chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a 65 year old female with sulfonamide allergy and a history of heart attack 4 years back who on 24-JAN-2008 was vaccinated on right arm with a single dose of Zostavax (Oka/Merck).  Concomitant therapy included LIPITOR and PREMARIN.  On 24-JAN-2008 3 hours after vaccination the patient's right arm was red and inflamed at injection site.  The patient also experienced weakness on her body and headaches on the right side of her head.  According to patient's husband, her behavior was rather "different" than usual.  No diagnostic laboratory tests were undertaken.  Unspecified medical attention was sought.  At the time of report the patient was recovering.  A product quality complaint was not involved.  Additional information has been requested.
Patient fainted within 15 minutes of vaccination and fell and hit his head on the floor.  He felt better after resting and was released to home.
has taken 3 capsules; on the first day started w/skin reaction on rt leg & since then has moved up body & on to rt arm;
Tired; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of FATIGUE (Tired) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 FATIGUE (Tired). At the time of the report, FATIGUE (Tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported.
tingling in his left fingers and hand; This case was reported by a consumer via call center representative and described the occurrence of tingling in a 61-year-old male patient who received Rabies NVS (RabAvert) for prophylaxis.   Co-suspect products included Tetanus NVS (Tetanus vaccine) for prophylaxis and amoxicillin sodium, potassium clavulanate (Augmentin) unknown for drug use for unknown indication.   Concurrent medical conditions included animal bite.   On 20th November 2019, the patient received the 1st dose of RabAvert. On 18th November 2019, the patient received Tetanus vaccine. On an unknown date, the patient started Augmentin at an unknown dose and frequency. On 20th November 2019, less than an hour after receiving RabAvert, 2 days after receiving Tetanus vaccine and an unknown time after starting Augmentin, the patient experienced tingling. On 22nd November 2019, the outcome of the tingling was recovered/resolved.   It was unknown if the reporter considered the tingling to be related to RabAvert, Tetanus vaccine and Augmentin.  Additional details were provided as follows: The patient sustained a squirrel bit and was seen at the emergency room and received a Tetanus shot (unspecified) and antibiotic Augmentin for ten days. Within few minutes after Rabavert vaccination, started to experienced tingling in his left fingers and hand. The patient continued to experience the tingling till 22nd November 2019. He did not have any tingling on 23rd November 2019 and 24th November 2019. Based on the patient's adverse event, the healthcare provider has decided to not administer the other remaining doses. The patient has not provided his address and also healthcare information was not provided. The reporter denied consent to follow up.
pt recvd vax; 10 hrs later, exp 6x6cm local erythema, induration, swelling & tenderness; fever; md expressed a concern for particular lot;
Evening 12/19 just after dinner I had abdominal pain and was sore to the touch. Also had a low-grade fever with chills. Tried to sleep it off and woke the next morning to pain and fever. Called into work and called my Gastrointestinal doctor. Was advised that evening to go to urgent care. The next morning was feeling a little better but still sick. It seemed to me that I either contracted food poisoning or had a reaction to the booster. Decided to stay at home to see if I could wait it out. My issues with Gastrointestinal tract are still ongoing.
1st vaccination Friday. I was fine on Friday. Saturday woke with sore throat, neck, mucus, sore muscles and weak. By mid-afternoon had to go to bed and slept for hours. Got up at 9PM and went back to bed at 11PM. Sunday was better, but this AM (Monday) awakened with itchy skin, pins and needles on hands and feet (gone now) and total exhaustion. Had difficulty breathing (better now), can barely lift arms and had to miss work and went back to bed. I am reporting this because I am scheduled for a 2nd shot on the 26th and not certain it's a good idea.
Patient received Moderna vaccine but he was only 17 years old. Per CDC recommendation at the time, Moderna Covid Vaccine was for 18 years and older.  Per patient's mother, no adverse reactions occurred that she was aware of.
Patient came to pharmacy around 2:00 PM on 6/3/2014 to report that she had an adverse reaction from the vaccine. Her arm was bruised red and purple at the injection site. The diameter is about the size of a golf ball and the bruise was not raised. She reported that she had a mild headache, denied having a fever, and stated she had some pain at the injection site. After receiving the vaccine on 6/2/14 very light bleeding was noticed at the injection site. The patient denied using any aspirin or blood thinners since receiving the vaccine and was instructed to follow up with her primary care physician who prescrived the vaccine. Receptionist at her primary care physician's office was notified of the adverse event via telephone at 2:22 PM on 6/3/14.
Patient feelss tightness in chest. vitals and EKG completed. no abnormalities found
Information has been received from a consumer concerning her daughter, a 17 year old female with a history of drug hypersensitivity to PEDIAZOLE, who sometime in 2007 was vaccinated with all three doses of GARDASIL (lot numbers and dates unspecified) and has been diagnosed with arthritis.  Sometime after receiving the first dose, her daughter developed pain all over her body including ankles, knees, and elbows.  Right before receiving the third dose her symptoms started to improve but still existed.  The consumer is wondering if her daughter's symptoms will worsen after receiving dose #3.  The consumer did not want to provide the physician's information or provider's name.  No other details.  The patient's arthritis and pain all over her body persisted.  No further information is available.
Information has been received from a health professional concerning a patient under 1 year old who was vaccinated with an oral dose of Rotateq. Subsequently the patient experienced a bloody stool. It was reported that the patient had "a G tube" for an unspecified reason. Unspecified medical attention was sought. No product quality complaint was involved. Upon internal review, the patients bloody stool was considered to be an other important medical event. Additional information has been requested.
patient received an expired Act-Hib with no reported adverse event; Initial information received on 29-Nov-2021 regarding an unsolicited valid  non-serious case from a pharmacist and other health care professional via regulatory agency (under reference 00875926).  This case involves a 75 year old male patient who received an expired HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination included MENINGOCOCCAL VACCINE and PNEUMOCOCCAL VACCINE (lot numbers and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On 24-Nov-2021, the patient received a dose of suspect HIB (PRP/T) VACCINE (once, lot UJ351AAB and expiry date: 09-Aug-2021) via unknown route in an unknown administration site for prophylactic vaccination (it was stated that they did not document).  It was an actual medication error due to expired vaccine used (same day latency).  It was reported "The Medical Information agent confirmed the spelling of demographics with the caller for accuracy. The caller reported that a patient received an expired Act-Hib and she wanted to know what to do now."  At time of reporting, no adverse event was reported.  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 guidelines. 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.
Vaccinee's account: "I received the vaccine on March 27, 2003.  On March 29-30, I had a slight headache, no fever.  March 31, slight myalgia, and lymphadenopathy.  After those symptoms resolved, I had no noticeable symptoms.  On April 5, I had a severe headache with photohypersensitivity.  I sought treatment at the ER,I was given several meds IV, none worked until they tried Demerol.  The ER physician did not think the headache was associated with the vaccine.  During the next few days I had several headaches of about the same severity.  I made an appointment with my regular physician, who also didn't think there was a relationship with the headaches and the vaccine, but felt it should be reported.  I've still been having the headaches, so I don't think they're vaccine related either, but probably coincidental with the vaccination."
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 27Oct2021 as dose 2 (booster), single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 22Mar2021 as dose 1, 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) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.  Clinical Information: Adverse event: Tired. Fever. Congestion. Positive COVID test. Anti viral details: product: COVID 19 Treatment  (Paxlovid), start date: 23May2022 and  stop date: 29May2022, indication was treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
PATIENT REPORTED RIGHT FOOT SWOLLEN FOR ABOUT 4 TO 5 DAYS.  LEFT FOOT HAD "MINOR" SWELLING.  THIS WAS AFTER THE SECOND COVID MODERNA SHOT.  SHE ALSO HAD SWOLLEN LEG AFTER THE FIRST SHOT WHICH RESOLVED ON ITS OWN BUT PERSISTED FOR ALMOST 13 DAYS.
A few minutes later had runny nose, sore throat, coughing, pain in the arm where vaccination was administered.  At 10:00 PM had chills for a few hours.  Had extreme exhaustion for 3 days and pain in arm for 1 month.
Pericarditis or myocarditis (wasn't determined). Sharp and persistent chest pain started ~12 hours after the Pfizer vaccine. The pain was worse when laying on my left side. I went to the emergency room. They did a full workup with a blood work, a chest X-ray and EKG to determine that my heart was functioning properly and I had adequate oxygen levels and was not having a heart attack. I was in the ER for approximately 3 hours and the physicians determined it was an inflammation of the heart area and either pericarditis or myocarditis. I was instructed to take at least 800mg of ibuprofen 2x per day until the inflammation was reduced and pain subsided. I was instructed to return to the ER if the pain increased.   The chest pain subsided over the next 7 days and hasn't returned since.   I also had a fever, chills, etc. that started ~8 hours after the vaccine. It was undetermined if these were related to the heart issue or a side effect of the vaccine.
ACUTE PULMONARY EMBOLISM; This spontaneous report received from a parent via a company representative via social media concerned a 58 year old female of unspecified race. 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 (Dose number in series 1) (suspension for injection, route of admin was not reported, batch number was unknown and expiry date was unknown) dose was not reported, 1 total, administered on 21-SEP-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient had acute pulmonary embolism. On 01-OCT-2021, the patient died due to acute pulmonary embolism. It was unspecified if an autopsy was performed. As per the reporter "My daughter received the J&J vaccine 21-Sep-2021. Died 01-Oct-2021 due to an acute pulmonary embolism. She was 13 days from celebrating her 59th birthday." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0:20220100225-COVID-19 VACCINE AD26.COV2.S-Acute pulmonary embolism. This event(s) is considered unassessable. 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).; Reported Cause(s) of Death: ACUTE PULMONARY  EMBOLISM
presented with SOB x 5 days, fever, hypoxia, cough; + Covid; admit with Covid PNA; tx with singulair, maxipime, steroid, remdesivir, zinc, actemra, zyvox, merrem, vanc; maintained on high flow O2 initially; moved to ICU 9/14; intubated; COVID ARDS- FiO2 @ 70% currently.Despite all measures, she continued to deteriorate and became moribund on 11/5/2021. After a long battle with her illness, her family felt that she had fought enough and opted for comfort measures. She was pronounced deceased on 11/5/2021
Since this vaccine has been given in my left arm in March, I have had pain and discomfort.  To start I was unable to lift the left arm completely over my head with out pain.  I went to urgent care and an ultrasound was given to see if there was fluid build up and none was found, the doctor then sent me to occupational  therapy for stretching.  I have been doing the stretching and it has assisted me with lifting my arm above my head, however I am still having a lot of pain and discomfort of this arm.  The area affected is also swollen and now it is waking me during the night.  I have recently gone back to urgent care to have this reexamined in hopes that the doctor would obtain some imaging to see what is happening.  Nothing was done except muscle relaxer and lidocaine patches.  I tried that and the medicines side affects were bothering me to a point that I was very irritable to my friends and family, short temper and so on.  I emailed my primary care doctor  and she scheduled my left arm for an MRI.  I explained that this is really bothersome and I am not wanting to be in pain any longer.
This case was reported by a other health professional and described the occurrence of expired vaccine used in a female patient who received FLUARIX (batch number XE294, expiry date unknown). On 30th September 2014, the patient received FLUARIX. On 30th September 2014, an unknown time after receiving FLUARIX, the patient experienced vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. It was unknown if the reporter considered the expired vaccine used to be related to FLUARIX. Additional information: Nurse reported she gave 4 female adult patients an expired dose of Flu vaccine on 30 September 2014, morning. No adverse event reported.
Tinnitus developed the day after the vaccine.   I saw him 3 months later and the sx were improving but still present
Information has been received from a physician concerning a 24 year old female who "more than a year ago" was vaccinated with GARDASIL, 0.5 mL, intramuscularly.  Concomitant therapy included NUVARING.  It was reported that the patient was tested for HPV prior to HPV vaccination: DNA negative for HPV and had a normal PAP smear.  The patient completed her series about a year ago.  The physician stated that at the end of NOVEMBER 2008 the patient had a HPV test, and was positive for the HPV in the high risk panel.  At the time of the report the patient was not recovered.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/16/2009. Follow-up information received from her physician indicated that she was a female patient with no known allergies who on 04-JUN-2008 was vaccinated with a first dose of GARDASIL (lot number 656049/0187U), the second dose of GARDASIL (lot number 658558/1061U) on 27-AUG-2007, and the third dose of GARDASIL (lot number 659055/1522U) on 11-DEC-2007. The physician noticed that the patient had a pap smear on 22-DEC-2008, the following abnormalities were found: low grade squamous intraepithelial lesion (LGSIL), positive high risk panel for GARDASIL, Colposcopy confirmed LGSIL. Patient not recovered. Additional information is not expected.
Around 11:00 on 09/24 I started feeling like my whole body ached. This lasted until about 8:00 pm that same night.
Immediately following vaccination, patient reported difficulty breathing/anxiety which subsided shortly.  In weeks following vaccination, patient has been experiencing auditory hallucinations (ie. hearing voices telling her disturbing things about her family, telling her to end her life).  Patient was started on quetiapine on 1/4/23, with the dose being increased on 1/12/23.  She was also started on treatment for UTI on 1/17/23.  Family member reports that hallucinations are continuing, but otherwise patient is lucid and at physical baseline.  She has an appointment scheduled with neurology some time at the end of January 2023.
Almost exactly seven days after my second Moderna shot, I had a urination which was dark blood red. It included a small blood clot, which by my estimate was at most 1/2" long by 1/8" in diameter.  There was no pain or burning on discharge, either with that urination, or before, or after. My next urination after that had a very small amount of dark red discoloration; and there has been no dark red in my urine after that [now six days]. Following that bloody urination, I did have a slight discomfort in the area below my belly button for several hours, but then it stopped. Since that incident, I have increased my intake of water and decreased my intake of acidic and carbonated drinks. I have not smoked in more than 45 years; and the occasional urinary dribbling I had experienced for some years before that incident has decreased noticeably. All else is OK. As a non-healthcare professional, I concluded the outcome to date is good. I have an appointment to see my doctor, on April 22.
He stated he has no energy.; he woke up and he was sweating; He did not feel good; He also has discomfort at the side of the injection.; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (He stated he has no energy.), HYPERHIDROSIS (he woke up and he was sweating), FEELING ABNORMAL (He did not feel good) and VACCINATION SITE DISCOMFORT (He also has discomfort at the side of the injection.) in an 81-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7171B) for COVID-19 prophylaxis.     Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient stated he had no medical History, condition, allergy or disease.     On 16-May-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 16-May-2023, the patient experienced ASTHENIA (He stated he has no energy.), HYPERHIDROSIS (he woke up and he was sweating), FEELING ABNORMAL (He did not feel good) and VACCINATION SITE DISCOMFORT (He also has discomfort at the side of the injection.). At the time of the report, ASTHENIA (He stated he has no energy.), HYPERHIDROSIS (he woke up and he was sweating), FEELING ABNORMAL (He did not feel good) and VACCINATION SITE DISCOMFORT (He also has discomfort at the side of the injection.) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported. It was reported that patient woke up and he was sweating. Patient did not feel good. So, Patient took a sleeping pill. Patient stated he had no energy. This is his 4th booster. Patient does not want to do this again. Patient also had discomfort at the side of the injection.
Shot given 3/24/16 called 3/27/16 and said a little swollen called pt 3/25/16 said deltoid between red and pink- is swollen.
PT VACCINATED WITH PFIZER ON 1/7/21 (LOT EL0140) + 2/24/21 (LOT EL0332). S/O BEGAN 9/1/21, TESTED + 9/2/21
Severe rash that began as a small patch on my left thigh and has now spread up and down both legs, my buttocks, forearms, and today my armpits and back.
outbreak of genital herpes; 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 GENITAL HERPES (outbreak of genital herpes) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 GENITAL HERPES (outbreak of genital herpes). At the time of the report, GENITAL HERPES (outbreak of genital herpes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment medication was provided.   Reporter did not allow further contact
pt is very moodness & crying; all TYPS of noc from 6:00 to 3:00AM & still diarrhea
2/4/14 - 8:00 AM - felt soreness with movement, no localized reaction. About 4 wk later went to PCP -> thought had hurt herself - sore shoulder and arm. XRay and blood work all neg. End of March had medical message - no relief. 5/15/2014 - (R) upper arm examined no redness, no swelling, nothing felt at site, no pain site, painful with movement at site - unable to pick up grocery bag with right arm, feels weak. 6/4/2014 - symptoms continues.
Started having flu like symptoms the next day, worsened over the next few days (fatigue, nauseous). Cellulitis started on right arm Sunday and extends from top of shoulder to elbow/antecubital area.
Received flu and pneumonia mist at 10:45 a.m. At 11:45 a.m. returned to clinic site stating tongue was numb. Redness (flushed look) to her face. 0.5 ml EPINEPHRINE administered. EMS arrived - refused to go to the hospital.