chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse and refers to a 5 year old patient of unknown gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On 01-AUG-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N013865 with expiry date 31-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
Pt recv vax on 3/11/99; on 3/12/99 pt exp rt leg swelling & red; tx=ice, Tylenol
Patient in waiting room following vaccination to wait 15 minutes as recommended. Under 5 minutes following vaccination according to mother, patient for 10 seconds unresponsive, blew bubbles from mouth, back arched and left arm and hand ?. Mother called nurse. Patient pale, non-responsive for approx. 5 min with glazed look. No prior seizure history according to mother.
Information has been received from a registered nurse referring to a patient of unknown age and gender. On 15-FEB-2016 the patient was vaccinated with an expired dose of VARIVAX (Merck) (dose and route unknown, lot #: K002043, expiry date: 10-FEB-2016). No adverse effects were reported. Additional information has been requested.
developed itchy red rash around elbows with swelling and the spreading to for arms, legs at this time, applied hydrocortisone cream 1% several imes a day, rrecieved 8 mg shot of predisone shot on 4-19-2021
fever; terrible aching; headache; nausea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Feb-2021 and was forwarded to Moderna on 25-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), MYALGIA (terrible aching), HEADACHE (headache) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-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 PYREXIA (fever), MYALGIA (terrible aching), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, PYREXIA (fever), MYALGIA (terrible aching), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. concomitant medication was not provided.
reports four PTs caught COVID after vaccine, they are symptomatic; reports four PTs caught COVID after vaccine; This is a spontaneous report from a contactable other health care professional. This other health care professional reported similar event for 4 patients. This is one of the 4 reports. A 67-year-old female patient received BNT162B2 (Batch/Lot number was not reported), via an unspecified route of administration in Jan2021 as dose number unknown, single for COVID-19 immunisation. The patient's medical history and the concomitant medications were not reported. It was reported that, four people who were vaccinated in January and had already COVID in 2021. The reporter did not think the patients were associating to it at the hospital, but they were symptomatic. The outcome was unknown for the reported event.  Causality: Not reported  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of LOE (Drug ineffective,Covid-19),Linked Report(s) : US-PFIZER INC-202101392304 different patient, same event and dose;US-PFIZER INC-202101392297 different patient, same event and dose;US-PFIZER INC-202101392305 different patient, same event and dose
Patient noted several lesions on his toes consistent with pernio about 10 days after first vaccine administration. Lesions have remained. Patient received second vaccination 01/07/2021 to complete the series. Patient notes additional pernio lesions within 1-2 days of second vaccine.
Patient presented to Ed with rhythmic movements concerning for seizure. Seizure was witnessed by providers. Given versed, fosphenytoin. Lumbar puncture done and started on antibiotics. Placed on EEG.
Pt recvd a series of 3 Engerix-B vax given 28JUN90, 01AUG90, 28DEC90; Pt tested 28MAR91 & found to lack antibody development;
Greater than usual swelling/redness.  Administered in Left deltoid.  Erythema and edema extends from left shoulder down to left elbow.  Appearance similar to a cellulitis.
Started with fever approximately 2:00 am April 6th.  Also sinus nasal drip and slight pressure in chest when taking deep breaths.  These subsided when I took Tylenol.  Very tired and achy joints.  Covid Arm angry red rash painful and itchy extending beyond injection site and down arm. April 7th - slight temperature not as bad.  the temperature nasal drip and slight pressure in the chest come back when the Tylenol wears off.  Not as tired and joints not so achy.  covid arm rash is worse.
FEELING ABNORMAL; DRY MOUTH; DRY LIPS; FATIGUE; This spontaneous report received from a consumer via Regulatory Authority concerned a 73 year old male. The patient's height, and weight were not reported. The patient's past medical history included surgery, knee replacement, and back surgery, and concurrent conditions included type 2 diabetes mellitus, aortic aneurysm, alcohol use, cigar smoker, and high cholesterol. The patient had no known allergies. On an unspecified date in 2019, the patient underwent coronary stent placement. The patient was also prescribed with overdose and experienced product odor abnormal. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown) dose was not reported, 1 total administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included pantoprazole for acid reflux (esophageal), lisinopril for blood pressure high, pancreatin for gastrointestinal disorder therapy, allopurinol for gout, acetylsalicylic acid for heart disorder, propranolol for heart disorder, evolocumab for high cholesterol, alprazolam for panic attack, clonazepam for panic attack, and post-traumatic stress disorder, topiramate for post-traumatic stress disorder, alogliptin for type 2 diabetes mellitus, glipizide for type 2 diabetes mellitus, and metformin for type 2 diabetes mellitus. On FEB-2021, Laboratory data included: Triglycerides (NR: not provided) 240 (Unspecified unit).  On 06-MAR-2021 after vaccination, the patient felt abnormal and had dry mouth and dry lips. The patient also experienced fatigue. Laboratory data (dates unspecified) included: Triglycerides (NR: not provided) Baseline 1000. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, feeling abnormal, dry mouth and dry lips was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 - 20210447135-covid-19 vaccine ad26.cov2.s -Feeling abnormal, Dry mouth, Dry lips. 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). 20210447135-covid-19 vaccine ad26.cov2.s -Fatigue. This event(s) is labeled per RSI and is therefore considered potentially related.
12 year old male during observation of second dose Pfizer complains of double vision and denies any other symptoms including SOB, chest pain, palpitations, or difficulty breathing. Mother onsite denies any medical history of allergies. Vital signs taken BP 126/78, HR 120, R 17, Pulse Ox 98%. Patient states only had one glass of water and had field day at school and admitted to feeling exhausted. Patient was given water and observed for 15 minutes, Vital signs take BP 124/91, HR 120, R 17 Pulse Ox 98% and states has "floaties" in vision. EMS called for no improvement of vision changes and elevated resting heart rate. Patient left site via EMS
approx 40 pts exp burning upon inject w/the 1st dose of Engerix-B; No further details are available;
Patient experienced vasovagal syncope; he lost consciousness, had excessive sweating and started seizing on the floor approximately 3-5 minutes after receiving the vaccines. Patient was then given water and crackers and had his blood pressure taken every 15 minutes. After he slowly recovered, he regained consciousness and contacted his friend to pick him up. His blood pressure was still low, around 100/70 mmHg an hour later of the incident.
Began to have chills, fatigue, sore throat and low grade fever at 0130 1/20.
12 hours after vaccine, started to have eye flashers in right eye, next day flashers went away, and floaters began to form as well as a 'gray screen' - screen lasted about a day.  Following day, screen had gone away and floaters remained and still remain today.
sick for three months; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 03-Dec-2020.  This case is linked to case 2020SA350308 (same reporter).  This case involves a patient of an unknown demographics who was sick for three months (illness), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, past vaccinations, family history and concomitant medications were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was  sick for three months (illness), (unknown latency) following the shot of INFLUENZA VACCINE.   No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Onset of difficult breathing, itchy tongue, confusion, generalized paresthesias, voice changes, and coughing within 1 hour of receiving vaccine for influenza   Treated with epinephrine with improvement Also received dexamethasone and diphenhydramine   Take famotidine and loratadine at home
recipient was a covid survivor.  Adverse side effects included fever, chills, joint pain, extreme headache, nausea and fatigue
Pt presented on 12/18/21 for vaccine clinic. Pt scheduled for his booster dose of Moderna vaccine. Pt stated he did not have his vaccine card. Patient did not state he had received a previous booster dose of COVID vaccine and presented as if he was receiving his first/only booster dose on this day. Patient was asked all appropriate questions and was vaccinated with Moderna 0.25mL booster dose. Patient had new vaccine card made by RN during the time patient was being vaccinated by reporting RN. Upon searching, RN noted that patient had already had one dose Janssen 4/9/21 and Moderna booster 10/22/21. RN approached patient to discuss the fact that he had already had a booster and he stated to her "Yes I meant to do that", implying he had intentionally gone against CDC guidelines and engaged in a deceptive practice.
Vaccine received approximately 11:10 a.m. 5/6/21. Fatigue, nausea, headache, mild fever began approximately 1:30 p.m. 5/6/21 and continue to persist throughout the next day after vaccination
Actual event and cause of death were unknown; This is a spontaneous report from a non-contactable consumer. A 90-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at single dose for COVID Prevention. The relevant medical history included aortic valve replacement from Nov2019. Concomitant medications were not reported. The consumer stated that she was taking the reporting responsibilities to report that a friend of hers, informed that the patient passed away on Friday, and had received the COVID vaccine on Wednesday. The consumer stated that it was unknown to her at this time, if the friend had called to complete a report herself, regarding the incident. Their conversation was very brief. The patient was 90 years old, and it was her friend's mother that was the patient. Actual event and cause of death were unknown. The patient had her vaccine on Wednesday 06Jan2021, and then the patient collapsed in front of the reporter at Friday night on 08Jan2021 and passed away that same day. The autopsy was unknown. The outcome of the event was fatal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Actual event and cause of death were unknown
Child developed fever of 103+ within 24 hours of vaccine administration.  No other symptoms occurred.
pt recvd vax 13OCT95 & no immed untoward events until 24OCT95-devel macular, well delineated rash on extremities, next day progressed to chest abd, upper back & then face; no lesions on mucosal surface;PE well delineted macular, urticarial
Headaches and stiff neck for 2 weeks and blocked oil glands in right eye.
During 15 minutes waiting period after second immunization, patient experienced metallic taste in their mouth. Metallic taste lasted during the entire monitoring period.
pt recvd vax; chest x-ray were positive for pneumonia;tx in hsp w/ IV ATB's;
headache, racing heart, very weak and tried, chills, hot flashes,  stomach pain and cramps, nausea, fever , body pain .
Sore arm; Body ache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MYALGIA (Body ache) and PYREXIA (Fever) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), MYALGIA (Body ache) and PYREXIA (Fever). The patient was treated with IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), MYALGIA (Body ache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Patient experienced severe abdominal pain and ended up in the ER on 6/14/13 where she had testing that showed she had a large ovarian cyst on her right ovary.  She ended up having surgery on 8/22/2013 where they had to remove her ovary.
Pt t103.6 4-6 hrs following vax; temp remained elevated >100 - 103 on 7MAY92; screaming episode on 6MAY92; vomited milk on 7MAY92;
Information has been received from a physician concerning a 6 year old female with no medical history who was vaccinated with a dose of Varivax.  There was no concomitant medication. Subsequently the pt experienced breakthrough varicella. She had less than 50 pox and a low grade fever. She was treated with 5 days of Valtrex therapy, no laboratory tests were done and she recovered. The pt's experienced was considered an other important medical event (OMIC). Additional information has been requested. Additional information has been received from personnel of the physician's office stating that they do not know the identity of the patient. No further information is available.
Patient came in for their second COVID vaccination. He was administered Pfizer for the second dose, but received Moderna for his first. Attending healthcare professional and patient notified about the event. Plan to follow-up as needed.
States that he got the J&J COVID vaccine Thursday 4/8/21 States that he had immediate muscle pain right away and a cough right away Upper chest is painful and he is having trouble breathing Chest pain has started yesterday- reports the pain has gotten worse States that he exercises every day and ran this AM States that today the chest pain has gotten worse and his breathing has gotten worse as well States that he works around chemicals in a woodworking shop but doesn't think that this is the cause of his chest pain Chest pain is located at the top of his sternum  States that he feels queasy and unwell over all  Advised that with current symptoms that he needs to be evaluated urgently and advised calling 911 if he did not have someone to bring him in. Patient refuses 911 but agrees to be seen in the ER. Will go to his closest ER now.
Patient had fever from 101.7 to 102.5 one week after recieving MMR shot, Fever was kept down by Ibuprofen and cold baths. Patient never had a reaction before recieving this vaccine.
arm has some redness; arm is a little sore/arm kind of hurts/it's still pretty sore; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm has some redness) and PAIN IN EXTREMITY (arm is a little sore/arm kind of hurts/it's still pretty sore) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065FZ114, 007B21A and 002B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced ERYTHEMA (arm has some redness) and PAIN IN EXTREMITY (arm is a little sore/arm kind of hurts/it's still pretty sore). At the time of the report, ERYTHEMA (arm has some redness) outcome was unknown and PAIN IN EXTREMITY (arm is a little sore/arm kind of hurts/it's still pretty sore) had not resolved.            No concomitant drug details were reported. No treatment details were reported.
fever; headache; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced fever and headache. On an unknown date, the outcome of the fever and headache were recovered/resolved.   It was unknown if the reporter considered the fever and headache to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient suffered from headache and fever for 3 days. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020220508:same reporter
Vaccine administered beyond use date; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030h21b) for COVID-19 prophylaxis.     It was unknown if patient ever been diagnosed with or tested positive for COVID-19. It was unknown if patient had acute illnesses at the time of vaccination and up to one month before. unknown if patient had Chronic or long-standing health conditions.     On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patients age was reported as 40 years 7 months.  Prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at the time of vaccination and/or at the time of adverse event was unknown.  On 10-Jun-2022, the vaccination facility was notified of an audit that was done and it was informed that vaccines were administered beyond use date after the thaw process.  There was no patient that had any adverse reactions and no reports of any reactions after the administration of these vaccines. The patient got Moderna vaccine with NDC code: 80777-0273-99.  It was unknown whether the patient was ever diagnosed/tested positive for COVID-19.  It was unknown whether the patient had any acute illness at the time of vaccination and up to one month before it. It was unknown whether the patient had any chronic or long-standing health conditions.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-542869 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-542869.
Suspected COVID-19 virus infection, Cough, Exposure to COVID-19 virus  Chills  ? Fever  ? loss of taste
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 026C21A) for COVID-19 vaccination.     Concomitant products included TRIAMCINOLONE ACETONIDE from 25-Oct-2021 to an unknown date, MUPIROCIN from 25-Oct-2021 to an unknown date and IBUPROFEN from 25-Oct-2021 to 25-Oct-2021 for an unknown indication.   On 25-Oct-2021 at 4:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Nov-2021 at 10:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Nov-2021 at 10:15 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 27-Nov-2021 at 10:15 PM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No medical history information was reported. The patient got administered  a 2nd dose from a different vial with the same lot number on 27 Nov 2021. The Moderna vial was moved from freezer to refrigerator on 27 Nov 2021, the same day the dose was administered.  No treatment medication was provided.   This case was linked to MOD-2021-413201 (Patient Link).