chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu; respitory virus; Initial information was received on 07-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/ non-health care professional via social media.  This case involves a 72 year old female patient who had flu (influenza) and respiratory virus (respiratory disorder), while she received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications 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 not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) and respiratory virus (respiratory disorder) (unknown latency) following the administration of INFLUENZA VACCINE that lasted for months. It was a year since she was vaccinated with flu shot  No laboratory data was provided   It was not reported if the patient received a corrective treatment.  At the time of report, outcome of events was unknown.  There will be no information available on the batch number for this case.
31AUG91 to ER for inc bruising over 2-3 days; admitted to Hosp & d/c 2SEP91 in AM;
Admitted to the hospital for left hand tingling, and neuropathy. Tested positive for Covid-19. Hospitalized from 10/23/21 - 10/25/2021.
Patient received the SHINGRIX Vaccine on 06/04/18. On 06/06/18 she began taking diclofenac 75mg DR tablets for shoulder pain. On 06/11/18 she presented to the clinic with a BP of 200/105, slurred speech, blurry vision, and was disoriented. An ambulance was called and patient was taken to the ER and diagnosed with an adverse reaction to diclofenac. I do not suspect the adverse reaction was to SHINGRIX, but due to the proximity of the immunization to the reaction I wanted to report it.
Complained of left arm pain after flu shot. Took Advil for relief. Took Medrol dose pack for relief. Referred to neurologist. Diagnosed with Brachial Plexitis and ordered P. T. , Vioxx, Iontophoresis with Dexamethasone. Back to work 12/11/02 (full duty). Referred to orthopedist and scheduled EMG study. Thinks shot was given too high.
Swollen lymph node in left armpit the day after vaccination; Dose number 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 45-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 29Dec2021 at 12:00 (Lot number: unknown) at the age of 45 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: UNKNOWN, Anatomical location: Left arm, Administration time: 14:30), administration date: 18Mar2021, when the patient was 44 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: UNKNOWN, Anatomical location: Left arm, Administration time: 12:45), administration date: 08Apr2021, when the patient was 44 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 29Dec2021 at 12:00, outcome "unknown", described as "Dose number 3"; LYMPHADENOPATHY (non-serious) with onset 30Dec2021, outcome "not recovered", described as "Swollen lymph node in left armpit the day after vaccination". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Testing as COVID positive as of 18Sep2022; Testing as COVID positive as of 18Sep2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 3-year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), on 25Jun2022 at 10:15 as dose 1, single (Lot number: FT9142), in right arm, on 16Jul2022 at 10:15 as dose 2, single (Lot number: FT9142), in right arm and on 10Sep2022 at 09:45 as dose 3 (booster), single (Lot number: FT9142) at the age of 3 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. No Covid prior vaccination. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Sep2022 at 07:00, outcome "not recovered" and all described as "Testing as COVID positive as of 18Sep2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Sep2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
gave the Bivalent booster vaccine but they did it as .25; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (gave the Bivalent booster vaccine but they did it as .25) and NO ADVERSE EVENT (No Adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS716513) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (gave the Bivalent booster vaccine but they did it as .25) and NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (gave the Bivalent booster vaccine but they did it as .25) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (gave the Bivalent booster vaccine but they did it as .25).    No concomitant medications were reported.  Reporter had only given this to one patient.  No treatment information was reported.   Reporter did not allow further contact
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC RESPIRATORY FAILURE
Pt had unconsolable crying episode lasting more than 3 hrs. Drs encouraged parents to keep pt on Tylenol q4h due to unusual & high pitched crying spells that wk (25Feb-29Feb)
This spontaneous case was received on 06-Dec-2021 from other healthcare professional via agency(reference number: SEQW21-05853) and concerned a 26-year-old, female patient.  The patient's medical history and concomitant medications were not reported.   On 13-Dec-2018, the patient was vaccinated with Afluria Quadrivalent (Flu Vaccine Egg Split QIV; dose: 0.5 ml; route of administration, anatomical location: not reported) for influenza prevention. The batch number was reported YF39207 expiry date 30-Jun-2019.  On the same day, one to two hours after vaccination the patient started vomiting and same evening noticed hives around the injection site. The hives resolved two to three days after.  At the time of initial reporting, the patient had recovered from the events.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: The events Vomiting and Vaccination site urticaria was assessed as related to Afluria Quadrivalent.; Sender's Comments: The events Vomiting and Vaccination site urticaria was assessed as related to Afluria Quadrivalent.
DIAPHORESIS; NAUSEA; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced diaphoresis. On 07-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diaphoresis, and nausea on 07-APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210417122, 20210417456, 20210417209, 20210417469, 20210417550, 20210417620 and 20210418457.
Pt received vaccine at approx 10:24 while sitting in observation area with husband, he noted she was not responding to conversation and alerted nursing staff. When nursing staff arrived at pt side was still sitting upright in chair w/ eyes closed, and unresponsive to verbal or tactile stimulation.  EMS activated.  Nursing staff and pt husband lowered pt to side lying position on floor without incident and pt became responsive immediately. Vital signs obtained at approx 10:30 were BP 88/60, HR 70, O2Sat 99% on room air.  Pt able to answer questions appropriately. BP repeated at approx 10:34 - 100/72. EMS arrived at approx 10:34 and assessed pt and cardiac and blood pressure monitors applied. Pt reported to EMT's that she has a hx of fainting w/ any needle stick, including injections, IV starts and blood draws. Refused to have capillary blood sugar take because though would pass out again. Repeat BP per EMT 119/82 at approx 10:40am. Pt refused to go to local Emergency dept for additional evaluation, was monitiored an additional 30 min without further incident.
her son is already 2 years old and they were exposed to someone who had the Covid 19 virus; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the parent.  A 2-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 2 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPOSURE TO SARS-COV-2 (non-serious), outcome "unknown", described as "her son is already 2 years old and they were exposed to someone who had the Covid 19 virus".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I was watching tv and started to feel  flushed and experienced an unexplained spike in blood pressure (208/105) with heart palpitations, tachycardia and irregular heartbeat (pvcs). I was taken by ambulance to  ED, spent six hours in the ER, no meds given and symptoms decreased within about 2 hours. After labs, EKG, and chest x-ray, no cause discovered. Until this episode, my  blood pressure has been consistently below 130?s/80 for the past 2 months.
Document Type: US Liver Elastography Document Subject: US Liver Elastography Performed By: MD on September 19, 2022 09:24 EDT Verified By: Alternate MD on September 19, 2022 11:23 EDT Encounter Info: Outpatient, 09/19/22 - 09/19/22  * Final Report *  Reason For Exam fatty liver  Report Exam: Right upper quadrant abdominal ultrasound  History: fatty liver;   Comparison: 4/7/2021  Findings:The liver appears of normal size. There is diffuse increased echogenicity of hepatic parenchyma compatible diffuse fatty infiltration. There is no evidence of hepatic mass lesion, intra-or extrahepatic ductal dilatation. The gallbladder appears normal. There is no evidence of cholelithiasis. The spleen is not enlarged. There is no evidence of focal splenic mass. No free fluid is seen within the abdomen.  The median hepatic stiffness is 1.79 m/s. This is compatible with mild to moderate hepatic fibrosis or a Metavir score of F2- F3.  IMPRESSION: 1. View study infiltration of the liver. 2. Otherwise normal-appearing right upper quadrant ultrasound. 3. The median hepatic stiffness is 1.79 m/s. This is compatible with mild to moderate hepatic fibrosis or a Metavir score of F2- F3.  Electronically Signed by: "PRIVATE" Dictated on: 9/19/2022 11:18 AM    Signature Line This examination and reported findings have been reviewed and confirmed by the undersigned.   Read By:  Onsite MD
I received the flu vaccine on Tuesday, 10/10 at 1:30pm. About three hours later, I started to have a debilitating headache. My headache never subsided. A week later, on 10/17, my headache progressively got worse, in my feet, hands and legs began to tingle and feel numb, and I was unable to void. I went to the emergency room on 10/18 and was admitted to the hospital on the neurology floor. I underwent a CT, MRI, and MRA of the head and an MRA of the spine. I also received an X-ray, EKG, and lumbar puncture. They put in a Foley catheter and received 1300 CCs of urine. A battery of blood tests were run with no conclusive results. I was placed on high dose SOLU-MEDROL of a gram a day for six days. They still do not know what the cause was, but have diagnosed me with transverse myelitis. I was discharged after five nights once I was able to void and have a bowl movement on my own. I still continue to have tingling in my feet/legs as well as headaches. I've been prescribed 9 weeks of prednisone and to follow up with a neurologist who specializes in myelitis.
Fever at 2:00am 101.7 (01/04/2018); Vomiting 6 times 1:00noon (01/05/2018); Drowsy napped 6 times (01/05/2018).
AFTER EACH INJECTION IT TOOK OVER A WEEK FOR MY TO GO SOMEWHAT BACK TO ITS NATURAL STATE.  10/6, I WAS PLACED ON LIGHT DUTY AT WORK . 10/15 LIGHT DUTY ENDED. 10/12, SAW ORTHO DR, SHE DIAGNOSED ME WITH  BURSITIS AND TOLD ME MY ROTATOR CUFF WAS SPRUNG.  I PLACED ON LIGHT DUTY  10/19. I HAD TO GO ON SHORT TERM DISABILITY 10/19  FOR 6 WEEKS BECAUSE MY JOB COULDN'T ACCOMMODATE ME. 11/30, I SAW MY ORTHO DR AND SHE EXTENDED MY LEAVE FOR 8 MORE WEEKS AND I STARTED PHYSCIAL THERAPY LATE BECAUSE THE LOCATION I  GOTO PUSHED APPTS FAR OUT.
I had the J&J vaccine on 4/1/21.   I have a history of blood clots. I have tested positive twice. Once back in 2001 when I was pregnant and later on around 2008. I have had these symptoms before, but since I have a rare bone disease and have medical issues I really don't like to complain and just deal with this stuff with the pain pills I have a prescription for.   Anyway, yesterday I was feeling a little off. My hands, feet and limbs in general tingling. I had a headache which is rare for me and tried to drink extra water, but by 5pmish came I took a handful of tylenol since I had an after work walk to go on with a girlfriend. After the walk I came home and had a desire to lay down and go to sleep. my leg was starting to go from tingle to burn. i decided that i needed to eat some dinner. after dinner i was struggling with breathing while sitting in the recliner chair watching TV, so I told my other half I needed to lay down, this was around 7pm. Then it was just a crazy leg burn from the back of my knee into my foot. I was describing it as if I someone pour gasoline on me and lite the match and I was burning alive. I took a muscle relaxer and forced myself to sleep.   The day after the J&J shot. i had chills and was so cold that mid day when I had breaks during my work from home, i climbed in bed with a heating pad to warm up. the shot also left a scare on my arm, which i found odd since i give myself six injections a week for my bone disease.   I tested positive with Covid December 20th, 2020 and it was a rough first week, but after about 10 days I was pretty much back to walking around and feeling better.    You're more than welcome to have all of my medical record information, just let me know what you need.   My doctor switched over to a different portal that I don't have access to and I haven't talked to her or her office since I had covid back in December and it's still a few hours before her office opens to report this, but I saw this on the news.   My leg is still tingling and stiff.  Again this is not my first time going through this, so I usually just push through it, but since I saw the news I am reporting it.
injection site pain for about 10 days afterwards; Patient reports that she was given ADACEL by a nurse last week; reports the nurse administered it in her triceps rather than her deltoid; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional (patient) via Global Medical Information (Reference number- 00711995) and transmitted to Sanofi on 05-Aug-2021.  This case involved an unknown age female patient was given DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] by a nurse last week reports the nurse administered it in her triceps rather than her deltoid (product administered at inappropriate site) and experienced injection site pain for about 10 days afterwards (vaccination site pain)  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.  On 28-Jul-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6964AA) (Frequency: once) (total) via intramuscular route in right triceps for prophylactic vaccination (product administered at inappropriate site)  On 28-JUL-2021 the patient developed a non-serious injection site pain for about 10 days afterwards (injection site pain) same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was reported that, "Patient asking if this dose is still effective or if she should get another dose of ADACEL and reports injection site pain has started to subside".  This vaccine administered at inappropriate site event was an actual medication error (latency same day)  Patient did not receive treatment  At time of reporting, the outcome was Resolving for vaccination site pain  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.
Hematoma. Upper right extremity. Advised pt to apply ice compress to the affected area, 20 mins at a time, up to 8x daily. Elevate the limb whenever you are lying down, and continue to rest the affected limb and avoid heavy lifting/unnecessary movement. I want to f/u on the resolution of this. Kindly see me back in one week. Injection site pain (from 3 days ago). It does appear that you had a reaction with the SHINGRIX injection at our clinic.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. On 22-JUL-2014, the patients were vaccinated with doses of VARIVAX (Merck) (lot # J012377 exp date 03-OCT-2015 also reported as 08-NOV-2014) (dose not reported) subcutaneously that were improperly exposed to 7 degrees C from 13-MAY-2014 to 22-JUL-2014. No known adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected. All follow ups requested to complete the case were received.
Bad Migraine; fever get elevated, up and down; Chills; Rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 23Sep2021 (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: Bnt162b2 (Dose 1), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 24Sep2021, outcome "unknown", described as "fever get elevated, up and down"; CHILLS (non-serious) with onset 24Sep2021, outcome "unknown", described as "Chills"; RASH (non-serious) with onset 24Sep2021, outcome "unknown", described as "Rash"; MIGRAINE (non-serious), outcome "unknown", described as "Bad Migraine". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional Information: Patient said that she received the second dose last Thursday evening but experienced fever, chills and rash this Friday morning so the patient was asking is it normal that her fever goes up and down and also she mentioned that she took something (Further Clarifications Unknown). Patient experienced fever, chills and rash after the second dose and a bad migraine. Patient stated because, she woke up, it was better (voice not clear) but the fever came back and she took something (Further Clarifications Unknown) to gamble that was to bring the chills but the fever get elevated, up and down, up and down. She work with kids and they check you when you go to work she don't want the fever to come and then I have to go home you know, come like she don't want to. Saw a doctor tomorrow said they must have a day to make sure that her work with children because they don't want to work with children, because that it is all about, right.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received the Tdap and Meningitis in the right arm. Reported to troubles.  HPV given in the left arm. Patient reports feeling warm, dizzy and seeing spots. No LOC. Food, Water and cold pack given.  Puts head down on head rest. After 30 minutes patient reports no issues.
Fever (102 degF), chills, headache, nausea, rash around injection site
Approx. six hours post vaccination, red spots appeared on both forearms and later that night on one upper leg. Painful but not itchy. Urgent care was accessed and pt  was told that it was probably a non-histamine related reaction due to vaccination. No treatment was given and patient released. Further follow-up 2 days later and leg spots have increased and forearm spots were fading.
A bivalent Moderna booster indicated for patients aged 6-11 years was inadvertently administered to this patient.
Seen by MD on 8/15/02 with generalized achy left arm with large amount of swelling, redness with soreness X 2 days. Had TD on 8/13/02. Dx'd with cellulitis on 8/15/02. Treated with Keflex.
I woke up and tried to get up and everything was spinning around really bad.  Since I that night,  every time I?m laying down and start to get up I get a dizzy spell.  And for the first time at work today, I had a dizzy spell.
About 12 hours after receiving the injection, I felt nauseous, tired, achy, and had chills. The next morning, I had a temperature of 100.6, headache, nausea, fatigue, body aches, and pain and swelling at injection site. Fever lasted 24 hours, and all other symptoms continued for 4 more days. Swelling in arm got worse each day. I alternated Tylenol and Ibuprofen for pain and body aches, and iced the injection site. On 6th day, only pain and arm swelling remains. I spoke with my doctor's office several times throughout the week, and visited a walk-in clinic to look at the injection site on the weekend, when it got worse.
PT recvd JJ booster vaccine to Left arm. PT began to feel nausea about 5mins post vaccine. PT confirms no previous advised vrs reaction to first dose. PT confirms not eating today. PT given Famotadine 40mg and improved noted in 5mins. Symptoms resolved PT observed a total of 30mins.