chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SERIOUNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received on 22 March 2007 from the patient. A 57-year-old female with a medical history of allergy to "PCN", beta blockers, Seldane and "Anetime", and who had a cut on her leg from "furniture", had received a dose of TET TOX ADS USP, lot number 26388A, in the right arm on 18 October 2006. At an unspecified amount of time later, the patient's right hand was numb and her right hand and arm were swollen. She was seen in the emergency room and treated with Prednisone and antihistamines. The patient was evaluated by a surgeon and X-rays were sent to a neurologist. An ultrasound of the right arm and nerve conduction tests were completed. The results were not provided. Reportedly, there is "nerve damage". At the time of this report, the patient had not recovered.
1.5 cm erythematous, indurated area over injection site. Developed 10 days after vaccine and has worsened over 3 days. No pain, no warmth. No treatment at this time.
Red spot growing bigger at site of injection. Hot upon touch. Temperature of 101.4 at the site but normal body temp. Pain in right axillary area. Difficulty moving arm after vaccination. These effects have lasted 3 days.
5:30 pm 3/29/21 received phone call from aunt that ems had taken dad to hospital because he was feeling unwell. he vomited prior before and just didn't feel right. ems showed up and observed him, glucose was 139..not out of range...vitals stable..2nd moderna vaccine 5 days prior...ems said that is was probably side effects...asked if he really wanted to go in...said yes, took him to hospital...5:45 daughter called hospital to get status check....she is poa for medical...er doc said he was intubated and on vent.....er doc said he was very sick...6:50 pm daughter got to er and room he was on vent and knocked out...he had antibiotics, sleeping meds..meds to rise bp in iv.....er doc came in daughter  asked why he was on vent...asked about o2 doc said he was fine just unresponsive...labs were being done at time...had him on dextrose, propofol, dexmedtominine,..asked to have him transferred to own hospital..8:10 dr. comes in with lab results...kidneys and livers were showing multi organ failure...triponin was high as well..red flags were: creatine 9.93, gsr-5, hemoglobin-7, liver lft-500, triponin 14, covid test was negative, white count was in range, daughter mentioned vaccine again and doc said nothing nor did she mention heart being in trouble, no answers regarding what the cause of this was...for the record he only had kidney issues due to type 2 diabetes, was not at dialysis level...9:30 ems shows up to take dad to another hospital were not ready from him yet...9:41 dad heart started to drop on monitor withing 15 secodes iit flatlined in front of daughter......med staff did cpr...brought in epi pens and manual cpr for heart...a little after 10 heart was started it ran for 4 minutes then crashed again..10:05 continued cpr until 10:28, dr showed that walls i heart not squeezing very damaged, brought in echo during process, 10:28 time of death
Sore injection site, fever, chills,extreme muscle fatigue 24 hours after injection.       Full ?recovery ? by 1/8(Friday)
Treatment of COVID-19/Positive; Treatment of COVID-19/Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 03Mar2021 at 12:00 as dose number unknown, single (Lot number: EN6198), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "heart attack" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19/Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Headache, Fever, NauseaVomiting, T102.5 No vomitting symptoms ended x 1 day
Case number PHEH2013US023614 is an initial spontaneous report received from a pharmacist on 28 OCT 2013. This report refers to a patient whose identifiers were not reported. The patient's medical history and concomitant medications were not reported. The pharmacist reported that she suspected that a patient under 18 years of age received FLUCELVAX 2013/2014 (batch number: 006011A, expiry date: JUN 2014) three weeks ago (vaccination date was not reported). No adverse event was reported following the maladministration.
A broken blood vessel on my left eye.; A spontaneous report was received from a consumer concerning a 67-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed a broken blood vessel on her left eye.    The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included valproate semisodium, amlodipine, clopidogrel bisulfate, bupropion hydrochloride, iron polysaccharide complex, multivitamins, potassium, acetylsalicylic acid, sodium bicarbonate and humira.   On 26-MAR-2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 046A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 26-MAR- 2021, she noticed a broken blood vessel on her left eye which doesn't really bother her.   Treatment information was not provided.    The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events was not reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Lesion appeared on left thigh.  Red in color.  Lesion is 7 cm in size.  The type of lesion is eythematous.  Isolated arrangement and has a localized distribution.  The status is spreading.
Mild fever; Swollen lymph nodes on the left side ofmy body (the side of the injection),especially along my neck, jaw, and underarm.; Tender lymph nodes on the left side ofmy body (the side of the injection),especially along my neck, jaw, and underarm.; Neck soreness; Shoulder soreness; Upper arm soreness; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 at 17:45 (at the age of 21-years-old) for COVID-19 immunisation. Medical history included latex allergy. The patient was allergic to macrobid (antibiotic). Concomitant medications included birth control pills (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 31Mar2021 at 08:00, the patient experienced mild fever, very swollen and tender lymph nodes on the left side of the body (the side of the injection) especially along the neck, jaw, and underarm, neck and shoulder soreness along with the upper arm. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No therapeutic treatment was taken for the reported events. The clinical outcome of the events mild fever, very swollen and tender lymph nodes on the left side of the body (the side of the injection) especially along the neck, jaw, and underarm, neck and shoulder soreness along with the upper arm were resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Shakiness-Severe, Systemic: Weakness-Severe, Additional Details: Patient fainted for a few seconds within a couple minutes of vaccine. He the was shaking uncontrollably for a few seconds. We laid him down as per his request. We called 911. BP was 119/94. Fire dpt arrived and BP was 81/31 then 84/42. EMS arrived and took him into ambulance. Within 15-20 minutes, BP returned to normal and EMS sent patient home. We informed the MD and patient not to get her second one.
A little sore arm after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A little sore arm after 2nd shot) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (A little sore arm after 2nd shot). On 08-Feb-2021, PAIN IN EXTREMITY (A little sore arm after 2nd shot) had resolved.            No Concomitant product use was reported.  After the 2nd shot, they had a little sore arm for a few days.  No treatment information was provided.   This case was linked to MOD-2021-407363, MOD-2021-407441 (Patient Link).
This case was reported by a consumer and described the occurrence of arthralgia in a female subject aged between 30 and 39 years old who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included partial thyroidectomy. Concurrent medical conditions included Graves' disease and high blood pressure. Concurrent medications included Hydrochlorothiazide (HCTZ), SYNTHROID and CELEBREX. On unspecified dates in the 1990s, the subject received two unspecified doses of LYMERIX (unknown). In the 1990s, shortly after vaccination with LYMERIX, the subject experienced pain in knees and joints. In October 2012, she underwent right knee operation (meniscus repair and clean out of arthritis). In April 2014 the subject experienced pain in left knee, ankle and hips. The subject stated she first began to experience pain in her knees and joints shortly after the second dose of LYMERIX sometime in the 1990s (date unknown). She clarified that it was "pain in her joints, including both knees and hips". Limited information was provided because the subject could not remember. At the time of reporting the arthralgia was unresolved; knee repair resolved on an unspecified date. This case was assessed as medically serious by GSK.
3/16/13 - 7:25 pm mother notified physician on call that child vomited a few times that day, is lethargic & has blood mixed with stool. Advised to go to ER for eval. of possible intussusception. Parents stated they would go but didn't - physician received call 3/17/13 at 3:45 pm now taking pt to ER.
Patient states ~ 20 minutes after vaccine, she felt a burning sensation in her left arm.  She then noticed numbness and tingling in the left arm.    Several minutes later, numbness and tingling occured in her lips and face but no burning.  States she then took 50 mg Benadryl by mouth.  Symptoms did not worsen and no other symptoms occured.  ~ 26 hours later, she states she felt back to her normal self.  She later phoned her PCP about it.  He advised her to take 50 mg Benadryl by mouth 30 minutes prior to her 2nd Varivax vaccine.
On 2/13/00, the pt presented with approximately thirty lesions and a fever of 100.7. Additional information has been requested. Follow up states patient recovered.
This case was reported by a healthcare professional and described the occurrence of hepatitis b antibody negative in a 26-year-old male subject who was vaccinated with hepatitis B vaccine (manufacturer unspecified) for prophylaxis.  On an unspecified date the subject completed the hepatitis B vaccine series.  He was tested and showed protective hepatitis B levels.  This was approximately two years ago.  When tested in 2007, the subject's titers came back showing non-protective levels for hepatitis B.  No additional details were provided.
Swollen upper lip; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swollen upper lip) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy (Allergic to crab, gave hives.). Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL, METFORMIN, BUPROPION and NABUMETONE for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LIP SWELLING (Swollen upper lip). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, LIP SWELLING (Swollen upper lip) outcome was unknown.
tested positive for covid and is in the hospital; tested positive for covid and is in the hospital; This is a spontaneous report received from a contactable consumer (Patient husband) via Medical Information Team. A 61-Year-old female patient received first dose of BNT162B2 (Pfizer- Biontech COVID-19 Vaccine, solution for injection, Lot number: unknown) via an unspecified route of administration on 15Apr2021 (at the age of 61-years-old), as a single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, patient tested positive for COVID and was in the hospital. The patient under lab test that included: SARS-CoV-2 test: Positive on an unspecified date. The patient was due for the second dose on 06May2021. The outcome of the events was unknown.    Information about batch/lot number has been requested.
Lymphadenopathy, sore throat, back & neck pain, diffuse rash, fever, arthritic pain in knees & foot; sx lasted approx 10 days but arthritic pain continues;
Pregnancy two weeks after second dose. Strong reaction to moderna shot.  Inflamed glands in armpit and breast. Fever. Body aches. Redness and raised at site of injection for weeks. Pregnancy ended in miscarriage 4/18/2021. Second pregnancy in November 2021. Ended January 21, 2022 at 10 weeks pregnant. Ultrasound showed Fetus stopped growing at 8weeks 4days. Ending in miscarriage. 4 healthy prior pregnancies before vaccines.
diagnosed with covid/SARS-CoV-2 test positive; diagnosed with covid/SARS-CoV-2 test positive; This is a spontaneous report from a contactable consumer. A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 1 on 23Feb2021 and dose 2 on 16Mar2021; both via an unspecified route of administration as single dose for covid-19 immunisation. Age at vaccination was 50 years old. Medical history was none. The patient's concomitant medications were not reported. The patient was diagnosed with covid on 08Jul2021, with symptoms of lethargy, sniffles, and cough. He did not receive treatment for the event. He was not immunocompromised. The event did not require a visit to emergency room or physician office. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date, and positive on 08Jul2021. The outcome was unknown.  Information on the lot/batch number has been requested.
Flu; Initial information was received on 12-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender patient who experienced flu while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) 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 (strength, expiry date: unknown) for flu.  On an unknown date the patient developed a non-serious event of flu (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Patient is fully vaccinated and boosted.  COVID positive 2/15/2022 on admission to the hospital.  81-year-old male who presented to the hospital shortness of breath and was found to be in acute hypoxic respiratory failure in the setting of covid 19 pneumonia. D dimer 1366, Tropinin 0.07   He was treated with supplemental oxygen, breathing treatments, and IV remdesivir For 5 days.  Patient symptomatically and clinically improved throughout his stay.  He also had AKI, which resolved with IV fluid hydration.  Patient is medically stable for discharge home. Patient discharged.
fever after vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever after vaccinated) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever after vaccinated). At the time of the report, PYREXIA (fever after vaccinated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.   Reporter did not allow further contact
NUMBNESS AND TINGLING OF LEFT ARM, SHOULDER,  FACE, AND TONGUE. NO SWELLING DIAPHORESIS, CHILLS,  SOME ITCHING AT 5:10 PM
Severe joint/muscle pain. Knees. Neck. Shoulders. Back. Along and down the sides of my torso and chest. Diaphragm area.
Information has been received from a medical assistant for GARDASIL, a Pregnancy Registry product, concerning a female patient with herpes simplex, cervical dysplasia and penicillin allergy and a history of miscarriage who on 29-JUN-2011, was vaccinated with the first dose of GARDASIL into her left deltoid. There were no concomitant medications. On 05-JUL-2011, the patient reported that she was pregnant. There were no diagnostic tests performed. The patient sought medical attention by an office visit. Follow up information has been received from the physician who reported that the patient experienced spontaneous abortion (<20 weeks) on an unspecified date. Product of conception was not examined. It was unknown if the fetus was normal. Outcome was unknown at the time of reporting. Upon internal review, spontaneous abortion (<20 weeks) was determined to be an other important medical event. Additional information has been requested.
extreme soreness at injection site, intermittent fever, body aches, head ache, lethargy worsening over the first 24 hours
Red rash started day after vaccination. Spread and worsened by 4/18. Exam: Circumferential band of erythema, warm, raised (non-tender) approx 5 am cranial-caudal.
Presented with SOB, fever, cough x 2 days; + Covid in ED; admited with to tele with Covid PNA; tx with maxipime, steroids, remdesivir, singular, zinc,; initialy on NRB O2; down to Room Air by d/c;
Within 45 minutes of receiving  vaccination I experienced  severe tinnitus, headache at the top of my head, body aches,  fatigue, and neck ache.  All symptoms  lasted about 2 days except severe tinnitus remains.
No additional AE reported; VAQTA administered after a temperature excursion; This spontaneous report was received from a medical assistant and refers to a 5-year-old female patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 01-DEC-2022,  doses of hepatitis A vaccine, Inactivated (VAQTA) underwent a temperature excursion of 47.9 Fahrenheit degrees for 47 minutes, a digital data logger was involved.  On an unknown date in December 2022, the patient was vaccinated with an improperly stored second dose of hepatitis A vaccine, Inactivated (VAQTA) pre-filled syringe, administered intramuscularly on the left thigh, lot #W023937, expiration date: 06-DEC-2023 (strength and dose were not provided) as prophylaxis (product storage error). No adverse event was reported.  This is one of several cases reported by the same reporter. ; Sender's Comments:  US-009507513-2301USA009943:
Appearance of a quarter inch red line extending from the outside of the patient´s arm to the patient´s arm pit; Patient was unable to raise affected arm; This spontaneous report was received from a pharmacist concerning a 66-year-old male patient.  The patient's pertinent medical history, concurrent conditions and concomitant therapies were unknown by the reporter.  On 09-DEC-2020 at 11:30, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) (dose, route and frequency were not reported) lot # T032003, expiration date: 08-MAY-2022 for prophylaxis.         On 11-DEC-2020 at 11:30, the patient reported the appearance of a quarter inch red line extending from the outside of the patient´s arm to the patient´s arm pit (erythema) and at the event time, patient was unable to raise affected arm (hypokinesia). The pharmacist had extremely limited information at call time.  At the time of reporting, the outcome of erythema and movement disorder was unknown. The relatedness between the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) and the events was not provided.
Headache; low grade fever; chills; body aches; joint pain; It feels like she had Covid all over again; This is a spontaneous report received from a contactable (patient). A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on 25Jul2021 as dose 1, single for covid-19 immunisation. The patients medical history included patient had Covid in October and was sick for a long time, but then got well. The patient's concomitant medications were not reported. The patient got her fist dose of the Pfizer BioNTech Covid-19 vaccine on Sunday, 25Jul2021 and on Jul2021, the patient experienced it feels like she had Covid all over again. Her symptoms included low grade fever, chills, body aches, joint pain, and headache. Patient was asking if it was normal to have it (side effects) this long and was it something she should be concerned with,How long will that last? Seriousness reported as no. The patient underwent lab tests and procedures which included positive sars-cov-2 test on Oct 2020. The outcome of all events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.