chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen left chest and  swollen left shoulder; Severe swollen lymph node under left arm; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 30Aug2021 at 12:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic fatigue, low testosterone and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included testosterone (FORTESTA) and daily supplements (unspecified); from an unknown date for an unknown indication and unknown if ongoing. On 31Aug2021 at 17:00, the patient experienced severe swollen lymph node under left arm, swollen left chest and swollen left shoulder. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events severe swollen lymph node under left arm, swollen left chest and swollen left shoulder were resolved with sequelae (also reported as resolved with lasting effects) on an unknown date in 2021.
initially shooting pain from to hand post 4 hr., 15 hour after extreme fatigue,  24 hr after fever 101, 30 hr after shooting pains in extremities all night. 44 hr after dizziness, nausea, vomiting. One week after diagnosed with diverticulitis.  Diagnosed with UTI 1 month after.
This case was reported by a physician to a sales rep and described an adult male pt who did not respond to immunization with Hep b vaccine (manf unk). On unspecified dates, the pt received an unspecified number of doses of hep B (manf unk). Subsequently, on an unspecified date, a hep B surface antibody titer was negative.
Pt Contracted Covid-19 Illness post vaccination.  Pt is hospitalized with covid  pneumonia
Found out I miscarried on 11/10/09. I was around 12 weeks. They said the fetus was about 6 weeks developed when it died. That date was around when I got the vaccine. I don't know if they are related but wanted to report it. 11/20/09 Medical records received for DOS 11/13/09.  Final DX: Miscarriage. 12 weeks gestation, spotting. Bright red blood followed by brownish discharge and later mucous discharge at cervical os.   No FHT noted.
Rapid Heart rate; Shortness of breath; Weakness; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), dose 1 via an unspecified route of administration on an unspecified date (Reason for no lot number: of Covid Vaccine: Complainant hung up abruptly/transfer incomplete Expiry Date of Covid Vaccine: Not Supplied) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient experienced rapid heart rate, shortness of breath, weakness on an unspecified date. The outcome of the event was reported as unknown for all event.  Information on batch/number has been requested.
Mixed with some volume of a Pfizer vaccine; Mixed with some volume of a Pfizer vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received HBV (Engerix B) (batch number AC397, expiry date 8th August 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced inappropriate preparation of medication and drug administration error. On an unknown date, the outcome of the inappropriate preparation of medication and drug administration error were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: The age at vaccination was not reported. The pharmacist reported that a pediatric patient received a dose of Engerix-B mixed with some volume of a Pfizer vaccine mistakenly, which led to inappropriate preparation of medication and drug administration error. The reporter did not consented to follow-up.
Sore arm, sinus congestion, diahera, vomitting, coughing, sneezing, fever-101 degrees, fatigue, chills
Tested positive for Sars-COV-2; This is a spontaneous report received from a contactable consumer (Patient reported for herself) via medical information team. A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: not reported), dose 1 via an unspecified route of administration on 09Mar2021, as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 13Mar2021, the patient was tested positive for Sars-COV-2. The patient wanted to know that if she should and how to reschedule appointment, which was scheduled for second dose on 31Mar2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Site: Bruising at Injection Site-Mild, Additional Details: pt got bruise on his left arm after the second dose of moderna covid vaccine. pt will keep monitor to see if the sx is getting better. pt discussed with pcp already and advise to continue to monitor
Two days after getting the vaccine i became dizzy, confused, felt sedated, my vision was blurry and I started seeing black dots that looked like nats flying in front of my eyes. It is now over a week later and these symptoms are still happening.
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (1st dose received on the 30th August 2018, refer case for 1st dose US2019003458). On 17th January 2019, the patient received the 2nd dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced muscle pain, fever, pain in arm and nocturnal awakening. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the muscle pain, fever, pain in arm and nocturnal awakening were recovered/resolved. It was unknown if the reporter considered the muscle pain, fever, pain in arm and nocturnal awakening to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received a 2nd dose of SHINGRIX in the late afternoon. On Friday night, the patient experienced muscles became achy and the patient had a low-grade fever along with a sore arm, which woke her up. The adverse events were mild compared to those when the patient had after a 1st dose. On Saturday, the patient was fine but the cycle repeated on Sunday night. On Monday all symptoms were resolved.
Information has been received from a pharmacist concerning a 65 yr old male with an enlarged prostate and a history of benign prostatic hyperplasia who on 17Oct05 was vaccinated with a 0.5mL IM dose of pneumococcal 23v polysaccharide vaccine (lot 649988/0692P). Suspect vaccination that day included a dose of influenza virus vaccine (unspecified). Concomitant therapy included morniflumate (Flomax). The pt complained the same evening that he difficulty voiding. It was reported that the pt had enlargement of the prostate the day after vaccination. Medical attention was not sought. No laboratory diagnostic tests were performed. Subsequently the pt recovered. There was no product quality complaint involved. Additional information is not expected.
Information has been received from a physician via a company representative refers to a 12 month old male patient. No concurrent condition or medical history was reported. Concomitant therapies included VAQTA pediatric and PREVNAR. On 10-MAY-2016 during the patient's one year check up, the patient was vaccinated the first dose of a two dose series with an expired dose of VARIVAX (lot # J008522 with expiration date of 10-JUL-2015, 1 shot, subcutaneous). Other suspect therapy included MMRII (dose and route unknown) since an unspecified date. No adverse experience was reported. No treatment was given to the patient. The patient did not seek medical attention. Additional information has been requested.
Covid-19; Covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2022 at 10:00 as dose number unknown, single (Lot number: FK9893) at the age of 52 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. 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 "Covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received COVID 19 treatment with Paxlovid from 29Dec2022 to 02Jan2023.  No follow-up attempts are possible. No further information is expected.
Extreme fatigue lasting 1 week+, falling asleep in public, etc. Loss of muscle control and extreme muscle spasms: in arm and face, primarily on side where flu shot was administered lasting 1 week+. Slight fever lasting 1 day. Cyst or swollen lymph node in armpit on side where shot was administered, approx. 1 inch in diameter- lasting 1 week+.  Hives, primarily around area of flu shot, lasting 1 week+. Dizziness, lethargy lasting 1 week+. Headache- lasting 2 days. Intermittent morning insomnia lasting 1 week +. I have no health insurance so I have not been to the doctor. I don't know the outcome yet, because I still have symptoms.
On 6/12 when putting child in car after having immunization he seemed to be staring and unresponsive for 1 1/2 minutes. Mother did not think much of it but on 06/21 he had a similar episode witnessed by grandmother who brought him in and notified us. An EEG was normal. There is a family history of seizure disorder.
I woke up with my heart pounding in my chest at 0038.  I put on my daughter's pulse oximeter (she has asthma) and my heart rate ranged from the 110s up to the 130s.  I got back into bed and tried to relax, then took a Restoril, fell asleep, but woke up again around 0300 with the same symptoms.
Numbness on the left side of her body; Its hard for her to walk; I don't have balance; This is a spontaneous report received from Pfizer sponsored program. A contactable female consumer (patient) reported for herself.  A female patient of an unspecified age received bnt162b2 (BNT162B2, Batch/Lot number was not reported), via an unspecified route of administration on 05Jun2021 as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On Jun2021, the patient experienced numbness on the left side of her body, its hard for her to walk and don't have balance. Response received as Offered to give caller a website address to access the Fact Sheet for Recipients however she never stated if she wanted it or not. Stated the PI for the vaccine does not contain any information about numbness going down the side of the body as a side effect. Outcome for the case was unknown.  Information on the lot/ batch number has been requested.
itching immed post inject; c/o nausea, constipation up to 4 days post inject; employee did say is allergic to many things; abdo pain, itching, flushed feeling; nausea & vomiting; stomach cramps;
pt recvd vax; devel rash w/ 1st dose of vax;
Pain at injection site it was sore. Took temp at noon on the 23rd 99.8 with very severe headache nausea and took extra strength Tylenol. I continued to take temp and it got up to 101.1 and continued to take more Tylenol. From then temp went back down to 99.1. Normally have low temps and usually cold. However, four days later my arm is still tender but not keeping me from my activities.
tested positive for Covid virus, after being fully vaccinated; tested positive for Covid virus, after being fully vaccinated; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 37 patients. This is 18 of 37 reports. This consumer reported for a 78-year-old male patient. A 78-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, (Batch/Lot Number: EN5318)), dose 1 via an unspecified route of administration on 28Jan2021 as dose 1, single, dose 2 via an unspecified route of administration on 03Mar2021 (Batch/Lot Number: EN6202) as dose 2, single for COVID-19 immunisation. The patient's medical history included ongoing cardiac failure congestive. The patient's concomitant medications were not reported. Caller was an healthcare supervisor and works at a public health provider called because she had some concerns, and the regulatory health authority was tracking breakthrough cases in her area. Stated 15% of breakthrough cases were from one Pfizer COVID-19. On 04Aug2021, 78-years-old male patient tested positive for covid virus, longer than two weeks after both doses. The seriousness of the reported was hospitalization. The patient underwent lab tests and procedures which included body mass index: 25.1 on an unspecified date, sars-cov-2 test: positive on 04Aug2021. Product Complaint description included Caller reported 37 breakthrough cases, for fully vaccinated patients testing positive for Covid. The clinical outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/ drug/ event for different patients
LOOSE STOOL/LITTLE DIARRHEA; CHILLS; FELT TIRED FOR 5 TO 6 HOURS; This spontaneous report received from a patient concerned a 70 year old. The patient's weight was 184 pounds, and height was 163.83 centimeters. The patient's concurrent conditions included high blood pressure, autism, mild glaucoma, cholesterol, non smoker, non alcohol user, extreme anxiety, and stress, and other pre-existing medical conditions included the patient had no illness at time of vaccination, no past history of similar event, no adverse event after any previous vaccination, the patient had no known drug allergies and no any drug abuse / illicit drug use, no history of allergy to vaccine, drug or food. the patient had no pre-existing acute illness, history of hospitalization in last 30 days, family history of any disease or (relevant to vaccination) or allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination on left deltoid muscle. Concomitant medications included amlodipine besilate/benazepril hydrochloride for blood pressure, simvastatin for cholesterol, and timolol maleate for glaucoma. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced felt tired for 5 to 6 hours. On 11-MAR-2021, the subject experienced loose stool/little diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loose stool/little diarrhea, and felt tired for 5 to 6 hours on 11-MAR-2021, and chills on 10-MAR-2021. This report was non-serious.  Additional information recieved from patient on 30-MAR-2021 The following information was updated and incorporated into the case narrative: Reporter details (middle name of the reporter and new reporter), patient details (date of birth, age group, hight, weight and gender), patient medication history, concurrent condition (high blood pressure, autism, mild glaucoma, cholesterol, non smoker, non alcohol user, extreme anxiety, and stress) and concomitant medication (amlodipine besilate/benazepril hydrochloride, simvastatin and timolol maleate), RRT of the event updated to loose stool/little diarrhea and reporter causality updated.
Reddened, raised area. Size of dime-quarter, papular lesions with scab on raised area.
Employee with  complain of lightheadedness, dizziness and feeling faint.  Symptoms started at 3:30pm employee fainted episode lasting 2-3 minutes in total. Employee experienced fainting in intervals that were continuous lasting no more than 2-3 minutes. Vitals obtained continuous monitoring continued and Ems services called for employee at 4;08pm arrival of EMS evaluated and assessed employee and departed with employee from center at 4;15pm. Employee transferred to hospital for further evaluation and treatment.
Pt reported waking up with R arm swollen, when came into office, arm was 2-3 x it's usual size. Red, tender to touch. Hot. When f/u on pt on 10/22/2012, pt reported that her arm was still pretty tender but the swelling is down. "Not worried about it now."
This spontaneous report as received from a pharmacist refers to a patient of unknown age. No medical history and concurrent conditions were reported. On unspecified dates the patient was vaccinated with first and second dose (each dose on a separate unspecified date) of RECOMBIVAX HB (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. On 05-FEB-2016 the patient was in the pharmacy to receive the third dose of RECOMBIVAX HB which was greater than six months from the first dose which was outside the recommendation per the prescribing information (inappropriate schedule of drug administration). No adverse effect was reported. No product quality complaint was reported. The action taken with the therapy with RECOMBIVAX HB and outcome of the event was unknown. Additional information has been requested.
Arms were sore; Kind of itched; it was hot; shingles on left arm; another place of the exact kind of redness appeared; It turned red; Feverish; there was a knot there; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arms were sore), PRURITUS (Kind of itched), ERYTHEMA (another place of the exact kind of redness appeared), VACCINATION SITE WARMTH (it was hot) and HERPES ZOSTER (shingles on left arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037L20A and 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chickenpox, Arthritis and Accident (whiplash from a car accident 40 years ago.).   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2020, the patient experienced VACCINATION SITE ERYTHEMA (It turned red) and PYREXIA (Feverish). On 03-Jan-2021, the patient experienced ERYTHEMA (another place of the exact kind of redness appeared). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arms were sore), PRURITUS (Kind of itched), VACCINATION SITE WARMTH (it was hot), HERPES ZOSTER (shingles on left arm) and VACCINATION SITE INDURATION (there was a knot there). On 02-Jan-2021, PYREXIA (Feverish) had resolved. On 07-Jan-2021, VACCINATION SITE ERYTHEMA (It turned red) had resolved. On 13-Jan-2021, ERYTHEMA (another place of the exact kind of redness appeared) had resolved. At the time of the report, PAIN IN EXTREMITY (Arms were sore), VACCINATION SITE WARMTH (it was hot) and VACCINATION SITE INDURATION (there was a knot there) had resolved, PRURITUS (Kind of itched) outcome was unknown and HERPES ZOSTER (shingles on left arm) had not resolved.            No concomitant medications were reported. Treatment information included antivirals for shingles.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Reporter's contact details was added, updated the event, duration and outcome of event.
was given vaccine warm temperature excursion and she needed to get re vaccinated with no reported adverse event; she is breastfeeding with no adverse event; Initial information received from on 27-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 41 years old female patient who was given vaccine warm temperature excursion and she needed to get re vaccinated and she is breastfeeding with no adverse event while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect Influenza Vaccine by unknown manufacturer (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination.  On an unknown date the patient was given vaccine warm temperature excursion and she needed to get re vaccinated with no reported adverse event (poor quality product administered) (unknown latency). On an unknown date the patient is breastfeeding with no adverse event (exposure via breast milk) (unknown latency). It was reported that her family member got a flu vaccine and got a call that the product that she was given had a warm temperature excursion and she needed to get revaccinated but she is worried since she is breastfeeding.  Action taken: not applicable.  Outcome: Unknown.   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 the 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.
Found out I was pregnant on March 17, 2021. Date of conception was February 25, 2021. So conception was between the first and second dose of vaccine.  My first dose of the vaccine was Moderna on February 14, 2021. Lot # of first dose was 007m20a. The day after my second dose, on March 15, 2021 I developed a fever of 101.4° F for about three hours.
Body aches fever chills lethargic sore throat moderate left breast pain moderate site pain moderate left arm to hand pain enlarged clavical lymph node  and pain