chrisvoncsefalvay/vaers-outcomes huggingface dataset:
If covid tested post vaccination: yes, covid test result positive; If covid tested post vaccination: yes, covid test result positive; Tachycardia; elevated d dimer; elevated blood pressure; This is a spontaneous report from a contactable consumer.   A 36-year-old (non-pregnant) female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EL8982), via an unspecified route, administered in left arm on 12Jan2021 as dose 2, single for COVID-19 immunization at Hospital. The patient medical history included ongoing hypothyroidism, right bundle branch (block), cardiomegaly and no allergies. Concomitant medications included levothyroxin. The patient previously received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EL1284), intramuscularly administered in left arm on 22Dec2020 at 13:00 as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines in four weeks prior to COVID-19 vaccine. The patient did not have COVID-19 prior vaccination. On 12Jan2021 at 13:30, the patient experienced tachycardia, elevated d-dimer and elevated blood pressure. On 07Mar2021, the patient was diagnosed with Covid-19. The patient underwent lab tests and procedures which included blood pressure: elevated, D-dimer: elevated on 12Jan2021 and nasal swab: SARS CoV-2 test positive on 07Mar2021. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was not treated for the events. The outcome of If covid tested post vaccination: yes, covid test result positive was unknown. The outcome of rest of the events is recovered with sequel.  Follow-up attempts completed. No further information expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 or comirnaty to the reported event vaccination failure and covid-19 cannot be ruled out.
mentioned several other cases of adverse reactions; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (mentioned several other cases of adverse reactions) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (mentioned several other cases of adverse reactions). At the time of the report, VACCINATION COMPLICATION (mentioned several other cases of adverse reactions) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   Reporter did not allow further contact
No adverse effects; the patient was inadvertently administered an expired dose of ROTATEQ; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 29-JUL-2019, the patient was inadvertently vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # R030924, expiration date reported as 11-JUN-2019, but upon lot# validation, expiration date was established as 10-JUL-2020 (dose was not provided) for prophylaxis. No adverse effects were reported.
Cough bringing clear phlegm; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough bringing clear phlegm), PYREXIA (Fever) and CHILLS (Chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced COUGH (Cough bringing clear phlegm), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency. At the time of the report, COUGH (Cough bringing clear phlegm), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not provided by the reporter.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Information has been rec'd concerning a pt with no past medical history and no known allergies who on 4/4/02 was vaccinated with a 1st does of hepatitis B vaccine recombinant (lot#638671/0656L). Concomitant therapy that day included tuberculin purified protein derivative. The physician reported that the pt was probably given 3.0 instead of 1.0ml. It was noted by the physician that "it seemed like it took the nurse a long time to administer the shot". Later that day on 4/4/02, the pt had slight nausea and diarrhea and some arm soreness. The pt sought unspecified medical attention.  Follow up information indicated that the pt rec'd a 2nd dose of hepatitis B vaccine recombinant (lot #638671/0656L) (0.5ml) on 5/3/02 in the right arm. There were no concomitant medications and no illnesses at the time of vaccination. On 7/15/02 the pt developed arm pain, nausea and diarrhea. The pt recovered on 7/17/02. Additional information is not expected.
I21.9 ACUTE MI 3/23/2023 NON-ST ELEVATION MYOCARDIAL INFARCTION
Listlessness and fever to 102.  Then developed ataxia and h/a.
The day I receive the booster, I felt weird.  The next morning I had 5 seizures and began vomiting with waves of sickness  at home and was taken by my husband to the Hospital.  I was immediately given medication for nausea and for seizures.  I have no history or family history of seizures.  They did a CT scan, two different MRI?s, an EEG, and all were normal.  I was hospitalized until, Monday, the 25th and sent home on seizure medication, LevETIRAcetam 500 mg, which I am not adjusting well to.  I now have 3 months that I can?t drive, 6 months of medication I?m not tolerating well, and a huge hospital bill!
Myalgia, Arthralgia, Fever,  body aches; fever; fatigue Narrative: Tylenol and Motrin as needed
This report describes the occurrence of mercury poisoning in a male child of unspecified age who was vaccinated with hep B vaccine recombinant (Engerix B) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The subject's medical history, concurrent conditions, and concurrent medications were not reported. The subject received an injection of Engerix B on 11/29/95 (651B2). He also received hep B vaccine (manuf unk; 3/3/95 and 4/19/95), combination DTP+ActHIB 4/19/95, 6/28/95, 8/23/95, and 6/26/96; Orimune 4/19/95, 6/28/95, 8/23/96 and 6/26/96; and MMR II 2/28/96. The subject's attorney alleged that "As a result of mercury in thimerosal-adulterated infant injections that the subject received as an infant, he now suffers, and in the future will continue to suffer, from the toxic neurological effects of mercury poisoning. The mercury poisoning in this report is considered medically serious (OMIC).
This spontaneous report was received from a physician and refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, allergies, and concomitant therapies were not reported. On 15-SEP-2017, the patient was vaccinated with an unspecified improperly stored dose of VARIVAX), lot number M033905 with expiration date 28-JUL-2018, for prophylaxis (strength, dosage schedule, route and anatomical location were not reported), which was reconstituted with a properly stored sterile diluent. No adverse event was reported. The administered dose experienced a temperature excursion of 15 to 46 degree Fahrenheit for 1 hour and 20 minutes; it was also reported that due to a natural event the VARIVAX was transported from the physician's facility to another in a refrigerator container instead of a freezer, and the container temperature was 40 degree Fahrenheit for 40 minutes for both outgoing and return trips, data logger was involved. No previous temperature excursion was reported. This is one of two reports from the same reporter. Sender's Comments: US-009507513-1709USA008728.
Fever, Cold Sweats, Chills, Shivering, Whole Body Ache, Headache. Onset about 8-10 hours after vaccine dose. Back to full health in about 48 hours.
Pt recv vax on 11/14/98; on 11/16/98 pt exp fever (101.7F), decreased appetite, lethargy, diarrhea
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergy : Amoxicillin", notes: Known allergy : Amoxicillin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient did not receive any other medication in 2 weeks. Antiviral treatment details: Patient received Paxlovid from 15Jul2022 to 20Jul2022 for the treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Swelling, redness, and hard bump at injection site. Bump painful and hot to the touch
Left clinic after injection + returned to hotel room @ 12:30pm stated noticed itching @ injection site (left deltoid) and she applied Hydrocortisone (1% otc) there. @ 1:30 while shopping in hotel reports itching became more intense. Noticed two vertical parallel marks on both sides of injection site. Itching continued down L arm. She applied Benadryl cream X1. Had barium enema in clinic 830am 3/10/09. Radiologist  called doctor RE: L arm 11:30 am exam per doctor. 1145 Ibuprofen 600mg. #1 P.O. as ordered. To nurses at 1230pm L arm red + swollen from deltoid to upper third of lower arm- more intense below deltoid to Elbow - all warm to touch. Denied pain + had little itching at this time. Measured R+L arm. R delt = 8 1/2" L 11 1/2" R @ Elbow = 7 1/2" L 10 1/2" Other wise appears NAD . May use cool compresses. To return to clinic + doctor at 4pm for re check. 310pm Pt seen by doctor. Slightly less swollen. Pt states arm feels better. Ibuprofen 600mg 1 with dinner, 1 with breakfast in am. Return if condition worsens.
Fever and dyspnea within 24 hours, then acute respiratory failure with hypoxia. Admission 9/30 to 10/3. CT chest showed non-cardiogenic edema  and effusions. DID NOT require intubation. . Started on methylpred. Now on oral prednisone taper. Improving as of 10/12/2021
Patient stated he felt hot and was sweating, then he felt cold.  Vitals were taken:  BP 124/78,  temp , 93.4, HR 89.  Patient had a granola bar with him; he ate bar, stated he was feeling better.  Advised to drink electrolytes.  Patient confirmed he understood.  Patient was cleared.
Stinging hard plus bruise, pain on touch and extending to elbow. No fever or decrease range of motion.
shingles/Herpes zoster; Information was received from a lawyer regarding a case in litigation concerning a patient (pt) of unspecified age and gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications. On or about 12-NOV-2015 (at the age of 63-years-old), the pt was vaccinated with zoster vaccine live (ZOSTAVAX), administered by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions (Strength, dose, route of administration, anatomical location, lot number and expiration date were not reported). Subsequently, on an unknown date, as result of the zoster vaccine live (ZOSTAVA) use, the patient experienced shingles/herpes zoster and was treated (unspecified) by a physician. Loss of consortium was filed. The outcome of the event was not provided. Causality was related.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Tinnitus-Mild, Systemic: Vomiting-Mild
He received his 1st dose vaccination 2/3/2021 and he began feeling sick on Sunday night 2/7/2021.  He had pain and swelling along with an infection in his teeth and ears, cough and fever.  No appetite, no smell, some chills, body aches and headaches.  This past Saturday the 13th he said that he was having bad headaches and fatigue.  He did also say that he was having vomiting but that had been after taking his antibiotic and medications for the shingles, basically his right side of his body.
Fever, abdominal pain, malaise, joint pain, headache lasting for >5 days
1st night numbness in right arm (not the vaccinated arm) spreading to the entire right side of the body with the next 2 hours. Numbness similar to the numb feeling from Novacaine. By next morning, entire body was numb from toes to scalp. Full body numbness for 3-4 days, then both arms started to feel more normal, then in the next 2-3 days remaining body parts started to come back to normal, except for the scalp. After another week, the numbness faded and felt normal again. After the numbness subsided, started having difficulty falling asleep, taking up to 3-4 hours to fall asleep. Still having difficulty now falling asleep. Not sure if the sleep issues are vaccine related.
A non-serious, spontaneous report of fever of 104 and hives was received from a consumer, concerning a six year-old female subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 30-Oct-2008. On 01-Nov-2008 the child experienced fever of 104 F and hives on her feet and lower back. On 02-Nov-2008 the reporter called their pediatrician and on 02-Nov-2008 was instructed to administer diphenhydramine. As of 03-Nov-2008 the fever is no longer present and the hives have subsided somewhat.
Entire arm became red, hot and throbbed all night.  Woke with raging sore throat going all the way down my esophagus.  Next day work with massive headache and next day had all of the above plus deep cough.  I was winded walking from my car to my office.  I was seen in the ED.  Covid test done- negative.  Diagnosis -pneumonia.  Out of work 2 weeks.  Employer mandating all staff to be fully vaccinated.  Suffering from anxiety, depression and still coughing after the two weeks.  Not all days off are covered by employer.  Worried about job security.
7 days after receiving the first dose of Moderna I developed lasting arm pain. This was different from the arm pain/soreness I had 3 hours after I first received the shot (which only lasted 2 days). Once the initial soreness wore off I had no pain, and then 7 days after the injection I developed this lasting arm pain at the site of injection. It can range from a dull ache, to intermittent sharp pains that radiate down from the site of injection to the base of my deltoid muscle. Sometimes it will keep me up at night, and seems to get worse when it's going to rain.
getting the Prevnar 13 vaccine this year and reports flu like symptoms lasting 1-2 weeks (2nd time in a few years; 1st occurrence led to hospitalization); This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program. The reporter is the patient.  A 54-year-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13) (Batch/Lot number: unknown) as dose number unknown, single for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (hospitalization), outcome "unknown", described as "getting the Prevnar 13 vaccine this year and reports flu like symptoms lasting 1-2 weeks (2nd time in a few years; 1st occurrence led to hospitalization)".  The lot number for pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) was not provided and will be requested during follow up.; Sender's Comments: There is not a reasonable possibility that the reported event was related to the suspect product event most likely due to patient underlying contributory factors  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Pt was given BEXSERO then realized pt needed MENACTRA per mother. Upon re-entry to exam room had hives on chest and starting at injection site. Pt was not given MENACTRA for this reason. Vitals were stable, on-call provider Dr. called to assess pt. Pt was then sent to urgent care for allergic reaction. Per urgent care note: "Patient is a 18 year old female who presents for hives. She was in the clinic today for a meningococcal vaccine and subsequently developed a rash on the arms, chest, face (red). BENADRYL every 4-6 hours PRN and prednisone 20 mg QDx5 days." Spoke to pt's mother today (1/9/19) pt took 2 doses of BENADRYL yesterday but decided to not take the prednisone.
EXTREME IRRITATION AND SWELLING AT INJECTION SITE, HEART PALPITATIONS, AND CONSTANT PAIN IN RIGHT LEG
1 of 2 pts vaxed from the same lot who devel an inj site rxn (erythema/induration/swelling) & fever (unmeasured); rx w/APAP & warm compresses;pt vaxed 20SEP94; 25SEP fever 103 & nasal discharge; rx w/Ceclor;MD suspects underlying illness
starting screaming about 5PM woke p/ 3 or 4 hrs nap crying when touched or moved was consolable; mom panicked ran to ER;
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 60-year-old male patient who received SHINGRIX. On 2nd February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 3rd February 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site itching and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site itching and injection site warmth were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site itching and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient reported that side effects as injections site reactions. The patient planned to follow-up with his physician on an unknown date. Only partial information was provided. The patient was at work and wanted to get back to work. The vaccine was prescribed by Family Medicine.
On February 19, 2023 I started having a sore throat, as my wife had tested positive the day before I decided to use a home COVID-19 test. Once it came back positive, I called my doctor who called a prescription of Paxlovid to my pharmacy that I started immediately. I was testing negative by the 24th of February. I did get rebound COVID-19 on February 27th that I felt was much worse, I had a cough, congestion, runny nose. My doctor advised me to use over the counter medication to help combat the rebound as I had already taken the Paxlovid. I was testing negative by March 3.
an itchy red on my face, then chest, then back, and over a few hours, they would pop up all over, not in clusters.; red on face; Bump is measlelike, not a rash; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0158) via an unspecified route of administration in the left arm on 14Apr2021 at 17:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Concomitant medications included diclofenac potassium (ZIPSOR), gabapentin (MANUFACTURER UNKNOWN), steroid shot injection and D sup; all taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730) via an unspecified route of administration in the left arm on 24Mar2021 at 11:45 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 17:15, within minutes, the patient noticed an itchy red on face, then chest, back and over a few hours, they would pop up all over, not in clusters. Bump was measles like but not a rash. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with Benadryl by mouth. The clinical outcome of the events an itchy red on my face, then chest, then back, and over a few hours, they would pop up all over, not in clusters, red on face and bump measle like, not a rash were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
While withdrawing needle from arm, innoculate sprayed onto my mask, my arm and the interior of the passenger door of my car.    The medic jumped away and yelled WOW.   Put a band aid on the site and walked away     I tried to locate him to find out what happened and why, but could not.   I return to the vaccination site and spoke to two staffers about the incident.   One staffer told me the medic did not report any issues with the administration of the vaccine.   I reported it again on Monday 2/8/2021 via telephone and again via certified mail on 2/22/2021.   A certified letter was sent to County and to State Dept.   On 2/8/2021, I also reported it to Moderna.
I received the second vaccine injection at approximately 1:15 pm on 3/9/2021. At 8 o?clock pm of that same day I started having severe chills. At 10 o?clock pm on that same day I had a fever of  101 Fahrenheit. That fever of 101  lasted for 31 hours. In addition to the fever, I had severe chills, severe body aches, and injection site reaction of swelling and throbbing pain. I was on able to perform normal daily duties and was unable to get out of bed for more than using the toilet. I was also exhausted and slept for the majority of the 31 hours whilst having the fever. I was unable to function normally until mid afternoon on 3/11/2021. Truthfully, this was an horrific experience.
Soreness in left arm in the area of flu shot. Started within 3 days of vaccination.