chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant concerning several unspecified number of patients of unknown age and gender. There was no information about the patients' medical history, concurrent conditions or concomitant therapies reported. Between 16-DEC-2016 and 12-JAN-2017, the patients were vaccinated with unspecified improperly stored doses in series of VAQTA lot number: L031196 with expiration date: 05-FEB-2017 (strenght, dosage schedule, anatomical location and route of administration were not provided), for prophylaxis. On 16-DEC-2016, the administered doses were exposed to a lowest temperature of 29.5°F for 1.5 hours (digital data logger) without any previous temperature excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA006679:
DIED; This spontaneous report received from a consumer via a company representative via social media concerned a 34 year old male of unspecified race and ethnic origin. 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 was not reported, and batch number: unknown expiry: unknown) dose, start therapy date were not reported, dose number in series was 1, 01 total administered  for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  It was reported that, "neighbor's grandson (patient) died on day 8". The patient died from an unknown cause of death on an unspecified date (dose number in series was 1). It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the event died was fatal. This report was serious (Death).; Sender's Comments: V0- 20211259188- covid-19 vaccine ad26.cov2.s -Died. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s); Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced vaccination site pain. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for PREVNAR 13 was immunisation. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The patient experienced vaccination site pain. The outcome for this event was not reported. No additional information was available at the time of this report.
SITE REACTION- ERYTHEMATOUS ANNULAR REACTION AT SITE (ONGOING) FLUSHING OF EARS AND FACE AND T MAX OF 99.0 FOR ABOUT 3 HOURS.
Adverse Event: Chronic Hives Treatment: Zyrtec, Benadryl, Anti Itch cream Outcome: TBD
Patient is a 95 y.o. female patient of MD with history of HTN, HLD, COPD presented to a local Hospital with SOB .   Acute hypoxic respiratory failure COVID-19 virus infection Tested positive: 12/13/2022 Fully vaccinated Oxygen requirements at baseline: Room air Current oxygen requirement: The patient initially had worsening of her respiratory status and required increasing levels of supplemental oxygen.  However this improved and the patient was weaned off of oxygen to room air. Treatment: Dexamethasone     COPD with exacerbation Chest x-ray and CT angiogram consistent with acute bronchitis Patient is improved noting improvement in her respiratory status. Continue azithromycin and guaifenesin. Continue nebulizer treatments as needed.   Essential hypertension Continue losartan   Hyperlipidemia Continue statin
After about 5-7 minutes of receiving the vaccine, I felt a sudden wave/rush of dizziness followed by seeing black in my eyes, tightness in my chest and tightness/closing up of my throat making it difficult to breathe.  I instantly felt like I was going to faint and also broke out in a sweat with my heart racing.
SINUS INFECTION/ PAINFUL NOSE/SINUS/ SEVERE HEADACHE/ COULD NOT TOUCH HER FACE/ SICK ALL WEEKEND; BLURRY VISION; PAINFUL TEETH; VERY LETHARGIC; NAUSEOUS; SWOLLEN LYMPH NODES/ SWOLLEN GLANDS BEHIND THE KNEES/ SWOLLEN THROAT GLANDS; NUMBNESS IN THE LEFT ARM/ FELT LIKE THE AREA WHERE SHE HAD THE INJECTION WAS MISSING; TINGLY LIPS AND FACE LIKE BUGS CRAWLING AROUND; BRUISE 6 IN BENEATH THE INJECTION SITE/ GRAVITY BRUISE; 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: dermal fillers, and concurrent conditions included: high blood pressure, allergy to sulfas, and reaction to vaccine in general, and other pre-existing medical conditions included: The patient was at a higher risk for blood clots. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 08-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-SEP-2021, the patient experienced bruise 6 in beneath the injection site/ gravity bruise. On 08-SEP-2021, the patient experienced numbness in the left arm/ felt like the area where she had the injection was missing. On 08-SEP-2021, the patient experienced tingly lips and face like bugs crawling around. On 09-SEP-2021, the patient experienced swollen lymph nodes/ swollen glands behind the knees/ swollen throat glands. On 10-SEP-2021, the patient experienced sinus infection/ painful nose/sinus/ severe headache/ could not touch her face/ sick all weekend. On 10-SEP-2021, the patient experienced blurry vision. On 10-SEP-2021, the patient experienced painful teeth. On 10-SEP-2021, the patient experienced very lethargic. On 10-SEP-2021, the patient experienced nauseous. On 16-SEP-2021, treatment medications included: ethambutol dihydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingly lips and face like bugs crawling around on 10-SEP-2021, had not recovered from sinus infection/ painful nose/sinus/ severe headache/ could not touch her face/ sick all weekend, and the outcome of numbness in the left arm/ felt like the area where she had the injection was missing, bruise 6 in beneath the injection site/ gravity bruise, swollen lymph nodes/ swollen glands behind the knees/ swollen throat glands, very lethargic, nauseous, painful teeth and blurry vision was not reported. This report was non-serious. This case, from the same reporter is linked to 20210933069.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non serious.
Pt recv vax on 9/30/98; post vax pt exp pain in LA & hard to move x 2wk
Developed a rash on my back and neck, raised, dry, patchy areas slightly raised. Of note, as a healthcare provider several other colleagues also noted a similar rash 7-10 days after  receiving booster MRNA vaccine.  This is a minor inconvenience but fascinating and worth sharing in the event others note a rash.
Child was accidentally vaccinated with Moderna when she was not 18 years old. Child and mother did tell clinic staff that she was underaged, but she was still vaccinated. Child returned to clinic on 4/20/21 with parent. Per CDC Adminstration Errors and Deviations,dated 3/17/2021. And consultation with Dr., child vaccinated with 2nd dose of Moderna as an off label usage since child is still 17 years old. Mother completed incident accident report for medication error and VAERS report  child left vaccine clinic w/o incident with her parent on 4/20/21
Typical tetanus shot ache reaction lasting  2 days, then fine. On day 8 symptoms returned with redness, swelling, heat and pain starting day 8. History of cellulitis in leg - looked to be the same symptoms. Initially treated on day 9 with antibiotics from UTC (diagnosis potential cellulitis). By day 12 redness continued to spread with pain, itching and heat. 2nd trip to UTC confirms adverse Moderna reaction. Continuing antibiotics along with KENALOG to treat dermatitis symptoms and told to watch for additional reactions.
I having pain in my right arm can't rise my arm over my head it hurt when I reach for things it pain when I get out of bed shoulder to elbow I have not worked in 5months; can't rise my arm over my head; Patient received DOSE 1 on 8Aug20211 and DOSE 2 on 24Aug2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 24Aug2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 08Aug2021, for COVID-19 immunization, reaction(s): "Pain in extremity". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 24Aug2021, outcome "unknown", described as "Patient received DOSE 1 on 8Aug20211 and DOSE 2 on 24Aug2021"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I having pain in my right arm can't rise my arm over my head it hurt when I reach for things it pain when I get out of bed shoulder to elbow I have not worked in 5months"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "can't rise my arm over my head". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient started that he had pain in right arm can't rise arm over head and it hurt when the patient reached for things it pain when the patient get out of bed shoulder to elbow, the patient had not worked in 5months so it's probably not job related one Doc gave a x-ray and a MRI he had changed his insurance policy   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : UM-PFIZER INC-PV202200051492 Same patient/event, different dose;
I have been having issues for years and it took a lot of money and after cysts rupturing I went to the ER. After speaking with other people my age who diagnosis I found the common denominator of GARDASIL. It is a painful and ongoing struggle that has cost thousands of dollars, time from work, and emotional trauma.
pt recvd vax OCT94 & w/in a few wks pt devel dysphagia which @ time of report 1MAY95 is still persisting;pt also exp lack of peristalsis in esophagus & presently has esophageal motility problems;
The pt experienced a fever one day post vax of 102.6, hives, irritability noted in the middle of the night. Tylenol brought fever down.
Had to go to the emergency room; Flu like symptoms; Elevated heart rate; Increased blood pressure; Light headed/dizziness; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Elevated heart rate), BLOOD PRESSURE INCREASED (Increased blood pressure), DIZZINESS (Light headed/dizziness), INFLUENZA LIKE ILLNESS (Flu like symptoms) and EMERGENCY CARE EXAMINATION (Had to go to the emergency room) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced HEART RATE INCREASED (Elevated heart rate), BLOOD PRESSURE INCREASED (Increased blood pressure) and DIZZINESS (Light headed/dizziness). On 04-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On an unknown date, the patient experienced EMERGENCY CARE EXAMINATION (Had to go to the emergency room). At the time of the report, HEART RATE INCREASED (Elevated heart rate), BLOOD PRESSURE INCREASED (Increased blood pressure) and DIZZINESS (Light headed/dizziness) had resolved and INFLUENZA LIKE ILLNESS (Flu like symptoms) and EMERGENCY CARE EXAMINATION (Had to go to the emergency room) outcome was unknown.
arm stiffness; itching; red circle approximately 2 inches in size right across the injection site; arm soreness; little redness on the site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (arm stiffness), VACCINATION SITE PRURITUS (itching), VACCINATION SITE PAIN (arm soreness), VACCINATION SITE ERYTHEMA (little redness on the site) and VACCINATION SITE ERYTHEMA (red circle approximately 2 inches in size right across the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     Concomitant products included CALCIUM CITRATE (CITRACAL [CALCIUM CITRATE]) for Calcium supplementation, ROSUVASTATIN for Cholesterol high, LEVOTHYROXINE for Thyroid disorder, MULTIVITAMINS [VITAMINS NOS] for Vitamin supplementation.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm soreness) and VACCINATION SITE ERYTHEMA (little redness on the site). On 23-Jan-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (arm stiffness), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (red circle approximately 2 inches in size right across the injection site). The patient was treated with PARAFFIN (VASELINE [PARAFFIN]) at a dose of 1 dosage form. On 18-Jan-2021, VACCINATION SITE PAIN (arm soreness) and VACCINATION SITE ERYTHEMA (little redness on the site) had resolved. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (arm stiffness), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (red circle approximately 2 inches in size right across the injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Significant Follow-up received on 02-Jul-2021: Outcome of events updated, and dose number reported.
Information has been received from a physician concerning a 6 month old patient who on 03-APR-2007 was vaccinated with a 2mL oral third dose of Rotateq. On 02-MAY-2007, two days after vaccination, the patient developed severe diarrhea and vomiting. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Red; Itches terribly; 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 VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE PRURITUS (Itches terribly) 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 22-Aug-2021, 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 SITE ERYTHEMA (Red) and VACCINATION SITE PRURITUS (Itches terribly). At the time of the report, VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE PRURITUS (Itches terribly) outcome was unknown.            No concomitant medications reported. No treatment information was reported by reporter   This case was linked to MOD-2021-298578 (Patient Link).   Reporter did not allow further contact
8/26/02 immediately post injection bruised appearance with red streak running down leg. 8/27/02 red and swollen and hot L upper leg by next am. Augmentin 1tsp bid.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 29-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
For the first dose, patient reports soreness in the arm for a few days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (For the first dose, patient reports soreness in the arm for a few days) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Joint pain (she experienced this problem 20 years old ago, the joint pain, but the pain went away when she reduced her salt intake).    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced PAIN IN EXTREMITY (For the first dose, patient reports soreness in the arm for a few days). At the time of the report, PAIN IN EXTREMITY (For the first dose, patient reports soreness in the arm for a few days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant and treatment information were reported by the reporter   This case was linked to MOD-2021-377022 (Patient Link).
Pfizer vial was diluted with 1.5ml of diluent instead of 1.8ml. A vaccine was taken from the table before all doses had been drawn up and one dose was administer before the adverse event was realized. No other doses were administered.  Patient was notified and the on-site provider consulted with the patient.  Patient stated she experienced no symptoms or issues other then the normal headache experienced by other patients who were vaccinated with a correctly diluted vaccine.
I contracted COVID-19; one month after the vaccine. I'm experiencing coughing, sneezing, and nasal congestion.  Sometimes I have a fever. I
stiffness in arm, vomit, nausea, high fever 102.5, diarrhea x 24hr, achiness, sweats, chills;
Immediate  mild soreness at injection sight. Tiredness within 8 hours. Overnight light fever. Next day injection site soreness is gone but moderate tiredness and shortness of breath. On 04/18/2021, still mildly tired, slightly dizzy and same moderate shortness of breath.  Difficulty talking without dry cough. Deep breaths trigger dry cough because of shortness of breath.
Information had been received on 22-MAY-2017 from a medical assistant who reported that a male patient (age unknown) received an expired dose of PROQUAD (lot# L044055, expiration 02-MAY-2017) on 19-MAY-2017. No adverse effects were reported. No further details provided. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown ages and genders. Concurrent conditions and medical history were not reported. The nurse reported that on an unknown date, the patients were vaccinated with a improperly stored dose of (Oka/Merck) VARIVAX (lot#L004655, exp. date 11-FEB-2017; Lot # K016132 exp. 24-SEP-2016 and Lot # K003422 exp. date 06-MAR-2015) (Strength, route and dose were not provided). Concomitant medications were not reported. No adverse effects were reported. Additional information has been requested.
rash on neck & upper chest;treated w/pred w/resolution,but reoccurred p/stopping steroid;flu shots in the past w/o problem;2FEB95 biopsy 24NOV94 mast consistent w/papular urticaria;
Patient experienced some pain the day of the injection in the afternoon, but she was more concerned about the 2 inch square very warm, red area that appeared below the injection site 2 days later on Monday and Tuesday (vaccine administered on Saturday). I spoke with her on Wednesday and she said she did not require any medication or treatment for the reaction and that it had started to fade a little bit on Wednesday.
Initial information received on 03-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 12 months old patient who received a 0.5 ml expired dose (fourth) of vaccine ACT-HIB (lot UI817AA) via unknown route in the left thigh on 03-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PROQUAD for Immunisation; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and HEPATITIS A VACCINE (HEPATITIS A) for Immunisation. It was a case of actual medication error due to expired vaccine used and inappropriate schedule of vaccine administered. It was not reported if patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Within 30-minutes of vaccination, the patient reported feeling nauseous. The patient was reportedly hypertensive. No EMS report was filed. The patient did proceed to Emergency Department for follow-up. In the ED, the patient was hypertensive (153/69) and stated they continued to be nauseous. The physician administered 4mg IV Odansetron and 1L IV saline. Labs were unremarkable. The patient reported feeling improved after treatment and was discharged with a diagnosis of Side effect of vaccination.
Pt reported only today that after her last vaccines (4) administered that day she developed severe hives over all her body
Systemic urticaria 2wks after immunization. Pruritic. No fever/chills/pulmonary/cardiac findings. Tx. with antihistamines.
Patient's appointment was already cancelled prior and message was left on patient's voicemail. We then proceeded to cross her name off the roster for the day. Patient came in anyway and nurse administering the shot did not see that the name was crossed off and did not check age, so shot was administered.
The day following her second shot, she developed severe mouth ulcers on her buccal mucosa and tongue.   On March 4 , predawn, she experienced a spontaneous splenic rupture.
This spontaneous report as received from a physician assistant via a company representative and refers to a male patient in his 80's. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On an unknown date, the patient was vaccinated with the first dose (reported as "once") of ZOSTAVAX "one shot", (route and site of administration, dose, strength, lot # and expiry date were not reported). On an unknown date, reported as "about one week" after administration of ZOSTAVAX, the patient experienced "shingles-like rash" on his shoulder and the top of his chest. The outcome of the event was unknown. The causality between the event and ZOSTAVAX was not reported. The patient sought medical attention by contacting the physician assistant. Additional information has been requested.