been requested.
Multiple vaccines given on 7/10/00. On 7/11/00, pt had teeth clinching (more than usual), starring spell and unresponsiveness for a few seconds. No history of cyanosis, tonic/clonic activity or tongue thrusting.
Developed pain from L deltoid/L shoulder radiating into neck. Went to doctor - took LORTAB for pain got better by October 5th and completely removed symptoms by October 7th 2009
Uneasy stomach with very soft stools in every visit to the bathroom and on a few occasions in between.  Awkward, to say the least. Started overnight after day of vaccination and has continued for over 24 hours and has not yet resolved although frequency has started to diminish as of 48 hours.  Also visibly flushed face/hot flashes, slight rise in temperature at 98.4 (over my normal baseline of 97.5) this morning which has since receded.  Waiting to see how long this lasts.
This is a spontaneous report from a contactable Physician via company representative. An 18-year-old female patient of an unspecified ethnicity started to receive TRUMENBA via an unspecified route of administration at 0.5 ml, single on 01Jun2016. The patient medical history was not reported. The patient's concomitant medications were not reported. No other shot was given at the same time with TRUMENBA. The patient experienced fainted on an unspecified date with outcome of unknown. Follow-up (29JUL2016): Follow-up attempts are completed. No further information is expected.
Intense shoulder pain, reduced motion, numbness in fingers and arm,  sharp pain when lying face down, tightness and knots in shoulder, back, and neck muscles.
"Covid Arm" reaction to the Moderna vaccine. Started 7 days after the shot. Red and itchy at the injection site and surrounding area. Constant but with aggravated flare-ups accompanied by nausea.
Post vax the patient developed a fever of 102.6F on 08/15/2001. The patient still had the fever 08/17/2001. Patient's mother stated patient feels fine on 08/20/2001.
Patient received two Pfizer vaccines, one on 8/2/21 and the other on 8/25/21. Patient states that she received one dose in each arm. Patient called to report on 1/4/22 that she is still having arm pain. Patient states that is feels like a "bee sting in her muscle". Patient described pain as occurring when she turned her arm a certain way and when she lifts her arm. Patient has stated using OTC medication as well as topical products to no relief. It was recommended that patient follow up with her provider.
mom said pt broke out w/rash on face & behind ears on 10MAR99;had fever on sunday before of 102;called pharmacy & said to given DPH for rash;fever gone 11MAR99;has had allergic rxn a/& scarlatina but this rash different;referred to MD;
SLIGHT SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26. cov2. s (suspension for injection, route of admin, and batch number: Unknown, Expiry: Unknown) dose not reported, 1 total, start therapy date were not reported for prophylactic vaccination (dose number in series 1). It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose, start therapy date were not reported for prophylactic vaccination (dose number in series 2). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced slight side effects (dose number in series 2) . The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of slight side effects was not reported. This report was non-serious. This case, from the same reporter is linked to 20211242092 and 20211242790.
Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included AMOXICILLIN for an unknown indication.    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 PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: inconclusive (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Consumer received the first dose of the Moderna vaccine on last Thursday and developed fever and headache.  Treatment information was not provided.
Information has been received from a nurse practitioner and a physician concerning a 24-week-old female with no allergies and with a history of fevers (on and off) who on 01-NOV-2006 and 09-JAN-2007 was vaccinated PO with the first and second doses of Rotateq (Lot #'s 654352/0410F and /1082F, respectively). There was no concomitant medication. On 15-DEC-2006 the patient experienced fever. This fever was not related to therapy with Rotateq. On 26-DEC-2006 the patient experienced left eye ptosis. On 12-JAN-2007 the patient experienced diarrhea and vomiting and was hospitalized. The initial diagnosis was acute gastroenteritis. The patient's symptoms worsened, and the third day of hospitalization, the patient had blood in her stool and was diagnosed with bowel intussusception. The patient underwent surgical repair on 14-FEB-2007. The patient was discharged from the hospital within 24 hours of surgery, and was noted to be recovered. The patient was seeing another practice at the time of the report. No additional information is expected. There was no product quality complaint. The physician indicated that the intussusception was not related to vaccination with Rotateq. Additional information has been requested.  04/20/2007 Records received from PCP which include vax record and D/C summary from 1st hospitalization and D/C order form and Final Report  from transfer facility. Infant presented to PCP on 02/12/2007 with a 2 day hx. of diarrhea, vomiting, lethargy and not eating well.  2 lb weight loss. Assessment:  Acute gastroenteritis and dehydration.  Admitted to hospital for IV hydration and further management. Transfered to another facility on 2/13/07 for eval. by a pediatric surgeon for possible intestinal obstruction vs. intussusception. Barium enema was obtained on 2/14/07 which was (+) for intussusception which could only be partially reduced.  Pt went for laparoscopic reduction of the intussusception on 2/14/07. Discharged the next day. D/C DX:  Incarcerated Intussusception.
Numbness on the left side of neck and over to lower jaw and throat.  Started a few days after the first shot.
Pt called to report having chills and diarrhea on 2/24/2021.  Spoke to pt on 2/25/2021 and he only reported chills and he took some Tylenol and they subsided. Pt is having no issues reported on 2/25/2021.
3 cm area of erythema and induration at site of injection 20 hr post injection.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; O2 LEVEL 85%; This spontaneous report received from a patient concerned a 64-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included Crohn's disease, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, 1 total administered on 04-MAR-2021 to right arm for prophylactic vaccination. Concomitant medications included vedolizumab for Crohn's disease.  On an unspecified date in 2021, the patient experienced flu-like symptoms (fever 100F for about two days, very torturous and unusual headache, body aches). It was reported that the patient spent five days sick in bed. On an unspecified date in 2021, the patient took Tylenol but it did not relieve the pain and nothing seemed to help patient except getting some rest. After the vaccine administration, the patient stayed at home for 14 days, she double-masked, she had not been going out very much. On 11-APR-201, the patient experienced oxygen level 85%, felt ill and went to instant care and did Polymerase chain reaction test (PCR). On 13-APR-2021, the test result came positive. The patients Covid-19 symptoms included cough, fever (100F low grade fever) and oxygen (O2) level 85%.  On 2021, Laboratory data included: Body temperature (NR: not provided) 100 F. On APR-2021, Laboratory data included: Oxygen saturation (NR: not provided) 85 %. Laboratory data included: PCR (NR: not provided) Positive.  In 2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from O2 level 85%, and the outcome of confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210427837-covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Information has been received from a RN concerning a 74 year old female pt who on 12/15/03 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (Lot # 647654/0865N). On approximately 12/15/03 the pt experienced redness, soreness and heat at the injection site and malaise. Unspecified medical attention was sought. There was no product quality complaint involved. The reporter indicated that two other pt's (WAES # 0401USA00780 & 0401USA00781) had similar experiences following exposure to pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Two days post vax, this pt presented with arm soreness, redness, and swelling. "The soreness and red spot was from the shoulder to the elbow and halfway around the arm. The site of the injection was clear and the reddened area began beside the injection site. The pt was advised to use warm moist soaks and acetaminophen. The pt took naproxen sodium salt for pain.
Clinic Supervisor reported that 6 kids received Rotarix diluent alone with our mixing it.; inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Rota (Rotarix lyophilized formulation) (batch number KB7FJ, expiry date 19-SEP-2024) for prophylaxis.   On 25-OCT-2023, the patient received Rotarix lyophilized formulation. On 25-OCT-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate preparation of medication (Verbatim: Clinic Supervisor reported that 6 kids received Rotarix diluent alone with our mixing it.) and inappropriate dose of vaccine administered (Verbatim: inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-NOV-2023 Clinic Supervisor reported that 6 kids received Rotarix diluent alone with our mixing it which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up via email. This case is 1 out of 6 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2023152373:Different patient US-GSK-US2023152365:Different patient US-GSK-US2023152363:Different patient US-GSK-US2023152368:Different patient US-GSK-US2023152371:Different patient
Intense chest pain and chest pressure for two days. Other symptoms were just a headache, muscle pain, and fatigue, and no real appetite.