chrisvoncsefalvay/vaers-outcomes huggingface dataset:
What came out was just blood; Some of the vaccine had leaked out from the injection site; Patient received Prevnar 13, however, some of it leaked out; Patient received Prevnar 13, however, some of it leaked out; This is a spontaneous report received from a contactable nurse from medical information team.  A 2-month-old patient received pneumococcal 13-valent conjugate vaccine (Diphtheria CRM 197 Protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) at the age of 2 months for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE HAEMORRHAGE (non-serious), outcome "unknown", described as "What came out was just blood"; VACCINATION SITE DISCHARGE (non-serious), outcome "unknown", described as "Some of the vaccine had leaked out from the injection site"; INCORRECT DOSE ADMINISTERED BY DEVICE (non-serious), DEVICE LEAKAGE (non-serious), outcome "unknown" and all described as "Patient received Prevnar 13, however, some of it leaked out".  Additional Information: The nurse asked if they need to revaccinate the patient who received Prevnar 13, however, some of it leaked out. The events were considered non-serious. As of 10Mar2023, according to the nurse, that (some of it leaked out) is what the parents are saying happened. The clinic employee is saying that none of it leaked out. What came out was just blood. The nurse was calling because she was wanting to get some product information for what to do if some of the vaccine had leaked out from the injection site. The nurse doesn't know if it was an actual adverse event. Person who administered the vaccine said the vaccine did not leak out. The nurse doesn't think that it's really an issue. She just she wanted to make sure she had as much information as possible before she spoke with the parents.  The information on the batch/lot number for pneumococcal 13-valent conjugate vaccine (Diphtheria CRM 197 Protein) has been requested and will be submitted if and when received.  Follow-up (10Mar2023): This is a spontaneous follow-up report received from the same contactable nurse,. Updated Information: new events (added "What came out was just blood" and "Some of the vaccine had leaked out from the injection site"), reporter information, and course of events.  The information on the batch/lot number for pneumococcal 13-valent conjugate vaccine (Diphtheria CRM 197 Protein) has been requested and will be submitted if and when received.
loss of appetite; overall body aches; extreme lethargy; Initial information received on 07-Dec-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 81 years old female patient who experienced extreme lethargy (lethargy), loss of appetite (decreased appetite) and overall body aches (pain), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. It was suggested that body aches and fever can last 3 days after vaccination.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 01-Dec-2020, the patient received a 0.7 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ565AB and expiry date:30-JUN-2021] via intramuscular route in the left deltoid for prophylactic vaccination.  On 01-Dec-2020, the patient developed extreme lethargy (lethargy), loss of appetite (decreased appetite) and overall body aches (pain) (non-serious events), on the same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the patient did not recover from all the reported events.
This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a 4 to 5 adult patients who received SHINGRIX. On an unknown date, the patients received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced influenza-like symptoms, myalgia, arthralgia and headache. On an unknown date, the outcome of the influenza-like symptoms, myalgia, arthralgia and headache were unknown. It was unknown if the reporter considered the influenza-like symptoms, myalgia, arthralgia and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The healthcare professional (HCP) reported that his office had probably vaccinated around 60 patients with a dose of SHINGRIX vaccine and at least 4 to 5 of them had felt like they were hit by a truck, when asked to clarify, the reporter stated that, more like flu-like symptoms, myalgia, arthralgia and headache. The HCP did not have any additional information. This case has been linked with case US2018GSK095445, reported by the same reporter.
fast heart beat and heart palputations; fast heart beat and heart palputations; This is a spontaneous report received from a contactable consumer (Patient) from a Pfizer-sponsored program.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 19Jan2021 as 1st DOSE, SINGLE for COVID-19 Immunization. The patient medical history and concomitant medications were not reported. It was reported that caller had a reaction to vaccine after first dose, wondering fast heart beat and heart palpitations, after vaccine went to emergency room for increased of these upped dosage of blood pressure meds scheduled for next tuesday to get second dose. Outcome of events was unknown.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Patient received his booster dose 1.5 months earlier than he was supposed to.   I followed up with the patient's mother, on 01/03/2022, and she said that he was doing fine and had no issues.
Initial and follow up information has been received from a physician concerning a 63 year old white female with environmental allergies, a history of shingles in February 2007 and no known drug allergies who on 27-MAR-2007 was vaccinated SC with a 0.65 ml dose of Zostavax (Oka/Merck) (Lot #652947/1411F).  Concomitant therapy included aluminum hydroxide (+) magnesium hydroxide (+) simethicone (Mylanta).  On 17-APR-2007 the patient developed a herpes simplex eruption under her nose and on her lips.  The patient was treated with valacyclovir hydrochloride (Valtrex).  On 17-JUN-2007 the patient developed swollen eyes.  Medical attention was sought.  The patient was seen in the office on 28-AUG-2007 with red, swollen, and itchy eyes.  The patient was treated with prednisone.  No lab studies were performed.  At the time of this report the patient had not recovered.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
This spontaneous report was received from pharmacist regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # N004564, expiry date 22-OCT-2018) (dose and route not reported) for prophylaxis. The vaccine was exposed to temperature of 47 degrees Fahrenheit to 77 degrees Fahrenheit (49.1 Fahrenheit) for 1 hour and 45 minutes. No previous temperature excursion was reported. The call was not because of a data logger. No adverse effects and no product quality complaint (PQC) was reported. No further information provided. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1708USA011699: US-009507513-1709USA000689.
Heart/chest pain and discomfort. Treated with 800mg Advil, then high dose Tylenol, no significant improvement to the pain or discomfort.
Client returned to RN from her office 2 hours after reporting waves of feeling lightheaded, tingling of upper extremities, flushing, and L arm swelling at injection site. Injection site appeared raised, swollen, warm to the touch, painful and approx 4"x4" in size. Client denied difficulty breathing, swelling of the tongue/face/throat, rash/hives. She was alert and oriented x3 and VS WNL. BENADRYL 50 mg PO given. Cold pack applied to the left arm and client was seated for continued observation. VS monitored Q15' for 1hr and she made a steady improvement. No further reports of upper extremity tingling, feeling light headed, decreased swelling and redness of left arm (not as raised 3"x2") and not as warm. No further reports of feeling flushed. Client escorted to husband who was going to drive her to be examined at the ER. Advised client of risk of delayed anaphylaxis and need for ER follow up and reporting to her primary care. Client stated understanding. Called client for follow up but did not return phone call.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 06Feb2021 at 16:15 as dose 1, single (Lot number: EN9581), in left arm, on 27Feb2021 at 16:15 as dose 2, single (Lot number: EN6202), in left arm and on 28Sep2021 at 16:15 as dose 3 (booster), single (Lot number: 30145BA) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "Kidney disease" (unspecified if ongoing), notes: Kidney disease. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient took Paxlovid as a treatment for COVID-19 from 08Oct2022 to 12Oct2022.
This spontaneous report was received from a registered nurse and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 19-DEC-2018, the patient was vaccinated with improperly stored dose of VAQTA, lot # R018935, expiration date 05-SEP-2019 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (It was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
lose all of his muscular ability; got violently ill; Initial information received  on 12-Oct-2022 regarding an unsolicited valid  non-serious case received from a Patient.  This case is linked to cases 2022SA424503, 2022SA425041, 2022SA424529 and 2022SA422349.  This case involves Adult male patient who experienced got violently ill and lose all of his muscular ability after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Oct-2021, the patient received o.5 ml, total dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, strength, lot number: unknown) via unknown route in unknown administration site for immunization.  Patient stated that the last two years that he had a flu shot, he got violently ill (malaise)(unknown latency). He stated that his last flu vaccine he received on 13-Oct-2021, caused him to lose all of his muscular ability by (muscle atrophy) 15-Oct-2021 (latency: 2 days). Caller believes he had neuromuscular disease. The problems with his muscles lasted 5 months. He was asked if he was hospitalized, which he denied. Doctor ordered an "Electromyography (EMG)" test, but he refused due to having a defibrillator. He went to a chiropractor and all of a sudden it improved after that. His primary care doctor thinks his symptoms are improving, but he indicated he still has some effect.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (got violently ill, lose all of his muscular ability).  At time of reporting, the outcome was Recovering / Resolving for both events.
This case was reported in a literature article and described the occurrence of uveitis in a 44-year-old female subject who was vaccinated with hepatitis B vaccine recombinant (Hepatitis B vaccine, manufacturer unspecified). On an unspecified date the subject received 1st dose of Hepatitis B vaccine (unknown). One day after vaccination with Hepatitis B vaccine, the subject experienced uveitis. This case was assessed as medically serious by GSK. This is one of the 32 reported cases (B0662264A till B0662297A). It appeared that all subject's recovered, although the treatment for uveitis was not reported. The uveitis occurred in average of 3 days after vaccination in patients without other risk factors or disease that could cause uveitis. This could be consistent with immune complex deposition or nonspecific activation from vaccine adjuvants. Although there was a debate that uveitis occurs because of hepatitis B infection there was evidence that immune complex deposition diseases such as glomerulonephritis and cryoglobulinemia occurred during chronic hepatitis B infection. Furthermore it was possible the surface antigen of the vaccine and the hepatitis B antibodies of the immune response after vaccination formed immune complexes, which initiated the ocular response of uveitis.
nausea; headache; fever; joint pain; dizziness; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Feb2021 (Lot number: EM9810) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart disease" (unspecified if ongoing); "quadruple bypass", start date: 2008 (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: TOPROL (ongoing); CRESTOR taken for blood cholesterol (ongoing); ASPIRIN [ACETYLSALICYLIC ACID]. Vaccination history included: Bnt162b2 (1st Dose, Lot Number : EL3246, Route, Anatomical Location: right upper arm), administration date: 18Jan2021, when the patient was 68 years old, for Covid-19 immunization. The following information was reported: NAUSEA (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "nausea"; HEADACHE (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "headache"; PYREXIA (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "fever"; ARTHRALGIA (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "joint pain"; DIZZINESS (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "dizziness"; CHILLS (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "chills".  Additional information: Patient stated that he called regarding the Pfizer Covid vaccine and just wanted to report his experience with this, and he was a retired scientist from the and around his career, he had taken many different vaccines, including experimental vaccines never4sa had a reaction to anything until taking the Covid vaccine and he took the first dose early in the year. Patient stated that when he took the second dose, he had a very severe reaction to it. He had multiple symptoms from the vaccine, and it was severe and only lasted a few days. Patient stated that the event onset was a little sooner after getting the vaccine and the time, it lasted the same amount of time, about 48 to 72 hours.  No follow-up attempts are possible. No further information is expected.
Pt called to state that her right arm where the Prevnar was given is sore to the touch. Pt denied fever, swelling, rash and redness. MD advised pt take Tylenol and ice to site.  On 1/28, right arm ok but hurts when lifting arm over her head.  On 1/29, pt came to MD office for check.  MD prescribed Voltaren EC 50mg BID. On 1/31, pt reported arm better and Voltaren continued x 2 wks. On 2/11, pt had residual pain & MD referred pt to PT.
Developed fever the night of the vaccine which persisted. T max 103. Patient was not easily consolable since the vaccine was administered. He had decreased appetite as well along with decreased intake. Presented to UC without sx of dehydration. Otitis media dx. Returned  the next day with herpetic like lesions in the mouth and posterior pharynx as well as dehydration.
Symptoms:  Patient states that he has HX of COPD and has noted an increase in SOB on Sunday. He states he is taking his ProAIr inhaler every hour and it helps for the hour, but after that his breathing gets worse. Patient states he gets SOB with lying down and walking. Patient was speaking in full sentences and states it was because he just took his inhaler medication. Patient states he is positive for chills onset Sunday. Patient did have his first dose of COVID vaccine on Thursday. Denies difficulty breathing on Thursday, and per patient could have started Saturday night. DIAGNOSIS at time of disposition:   1. Chronic obstructive pulmonary disease with (acute) exacerbation (HCC)  Patient is a 64-year-old gentleman with history of chronic obstructive pulmonary disease, on p.r.n. albuterol at home as well as nightly Spiriva, coming to the emergency department for evaluation of worsening shortness of breath over the last 3 days with associated tightness with his breathing.  On arrival to the emergency department, patient is sitting forward, tachypneic, prolonged expiratory phase with diffuse expiratory wheezing.  He is saturating low 90s on room air.  He is placed on 2 L nasal cannula for comfort.  He received 2 DuoNeb treatments with EMS as well as Solu-Medrol.  I am going to treated with a continuous nebulizer treatment and obtained laboratory workup as well as chest x-ray.  Vital sign show tachycardia which is likely from his albuterol treatment, he is mildly tachypneic, otherwise stable.   Patient's laboratory workup is reassuring, troponin is negative.  Chest x-ray does not show any consolidation.  Patient does have some improvement in his symptoms after his continuous nebulizer treatment.  His VBG is repeated after treatment and shows that his pCO2 is going down however he is still slightly acidotic with the pH of 7.28.  Patient reports that he still tight in his chest, improved however uncomfortable going home.  He is still significantly wheezing on my exam, given this I did discuss this case with emergency department observation who agreed to accept for admission.  COVID testing is negative.  Patient is admitted in stable condition. Pulmonary:     Comments: Patient is sitting forward in the stretcher, he is tachypneic, prolonged expiratory phase with expiratory wheezing in all lung fields.
diarrhea; Scratch; Vaccination site rash; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), DIARRHOEA (diarrhea), SCRATCH (Scratch) and VACCINATION SITE RASH (Vaccination site rash) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     Concurrent medical conditions included Pregnancy (28th Week of Pregnancy). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 22-Jun-2021. On 05-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 05-Apr-2021 at 7:00 PM, the patient experienced DIARRHOEA (diarrhea), SCRATCH (Scratch) and VACCINATION SITE RASH (Vaccination site rash). At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved and DIARRHOEA (diarrhea), SCRATCH (Scratch) and VACCINATION SITE RASH (Vaccination site rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not take any treatment for the event. Events.
Patient fainted after receiving flu vaccine. RPh called 911, patient then woke 30 minutes later. 911 emergency was cancelled patient was fine.
11/22, woke up aching at site, under L/arm & inner aspect of L/arm. Visable swelling & "tight". Swollen lymph nodes, painful to touch. Referred to local medical care if no improvement.
Severe pain started in right arm the night vaccine was given.  Could not sleep.  Pain described as "in agony".  Missed work the following day.  Seen in emergency room 10/27/07 for pain, office visit 10/29/07 for pain and 11/07/07.  Interventions included ice to affected area.  Tylenol, Motrin, Percocet and Vicodin for pain.  None helped.
DIZZINESS, NAUSEA, HOT  TREATMENT- ICE PACK  FEELING FINE AFTER SOMETIME.
Pt was administered vaccine on 11/15/10. He called our office on 11/16 that he had severe shaking and blood shot eyes the evening of 11/15. On 11/16 he only c/o blood shot eyes.
This spontaneous report as received from a female patient of unknown age refers to herself. No concurrent conditions or medical history were provided. The patient reported to be taking an unspecified antiviral medication, which she discontinued taking (no date specified) prior to receiving ZOSTAVAX. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX injection (strength, dose, site and route of administration, lot# and expiry date unspecified). No concomitant medications were reported. The patient reported an immediate injection site swelling with a 2 to 3 inch red circle at the injection site. The injection site swelling became a raised red lump that stayed for 8 days. The redness and swelling has since disappeared (dates not specified). There was also a soreness in her arm, which was still present at the reporting time, however, it was recovering. The relatedness between the events and ZOSTAVAX was not provided. It was also stated that the therapy with ZOSTAVAX was not discontinued. Additional information is not expected as no demographics were provided for the physician.
Fatigue, sore abdomen, aching joints, slight chills. No fever. Less than 24 hours.
About 8 hours (1800) after receiving vaccine, developed nausea/vomiting, fever/chills, headache. Recorded temp ?a little over? 101 F.; vomiting lasted until 1/1/2021 0300; headache lasted through 1/3/2021. On 1/2/2021 took 2 extra strength Tylenol, repeat 2 pills on 1/3/2021 with improved headache ; Took total of 4 TUMS, 1 each after vomiting episode felt relief.
Complained of itchy throat 40 minutes after receiving multiple vaccines (TYPHIM VI, HAVRIX and yellow fever YF-VAX). Administered BENADYL 50 mg IM.