chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At first directly after vaccination, I had soreness at the injection site. I took 2 Tylenol pills about 45 minutes after vaccination. I then began feeling lightheaded and dizzy about 2 hours after vaccination. Shortly after I became feverish with chills. I then took 2 Ibuprofen and fever/chills subsided, however lightheadedness continued but improved slightly.
Had Td and Typhim V in left arm Thursday PM 3/4/04: arm sore. Tues, 3/8/04 client noticed that left arm was weak. Could not hold coffee cup- numb and tingling. Went to ER-- ruled out stroke, heart attack. PA aid it was a reaction to immunization. Pt states that gradually feeling strength came back to arm. Now only slight numbness. Left middle finger- strength good.
I did and the flu came and went with little infection; Initial information received on 10-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age/gender patient who experienced i did and the flu came and went with little infection after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Dec-2022, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (dose, formulation, strength, lot and expiry date: unknown) via unknown route in unknown administration site for prophylaxis vaccination.  On an unknown date the patient developed a non-serious i did and the flu came and went with little infection (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (I did and the flu came and went with little infection).  At time of reporting, the outcome was Unknown for the event i did and the flu came and went with little infection.
Injection site sore, throbs at NOC, bruise x about 5 days. Warm moist pks to area. Takes BENADRYL routinely. Called Health Dept 10-9-09 et notified of reactions.
administered Menactra after the expiration date with no reported adverse event; Initial information received on 03-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 years old male patient who was administered MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (Menactra) after the expiration date with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were reported as none    On 03-Aug-2022, the patient received a  dose 2 of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, at dose of 0.5 ml once, ( lot: U6952AA ; expiry date: 09-Jun-2022)  via intramuscular route in the left deltoid for immunization.  It was reported that the patient was administered Menactra after the expiration date with no reported adverse event (expired product administered) (onset date: 03-Aug-2022) (latency: same day)  following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.   Action taken : not applicable.  Outcome: unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Chills, fever thru the night, joints ached, naseaus, and extremely tired.  Took extra strength tylenol every 6 hours.  The next day the fever broke but all other symptoms remained.  Chills were not as bad.  The next day, I was fine, just a little tired. Not much of an appetite.
Redness at injection site, Chest tightness, lip tingling Itchy mouth. Initial VS (12:44) 165/96 p124,o2 98%ra. F/u Vs (12:49) 140/87 p 122 Narrative:  Epi e IM given 1247 Diphenhydramine 50mg IM 1251
Client received vaccines, client stayed in clinic for 25 minutes post vaccination, Client stated that she felt fine the entire time, no S/S of side effects. Client was able to leave clinic with her parents. Client was seen skipping to her family's car in the clinic parking lot when she bumped into the parked car, stepped back and fell slowly to the ground. RNs, rushed to the parking lot to help client, she was A&O, client vomited 2 times and then laid supine with legs elevated, BP unable to be assessed due to traffic noise, client started to feel better, she declined juice or candy, client drank water, ice pack was applied to back of client's neck. Client was able to sit up in a chair, client stated that she feels fine and was able to walk straight to her families car, client states that she feels fine, denies feeling nauseas or dizzy. Client's skin is warm and pink. Client declined hitting her head and declines any pain. No obvious injuries. Client's parents were counseled to seek medical attention for their child for any further S/S of a side affect. Patient was instructed to drink fluids. Client was able to leave with her parents.
Began having a headache about an hour after the vaccine was given.  The next day, I am nauseous, have a mild fever, and body aches.
Ck levels shooting up; cancer antigen doubling; raise in alkaline phosphatase; This is a spontaneous report based on the information received by Pfizer from Genentech (Reference: LRN4245557). A Non-Contactable 77-year-old female consumer (patient) reported that: A 77-years-old female patient received bnt162b2 (PFIZER COVID-19 VACCINE, FORMULATION: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included Cobimetinib Fumarate (COTELLIC); Vemurafenib (ZELBORAF) and Trastuzumab Emtansine (KADCYLA) taken for an unspecified indication, start and stop date were not reported. The patient experienced CK levels shooting up, Cancer antigen doubling from 62 to 156 and raise in alkaline phosphatase on an unspecified date. The patient underwent lab tests and procedures which included blood alkaline phosphatase: raise on an Unspecified date, blood creatine phosphokinase: from 148 to 605 on an unspecified date. The outcome of event was not recovered.  No follow-up attempts are needed. Information about lot/batch number cannot be requested.
Developed Large Bruise on inside calf left leg after 1.5 day.s. Large bruise above inside left ankle on day 16 after 1st shot.
TONGUE TIE; LIP TIE; FOETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a male neonate of an unspecified race and ethnicity. The patient's mother was enrolled in a non-company sponsored study. The patient's birth weight was 7.15 pounds, and height was 20 inches. No concurrent conditions were reported. The patient's parent's medical history Maternal medical history included bipolar disorder. Maternal obstetrical history included two previous pregnancies, both resulting in an elective termination. The mother had history of tobacco, e-cigarette and recreational drug use, however reported no alcohol use. Maternal first day of the last menstrual period (LMP) was calculated to be 15-MAR-2021. The estimated delivery date (EDD) was reported to be 20-DEC-2021. Type of pregnancy was reported as singleton. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, transplacental, batch number: 201A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 09-APR-2021 for covid-19 immunisation. Concomitant medications included carbamazepine, lamotrigine, minerals nos/vitamins nos, pantoprazole sodium sesquihydrate, and quetiapine fumarate.  On 09-APR-2021, at gestational age three weeks and four days, the mother of the neonate received the vaccine and patient experienced foetal exposure during pregnancy. At gestational age 40 weeks, the mother delivered a live, full-term, male neonate by cesarean method of delivery (C-section). Primary reason for C-section was reported as labor not progressing. On an unspecified date in DEC-2021, Laboratory data included: Hearing test Not reported. On an unspecified date after birth, the neonate was diagnosed with tongue tie and lip tie. On 08-JUN-2022, the infant underwent removal of tongue tie and lip tie. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tongue tie, and lip tie on 08-JUN-2022, and foetal exposure during pregnancy on 20-DEC-2021. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and tongue tie, and lip tie as unassessable, and between covid-19 vaccine ad26.cov2.s, and foetal exposure during pregnancy as not related. Company causality between covid-19 vaccine ad26.cov2.s, and tongue tie, and lip tie was related.  This report was serious (Other Medically Important Condition). This parent/child case is linked to 20210800839.; Sender's Comments: V0: 20220754639-covid-19 vaccine ad26.cov2.s- Tongue tie, Lip tie. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered related.   20220754639-covid-19 vaccine ad26.cov2.s-Fetal exposure during pregnancy. . 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. Therefore, this event(s) is considered not related.
Severe swelling in left arm followed by dystonia (spasms of body) followed by severe pain in muscles, spine, shoulders and other various places in the body, including weakness and confusion.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Feb2021 as dose 1, single (Lot number: EN6200), in right arm, on 19Mar2021 as dose 2, single (Lot number: EP6955), in right arm and on 03Oct2021 as dose 3 (booster), single (Lot number: 301458A) at the age of 47 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergy: vaginal suppositories" (unspecified if ongoing); "thyroid cancer" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: Jan2010; PEPCID [FAMOTIDINE], start date: Apr2021; FLUTICASONE, start date: Oct2013, stop date: 04Jun2022; FLOVENT, start date: Jan2010, stop date: 04Jun2022; ALBUTEROL [SALBUTAMOL], start date: Jan1980; LEVOXYL, start date: Oct2001. Past drug history included: Nifedipine, reaction(s): "known allergy:Nifedipine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Information: Therapeutic measures for covid-19 included Paxlovid with start date 04Jun2022 and stop date 08Jun2022.  No follow-up attempts are possible. No further information is expected.
non-severe allergic reaction (hives) in multiple areas of the body, including left arm (injection arm), lower back, right upper thigh, upper back, and chest. start 4/23/2021 and ongoing as of report.  Other adverse events include: sore left arm at site of injection within 4 hours and subsided within 24 hours; body chills within 4 hours and subsided within 24 hours.
APPROXIMATELY 24 HOURS AFTER ADMINISTRATION, PATIENT HAD TEMPERATURE OF 101, WITH SORE THROAT, MUSCLES PAINS, AND HEADACHE.  He took Benadryl before he was seen and was given Claritin prescription and advised to go to ER if hives or SOB.
Pt stated lg abscess to Lt deltoid. Admitted to hospital, I and D done.
Painful erythematous upper arm distal to injection site with subjective shortness of breath, marked anxiety, anorexia.
prolonged (2hr) episode of uncontrolled crying evening p/shot given; APAP given; pt seemed fine p/crying stopped & parents did not feel report to MD was necessary @ the time;
This spontaneous report has been received from a 63 year old male patient via a company representative (reported as relative). The patient's medical history, concurrent conditions and concomitant medications were not provided. On 19-MAR-2018, the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. On an unknown date in 2018 (reported as after administration), the patient experienced swelling neck and rash on both arms and neck. The patient was currently taking cephalexin 500 mg twice daily, however the company representative assumed may be the treatment, but could not 100% confirm. The outcome of swelling neck and rash on both arms and neck was unknown. The causal relationship between the adverse events and the therapy was not assessed.
Arm is very sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is very sore) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm is very sore). At the time of the report, PAIN IN EXTREMITY (Arm is very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Red rash over injection site; Right upper arm typical discomfort after vaccination; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of LIMB DISCOMFORT (Right upper arm typical discomfort after vaccination) and VACCINATION SITE RASH (Red rash over injection site) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced LIMB DISCOMFORT (Right upper arm typical discomfort after vaccination). On an unknown date, the patient experienced VACCINATION SITE RASH (Red rash over injection site). At the time of the report, LIMB DISCOMFORT (Right upper arm typical discomfort after vaccination) and VACCINATION SITE RASH (Red rash over injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided 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.
Pt states right after shot (anthrax) had burning sensation, swelling, redness, numbness and pain lasting for a couple of days, under the area to the hand.  Nerve problems occurred that were not present before. Pt referred to Neurologist. Per follow-up: 7/26/00 850 - Spoke to pt - numbness has abated, but pain from shoulder to elbow persists - diagnosed as "tennis elbow", consent form sent for medical records for neurological consult.
OFF LABEL USE; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a pharmacist concerned a 16 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. The batch was not reported and has been requested. No concomitant medications were reported. On 12-MAY-2021, the subject experienced off label use. On 12-MAY-2021, the subject experienced product administered to subject of inappropriate age. The action taken with covid-19 vaccine  was not applicable. The outcome of the off label use and product administered to patient of inappropriate age was not reported. This report was non-serious.
headache, anxiety, lethargy, shortness of breath with minor exertion. 2 days after vaccination; felt better, but got tired after a couple hours of desk work. Slept 2 hours, did more desk work, got tired again. 3 days after vaccination; no symptoms.
Patient received immunization. Seemed to be doing well. Was sitting in waiting area and Pharmacist noticed patient slumped in chair. Went to patient and shook her shoulder and patient awoke. Appears patient was unconscious for just a few moments. Patient was very clammy and sweating but breathing was normal. No swelling in face or throat and could speak well with no problems. Patient was monitored for an extended amount of time and had driver to take her home.
-Chills 1300-1400 -Fever 2100 102.2 -Nausea  -Headache  -Body aches
I received the vaccine on 09/23/21. I started getting back pain and cramps 09/30-10/1, and started bleeding on 10/2-4. It was confirmed that I had a miscarriage.
This spontaneous report as received from a registered nurse refers to a 6 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 14-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012735 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the number US-009507513-1610USA014706 has been changed from Company Number to Linked Report.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706.
Patient woke up on 1/29/2007 with one red spot on side.  As morning progressed, develope 3-4 other spots.  These spots then turned into blisters as day went on.
Injection on 11/29 @ 0900  09:00 - minimal injection site pain 18:00 - onset of generalized myalgia, headache  20:00 - mild fever (below 100 F) 11/30 @ 01:00 - acute onset of abdominal cramping - 7/10 pain, diarrhea  01:00-12:00 - abdominal cramping, diarrhea 11/29-11/30 all day - generalized myalgia, fatigue, headache  11/30 fell asleep at 19:00, woke up 12/1 @ 07:00 feeling 90% better. Mild fatigue/myalgia continued, diarrhea resolved.
no adverse effect but the patient was 16 years of age and I missed it when the vaccine is indicated only for 18 years of age
burning sensation on her body; itchy and burning sensation on her body; swollen gland; rash underneath her elbow; fatigue; Arm swelling (injection site); This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning sensation on her body), PRURITUS (itchy and burning sensation on her body), LYMPHADENOPATHY (swollen gland), RASH (rash underneath her elbow) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No adverse event reported).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Arm swelling (injection site)). On 04-Mar-2021, the patient experienced BURNING SENSATION (burning sensation on her body), PRURITUS (itchy and burning sensation on her body), LYMPHADENOPATHY (swollen gland), RASH (rash underneath her elbow) and FATIGUE (fatigue). At the time of the report, BURNING SENSATION (burning sensation on her body), PRURITUS (itchy and burning sensation on her body), LYMPHADENOPATHY (swollen gland), RASH (rash underneath her elbow), FATIGUE (fatigue) and VACCINATION SITE SWELLING (Arm swelling (injection site)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
I received injection in left upper arm and 5 minutes after my upper arm began to swell, turn red, and a rash developed with weakness and numbness felt in left arm.
Within first few days of shot... Headache arm soreness, exhaustion, dizziness. Today 2/25/2021- Headache/exhaustion 2/26/2021- GI issue
Information has been received from a healthcare worker concerning a female who on 27-MAR-2007 was vaccinated with a dose of Zostavax. On 28-MAR-2007 the patient experienced inflammation and redness at the injection site. The patient's inflammation and redness at the injection site persisted. Unspecified medical attention was sought. No product quality complaint involved. Additional information has been requested.
Breakthrough COVID-19 case with unknown symptom onset date: Fatigue or tiredness and weakness. Patient presented to ED on 08/19/2021 after a fall with weakness and feeling tired. Patient death reported by hospital. Patient was admitted on 08/20/2021 and died on 08/24/2021.
Leg/foot edema. Furosemide dose increased and if no significate improvement by today, will call into doctor by afternoon today for further instructions.
TESTED + FOR COVID ON  08/29/2022.   TRANSFERRED  ON   9-9-22 with septic shock, resp failure, covid, acute kidney injury, elevated troponin, anemia and GI bleed.  She had multiple specialty consults including pulmonary, cardiology, infectious disease, nephrology.   Had complicated course with being  on ventilator,  on levophed ,  given merrem antibiotics, dexamethason and baricitinib,  had serratia in sputum and blood,  developed afib with rapid ventricular response with hypotension.  amiodarone and pressure support   , had bloody stools, anemia ,t ransfusions .  Deceased  9-27-22.
Patient reported small rash on arms and lips swelling last night. She took an antihistamine and it seemed to help. Today she has less rash and swollen eyes.