chrisvoncsefalvay/vaers-outcomes huggingface dataset:
have a history of tinnitus and it got really bad; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. Relevant medical history included: "tinnitus" (unspecified if ongoing), notes: history of tinnitus. The patient's concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "have a history of tinnitus and it got really bad".  Additional information: Patient reported that he has a history of tinnitus and it got really bad after he took the first dose. His fear was that it would get worse after the second dose which he was scheduled for three weeks out.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Client received the 1st COVID vaccine, Janssen, at 1:00 pm.  At 1:19 pm, client reported his observation time was up, however he was feeling "slightly dizzy and slightly short of breath".   Client at this time denies difficulty breathing, tightening of throat, difficulty swallowing, or itchiness.  Client is sitting upright in chair, able to talk and respond questions, states "I'm also wearing two face masks and I was also anxious about receiving the vaccine".  Client denies ever having similar reaction to any other vaccine, reports fainting with injection of Penicillin 26 years ago, unsure why, never told he's allergic to Penicillin.  Client denies any medical conditions other than "unconfirmed long QT wave", denies taking medication.  RN offers client Benadryl IM for symptoms, client accepts.  Vital signs @ 1:24 pm:  blood pressure 160/82, heart rate 111, respirations 16, oxygen saturation 95%.  At 1:28 pm, RN is ready to give Benadryl IM dose, but client refuses, states he wants to wait for now on the medication, states "It could be the stress of getting vaccine and fear of needle".  Vital signs at 1:30 pm:  blood pressure 148/76, heart rate 97, respirations 16, oxygen saturation 96%, client continues to have conversation with EMT and his wife, who is present.  At 1:32 pm, client reports he continues to have shortness of breath, no difficulty breathing, itchiness, throat tightening, trouble swallowing, no more dizziness.  Client rates shortness of breath 1/10 on scale, RN offers Benadryl intramuscular dose, also makes client aware that can be given orally, client refuses once again.  At 1:35 pm, client states he feels ready to go home, RN makes him aware would like to monitor 30 minutes from time of initial complaint, client agrees.  Vital signs at 1:40 pm are:  blood pressure 140/76, heart rate 102, oxygen saturation 96%, respirations 16, client states "symptoms are half of what I started with".  At 1:50 pm, vital signs are:  blood pressure 136/82, pulse 94,  oxygen saturation 96%.  Client reports symptoms have totally resolved.  Client educated on ER precautions and to follow up with primary care as needed.   At 1:51 pm, client is able to leave observation area with wife, walks with steady gait.
Pentacel components were not mixed together and patient was called back to received the Act-HIB portion, no AE; Initial information received on 20-Aug-2020 regarding an unsolicited valid non-serious case from the other health care professional.   This case involves a two months old male patient who received a first dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot: UJ260AA, expiry date: 14-May-2021) via an intramuscular route in the left thigh on 17-Aug-2020 as prophylactic vaccination and components of Pentacel were not mixed together and patient was called back to received the ACT-HIB portion (Product preparation issue).  The patient's medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE), PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination .  It was an actual medication error due to inappropriate reconstitution technique on same day.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
RIGHT THIGH BECAME RED, WARM TO TOUCH, AND SWOLLEN.  WENT TO LOCAL ER, RECIEVED 10 DAY SUPPLY OF AUGMENTIN AND BENADRYL AS NEEDED
Had a mild fever close to 100 on day one as well as a sore throat. Day two had a 102 fever most of the evening and a sore throat all day. Day four, felt weak and then vomited. Still has a sore throat. The sore throat includes a swollen gland on the left side. After vomiting he felt much better but still has the sore throat. We have been treating with ibuprofen and Tylenol. Alternating the medications every 4 to 6 hours or as needed.
Patient had swelling, Redness and a large know at site of injection. It had grown in area over 5 days. Patient was treated by a Dr with a steroid and antibiotic.
a mass under my right neck area, this has developed into a solid mass which has ever since extended downwards towards my sternum and clavicle area; It is ejecting pains into my middle right ear which has caused a partial deafness in that ear; It is ejecting pains into my middle right ear which has caused a partial deafness in that ear; had issues with swallowing anything, including my own saliva; fever; body aches; sore throat; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in the left arm on 23Mar2021 at 15:00 (at the age of 51-year-old), dose 1, single for COVID-19 immunisation. Medical history included allergy and there were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. On an unspecified date, the patient got fever, body aches, sore throat. Five days after that he observed a mass under his right neck area, this had developed into a solid mass which had ever since extended downwards towards his sternum and clavicle area. The mass felt tender with protruding ends. It was not very painful; however, it was ejecting pains into his middle right ear which caused a partial deafness in that ear. Initially, the patient had issues with swallowing anything including his own saliva, the problem of swallowing had ever since dissipated. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Child had slight cough before vaccines given. He developed a fever about 3 hours, post vax. Had had a fever "on and off" since going as high as "almost 103F". Cough has become worse. Mother is giving both children's Tylenol and Motrin together since 3/7/01. Told to call doctor. He was dx'd with earl infection.
Splotchy hives over various parts of body.  Started 7.5 hours after injection.  Gave Benadryl.  Hives have reappeared seemingly sporadically ever since.  Lessening in severity.
feeling overwhelming fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 28Feb2021 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and allergic to sulfa meds. 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 COVID vaccine. Concomitant medications included escitalopram oxalate (LEXAPRO), buspirone hydrochloride (BUSPAR) and irbesartan (MANUFACTURER UNKNOWN); all taken for unknown indication from an unknown date and unknown if ongoing. On 01Mar2021, the patient stated that she felt overwhelming fatigue ever since the first dose. It started about 24 hours after and had not let up even now, 10 days later. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event feeling overwhelming fatigue was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swollen lymph nodes in my neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 10:00 (Lot number: EL3247) at the age of 48 years as dose 2,single for covid-19 immunisation. Relevant medical history included: "Blood cholesterol increased" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Covid-19 immunization, lot number= EL3247, administration time=01:15 PM,, vaccine location=Left arm,, dose number=1), administration date: 09Mar2021, for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 01Apr2021, outcome "not recovered", described as "Swollen lymph nodes in my neck". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information- It was reported that patient administered vaccine at clinic .The patient  did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not take any other  medications  within 2 weeks of vaccination.Prior to vaccination,  the patient  was not diagnosed with COVID-19 and  Since the vaccination,  the patient  had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Diarrhea around 8 PM, felt ok besides a sore arm when I went to bed around 10 PM.  Woke up around 12:30 AM with severe chills, fever, and fatigue.  I put on more blankets, several layers of clothes and took Nyquil.  I woke up around 7 AM with a fever, chills and fatigue.  Had to call in sick to work for the first time in several years.  Slept until 3 PM.  It's now 8 PM and I still have diarrhea and fatigue.
This non-serious medically confirmed report (initial receipt 14-May-2014) concerns a female patient. The patient had development of supraclavicular nodes after administration of GARDASIL and FLUMIST. On an unspecified date, the patient received the influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date two years ago (in 2012) in patient developed supraclavicular nodes. Outcome was not reported.
Increasing the itchiness. now in my legs too/itchiness in my skin; Rash in my left side of my face, neck , ears, arms and chest; My under left eye was swollen & redness; My under left eye was swollen & redness; It's very uncomfortable; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 59-years-old via an unspecified route of administration, administered in arm left on 22Apr2021 12:15 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history included hypertension, depression and known allergies: yes from an unknown date and unknown if ongoing. Concomitant medications included losartan; escitalopram oxalate (LEXAPRO); bupropion; hydrochlorothiazide all taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 59-years-old, via an unspecified routed of administration administered in left arm on 01Apr2021 12:15 (lot number was not reported) for covid-19 immunization. The patient reported 2 days after her second vaccine, she was with rash in the left side of her face, neck , ears, arms and chest. Her under left eye was swollen & redness. Increasing the itchiness now in her legs too. It's very uncomfortable. The events occurred on 24Apr2021 06:00. She have been using several products over the counter such as Zyrtec, Benadryl cream, Caladryl, Hydrocortisone, Aveeno body wash and Curel lotion. But still suffering of the itchiness in her skin. The patient did not recover from the events.   Information on the lot/batch number has been requested.
Had red swelling rashy area that moved down arm at least 6 inches. Told to watch take a BENADRYL and ice if hot. Go to Dr if gets worse.
ACUTE NON ST ELEVATION MI 4/16/2023 ACUTE NON ST ELEVATION MI ACUTE NON ST ELEVATION MI 4/16/2023 ACUTE NON ST ELEVATION MI CAD (CORONARY ARTERY DISEASE) WO ANGINA
Sub centimeter sore L lay tongue with resultant adenitis. Gone in < 48 hrs.
Ear Fullness and fluid build up in ear. Mild discomfort and slight hearing loss. Getting progressively better after 6 day Prednisone prescription.
Within 5 minutes experienced dizziness for two and a half days; felt weird; This spontaneous case was reported by a health care professional and describes the occurrence of DIZZINESS (Within 5 minutes experienced dizziness for two and a half days) and FEELING ABNORMAL (felt weird) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Within 5 minutes experienced dizziness for two and a half days) and FEELING ABNORMAL (felt weird). At the time of the report, DIZZINESS (Within 5 minutes experienced dizziness for two and a half days) and FEELING ABNORMAL (felt weird) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) high.     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.   The Concomitant medications were not provided. The Treatment information was not provided.
Pt had 2nd MMR and Hep A vaccine. Mom stated child could sit alone does well with shots doesn't even cry. Encouraged mom to hold. Did well approx 5 mins after. preparing to give PPD skin test, pt stood up off mom lap and went to fall on all 4's. On the above date, pt had received a hep A and an MMR vaccine from another employee. I arrived to change duties. Shortly after receiving the immunization, pt was noted by her mother to "not be acting right." (Occurring at approximately 1:50pm) pt was on her mother's lap. She began to have a fixed stare, then brief jerks of the upper extremities. The apparent seizure lasted 10-15 seconds. Afterwards she appeared to be in a post0ichtal state. She was drowsy. At 2pm she had a heart rate of 64, resp. rate of 28. She was noted to be diaphoretic, and cool. She had a small emesis. At 2:10pm her heart rate was 80, resp rate 24 and blood pressure 90/60. When paramedics arrived she had oxygen saturations of 99%. Later inquiry discovered that she was transported to hospital, where she was released after a short time. Follow call to hosp approx 8/22/02 17:00 child was discharged. 8/26/02 spoke with mother today. On follow up visit with PMD with pt, mother was told by PMD that child had a "syncopal episode" related to being given the vaccine. It was not a reaction to the vaccine itself according to PMD. Mother was advised by me to see MD for any future vaccines needed as we have no MD's at over health center.
This case was reported by a physician via call center representative and described the occurrence of myalgia in a 18-year-old female patient who received BEXERO. Concomitant products included HAVRIX pediatric. On 19th JULY 2016, the patient received BEXSERO. On 20th JULY 2016, 1 days after receiving BEXSERO, the patient experienced myalgia, nausea, sore throat and fever. On an unknown date, the outcome of the myalgia, nausea, sore throat and fever were not recovered/not resolved. The reporter considered the myalgia, nausea, sore throat and fever to be probably related to BEXSERO. Additional details were received as follows: The age at vaccination was not reported. The patient received a dose of BEXSERO and HAVRIX in unknown arms. The reporter did not have any product information and date of birth of the patient.
had Tetanus shot & fainted @ the MD office; that evening devel a fever of 103 & next day had vomiting; had h/a but this could have been from the fainting were hit head on the floot;
The day after the vaccination, the injection sight was swollen, red, painful and was hot to touch. This lasted approximately 48 hours.
One day after the vaccine, I got a migraine with visual disturbances (aura); 2 days after that, on August 9, I had what seemed to be UTI symptoms: burning and discomfort on urination. This lasted for a week and then I was placed on antibiotics, but the pain continued. A urine culture showed NO infection.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Product temperature excursion issue; Product administration error; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F), PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and PRODUCT ADMINISTRATION ERROR (Product administration error) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 5:05 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Product administration error). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F), PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and PRODUCT ADMINISTRATION ERROR (Product administration error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment information was provided by reporter.
This is a spontaneous report from contactable consumer or other non-HCP. A 38-year-old (non-pregnant) female received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), at the vaccination age of 38, via an unspecified route of administration on Apr 1, 2021, at 11:00, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient has not tested for COVID-19. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. No medications received within 2 weeks of vaccination. On Apr 2, 2021, patient experienced excessive nose bleeds; with outcome of recovered on an unspecified date in Apr 2021. No follow-up attempts needed. Information about lot/batch number cannot be obtained.
This spontaneous report as received from a consumer refers to her 13 year old daughter with no pertinent medical history and no drug reactions or allergies. In October 2014, the patient was vaccinated with the first dose of GARDASIL (route, dose and lot # not reported). There was no concomitant medication. The consumer reported that in November 2014, the patient experienced arthralgia and amenorrhea. The patient had pain in her hips. The patient's mother stated that the last record of her daughter having her menstrual period was before she was administered the GARDASIL. The patient had not had her menstrual period since starting the GARDASIL. The patient did not receive treatment for the adverse events. There were no lab diagnosis or studies performed. Therapy with GARDASIL was reported as discontinued. The outcome of arthralgia and amenorrhea was reported as not recovered/not resolved. Additional information has been requested.
Swelling with possible cellulitis occurred at the injection site; left deltoid (HAV #1). most of deltoid muscle affected. Site was hot to touch. Keflex and Motrin prescribed. Recheck scheduled 03/01/11.
postherpetic neuralgia; vision issues; multiple outbreaks of herpes zoster; This spontaneous report was received on 16-MAY-2022 from a lawyer, regarding a case in litigation and refers to a patient (pt) of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, site of administration, lot #, and expiry date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, after receiving zoster vaccine live (ZOSTAVAX), the pt suffered multiple outbreaks of herpes zoster, postherpetic neuralgia, blistering rash, pain and vision issues. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The pt have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not resolved. The lawyer determined the events to be related to zoster vaccine live (ZOSTAVAX).  The events were considered to be disabling by a reporter.