chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was in the hospital a month after the flu shot. Breathing difficulties; Viral infection; feel terrible the next and several days after; This case was reported by a consumer via interactive digital media and described the occurrence of difficulty breathing in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, 1 day after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced difficulty breathing (serious criteria hospitalization), viral infection (serious criteria hospitalization) and feeling bad. On an unknown date, the outcome of the difficulty breathing, viral infection and feeling bad were recovered/resolved.   It was unknown if the reporter considered the difficulty breathing, viral infection and feeling bad to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The patient had reported the events for herself/himself. The age at vaccination was not reported. The patient experienced breathing difficulties and hospitalized a month after the flu shot. The reporter mentione that, they said it was a virus, but never told him/her what kind of virus and he/she should have paid attention to it. The reporter mentioned that, people were not spread lies, he/she knew when felt bad, and it was happened each time after a flu shot, perfectly fine the day he/she get it, felt terrible the next and several days after and that was not his/her imagination. This case had been linked with US2020AMR199551, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR199551:Same reporter
Less than 24 hours after getting vaccine. developed, fever, chills, body aches. Highest fever was 103.1. Treated with 600 mg Ibuprofen. Left shoulder, bruised (purple and red). swelling, hot too touch. Very painful for last two days.
Hard firm red spot on and around injection site. Feel hot and painful to touch. Seems to be spreading outwards. Also in general just feel pain and fatigue. Chest pains. Itchy all over body and back pain.
On the same arm as vaccine he developed a muscle twitch; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in the arm on 01May2021, 2nd dose, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0158, expiration date: 31Jul2021) administered via an unspecified route of administration on 10Apr2021, 1st dose, single, for COVID-19 immunization. About 2 to 3 days after the second dose, the patient developed a muscle twitch on the same arm where the vaccine received. It was not constant but periodic throughout the day. The patient wanted to know if there had been any notes on it about the vaccine and should he expect it to go away. The outcome of the event was unknown.  No follow-up attempts are possible; No further information is expected.
Client began feeling flushed approximately 10-15 minutes following vaccination with COVID-19 vaccine.  Client stated her "chest had a heavy feeling" and she was experiencing heart palpitations (which she also reports are normal for her).  She was concerned as the heart palpitations were occurring along with chest pain.  EMS on scene at clinic site (precaution) and escorted client to area where EKG was completed.  Normal sinus rhythm was noted along with possible infarct age undetermined ( as reported on strip)and client was asked if she would like to go to ER for additional evaluation which she refused.  (Client signed refusal of medical treatment, transport and/ or evaluation form).  Client was advised by EMS and health district staff to seek medical treatment or call 911 if symptoms persist or become worse.  Client voiced understanding.
MENACTRA was given to patient accidently by LPN instead of PREVNAR 13. Patient with no ill sx's, no adverse rxn. Mother was contacted. Incident explained and scheduled patient for correct vaccine. Policy/protocol being followed at our office to prevent this from happening again.
Seizures, patient was taken to Hospital where they performed test for Meningitis. Stayed at the hospital for  3 nights.
COVID Infection; COVID Infection; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An 8-year-old male patient received BNT162b2 (BNT162B2), on 13Nov2021 as dose 1, single (Lot number: FK5127) and on 04Dec2021 as dose 2, single (Lot number: FK5127) at the age of 8 years, in right arm 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 16Apr2022, outcome "recovered" and all described as "COVID Infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Dec2021) Negative, notes: Nasal Swab; (16Apr2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  The patient was not received other vaccine in four weeks and covid prior vaccination. She was covid tested post-vaccination.  No follow-up attempts are possible. No further information is expected.
Information ahs been received from a health professional concerning a 10 week old female, with no medical history and no allergies, who on 09/11/06, spit up while being vaccinated with a firs oral dose of Rotavirus vaccine (lot 653661/0146F) (also reported as lot 654664/0726F), and did not received a full dose. Other vaccines administered on 8/25/06 included a first IM dose in the right thigh of Pediarix (lot AC21B065AA), a first IM dose in the left thigh of ActHib (lot 4E902AA) and a first dose IM dose in the left thigh of Prevnar (lot B086498). There was no illness at the time of vaccination and no adverse events following prior vaccination. No product quality complaint was involved. Follow up information from a health professional indicated that on 9/11/06, about 15 seconds after receiving Rotavirus vaccine the pt projectile vomited. It was noted that the pt did not appear fussy following the dose. Additional information is not expected.
hepatic injury; This literature-study case was reported in a literature article and describes the occurrence of LIVER INJURY (hepatic injury) in a 68-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) 1 dosage form. On an unknown date, the patient experienced LIVER INJURY (hepatic injury) (seriousness criterion medically significant). At the time of the report, LIVER INJURY (hepatic injury) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered LIVER INJURY (hepatic injury) to be related.    Concomitant and treatment medication were not reported  Company comment: This is a literature case concerning a 68 year-old, female patient with no reported medical history, who experienced the serious (due to medically important condition) unexpected, according CCDS, AESI of Liver injury. The event occurred on an unknown date after mRNA-1273 vaccine, dose number and date not provided. The rechallenge was not applicable since dose number was not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-419607, MOD-2021-419558, MOD-2021-419609 (Patient Link).; Sender's Comments: This is a literature case concerning a 68 year-old, female patient with no reported medical history, who experienced the serious (due to medically important condition) unexpected, according CCDS, AESI of Liver injury. The event occurred on an unknown date after mRNA-1273 vaccine, dose number and date not provided. The rechallenge was not applicable since dose number was not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
mom reported on 17MAR98 c/o nondescript rash & bruising;MD ordered a CBC & it was discovered that pt platelet count was 17;pt was adm to hosp by hematologist;
BLOOD CLOT IN BRAIN; This spontaneous report received from a patient via a company representative concerned a 70 year old male. 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, frequency 1 total, start therapy date were not reported for prophylactic vaccination. 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, the patient experienced blood clot in brain, and was hospitalized for 3 weeks (21 days) and was out of hospital on a blood thinner and was doing fine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blot clot in brain. This report was serious (Hospitalization Caused/Prolonged).; Sender's Comments: V0: 20210725389-covid-19 vaccine ad26.cov2.s-Blot clot in brain. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
On 11/06/2021 patient was administered 0.3 ml, Intramuscular of the adult  Pfizer Biontech COVID19 vaccine. Mother and Physician where aware of incident at the time. Patient was monitored 15 minutes after injection. Patient did not have any adverse reaction to vaccine. On 11/08/2021 I called Mother and she stated patient is doing well. Patient only complained of pain on the arm of the injection site on day one. Denies fever, fatigue, and headaches.  Overall condition, is stable.    Our office has taken measures and separated the vaccine for the adults and children. Reviewed Pfizer-Biontech "Standing Orders for Administering Vaccine" and have purchased additional orange round labels to place on syringes.
SEVERE joint pain......both shoulders, knees, hips, ankle, hand, SR joint inhibiting movement & causing extreme pain. ongoing till May 26 , 2021  still ongoing, after 3 months, but improving with methylprednisolone
experienced adverse reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (experienced adverse reaction) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (experienced adverse reaction). At the time of the report, VACCINATION COMPLICATION (experienced adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up received and patient demographics updated(Email address added)
Headache; Redness at injection site; Itching at the injection site; Chills; fever of 107; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (fever of 107), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE PRURITUS (Itching at the injection site) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced CHILLS (Chills) and PYREXIA (fever of 107). On 16-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PRURITUS (Itching at the injection site). On 18-Jan-2021, the patient experienced HEADACHE (Headache). On 10-Jan-2021, CHILLS (Chills) and PYREXIA (fever of 107) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injection site) had not resolved and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.; 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.
Irregular and frequent menstrual bleeding. My periods are regular so this is not  expected. I?ve had bleeding for a day, then it stops, then a few days it starts again, and same thing repeated 3 times now
The morning after injection, I began feeling achy. Developed chills, intense aches and a fever of 101.5 by 4pm . Had the fever and other symptoms all night. Morning of 3/18, fever gone, still some achyness. Took 1000mg of Tylenol every four hours.
Patient reported fever up to 102.9ºF the day after vaccine. Also, left axilla lymph node swelling, malaise, fatigue, shortness of breath, back aches and congestion. 100.5ºF, 2 days post vaccine. 99ºF today on day 3. Fever treated with Motrin. Asthma treated with prescription inhalers. Congestion treated with daily OTC preventives.
Moderna vaccine x2. Tested positive for covid 19 on 02/07/2022. Admitted to Medical Center on 03/18/2022. Expired on 03/26/2022 while still hospitalized.
Localized reaction induration and redness at the injection site. Plan of care use BENADRYL and antihistamine. Expect full resolution.
Arm pain (sore to the touch) for 5 days, a small knot at injection site and hot to the touch.(all lasted the 5 days after the shot).  Very sleepy after the shot and slept a few hours.
patient got the flu; Initial information received on 10-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves patient of unknown demography who patient got the flu (influenza), after receiving INFLUENZA VACCINE.  The patient's past vaccinations included Influenza vaccine and after every vaccination patient got flu..  Medical treatment(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious patient got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reports, the outcome was not reported for the event influenza.  There will be no information on the batch number for this case.
18 hours after 2nd dose, severe cramping, diarhhea, sweating. Passed out while on toilet. Came to with nose bleeding from both nostrils, goose egg on forehead. Husband helped me back on commode, more diarhhea, then threw up 3 times. After 15 minutes, helped back to bed, chills, shakes, fatigue. May have broken/cracked nose and slight concussion - was slightly confused for 24 hours, headaches, unable to wear eyeglasses due to swelling and bruising on nose. Ice pack on nose 4x day for 15 minutes. Tylenol and Ibuprofen for pain. At 60 hours (after injection) welt is fading and not hot, beginning to feel better, although still fatigued,  and headaches continue. This description was sent to my doctor.
Information has been received from a pharmacist concerning an 82 year old male patient with no drug reactions/allergies, who on 19-JUN-2012 was vaccinated with a dose of ZOSTAVAX 0.65mL, S.Q. in his left arm (lot number 672559/1657AA). Concomitant therapy included unspecified blood pressure medication and simvastatin (manufacturer unspecified). The reporter stated that the patient who received ZOSTAVAX had an ear infection. The treatment was given for an AE: prednisone. The patient sought medical attention - office visit. At the time of the report the patient's outcome was not recovered. Follow up information has been received from pharmacist refers to a 82 year male patient who on 19-JUN-2012 was vaccinated subcutaneously with a second dose of ZOSTAVAX (dose not reported, Lot # 672559/1657AA). It was reported that on 21-JUN-2012 patient developed ear infection. The patient received prednisone 20 mg for 9 days, for adverse event treatment. Additional information is not expected.
a dose given from a vial with the lot # 057M21A  today 7/12/22 when the BUD sticker was 7/9/22 of 30 days in the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a dose given from a vial with the lot # 057M21A  today 7/12/22 when the BUD sticker was 7/9/22 of 30 days in the fridge) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 057M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (a dose given from a vial with the lot # 057M21A  today 7/12/22 when the BUD sticker was 7/9/22 of 30 days in the fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a dose given from a vial with the lot # 057M21A  today 7/12/22 when the BUD sticker was 7/9/22 of 30 days in the fridge) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  A dose given from a vial with the lot (057M21A) today 7/12/22 when the BUD sticker was 7/9/22 of 30 days in the fridge.  No treatment medications were reported.
the patient had had been having flares. He experiences it in his wrists, shoulders, GI, and spine; This is a spontaneous report from a contactable consumer. A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history included ongoing ankylosing spondylitis. Concomitant medication included etanercept (ENBREL, Solution for injection in pre-filled pen) taken for ankylosing spondylitis. On an unknown date, the patient took covid vaccine, since he had the covid vaccine, the patient had had been having flares (ankylosing spondylitis). He experienced it in his wrists, shoulders, GI, and spine. The action taken in response to the event for concomitant drug etanercept was unknown. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Went to pharmacy to receive flu vaccine, the immunization was given in the wrong location (high shoulder region), experiencing pain when trying to lift left arm.
Chest pain, sore throat, uncomfortable breathing, neck glands extremely sore, painful teeth, pain in right ear, extreme tiredness (3 days not enough energy to get out of bed, not wanting to eat but no upset stomach.   No personal doctor so did not seek medical attention.  Took tylenol and did breathing exercises.  After beginning to feel better took Mucinex and Sudafed.  Day 4 started getting strength back.  Day 5 walking inside of home.
No ADE after giving shot directly. Patient called from home stating "hot feeling well, body aches, diarrhea, RPh/administrator explained couldn't get Flu from inactivated FLUVIRIN.
it was rpt from territory representative concerning pt who was vax & subsequently devel rotaviral gastroenteritis; recovered p/5days;
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 19-APR-2013 the patient was vaccinated with MMR II, 0.5 ml, subcutaneous. Dose number and lot number were not reported. The nurse reported that the vaccination and expired on 08-APR-2013. The patient was not experiencing any known symptoms. Additional has been requested.
Headache x 5 weeks (still having). Myalgia x 1 week. Fatigue x 5 weeks (still having). 7 days later sore throat and swollen glands in neck x 5 days.
Patient self reported a 3" x 1" red itchy rash that appeared on her face 1 week about after receiving vaccine. She said NEOSPORIN seemed to help.
HUGE swelling under arm.  About the volume of a softball or larger.  Now, 20 days later, I am still swollen.  It is about 4 inches in diameter and feels about the volume of a racquetball.  My underarm is convex, not concave like it should be.  I feel a slight pinch or pressure under my arm.
Pain on injection site (soreness, 2 days) Arm pain (pain from shoulder to hand, 2 days) Headache (moderate pain, 2 days) Nasal congestion, secretions (same day after vaccine, 2 days) Fatigue (less active, tiredness, 2 days)
This vaccine has caused balding on this beautiful head of hair which had been perfect for 45 years.  I demand compensation!
Patient was diagnosed with COVID-19 3 weeks 2 days after first dose (prior to second dose) of vaccine.  He was hospitalized for 2 days secondary to mild hypoxia but has otherwise had mild course thus far.
Information has been received from a physician assistant concerning a female (age not reported) with a history of abnormal Papanicolaou smear (CINI) who on 25-JUL-2007 was vaccinated with a dose of GARDASIL (lot # 654741/1208F) and was 5 weeks pregnant.  The patient's last menstrual period was reported to be on 24-JUN-2007 and an estimated delivery date of 30-MAR-2008.  Concomitant therapy vaccination included MMR, vitamins (unspecified), hepatitis B virus vaccine (unspecified) and meningococcal vaccine (unspecified).  On 23-AUG-2007 an ultrasound was performed with normal results.  A "full prenatal panel" was also performed with an abnormal PAP smear.  The patient's status was reported as "good".  Follow up information received on 09-JUN-2008.  The physician assistant reported that the patient gave birth to a baby boy at 40 weeks gestation.  He was 8lbs 8oz and Apgars were 7 and 8.  He is healthy and normal and there were no gross anomalies listed.  It was reported that the mother did have a c-section for failure to progress and no dilation, but there were no complications.  Upon internal review c-section for failure to progress and no dilation was considered to be an other medical event.  Additional information is not expected.
Chest tightness, racing heart, chills, cold sweats, insomnia, irritation, abnormal anxiety, fever, vomiting, diarrhea, light headiness, uncontrollable shaking
Redness, swelling and tenderness at ejection site.  Menstral bleeding.
After vaccination the patient said his arm was sore. And now sometimes he gets a sharp pain at the injection site. The pain is not there all the time but it does wake him if he is sleeping or if he moves his arm a certain way.
Morbilliform rash developed 7 days after MMR, no cough or congestion, no fever, started on scalp and moved down to feet in 24 hrs. No treatment.