chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from the patient's parent on 10/4/05. A 17 year old male with no previous medical history received an injection of Menactra, lot number unknown, on 6/29/05. The route and site of administration were also unknown. Seven days later, the patient developed red spots on his skin throughout his body, black stops on his tongue and felt weak. He was examined in a clinic and referred to a hematologist for evaluation. The hematologist diagnosed thrombocytopenia, and the patient was hospitalized for six days at which time he was treated per the reporter with gammaglobulin and high doses of prednisone. The platelets increased. Approximately two weeks prior to this report, the patient was feeling weak again. A repeat CBC and platelet count were within normal limits. At the time of this report, the client had recovered but continued to be monitored.
I started feeling weak and lightheaded in the evening of 10/18 after taking the flu shot at noon. Went to bed and woke up the next day around 7:00 AM and felt really weak and lightheaded and passed out cold. Wife called 911 and an ambulance took me to the hospital where I stayed all day Thursday (10/19) and during the night until noon Friday (10/20) for observations. Many tests were done and the doctor concluded that my body reacted adversely to the flu shot, which made me very dehydrated and weak. I scraped the cornea of my right eye during the fall and still have blurred vision.
Pt recvd 1st dose of Hep B on 27SEP90 & on 27OCT90 pt recvd 2nd dose of vax & on 27NOV90 devel a fever, pharyngitis, adenitis, sinus h/a, fatigue, myalgia; PE nl x/tenderness in rt & lt upper quad;
No adverse event; Child received a first primary dose from Pfizer on 21Aug2022 and HCP gave her Moderna Covid 19 vaccine as a second primary dose; Child received a first primary dose from Pfizer on 21Aug2022 and HCP gave her Moderna Covid 19 vaccine as a second primary dose; This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Child received a first primary dose from Pfizer on 21Aug2022 and HCP gave her Moderna Covid 19 vaccine as a second primary dose), COVID-19 IMMUNISATION (Child received a first primary dose from Pfizer on 21Aug2022 and HCP gave her Moderna Covid 19 vaccine as a second primary dose) and NO ADVERSE EVENT (No adverse event) in a 2-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer on 21-Aug-2022. Past adverse reactions to the above products included No adverse event with Pfizer. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Child received a first primary dose from Pfizer on 21Aug2022 and HCP gave her Moderna Covid 19 vaccine as a second primary dose), COVID-19 IMMUNISATION (Child received a first primary dose from Pfizer on 21Aug2022 and HCP gave her Moderna Covid 19 vaccine as a second primary dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Child received a first primary dose from Pfizer on 21Aug2022 and HCP gave her Moderna Covid 19 vaccine as a second primary dose), COVID-19 IMMUNISATION (Child received a first primary dose from Pfizer on 21Aug2022 and HCP gave her Moderna Covid 19 vaccine as a second primary dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INTERCHANGE OF VACCINE PRODUCTS (Child received a first primary dose from Pfizer on 21Aug2022 and HCP gave her Moderna Covid 19 vaccine as a second primary dose) and COVID-19 IMMUNISATION (Child received a first primary dose from Pfizer on 21Aug2022 and HCP gave her Moderna Covid 19 vaccine as a second primary dose). HCP was calling on behalf of a mother. No concomitant drug was reported. No treatment drug was reported.   Reporter did not allow further contact
Heavy metal taste in her mouth; Heart rate of 163, and it reached 174; Elevated blood pressure; This is a spontaneous report from a contactable consumer or other non hcp and from a Pfizer sponsored program. A female patient of an unspecified age (46 Unit not given) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included cardiac murmur, hypothyroidism, migraine from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine sodium (LEVOTHYROXINE SODIUM) taken for an unspecified indication, start and stop date were not reported. On Mar2021, the patient experienced heavy metal taste in her mouth, heart rate of 163, and it reached 174, elevated blood pressure. It was reported Caller, female, aged 46, received first dose of Pfizer BioNTech Covid 19 vaccine, the first week in March, not sure of the exact date. Within 30 seconds she developed a heavy metal taste in her mouth, and started having a heart rate of 163, and it reached 174. She was monitored for one hour for pulse and blood pressure. It took 3-4 days for her resting heart rate to go back down even to the 120s. She has a past medical history of heart murmurs, hypothyroidism and migraines. She currently takes 175mcg of levothyroxine. When she consulted her HCP they said just to monitor but that they didn't feel comfortable advising one way or another whether she should receive the second dose. The patient underwent lab tests and procedures which included blood pressure measurement: elevated on Mar2021, heart rate: 163, and it reached 174 on Mar2021 It took 3-4 days for her resting heart rate to go back down even to the 120s. The outcome for event Heart rate of 163, and it reached 174 was recovering while rest was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Still getting off and on chills; Easily fatigued; Arm is still sore; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 05Sep2021 at 16:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine.  The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Aug2021 at 12:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. On 05Sep2021 at 18:00, the patient experienced off and on chills, easily fatigued and his arm was sore. Reportedly, it was then 7 days later he was still getting off and on chills. He was easily fatigued. His arm was still sore. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, fatigue and arm was still sore was not recovered at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 14-AUG-2016, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 (lot # L049744, expiration date 12-OCT-2017, dose and route not reported). The vaccine was improperly stored at 55 degree Fahrenheit (F) for 16 days, 47.8 F for 13 hours, 50 F for 32 hours and then 47.8 F for 4 hours. There was no previous temperature excursion. Data logger was involved. No adverse effect was reported. This is one of two reports received from the same reporter. Additional information has been requested.
A medical assistant called and reported a AE. The caller reported that a 5 month old was administered a "double dose of HIB". The HCP reported that the 5 month old patient received a dose of Pentacel and a dose of PEDVAX HIB at the same office visit.; No adverse event; This spontaneous report has been received from a medical assistance concerning a 5-months-old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, previous drugs reactions or allergies and concomitant medications were not reported.  On an unspecified day, the patient was administered a '' double dose of haemophilus influenza type B (HIB) ''. The patient received a dose of diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL) (dose, strength, frequency, route of administration, anatomical location, lot # and expiration date were not provided) and a dose of vaccine haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot number T026962, expiration date: 06-APR-2023 (dose, strength, frequency, route of  administration, and anatomical location  were not provided) administered for prophylaxis, at the same office visit (Extra dose administered). The reporter stated the doctor ordered diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX) but the diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL) was inadvertently administered at the same time of the vaccine haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), instead of the diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX). However, no adverse effects were noted. No additional information was provided.
I did my Injection Friday 1/15/2021 at 09:00 PM and woke up Saturday feeling unwell, chills and muscle pain all day. Sunday 1/17/2021 I awoke at 6:00 AM with my Right ear swollen at least three times normal size. The ear has visable sores and is extruding a clear liquid all day Sunday 1/17/2021 and today Monday 1/18/2021. I made an appointment for 4:30 PM today with NP
Patient returned to clinic on 8/28/2007 with a red rash to face, torso and arms.  Pts mother states the rash was worse and child ran a fever and felt bad for a few days.
"Ten hours after vaccine, general fatigue, 16 hours post injection, severe shivering, chills, muscle pain, and fever. Followed by headache, backache, weakness."
Chills, Fever. Fever started  about 10 hours after injection. Highest fever was 101.9 lasting through the night and was back to normal by 0800 next day. Took Tylenol at night...
I tested positive for COVID-19 on 10/31/2022. On 10/28/2022, I noticed I had a sore throat, terrible headaches, body aches, congestion, runny nose, chills, low grade fever, dry cough, night sweats, fatigue, altered smell, and altered taste. I did not have diarrhea, nausea, or vomiting. I received the monoclonal antibody therapy, bebtelovimab was the name of it. They did not want me to take PAXLOVID. I am feeling much better now.
Headache, fever, soreness throughout joints and at injection site, fatigue, burning eyes  Treated with tylenol and rest.  Symptoms persist but are easing.
pt had a positive COVID test on 8/18/21; 9/1/21 pt transferred from Medical Center to another Medical Center for respiratory failure, COVID, acute encephalopathy, Klebsiella UTI, sepsis, A Fib with RVR; had been given dexamethasone; on BiPAP when transferred; condition worsened requiring intubation; worsening shock and hypoxia; suffered bradycardic PEA; meds and CPR administered; family decided on no CPR and pt passed away in the hospital
On 02/14/2002, the child developed arm red around injection site and had a whelp on bottom of it. Afebrile. No problems but is sore. Advised to apply warm compresses and watch for injection site. Given Motrin and Benadryl as needed.
This spontaneous report was received from a physician and healthcare worker and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 24-AUG-2015, the patient was vaccinated with a dose of improperly stored VAQTA, lot # K007791, expiration date 22-AUG-2016 (strength, dose and route of administration were not provided). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Flu, diarrhea, fever, chills, loss of breath, chest pain, shortness of breath.
Pt was vaxed w/HIB 27MAR91 subsequent to administering the vax, it was noted the vax was beyond its expiration date; @ time of report were no noted problems;
A physician reported the occurrence of an injection site reaction in a 6-month make who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The pt's medical history, concurrent conditions and concurrent medications were unknown. The pt's brother had a "similar" reaction to Infanrix when he was 6 months old and was seen in the ER. On 08/05/2002 the pt received his 3rd injection of Infanrix. 24 hours later, he experienced an injection site reaction characterized by induration, erythema and swelling. He was seen by the physician. As of 08/08/2002, the injection site reaction persisted.
Intense headache and chills. Had a fever of 103 at it?s highest. Had to go to urgent care.
Generalize hives and rash, trunk, torso, arms, and legs.  Symptoms on day 3 after vaccination and persist for 7days after vaccination.  Employee has taken benadryl and tylenol for discomfort.
Symptoms were bad the first day, but all normal. Fatigue has persisted, back aches a lot of Sunday and Monday, but today I have a sore throat that seems to be increasingly irritated.
Have had continued, persistent elevated heart rate during aerobic activity (running) since the second vaccine shot, now over a month; unable to keep below ?easy? heart rate at almost any pace. RHR is slightly elevated. Feel fine during the day, but during activity routinely seeing heart rate in the 165-180 zone during slow paces.
Fever, headaches, vomiting, diarrhea, body aches; Headache; Vomiting; Diarrhea; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 06Apr2021 at 16:00(at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was 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 COVID vaccine. On 07Apr2021 at 08:00, the patient experienced fever, headaches, vomiting, diarrhea and body aches. The patient did not receive any treatment for the events. The clinical outcome of the event fever, headaches, vomiting, diarrhea and body aches were recovering.  No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient email address added and updated narrative ("The patient did not receive any medication within two weeks of vaccination" deleted and Final sentence updated to "No follow-up attempts are possible. No further information is expected").
Employee reported temp of 101.0, with chills, Head ache, body aches, diarrhea, arm pain & night sweats.
THIS YEAR I GOT THE FLU SHOT. NO PROBLEM. I EAT  EGGS EVERYDAY. NO PROBLEM. ON 3/31/04 I WENT TO DR. WITH 103.5 FEVER AND BRONCHITIS. I TOOK  ONE LISINOPRIL-HCTZ 12.5 MG FOR BLOOD PRESSURE, TWO BIAXIN 500 MG AND TWO ADVAIR DISKUS  250/50 AND GOT AN INHALATION TREATMENT FROM DR FOR BRONCHITIS. I ALSO GOT A PNEUMONIA SHOT. WENT BACK TO DR ON 4/2/04 FOR TREATMENT FOR SHOT REACTION. DR RECOMMENDED HEAT AND CALL BACK ON 4/5 FOR FOLLOWUP. SHE SAID SHE HAS NEVER SEEN A REACTION LIKE MINE. MY CURRENT SYMPTOMS ARE NO FEVER DUE TO 2 BIAXIN PER DAY, ARM SOLLEN, HOT, SORE, AND RED FROM SHOT SITE TO 8 INCHES BELOW COVERING 80 TO 90 PERCENT OF MY ARM SKIN. I AM CURRENTLY TAKING BENADRYL. YOU MAY CONTACT ME BY PHONE OR EMAIL FOR QUESTIONS OR TREATMENT. YOU HAVE MY PERMISSION TO FAX THIS FORM. THIS IS MY PERMISSION FOR DOCTOR TO RELEASE ALL OF MY MEDICAL RECORDS.  JUST TALKED TO DOCTOR AND SHE WILL ALSO SUMBIT A FORM SO YOU DON'T HAVE TO CALL ME WITH A TREATMENT.
Swelling in lt leg from hip to knee.  Measured 1" above lt knee = 29cm; 1" above rt knee = 26 1/2cm. Area red and tender to touch. Treatment: Keflex, warm compresses, Motrin.
Developed flare of interstitial cystitis that has been continuing and worsening for 2 weeks. Received 2nd dose today, worried about exacerbation of symptoms.
Patient was administered Janssen vaccine and instructed to stay seated for 15 minutes as had no prior reactions to drugs or vaccines previously. About 5 minutes after vaccine patient stood up to report to pharmacy counter that he was feeling very dizzy. He was instructed to sit back down. While turning for seat, patient fell and hit mouth on cabinet that resulted in a cut lip. Patient loss consciousness briefly. He was able to respond to verbal commands to roll onto left side. Blood pressure was check and read 94/59 mmHg. Patient remained in this position until feeling well enough to sit up on floor, per ok from paramedics via phone. Patient was perspiring on forehead. Patient took a few sips of water and reported feeling better. Paramedics repeated blood pressure and took patient to hospital. Patient stated he did not remember falling but remembers instruction to roll to side.
Jerking of right arm, redness to right side of face, twitching of eye and grinding of teeth seizure-like but responsive.
Pfizer vaccines dose 1,2,3,4,5 and Moderna vaccine; Caller reports all her prior COVID-19 vaccinations were Pfizer but one may have been Moderna/she tested positive on 26Oct2023 while in the hospital; Caller reports all her prior COVID-19 vaccinations were Pfizer but one may have been Moderna/she tested positive on 26Oct2023 while in the hospital; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  An 80-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 5 (booster), single (Lot number: GJ6665) for covid-19 immunisation; bnt162b2 (BNT162B2), on 09May2022 as dose 4 (booster), single (Lot number: FJ4991) for covid-19 immunisation; bnt162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EN6202), on 17Mar2021 as dose 2, single (Lot number: EN6208) and on 11Oct2021 as dose 3 (booster), single (Lot number: FE3292) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 6 (booster), single (Lot number: RA5325) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), in Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for influenza immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN taken for blood cholesterol increased. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Oct2023, outcome "unknown" and all described as "Caller reports all her prior COVID-19 vaccinations were Pfizer but one may have been Moderna/she tested positive on 26Oct2023 while in the hospital"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Pfizer vaccines dose 1,2,3,4,5 and Moderna vaccine". The patient underwent the following laboratory tests and procedures: Blood test: (26Oct2023) Normal; SARS-CoV-2 test: (26Oct2023) Positive, notes: when she tested positive on 26Oct2023. Therapeutic measures were taken as a result of drug ineffective, covid-19.
kidney stone; asthma exacerbation; arm burning right arm; loss mobility right arm; golf ball size knots right arm; redness 'iron on me'; purple around arm; appetite loss; raised skin; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (kidney stone) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma exacerbation prophylaxis on 27-Mar-2021 and Kidney stone on 02-Apr-2021. Concurrent medical conditions included Allergic reaction (History of vaccine allergic reactions). Concomitant products included FORMOTEROL FUMARATE;MOMETASONE FUROATE from 27-Mar-2021 to an unknown date and ALBUTEROL [SALBUTAMOL] from 27-Mar-2021 to an unknown date for Asthma exacerbation prophylaxis.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced BURNING SENSATION (arm burning right arm), MOBILITY DECREASED (loss mobility right arm), MASS (golf ball size knots right arm), ERYTHEMA (redness 'iron on me'), SKIN DISCOLOURATION (purple around arm), DECREASED APPETITE (appetite loss) and RASH PAPULAR (raised skin). On 27-Mar-2021, the patient experienced ASTHMA (asthma exacerbation). On 02-Apr-2021, the patient experienced NEPHROLITHIASIS (kidney stone) (seriousness criterion medically significant). On 15-Mar-2021, BURNING SENSATION (arm burning right arm) and MOBILITY DECREASED (loss mobility right arm) had resolved. At the time of the report, NEPHROLITHIASIS (kidney stone), ASTHMA (asthma exacerbation), MASS (golf ball size knots right arm), ERYTHEMA (redness 'iron on me'), SKIN DISCOLOURATION (purple around arm), DECREASED APPETITE (appetite loss) and RASH PAPULAR (raised skin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included: unspecified anesthesia, hydrocodone/acetaminophen, unspecified antiemetic albuterol nebulizer and dulera.   On unknown date, the patient had a computerized tomogram which indicated patient had a kidney stone.; Sender's Comments: Based on the known etiology and timing to diagnosis of nephrolithiasis, a causal relationship with the administration of mRNA-1273 is assessed as unlikely. The other events show temporal association between the use of the product and onset of the events, hence, a causal relationship cannot be excluded. Causality for nephrolithiasis is confounded by the patient's concurrent history of kidney stone.