chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 04-Apr-2019 regarding an unsolicited valid serious case received from a consumer (patients mother). This case involves a female patient (age unknown) who experienced staring seizures, while she received vaccine DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE. The patients past medical treatment included Flovent inhaler that caused her severe depression and was back to normal when she stopped the medication. The patients past vaccination included MMR at 15 months of age and was catatonic and non-responsive for 10-12 days then just snapped out of it. The patients past medical history and family history were not provided. The patient is allergic to trees and nuts and broke out in hives when someone suggested to her to use a raw potato to lighten her skin. On an unknown date, when patient was at infant age, the patient received injection of suspect DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE produced by unknown manufacturer lot number, expiry date not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious staring seizures (Petit mal epilepsy) with unknown latency following the administration of DIPHTHERIA and TETANUS AND NOS PERTUSSIS VACCINE. This event was assessed as medically significant. Lab data was not provided. Final diagnosis was seizures. It was not reported if the patient received a corrective treatment. The outcome of seizure was not reported hence captured as Unknown for seizures. List of documents held by sender- none.; Sender's Comments: This poorly documented case concerns a female patient of unknown age who presented with absence seizures after receiving suspect DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE produced by unknown manufacturer. Time to onset is unknown. Moreover, there is no information regarding patient's medical condition at time of vaccination and lab tests ruling out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed.
adverse reaction to the booster shot; blood sugar level went into more than 400 range and mostly stayed high, next day mostly stayed above 500; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse reaction to the booster shot) and HYPERGLYCAEMIA (blood sugar level went into more than 400 range and mostly stayed high, next day mostly stayed above 500) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (adverse reaction to the booster shot) and HYPERGLYCAEMIA (blood sugar level went into more than 400 range and mostly stayed high, next day mostly stayed above 500). On 30-Jan-2022, HYPERGLYCAEMIA (blood sugar level went into more than 400 range and mostly stayed high, next day mostly stayed above 500) had resolved. At the time of the report, VACCINATION COMPLICATION (adverse reaction to the booster shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2022, Blood glucose: 110 (normal) normal range of 110. On an unknown date, Blood glucose: above 400 (High) Went into more than 400 range and mostly stayed high and above 500 (High) mostly stayed high above 500.         The patient was diabetic. The blood sugar level of the patient went into more than 400 range and mostly stayed high, next day mostly stayed above 500. The levels were dangerously high levels.  On the day of reporting, when patient got out of bed it was normal range of 110 and patient hope it came back to normal.  No concomitant medications was reported. No treatment drug details was reported.
Joints and muscle aching and throbbing Skin extremely sensitive to the touch - even clothes hurt
Woke up in a cold sweat and had abdominal cramps.  I was very thirsty and had difficulty urinating.  I was experiencing extreme dizziness and had difficulty seeing well enough to open a bottle of pain relievers and get a glass of water.  I decided to lie down for a whle and in the short distance back to my bed, the dizziness was so bad that it caused me to fall over.  I tried to pick up my glass of water, but couldn't see well enough to find it.  I also felt nauseous.  After lying down for over an hour, the cold sweat was gone and I experienced only very mild dizziness sporadically for the rest of the day.
This spontaneous report was received from a pharmacist referring to a 72 years old female patient. The patient's medical history and concurrent conditions were not reported. On 19-OCT-2016 at 12:00, the patient was vaccinated with PNEUMOVAX 23, lot # M020521, expiry date: 17-NOV-2017, (strength, dose, route and anatomical location of administration were unknown). Concomitant therapies were not reported. On the same date at an unspecified time after injection, the patient experienced soreness in her arm (pain in extremity) and also shortness of breath (dyspnoea). The patient's daughter took her to the emergency room, but it was not specific if the patient was actually admitted to the hospital. No product quality complaint (PQC) was involved. At the time of reporting, the patient was recovering from the pain in extremity and the dyspnoea (reported as "patient now felt better but still had some arm soreness"). The causality assessment between the pain in extremity, the dyspnoea and PNEUMOVAX 23 was not provided. Additional information is not expected, no permission for further contact was provided.
Chills, vomiting,  malaise for 48 hours, pain in armpit
Pt recv vax on 11/9/98; on same day pt exp red, itchy & swollen vax site w/ hard lump; swelling then to elbow; dx=allergic rx; tx=Benadryl
This is a spontaneous report from a contactable physician who reported for a patient through a Pfizer Sales Representative. This is second of the 4 reports from same reporter. A patient of unknown age and gender received PREVNAR 13 single dose on unknown date. The patient experienced cellulitis at injection site and fever.
The next afternoon on 12/30/20  I experienced a slight pain like someone scratched me on my chest, stomach, and back.  The next morning (12/31/20) the pain turned into burning sensation like a mild sunburn all over my chest, stomach, and back areas.  I am still experiencing the burning sensation today.
diagnosed with cutaneous T-Cell lymphoma; A pimple- like mushroom lump; This is a spontaneous report from a contactable consumer. A 67-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Mar2021 (Batch/Lot Number: EN6208) as UNKNOWN, SINGLE for COVID-19 immunization. Medical history included high blood pressure. On 30Mar2021 (reported as 10 days after the last vaccine), the patient had a pimple-like mushroom lump. On 01Apr2021, the patient was diagnosed with cutaneous t-cell lymphoma. The patient underwent lab tests and procedures which included biopsy: unknown result on 22Apr2021. The patient received an unspecified treatment for the events. The outcome of the events was not recovered. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested post vaccination.
water and blood coming out the legs; paralyzed feeling in my legs completely, cant even walk around the house; uncontrollable diarrhea; severely decreased appetite; severe bloating; high body temperature of 103; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMORRHAGE (water and blood coming out the legs) and PARALYSIS (paralyzed feeling in my legs completely, cant even walk around the house) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (water and blood coming out the legs) (seriousness criterion medically significant), PARALYSIS (paralyzed feeling in my legs completely, cant even walk around the house) (seriousness criterion medically significant), DIARRHOEA (uncontrollable diarrhea), DECREASED APPETITE (severely decreased appetite), ABDOMINAL DISTENSION (severe bloating) and PYREXIA (high body temperature of 103). At the time of the report, HAEMORRHAGE (water and blood coming out the legs), PARALYSIS (paralyzed feeling in my legs completely, cant even walk around the house), DIARRHOEA (uncontrollable diarrhea), DECREASED APPETITE (severely decreased appetite), ABDOMINAL DISTENSION (severe bloating) and PYREXIA (high body temperature of 103) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was included TORSEMIDE, CEFUROXIME and MUPIROCIN cream.  Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded.
patient developed minor swelling and small rash adjacent to the ID injection site. sx started 15 minutes after injection. sx remained localized, but patient was advised to go to urgent care for follow up. no s/sx of respiratory or cardiac distress. patient declined to seek treatment. patient was followed up with 7 days later and her reports that symptoms were gone "in a day" and that he feels fine.
c/o redness to lt deltoid-site of flu vax; no itching; lumpy feeling @ site of vax; ice pack to site;
Tinnitus in both ears; some temporary hearing loss in left ear (happens in short bursts)
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Jan2023 at 10:00 as dose 5 (booster), single (Lot number: GL0087) at the age of 52 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Hot flashes" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; EFFEXOR taken for hot flush, start date: 01Aug2022; METFORMIN; SINGULAIR; NASACORT; VITAMIN C [ASCORBIC ACID]; VITAMIN D NOS; MULTIVITAMINS [VITAMINS NOS]. Past drug history included: Macrobid, reaction(s): "Allergy", notes: Known allergies: macrobid; Sulfonamide, reaction(s): "Allergy", notes: Known allergies: Sulfa. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Paxlovid from 09Mar2023 to 13Mar2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300109526 Same reporter/patient, different drug/event.;
viral exanthem (blanching, non palpable erythematous macules from scalp excluding palms & soles including diaper area;+ irritable;no fever;no other sx;
Information has been received from a primary physician, concerning a 7 year old female patient who six years ago, in approximately 1998, at the age of 1 year old was vaccinated with a dose of varicella virus vaccine live. Conflicting information received from an oncologist indicated that the patient was vaccinated in approximately 2003. Subsequently, the patient developed T-cell Lymphocytic Leukemia and she is being treated with methotrexate, prednisone, 6- mercaptopurine and vincristine sulfate. On 4/29/04, the patient developed varicella lesions on her ears, and since that time she has experienced additional lesions intermittently and continuously on her upper extremities and different areas of her body. The lesions have been diagnosed as Herpes Zoster. It was noted that the patient received Acyclovir (dose and dates of administration not reported) and her chemotherapy is being withheld until the lesions resolve. The patient has not recovered. There was no product quality complaint reported. Further information regarding medical intervention was unknown. Follow up information received from a physician reported that the patient is on chemotherapy and experienced disseminated chicken pox six years after vaccination. The physician reported that the patient did not have chicken pox in the past and was not recently exposed to chicken pox or shingles. The physician reported that the patient is allergic to famotidine (WAES0407USA02508). It was reported that she is not recovered. The physician reported that a specimen of a vesicle type lesion was obtained on 7/28/04 and sent to a medical laboratory on 8/2/04 and also sent to a laboratory for VZV identification. Follow up information received from a health professional reported that on 8/3/04 the specimen arrived for VZV identification. It was reported that the swab received was diluted in tons of media and was therefore considered an inadequate sample. No VZV was amplified, B-globulin was negative and strain was not identified. Unspecified medical attention was sought. Additional information has been requested.
Pt. received 2nd Covid vaccine on 05/14/2021. On 05/15/2021 pt. reports not feeling well with s/s of body aches and chills. Pt. reports that on 5/16/21 that he noticed fever, cough and increased SOB. Pt. presents with c/o increase SOB on 05/18/2021. Pt. was admitted with diagnosis of right upper and middle lobe pneumonia on 05/18/2021. Pt. required 2-3 L of O2 per nasal cannula. Pt. was also on antibiotics on Rocephin 1 gm IV every 24 hours. Pt. received a one time dose of Azithromycin 500 mg in ED.
This spontaneous report as received from a Registered Nurse regarding a 4 year old Child patient of unknown gender. There was no information about concurrent condition, historical medication and concomitant medication. On 13-SEP-2018, the patient was vaccinated with improperly stored PROQUAD for prophylaxis (product storage error). Vaccine was stored out of range at -6 degrees for an approximate time of 15 minutes. This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-1902USA001085.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 08-JUN-2009, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 10-SEP-2015, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested
first vaccine no adverse effects, only fatigue and sore arm. second vaccine no soreness only fatigue until mentioned date 6/29 started with small red bumps in neck and shoulder. Has advanced to flu like symptoms, itching and red bumps that have advanced to entire body and vesicular in nature. continuing to spread over entire body.
Blood clots (2 in left leg, and 2 in each lung). Now on Warfrin 5mg daily.
Patient Was injected in left Deltoid on August 25,2021 and 1 week later her deltoid  had hemorrhaging that larger than a silver dollar around the deltoid on the site of the injection. It is resolving.
Right arm extremely heavy/achy immediately after administration.  Almost a month later, acute shoulder pain, loss of range of motion (can't move arm back/lift arm).
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 3:18 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 3:18 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the fridge on 30-Mar-2021, moved to the clinic on 03-Apr-2021 and proposed beyond use date was 29-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit.  On 31-Mar-2021, at 08:00 A.M., the temperature recorded was 32 degree Fahrenheit and at 09:00 A.M., the temperature recorded was 32 degree Fahrenheit that has been reached by the vial.  On 03-Apr-2021, at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit that has been reached by the vial.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
Started feeling flu symptoms on 01/05/2023; Took a home COVID-19 test and it was negative; Still felt bad a couple of days later so took another COVID-19 test and it was positive; Went to urgent care, tested for the Flu as well as COVID-19; Tested negative for the Flu, but COVID-19 was confirmed.
11AUG93 pt started running a fever; father took to clinic; treated for ear infect; 12AUG93 started having diarrhea; went to clinic; redness @ shot site; urticaria;
Seizure withint 48 hours of vaccine administration. No illness noted. No history of seizures.
No adverse Event; Patient got vaccinated after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse Event) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD).    Patient registry ID was reported.  No concomitant medications were reported.  It was reported that, the patient received vaccine after the beyond use-by date.  No treatment medications were reported.
diarrhea; Aches; started throwing up; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), PAIN (Aches), VOMITING (started throwing up) and CHILLS (chills) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012FZ11A) for COVID-19 vaccination.     Concurrent medical conditions included Cardiac valve disease.    On 24-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced DIARRHOEA (diarrhea), PAIN (Aches), VOMITING (started throwing up) and CHILLS (chills). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhoea, at an unspecified dose and frequency. On 26-Oct-2021, VOMITING (started throwing up) and CHILLS (chills) had resolved. At the time of the report, DIARRHOEA (diarrhea) and PAIN (Aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   This case was linked to MOD-2021-365461 (Patient Link).
Immediately after receiving immunization, pt states she felt "funny". 5 minutes after receiving Varicella immunization, pt's lips swelled and her tongue felt thick. Pt brought back to exam room and given subcutaneous epinephrine.