chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician assistant refers to a female patient of unknown age who on 29-SEP-2012 and on 29-MAR-2013 was vaccinated with the first and the second dose of GARDASIL (doses and lot numbers not reported) respectively. On 27-JAN-2014, the patient would like to receive the third dose. No adverse symptoms were reported. Additional information has been requested.
Initial report received from a health care professional on 24 September 2009 which involved a cluster of ten patients; one of which experienced a serious adverse event which has been captured in case number 2009-04084. A cluster of ten patients (mixed genders, ages not reported) had received an intramuscular left deltoid injection of FLUZONE, lot number U3194AA on 22 September 2009 and within 24 to 48 hours (also reported as 23 September 2009), they complained of scratchy throats,  headache, general malaise, ear pain, GI symptoms and red itchy injection sites. The events required a doctor's visit; however the reporter stated that not all of the patient's experienced all of the reported symptoms. In addition to the reported symptoms, one patient developed a swollen throat and had been sent to the emergency room (captured in case 2009-04084). At the time of the report, the patients had not recovered from the events. Follow-up information received 16 October 2009 from a health care professional who provided patient specific information for one patient out of the remaining nine unidentified patients; This case shall now be the case of reference for a 43-year-old female who had no concurrent illness at the time of vaccination on 22 September 2009 at 08:00 hours. The event began at 22:00 hours on 23 September 2009 and did not require evaluation by a physician (previously reported as requiring a doctor's visit). According to the reporter, the patient recovered (date of recovery not reported). No additional information was provided for the remaining eight unidentified patients. The reporter for this case is the same as case number 2009-04084. Documents held by sender: None.
Intolerance to cold or heat, seizures upon waking up from general anthesia, irritable bowl syndrome, hair loss, severe fatigue and lethargy, finally after going to several doctors in specific location when moved to another state a doctor finally diagnosed me with the autoimmune disease, Hashimoto?s thyroiditis, in 2011 after years of struggling with all the symptoms and trying to get a doctor to figure out what was going on.  Then in 2015 I was diagnosed with triple negative breast cancer.
Patient had respiratory distress unknown cause . Onsite EMS was called vitals BP 111/74  100% O2 room air HR 78  BG 97  Patient refused evaluation/care went home against medical advice.
Got the first Moderna dose, 5 minutes later, my heart started raising, I got lightheaded, my hands cold, my throat narrow. Personnel took me to observation, my blood pressure jumped up to 204, my heart bit to 190, felt like that for 15 minutes, then my BP started to come down. They called an ambulance took me to the hospital, in the ambulance my BP came down to 170. Go to the ER, blood test ok, after two hours there BP came down to 130 they released me. FYI, 51 year old man, very active, I can run a marathon (26.1 miles) in 3:45, Im not diabetic, I dont take any medication, I dont have high blood pressure. Dont know what that  happened, no insurance, now waiting for a bill from the hospital, not to mention Im scared to death now taking the second dose.
Pt. w/ peri-umbilical follicultis on 2 May 09.  No tx. required.
Constant (24/7) dull headache since a few hours after the shot was administered.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-JAN-2016 at 00:20, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 8.6 (23 hours 32 minutes) and 8.0 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
This case was reported by a physician and described the occurrence of injection site reaction in a 5-year-old subject (now age 11 at the time of reporting) of unspecified gender who was vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date (years prior) the subject received unspecified dose of INFANRIX. At an unspecified time after vaccination with INFANRIX, the subject experienced a severe local injection site reaction. At the time of reporting the outcome of the event was unspecified. No additional details were provided. The physician was wondering, now that the subject is 11 years old, if the Tdap vaccine was contraindicated for this subject. Follow up information received from the physician on 24 January 2012. The physician noted that there was no information available about the subject. He explained that his call to GlaxoSmithKline was in response to a telephone consultation and conversation with another physician. No further information was provided.
Sore arm that lasted a couple days.  Approximately 10 hours after receiving 2nd dose/shot - while sleeping had chills and shakes that lasted about 2 hours.  Mild headache that went away after 24 hours.
Information has been received from a pharmacist concerning a 17 month old female patient who on 12-JUN-2008 was vaccinated IM with a first dose of MMR II. The pharmacist reported that the patient experienced an absence seizure, followed by a tonic-clonic seizure, 11 days after administration of her first dose of MMR II. The date of administration of MMR II was not available. The patient was found to have a 109 degree F temperature (confirmed temperature was 109 degree F). The patient was admitted to the pediatric intensive care unit on 23-JUN-2008. The patient received ATIVAN. Testing included a chest x-ray and computerized tomography of the head, which were both normal, and an electroencephalogram, results pending. The patient is scheduled to be discharged from the hospital on 24-JUN-2008. No further information was available.  Follow-up information was received the pharmacist. The pharmacist reported that the patient was vaccinated IM with a dose of MMR II (Lot# 0357X) on 12-JUN-2008. The patient had a medical history of milk, strawberry, and cinnamon allergies; croup; and birth by c-section. Concomitant medications included MIRALAX, TYLENOL, and ibuprofen. After receiving a dose of MMR II the patient experienced a low grade fever. Forty-eight hours prior to the hospital admission, the patient had 102degree F fever. Twenty-four hours prior to the admission, the patient started vomiting. On 23-JUN-2008, the day of the admission, the patient had diarrhea. The first "tonic" seizure occurred at 7:30 PM and the patient's lips turned blue and lasted 3 minutes. The patient had the second seizure, which consisted of "tonic clonic and lip smacking", around 9:00 PM and it lasted about 1.5 minutes. The patient did not receive any medications because the seizures were self resolved. The patient was considered recovered on 24-JUN-2008. No product quality complaint was involved. Additional information has been requested. A lot check has been initiated. The patient's experience was considered to be life threatening by the pharmacist. Follow up information was received from a nurse in the physician's office who confirmed that the 17 month old female was a patient in the pediatric intensive care unit. No further information was available.
I HAD SUDDEN MILD THROAT DISCOMFORT DIFICULTY SWOLLOWING THAT NEVER WENT ALWAY.
Patient called on 10/27/2005 saying after receiving flue shot on 10/26/2005 she was feeling dizzy, achy and ill when questioned, she reported itching and a rash she was advised to go to ER she refused. Called next day 10/28 she said rash was gone she was feeling better.
COULD not Move my arm from the shoulder to the elbow. Deltoid muscle would not respond at all.; Extreme pain; fatigue; headache; chills; This is a spontaneous report received from a contactable consumer or other non hcp. A 74-years-old female patient received  1st dose of bnt162b2 (Pfizer covid19 vaccine,Batch/Lot Number: EL8982), via an unspecified route of administration, administered in Arm Right on 11Feb2021 08:00,at the age of 74 years old, as Dose 1,single for covid-19 immunization.Medical history included drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included loratadine, hctz,famotidine,calcium carbonate (TUMS) taken for an unspecified indication, start and stop date were not reported.  The patient previously took clindamycin and experienced drug hypersensitivity.The patient experienced she could not move her arm from the shoulder to the elbow. deltoid muscle would not respond at all, extreme pain, fatigue, headache and chills on 11Feb2021 08:45.Therapeutic measures were taken as a result of could not move my arm from the shoulder to the elbow. deltoid muscle would not respond at all.,extreme pain,fatigue,headache and chills.The patient had not received any other vaccine within 4 weeks.The patient received Percocet: CBD cream for adverse event treatment.The patient was not diagnosed with covid prior to vaccination and not tested for covid post vaccination.The outcome of the events was recovered.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Information has been received from a mother concerning her 5 month old underweight daughter who "had been throwing up a lot since around the time she was born and who in August 2007 "was really constipated and had a fever of 103F" who on 24-OCT-2007 was vaccinated with a first dose of PEDVAXHIB. A second dose of PEDVAXHIB was administered on 07-DEC-2007. The mother reported that the patient "was given a lot of other shots" on the same days. The patient was reportedly "really sick" after the second dose of PEDVAXHIB on 07-DEC-2007. The patient was being seen by the health department. Subsequently the patient died on 16-DEC-2007. It was reported that they were awaiting autopsy results but an initial report from the medical examiner that stated "there was cocaine metabolized in her hair." Additional information has been requested.    3/5/08 Autopsy report states COD & manner of death as undetermined.  Circumstances suggested smothering & mechanical asphyxia w/blunt force injuries, acute bronchopneumonia RUL.
we were heavier when we got the shot; GERD; ministroke; lost vision in 1/2 right eye; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 21Feb2021 as dose 2, single (Lot number: EL9266, Expiration Date: 31Mar2021) at the age of 75 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing); "Breathing" (unspecified if ongoing), notes: He is on Breo Ellipta inhaler for breathing; "Rt side carotid artery-100% blocked", start date: Nov2020 (ongoing), notes: cardiac stress test and echocardiogram both normal, collateral circulation present so not new. Concomitant medication(s) included: CRESTOR taken for blood cholesterol; BREO ELLIPTA taken for dyspnoea. Vaccination history included: BNT162b2 (Anatomical location: Lt arm, Route: intramuscular, Batch/lot number: EL3249, Time: AM), administration date: 19Jan2021, when the patient was 75-year-old, for COVID-19 immunization. The following information was reported: BLINDNESS (medically significant) with onset 17Sep2021, outcome "unknown", described as "lost vision in 1/2 right eye"; TRANSIENT ISCHAEMIC ATTACK (medically significant) with onset 17Sep2021, outcome "recovered" (18Sep2021), described as "ministroke"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "we were heavier when we got the shot"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious), outcome "unknown", described as "GERD". The patient underwent the following laboratory tests and procedures: Blood test: (17Sep2021) Mini stroke; Cardiac stress test: (Nov2020) Normal; Computerised tomogram: (17Sep2021) Mini stroke; Echocardiogram: (Nov2020) Normal; Magnetic resonance imaging: (17Sep2021) Mini stroke. Therapeutic measures were taken as a result of transient ischaemic attack, blindness, gastrooesophageal reflux disease. The patient was 6' and was 188 pound. That's what they currently are, and they were heavier when got the shot. He was on a heart tablet twice a day for Metoprolol Tartrate and he has GERD and he's on Nexium (Treatment). He had ministroke on 17Sep2021 and Retina doctor said not an ocular stroke. On 26Jul2021, Rt eye lens replaced and on 17Sep2021, lost vision in 1/2 of Rt eye-horizontally. On 09Aug2021, Lt eye lens replaced and Retina Doctor said Not an ocular Stroke.  Follow-Up (12May2022): Follow-up attempts are completed. No further information is expected.  Follow-up (24May2022): This is a spontaneous follow-up report received from a contactable consumer (patient's wife). Updated information: Age, medical history, lab data, historical vaccine, suspect drug details, new event and clinical information.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200687387 as same reporter/drug/event, different patient.
Felt a little funny after getting vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1), for Covid-19 Immunization.  The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Felt a little funny after getting vaccine".   Additional information: The patient wanted to know if he really received new Comirnaty and if it was actually FDA approved. Said his DR said new Comirnaty vaccine was not fully approved just the license was approved and it's not even available. Started arguing about him having a medical team on hand and know nothing. Also mentioned his DR wants him to have an EKG just to make sure everything ok.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Injection 1/7/21. Night of 1/13/21 injection site became inflamed, entire upper arm was swollen, red, hot, painful and itchy.  This reaction began to resolve in 2 days. Currently some redness, occasional itchiness.
PT STATES THAT THE AFTERNOON OF HER HIGH DOSE FLUZONE VACCINE, THAT HER LEFT ARM WAS VERY PAINFUL AND SHE COULD NOT RAISE IT FOR ABOUT 24 HOURS. NO TREATMENT, NEVER CALLED PCP OR HEALTH DEPT TO REPORT.
right arm was sore the day after vaccine was given . 2 days later HA, fatigue, chills, Right arm was swollen and red.
This spontaneous report was received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported.    On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M018957, orally, as prophylaxis (Strength, dose and expiration date were not reported), which experienced a temperature excursion between 32 and 35 Fahrenheit degrees for 24 hours. No previous temperature excursions were reported. Data logger was involved. No adverse effects were reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA009946: US-009507513-1703USA009947:
Patients complained that the site of injection (ZOSTAVAX) left arm has been itching and swelling.
This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking ), PYREXIA (Fever), PAIN IN EXTREMITY (Pain in arm), GAIT DISTURBANCE (Walking difficulty ) and NASOPHARYNGITIS (Cold) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced TREMOR (Shaking ), PYREXIA (Fever) and GAIT DISTURBANCE (Walking difficulty ). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm), NASOPHARYNGITIS (Cold), SWELLING (Swelling ), CHILLS (Chills) and CHILLS (Teeth chattering). At the time of the report, TREMOR (Shaking ), PYREXIA (Fever), PAIN IN EXTREMITY (Pain in arm), GAIT DISTURBANCE (Walking difficulty ), NASOPHARYNGITIS (Cold), SWELLING (Swelling ), CHILLS (Chills) and CHILLS (Teeth chattering) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: Positive. 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. Concomitant medication use was not provided. Treatment information included Tylenol.
Body aches; Low grade fever; nausea; swelling at shot site; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 30Apr2021 at 08:00 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included restless leg syndrome. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took prochlorperazine edisylate (COMPAZINE) on an unspecified date for an unknown indication and experienced drug allergy. Concomitant medications included ropinirole hydrochloride (ROPINIROLE) and chondroitin, glucosamine (CHONDROITIN; GLUCOSAMINE) on an unknown date for unknown indication. The patient also previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09Apr2021 at 08:00 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 at 02:00 the patient experienced body aches, low grade fever, nausea, swelling at shot site. No therapeutic measures were taken as a result of event. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event body aches, low grade fever, nausea, swelling at shot site was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Shortness or breath / breathing difficulty; weak; Sore arm / mild soreness in arm; fatigue; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Apr-2021. The most recent information was received on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness or breath / breathing difficulty), ASTHENIA (weak), VACCINATION SITE PAIN (Sore arm / mild soreness in arm) and FATIGUE (fatigue) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD. Concomitant products included HYDROCODONE for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced DYSPNOEA (Shortness or breath / breathing difficulty), ASTHENIA (weak), VACCINATION SITE PAIN (Sore arm / mild soreness in arm) and FATIGUE (fatigue). On 19-Mar-2021, VACCINATION SITE PAIN (Sore arm / mild soreness in arm) had resolved. At the time of the report, DYSPNOEA (Shortness or breath / breathing difficulty), ASTHENIA (weak) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included steroids for COPD No treatment information was provided.  Patient took the second dose on an unknown date. Upon follow up received on05/Aug/2021 reporter stated vaccine was more like the flu shot. Patient had mild soreness in arm and some breathing and fatigue difficulty.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up received on 05-Aug-2021. Updated event intensity for sore arm and added dose 2 information. Reporter's comment added. Corresponding field and narrative updated accordingly. On 09-Aug-2021: Non-Significant Follow up added on 09-Aug-2021 and contains no new information.
Patient developed petechiae and purpura 13 days after getting FLUMIST and has been diagnosed with ITP. Also had allergy/cold symptoms in previous week per Mom.
Pt with a history of advanced vascular dementia comes from his AFC home due to worsening confusion and persistent fever.  Pt is admitted for COVID-19 infection with pneumonia.
I experienced sudden extreme dizziness and fainting which resulted in a "shattered" ankle (doctor's word).  I now have 15 pins in my ankle.  I required 3 days in hospital, 3 weeks in rehab and 6 weeks in assisted living before I could return home.  I was in a wheel chair for8 weeks and received 6 months of physical therapy