chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Adverse event at home, 12/26/21. Fifteen minutes after breakfast I developed severe pressure over my heart area. Lasted for five hours then suddenly dissipated and a strange feeling moved to the center of my chest. With each inhale, there was a squeezing in my chest and I felt as if a balloon (from both sides of my chest and from my neck to my belly button) was fully inflated. More pressure. These. two feelings lasted for seven hours.       Two days later, an EKG revealed that I did not have a heart attack. A stress test and an echocardiogram are scheduled next week to obtain more information.
Information has been received from a woman in a physicians office concerning a 34 month old male with no known medical history or allergies who on 19Aug03 was vaccinated in the left thigh with a first dose of varicella virus vaccine live (lot645052/0204N). Concomitant vaccination that day included a first dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot645146/0060N) in the right thigh. There was no illness at the time of vaccination. On 27Jun05 at 11:20am the pt was seen in the office with greater than 50 lesions throughout his entire body. The pt complained of red, raised bumps all over his body for one week with watery discharge and slight crusty, dryness. The pt had increased itching and a slightly runny nose. The pt was afebrile and rapid strep was positive. Treatment included anti itch cream and diphenhydramine hydrochloride (Benadryl). There was no product quality complaint involved. The pt's vaccination history included: A first, second, third and fourth dose in the left thigh of diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (Daptacel) on 16Oct02 (U0583DA), 03Jan03 (lotU0849DA), 05Mar03 (lotU0852AA), and 28Oct03 (lot C1606AA), respectively. A first, second and third dose in the right thigh of hep B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine on 16Oct02 (lot643661/0723M), 03Jan03 (lot643884/0741M) and 28Oct03 (645708/0284N), respectively. A first, second and third dose in the left thigh of poliovirus vaccine inactivated (Ipol) on 16Oct02 (lot W0063), 03Jan03 (lotW0332), 28Oct03 (lotX0148), respectively. A first, second, third and fourth dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (crm197)(PREVNAR) on 16Oct02 (lot489-752) in the right thigh, 03Jan03 (lot 485-991) in the right thigh, 05Mar03 (lot 490-909) in the right thigh, and 19Aug03 (lot 491-193) in the left thigh. Additional information is not expected.
1. Bruising x 3 weeks. 2. Local pain where shot or injection was given.
Client came for 2nd dose Pfizer and was inadvertently given Moderna.  Left message for pt to call back so we could notify her of the error. When pt responded and notified she stated that she was feeling well since her shot 2 days ago and no adverse reactions at this time, only complaint was a sore arm.
Generalized asthma; when he's laying down he makes a kind of a whistling or clicking sound which interferes with his; This spontaneous case was reported by a patient and describes the occurrence of SLEEP DISORDER (when he's laying down he makes a kind of a whistling or clicking sound which interferes with his) and ASTHMA (Generalized asthma) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer Covid-19 Vaccine (2nd dose) on 27-Apr-2021 and Pfizer Covid-19 Vaccine (1st dose). Past adverse reactions to the above products included No adverse event with Pfizer Covid-19 Vaccine and Pfizer Covid-19 Vaccine. Concurrent medical conditions included Joint pain.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced SLEEP DISORDER (when he's laying down he makes a kind of a whistling or clicking sound which interferes with his). In February 2022, the patient experienced ASTHMA (Generalized asthma). The patient was treated with PREDNISONE for Asthma, at an unspecified dose and frequency and ALBUTEROL [SALBUTAMOL] for Asthma, at a dose of 2 to 3 times a day. At the time of the report, SLEEP DISORDER (when he's laying down he makes a kind of a whistling or clicking sound which interferes with his) and ASTHMA (Generalized asthma) outcome was unknown.            No relevant concomitant medications were reported.  Patient began to had asthma issues including wheezing, shortness of breath and a small amount of mucous production. It was worse at night and was when laying down ,patient would make a kind of a whistling or clicking sound which interfered with the sleep. Patient would cough, which cleared things up, and would to go back to sleep, then be awakened again after an hour or two. Furthermore, the patient took prednisone for a week that did nothing for the asthma but made previously established periodic joint pain go away.Albuterol inhaler last from 4 to 6 hours.
From initial information received on 5/26/04 from a health care professional, it was reported that a female patient, age not provided, received her second dose of IMOVAX RABIES vaccine on 5/22/04. Six hours post immunization, the patient complained of symptoms of headache, nausea, vomiting, fever of 102 degrees F, hives, a rash at the injection site, on her chest, neck and face and also swelling of her lips and eyelids. The patient's recovery status was not reported. From additional information received on 6/14/04 from a health care professional, the patient's date of birth was provided. The patient was 48 years old at the time of vaccination. The lot number of IMOVAX RABIES administered on 5/22/04 was X0581 and the vaccine was administered IM in the left deltoid. Concomitant medications at the time of vaccination included Celexa, Levoxyl, and Norvasc. The patient did not have any illnesses at the time of vaccination. Reportedly the patient recovered from these events. No further information is anticipated, this case is considered closed.
N17.9 - AKI (acute kidney injury) (CMS/HCC) N17.9 - Acute kidney injury (CMS/HCC)
Patient is 12 years old and received today 12/2/2021 a 5-11 dose of Covid Vaccine as the first dose. Pt was stable, Doctor and parent were notified.  Patient was monitored for over 30 min, no adverse reaction noted.
Left arm whelped up for 48 hours all the way down to my wrist.  Injection site is still red.  Applied OTC band of Hydrocortisone cream and took Benadryl.
103 temperature, chills and shaking, severe headache, nausea/dry heaving, no taste or smell, no energy to even get out of bed. Lasted 5 days at this level and then tapered off. Lasted a total of 8 days.
Information has been received from a physician concerning a patient who was vaccinated with a dose of GARDASIL. The physician reported that during the visit of another patient the patient's mother refused to give the second dose of GARDASIL to her daughter because "a friend of the patient received GARDASIL and was paralyzed". The patient's outcome was unknown. It was unknown if the patient sought medical attention. Upon internal review paralysis was considered to be an other important medical event. Attempts are being made to verify the existence of an identifiable patient. Additional information has been requested.
Initial unsolicited misuse report received from a Pharmacist On 27 January 2015. A 56-year-old female patient had received a dose of FLUZONE QIV vaccine (lot number: UI192AB, expiry date was 30 June 2015, route of administration reported as intravenous and dose number, site of administration was not reported) on 26 January 2015. The patient's concomitant medications were not reported. The patient was hospitalized for heart symptoms. The patient was reported as allergic to ace inhibitors. It was reported that the vaccine was administered intravenously instead of intramuscular route. On an unspecified date post vaccination, the patient experienced body aches and chills. Corrective treatment and laboratory details were not reported. At the time of this report, the patient was not recovered from adverse events. Documents held by sender: None.
irritable, itchy, hives devel over entire abd, genitalia, buttocks, ear,s nose & nape of neck onset approx 1hr p/vax;
flu; Initial information received on 09-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves patient (unknown demographics) who experienced flu (influenza), when received INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication 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 an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.   Laboratory details were not reported.   It was not reported if the patient received any corrective treatment.  The event outcome was unknown for influenza.  There will be no information available on the batch number for this case.
pt recvd vax 29DEC95 & 3JAN96 pt devel fever of 103.4;seen in MD office the next day w/fever of 105 & listlessness;dx @ that time w/conjunctivitis & viral synd;pt adm to hosp w/in next several days peds cardiologist dx kawasaki's disease;
in the hospital because he fell and broke his hip; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HIP FRACTURE (in the hospital because he fell and broke his hip) in an elderly male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included Fall.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced HIP FRACTURE (in the hospital because he fell and broke his hip) (seriousness criteria hospitalization and medically significant). At the time of the report, HIP FRACTURE (in the hospital because he fell and broke his hip) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant drug was reported. Reporter mentioned that patient did not have his vaccine card which he needed to go to a facility for rehab on his hip. No treatment drug was reported.  Company comment: This spontaneous case concerns a male patient (age and gender unspecified), with no medical history reported, who experienced the unexpected serious (hospitalization, medically significant) event of Hip fracture, on an unspecified date after receiving a dose of mRNA-1273 vaccine. The patient had a fall and sustained the injury. The outcome was reported as unknown. Details of medical history/circumstances that led to fall, concurrent conditions, concomitant medications, clinical course, investigation reports and treatment were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a male patient (age and gender unspecified), with no medical history reported, who experienced the unexpected serious (hospitalization, medically significant) event of Hip fracture, on an unspecified date after receiving a dose of mRNA-1273 vaccine. The patient had a fall and sustained the injury. The outcome was reported as unknown. Details of medical history/circumstances that led to fall, concurrent conditions, concomitant medications, clinical course, investigation reports and treatment were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sudden onset bilious vomiting. Intestinal intussusception. Hospitalized - reduced with air enema. Recovered well. Hospitalization complicated by measles exposure.
Tinnitus in left ear. Non-stop buzzing in the ear day and night. Loud enough that I can hear the buzzing in a noisy setting.
Info has been received from a CMA concerning a healthy 11 year old white male pt with no allergies, who on 7/8/96 was vaccinated, SC, in the left arm with a dose of varicella virus vaccine live (lot 608666/0392B). On 11/15/05, he was prescribed acetaminophen (Tylenol) for symptomatic and supportive care. There was no product quality complaint reported. There was no other info available regarding the adverse event or the pt's outcome. Follow-up info indicated that the pt recovered on 11/23/05. No additional info is expected.
I administered a bivalent vaccine  past the 12+ hours post puncture. although, the dose is considered valid with an excursion time of + 12 hours post puncture..  The standard best practice is to use a vial of Pfizer for 12 hours after puncture I contacted the Health Dept. which I was then directed to call Pfizer mfgr, I was emailed a response that the vial puncture time was 24 hours.
A report has been received from a Physician concerning a 7 year old, Female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). The patient's concurrent diseases(s) included arthritis and she was immune compromised. Concomitant medications included methotrexate. FLUMIST QUADRIVALENT started on an unknown date. Patient was received FLUMIST QUADRIVALENT but she was immune compromised on 27-Oct-2014. The outcome of the event of patient received FLUMIST QUADRIVALENT but is immune compromised was unknown. The report was considered to be non-serious by the reporter.
Temperature: About or greater than 40.5 Celcius within 8 hours of vaccine, treated with Tylenol.  Persisted, inconsolable crying greater than 3 hours, 12-24 hours after vaccine.  Fever continued for at least 72 hours; irritability/crying at least 48 hours.
Severe chest pain; extremely breathing difficulty; Patient's parent suspected that the chest pain was casued by surrounding muscle aches, which caused breathing difficulties and lack of oxygen; This is a spontaneous report from a contactable consumer or other non hcp (reported for herself). A 17-years-old non-regnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: unknown), via an unspecified route of administration, administered in Arm Left ((at the age of 17 years) on 07May2021 15:45 (Batch/Lot number was not reported) as DOSE 2, SINGLE for Covid-19 Immunisation. The patient medical history and concomitant medications were none. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via unknown route of administration on 16Apr2021 at 10.30 AM, dose 1 single administered in Left arm for Covid-19 Immunisation. Patient did not have Covid prior to vaccination. Patient did not test for Covid-post vaccination. Patient had severe chest pain and extremely breathing difficulty 36 hours after 2nd dose on 09May2021 8:00 AM. Blood oxygen level in 70-80% range. Checked into ER at 1pm. Blood tests, urine tests, and x-ray all were normal. Finally, a simple Tylenol (650 mg) took care of the chest pain. Patient's parent suspected that the chest pain was caused by surrounding muscle aches, which caused breathing difficulties and lack of oxygen. The outcome of events was recovered on an unknown date in May2021.  No follow-up attempts are possible. Information about lot or batch number cannot be obtained.
I am a breastfeeding mother. My daughter (3 months old) ended up hospitalized/very sick; I am a breastfeeding mother. My daughter (3 months old) ended up hospitalized/very sick; This is a spontaneous report from a contactable Other HCP. This Other HCP (Patient's mother) reported for a 3-month-old female patient that received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL9269) via transmammary (parent route Intramuscular at Left arm) on 08Feb2021 06:00 PM at single dose for COVID-19 immunization. Medical history was none. Concomitant drugs were not reported. Her mother was a 23 years old female and was a breastfeeding mother, her daughter (3 months old) ended up hospitalized (in Feb2021 for 6 days) and very sick a week and a half after mother received the vaccine. The event start date reported as 16Feb2021 with outcome of recovering. Treatment was unknown. No covid prior vaccination. Covid test post vaccination on 18Feb2021: (Nasal Swab) Negative.; Sender's Comments: Very limited information was provided in this report regarding the clinical course of the event.  The reported "very sick a week and a half after mother received the vaccine" is unspecified. Pending more detailed information became available, at this moment, the Company cannot completely exclude the possible causality between the reported events and COVID-19 vaccine, BNT162B2.   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 RA, IEC, as appropriate.
sore lump that is warm to touch, no treatment advised to start cold compresses and OTC ibuprofen
Tingling in legs right after the first dose for about 30 minutes. Continues to have tingling in left leg between knee and hip at least once a day.
Received first dose Moderna on 4/14/2021.  Received second dose of Moderna vaccine 5/5/2021 and was not due until 5/14/2021.
Janssen VOVID-19 Vaccine ,   Extreme headache lasting 4 days, fatigue, muscle aches
COVID 19 Treatment; COVID 19 Treatment; Pfizer / BioNTech/Modedrna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 82 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Apr2022 as dose 4 (booster), single (Lot number: 048L21A) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Prostrate cancer" (unspecified if ongoing); "Non Hodgkin lymphoma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sodium pentothal, reaction(s): "Allergy: sodium pentothal". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 2022, outcome "unknown", described as "Pfizer / BioNTech/Modedrna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid treatment for Covid-19. The patient taking any other medications/products within 2 weeks of starting COVID-19 treatment was reported as no. The patient previously receive a COVID-19 Vaccine was reported as yes. Reported Event were Sore throat, runny nose, tired eyes. Went to a hospital for pre-op testing and was tested for COVID-19 and was found to be positive. Slightly tired.
pts 5th dose where Boostrix was admin instead of Infanrix; pts 5th dose where Boostrix was admin instead of Infanrix; 5 year old male received a dose of Boostrix on 20Sep2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 5-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2B723, expiry date 17-OCT-2025) for prophylaxis.   On 20-SEP-2023, the patient received Boostrix. On 20-SEP-2023, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: pts 5th dose where Boostrix was admin instead of Infanrix), inappropriate schedule of vaccine administered (Verbatim: pts 5th dose where Boostrix was admin instead of Infanrix) and inappropriate age at vaccine administration (Verbatim: 5 year old male received a dose of Boostrix on 20Sep2023).  The outcome of the wrong vaccine administered, inappropriate schedule of vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 3-Oct-2023 The medical assistant reported no symptoms. The reporter consented to follow-up via email. The patient received a dose of Boostrix as 5th dose instead of Infanrix at an inappropriate age, which led to wrong vaccine administered, inappropriate schedule of vaccine administered and inappropriate age at vaccine administration.
Information has been received from a nurse concerning her 15 year old daughter who in March 2008 was vaccinated with a first 0.5 ml dose of GARDASIL (Lot number not provided). In March 2008, the patient experienced dizziness, nausea, migraine and injection site reaction like swelling "which is size of silver dollar" after getting her dose of GARDASIL. The nurse also reported that the patient will not be getting any further doses of GARDASIL. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. On an unknown date the patient recovered from all symptoms. Additional information has been requested.
Dose administered after 30-day Use By Date; no adverse event; They kept a vial in the fridge for an extra 4 days.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They kept a vial in the fridge for an extra 4 days.), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 011H22A) for COVID-19 prophylaxis.    Co-suspect product included non-company product VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for an unknown indication.    No Medical History information was reported.   On 09-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient received dose of VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) (unknown route) 1 dosage form. On 09-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (They kept a vial in the fridge for an extra 4 days.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They kept a vial in the fridge for an extra 4 days.), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (They kept a vial in the fridge for an extra 4 days.) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.
Employee received a dose of Hep B vaccine (Comvax) 0.5ml IM x 1 dose on 2/28/06 and reported skin reaction (rash) on 3/6/06.