chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no symptoms were reported by  the patient after administration; VARlVAX was administered to patient since the excursion; This spontaneous report was received from a certified medical assistant referring to a patient (age and gender unspecified). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 21-JUL-2021, the temperature exurcion ocurred.  On 05-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX), dose reported as 1 (units not provided),  lot # T032319, expiration date:22-SEP-2022 for prophylaxis (dose number and  route of administration were not reported) during the excursion. The administered dose of the vaccine experienced a temperature excursion was 10.2 degrees Fahrenheit~for 1 hour 15 minutes, as recorded by a data logger. No previous excursions were reported. No symptoms were reported by the patients after administration. No product quality complaint reported. This is one of several reports received from the same reporter; Sender's Comments:  US-009507513-2108USA001788: US-009507513-2108USA001787: US-009507513-2108USA001770: US-009507513-2108USA001786:
Vaccine was administered to child on 8/30/16 as a second dose, previously vaccinated in error on 10/30/2008 with a first dose. Pt has a documented HX of chicken pox virus on 7/18/2007 by MD
myocarditis after coronavirus disease 2019 vaccination; This is a literature report.  A 14-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "recovered", described as "myocarditis after coronavirus disease 2019 vaccination". Presenting symptoms 2-5 days after second dose of mRNA COVID-19 vaccination included burning chest pain and shortness of breath for 24 h.The patient underwent the following laboratory tests and procedures: C-reactive protein (2.69-47.75): unknown results, notes: elevated; Echocardiogram: 62 %, notes: No RWMA (regional wall motion abnormality), normal diastolic function; Transthoracic echocardiograms on presentation; 67 %, notes: No RWMA, normal diastolic function; Follow up Transthoracic echocardiograms; Electrocardiogram: ST elevations in antereolateral leads, notes: on presentation; Early repolarization changes, notes: Follow-up ECG; Magnetic resonance imaging heart: Edema, patchy sub epicardial late gadolinium, notes: enhancement; on presentation; Resolved edema, no late gadolinium, notes: enhancement Follow-up cardiac magnetic resonance (CMR); Troponin (1094-2126): unknown results. Patient underwent CMR during acute hospitalization. Therapeutic measures were taken as a result of myocarditis. Treatment comprised ibuprofen for 2 weeks with complete resolution of symptoms at hospital discharge.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the event myocarditis and suspect drug BNT162B2 cannot be excluded.  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. ,Linked Report(s) : US-PFIZER INC-PV202200088740 Same article/drug/event; Different patient;
Pt began to stumble, sometimes not able to walk. ? limping. Examined on 8/14/01 and 8/16/01 with a normal exam. Examined on 8/18/01 and noted to be ataxic. Referred to neurologist who saw on 8/22/01 and noted to be weak in lower extremities with absent deep tendon reflexes. Guillain-Barre Syndrome; received IVIG on 8/28/01 and 8/29/01.
Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C; Possible administration of invalid dose to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C) and POOR QUALITY PRODUCT ADMINISTERED (Possible administration of invalid dose to patient) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In April 2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Possible administration of invalid dose to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C) and POOR QUALITY PRODUCT ADMINISTERED (Possible administration of invalid dose to patient) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  It was reported that there are 4 days temperature data(between 4/1/2022 and 4/4/2022) for the freezer storage unit, however it never reached an acceptable range and was always warm by at least 2 degree C. Between 2/22/21 to 4/26/22 there is no other temperature data available. Total 6640 doses of COVID-19 Moderna Vaccine were received by this facility during this time period and LOT numbers were provided(057M21A, 025L21B, 066H21A, 069H21A, 027H21B, 032F21A, 011F21A, 004F21A, 025C21A, 017C21A, 002C21A, 042B21A, 031B21A, 027B21A, 026B21A, 016B21A, 008B21A, 045A21A, 001B21A, 029A21A, 025A21A, 001A21A).Some vials may have been moved to a refrigerator at some point. There was no temperature data for that storage unit.  Treatment information was not reported.
This spontaneous report as received from a office manager refers to a patient of unknown age. It was reported that the patient may have vaccinated with the third dose GARDASIL early. Vaccine lot #, route and date were unspecified. The patient was not experiencing any known symptoms. The outcome of patient was unspecified. Additional information has been requested.
Pt. noticed a small rash first on his finger of his right hand. A little later in the same day he noticed the same rash on his forehead and lower back.  He described it as a "heat rash".  He said the bumps were small about the size of a ballpoint pen point, with all of them being raised and all just red, no pus or drainage.
This spontaneous report received from a nurse and refers to a 19 year old female patient. The patient's pertinent medical history, drug reaction/allergies or concomitant medication were not reported.    On an unknown date (reported as "in childhood"), the patient was vaccinated with routine doses of properly stored M-M-R II (route, dosage schedule, lot # and expiration date were not reported) and with VARIVAX (route, dosage schedule, lot # and expiration date were not reported) both therapies for prophylaxis. On an unknown date, the patient did not show any evidence of unspecified antibody titers (antibody test negative). At the reporting time, the outcome of antibody test negative was unknown. The reporter did not assess causality between the antibody test negative and the vaccination with M-M-R II and VARIVAX. There was no Product Quality Complaint (PQC) involved.  Additional information is not expected as there is not consent to follow-up.
pt recvd vax;first 2 days of vax, devel extreme swelling & pain & swelling at the lymph nodes under arms which lasted 4 days;
sore arm; High fever; chills; headache; body ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PYREXIA (High fever), CHILLS (chills), HEADACHE (headache) and MYALGIA (body ache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PYREXIA (High fever), CHILLS (chills), HEADACHE (headache) and MYALGIA (body ache). At the time of the report, PAIN IN EXTREMITY (sore arm), PYREXIA (High fever), CHILLS (chills), HEADACHE (headache) and MYALGIA (body ache) outcome was unknown.            The action taken with mRNA-1273 in response to the event was not applicable.  Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact
Initial information received on 19-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old female patient had the PENTACEL liquid part but not the powder part of the vaccine, while she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient also received ROTATEQ, PREVNAR 13 and HEPATITIS B VACCINE as concomitant medication. On an unknown date, the patient received a dose of suspect PENTACEL lot C5447AB, expiry date- 15-Nov-2019 via unknown route. It was a case of actual medication error due to inappropriate reconstitution technique. (Other relevant tests included no lab test.) Final diagnosis was gave the PENTACEL liquid part but not the powder part of the vaccine. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for gave the PENTACEL liquid part but not the powder part of the vaccine.
Vaccine recipient reported on 1/19/2021 that she developed itching, swelling, discomfort and a large welt at the injection site on her left arm. She went to occupational health and reported that the affected area was (9 cm x 7 cm, raised, and warm to touch). She reported that the provider told her it was a possible cellulitis. The occupational health provider wrote a prescription for doxycycline and allergy medication. She has a follow up appointment on 1/27/2021.
A report was received from a health care professional on 11/18/03, concerning a female vaccinee in her 30s who experienced a cold sensation and numbness on the left side of her face neck and arm one hour after receiving Fluvirin on 11/18/03. On 11/18/03, the vaccinee received Fluvirin 0.5ml. One hour later the vaccinee complained of a cold sensation and numbness on the left side of her face, neck and arm. There was insufficient information to determine the reporter's causality assessment. Update 4/19/04: A follow up report was received from a health care professional indicating that the 34 year old female vaccinee experienced paraesthesia with cold sensation and numbness on the ipsilateral side of her face, neck, and arms. The vaccinee was referred to a primary care physician for examination and no neurological defect was noted. The vaccinee recovered on an unspecified date. The vaccinee had no previous exposure to Fluvirin. The reporter has assessed the relationship of the vaccinee to the events as probable. No follow up pending, all information received.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Mild, Systemic: Weakness-Medium, Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-, Additional Details: felt worse after this dose then prior.  she came expecting bivalent but got the monovalent instead by accident.  a 0.5ml dose.
No adverse reaction reported by guardian  covid pfizer vaccine 5 yrs - 11 yrs (orange cap) 0.2ml administered to 14 year old for dose #1
Recombinant Zoster: Significant muscle pain, headache, shivering, stomach pain, nausea. This was my second dose. Symptoms were more severe than for first dose. In bed most of July 25, day after injection. Much better July 26.
Pt received vaccines on 3-3-10, developed fever on 3-26-10. Presented with post viral cerebellitis on 3-28-10. Spent 2 days at PICU and 4 days on regular floor. Developed severe neutropenia & neurology diagnosed pt with post viral cerebellitis. OF rate CSF no WBC.
Information has been received from a registered nurse concerning a 5 year old male who on 01/05/2005 was vaccinated with a dose of varicella virus vaccine live.  On 01/12/2005, seven days post-vaccination, the patient developed a fever of 103 degrees.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  There was no product quality complaint involved.  Follow up information indicated that additional information was not available due to concerns of a HIPAA violation.  No further information is expected.
Pt experienced numbness from wlbow to wrist around noon time. By 2.30pm he was fine.
right arm swelling; right arm burning; right arm irritated and hurting; right arm irritated and hurting; severe hives  in right hand; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (severe hives  in right hand), PERIPHERAL SWELLING (right arm swelling), BURNING SENSATION (right arm burning), IRRITABILITY (right arm irritated and hurting) and PAIN IN EXTREMITY (right arm irritated and hurting) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009c21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LINACLOTIDE (LINZESS) for an unknown indication.    On 24-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced URTICARIA (severe hives  in right hand). On 01-May-2021, the patient experienced PERIPHERAL SWELLING (right arm swelling), BURNING SENSATION (right arm burning), IRRITABILITY (right arm irritated and hurting) and PAIN IN EXTREMITY (right arm irritated and hurting). At the time of the report, URTICARIA (severe hives  in right hand), PERIPHERAL SWELLING (right arm swelling), BURNING SENSATION (right arm burning), IRRITABILITY (right arm irritated and hurting) and PAIN IN EXTREMITY (right arm irritated and hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment included ice placing on the swelling.
pt started feeling really dizzy and nauseated immediately after taking the vax.  she started having a seizure and made a growling type of noise and urinated on herself.  The nurse at the vax site helped bring her back and was told to take her to a doctor.  She was monitored and released from the vax clinic when her BP was 107/76.  She was taken to medical center where she saw.  She was told she had Syncope due to the stress of the situation of getting the vaccination.  She is resting today and seems to have some fatigue.
no adverse event; VARIVAX given intramuscular instead of subcutaneous; This spontaneous report as received from a healthcare professional refers to a 31 years old female patient. The patient's medical history and concurrent conditions were not reported. The patient's concomitant therapies included sterile diluent(MERCK STERILE DILUENT).       On 11-MAR-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX), intramuscularly instead of subcutaneous in the right deltoid (lot # and expiry date was not reported) for prophylaxis (incorrect route of product administration). The patient had no adverse event. There was no product quality complaint reported.
Cough; Runny nose; Got a cold; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), RHINORRHOEA (Runny nose), NASOPHARYNGITIS (Got a cold) and VACCINATION SITE PAIN (Sore arm) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K201A) for COVID-19 vaccination.     Concomitant products included TRAMADOL, TADALAFIL (CIALIS), TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), PANTOPRAZOLE, METOPROLOL and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 19-Jan-2021, the patient experienced COUGH (Cough), RHINORRHOEA (Runny nose) and NASOPHARYNGITIS (Got a cold). On 19-Jan-2021, RHINORRHOEA (Runny nose) and NASOPHARYNGITIS (Got a cold) had resolved. At the time of the report, COUGH (Cough) and VACCINATION SITE PAIN (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included 1 cough drop and oxymetazoline hydrochloride nasal swab for runny nose.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Swollen lymph nodes in neck, the supraclavicular lymph node and the anterior cervical lymph node on the left side, same side as injection. The soreness and pain travel down in the arm muscle past the injection site and up into the neckbehind the ear; Accompanied by feeling feverish, chills, dizziness,headache, pressure on head and fastheart beat; Accompanied by feeling feverish, chills, dizziness,headache, pressure on head and fast heart beat; Accompanied by feeling feverish, chills, dizziness,headache, pressure on head and fast heart beat; Accompanied by feeling feverish, chills, dizziness,headache, pressure on head and fast heart beat; Accompanied by feeling feverish, chills, dizziness,headache, pressure on head and fast heart beat; Accompanied by feeling feverish, chills, dizziness,headache, pressure on head and fast heart beat; This is a spontaneous report from a non-contactable consumer, the patient. A 17-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date(at the age of 17-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient did not have allergies to food, medication or other products. Concomitant medications were not reported. 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 13Apr2021 the patient experienced swollen lymph nodes in neck, the supraclavicular lymph node and the anterior cervical lymph node, on the left side, same side as had injection. Swollen nodes cause pain when moving neck and arm, and hurt to touch. The soreness and pain travel down in the arm muscle past the injection site and up into the neck behind the ear. Accompanied by feeling feverish, chills, dizziness, headache, pressure on head and fast heartbeat. Therapeutic measures were not taken as a result of the event(s). The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events Swollen lymph nodes in neck, the supraclavicular lymph node and the anterior cervical lymph node, pain, hurt to touch, feeling feverish, chills, dizziness, headache, pressure on head and fast heartbeat were not recovered at the time of report.    No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.
This vaccination was given instead of the MMR vaccine that was ordered.  Patient did not receive the MMR vaccine and is now waiting for that one.  Patient did not have a reaction to the vaccine and was observed for 15 minutes after.  Mother was spoken to later in the day and patient still was not having any reactions.  Mother was notified of the error and proper teaching was given to the nurse.
01/10/2014 Mild, other. Parent noticed a high temp (101 degrees Fahrenheit was the highest) and flat red dots on patient's belly on 1/10/14. His mother said the dots looked like someone had dotted him with a marker. The dots spread to his entire body and became bumps on 1/13/14. The mother gave TYLENOL for the fever and put Vaseline lotion on the dots. Patient was seen by doctor who initially thought that the reaction may have had something to do with patient's brother possibly having Fifth disease. The spots went away soon after the doctor's visit.
severe nausea; she is having a hard time drinking tea or anything; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry dates: unknown), via an unspecified route of administration, on 14Apr2021, as single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. The patient reported that on an unknown date in Apr2021, after receiving the first dose of the vaccine, patient had severe nausea. Patient stated that, this was the third day, and she was having a hard time drinking tea or anything. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Patient experienced Big lump, presented hot and swollen about quarter-sized. Resolved on its own after 4-5 days
I was very tired after the shot, however, the following day when I went to ride my exercise bike for half an hour as I usually do about 5 times a week for the prior year, I could not pedal for more than a minute. I thought I was just tired, but this complete exhaustion at exercise continued for months. This included not being able to walk up the escalators or stairs I walked up every day. I saw my doctor eventually for a physical, and I apparently have some heart issues that I didn't have before this. Only at about 6 months after the shot did I begin to be able to exercise again.
Information has been received from a medical assistant concerning a female who was vaccinated with GARDASIL, subsequently at another office. Subsequently the patient experienced a small lump at the injection site. Additional information has been requested. Information has been received from a medical assistant concerning a female who was vaccinated with HPV vaccine, subcutaneously at another office. Subsequently the patient experienced a small lump at the injection site that lasted for 2 months. No product quality complaint was involved. Additioal information has been requested.