chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After all vaccines were given (Tdap was given first on Right Arm, HPV9 second on Left arm and lastly Menquadfi on Left Arm) patient stated that eyes were blurry. Patient was instructed to lay down and once she was laying down her eyes rolled back and she started shaking. After a few seconds patient stopped shaking and that's when the provider came in. Patient waiting in the office for about 25-30 minutes.
Fainting with no apparent distress or anxiety beforehand. Not conscious for a couple of minutes, jerking movements. Multiple red spots on upper arms and chest. Pallor and circumoral cyanosis. These symptoms resolved in a few minutes without intervention. Head injury from fall to the floor, resulting in slight confusion for a couple of hours and headache up to a week. Red sore raised area at the site of injection for several days.
This spontaneous report as received from a physician refers to a child patient of unknown age (gender was unknown). On an unknown date the patient was vaccinated with a dose of VARIVAX (Merck) (lot #, dose and route not reported). On an unknown date the patient developed chickenpox after receiving VARIVAX (Merck). The outcome of the event was unknown. This is one of several reports from same source. Additional information is not expected.
discomfort in the kidneys; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (discomfort in the kidneys) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RENAL PAIN (discomfort in the kidneys). At the time of the report, RENAL PAIN (discomfort in the kidneys) outcome was unknown.            Concomitant medications was not provided by the reporter.  treatment information was  not provided.  The patient stated they are experiencing discomfort in the kidneys and that the second shot seemed to aggravate the kidneys.
Caller says his wife's blood tests were up, until the booster vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 (Lot number: EP7533) at the age of 74 years as dose 2, single and administered in arm left, administration date 15Mar2021 (Lot number: EP6955) as dose 1, single for covid-19 immunisation. Relevant medical history included: "ITP", start date: 2017 (unspecified if ongoing), notes: ITP, this was diagnosed four years ago, before she got the vaccines. There were no concomitant medications. The following information was reported: BLOOD TEST ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "Caller says his wife's blood tests were up, until the booster vaccine.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter said that his wife got the vaccine because of COVID, clarified to her did not have COVID, she got it to prevent COVID. Her blood tests were up, until the booster vaccine and they seemed really, good and she had one a year apart, when they tanked.  No follow-up attempts are possible. No further information is expected.  Follow-Up (15Feb2022): Follow-up attempts are completed. No further information is expected.
Information has been received from a physician, via a company representative, concerning five or six patients between the ages of five and seven years old and of unknown gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. Approximately in 2017 (reported as: administered within the last two weeks), the patients were vaccinated with M-M-R II (dose, strength, frequency, route of administration, anatomical location, lot# and expiration date were not provided), for prophylaxis. On unspecified dates in 2017, the patients experienced mumps outbreak. The patients visited the doctor on unspecified dates and were treated with an unspecified antibiotic.   The reporter stated that the suspected cases of mumps outbreak were related to M-M-R II administration. The patients' outcome was reported as recovered. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA008042:
Severe headache, extremely high blood pressure 220/120, low blood sugar, anxiety, insomnia
A spontaneous report received from health professional via regulatory authority (VAERS), concerns a 5 year old male patient. The patient's medical history and concomitant medications were not reported. On unspecified date, the patient received FLUMIST (intranasal). It was reported that patient experienced Guillain-Barre syndrome. The outcome of the event of Guillain-Barre syndrome was unknown. Company physician assessed the Guillain-Barre syndrome to be serious as hospitalization. Summary of follow-up information received by AstraZeneca/MedImmune on 16-Jan-2015 from health professional via VAERS: Lab data were added. Narrative updated. Correction in database only: Reporter's information updated. Vaccine field added.
Telephone call 11/15/05 from child's grandmother; c/o "golf ball sized lumps with pus" coming from immunization injection sites, bilateral thighs. States child currently on antibiotic for croup and PCP observed injection sites at last PCP visit and was not concerned. A febrile encourage grandmother and for mother to telephone PCP for follow-up appt. Mom took child to local ER. Administered antibiotic Bactrim.
This spontaneous report was received from a medical assistant concerning a 18-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 23-FEB-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot number: L027282, expiration date: 21-SEP-2017, dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
After vaccines and blood draw patient appeared pale and also appeared to lose consciousness. Patient then proceeded to show signs of rhythmic jerking. We layed her down on table where she was already sitting. She was unresponsive for less than 30 sec. She appeared to be aware of her surroundings. Vitals were taken and patient was monitored while in lying position.
pt recv vax 7JUN96 & 17JUL97 pt devel 40-50 lesions all over body & a low grade fever;pt recovered from exp;
the vial was initially stored in the refrigerator on 18-Oct-2022 and vaccine administered on 18-Nov-2022; No adverse event; bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17Nov2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17Nov2022), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 18-Oct-2022 and vaccine administered on 18-Nov-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051d22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17Nov2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 18-Oct-2022 and vaccine administered on 18-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17Nov2022), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 18-Oct-2022 and vaccine administered on 18-Nov-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17Nov2022) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 18-Oct-2022 and vaccine administered on 18-Nov-2022).    No concomitant medication details was reported. It was reported that individual vails was used and vial size was reported as 2.5ml. The vial did not undergo any temperature excursions. No treatment medication details was reported.   This case contains information for the 1st of 14 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-675260, US-MODERNATX, INC.-MOD-2022-675264, US-MODERNATX, INC.-MOD-2022-675268 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-675260:Patient 1 US-MODERNATX, INC.-MOD-2022-675264:same reporter US-MODERNATX, INC.-MOD-2022-675268:Patient 1
Moderna COVID vaccine. My vein started bleeding after vaccine was given. Immediately smelled strong medicine. Two days later, I had severe chest pain and shortness of breath. I had to go to the ER for evaluation. I am scared to get my second dose tomorrow. I had such a bad reaction. My doctor said to get it even though I'm not sure after that severe reaction from the first dose.
Dizziness lasting approx 48 hours; Fever; Chills; Headache; Nausea; Diarrhea; This is a spontaneous report from a non-contactable consumer (patient). A 66-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch/lot number was not reported) via an unspecified route of administration, administered in arm left on 04Mar2021 at 04:00 PM (age at vaccination was 66 years, she was not pregnant at the time of vaccination) as dose number unknown, single dose for covid-19 immunization at hospital. The patient's medical history included chronic inflammatory arthritis and other autoimmune illness from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No other vaccine administered in four weeks. No covid prior vaccination and not tested post vaccination for covid. There were no known allergies. It was reported that after receiving the dose of vaccine, the patient experienced fever, chills, headache, nausea, diarrhea, dizziness on 04Mar2021 08:00 PM. Dizziness was lasting approximately 48 hours. The patient did not receive treatment for adverse events. The outcome of events was recovered on an unspecified date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Information has been received from a licensed practical nurse concerning a female (age not reported) who on 16-OCT-2006 was vaccinated in the upper arm with a 0.5 mL dose of Pneumovax 23 (lot 651374/0485F). Subsequently, the patient developed localized swelling, redness and tenderness. The patient sought medical attention and was told to take an antihistamine and apply warm compresses to the affected area. At the time of this report, the outcome was unknown. Additional information has been requested.
I can no longer walk without debilitating pain and stiffness in my knees and thighs both right and left.  I am experiencing fevers of 100 an above.  I am exhausted all the time and feel faint all day.  The pain in my joints is so debilitating that I cannot sleep.  I cannot work as I cannot stand or walk  since the Pfizer vaccination.
my menopause ended temporarily; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 61-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered at Pharmacy or Drug Store, via an unspecified route, in right arm on 08Apr2021, at 61 years of age, (Batch/Lot Number: EL8982) as single dose for COVID-19 immunization. Medical history included Chronic Lyme Disease from an unknown date and known allergies to penicillin, sulfa drugs, tramadol, ciprofloxacin (CIPRO), cephalosporin and atorvastatin (LIPITOR) from an unknown date. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered in right arm on 19Mar2021, at 61 years of age, (Batch/Lot Number: EL8982) as single dose for COVID-19 immunization. The patient didn't receive any other vaccine within the 4 weeks before vaccination. The patient was not diagnosed with COVID-19 prior vaccination. Concomitant medications included bupropion, levothyroxine, melatonin, colecalciferol (D3) and magnesium, all taken for an unspecified indication, since an unknown date. The patient reported that one month following her 2nd shot, on 14May2021, her menopause ended temporarily leading to two surgical procedures to rule out cancer and to stop or reduce menstrual flow. The event also resulted in Doctor or other healthcare professional office/clinic visit. Her postmenopausal phase was first identified at her women's health center in Apr2018 or Mar2018, but hormone testing on 14May2021 revealed that the patient was mid-cycle. This is highly irregular considering her age and considering how long she had been postmenopausal. The patient was treated with Dilatation and Curettage (D&C) as an outpatient on 15May2021 and with D&C and ablation on 20Jul2021. The patient underwent SARS-CoV2 test via nasal swab on 06Aug2021 which gave negative results. The reported events resolved on an unknown date.
Participant complained of tingling in the neck and shoulder after receiving the flu vaccine. After the participant alerted the staff, they continued to note that the participants arm and leg as well as behind the left earlobe was still tingling. No dizziness, swelling, redness, or pain. Participant was asked to sit down with the nurse and given water. The stated the symptoms began to resolve. They returned at the end of the event stating that the symptoms had resolved and had no further complaints.
Within 24 hours left upper arm was big and warm minimal pain, today warmer to touch, no fever, soft to touch non tender, full range of motion surrounded all upper arm.
Information has been received from a physician concerning a 12 year old female with no pertinent medical history who on 13-SEP-2007 was vaccinated with a first dose of GARDASIL. Concomitant therapy included MENACTRA. The physician reported that on 13-SEP-2007 the patient became lightheaded shortly after receiving her first dose of GARDASIL. It was reported by the physician that the patient's blood was drawn prior to receiving the vaccinations. She became disoriented, and confused. The patient reported that she felt "like her head was spinning and she was going to vomit". The child was kept quiet, observed and given juice. It was reported that her blood pressure dropped from 90/70 to 80/60, pulse slightly dropped from 88 to 76. On the 13SEP-2007 the patient recovered, while in the physician office. No further information is available.
Increased blood pressure (Machine 140/90; Manual 165/138) and HA.  Sent to ER for treatment.  AT ER:  EKG, CAT scan, meds given (3 Tylenol, 3 nitro, 50 mg Metoprolol. 12/8/06 Received medical records from hospital which reveal patient experienced pounding headache while at dentist. BP check revealed significant hypertension & was sent to ER for evaluation.  BP in ER was 165/138 & HA was 7/10 since vax earlier on same day.  Treated w/antihypertensives & NTG in ER with good relief & was released to care of PCP.  Final Dx: hypertension.
MOM OUT OF TOWN AND CALLED TO SAY HAD A SEIZURE. TAKEN TO HOSPITAL AND TOLD HAD TEMP OF 101.8 AND OTITIS MEDIA -  STARTED ON AUGMENTIN.
Pt given 3rd dose of covid vaccine per primary care provider advice 1st dose J&J 5/11/2021 2nd Dose Pfizer 8/3/2021 3rd Dose Pfizer 8/24/2021
On 12/20/2021 I thought that I may have had acid reflux because I had a light burning pain in the diaphragm area that lasted for about 2 days.  I noticed the sensation again on 1/15/2022, and I made an appointment to see my Doctor on 1/18/2022 because I was unable to sleep that night due to the burning sensation, and pressure feeling in the same area. My doctor ordered blood work that showed I had elevated Liver enzymes. I am still being treated for this condition.
cancer; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (cancer) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (cancer) (seriousness criteria death and medically significant). The reported cause of death was Cancer. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NEOPLASM MALIGNANT (cancer) to be related.    It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. It was reported that the Moderna Covid-19 caused cancer in 25 patients who were the friends of reporter. The patient will not provide any additional information on these patients. It was also reported that those patients who died were killed by the Moderna Covid-19 vaccine because Moderna vaccine was poison Cancer rates for jabbed Moderna Cancer patients was up 300% The Doctors are part of it along with Moderna. Treatment details was not reported by the reporter. This case contains information about 6th patient out of 25 patients. Company comment: This spontaneous case concerns a patient of unknown age and gender, with no medical history reported who experienced the unexpected, serious (due to medically significant and death criteria) event of Neoplasm malignant after a dose of mRNA-1273 vaccine was administered. Temporal association cannot be assessed due to lack of information on onset date of the event. The reported cause of death was Cancer. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-735987 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735987:Master case; Reported Cause(s) of Death: Cancer
Severe local reaction, swelling, pain, redness and lymphadenopathy developed within 3-5 hours of injection.
LIGHTHEADED; NOT FEELING GOOD; TIRED; This spontaneous report received from a patient concerned a 77 year old female. 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: 1805029, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced lightheaded, not feeling good, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from not feeling good, tired, and lightheaded. This report was non-serious.
no symptoms; improperly stored dose of Gardasil 9 (lot R028656, expiration 7/27/2021) was administered; This spontaneous report as received from a healthcare worker and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 21-MAY-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R028656, expiration date 27-JUL-2021, intramuscularly (strength and dose was not reported), for prophylaxis. Temperature and time frame of storage was reported as 27 degrees Fahrenheit for 3 hours. There was no previous temperature excursion. Digital data logger was involved.T he patient experienced no symptoms. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R028656; expirationdate: 27-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
tinnitus in the left ear.  Had the last shot on 9.24 and tinnitus developed 9.27....no history etc of health or hearing issues.
Diarrhea, vomiting x 3 days, hospitalized on IVF protracted vomiting despite NPO and was bilious vomiting after 24 hrs; period of waxing  and waning, sighing and clutching belly-Referred to hosp- Operated for Intussusception 04/30/08-record received for DOS 04/13-04/14/08-DC DX: Inutssusception. Presented to ED with persistent abdominal pain. Fussy, blood in rectum. Oral thrush noted. Vomitng began 2 days prior initially diarrhea green colored stools then orange, dehyrdsation. No stool for 2 days.Surgery:Laparotomy, manual reducible ileocolic intussusception. Returned to ED post operative with C/O abdominal pain.
no adverse event occurred. Patient received a booster dose of the pfizer vaccine 2 months earlier than the recommended interval.
Patient stated after 2nd dose of Moderna, 1.5 hours and 14 hours after receiving the shot he was shaking convulsively.
Rash on face and neck; This case was reported by a nurse via sales rep and described the occurrence of rash in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (the patient received 1st dose on 29th November 2021) and COVID 19 VACCINE PFIZER (received on 8th December 2021).   On 25th March 2022, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced rash. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-Aug-2022 Reporter's Comments: The reporter stated that the patient was seen by physician on 20th June 2022 for rash that the patient had on and off for 2 to 3 months, rash presented on face and neck. The reporter mentioned rash had been treated with steroids and steroid shot. Rash goes away and then comes when in the sun or it was triggered by heat. The reporter gave consent to follow up.; Sender's Comments:  US-GSK-US2022AMR120093:Same reporter, same patient
high temp 102-105, rash on face 8 days post vax;tx w/cool baths, APAP & motrin;lasted 2 days;