chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hives reaction throughout the body; Booster / 3rd dose of Pfizer vaccine; Headache; not feeling well; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16 year-old male patient received bnt162b2 (BNT162B2), administration date 16Dec2021 16:00 (Lot number: FL3197) at the age of 16 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: Lactose intolerant" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0161, Vaccine Administration Time: 04:00 PM), administration date: 16Apr2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0167, Vaccine Administration Time: 04:00 PM), administration date: 07May2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021 16:00, outcome "unknown", described as "Booster / 3rd dose of Pfizer vaccine"; HEADACHE (non-serious) with onset Dec2021, outcome "unknown", described as "Headache"; MALAISE (non-serious) with onset Dec2021, outcome "unknown", described as "not feeling well"; URTICARIA (non-serious) with onset 23Dec2021 08:00, outcome "unknown", described as "hives reaction throughout the body". The events "headache", "not feeling well" and "hives reaction throughout the body" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of headache, malaise, urticaria.  Additional Information: It was reported that, the patient had headache the first day after vaccine, not feeling well for next 5 days and hives reaction throughout the body today (7th day after vaccine). The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GAIT DISTURBANCE (Felt her legs start to wobble and needed her cane to walk.), DIARRHOEA (Diarrhea), COUGH (Cough), FATIGUE (Tired), PAIN (Body aches), HEADACHE (Headache), DECREASED APPETITE (Wasn't hungry), OROPHARYNGEAL PAIN (Sore throat from vomiting often) and VOMITING (Vomiting) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013a21a) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.   On an unknown date, the patient experienced GAIT DISTURBANCE (Felt her legs start to wobble and needed her cane to walk.) (seriousness criterion hospitalization), DIARRHOEA (Diarrhea) (seriousness criterion hospitalization), COUGH (Cough) (seriousness criterion hospitalization), FATIGUE (Tired) (seriousness criterion hospitalization), PAIN (Body aches) (seriousness criterion hospitalization), HEADACHE (Headache) (seriousness criterion hospitalization), DECREASED APPETITE (Wasn't hungry) (seriousness criterion hospitalization), OROPHARYNGEAL PAIN (Sore throat from vomiting often) (seriousness criterion hospitalization) and VOMITING (Vomiting) (seriousness criterion hospitalization). The patient was hospitalized for 2 days due to COUGH, DECREASED APPETITE, DIARRHOEA, FATIGUE, GAIT DISTURBANCE, HEADACHE, OROPHARYNGEAL PAIN, PAIN and VOMITING. At the time of the report, GAIT DISTURBANCE (Felt her legs start to wobble and needed her cane to walk.), DIARRHOEA (Diarrhea), COUGH (Cough), FATIGUE (Tired), PAIN (Body aches), HEADACHE (Headache), DECREASED APPETITE (Wasn't hungry) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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. Noting the history of COVID infection (Nov 2020) may remain as risk factor. Further information has been requested.
Redness and tender to touch. Noticed it 4 day after vaccination. Location below deltoid.
Had high pitched cry for 45mins, SOB which cut off crying inc temp of 101 & chest congestion 4-5 hrs p/vax recvd; pt brought to ER & given ATB;
Temp 102(+), chills , hot spells, achey, feverish, bones hurting dizzy
Allergic skin reaction; rash; memory loss; brain fog; This is a spontaneous report from a contactable other hcp (patient) via database. A 33-year-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 13Feb2021 14:00 (at 33 years old) (Batch/Lot Number: EL9261) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Known allergies: nuts, penicillin, from an unknown date. There were no concomitant medications. Historical vaccine included 1st dose BNT162B2 on 22Jan2021 at 33 years old (Batch/Lot No: EL9261,Location of injection: Arm Left,Vaccine Administration Time: 02:00 PM) for Covid-19 immunization. The patient experienced Allergic skin reaction, rash, brain fog, memory loss, all on 13Feb2021 with outcome of not recovered. Facility type vaccine: Hospital.No other vaccine in four weeks. No Covid prior vaccination.Not Covid tested post vaccination. AE resulted in visit to doctor. No treatment for the events.  No follow-up attempts are required. No further information is expected.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported Allergic skin reaction, rash, brain fog, memory loss, and the administration of the suspect vaccine, BNT162B2, based on the reasonable temporal association.   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 RA, IEC, as appropriate.
Conjunctivitis, erythematous tongue/lips, rash (maculopapular) on back, SM/cervical nodes, fever about 6 days. Presumptive Kawasaki disease. Discharge Summary received on 1/3/2005 states pt experienced adenopathy.  Medical Record received on 1/3/2005 states pt experienced anorexia and was irritable.
Arm red, swollen and hot. Diarrhea, headache and body pain.
Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Rash on torso which extended to the legs; weakness, loss of pressure in hands; Generally lethargic, super slow; super slow and joint pains; Anatomical Location:Leg Left; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: was not reported) via an unspecified route of administration in the left leg on 14May2021 at 14:00 (at the age of 56-years-old) as dose 2, single dose for COVID-19 immunization. Medical history included high blood pressure and high cholesterol. The patient received unspecified normal medication within two weeks of vaccination. The patient was not allergic to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of bnt162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: was not reported) via unspecified route of administration in the left leg on 23Apr2021 at 10:00 as dose 1, single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 20May2021 at 16:00, the patient experienced rash on torso which extended to the legs, weakness, loss of pressure in hands, generally lethargic, super slow and joint pains. On 19May2021, the patient underwent SARS-CoV-2 test through nasal swab and the test result was negative. The event resulted in doctor visit twice. The clinical outcome of the event rash on torso which extended to the legs, weakness, loss of pressure in hands. generally lethargic, super slow and joint pains was not resolved at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Chills, ache, fainted, revived and fainted second time during which time patient stopped breathing, went rigid, turned ashen, eyes turned to side and locked in place. When patient revived, she reported feeling very cold and inability to stop shaking.
Never got the flu before the flu shot; Initial information received on 25-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves an unknown age male patient who never got the flu before the flu shot (influenza) after receiving INFLUENZA VACCINE.  The patient's medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "never got the flu before the flu shot" (influenza) (unknown latency) following the administration of vaccine.  It was unknown if the patient experienced any additional symptoms/events.   No laboratory data reported.  It was reported "Every year since the birth of my son my wife has forced me to get a flu shot. I am looking forward to getting the flu once again for the fourth year in a row. Never got the flu before the flu shot. Sure glad I am protected now."  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There would be no information on the batch number for this case.
Regression on development including speech (sounds, words, mouth movements), motor (clumsy, tripping), and fine motor (grasping, hand movement and control, etc.). Began drooling immensely. Increased aggression and tantrums.
pt recv vax; pt dropped head, threw it back, hit wall; looked dazed for 5 min;
woke up with short mild vertigo like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 at 10:00 as dose 5 (booster), single (Lot number: GJ3275), in right arm for covid-19 immunisation. The patient's relevant medical history included: "pulmonary embolism" (unspecified if ongoing); "factor V leiden" (unspecified if ongoing), notes: Other medical history: factor V leiden; "type II diabetes" (unspecified if ongoing), notes: Other medical history: type II diabetes; "morbid obesity" (unspecified if ongoing); "bilateral lymphedema legs" (unspecified if ongoing). Concomitant medication(s) included: WARFARIN SODIUM; ALLOPURINOL; CRESTOR; LASIX [FUROSEMIDE SODIUM]. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: PHIZEREW0162, Anatomical location:, Arm Right, Vaccine Administration Time: 09:00 AM), administration date: 11Mar2021, when the patient was 60-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot number: PHIZERER8727, Anatomical location:, Arm Right, Vaccine Administration Time: 09:00 AM), administration date: 21Mar2021, when the patient was 60-year-old, for COVID-19 immunization, reaction(s): "Dose 1: 11Mar2021; Dose 2: 21Mar2021"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: PHIZERFH8027, Anatomical location: Arm Right, Vaccine Administration Time: 10:00 AM), administration date: 19Oct2021, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Lot number: PHIZERFK9893, Anatomical location: Arm Right, Vaccine Administration Time: 10:00 AM), administration date: 22Apr2022, when the patient was 61-year-old, for COVID-19 immunization. The following information was reported: VERTIGO (non-serious) with onset 29Oct2022 at 07:00, outcome "not recovered", described as "woke up with short mild vertigo like symptoms". Therapeutic measures were not taken as a result of vertigo.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID. The patient did not receive other vaccine in four weeks. Post vaccination, the patient was not tested for COVID.
For three nights after the first vaccine shot I had flashes of lights in my right eye when I closed them. After three days my right eye became very dry. Since that time my right eye is blurry off and on.  After the second vaccine shot both eyes   Ache all the time and I se flashes of light off to the sides of my eyes when they are closed. I have waited to get them checked to see if they would recover. This has not happened.
Attendee reports 5 minutes post vaccine chest tightness, palpitations and apprehension. No other symptoms. EMS notified and transported to local hospital for evaluation
had severe dizzy from 7AM-11AM on 28OCT95 w/nausea; had to go outside to get fresh air to breath;stayed outside 15-20mins then went inside & sat around; gradually got better;was unable to lay down d/t to swimming effect;
Vaccine kept in refrigerator on 11/8/2021, expiration date is 10/13/2021, administered on 11/10/2021; doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine kept in refrigerator on 11/8/2021, expiration date is 10/13/2021, administered on 11/10/2021) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine kept in refrigerator on 11/8/2021, expiration date is 10/13/2021, administered on 11/10/2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine kept in refrigerator on 11/8/2021, expiration date is 10/13/2021, administered on 11/10/2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Date the vial was placed in the refrigerator was 08-Nov-2021. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-491837 (Patient Link).
LYMPH NODE IN NECK ON RIGHT SIDE SWOLLEN, RIGHT ARM AND LEG GOING NUMB, BLOOD PRESSURE INCREASED HAD TO BE PUT ON BP MEDICATION, NOW NECK STILL SWOLLEN AND SWEAT GLANDS ARE CONTINUING TO BECOME INFECTED. BEEN ON CONTINUAL MEDICATION SINCE 4/17
Pt seen 1 week, post vax, with left arm painful with redness. Left arm is tender to palpation. Pt treated for cellulitis with Augmentin for 10 days. Pt with decreasing pain and redness after treatment. Resolved by 8/22/00.
pt recv vax 25MAR99 1130AM & 4PM fever about 99-102 for 24-48hr;72hr p/vax rash, trunk of body;itching;
pt recvd vax; burning in esophogus, n, chills; t 91.5; general aches, d,states anything she eats causes burning sensation; MD called;
fever started that same evening;mom gave motrin PO then 4hr later used APAP supp q 4hr;t105 x 7days pt taken to ER 30SEP;no sz, no passing out, not cont crying;cont whining & hot w/fever & weak w/fever or limp;
From initial information received on 8/23/04 from newspaper articles regarding an adverse event occurring in the USA, it was reported that a 19 year old male patient received Meningococcal vaccine approximately one year ago in 2003, exact date not specified. No details were provided regarding the lot number of the vaccine nor route and site of vaccination. In August of 2004, the patient became ill with bacterial meningitis and was taken to the emergency room. By 9:00 PM that same evening, the patient was in septic shock. The patient was admitted to the hospital and was placed on large doses of antibiotics and on a ventilator. Per the patient's father, who is also a physician, the patient is improving and has been taken off the ventilator. The patient's father also stated he expects his son to make a full recovery. Follow up 12/06/04: Patient recovery status is unknown, there is no contact information for this case retrived from a newspaper.
This patient reported receiving his primary SMPX vaccine sometime in January 2003.  He also reported received his first AVA vaccination 12/29/2002 and a second AVA vaccine 2 weeks later. Approximately 3-4 weeks post SMPX vaccine (estimated 1/21/03 onset) he developed multiple fine, itchy red raised macular rash starting at/about his inner elbows that slowly spread to his lower and upper arms. The rash had single dots that had a sporadic pattern and grouping...some single, some clustered. He denies any rash to his torso or face. This rash was dry, scaley w/o flakes, worsened with heat or hot water, Lubiderm lotions burned area (hurt) however hydrocortisone cream (over the counter) helped with the itching and rash.  The rash lasted 2-4 weeks depending on if summer vs winter months or activity, or amount of itching.  He reported having 3-6 occurrences or more since 2003 with his last episodes in May and again in November 2005.  He denied any current or past allergies, new/old food allergies, no detergents, perfume, soap, clothing triggers.  He has not sought medical care for this problem as treating it on his own has been successful.
Arm hurts daily in the same location of the vaccine pain is extreme and radiates down the left arm. This happens all day most days maybe ever now and then it will not hurt.
Rash on arm 10/19/17, progressive redness and warmth. Cellulitis. Tx BACTRIM DS 10/20/17 one PO BID x 10 days.
felt achy; chills; feverish to the second shot.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (felt achy), CHILLS (chills) and PYREXIA (feverish to the second shot.) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN (felt achy), CHILLS (chills) and PYREXIA (feverish to the second shot.). In 2021, PAIN (felt achy), CHILLS (chills) and PYREXIA (feverish to the second shot.) had resolved.            No concomitant medications were reported.  No treatment medications were reported.
11/19/04 c/o red, painful, lump left arm at site Td, noted 11/18/04 when lying in bed. Pt tx Aleve. MD to Biacin x 500mg 2 qdx10d; warm soak, f/u 11/20/04 s/s improving.
Report 2001025054-1 describes aching of the arm in a 43 year old male who received Lyme disease vaccine recombinant OspA (LYMErix). This report was received from the vaccinee's spouse and has not been confirmed by a physician or other healthcare professional. Medical history, concurrent conditions, and concurrent medications were not specified. The vaccinee received his first and second injections of LYMErix in Oct. 1999 and Nov. 1999, respectively. Exact dates of immunization were not known. He received his third injection of LYMErix in Aug. 2000, 10 months after the first injection. The recommended interval between the first and third injections is 12 months. Approx. one or two months following receipt of the third injection of LYMErix, he reportedly began to experience aching of the arm into which the vaccine had been administered. The aching occurred "off and on." He did not seek medical attention for this. The vaccinee reportedly believed the aching was possibly related to LYMErix administration. As of 02 October 2001, the aching persisted "off and on." Additional information was received from the vaccine provider on 03 December 2001. The vaccine provider considered the aching in the arm to represent myalgias. he stated that the vaccinee did not report any adverse event to him, and did not seek medical attention for the myalgias.
Pt seen and examined and chart reviewed and agree with H&P, assessment and plan, addendum, and level of care. Pt is a 4yr old male w/ hx of asthma admitted w/left arm cellulitis vs large local reaction   after administration of immunizations. Per mom, pt did move when a shot was given in affected arm and was scratched by the needle while shot was being given. When swelling began and mother alerted PMD, she was instructed to apply an ice pack and give ibuprofen q6 for pain and to prevent fever.  Mom stated last dose of ibuprofen she gave was at 10 am yesterday. Pt has been afebrile since admission but was given ibuprofen this am for pain/discomfort.  Pt's BP has been elevated but renal function good, U/A essentially normal, diastolics wnl but will cont to monitor.  On exam pt clingy but comforted by mom, L. arm- erythematous > at lower arm decreased at shoulder, arm is warm, swollen and indurated/ tense w/ no drainage.  Erythema did not spread past marked area. Plan: will cont to monitor BP, ID on consult, to see this pm- will follow recs. Plan d/w housestaff and pt's mother- questions answered.
The pt experienced a fever of 102 degrees and a severe headache and aching all over that lasted for 48 hours.
Developed fever 102 R following Hep A and Influenza #2 drooling reported by father, father brought patient to PCP office, where she was noted to be febrile, drooling unresponsive to verbal, tactile and auditory stimuli.
Extreme fatigue, very heavy feeling eyes, muscle aches, unusual joint pain, some SOB when walking