chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 11-May-2022; patient administered expired moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient administered expired moderna vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 11-May-2022) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 038B21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient administered expired moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 11-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient administered expired moderna vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 11-May-2022) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial did not undergo any temperature excursions.  No other adverse reaction were reported.   No treatment medications were reported.
lmproperly stored, administered vaccine; No symptoms or additional adverse effects reported; This spontaneous report was received from a licensed nurse practitioner and refers to a 4-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided. Concomitant therapies included properly stored sterile diluent. On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S031704 has been verified to be a valid lot number, expiration date: 06-APR-2021 (formulation, strength, dose, frequency, route of administration were not reported) for prophylaxis. Albumin status for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) has been verified as recombinant human albumin (rHA). Administered dose of vaccine experienced the temperature excursion of 67 degrees Fahrenheit for 17 hours. Data logger was involved. There were no previous excursions reported. No symptoms or additional adverse effects reported. Action taken with the suspect therapy and the outcome of the adverse event was not provided.
THE  AREA WAS ROUND (2 INCH BY 3 INCHES) RED AND RAISED EVENLY. THE PATIENT EXPLAINED HAVING MILD ITCHINESS.
This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age. The reproter reported that an unknown number of doses of PROQUAD (Merck) (lot# unspecified), which underwent temperatures outside the prescribing information (PI) and were supported, had been administered (dose, route unspecified). No adverse effects reported. The outcome of the event was unknown. This is one of two reports from the same reproter. The other report is 1404USA014365. Additional information has been requested.
Anaphylactoid rxn reported in pt receiving Fluogen pt devel chest tightness, dyspnea, chest pain, hoarseness & became cold & clammy; 3 other cases w/similar rxn used same box of syringes;
sl warm (mom  had no thermometer); red raised area @ inject site about 1 1/2 in diameter; pt crying screaming inconsolably x 30 mins given APAP;
Above the wrist, my arm is like reddish and it is hurts to the touch; Above the wrist, my arm is like reddish and it is hurts to the touch/Ache in the right arm above the wrist; I was really exhausted so I slept; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 81-years-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 25Feb2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization (81 year when vaccinated). The patient medical history and concomitant medications were not reported. On 27Feb2021, the patient reported that post 2 days of vaccination the patient felt really exhausted so she slept. On 02Mar2021, the patient reported that her right arm was like reddish and it hurt to the touch. The patient took aspirin to treat the events, also the patient had enough medicines for other stuff. The outcome of the event was reported as recovering, while for the events her right arm was like reddish and it hurt to the touch was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained.
pain in arm pit; swelling; This is a spontaneous report from a Pfizer-sponsored program via contactable consumer (patient).  A female patient of an unspecified age received first dose of BNT162B2 (PFIZ-ER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had 1st dose of covid vaccine Monday and on an unspecified date having side effects not going away, such as pain in arm pit and swelling. The patient was wondering what she could do for side effects and will they go away. Outcome of the events was not recovered.  No follow-up attempts are possible; Information about lot/batch cannot be obtained.
No further AE; temperature excursion; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 02-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # R025726, expiration date: 26-MAY-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursions of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. 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: R025726; expirationdate: 26-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Onset 1 day post vaccines of erythematous papules and vesicles on trunk.
7AUG recv vax & exp pain, erythema, induration of lt deltoid area;returned to clinic on 9JUL95 dx cellulitis lt deltoid w/2.5cm fluctuance;placed on Dicloxicillin;11AUG95 cellulitis resolving
THE PATIENT WAS GIVEN A SHOT OF THE J&J COVID VACCINE. AFTERWARDS HE WAS ADVISED TO SIT AND WAIT FOR ROUGHLY 15 MINUTES JUST TO MAKE SURE THAT HE DID NOT HAVE AN ALLERGIC REACTION TO THE VACCINATION. HE WENT OUT TO HIS VEHICLE AND GRABBED A BOTTLE OF WATER THEN CAME BACK INSIDE WHERE HE PASSED OUT BY THE GREETING CARD SECTION. THE FRONT END MANAGER GRABBED HIM A CHAIR, SAT HIM UP AND INFORMED ME ABOUT WHAT WAS GOING ON. WE OBSERVED HIM FOR SEVERAL MINUTES WHILE HE DRANK SOME WATER AND SAID THAT HE FELT BETTER. FRONT END MANAGER BEGUN ENTERING A REPORT. I INFORMED THE PATIENT TO SIT A LITTLE WHILE AND CONTINUE DRINKING WATER AND TO LET ME OR FRONT END MANAGER KNOW IMMEDIATELY IF HE STARTED FEELING WORSE AGAIN. HE SAT FOR A FEW MORE MINUTES UNTIL HE FELT BETTER AND THEN LEFT. THE PATIENT DID NOT HIT HIS HEAD BUT DID SUSTAIN SOME ABRASIONS TO THE LEFT LOWER ARM AND STRUCK HIS HIP WHEN HE FELL.
EXPIRED PRODUCT ADMINISTERED; This spontaneous report received from a health care professional concerned multiple patients. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced expired product administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired product administered was not reported. This report was non-serious.
At 11:25am the child stated that she felt dizzy and hot. Public Health Nurse  had child lay down on a patient table inside the room. Her head propped and ice pack to child's back part of neck and given water. Child stated she had not had lunch yet but did have breakfast. Child escorted to the nurse's office to continue lay down and to call mom at 11:38am. The child felt better and was able to return to class.
Swelling and pain at injection site. Pt given cephalexin at urgent care clinic d/t suspected cellulitis.
crying inconsolably for >3hr p/9AM shot;seen in office again @3PM for crying;
Throat swelling; Face swelling; Flush Face; headache; fast heart beat; difficult breathing; chills; This is a spontaneous report from a contactable other healthcare professional (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) first dose and second dose both via an unspecified route of administration on an unknown date in right arm as single dose for COVID-19 immunization at Hospital. The patient had no medical history. He had no known allergies. The concomitant medications within 2 weeks of vaccination of the patient included tramadol and losartan. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine and if patient was diagnosed with COVID-19 prior to vaccination. On 08Apr2021 at 12:00 PM the patient experienced throat swelling, face swelling, flush face, headache, fast heartbeat, difficult breathing and chills. It was mentioned that 8 weeks after 2nd shot patient still had these side effects at night-time. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The seriousness for all the events was accessed as hospitalization. No treatment was received for the events. The patient underwent lab tests and procedures which included Nasal Swab: negative on 05May2021. The outcome of all the events was not recovered.  Follow up attempts were needed. Further information has been requested.; Sender's Comments: for serious hcp unlisted events  Based on temporal association, the causal relationship between BNT162B2 and the events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate
Large reddened swollen knot at injection site associated with a temperature of 103 degrees. Keeps spreading and worsening.
For Dose 1, no adverse events other than mild light-headedness and mild joint ache, which began approximately 2 hours after injection and resolved within 24 hours; soreness at the injection site began approximately 6 to 12 hours after injection and persisted for 48 to 72 hours. For Dose 2 (1:15pm), soreness at the injection site began approximately 2 hours after injection (3pm) and was more pronounced than Dose 1. I felt onset of mild fatigue beginning approximately 3 hours post-injection (4pm). Approximately 10 hours post-injection (11pm), onset of fever, chills, muscle ache, and joint ache, was dramatic. I was unable to record my temperature, but felt the fever diminish in intensity approximately 13 hours post-injection (2am). It persisted from this time as muscle aches, joint aches, and sweating intensified throughout the night, and the onset of heart arrhythmia and mild tightness in the chest, as well as a light cough and trouble breathing became a concern. I was unable to sleep and took Tylenol approximately 15 hours post-injection (4am). I took more Tylenol in the morning at approximately 9am, by which time the fever still felt present but low-grade, the muscle and joint aches were still fairly intense, and I noticed that my axillary lymph nodes had swollen to the size of golf balls, with the larger on the same side as the injection. I then took ibuprofen around 1pm. Very mild fever, moderate sweating, cough, muscle aches, joint aches, and heart arrhythmia persisted throughout the day and into the night. All symptoms had not resolved until Friday, Day 3 post-injection.
Patient had requested Moderna COVID-19 vaccine Booster 2 and I inadvertently administered Pfizer COVID-19 vaccine Booster 2.
Pt recv vax on 11/9/98; on 12/8/98 pt mother dx=mumps
Pain  through out entire body on most of the day after injections. On the second day, felt dizzy and fainted two times rested most of the remainder of the day. On the third day was dizzy and unstable and nauseated and threw up and feeling weak most of the day.  No treatment as of yet just resting.
Pt complained of pain at injection site. She also felt a lump and sore to the touch.
Office drew up all vaccines from vial at the beginning of the day and discarded vial. They put the bivalent NDC, lot and expiration on a sticky note and entered all data into the medical record from that sticky note. After a few weeks they realized that some days they had pulled monovalent vial and administered instead of bivalent booster as intended. It is impossible to discern which patient received which vaccine.
shallow breathing shakiness fever 102.8 flushed face given Tylenol v.s. checked
Onset of ringing to R ear 30min post vaccination.  Developing into tinnitus R ear, dizziness with motion over next 24 hrs.  Significant hearing deficient on 2/12 on R ear.  PCP seen on 2/15, identified normal auditory exam, high dose predisone started.  ENT/Audiologist scheduled 2/16 - diagnosed neuro hearing loss to R ear, not related to covid virus or etiology with normal eardrum mechanics, recommended continue steroid taper x3 weeks.  Next audiology appt 3/9 for re-eval.  Unknown disability or permanent damage at this time.
This spontaneous report was received from a physician via company representative referring to patient of unknown age and gender. The patient's medical history, drugs reactions or allergies, concurrent conditions and concomitant therapies were not reported. On 19-APr-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB. "10 PK 0.5 mcg/0.5ml SDLLolCap Ped" and lot number L023387 with expiration date of 22-JUN-2017 (route and anatomical location of administration were not reported). The vaccine had two temperature excursions one of 16 hours with a lowest recorded temperature of 49 Fahrenheit (F) (9.444444444 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
Information has been received from a female patient concerning herself who on an unspecified date ("many years ago") was vaccinated with a dose of MERUVAX II (lot# not reported) when she was 28 years old and the patient developed joint pain and swelling in the 3 fingers on her right hand. Unspecified medical attention was sought via visiting the physician. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
dermatographia and idiopathic urticaria developed about  3 weeks after Moderna booster. Taking one Zyrtec /day to control symptoms. Advised to up dosage to 4/day if necessary. Will be getting bloodwork. Will see allergist again if symptoms persist after another two weeks.
Racing heart and shortness of breath for days. I normally have stellar heart rate, blood pressure, etc. I'm fit, eat low-carb, lift weights. I don't drink alcohol. Don't smoke. Take magnesium, vitamin D, K2, and krill oil. Have changed nothing about my diet or behavior. Only different thing is the vaccine I got.   I'm grateful to get it and will get shot #2. I think it's unlikely I will die of the heart/breathing issues, since I'm healthy. Hoping they'll pass soon. Can't afford to go to doctor and get heart tests. Previous affordable care was ruined.
administered an pediatric dose of Havrix to a 20 year old patient; administered an pediatric dose of Havrix to a 20 year old patient; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 19-year-old female patient who received HAV (Havrix pediatric) (batch number K5FA5, expiry date 12th June 2021) for prophylaxis.   On 20th May 2021, the patient received Havrix pediatric. On 20th May 2021, unknown after receiving Havrix pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional information was provided as follows: The patient received vaccination in left deltoid region. The reporter called to inform that a pediatric dose of Havrix was administered to an adult which led to underdose and adult use of a child product. The reporter did not consent to follow up.
Papular vesicular lesions with blisters on face, torso, lower legs and ankles.  TX- Vancomycin, Benadryl, EPIPEN, Zantac, Lovenox, Hydroxyzine, Doxepin, Calamine, Refresh Celluvisc *GREEN*, Tylenol, Motrin, Eucerin.  2/18/09 Received medical records from reporter for 10/10-10/23/2008. FINAL DX: pustular exanthem & nonviral bullous pustulosis following smallpox vaccination; immune mediated reaction to smallpox vaccine. Records reveal patient experienced raised pruitic rash all over on 10/9/08.  Exam revealed papular vesicular lesions w/blisters on face, torso, LEs.  Derm eval.  Tx w/Vancomycin.  Improved, lesions crusted over & d/c back to station.
Discharge Provider: MD Primary Care Provider: MD Admission Date: 6/23/2022 Discharge Date: Jun 27, 2022  PRESENTING PROBLEM: Acute respiratory failure due to COVID-19 (HCC) [U07.1, J96.00]   HOSPITAL COURSE: Pt. is a 71 year old male with PMH of HTN, BPH, neuropathy, and familiar tremor. Pt. presented to the ED with SOB and found to have COVID pneumonia. He was mildly hypoxic and admitted to the hospital. Dexamethasone and remdesivir were given throughout his stay. Patient is fully vaccinated with booster. Initially required two liters of supplemental O2 and was weaned down to room air. COVID inflammatory markers were initially elevated and also improved throughout his stay. He was initially generally weak and fatigued, which improved. PT.OT recommended home PT. He will continue a total of ten days of oral steroids and follow up with his PCP. Patient is discharging in improved and stable condition.
Patient reports of vaccination site to be higher on his arm than last time. Reports pain in left arm and difficulty lifting hisarm
Patient received his vaccine in his right deltoid muscle.  The following day, time unspecified, he gradually felt that his left leg went to sleep.  He lost motor control of his leg and had to assist move it with his hands for 24-36 hours.  It gradually improved, but did not go back to normal motor and sensation for almost 3 days per the patient.  He was seen on the 21st and had complete resolution of his symptoms by that time.  He was seen again on 01/28 and remains asymptomatic.
This spontaneous report was received from a physician and a healthcare student, who is also the patient's mother, concerning a 17 year old female patient, with no pertinent medical history or drug reaction/allergies. On 16-JUN-2014, the patient was vaccinated with the first dose of GARDASIL (lot number, expiration date, frequency, strength and route were jot reported). Concomitant therapy includes an unspecified birth control pills. Healthcare student reported that patient received GARDASIL injection and experienced pain, bleeding and a significant quantity of the GARDASIL ran done the patient's arm, on 17-JUN-2014. Healthcare student was concerned that patient did not received full dose of GARDASIL. Bleeding stopped and pain resolved after use of ice pack at the injection site. The physician stated that the date on which the patient received her first dose of GARDASIL was 16-JUN-2014. The physician does not believe that "more than a drop" of the dose leaked out of the patient's injection site. At the time of the report the outcome was unknown. The patient seek medical attention at the physician's office. Patient received an ice pack to injection site as treatment. Additional information has been requested.
patient reported on 10/17 her arm is still red.   It was red and swollen.  Swelling down but still red.  Pt will be following up with her doctor on her next visit in november.
Loose very foul smelling stool.; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient). A 74-years-old male patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 02Aug2021 14:00 (at the age of 74-years-old) as dose number unknown, single for COVID-19 immunisation. Medical history included none. The patient concomitant medications were not reported. Patient had no known allergies. Patient received vaccine facility in pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. The patient experienced loose very foul smelling stool. on 07Aug2021. Treatment was received for the event as pepto bismol per label. The outcome of the event was reported as recovering.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Patient with coughing and vomiting starting on 4/10/2021.  Patient presents to ER for symptoms and found with elevated BUN/creat.  During hospitalization he was dx with C-ANCA vasculitis.  Patient with worsening symptoms leading to stroke and need for dialysis.
Approx 10-14 days after vaccination, patient developed 10 "pox" lesions on face, torso, and legs. He was not seen by a physician for evaluation of rash. Reaction was reported to me at 15 month checkup.
Patient had a seizure two hours after recieving the vaccine.  She had no history of seizures and she did not have a fever at the time