chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This study case was received from the investigator in a trial on 04 September 2013. A female subject (age and date of birth not reported) had received the following vaccination on 28 August 2013: ACAM2000 (lot number, route and site not reported). The subject also received the following vaccinations on 23 August 2013: typhoid (Manufacturer Unknown, lot number, route and site not reported), and anthrax (Other Manufacturer, lot number, route and site not reported). Five days post smallpox vaccination, on 02 September 2013, the subject was diagnosed with possible myopericarditis. The subject recovered on the same day, 02 September 2013. The subject experienced "flu-like symptoms". The subject experienced the non-serious event of generalized myalgia (start date 30 August 2013, stop date 02 September 2013), was given unspecified medication, and was considered probably related to vaccination. The subject experienced non-serious event of fever (start date 30 August 2013, stop date 02 September 2013), was given unspecified medication, and was considered probably related to vaccination. The subject experienced non-serious ongoing event of headache (start date 30 August 2013), was given unspecified medication, and was considered probably related to vaccination. The subject experienced serious event of shortness of breath while jogging which lasted a couple minutes with no other symptoms (start date 01 September 2013, stop date 01 September 2013) and was considered possibly related to vaccination. The subject experienced serious event of chest pain that was centered at the sternum but did not radiate anywhere else (start date 02 September 2013, stop date 02 September 2013), was a pain level 3, and was considered possibly related to vaccination. The symptoms started when she woke up and lasted until mid-afternoon. The subject experienced serious event of shortness of breath again (start date 02 September 2013, stop date 02 September 2013) and was considered possibly related to vaccination. The ECG from 03 September 2013 was normal and subject was asymptomatic at time of ECG. The troponin I results were still pending. The subject's rapid troponin was negative. Subject circled "0" on the Wong-Baker scale. The subject did not take any medications for treatment. The subject's outcome was recovered on 02 September 2013. According to the Investigator, the event of possible myopericarditis was considered an important event and possibly related. Documents held by sender: None.
This spontaneous report as received from a pharmacist via a company representative refers to a 38 year old female patient. No medical history and concurrent conditions were reported. On 06-SEP-2016 the patient was vaccinated with PNEUMOVAX 23, (lot number and expiry date unknown) (dosing regimen and frequency unknown) intramuscularly. No concomitant medications were reported. On 07-SEP-2016 (also reported as the next day), the patient complained of arm was swollen, red and hot to touch (unspecified which arm). It was reported that the patient sought medical attention and went back to the pharmacy. No treatment was given for the events. There was no product quality complaint reported. The action taken with the therapy with PNEUMOVAX 23 was unknown. On 09-SEP-2016 the patient stated that she felt much better. The outcome of the peripheral swelling, skin warm and erythema was reported as recovering. The relatedness of the events to the therapy with PNEUMOVAX 23 was unknown. Additional information has been requested.
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 62-year-old male patient received BNT162b2 (BNT162B2), on 28Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left 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: "Coronary artery disease" (unspecified if ongoing). There were no concomitant medications. Patient had no known allergies. Patient did not received any other medication in two weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Expected soreness in arm muscle the next morning; pain and soreness in my Right armpit and down into my chest/breast tissue.; pain and soreness in my Right armpit and down into my chest/breast tissue.; pain and soreness in my Right armpit and down into my chest/breast tissue.; This is a spontaneous report from a contactable other health care practitioner (patient herself) COVID-19 Adverse Event Self-Reporting Solution. A 50 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number EW0191), via an unspecified route, administered in Right Arm on 11Jun2021 15:30 (at the age of 50 years old) as Dose 1, Single for Covid -19 immunization at Pharmacy or Drug store. The patient's medical history included type 2 diabetes mellitus, intraductal proliferative breast lesion, Ductal carcinoma in situ both breasts. treated with mastectomies on both sides, COVID -19 (prior to vaccination), drug hypersensitivity, mastectomy. The patient was allergic to penicillin. The patient received other medication (unspecified) 2 weeks. The patient did not receive any other vaccine four weeks. The patient had COVID infection prior to vaccination. The patient was not tested for COVID infection post vaccination. The patient was not pregnant at the time of vaccination. On 12Jun201 (next morning after first dose of vaccination), the patient expected soreness in arm muscle the next morning. On 13Jun2021 05:00 (2 days later after vaccination) the patient experienced pain and soreness in her right armpit and down into her chest/breast tissue. Device date was mentioned as 13Jun2021. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Patient was admitted with staphylococcal sepsis ulcer of the right foot toe with osteomyelitis and cellulitis-  right great toe amputation bone biopsy this healed up and did well he is discharged in stable but guarded condition high risk for recurrent events recurrent. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Arm was tender; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was tender) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (codeine and sulfa) and Penicillin allergy. Concomitant products included LOSARTAN and FAMOTIDINE (PEPCID AC) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was tender). At the time of the report, PAIN IN EXTREMITY (Arm was tender) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
A little bit of achiness; This is a spontaneous report received from a non-contactable other hcp (Patient). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had first dose of BNT162B2 for COVID-19 immunization on unspecified date. On an unspecified date, the patient experienced a little bit of achiness. The patient got a little bit of achiness after the second dose, and took some Tylenol. The outcome of event was unknown. Causality was reported as related.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient received vaccine in the counseling room, waited on chair out of the pharmacy in front of the pharmacist watch. after 15 minutes patient walked to the pharmacist to let me know that her throat feels sore, she can breath fine fine but she feels pain when she swallows. the patient called earlier very nervous and concerned about get in the vaccine.  She seemed calmer when she arrived to get her vaccine at the pharmacy. She wanted me to check if necessary to adiminster an Epipen. so we called 911 who came to check her in case she quickly deteriorated. once they arrived they checked her blood pressure and other vitals and determined that she wasn't having an allergic reaction.
Patient was given a Moderna shot that had been in the fridge in for 33 days instead of 30, so it was 3 days past its BUD. The patient experienced no adverse effects. And Moderna stated the patient did not need to re-vaccinate.
Within  20 minutes of leaving the clinic I became tachycardia  and diaphoretic.  I began to wheeze and have difficulty breathing. I  used my rescue inhaler immediately.  I began to vomit and have explosive diarrhea  shortly after that.  Later in the day, my temperature was 102.  I took Tylenol for the fever.   By evening, I had severe stomach pain.  I contemplated going to the emergency room but honestly felt too sick to drive.  I had almost the same reaction the 3 times I attempted to take the flu vaccine.  I did go to the ER  the first time I took the flu vaccine.  Following the COVID vaccine, I had diarrhea for approx. 3 days .  I had loose stools for a week.  I was unable to eat anything but crackers for 4 days and was only able to tolerate soda as a fluid..  It took my stomach 6 weeks to return to normal.  I did not take the second vaccine.  I was concerned it would require me to be hospitalized.
left eye twitching; left eye swelling; left eye puffy; This spontaneous case was reported by a health care professional and describes the occurrence of BLEPHAROSPASM (left eye twitching), EYE SWELLING (left eye swelling) and PERIORBITAL SWELLING (left eye puffy) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 011L20A) for COVID-19 vaccination.     Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) and INTRAUTERINE CONTRACEPTIVE DEVICE (IUD NOS) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced BLEPHAROSPASM (left eye twitching), EYE SWELLING (left eye swelling) and PERIORBITAL SWELLING (left eye puffy). At the time of the report, BLEPHAROSPASM (left eye twitching), EYE SWELLING (left eye swelling) and PERIORBITAL SWELLING (left eye puffy) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment- The consumer is using a cold compress to alleviate symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-significant follow up
high temperature/fever; severe chest pain; heart attack; myocarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Dec2022 as dose 3 (booster), single (Lot number: GJ3274) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history was not reported (no other medical history). Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, on 13Dec2022 as dose number unknown, single. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: FF2590), administration date: 31Oct2021, when the patient was 41-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: FF2587), administration date: 15Nov2021, when the patient was 41-year-old, for COVID-19 immunization. There was no other medications in two weeks, no covid prior vaccination, no known allergies. The following information was reported: MYOCARDIAL INFARCTION (hospitalization, medically significant, life threatening) with onset 24Dec2022, outcome "not recovered", described as "heart attack"; PYREXIA (hospitalization, life threatening) with onset 24Dec2022, outcome "not recovered", described as "high temperature/fever"; MYOCARDITIS (hospitalization, medically significant, life threatening) with onset 24Dec2022, outcome "not recovered"; CHEST PAIN (hospitalization, life threatening) with onset 24Dec2022, outcome "not recovered", described as "severe chest pain". The patient was hospitalized for pyrexia, chest pain, myocardial infarction, myocarditis (hospitalization duration: 3 day(s)). The events "high temperature/fever", "severe chest pain", "heart attack" and "myocarditis" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) high; SARS-CoV-2 test: (26Dec2022) Negative, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of pyrexia, chest pain, myocardial infarction, myocarditis.
Patient describes redness, swelling, warmth, and pain the day after her injection that lasted 3-4 days. She never notified the office until 1 month later.
About ten mins after leaving post shot I noticed my heart rate going up. I started shaking alittle and then my throat started tingling. Deep in my throat by my Adam?s apple. Then it go worse and as I look in the mirror I feel like the space in my mouth is swelling. I thought my throat was closing so I went in. I have photos that show a swollen younger and throat. My heart rate stirring was 125 when usually 99/100. The doctor didn?t believe that I could be having an adverse reaction but still treated me. I know my body and had this reaction to fish before so I knew what was happening. Dr made me feel silly coming in. After the epi pen shot I immediately felt a weight lifted off my chest and could breath. I took my first big breath. I know my throat wasn?t closed all the way it was minor but still scared me to pieces. And I still have a swollen tongue and now it?s a little bit of a where is some stations in my throat here and there but overall I?m OK they sent me home with a bunch of allergy medicine and an EpiPen but whether it was mild or what not it still was an allergic reaction that I wasn?t expecting it was really actually terrified to be going through
Pt recv vax on 10/1/98; on same day pt exp chills, sweats, tight chest, short breath, fever (103), tachypneic; dx=febrile rx to vax; tx=IV steroids, Hudson updrafts, Rocephin & Zithromax IV Follow-up: Temp 103; dyspnea, hypoxic, sinus tach (HR 134).
Myocarditis with histiocytic involvment on pathology. Presented with new onset acute heart failure with reduced ejection fraction of 15%. Had several days of dyspnea on exertion approximately 5 days prior to presentation.
3/5/21-rash developed. Red,swollen and slightly raised. Experienced chills and fatigue.  Took naproxen and resolved in 2 days. Second rash developed 3/12 @7am with redness, increased raised swollen rash,with itching , fatigue and headache,. Took naproxen. Continues to resolve. Still visible but not raised on 3/14/21.
1 week after Smallpox and Anthrax and Typhoid vaccines developed red "target" lesions on hands, genitalia, and buttocks. Three weeks after vaccines rash gone from genitalia and improving on hands/buttocks. Rash itchy and appears to be Erythema Multiforme.
BODY ACHES; HIGH FEVER; HEADACHE; This spontaneous report received from a parent concerned a male of unspecified age. 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, batch number: 042A21A, expiry: not reported) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced high fever. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever, headache and body aches was not reported. This report was non-serious.
patient reports today that she developed soft tissue necrosis at injection site.  she had a flu vaccine in early october then the first dose of shingrix on 10/27/2020.  She had the second shingrix shot in the right arm with no adverse reaction
24 hours after vaccine the person developed hives over entire body to include palms of hands and feet. 48 hours later body hives continued and developed hives on face and tongue, eyes and lips swollen.  Took Benadryl with some releif of symptoms Denied any use of new products or food or changes in enviroment.
Information has been received from a medical assistant concerning an approximately 14 month old male who on 24-MAR-2003 was vaccinated SC with a 0.5ml first dose of MMR II. Subsequently, shortly after his first vaccine, the patient experienced a rash over entire body and fever of 104 F. Subsequently, the patient recovered. Unspecified medical attention was sought. Additional information has been requested.
Rash over abdomen, back and upper thighs developed 1-2 days after vaccine administration. Itchy red sm. papular rash (no exudate) and no fever. ED visit questioned scabies but treatment not effective.
Found on the floor, unresponsive. sent to ER, Dx: subdural hematoma
Tested positive for COVID after receiving two Pfizer vaccines and two Pfizer boosters; Tested positive for COVID after receiving two Pfizer vaccines and two Pfizer boosters; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: EN6201), in arm, on 06Mar2021 as dose 2, single (Lot number: EN6205), in arm, on 17Sep2021 at 15:00 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 20Mar2022 as dose 4 (booster), single (Lot number: FK9893, Expiration Date: 27May2022) at the age of 75 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Progressive multiple sclerosis", start date: May2009 (ongoing), notes: She takes vitamins, supplements, and Aleve because her multiple sclerosis.; "allergic to sulfa or sulfur" (unspecified if ongoing), notes: allergic to sulfa or sulfur; "total hysterectomy" (unspecified if ongoing), notes: when she was 38 she had a total hysterectomy.; "C-section" (unspecified if ongoing), notes: prior to that she had a C-section.; "Mohs surgery on her ankle for a cancer thing" (unspecified if ongoing), notes: Mohs surgery on her ankle for a cancer thing; "cancer" (unspecified if ongoing), notes: Mohs surgery on her ankle for a cancer thing. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, on 17Sep2021 as dose number unknown, single; ALEVE taken for multiple sclerosis. Past drug history included: Allergic to sulfa or sulfur for acne medication, reaction(s): "made her face really red", notes: allergic to sulfa or sulfur. Vaccination history included: Flu shot (She gets a flu shot every year.  She doesn't know how many years, probably starting in 1989 or so and the only reason she knows that, she had a new job and the first day at the new job she had to get a flu shot and she had never heard of them at that point in 1988 or 1989), for Immunization. The following information was reported: VACCINATION FAILURE (medically significant) with onset 29Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 29Jun2022, outcome "not recovered" and all described as "Tested positive for COVID after receiving two Pfizer vaccines and two Pfizer boosters". The patient underwent the following laboratory tests and procedures: Blood cholesterol: (unspecified date) Result unknown; Blood test: (unspecified date) Result unknown; SARS-CoV-2 test: (unspecified date) Positive, notes: still said it again; (29Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course :No Prior Vaccinations (within 4 weeks) or any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s).Patient did a spinal fluid thing back in 2009 to diagnose her multiple sclerosis but nothing since then.
This initial spontaneous report was received from a registered nurse regarding an multiple unspecified patients of unknown demographics. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On an unknown date, the patients received a doses of improperly stored RECOMBIVAX HB lot # L016959, expiration date 12-MAR-2018 and lot # L038499, expiration date 26-JUN-2017 dose and route were not provided. It was exposed to temperature of 47.7F for 1 hour and 4 minutes. Previously it was exposed to temperature of 50.3F for 1 hour and 20 minutes as well as 48.9F for 2 hours. The call was because of a data logger. No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was accidentally administered HPV 9 vaccine when getting other immunizations at one year visit. No immediate side effects. Mother of patient informed.
This spontaneous report as received from a registered nurse (R.N) refers to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not provided. On unspecified dates, the patients were vaccinated with an improperly stored (temperature: 21.6 degrees Fahrenheit (F), time frame: 1 hour and 55 minutes; previous temperature excursion?: 28 F, time frame: 6 hours and 15 minutes; total cumulative temperature and time: 28 F for 8 hours and 10 minutes; the vaccine was back in range) doses of VARIVAX (Merck), lot # L006383, expiration date: 25-FEB-2017 (dose and route of administration were not specified). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested. Additional information has been requested.
patient received pfizer COVID19 vaccine and 10 minutes later complained of racing heartrate. checked her blood pressure 147/102 HeartRate 117. Patient says she suffers from anxiety and was also feeling very anxious. no injection site reaction, no redness or swelling at injection site, no difficulty breathing. monitored patient and continued to check blood pressure. diastolic blood pressure and heartrate remained elevated last reading was 124/102 HR 108. Called her primary Dr who advised to monitor and have her come to office if blood pressure did not go down. Monitored her as instructed. HR and Diastolic BP was still elevated. Patient does suffer from high blood pressure as well as anxiety and after 1.5 hours went home to take her anxiety medication and continue to monitor her blood pressure at home and was instructed to go to doctor if blood pressure did not go down.