chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Angioedema; This case was reported by a nurse via sales rep and described the occurrence of angioedema in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced angioedema (serious criteria GSK medically significant). On an unknown date, the outcome of the angioedema was unknown.   It was unknown if the reporter considered the angioedema to be related to Shingrix.  Additional details were provided as follows: The patient experienced angioedema after receiving 1st dose of Shingrix.
Chills, Muscle Soreness, fever and Severe Headache from about 5:30 p.m. 05-19-2021 - 1:30 p.m. 05-20-2021. Less severe chills, fever, and severe headache from 1:30 p.m. 05-20-2021 - 6:30 a.m. 05-21-2021. Less severe headache continues after shower finished 6:30 a.m. 05-21-2021 until present 05-21-2021.
Hospitalized, flu positive, now needs lung transplant, never got better. Was in ICU with metapneumovirus. Turned into possible bronchitis obliterans.
Itchy throat body Body flushed  Chest tightness  Throat tightness  Tachycardia  Hypertension  Nausea SOB
from shoulder to elbow bruise, central part of arm lateral side bruised; Fever; Chills; This non-serious case was reported by a nurse via sales rep and described the occurrence of contusion in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced contusion (Verbatim: from shoulder to elbow bruise, central part of arm lateral side bruised), fever (Verbatim: Fever) and chills (Verbatim: Chills). The outcome of the contusion, fever and chills were not reported.   It was unknown if the reporter considered the contusion, fever and chills to be related to Shingrix.     It was unknown if the company considered the contusion, fever and chills to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-OCT-2023 The reporter stated that, after first vaccination of Shingrix, the patient experienced bruise from shoulder to elbow, central part of arm lateral side bruised, fever and chills. The reporter did agree to follow up from GlaxoSmithKline.
BLOOD CLOT; This spontaneous report received from a patient concerned a multiple adult patients (ages 18-39 year) of unspecified sex, race and ethnicity.  No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total, for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patients experienced blood clot. It was reported that, "so 7 per million blood clot with JNJ ages 18-39". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20211264065 -COVID-19 VACCINE AD26.COV2.S- Blood Clot. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
booster; Tiredness; arm soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 34 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 57-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  There were no power outages that would have impacted the Moderna vaccine. However, the facility was unable to download the digital data logger and needed to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022.  No adverse reactions were reported by the patient.  No treatment medication was provided.
Patient is former 27 4/7 premie who was due for 2 month vaccines on DOL #60. At this time, she was stable in special care nursery at hospital. She was due to go home the following day. She was taking all PO, off catheter since 8/1. 2 month vaccines given on 8/10-by AM of 8/11 began having HR drops, irritability, feeding intolerance, and decreased activity. No fever....sepsis work up done along with CXR/KUB. Antibiotics were started (Vancomycin/Gentamycin) and continued for 48 hours until culture were complete negative. On the next day the irritability, vomiting, and multiple heart rate drops resolved. Patient returned to baseline, went home on 8/18 after 6 days of observation without repeated heart rate drops. 11/13/06 Received medical records from hospital which reveal patient had been hospitalized from birth.  Remained in NICU until 8/4/06 when transferred to special care nursery wt 1980 grams).  Was able to take oral feeding by 7/12/06.  Received 7 day course of antibiotics for suspected maternal chorioamnionitis.  Was scheduled for d/c on 8/11 & received 2 mo vax.  Became increasingly irritable, poor feeding & desat to 70s w/heart rate of 70s also & multiple emesis episodes.  Placed back on CPAP temporarily & w/u for sepsis done which was neg. Weight at D/C 2200 kg. D/C dx: preemie; RDS resolved; apnea of preemie resolved; right hip dysplasia resolved; retinopathy of preemie; anemia of preemie; ABO incompatibility; mild acute chorioamnionitis on placental path; and in utero marijuana exposure. Patient was to be followed by home health nursing, PT & OT.
pt recv vax 20MAY98 & reported redness, swelling, 5cm diameter;no fever, malaise;21MAY98 inc rxn 1PM;10cm diameter-induration, redness, tenderness;local rxn;
Dizziness, weakness, in 5 min. of receiving vaccine.  VS 121/86, HR 86, O2Sat 100%. 11:30am  Patient stated feeling much better and left.
developed aised red vesicular pruritic rash gen over upper thighs and arms. Recieved the vaccination on 7/23/2008 and rash developed on Thursday 7/24/2008.  Treated with zovirax, benadryl and topical hydrocortisone cream.
Janssen COVID-19 Vaccine EUA  Six hours after the vaccination I experienced an upset stomach, fever, chills, terrible body aches, headache, and sluggishness.  I only had children?s Tylenol so I took that but it did not treat the symptoms. Thirteen hours later I took extra strength Tylenol and that helped with the treatment of most of the symptoms. About eighteen hours later I started to feel better. I had residual hot flashes 48 hours later.
Gold ball sized lump to left armpit near breast that was tender and warm to the touch. No prior issues with armpit or breast tissue. Needed to take Motrin/Tylenol for pain and swelling for two days after vaccination.
Employee called on 10/15/01 to report that at 23:00 that evening, post vax, he developed a headache, lower back and knee "joint" pain. The following day, pot vax, on 10/10/01, he had a low-grade fever of 100F, muscle aches, felt very fatigued and experienced diarrhea. On 10/11/01, muscle aches improved, no diarrhea but had malaise. He took 1000mg Tylenol. On 10/12/01, myalgia was gone, had no diarrhea, no fever but felt tired. On 10/13/01, he felt fine.
Loss of hearing in left ear. Tinitus. Issues trying to keep left ear clear and pressure even.
This spontaneous report as received from a nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 06-APR-2018, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB (dose, frequency and route were not reported) (lot # N034005, expiry date: 31-JAN-2020) for prophylaxis. No adverse effect reported. No product quality complaint involved. The LIQUID PEDVAXHIB) was stored in temperature of 32 degree Fahrenheit (F) to 35 F (32 F) for 8 minutes. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 70 year old female. Initial information was processed along with the additional information received on 04-MAR-2022 and 09-MAR-2022. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received booster covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on an unspecified date for prophylactic vaccination. It was unspecified if the patient experienced any adverse event after vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient stated herself was trying to recover from Covid and have been very sick (suspected clinical vaccination failure, and suspected covid-19 infection) (dose number in series 2). patient had the J and J shot and booster, as the doctor said it could have been worse. The patient concomitantly received rivaroxaban (film-coated tablet, route of admin not reported, batch number: 1314754-10430 expiry: 27-OCT-2022) 20 mg, frequency, and therapy dates were not reported for an unspecified indication. The patient received a manufacture sealed 30 count bottle of Xarelto 20 mg, that was short of 2 tablets. she opened the bottle and counted the tablets and there were only 28 tablets in the bottle. She has not missed any days but wants something to be done about the missing tablets because they are so expensive The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000220076. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the RA evaluation/investigation performed. This case, from the same reporter is linked to 20220302858.; Sender's Comments: V0-20220304761-covid-19 vaccine ad26.cov2.s Suspected clinical vaccination failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
This is a spontaneous report from a contactable consumer (patient).  A patient, of unspecified age and gender, received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FF2589), via an unspecified route of administration, on Oct 11, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported.  The patient got the booster shot yesterday and felt absolutely terrible (Oct 2021). The patient was a little worried, because it didn't feel like this after the 2nd shot (unspecified date). The patient's heart was racing, had a fever and was just hurting all over. The patient knew this was some of the side effect, and asked if this is normal. "So what does a person do that is having an adverse reaction?" The patient didn't think they needed a hospital but needed to know if this was normal. Patient further added, "Can you tell me because I am having reaction with this (further not clarified hence event captured as per verbatim), is this something that's gonna go away? Is this normal, is all I am asking, is it normal?" The outcome of the events: unknown.
More Tired; More Sad; Lot of Chills; This is a spontaneous report from a non-contactable, other healthcare professional. A 36-years-old female patient received an UNKNOWN dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/Batch Number: UNKNOWN), via an unspecified route of administration at an unspecified site on 06Mar2021 (at the age of 36-years old) for COVID-19 immunisation. The past medical history of the patient included diagnosis with COVID-19 prior to the vaccination. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccine within four weeks before the COVID-19 vaccine and received the birth control patch within two weeks of the vaccination. On 06Mar2021, the patient experienced chills, tiredness, and feeling sad. The patient reported that she was feeling a lot of chills since she received the vaccine, and was more tired, and sad. The clinical outcome of the events, chills, tiredness, and feeling sad was unknown.    Information about lot/batch number cannot be obtained. No further information is expected.
autoimmune skin rash; blisters; postherpetic neuralgia; Information has been received regarding a case in litigation, concerning a currently 60-year-old patient (pt) of unknown gender. The pt's medical history, concurrent conditions and concomitant medications were not reported.   On or about 26-SEP-2014, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) at a medical office, for the long-term prevention of shingles and zoster-related conditions (dose, route of administration, anatomical location, lot number, and expiration date were not reported).   On an unspecified date (reported as "subsequently"), the pt was treated by a provider for autoimmune skin rash, blisters and postherpetic neuralgia. The outcome of the events was not reported.   The reporter considered the aforementioned injuries to be related to zoster vaccine live (ZOSTAVAX).
Pfizer-BioNTech COVID-19 Vaccine EUA  Started to feel ill around 8pm 1/11. Woke up with nausea and headache around 10am 1/12. Cough and fever developed by 4pm 1/12, cough was mild and fever never exceeded 101 degrees Fahrenheit. Also experienced fatigue and body aches. Nausea successfully treated with promethazine. All symptoms dissipated significantly or gone altogether around 1am 1/13.
no adverse effect reported; the patient received improperly stored PEDVAXHIB; This spontaneous report has been received from a medical assistant referring to a 4-month-old male patient. No information on patient's pertinent medical history, concomitant medications, drug reaction or allergies was provided.  On 11-SEP-2019, the patient was vaccinated with improperly stored Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (lot # S000352, expiration date: 17-OCT-2021, dose and route of administration were not provided) for prophylaxis (product storage error). The vaccine was exposed to temperature above 9 degrees Celsius (8.93 degrees Celsius) for 30 minutes. Previous temperature excursion included temperature above 9 degrees Celsius (8.87 degrees Celsius) for 30 minutes and 2-8 degrees Celsius (8.07 degrees Celsius) for 30 minutes. Data logger was involved. No adverse effects were reported.
This spontaneous report as received from a nurse regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On 26-AUG-2015, the patients were vaccinated with improperly stored MMR II lot # J013316, expiration date 22-OCT-2015 and lot # K005175, expiration date 10-APR-2016. No concomitant medication was reported. No adverse event was reported. No PQC (product quality complaint) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Swelling of arm, redness, tightness and muscle pain.  Arm still swollen next day (24+ hours later), redness and swelling spread to elbow and lower arm on second day.
had a very bad headache, Next day all better except dull headache which lasted for about 2 weeks.; Muscle soreness in neck and shoulders; Extreme tiredness; Sore arm day of shot and next day.; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: 8731) via an unspecified route of administration in the left arm on 23Apr2021 at 10:45 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within two weeks of vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0150) via an unspecified route of administration in the left arm on 02Apr2021 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. On 23Apr2021, the day of shot, the patient experienced sore arm. On 24Apr2021 at 14:00,on day after shot, the patient also had a very bad headache, muscle soreness in neck and shoulders and extreme tiredness until 22:00. It was reported that next day (on 25Apr2021) all better except dull headache which lasted for about 2 weeks. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm was recovered on 24Apr2021, while that of muscle soreness in neck and shoulders and extreme tiredness was recovered on 24Apr2021 at 22:00 and bad headache was recovered on an unknown date in May2021.   No follow-up attempts are needed. No further information is expected.
Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Additional Details: patient told us she was not good with needles.  she fainted for about 5 seconds and slumped over to the left.  she came back to and was vomiting.  gave her water and put ice pack on her neck.  paramedics came her bp and pluse were normal.  she did not go by ambulance
I'm allergic to the Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "I'm allergic to the Pfizer". Additional information: Patient called regarding the availability of the vaccines and why there is not enough. Asked if doctors office has the vaccine and the caller stated, "They only give out the Pfizer they can't get the Moderna...I can't take that. I'm allergic to it." Asked name of the vaccine and caller stated, "well I haven't got it in a year there's only two of them here its either Pfizer or Moderna and I get the Moderna shot because I'm allergic to the Pfizer I don't know what you're talking about other than that that's what we call it here. the corona virus shot. Note: The reporters/patients name was not provided on the phone call The following information was not confirmed during the call, but retrieved from the system: Reporter phone No.,The following information was not provided during the call: Patient gender  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Pain radiating from injection site down to palm. Ice pack provided, encouraged rest and ibuprofen over the counter.  Condition unchanged.
Within 5 minutes of receiving Covid Vaccine (Pfizer ), second dose..... Employee complains of difficulty breathing, warm, sweaty, left arm pain, lips swelling, tachycardia (p=140-100). Team called and sent to ER.