chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt "cold", started shaking uncontrollably, had muscle aches across back, in arms and legs. Went to ER about midnight. They did "blood work" and x-ray because patient was having difficulty breathing. 10/13/04: continues to have muscle aches, 'difficulty getting around" , very week. Afebrile.
Low level headache (~20 hours), body aches (~20 Hours) and mild diarrhea (1 time) Took Advil for body aches, worked OK
We had a preventative EKG completed on 6/26/21 for a baseline before the vaccine as a precaution and I am happy to make these available to you.  Vaccine was 7/3/21. Patient started having body chills within 24-48 hours after the shot. He still has daily chills  as of 7/20/21.   Starting 7/13/21 Patient complained of chest tightness and "pain", localized around the center of his chest and a little below. He has seasonal allergies, including a cough that started acting up 7/11/21.  The location of pain and description is significantly different than his normal allergy symptoms. Pain and tightness occurred with stationary activities and would come/go, regardless of whether he just coughed. He still has chest pain and occasional tightness as of 7/20/21. No breathing issues, fever, or other symptoms.
CLIENT RECIEVED MODERNA AS THIER FIRST DOSE OF COVID 19 VACCINE AND THEN RECIEVED PFIZER AS THEIR SECOND DOSE.
Right after administering the vaccine patient stood up to leave the vaccine room and felt dizzy and fell. Patient was given fluids, ice pack, and vitals were taken. After patient was able to get up and feeling better her heart rate and blood pressure were taken and came back normal. Patient seemed a lot better and her mom took her home to rest.
Patient developed left thumb swelling with subsequent bruising and significant localized tenderness.  This went away, but reoccurred on 2 separate occasions frequent to the vaccine.  Resolved independently without evaluation or additional diagnostic testing/pharmacological therapy.
Pt has a past medical history of type II DM and laryngeal cancer s/p laryngectomy and tracheostomy.  Pt arrives to the ER and is admitted due to poor PO intake and failure to thrive.
Pt stated that he had experience side effect of Janssen Vaccine like Headache, Muscle aches, Fever , Pain
Patient fell to floor and hit her head, developed LOC and tonic-clonic movements of arms for about 30 secs and recovered with full orientation for a few minutes then fell again and had a second similar episode. She was taken to the hospital ER when she had a 3rd episode hours later. Recovered without any further problems. 8/28/2007 MR received for ER visit following fainting episode with questionable seizure activity.  When pt fell at health dept pt hit head, but pain has resolved. Pt passed out x1 in the ED BR. Clinical Impression Syncope, Vasovagal.  Heart Murmurs NOS.
PASSING OUT/FAINTING; LOW HEART RATE (30 BEATS PER MINUTE); DECREASED BLOOD PRESSURE (60/50); SHAKING; This spontaneous report received from a patient concerned a 42 year old white, not Hispanic or Latino male. The patient's height and weight were not reported. The patient's concurrent conditions included seasonal allergy, non alcoholic and non smoker. The patient did not had drug abuse or illicit drug use. The patient did not had reactions before with any other vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) frequency one total, dose was not reported, administered on 12-APR-2021 at left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 12-APR-2021 after vaccination, the patient immediately experienced low heart rate (30 beats per minute), decreased blood pressure (60/50), profuse sweating and shaking and as the result he passed out immediately. The patient reported that he was under care of the medical staff at the facility and both his heart rate and blood pressure were reassessed multiple times within the hour of observation. The patient reported that vaccination provider advised him that his reaction was not related to the Janssen Covid-19 vaccine and that he fainted only because he was afraid of the needle but the patient denied and stated that he was not afraid of the needle. Laboratory data included: Blood pressure (NR: not provided) 60/50 mmHg and heart rate (NR: not provided) 30 beats per minute. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passing out/fainting on 12-APR-2021, and low heart rate (30 beats per minute), decreased blood pressure (60/50) and shaking on unspecified date APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210428755 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- Passing out/fainted, low heart rate, Decreased blood pressure. This event(s) is considered unassessable. The event(s) 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(s).
one week later its been itchy; rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (one week later its been itchy) and RASH (rash) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (one week later its been itchy) and RASH (rash). At the time of the report, PRURITUS (one week later its been itchy) and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  Treatment information include rubbing alcohol.   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2021: no information
This spontaneous report was received from a allied health official and refers to a multiple unspecified patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ Lot number M012495, expiration date 09-OCT-2017; Lot # L033693, Expiration date 31-MAY-2017, Lot # L008050, Expiration date 09-NOV-2016; Lot # L006184, Expiration date 13-DEC-2016 for prophylaxis. No adverse effects reported. The vaccine doses were had a temperature excursion of 13.5 Celsius Degrees for 10 hours and 14.8 Celsius Degrees for 43.75 hours. Data logger was unsure. There was no previous temperature excursion. This is one of the three reports received from the same reporter. Follow up information was received on 30-NOV-2016, all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.; Sender's Comments: MERCK 1610USA007020:Mfr number.
Client very apprehensive and anxious prior to adm of vaccine. Shortly after adm of Td client c/o lightheadedness, nauseated. Verbalized vomiting when she arrived home. Client verbalized that "my tongue started to swell", says she took Benadryl 2 capsules and slept for a while, verbalizes her arm is sore. After she awoke tongue normal.
administration of Trumenba; facility not having Bexsero; This non-serious case was reported by a physician via call center representative and described the occurrence of interchange of vaccine products in a 19-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On 13-OCT-2021, the patient received the 1st dose of Bexsero. On an unknown date, the patient received the 2nd dose of Bexsero. On 08-JUN-2022, the patient received TRUMENBA. On an unknown date, an unknown time after receiving Bexsero and not applicable after receiving Bexsero, the patient experienced interchange of vaccine products (Verbatim: administration of Trumenba) and product supply issue (Verbatim: facility not having Bexsero).  The outcome of the interchange of vaccine products and product supply issue 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 Information: GSK receipt date 2 Oct 2023: The physician stated that a patient received his first dose of Bexsero on 13-OCT-2021. At another facility, the patient received Trumenba on 8-JUN-2022 and 10-OCT-2022 due to the facility not having Bexsero, which led to interchange of vaccine products and product supply issue. The patient was scheduled to received second dose of Bexsero on 9th October 2023. Follow-up via email was accepted.
Severe pain in right upper back near inside of shoulder blade, tingling down my right arm and numbness in my thumb and first two fingers. Went for a deep tissue massage 10/21/16, did not help, saw my physician Dr. on 10/24/16 who referred me to Neurology for an EMG test on 11/1/16 which the Neurologist concluded Parsonage Turner Syndrome. Started Gabapentin. Got dizzy from the Gabapentin and fell down my stairs 11/26/16.
Fever 104 for 24 hours; redness, erythema, and swelling at injection site
Received COVID-19 Johnson and Johnson shot at 1:30 PM April 2. Throughout the night after 12 PM, felt bodyaches and feverish.Unsure if had an actual temperature so Took gel ibuprofen, three gelcaps. April 3 daytime, felt tired and flu like symptoms. Bodyaches, nausea, fever but head No fever. April 4, felt much better, 90% normal, then slight flu like symptoms later in the day. April 5 through April 9, belt 98% better with slight flu like symptoms, little bodyaches, fever and tired, nausea. April 10, felt slight feverish without no fever. As of April 12, No symptoms. Feel 100%
beyond the 30 days in the refrigerator on 24JAN2023; temperature excursion; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (beyond the 30 days in the refrigerator on 24JAN2023), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion), EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7171B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (beyond the 30 days in the refrigerator on 24JAN2023), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (beyond the 30 days in the refrigerator on 24JAN2023), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion), EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (beyond the 30 days in the refrigerator on 24JAN2023), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date).    No concomitant product reported by reporter.  Reporter stated that 4 adult patients received the Bivalent booster of Moderna COVID-19 vaccine beyond the 30 days in the refrigerator on 24-JAN-2023 with lot number AS7171B from intact cartons with vial size of 2.5ml. Vial was initially stored in the refrigerator 23-DEC-2022.  No treatment medication reported by reporter.
Headache .; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8734) via an unspecified route of administration in the right arm on 04Apr2021 at 09:00 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history included colitis ulcerative. Concomitant medications included mesalamine (MANUFACTURER UNKNOWN), desvenlafaxine succinate monohydrate (PRISTIQ) and daily vitamins (MANUFACTURER UNKNOWN) all for unknown indication and from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 17:00, the patient experienced headache that was not affected by Tylenol or Excedrin. On day 6 and still dealing with it. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of headache and included treatment with Tylenol or Excedrin. The clinical outcome of the event headache was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
My son threw up on way home from doctors office.  He was not nervous going in.  It came on quick.  He was fine once he threw up.
fever of 104.5 degrees; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 104.5 degrees) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever of 104.5 degrees). At the time of the report, PYREXIA (fever of 104.5 degrees) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104.5 (abnormal) 104.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No information regarding corrective treatment was reported by the patient.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Dec2021 as dose 1, single (Lot number: 4I3197), in Mar2022 as dose 2, single (Lot number: ER8733) and in Apr2022 as dose 3 (booster), single at the age of 62 years for covid-19 immunization. The patient had no relevant medical history and no known allergies. Concomitant medication(s) included: TRAZODONE, start date: Jan2003; METHYLPHENIDATE, start date: Jan2001; FINASTERIDE, start date: Jan2004; DULOXETINE, start date: Jan2001, also reported as other medications in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: UNKNOWN RESULT, notes: PCR test was worse every day. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 included Paxlovid (start date 13May2022, stop date 18May2022). Clinical course was reported as, Patient started testing better after day 5 and then each day symptoms and PCR test was worse every day. On 18May2022 the patient was on day 10 and her symptoms were back to day 1. No therapeutic measures were taken as result of symptoms and patient was not recovered from the symptoms.  No follow-up attempts are possible. No further information is expected.
tingling and numbness below the knee/whole leg is numb and tingling; tingling and numbness below the knee/whole leg is numb and tingling; This is a spontaneous report from a contactable pharmacist (patient's mom).   A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 25May2021 10:00 (Lot Number: EN0178) (at age of 34-year-old) as 1st dose, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. There was no other vaccine in four weeks.The pharmacist  reported her daughter received the first dose of the Pfizer COVID-19 vaccine yesterday (25May2021) at 10:00. She noticed some tingling and numbness below the knee 6 hours after receiving the vaccine. The whole leg is numb and tingling. There's edema, swelling and bloating around the leg (and later the pharmacist  reported that the patient stated that her legs feel like they are loaded like they've got edema, but the patient's legs are not edematous and there is no pitting edema.). It's tight. It's not swollen but its feel numb. It's a feeling you get after dental work. The patient stated the numbness feels more like the numbing like if the dentist shoots up your teeth and gums. The pharmacist reported that the numbness and tingling in the patient's legs started yesterday, 25May2021, below the patient's knees and today (26May2021), the patient's whole leg is numb and tingling. The pharmacist reported that the patient can feel her legs, and that if the patient were to smack her leg, she would feel it. Seriousness criteria: Caller reported that the seriousness is between serious and disabling, but the numbness and tingling is not disabling yet.  Caller stated that she just doesn't know what to expect. The events did not result in emergency room visit or physician office visit. The outcome of event was not resolved.; Sender's Comments: Based on the temporal relation, the association between the paresthesia and hypoaesthesia cannot be completely ruled out with the available information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Information has been received from a certified nurse midwife concerning a 15 year old female patient who on 18-FEB-2008 was vaccinated intramuscularly in the deltoid area with the first dose of GARDASIL (lot # 657621/0387U).  The nurse practitioner mentioned that the patient became faint several minutes after receiving the vaccine.  The patient received her first dose of GARDASIL and waited 15 minutes and was fine.  Then when she got up to leave, her knees buckled and she passed out.  The practitioner nurse reported that the patient had not eaten that day and was anxious about the shot. The nurse reported that the patient was terrified of needles so the fainting was dubious. The patient recovered immediately without incidence.  The patient sought unspecified medical attention.  Additional information is not expected.
Bloody diarrhea; Loss of appetite; Skin on her back started to peel; Lower intestine is sore; Feeling queasy; chills; Fever of 101.1F that took about 3 days to break; Soreness at the injection site; Tired; A spontaneous report was received from a consumer concerning a 62 years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events feeling queasy, loss of appetite, nausea, lower intestine is sore, bloody diarrhea, fever of 101.1F that took about 3 days to break, skin on her back started to peel, soreness at the injection site and tired.  The patient's medical history was not provided. No relevant concomitant medications were reported.      On 10 FEB 2021 prior to the onset of the events, the patient received her second dose of two planned doses of mRNA-1273 (lot/batch:041L20A) intramuscularly for prophylaxis of COVID-19 infection.    On  unknown date, the patient experienced the events   feeling queasy, loss of appetite, nausea, lower intestine is sore, fever of 101.1F that took about 3 days to break, skin on her back started to peel, soreness at the injection site, tired and  on unknown date event bloody diarrhea as medically significant serious criteria.   Laboratory details were not provided.    Treatment medication included Baby Aspirin.   Action taken with mRNA-1273 in response to the events was not reported.     The outcome of the events feeling queasy, loss of appetite, nausea, lower intestine is sore, bloody diarrhea, fever of 101.1F that took about 3 days to break, skin on her back started to peel, soreness at the injection site, tired was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
My tongue went numb almost immediately after receiving the injection - about 5-10 minutes after.  At about 33-35 minutes after injection, my throat started to tickle and I could not stop coughing - even after being given 2 bottles of water and a mint. at about 38 - 40 minutes after injection it started to feel like a lump or a rock was in my throat  At around 12:30 - 1:00 am on the morning of 04/22/2021, I notice there were blisters on my gums - one on my upper left gums, one on my upper right gums and one on my lower right gums
This case was reported by a nurse and described the occurrence of incorrect storage of drug in a infant patient who received ENGERIX B pediatric. On an unknown date, the patient received ENGERIX B pediatric at an unknown dose. On an unknown date, an unknown time after receiving ENGERIX B pediatric, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: Nurse reported that approximately 38 infants were vaccinated at birth with ENGERIX that was stored out of recommended temperatures for approximately 1 month. Nurse did not have any further information at this time as they are still gathering info on these patients.
11-27-12 AM Muscle aches fatigue sick feeling redness at injection site. 11-28-12 redness at injection site enlarging 3 1/2 mm deep red 7 mm lite red warm to touch. Treatment: 11-28-12 CEFDINIR 300 mg BID x 7 D.
Experienced period 2 weeks early. Unusual spotting before period started with bright red blood different from typical period blood (thinner and brighter red). Typically experience breast soreness 1 week before period which did not occur
Acute appendicitis resulting in the removal of my appendix .  3rd booster given at 10 am Monday November 1st.  Tuesday November 2nd around 3 pm my stomach started hurting.  By Wednesday night I was in the ER.  Surgery was Thursday afternoon.  I have never had a stomach issue at all prior to this.
None we had miss information from pt. and he had a total of 3 COVID Doses  #1 4/3/21  #2 6/08/21  #3 6/30/21