chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ruptured spleen; This spontaneous case was reported by a consumer and describes the occurrence of SPLENIC RUPTURE (Ruptured spleen) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Nov-2021, the patient experienced SPLENIC RUPTURE (Ruptured spleen) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 06-Nov-2021 due to SPLENIC RUPTURE. At the time of the report, SPLENIC RUPTURE (Ruptured spleen) was resolving.            No concomitant medication provided. No treatment medication reported.  Patient went into the ER on 06-Nov-2021 and after that they spent 3 days in ICU.  Company comment: This case concerns a 70-year-old female patient with no medical history reported, who experienced the unexpected, serious (hospitalization and medically significant) event of splenic rupture. The event occurred approximately 4 days after the booster dose of mRNA-1273. One day after vaccine administration the patient experienced malaise; the next day the patient experienced pain. The patient went to the emergency department where she was diagnosed with splenic rupture and had to be admitted to the ICU. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 70-year-old female patient with no medical history reported, who experienced the unexpected, serious (hospitalization and medically significant) event of splenic rupture. The event occurred approximately 4 days after the booster dose of mRNA-1273. One day after vaccine administration the patient experienced malaise; the next day the patient experienced pain. The patient went to the emergency department where she was diagnosed with splenic rupture and had to be admitted to the ICU. The benefit-risk relationship of mRNA-1273 is not affected by this report.
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 37-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 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-395985 (Patient Link).
Sore arm, Fatigue, Low grade fever, Sore joints, Light headache
Patient passed out and hit his head on a desk and the floor. Patient was conscious within one or two minutes. Patient was taken to the ER, but they discharged without performing a scan. Pt has vomited once.
hip pain, joint pain, rxn in shoulder rt p/ then no rxn;now 10 days p/hip, shoulder pain, significant;
Left deltoid was swollen, red, fever, warm to the touch, very painful for 6 days.
This spontaneous report as received from a 57 years old female consumer with allergy to Sulfa and cortisone, no pain medications or anti-inflammatories. The patient's concurrent condition included heart flutters and asthma, medical history "last July" (July, 2012), she had a rash on her ribs on one side of her body and her dermatologist told her that it was shingles, but her PCP, said it wasn't shingles. On 15-JAN-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot number not provided). Concomitant therapies included XANAX. She still had a purple area of 3X3 inches around the injection site. Since the injection she has been sick. She had had a fever on and off and got the chills a lot. She had horrible stomach and back pain and digestive problems. She felt like she had seizure (had tremors in her pain). Her face got really red and flushed. She had nerve pain throughout her body. Blood work was performed and results were unknown. KEFLEX (manufacture unspecified) for one week was put as treatment for adverse event. The outcome of adverse events was reported as not recovered. The patient saw the HCP for seeking medical attention. Her PCP thought that she was just having an allergic reaction to the vaccine. Upon internal review, convulsion was considered to be medically significant event. This is one of several reports received from the same source. Additional information is not expected.
HEADACHE; FEVER; SWEATING; KNOT AT INJECTION SITE; CHILLS; DIZZINESS; LIGHTHEADED; PAIN AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included corneal transplant, and penicillin allergy, and concurrent conditions included arthritis, hypertension, sinus problem, high cholesterol, asthma, and sleep apnea. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced dizziness. On 11-MAR-2021, the subject experienced lightheaded. On 11-MAR-2021, the subject experienced knot at injection site. On 11-MAR-2021, the subject experienced pain at the injection site. On 11-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced sweating. On 12-MAR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol, and isopropanol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, sweating, and fever on 14-MAR-2021, lightheaded, and chills on 13-MAR-2021, knot at injection site, and pain at the injection site on 21-MAR-2021, and headache on 11-APR-2021. This report was non-serious.
3 hours after shot given, patient developed wet cough, throat felt like closing, low grade fever (100.2 F), chills, limbs shaking, teeth chattering, continued through night; went to MD on Fri 10/03/14, was told to take Benadryl and afterwards, no symptoms
reaction to 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (reaction to 1st dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (reaction to 1st dose). At the time of the report, ADVERSE REACTION (reaction to 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications taken by the patient were not provided. Treatment information was not provided.
vaccine was Zostavax,large, painful, hot, red area (2 cm by 5 cm)with darker red inner area (1 cm by 2 cm)
- Dizziness - Acc. to patient, feels something in right leg/nerve pain. - Patient is transferred to gurnery. BP: 148/78 Pulse: 90 SPo2: 97% - After 15mins BP: 146/82 Pulse: 78 - Patient has history of vericose veins and procedure (ablation) is done in past. - Left for home with daughter - Adviced to cosult PHP regarding adverse effects. - Patient felt better left home with daughter. - Patient adviced to got to ER for further education. Refused by patient.
pt recv vax & exp fever, chills, h/a, myalgia, & then rash; pt dx w/clinical case of chickenpox; No further details were provided;
At or around 2:00 am I became very restless, got out of bed and walked into the bathroom. I became nauseous, had a slight headache, dizzy, a cold sweat and began having intense stomach cramps. Within 1 minute I passed out in my bathroom and was found face down in my bathroom. It was clear that I hit my head and lost a tooth. I was taken via ambulance to a local hospital.
COVID 19; COVID 19; Dose 1: Pfizer/ Dose 2: Pfizer/ Dose 3: Pfizer/ Dose 4: Moderna; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jan2021 as dose 1, single (Lot number: EK9231), in right arm, on 21Jan2021 as dose 2, single (Lot number: EL3249), in right arm and on 12Oct2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 48 years, in right arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 31Oct2022 as dose 4 (booster), single (Lot number: 061F22A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "insomnia" (unspecified if ongoing); "GERD" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bactrum, reaction(s): "Known allergies: Bactrum". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31Oct2022, outcome "not recovered", described as "Dose 1: Pfizer/ Dose 2: Pfizer/ Dose 3: Pfizer/ Dose 4: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Jul2023, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jul2023) Positive, notes: I tested positive for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient took Pavlovid for 5 days starting on the evening of the day she tested positive for COVID. The patient took Paxlovid from 21Jul2023 to 26Jul2023 for the treatment of COVID-19.; Sender's Comments: Based on the given information , the possible contributory role of the suspect for the events drug ineffective , Covid -19 and interchange of vaccine products cannot be completely excluded.
Intense soreness in arm of injection and soreness has lasted over 2 months. Patient reports that the first month, she was very uncomfortable but pain has subsided over the last 30 days, however patient still reports muscular stiffness and discomfort.
This spontaneous report was received from a registered nurse who read about the life story of a patient of unknown age on a website. On an unknown date the patient was vaccinated with GARDASIL, (dose, lot no. route not reported). On an unknown date the patient died from an unspecified cause. This is one of reports received from the same source. Additional information is not expected.
None covid 19 vaccine expired 11/22/2022 Given 12/09/2022
Arthritis Flare ups after second vaccine; Bumps on both hands come and go after second vaccine; Painful Hard Bumps on both hands after second vaccine; Can not work with hands after second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Bumps on both hands come and go after second vaccine), PAIN IN EXTREMITY (Painful Hard Bumps on both hands after second vaccine), MOBILITY DECREASED (Can not work with hands after second vaccine) and ARTHRITIS (Arthritis Flare ups after second vaccine) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A) and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PERIPHERAL SWELLING (Bumps on both hands come and go after second vaccine), PAIN IN EXTREMITY (Painful Hard Bumps on both hands after second vaccine) and MOBILITY DECREASED (Can not work with hands after second vaccine). On 15-May-2021, the patient experienced ARTHRITIS (Arthritis Flare ups after second vaccine). The patient was treated with DICLOFENAC (VOLTAREN [DICLOFENAC]) (topical) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Bumps on both hands come and go after second vaccine), PAIN IN EXTREMITY (Painful Hard Bumps on both hands after second vaccine), MOBILITY DECREASED (Can not work with hands after second vaccine) and ARTHRITIS (Arthritis Flare ups after second vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was received by the patient.  Treatment information included putting Copper Infused Gloves on hands reported by the patient.
Urticarial type rash few hours after MMR and HIB. Child is prone to urticarial rash of ? etiology. Reported by another.
about 6 days after the injection I noticed a large swollen red spot around where the injection was administered. It is about the size of the palm of my hand, is red, swollen, sore to the touch, and extremely itchy.
This spontaneous report as received from a health care professional refers to a patient of unknown age and gender. On 15-MAY-2015, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K006960 (route not provided) which was under 63 hours excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
My son has problems with pressure in his chest and that fluttery feeling in his heart.  He was at practice last night and said he had no stamina maybe 1/10 of his usual and his heart was bugging him. It has been a week since his shot. It comes and goes.  He had COVID back in December.  I do not want to give him his 2nd shot if this is his reaction to the first one.  He said he felt worse then when he had COVID.  But the effects of his heart really worries me.
feeling bad; This is a spontaneous report from a contactable consumer. An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced feeling bad. The outcome of the event was unknown. It was reported that the patient ate early. The reporter was querying if it was normal for the patient to feel this way after the vaccine. The patient was not given paperwork about the vaccine and was advised to contact health care professional. The reporter was asking if the patient should go to the emergency.   Information about lot/batch number has been requested.
baseline tinnitus exacerbated following the 1st Covid vaccine; from low background noise to loud throbbing with heartbeat at rest to echo sound when I talk and so loud I am having trouble hearing.
PATIENT IS HAVING DIARRHEA TO LOOSE STOOLS WITH BLOOD. NOT INTUSSUSCEPTION.
PT DID NOT INDICATE THAT IT WAS HER SECOND DOSE ON THE FORM. THE FIRST DOSE WAS ON 8/22/2021  SECOND DOSE WAS GIVEN TOO EARLY ON 9/3/2021. PT WAS CALLED FOR FOLLOW UP. NO ANSWER
Chronic myeloid leukemia; weakness; Night sweats; Fever,temperature over 103 degrees,low fever; Dizzy; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC MYELOID LEUKAEMIA (Chronic myeloid leukemia) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced ASTHENIA (weakness), NIGHT SWEATS (Night sweats), PYREXIA (Fever,temperature over 103 degrees,low fever), DIZZINESS (Dizzy) and FATIGUE (Fatigue). On 10-Aug-2021, the patient experienced CHRONIC MYELOID LEUKAEMIA (Chronic myeloid leukemia) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, CHRONIC MYELOID LEUKAEMIA (Chronic myeloid leukemia), ASTHENIA (weakness), NIGHT SWEATS (Night sweats), PYREXIA (Fever,temperature over 103 degrees,low fever), DIZZINESS (Dizzy) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, Body temperature: 103 (High) 103 degrees. On 10-Aug-2021, Blood test: chronic myeloid leukemia. (abnormal) chronic myeloid leukemia..         The concomitant medications were not reported.  Limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.   This case was linked to MOD-2021-303146.; Sender's Comments: Limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.
Administered 0.2mL of Adult Pfizer COVID-19 formulation instead of 0.2mL of Pediatric. Pfizer COVID-19 formulation.
Patient was inadvertently administered the Moderna vaccine before the age of 18.  Patient and parent did not report any adverse effects following vaccination.
Information has been received from a physician concerning a 21 year old female who on 30 Oct 2006 was vaccinated with 0.5mL of Gardisil (Lot# 653736/0689F). On 30 Oct 2006, the patient developed a vasovagal reaction and passed out within one minute post vaccination. The patient was revived with an ammonia inhalant. No other symptoms were noted. Unspecified medical attention was sought. At the time of this report, the patient had recovered from the events (date unknown). Additional information has been requested.
No additional AE; Product administered to patient of inappropriate age; This spontaneous report as received from a health professional referring to a 7-year-old female patient. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.      On 19-AUG-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # T028583 that has been verified to be valid expiration date 04-MAR-2023, 0.5 milliliter for prophylaxis (frequency, strength, route of administration, were not reported) (product administered to patient of inappropriate age).  No adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: devicelotnumber: T028583; expirationdate: 04-MAR-2023; deviceage and unit: 0 ; operatorofdevice: Unknown; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
This spontaneous report was received from a mother refers to her daughter of unknown age. On an unknown date in AUG-2012 the patient was vaccinated with first dose of GARDASIL, (lot number, expiry date and route was not reported). On an unknown date in JAN-2013, the patient was vaccinated with second dose of GARDASIL, (lot number, expiry date and route was not reported). On 25-MAR-2013, the patient was vaccinated with third dose of GARDASIL, (lot number, expiry date and route was not reported). Concomitant medications were not reported. The mother stated that though her daughter had received all the 3 doses of GARDASIL, but not at scheduled time. No adverse reactions were reported. Additional information has been requested.
pt was administered 0.5 ml of Moderna booster in left deltoid. No adverse reactions or side effects noted during observation period or pt's exit.
Headache, myalgias staring within 6-7 hours post vaccine dose #2, lasting for almost 36-38 hours. Right upper arm soreness lasted for almost a day. Still have a large macular rash at the site of  injection.
Patient began experiencing fever. chills, headache, and chest tightness on 12/13, and presented to the ED  on 12/14 with worsening left-sided chest pain. Patient admitted to cardiology unit for acute myocarditis. Troponins are being monitored every 12 hours, and the patient is receiving a daily EKG. Upon discharge the patient will have an exercise restriction for 3-6 months.
Redness at the injection site. The redness faded after 45 minutes gradually. The patient also complained of tingling sensation of the throat but no swelling occurred. Approximately 3:45 pm BP 110/68 HR 86. BP 108/69 (10 min later).
This is a spontaneous report obtained from a non-contactable consumer. This adult female consumer reported for her currently 2-year-old son. The baby, that was born premature, received intramuscular PREVNAR 13, (Lot not provided) single dose, on an unspecified date. The mother stated that PREVNAR 13 was not effective on her son. She went on to explain that since he was born premature they needed to undergo tests to determine efficacy of all childhood vaccinations received. No follow up attempts possible. No further information expected.
This spontaneous report as received from a pharmacist who refers to herself, a female patient of unknown age. Information on the patient's pertinent medical history, concurrent conditions and drug allergies were not reported. On 29-OCT-2016 the patient was vaccinated with ZOSTAVAX. Concomitant medication were not reported. On 30-OCT-2016, 2 days after onset of therapy, the pharmacist reported she experienced that the injection site was red, warm and slightly painful. The pharmacist reported the redness was the size of a quarter at the injection site and spread to the size of a pear. The pharmacist reported that the redness, warmth and slight pain at the injection site had not resolved. There was no Product Quality Complaint (PQC) involved. No further information was provided. Additional information has been requested.
Patient devloped shingles (erythematous vesicular rash), seen by physician on 3/2/07. Shingles involved left T2 dermatome on back and upper arm. Note that shingles occurred 10 days after patient was started on Flonase 1 puff in each nostril daily.  Patient was treated with acyclovir and given pain medication. Advised parents no daycare/school until lesions crust over. To follow up in 1 week.
Pt had flu and pneumonia vaccines. Fell to one side, turned red, had trouble breathing, looked like he was going to vomit, went pale, then came to and was talking. Pt came to was oriented and talking. Medics arrived BP 104/80 BS 148 HR 71 100%.
Tiredness: started from 4pm 4/1;  sore at the injection site, fever about 100 F: started from 10pm 4/1 till 2pm 4/2; sore in lower back and finger joints: 4/2  No treatment.
Patient states still has open sore where received vaccine. Lost 35 lbs in the last two weeks.  Really emotional, always crying, can't thinking right.
myocarditis ... died April 24th 2021 - one month after 2nd dose.
Given wrong dose. Pt was given one dose of Pink cap w/ yellow border vaccine (10Micro g) and should have received one dose of the blue cap w/ gray border (25 micro g)