chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is 39-year-old male with no significant past medical history who works at long-term care facility.  He received COVID-19 vaccine on 1/13/2021 and immediately developed numbness and tingling in the area of injection which was the left shoulder.  Over the next 15 to 30 minutes numbness and tingling expanded to the left side of his body including face arm and leg and the left side of his trunk.  He began to feel foggy and had some slurred speech.  He presented to the Emergency Room and tests were performed to rule out a stroke.  The patient denies any other symptoms such as fever chills myalgias.  He did not have any weakness of the extremities.  He did not have any speech disturbances or visual disturbances.  This morning on examination he states his symptoms are much better.  He still has some residual numbness in his leg and arm.  Facial numbness is almost all gone.  As of 1/18/2021, residual numbness and tingling is only in his left ring and pinky finger.
Fully  vaccinated, COVID breakthrough in an oncology patient.   Admit to general medical ward
Multiple nosebleeds flu like body aches. The multiple nosebleeds were the most concerning and unusual
Chills, sore throat, fatigue, congestion, sore arm followed by sore body, headache
Administered 2nd MMR and Varicella to child under age 4yrs.
Pt presents red, raised, hard to touch, swollen rash on 1/2 of upper arm (injection site arm) and was treated with ice compress
This spontaneous report was received from a 31 year old female patient who is also a physician. The patient had no pertinent medical history and drug reactions/allergies were none. Concomitant medications included birth control (unspecified name) started over 12 years ago. On 22-OCT-2018 at 16:00, the patient was vaccinated with GARDASIL 9 injection, via intramuscular route (strength, dose, lot # and expiry date were not reported) for prevention of disease. On 23-OCT-2018 after waking up in the morning, the patient experienced swelling, redness and heat in her right index finger, right hand, right large toe and right foot. It was reported that redness from foot was extending upward. The patient was given treatment for the adverse events. On 23-OCT-2018, the patient was seen by physician and advised to "monitor symptoms". No lab diagnostics/studies was performed. The patient sought medical attention. The outcome of peripheral swelling, erythema and feeling hot was reported as not recovered/not resolved. The causality assessment was not provided. There was no product quality complaint (PQC) reported.
Rec'd flu shot and Pneumovax 10/24/07. Fever 10/24 to 100.5, body aches. Fever to 102 on 10/26, some HA and nausea. Symptoms resolved by 10/28/07.
Had a stroke approximately 4 weeks after taking the Pfizer COVID vaccine in 2022 and again in 2023. Both times almost exactly 4 weeks after vaccine.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 29Sep2023 at 01:00 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PLAVIX; CRESTOR. Vaccination history included: Bnt162b2 (Had a stroke approximately 4 weeks after taking the Pfizer COVID vaccine in 2022), administration date: 2022, for COVID-19 immunization, reaction(s): "stroke". The following information was reported: CEREBROVASCULAR ACCIDENT (caused and prolonged hospitalization, disability, life threatening) with onset 27Oct2023 at 07:00, outcome "not recovered", described as "Had a stroke approximately 4 weeks after taking the Pfizer COVID vaccine in 2022 and again in 2023. Both times almost exactly 4 weeks after vaccine.". The patient was hospitalized and prolonged hospitalization for cerebrovascular accident (hospitalization duration: 4 day(s)). The events "had a stroke approximately 4 weeks after taking the pfizer covid vaccine in 2022 and again in 2023. both times almost exactly 4 weeks after vaccine." required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: Unknown Results; Echocardiogram: Unknown Results; Magnetic resonance imaging: Unknown Results. Therapeutic measures were taken as a result of cerebrovascular accident which includes: Blood thinners, MRI, CT, Echo cardio grams, meds (unspecified).   Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19 and not been tested for COVID-19 since the vaccination.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300353169 same patient/AE, different vaccine dose number;
Treatment of Covid-19; Treatment of Covid-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and in May2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "overweight" (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"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown". 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 which included Paxlovid from 07Oct2022 to 12Oct2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a healthcare worker via a company representative and refers to a 19 year old non-pregnant female patient. The patient was vaccinated with the first dose of GARDASIL (lot # H021346, expiry date: 01-OCT-2015) on 07-MAY-2013, with second dose of 17-JUL-2013 and third dose of GARDASIL (route and administration not specified). Concomitant therapies included doxycycline (manufacturer unknown) and an unspecified topical acne medication. Patient's medical history included acne. No known allergies were reported. The healthcare worker reported that the patient on 15-APR-2014 after receiving third dose of GARDASIL the patient developed vomiting (vomited twice), diarrhoea, a stomach ache and nausea and was still having a stomach ache during an office visit on 16-APR-2014 (reported as yesterday). There was no adverse events reported with the first two doses of GARDASIL. The treatment was given for the adverse events: fluids and ZOFRAN (manufacturer unknown). Laboratory test: complete blood count was performed on 16-APR-2014 in the office. The outcome of the events was recovering/resolving. The relationship between the GARDASIL and the events was unknown. This is one of several reports received from the same reporter (case # 1404USA012598). Additional information has been requested.
Asymptomatic at this time. Tested via PCR 12/21/21 return result = positive on 12/23/21.
4/24 - chills, muscle aches, slight fever (99-100), fatigue, sore arm  4/25 - still a bit of same but much better other than arm  4/26 chest tightness started. Got worse slowly. Sometimes not noticeable tho 4/28-4/29 migraine (pain level 1-2), still have chest pain (took Advil Migraine) 5/1-5/2 migraine (pain level 1-2, end 4-5), still have chest pain 5/3 -5/7 Chest pain worsening. Really bad this week 5/4 Emailed doctor who advised Aleve twice daily with advice to go to ER if shortness of breath.  5/5 Sister-in-law informed us of positive Covid testing 5/6 Covid19 testing at pharmacy, tested negative  5/10 chest pain easing but continued until 5/14 or so. Took Aleve when needed.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE
At the check out patient was standing and then fell on the floor was taken to the room. She was awake, alert, vital signs were normal, stayed in the room for 15-20 minutes and left when she felt better.
no other AE; temperature excursion; This spontaneous report was received from a medical assistant and an office manager and refers to a patient of unknown age and gender (number reported as 64675). There was no information about their concurrent conditions, concomitant therapies or medical history provided.  On 13-MAR-2021 (reported also as reported as between 04-MAR-2021 and 25-MAR-2021), the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) dose/frequency: 1, lot # T027118, expiration date 07-FEB-2022, recombinant human albumin (rHA) (exact dose, route of administration and anatomical location were not reported) for prophylaxis. The vaccine was stored in a temperature of 13.5 Fahrenheit degrees (F) for 40 minutes. There was no previous temperature excursion reported. Digital data logger was involved. No additional adverse event was reported.  As of 28-MAY-2021, no further information was available as the office manager stated she was not familiar with the case and the medical assistant has not been working at the facility anymore.  This is one of several reports from the same reporter.
A non-serious report of administration of expired FLUMIST was received from a Registered Nurse concerning a 34-month old male. Relevant medical history and concomitant medications were not reported. On 23-Dec-2009, the patient received expired FLUMIST. There was no adverse event associated with this medication error, therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered to be resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
The patient has a blood disorder; the patient felt "strange" after an expired PNEUMOVAX 23 vaccine was given on 6/10/2022.   The medical assistant did not elaborate what the patient meant by "strange"; he received the wrong vaccine; The medical assistant stated that the patient felt "strange" after an expired PNEUMOVAX 23 vaccine was given on/he received a three-month-old vaccine on his previous visit; he reported he hasn't been feeling well; has been very fatigued; This spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender.  Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 10-JUN-2022, the patient was vaccinated with one expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23), as prophylaxis, (strength, exact dose, route of administration, anatomical injection site, and frequency were not provided; lot number t033663 has been verified to be a valid lot number with an expiration date on 21-MAR-2022 (expired product administered).  On the same date, after the vaccine was administered, the patient felt strange (feeling abnormal). At the reporting time, the outcome of the event was unknown. The causal relationship between the event feeling abnormal and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) was not provided.  This is a non-valid case due to the lack of patient identifiers.  Follow-up information has been received from a nurse via telephone call on 25-JUL-2022.  On 01-JUL-2022, the patient reported that he wasn't feeling well (malaise) and that he had been very fatigued (fatigue), on the same day, he was informed that he received the wrong vaccine (wrong product administered), and then he was asked to speak with the director of the office on 07-JUL-2022 for a follow-up appointment, when he received a call where he was informed that he received a three-month-old vaccine on his previous visit.    The reporter also mentioned that the patient has a blood disorder, and provided information about the administration of the vaccine.  This case, before considered as non-valid, is now considered as valid since information about patient demographics was received
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot #, expiration date, dose and route were unknown). No adverse effect was reported. This is one of two reports received from the same reporter. Additional information has been requested.
Pt recvd vax & exp sl swelling & sl inc heat over inject site w/o redness, pain & swelling in lt arm w/radiation into elbow; lt elbow tenderness; hardening of tissue SC over site; epicondylitis; pain into lateral aspect of forearm;
My symptoms began approximately 14 hours after I received the vaccine.  They started suddenly and included the following: -Intense dizziness that was also electric like and lasted 36 hours -Severe headache lasted 36 hours and mild for 48 hours  -Fever last was intermittent for 48 hours.  I only started recording it 24 hours after the vaccine was administered.  My max temp was 101. -Nausea (1 episode of vomiting) lasted 36 hours -Muscle aches and joint pain lasted 36 hours -Extreme fatigue lasted 48 hours -Injection site pain and swelling are still present, but are now mild -Enlarged lymph node in armpit of the same arm that vaccine was administered.  This was discovered about 24 hours after receiving the vaccine and is still present.  It?s about 1 inch in diameter.
She tested positive for COVID-19; This is a spontaneous report received from a Pfizer-sponsored program. A contactable female Consumer reported for herself that: CEP ID: 159558. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Expiry date: Unknown), dose 1 via an unspecified route of administration on 31Mar2021 at SINGLE DOSE for covid-19 immunisation.The patient medical history and concomitant medications were not reported. The patient experienced she tested positive for covid-19 (covid-19) on 02Apr2021. The patient underwent lab tests and procedures which included covid-19: positive on 02Apr2021. Clinical course reported as Caller, got her first dose on March 31st. She tested positive for COVID-19 on April 2nd. She is scheduled to get the second dose on Wednesday (April 21st). She had the COVID-19 Test this morning and wants to know if she can get the second dose in case the result would be positive or not. The outcome of the event was unknown on an unspecified date.  Follow-up 01(21Apr2021): This is a follow up-spontaneous report received from a Medical Information Team. No new AE or SD is added.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This case was retrieved via a search of scientific literature on 14 November 2011. This reporter also reported other adverse events, which were captured in case numbers 2011-11217, 2011-11218, 2011-11219, 2011-11220, 2011-11221, 2011-11222, 2011-11223, 2011-11224, 2011-11225, 2011-11226, 2011-11227, 2011-11228, 2011-11229, 2011-11231, 2011-11232, 2011-11233, and 2011-11234. Verbatim from the abstract: "Background: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Methods: Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. Results: CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through other searches. Causality assessment using the modified agency criteria resulted in classifying 3 cases as definitely related to vaccine administration, 12 as probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful. Conclusions: The CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations". An infant (age reported as 0.3 y) had received on an unspecified date the following vaccines: DTaP (manufacturer, lot number, route and site of administration not reported), Hib vaccine (manufacturer, lot number, route and site of administration not reported), IPV (manufacturer, lot number, route and site of administration not reported), HepB (manufacturer, lot number, route and site of administration not reported), PCV7 (manufacturer, lot number, route and site of administration not reported) and Rotavirus (manufacturer, lot number, route and site of administration not reported) and 0.3 days from vaccination, experienced a bulging fontanelle and was fussy. The causality was reported as possibly related. No further information was available at the time of the report. The outcome was not reported. Documents held by sender: None.
Information has been received from a medical assistant(also reported as office manager) referring to a 19 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 27-APR-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis(Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program(VFC) stock and the VFC status appointment was reported as 2. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received. Sender's Comments: US-009507513-1704USA014784:
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 26-month-old female. Neither the patient's medical history nor the concomitant medications were reported. The product expired on 25-Dec-2011. On 05-Jan-2012, the patient received expired FLUMIST. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of two years to 59 months of age. Additional information was received on 26-Mar-2012 and incorporated into the narrative: No late occurring adverse events.
Large area of redness, swelling and itching at site of injections appearing approximately 24 hours after injection and decreasing in size and sensitivity in the next 24 hours. No fever or headaches.
Information has been received from a registered nurse referring to unspecified number of pediatric patients of unknown age and gender. The patient's medical history and concurrent condition were not reported. On an unknown date the patients were administered with GARDASIL 9 (Lot# L026602, Expiration date 19-OCT-2017, therapy type rHA, dose, route and frequency not reported). The vaccine was undergoing a possible (but not verifiable) second temperature excursion at 30.8 degree Fahrenheit for 15 hours. It was noted that the reading of "30.8" was based on a handwritten record that was not clear. It was strongly believed by the reporter that the vaccines instead remained in range at 38.8 degree Fahrenheit and that the reading "30.8" was based on a clerical error (handwriting legibility issue). The vaccines involved previously underwent an excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient started having raised, red whelps along with severe itching appearing on the hands, arms, legs, and feet. The whelps are warm to the touch. She went to her primary care physician and was prescribed triamcinolone ointment and a Medrol steroid pack and has taken diphenhydramine OTC. So far, she has had no relief from any of these treatments.
a 58 years old male patient received a dose of Adacel which had been arrived a day late and the temperature in the packaging was not in the red/No AE; Initial information received on 29-Aug-2019 regarding an unsolicited valid non-serious case received from an other health care professional.  This case involves a 58 years old male patient who received a 0.5 ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] that had been arrived a day late and the temperature in the packaging was not in the red lot U56401AA, expiry date: 26-Jul-2021 via intramuscular route in the left deltoid on 29-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to incorrect product storage.  Adverse event was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Second dose of Pfizer Covid-19 shot. Only sore arm for first 34 hours, with noticeable bump under skin at injection site. Then woke up at 4am (34 hours after injection) with very itchy rash across upper chest (front only, between neck and breasts), and some sweating. I must have itched enough in my sleep to break the skin before waking. No fever. Injection site bump had dissipated entirely.