chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax & devel an intense, burning pain @ the inj site which lasted about ten min;pt also screamed for a good 10min;
This case was reported by a consumer (also the subject) and described the occurrence of nausea in a 30-year-old female subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent vaccination included hepatitis B vaccine recombinant ;manufacturer unspecified;unknown;right arm given in 1983. In 1983 or 1984 the subject received 3rd dose of Hepatitis B vaccine (unknown route, right arm). In 1983 or 1984, 1 month after vaccination with the 3rd dose of Hepatitis B vaccine, the subject experienced nausea, headache, muscle pain, vertigo, eye sensitive to light, shortness of breath, chest pain, irregular heartbeat, rapid heartbeat, weakness, sweating and at an unknown time after vaccination with the 3rd dose of Hepatitis B vaccine, the subject experienced hepatitis b antibody abnormal. The subject reported that she received the Hepatitis B vaccine series in 1983 or 1984 as a requirement for work. She did not know the manufacturer of the vaccine. She reported that her "symptoms resolved, but it took 20 years". She explained that the events occurred approximately one month after the third dose in series. She stated that she treated the events with "massage and chiropractic care and nutritional help". She indicated that she had a titer done and the "normal was supposed to be less than 10 and hers was 200" (hepatitis b antibody abnormal). The subject explained that the physician screened her for a hepatitis infection, but "there was none and no explanation as to why the titers were so high". At the time of reporting the events were resolved. The subject explained that the symptoms resolved, but "came back with a vengeance" when she received FLUARIX. See case A1002560A for details regarding the events with FLUARIX.
No adverse effects reported for the patient.; administration of one dose of an improperly stored vaccine, VAQTA, to one patient; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history, drug reactions or allergies was not provided.     On 06-NOV-2019, the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (one dose, 5 milliliter, lot # S009943, expiration date 26-JUL-2020, route of administration was not provided) for prophylaxis. The vaccine experienced temperature excursion of 58.5 degrees Fahrenheit (F) for 10 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
AT 4 AM PATIENT WAS AWOKEN WITH AN AMBULANCE IN HEAD. 27,500HZ. HIGHEST "C" ON THE GRAND PIANO VERY LOUD SCREAMING SOUND IN HEAD AFTER THE SHOT,; FEVER NEXT DAY; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced at 4 am patient was awoken with an ambulance in head. 27, 500hz. highest "c" on the grand piano very loud screaming sound in head after the shot, fever next day, and headache. Treatment medications (dates unspecified) included: prednisone, and ascorbic acid/bioflavonoids nos/choline bitartrate/dl-methionine/hydroxocobalamin/inositol/nicotinamide/panthenol/pyridoxine/riboflavin/thiamine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever next day, and headache, and the outcome of at 4 am patient was awoken with an ambulance in head. 27,500hz. highest "c" on the grand piano very loud screaming sound in head after the shot, was not reported. This report was non-serious.
Information has been received from a pharmacist concerning an unspecified number of hospital employees who on an unknown date, were vaccinated with RECOMBIVAX HB (dose, route and lot # not reported) in the past had negative titers. No adverse reactions were reported. It was unknown if they sought medical attention. At the time of reporting, the outcomes were unknown. All telephone attempts to obtain follow-up information have been unsuccessful. This is an amended report. The lower level term and preferred term of AE of "had negative titers" was changed to "hepatitis B surface antibody negative". Additional information is not expected.
RHINORRHEA Narrative:  FATIGUE AND RHINORRHEA STARTED TWO DAYS AFTER INJECTION. A FEW HOURS LATER BUT ON SAME DAY HE BEGAN WITH A HEADACHE. TODAY ALL SYMPTOMS ARE RESOLVED.
3.5 hrs after shots - rash. Increased swelling to thighs, pain. Urgent care (bumps and bruises) noted entire leg swollen. Tx: TYLENOL and BENADRYL.
This spontaneous consumer report (initial receipt: 19-Sep-2012) concerns a 65-year-old female patient. Two years ago (2010) the patient received a flu shot (manufacturer, brand name and lot number were not provided). Two weeks after the shot, the patient came down with the flu. The event outcome was not reported.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 2, single (Lot number: EN6203) at the age of 71 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). There were no concomitant medications. No other medication in 2weeks. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Anti-viral details product COVID 19 Treatment, brand Pavlovid, treatment start date 06Jul2022, treatment stop date 10Jul2022.
fever (101.2 at home) and repeated vomiting starting a few hours after 2nd covid vaccination; guardian attempted to give Tylenol at home but patient immediately vomited so brought to ED for evaluation and treatment.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 79-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 79 years, in right arm for COVID-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Novacane, reaction(s): "known allergies: Novacane", notes: known allergies: Novacane. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 as patient received paxlovid treatment.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Advised by the local authority that Pfizer Covid Vaccine adminstered was stable based on manufacturer but was not stored in accordance of approved guidelines. Patient's are not recommended to be revaccinated  381  patients were effected
Nausea, dizziness, local erythema/pain Sx persisted at least through 10/30/18 (vaccine given 10/21/18).
30-45 min after receiving H1N1 vaccine. Patient suddenly became sweaty and extremely lightheaded. No previous reactions to yearly seasonal flu vaccine. Symptoms resolved within 20-30 min.
Narrative:  Pt admitted with shortness of breath and was diagnosed with acute pulmonary embolism on 5/3/21. Pt received second dose of COVID-19 vaccine on 4/30/21. Per physician documentation in medical record, either recent COVID-19 pneumonia in January 2021 or recent COVID-19 vaccination may have provoked the PE. According to the Moderna COVID-19 vaccine UA fact sheet for health care providers, there were no notable patterns of serious adverse effects (which included thrombotic events) that would suggest a causal relationship to COVID-19 vaccine. Given the proximity from vaccine receipt to event, it is within the realm of possibility that the COVID-19 vaccine may have been associated with this adverse reaction even though it has not been reported in the FDA EUA guidance document.
approximately 16 hours after injection started experiencing soreness and swelling at the injection site.; approximately 16 hours after injection started experiencing soreness and swelling at the injection site.; Approximately 4 hours after injection was struck with a wave of exhaustion; Head felt very heavy; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP 7533) via an unspecified route of administration in the right arm on 08Apr2021 at 09:30 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies. Concomitant medications include escitalopram (MANUFACTURER UNKNOWN); norethisterone acetate, ethinylestradiol, ferrous fumarate (Blisovi/FE); both for unknown indications and since unknown dates. 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 COVID vaccine. The patient did not have any allergies to medications, food, or other products. On 08Apr2021 at 14:00, Approximately 4 hours after injection the patient was struck with a wave of exhaustion and her head felt very heavy. It took approximately 3 hours of laying in bed for the feeling to pass. Additionally, on 09Apr2021, approximately 16 hours after injection, the patient started experiencing soreness and swelling at the injection site. The patient did not receive any treatment for the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. The clinical outcome of the events head felt very heavy, soreness at the injection site and swelling at the injection site were recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Vaccination Facility Country added. 2. The onset date for event 'approximately 16 hours after injection started experiencing soreness and swelling at the injection site.' update. 3. Narrative 'Approximately 4 hours after injection the patient was struck with a wave of exhaustion' added.
Muscle symptoms "feeling 70% of normal self" very sore, fever about 100 degrees Fahrenheit. Not feeling like himself. Upset stomach. This all went away by the evening.
EXTREME FATIGUE INVOLUNTARY MUSCLE CRAMPING CHEST PAINS FOCUS ISSUES INTERRUPTIONS IN SLEEP UNABLE TO SLEEP FOR MORE THAN 3 HOURS OR LESS AT A TIME...
Patient had received vaccine on 2/20 and started to have extreme fatigue the night of the 20th. patient states on Sunday 2/21 she was very short of breath and had some chest heaviness. Was taken to the ER where she was diagnosed with a vaccine reaction.
Patient came in to receive the vaccines above on 07/24/2023. The next day patient started experiencing pain, redness, and mild heat in her left lateral thigh . Patient was seen by PA for the vaccine reaction on 07/26/2023. PA counseled the mother about the reaction. Patient was prescribed benadryl allergy liquid, and ibuprofen. And to follow up if the reaction spreads or symptoms get worse.
lips tingling and "on fire"/tingling "8/10", "2/10"; lips tingling and "on fire"/tingling "8/10", "2/10"; This is a spontaneous report from a contactable other healthcare professional.  A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 18Dec2020 at single dose for COVID-19 immunization at hospital. The patient's medical history and concomitant medications were not reported. It was reported that the patient received first dose of Pfizer COVID-19 vaccine. After "10:00 minutes" of observation phase, patient complained Of (c/o) lips tingling and "on fire". Lips not swollen, denies short of breath (SOB), "skin WNLs", denies difficulty swallowing. The Medical Emergency Response Team (MERT) was called. Patient was assessed, stated tingling 8/10, no other symptoms. Patient was given bottle of water and was tolerating that fine. Allegra 60mg was ordered and administered at 8:52 A.M. Patient stated was at a 2/10, 10 minutes after getting the Allegra. Patient was drinking water without difficulties. Patient remained without further symptoms, lips still 2/10 with tingling. Outpatient lab work was ordered. Patient left at 10:00 A.M ambulatory to outpatient lab. MERT educated her to notify administrator of her symptoms prior to her second vaccine. The outcome of the event was reported as recovered (in Dec2020).  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
J&J 1st dose. Patient reported feeling lightheaded. Called paramedics, after evaluation, patient walked out.
I woke up at approximately 2 am 137 hours after the first injection with hives on my arms, legs, backs and chest and stomach. told me to use a steroid cream and antihistamines, zyrtec, or benadryl. None of it worked, but after about a week the itching went away on it's own. I received the second dose at about 9:30 am, on March 27th, 2021, and by 11:30 am my entire body was itching from head to toe. Multiple times since I have had outbreaks of itching, without an apparent presentation of hives. Specifically when the temperature was higher and I was active outdoors in direct sunlight, though the itching occurs in every location on my body, eyes, ears lobes and canals, nose, face, arms, legs, hands, feet, chest, back, butt, scrotum, and pretty much everywhere else. Continued treatment included prednisone and Banophen after other things failed to Work. Prednisone caused the pain to intensify. Banophen failed to ease the itching.
Existing mild tinnitus became severe five days after vaccination on March 31, 2021.   24 hours per day--Ears pulsing.  Ears hurt. Headache.  Can't sleep due to EXTREMELY loud ringing in both ears.  Difficulty performing everyday tasks.  I know of no other adverse event that occurred at this time other than vaccination.  Visited primary care physician on April 8, 2021.  She could not say for certain why I have these sudden ear symptoms.  She wants me to monitor for 2-3 weeks.
5/2 64y.o. male with PMH of CAD/stents x 3, HTN/dyslipidemia, and allergic rhinitis presented with episode of lightheadedness and collapse and LOC. Found down at work with back of head bleeding. Patient discharged home post Remdesivir course.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions, and concomitant medications provided. On 20-NOV-2018, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 lot # R012550 and expiration date: 25-JAN-2020 (dose, site and route of administration were not reported) for prophylaxis. No adverse effects were reported. The administered dose of vaccine was exposed to the temperature between 9 degree Celsius to 25 degree Celsius (20.3 Celsius) for 22 hours. Digital data logger was involved. There were no previous excursions reported. Sender's Comments: US-009507513-1811USA009749: US-009507513-1811USA012584: US-009507513-1811USA012585.
7 cm area of erythema,edema and tenderness to site of vaccination.Low grade fever.              Vaccination was 12/5/07.
Throbbing headache - top of head and back of head that was barely touched by any medicine. Severe fatigue. Symptoms still ongoing. Today the 10th day
Rash on left forearm and trunk, Sat & Sunday itched, red vesicles
Day after received vaccine. Started with arm pain and swollen (vaccine area) 10 x 8 cm. No fever. Did not take meds.
Nausea within 15 minutes of vaccine, vomiting approximately 30 minutes later.
tested positive for COVID-19; tested positive for COVID-19; This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID-19) and DRUG INEFFECTIVE (tested positive for COVID-19) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included Oral contraceptive. Concomitant products included ETHINYLESTRADIOL, NORGESTIMATE (NORGESTIMATE & ETHINYL ESTRADIOL) for Oral contraceptive.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 01-Dec-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID-19) and DRUG INEFFECTIVE (tested positive for COVID-19). On 01-Dec-2021, DRUG INEFFECTIVE (tested positive for COVID-19) had resolved. At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Dec-2021, Polymerase chain reaction: positive (Positive) Tested positive for COVID-19.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment drug details was reported.  Company comment: This is a spontaneous case concerning a 25-year-old female patient with no medical history reported, who experienced the unexpected events of SARS-CoV-2 test positive and drug ineffective. The events occurred approximately 9 months and 4 days after the second dose of the mRNA-1273 vaccine. At the time of report outcome of both events were still unknown. The reporter did not provide any causality assessments. The benefit-risk relationship of the vaccine is not affected by this report.   This case was linked to MOD-2022-472265 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 25-year-old female patient with no medical history reported, who experienced the unexpected events of SARS-CoV-2 test positive and drug ineffective. The events occurred approximately 9 months and 4 days after the second dose of the mRNA-1273 vaccine. At the time of report outcome of both events were still unknown. The reporter did not provide any causality assessments. The benefit-risk relationship of the vaccine is not affected by this report.
Redness to the touch, swelling and painful; Hives; Initial information received on 30-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 9 years old female patient who experienced redness to the touch, swelling and painful (inflammation) and hives(urticaria), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Oct-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ223AB Expiry date: 30-Jun-2020 via unknown route and in unknown administration site.  On an unknown date, the patient developed a non-serious redness to the touch, swelling and painful (inflammation) one day (reported as next day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On an unknown date, the patient developed a non-serious hives(urticaria) unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was not reported if the patient received a corrective treatment.  The patient had recovered from inflammation (reported as for 1 day) and outcome was not reported for hives.
Anaphylaxis after being given 3 vaccines in office --> returned from front door area with resp distress, edema, hives wheeze --> given BENADRYL, EPI PEN Jr x 2, O2/albut neb --> 911 transport to hospital.
Period was delayed 3 days past expected; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0162) via an unspecified route of administration in the right arm on 13Apr2021 at 11:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome and infertility. The patient had no known allergies. Concomitant medications included menotrophin (MENOPUR), OVASITOL, choriogonadotropin alfa (OVIDREL) and prenatal vitamins (MANUFACTURER UNKNOWN), etc. from an unknown date used for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8733) via an unspecified route of administration in the left arm on 25Mar2021 at 15:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. 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 01May2021, the patient period was delayed three days past expected since patient knew ovulation day from ovidrel trigger. The clinical outcome of the event period was delayed was resolved on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.