chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning a 31 year old male with no past medical history and a penicillin allergy who on 22 mar 2001 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation.  concomitant therapy included hepatitis a vaccine Havrix and polivirus vaccine ipol.  On 24 mar 2001 the patient experienced chills and malaise.  On 03/26/01 the patient experienec hives on his forehead, chest and arms and itchy eyes. The patient was seen by a doctor and treated for conjuncitivitis and drug reaction.  There was no information on the medication ordered.  It was noted that the patient received measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live as a child. Follow Up information has been received from a health professional who reports that on 03/26/01 the patient had a rash on his face, chest and spread to his arms. The rash worsened over the course of one week. It was reported that his eyes itched and on 03/26/01 he had the chills for one day. The patient recovered on 04/01/01.
Patient received the 1st COVID-19 vaccination today in the office.  Per parent report the patient briefly lost consciousness. When I arrived to the exam room he was lying on his back and his mother was holding his legs above his head. By that time he was appropriately responsive and alert and oriented. No signs of respiratory distress, no edema, or other signs of anaphylaxis. He was given a drink of water. He was observed for 20 minutes in the exam room and remained at his neurologic baseline. I suspect syncopal reaction after the vaccination. This is not a contraindication to the second vaccine for COVID as I do not believe this was an anaphylactic reaction. Mom verbalized understanding.
This case was reported in a literature article and described the occurrence of atypical autism in a subject who received Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, the subject developed atypical autism. Serious criteria included GSK medically significant. The outcome of atypical autism was unknown. The investigator considered that there was a reasonable possibility that the atypical autism may have been caused by Hepatitis B vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of atypical autism in a patient of unspecified age and gender who was vaccinated with unspecified hepatitis B virus (HBV) vaccine (manufacturer unknown). This case corresponds to table 4 of this literature article. The patient was a part of the study that examined the relationship between infant mercury (Hg) exposure from Thimerosal-containing hepatitis b vaccines and the long-term risk of a child being diagnosed with atypical autism. The patient was born between 1991 and 1998. No information on patient's medical or family history or concurrent condition or concomitant vaccine was provided. On an unspecified date, the patient received 1 dose of unspecified HBV vaccine (administration route and site unknown; batch number not provided). The patient was exposed to 12.5 ug of mercury within first 6 months. (In  this study, the vaccine administered contained 12.5 micrograms (ug) Hg per dose of hepatitis B vaccine. The Advisory Committee on Immunization Practices (ACIP) recommendations called for the administration of the first dose of hepatitis B vaccine between birth and 2 months of age, the second dose between 1 and 4 months of age, and the third dose between 6 and 18 months of age). On an unspecified date, an unknown period after vaccination, the patient developed atypical autism. Treatment was unknown. The outcome of the event was not reported. The authors considered that event of atypical autism significantly associated with thimerosal in unspecified HBV vaccine. The authors concluded, "The use of routine childhood vaccination is an important public health tool to significantly help reduce the morbidity and mortality associated with infectious disease. The results of this hypothesis-testing, prospective longitudinal, case-control study suggest that the mercurial component, Thimerosal, used as a preservative in many multi-dose vial preparations of vaccines worldwide, is significantly associated with overall and dose-dependent increased risk for atypical autism diagnoses. It is recommended that Thimerosal should be eliminated from all vaccines as soon as possible." This is 1 of the 2 valid cases in the same literature article.
shingles; other zoster-related conditions; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. In 2016 the patient was prescribed and/or administered by a healthcare provider with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date (reported as subsequent to the vaccination), the patient was treated by healthcare providers for shingles, and other zoster-related conditions. As a direct and proximate result of zoster vaccine live(ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was not provided. The reporter considered both events to be related to zoster vaccine live(ZOSTAVAX).
she experienced chills; slept the whole day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization.   The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: CHILLS (non-serious) with onset 20Mar2021, outcome "unknown", described as "she experienced chills"; SOMNOLENCE (non-serious) with onset 20Mar2021, outcome "unknown", described as "slept the whole day".  Additional information: She also called in to ask if the second dose would be more potent than the first. Her second dose was scheduled on 09Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Next day post vax, the pt developed an injection site reaction characterized by swelling, redness, and a rash. This is one of three employees from this facility who experienced this event following receipt of vax.
Information has been received from a physician concerning an 11 year old 79 1/2 lb. 55 1/2 in. female who on 09-NOV-2007 at 11:00 hours received her second dose of varicella virus vaccine live (Oka/Merck) (lot#659156/1367U). Concomitant vaccination included Fluzone (lot # U2476HA). There was no reported illness at the time of vaccination. On 09-NOV-2007, after receiving the vaccination, it was reported that the patient felt something shooting down her upper extremity, felt dizzy and was pale. Her pulse rate was reported as 80 to 90 with a blood pressure of 60/42. A repeat blood pressure in 10 minutes was 72/48. After 15 minutes, her blood pressure was 90/70. Reported treatment measures were oral fluids (water) and to rest. It was reported that she left the physicians office after about 30 minutes. It was reported she presented on 10-NOV-2007 to the physicians office with dizziness. It was reported that on 10-NOV-2007, her blood pressure was 80/60. Follow up information from the physician indicated that on 15-NOV-2007, she had recovered. A product quality complaint was not reported. Additional information has been requested.
Received Moderna vaccines on 2/5/21, 3/2/21 Tested positive for COVID 19 by PCR on 5/25/21 onset of symptoms 5/23/21 with diarrhea, congestion/rhinorrhea;anosmia/dysgeusia;cough;nausea/vomiting/abdominal pain
OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a consumer via other manufacturer (Abbvie) concerned a 3 decade old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe hidradenitis suppurativa. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 in total administered, on an unspecified date in AUG-2021 for prophylactic vaccination.  On an unspecified date, the patient experienced occasional hidradenitis suppuritiva flares, sick, and bruises easily (dose number in series 1). The patient received booster dose of Moderna COVID-19 vaccine (spikevax, elasomeran) (dose number in series 2) (form of admin was not reported, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination.  It was unknown whether the patient had any adverse events following vaccination with Moderna COVID-19 vaccine (elasomeran) (dose number in series 2). The patient received third dose of covid-19 vaccine ad26.cov2.s (Dose number in series 3) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date in 2021 for prophylactic vaccination which was off label use as inappropriate schedule of vaccine administered (Dose number in series 3). Age at time of vaccination 3 decade old. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The patient received non-company suspect drug: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) citrate free, dose, frequency, and therapy dates were not reported for moderate to severe hidradenitis suppurativa.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of the off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious. This case, involving the same patient is linked to 20220512914.
He started to experience migraines. After about three days his heart would start racing at rest. His heart rate would go as high as 170 beats per mins. So we made an appointment with his primary care physician. They ordered an MRI for his head and the results were normal. We were referred to a cardiologist for his heart rate. The did an Echocardiogram and was diagnosed with pots and sinus tachycardia. He was prescribed metoprolol and given a heart monitor to wear for two days to monitor his heartrate while he slept. He was also sent to the neurologists for the headaches. She stated that it was common to have headaches from pots. She prescribed zonisamide. He has a follow up appointment in 11/2022 to see about weening him off of the zonisamide. I'm not sure if this has anything to do with it. But I had COVID in 09/2020 and my son was exposed, but never tested positive.
MODERNA COVID-19 VACCINE EUA Patient received Covid-19 vaccine on 02/01/2021 and had soreness that afternoon and the next day, she applied cold compress to arm and soreness was relieved. Patient started having swelling in the arm and on 02/03 and is still swollen today 02/12.  Swelling is about 3 inches vertically and 2 inches horizontally on left arm.  It has a knot on palpation. Still has redness at injection site that is about 2 inches in diameter. Patient is not having any pain.
Case number PHEH2013US003447 is an initial spontaneous report received from a pharmacist on 05 Feb 2013. This report refers to a female patient whose age was not reported. She was vaccinated with a dose of expired MENVEO (batch number: A10047, expiry date: Dec 2012) intramuscularly on 03 Feb 2013. No adverse reactions were reported following the maladministration.
Pt. received vaccine on 10/18/11 - started to feel funny on 10/19/11. By 10/21/11 patient lost all hearing in left ear. Went to MD on 10/21/11. Received steroid shot on 10/21/11 and 11/4/11. Patient stated on 11/7/11 hearing was coming back. Scheduled for another injection on 11/18/11 then hearing test to follow last injection.
Information has been received from a physician concerning a 4-month-old patient who was vaccinated with the first dose of Rotateq. Unspecified medical attention was sought and no problems reported. Additional information has been requested.
Syncopal episode and a second episode of possible seizure Treatment is ongoing - did not receive medications for possible seizure activity
Feels foggy/cloudy; Headaches every day since the 1st dose/headaches when coughs; A spontaneous report was received from a consumer concerning a 68-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headaches every day since the 1st dose/headaches when coughs/cluster headache and feels foggy/cloudy/feeling abnormal.  The patient's medical history included allergies. Concomitant medications reported were fexofenadine hydrochloride, fluticasone propionate and eye drops.  On 05 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 010M20A) via unknown route for prophylaxis of COVID-19 infection.  On 05 Feb 2021 onwards, the patient is experiencing headaches every day. The patient also reported that, she had headaches when coughs and then felt foggy or cloudy.  Treatment details included Tylenol and naproxen.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event headache every day since the 1st dose was ongoing. The outcome of the events headaches when coughs and feels foggy/cloudy were unknown.
no additional AE'S; improperly Stored; Administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medication were not provided.  The previous temperature excursion of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was reported as 30.28 Fahrenheit degrees (F) for 19 minutes and 34.81 F for 35 minutes. On 06-APR-2021, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T020616,expiration date 16-MAR-2023, dose was reported as 1 (unit unknown); strength and route were not provided) for prophylaxis (product storage error). Administered dose of vaccine was stored in the temperature of 28.34 F for 1 hour and 2 minutes. No additional adverse event was reported. Data logger was involved.  This is one of several reports received from same reporter.; Sender's Comments:  US-009507513-2104USA002463:Original Case : 2104USA002463
arm was blotchy, oblong shaped from the top ofthe shoulder down 5inches and 3 inches wide.; Arm was swollen, red, and very warm near the injection site; Arm was swollen, red, and very warm near the injection site; Arm was swollen, red, and very warm near the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm was swollen, red, and very warm near the injection site), LIMB DISCOMFORT (arm was blotchy, oblong shaped from the top ofthe shoulder down 5inches and 3 inches wide.), VACCINATION SITE ERYTHEMA (Arm was swollen, red, and very warm near the injection site) and VACCINATION SITE SWELLING (Arm was swollen, red, and very warm near the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history was not reported .     On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Arm was swollen, red, and very warm near the injection site), VACCINATION SITE ERYTHEMA (Arm was swollen, red, and very warm near the injection site) and VACCINATION SITE SWELLING (Arm was swollen, red, and very warm near the injection site). On 27-Jan-2021, the patient experienced LIMB DISCOMFORT (arm was blotchy, oblong shaped from the top ofthe shoulder down 5inches and 3 inches wide.). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) (oral) on 26-Jan-2021 for Allergy, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Arm was swollen, red, and very warm near the injection site), LIMB DISCOMFORT (arm was blotchy, oblong shaped from the top ofthe shoulder down 5inches and 3 inches wide.), VACCINATION SITE ERYTHEMA (Arm was swollen, red, and very warm near the injection site) and VACCINATION SITE SWELLING (Arm was swollen, red, and very warm near the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided    This case was linked to MOD-2021-020825 (Patient Link).
She has a fever 99 Fahrenheit; Had a fever on the vaccination day; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (She has a fever 99 Fahrenheit) and PYREXIA (Had a fever on the vaccination day) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Sep-2021, the patient experienced PYREXIA (Had a fever on the vaccination day). On 20-Sep-2021, the patient experienced PYREXIA (She has a fever 99 Fahrenheit). At the time of the report, PYREXIA (She has a fever 99 Fahrenheit) had not resolved and PYREXIA (Had a fever on the vaccination day) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Sep-2021, Body temperature: 99 (High) fever 99 Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
FACE SWELLING; SKIN HOT TO TOUCH; SKIN FLAKY TO TOUCH; ITCHINESS; COUGH; NAUSEA; This spontaneous report received from a patient concerned a 75 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced cough. On 12-MAR-2021, the subject experienced nausea. On 14-MAR-2021, the subject experienced itchiness. On 14-MAR-2021, the subject experienced face swelling. On 14-MAR-2021, the subject experienced skin hot to touch. On 14-MAR-2021, the subject experienced skin flaky to touch. Treatment medications (dates unspecified) included: cortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cough, and nausea on 13-MAR-2021, and was recovering from itchiness, face swelling, skin hot to touch, and skin flaky to touch. This report was non-serious.
I?m 8 days past my first Moderna  Covid vaccine. The arm where I got the shot had a red rash, it's a bit hard, & a bit sore.  Rash is oval shaped & approximately 6 inches across. I discovered that this morning. Have felt fine & had no affects before today.  No treatments. Might take Tylenol if it continues to be sore.
Pt. called stating the SHINGRIX vaccine had made her sick. Severe arm pain hot red severe swelling. Sick in bed x 3 days with a fever of 101. She also had nausea.
Left upper arm cellulitus, red, round, hot, tender, swelling on left deltoid 3 1/2 x 4inches. D.O. Keflex 250/5 1 1/2 tsp TID x 10 days. Motrin 100/2 2 1/2 tsp q 6-8 H prn. RTC on AM 06/01/02.
A fib; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (A fib) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 029A21A) for COVID-19 vaccination.     The patient's past medical history included AFib (Takes Flecainide for Heart Rate control) since an unknown date and Cardioversion in 2019. Concomitant products included FLECAINIDE for AFib, LOSARTAN, ATORVASTATIN, FUROSEMIDE (LASIX [FUROSEMIDE]) and POTASSIUM for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced ATRIAL FIBRILLATION (A fib) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (A fib) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: unknown (Inconclusive) Results not provided. On an unknown date, Electrocardiogram: unknown (Inconclusive) Results not provided.         Patient was taken to ER (Emergency Room) where an EKG and a chest X-RAY were done. The results of the EKG and chest X-ray were not provided. Patient reported that she takes Flecainide for Heart Rate control.  No other treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.   This case was linked to MOD21-072680 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded. MOD21-072680:MOD-2021-072836 1st dose case
Flu like symptoms, chills nausea headaches LOSS OF APPETITE! Lost nearly 20 lbs
Information has been received from a consumer concerning her 4 year old granddaughter who on an unspecified date was vaccinated with a dose of MMR II. In approximately September 2008, the patient was diagnosed with autism. The consumer did mention that her granddaughter received vaccines, but did not blame any specific vaccine. It was unspecified if the patient sought medical attention. As of 16-MAR-2009, the patient had not recovered from the event. Upon internal review, autism was considered to be an other important medical event. No further information is available.