chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative:  Pt received first Moderna COVID vaccine 3/21/21 through the clinic. Clinic was notified on 4/15 that the patient had passed away at home on 4/7/21 - this death has not been verified and additional details of death have not been provided. Was pt previously covid positive? No Are there any predisposing factors (i.e. PMH, HPI, allergy history etc) for patient experiencing adverse drug event? Yes - chronic comorbidities placing at an increased risk of death Any occurrence of an ADR at time of administration or during time of observation? No Did patient recover from event? N/A, died Was there an ADR between observation period and date of death? No Was patient hospitalized prior to vaccination? No Was patient hospitalized between vaccination and date of death? No Was patient hospitalized prior to death No What are the possible cause of death? unclear, passed at home with no further details.
Itchy rash developing at site of injection.  Some swelling.  2 inch diameter.
After the vaccination mostly exhaustion, chills, and fever for a day. It went away after a couple of days.
On the day following receiving the first vaccine, January 20, 2021 at 2:30 in the afternoon, Patient's legs and feet became paralyzed and he was unable to walk requiring a wheel chair.  His doctor was called and after determining he did not have another stroke, it was suggested to rest and wait for 24 hours.  By 8 AM the following morning, January 21, 2021.  The very same sequence of events occurred after his second dose on February 16, 2021.
Employee felt flushed within 2 min of vaccine administration.  Heart rate varied 56-68  Employee was observed and offered fluids and pretzels. 12:40-  Bp 138/65, HR 62 100 %  o2 sat.  14:00 156/80 68 100% on RA   Lungs CTABL rrr no murmer.  Employee was discharged to home.   1/15 Called employee for follow up and employee  reported that she experienced intermittent chest pressure  x approx 2 days at home and elevated BP which resolved on 1/1/21    had taken losartan 25 in the morning, thend again after COVID vaccine and again before bed.  Employee was referred to contact PMD to assist in determining if secondary dose is okay to receive or if she will need cardiac eval.  Employeee was referred to Oc health clinic, examined and discharged with recommendation to double losartan before next vaccine and talk to PMD before second dose of covid vaccine.  Employee was also provided with the PFIZER number to report this to Pfizer.
On the 12th I started feeling a generalized itchiness around 4PM. Arrived home around 7PM and my arm was looking a little bit red probably about 2 or 2 1/2 cm below the injection site was getting red probably about a quarter size at that point.  The next morning the area started getting a little bit larger and not only with itchiness but also elevated as well. It just kept getting larger and larger and by the time I would say on January 13th, the area got about the size of a baseball. On January 14th it was size of 2 baseballs, not going toward my shoulder but more towards my elbow. It was about 3 mm away from the injection site (pretty much from the elbow until 3 mm to the injection site). I went to see my PCP, he was not available and saw the PA. On the 15th it still got a little larger. Not much but a little larger. Prescribed prednisone on the 14th the day I was seen. On Saturday the 16th the area started to shrink. It took about 10 days for it to be completed gone. My skin was discolored for about 33 days in the area.
MIGRAINES- medication; MRI of brain; massages; acupuncture  ANXIETY- antidepressants, behavioral therapy INSOMNIA-  a second antidepressant
Fever; Ache; under arm ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 58 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Nov2021 23:15 (Lot number: F63527) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8734, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 03Apr2021, when the patient was 58 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN4204, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 13Mar2021, when the patient was 58 years old, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 06Nov2021 23:00, outcome "recovered" (Nov2021), described as "Fever"; PAIN (non-serious) with onset 06Nov2021 23:00, outcome "recovered" (Nov2021), described as "Ache"; AXILLARY PAIN (non-serious) with onset 06Nov2021 23:00, outcome "recovered" (Nov2021), described as "under arm ache". Therapeutic measures were taken as a result of pyrexia, pain, axillary pain.  Additional information: No other medications received in two weeks. No other vaccine received in four weeks. Fever, ache, and under arm ache started after 10h following booster. Treatment received for events was advil. No covid present prior vaccination. Covid was not tested post vaccination. No known allergies. No other medical history was present. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a male with hepatic function abnormality (elevated liver function tests before his needle stick) and a history of needle stick in approximately July 1998. Subsequently, the patient was vaccinated prophylactically with one dose of hepatitis b vaccine recombinant (yeast) and hepatitis b immunoglobulin. In approximately November 1998, 4-5 months later, the patient was placed on zidovudine for prophylaxis (dosage, route, and duration not provided). The physician reported that since July 1998, the patient had developed angioedema and urticaria that had lasted 3 years. It was indicated that the patient had sought medical attention. No further information was provided. Additional information has been requested.
FLUZONE QUADRIVALENT given to a 67 year old instead of FLUZONE HIGH-DOSE QUADRIVALENT, no AE; Initial information received on 10-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 67 years old patient (unknown gender) who was vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]  (lot number and expiration date were not reported) (PT:Wrong product administered) as prophylactic vaccination on an unknown date.   Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   It was an actual medication error case due to wrong vaccine administered.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.  There will be no information on the batch number for this case.
About 5 minutes after getting the vaccine, the patient reported to me that she was seeing bright lights in the room, or the room was really bright, she had a metallic taste in her mouth, and also reported feeling jittery.  I had her sit for observation for about 30 minutes or more.  She wasn't having any type of swelling of the face, lips, or throat, or any trouble breathing. After observation she did leave the pharmacy area, but said the lights were still bright and she was feeling jittery.
This spontaneous report was received from a 31-year-old female patient who was reporting on herself. The patient pertinent medical history included asthma and unspecified hear problems. The patient had a drug reaction to DEMEROL and allergy to latex. No information regarding the patient's concomitant medication was provided. On unknown date in 2004, 2005 and 2006 (reported also as when she was the age of 17 years old, 18 years old, and 19 years old), the patient was vaccinated with doses of GARDASIL (lot number, expiration date, route of administration and dose were not provided). No adverse effects were reported. The outcome of inappropriate schedule of product administration and no adverse event is unknown. This is one of the two reports from the same reporter who is also the patient. Sender's Comments: US-009507513-1811USA001939.
Initial misuse report received from non-healthcare professional on 228 October 2013.  The cases were received on 21 March 2014 at GPV. A 14-year-old patient received 0.5ml FLUZONE by nasal route (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
this is one of 4 individuals out of 25 vaccines to devel a red, hard not @ the inj site p/vax;
Narrative:  Pt was an 87 YO male with PMH of DM, HTN, CKD, hypothyroidism, BPH, and arrhythmia. Facility learned of his death via an query. No details provided and no evidence that death was related to COVID-19 vaccine.
Chicken pox rash.  Parent reports it started 2 days ago with about 20 lesions, now she has at least 200.
Fever 101.8, chills, shaking, sweating.  took Advil and Tylenol alternating every 3 hours. Fever went away after 10 hours Fatigue, slept for most of the following day mild body aches and mild headache for 24 hours, moderate arm pain from injection for 24 hours, could not lift arm. lymph node, jaw line,  neck swelling left side,  ice pack and Advil, still swollen on day 4.
I had superventricular tachycardia from age 12 to age 28.  At 28 years old, I had an ablation to correct this condition.  I did not have a single episode of afib from my ablation until I received my COVID-19 vaccine.  Now, I have episodes regularly.  I also have an extremely regular menstrual cycle.  My cycle has been abnormal and erratic since my first shot, 2/19/21.
got one dose and hasn't gotten second dose, past 42 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got one dose and hasn't gotten second dose, past 42 days) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got one dose and hasn't gotten second dose, past 42 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got one dose and hasn't gotten second dose, past 42 days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: 007M20A) with no associated AEs.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 01-JUL-2013, the patient was vaccinated with the first dose of GARDASIL intramuscularly. Lot# was not provided. Reporter reported that patient was currently in the office, on 28-MAY-2014, to receive the second dose of GARDASIL. No adverse effects reported. Additional information has been requested.
Narrative:  64 YOM tested positive for COVID19 on 8/23/21 after receiving one dose of Janssen COVID19 vaccine at his assisted living facility on 4/12/21.
This vaccinee, with no symptoms of connective tissue disease prior to vaccination, developed systemic lupus erythematous after receiving influenza vaccine, typhoid, meningococcal and tetanus vaccine and immune serum globulin. He had not received any drugs known to induce SLE prior to vaccination. Treatment included corticosteroids, cyclophosphamide, hydroxychloroquine and azathiprine. He continued to experience residual symptoms for up to 7 years of follow-up. Date of influenza vaccination and onset date of adverse event, not specified therefore associated with 1999/2000 season.
I have had the same symptoms with both doses of the Moderna Vaccine. The weeks following after my first shot,  my symptoms didn?t show up as strong until about 1-2 weeks post the vaccination.  I called out if work at 2:45 in the morning for that day and slept all day/night.  My 2nd shot was yesterday 2/12/21 @ 11:30 AM && around 5pm yesterday afternoon I started feeling symptoms and they have just gotten worse through the night and day. Which in turn caused me to have to miss a State Final Exam I?ve had scheduled for months now and have had to reschedule due to Covid multiple times.
ZOSTAVAX administered on 5/1/14, reported to the pharmacy on 5/9/14 that she had shingles, has seen a doctor to receive treatment with gabapentin, valacyclovir, NORCO and lidocaine patches.
This is a spontaneous report from a Pfizer-sponsored program. A contactable other HCP reported for a 21-year-old male patient of an unspecified race who received the second dose of TRUMENBA (lot N11903, exp.date 01Jul2017, NDC number: 000050100010) via intramuscular route in the left deltoid on 15Oct2016 09:03 at 0.5ml single dose for immunization and the second dose of influenza vaccine (manufacturer Sanofi Pasteur, lot UI690AB, exp.date 30Jun2017, NDC number: 49281041650) as seasonal flu protection via intramuscular route in the right deltoid at 0.5ml single dose on 15Oct2016. Medical history included seizure disorder, seasonal allergies, brain surgery, mass on the brain, this has a date of 12Aug2015 but unsure of initial diagnosis date. Later clarified it was at least 2012. Concomitant medication included KEPPRA for seizure disorder at 3000 mg, daily, CLARITIN for seasonal allergies at 10 mg, as needed and vitamin B6 per Vitamin supplementation since 18Aug2016 at 100 mg, 1x/day all ongoing. The patient had received the first dose of TRUMENBA (Lot Number/Expiry Date: N16808 01Jul2017) via intramuscular route in the left deltoid on 19Aug2016 and the first dose of influenza vaccine in 2013. In the morning of 16Oct2016 the patient experienced seizure. The outcome of the event was reported as recovered. Patient was seen in the ER in response to the seizure, on 16Oct2016 and he was not admitted. Sender's Comments: 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, as appropriate. The case will be reassessed if additional information becomes available.
Severe Blisters       Bullous Pemphigoid        Is Taking Dupixient
Sever fever with chills and body ache and headache and chest pains. Temperature 101.6
Patient admitted to hospital within a week of second COVID vaccine.  Patient had second dose of Pfizer on 09/07/21, she came to ED on 09/10/21 for weakness, fever, and vomitting - was not COVID tested at time symptoms were attributed to vaccine side effects.  Patient returned 09/11/21 reporting same symptoms, bloodwork and CT unremarkable so she discharged home.  She came in again on 09/13/21 reporting she "hadn't felt right" since her second vaccine and her husband tested positive for COVID.  She reports loss of appetite and start of shortness of breath.  Patient tested positive for COVID on 09/13/21 and required CPAP support for respiratory needs.
patient received improperly stored vaccine on 19-APR-2019; This spontaneous report was received from a medical assistant and refers to a patient of unknow age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 19-APR-2019, the patient was vaccinated with a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB), lot number R021078 with expiration date 12-JUN-2021. There was no previous temperature excursion reported, the vaccine was exposed to temperature of 52.5 Fahrenheit degrees during 4 hours and 40 minutes. Digital data logger was filled.
Moderna COVID-19 Vaccine  Muscle aches (full body)- 9pm 3/30-4/1 Injection site pain (unable to lift arm or move outward more than roughly 30 degrees without severe pain)- 4pm 3/30, 24-36 hours Fever of 100.4, full body  uncontrollable chills, sweating: 3 am 3/31- 9pm 3/31 (slept 19ish hours from night of 3/30 until 9:00 3/31, VERY unusual for me, and had nightmares) Only woke up a couple times long enough to take dog out briefly & go to bathroom. Had severe pain in upper body while trying to get out of bed or move around even slightly.  Headache: 3/31 9pm- all day 4/1  Treatment: Tylenol (500mg) for fever but also helped pain beginning 3/31 3am through all day 4/1; heating pad for upper body cramps, water as able. Sleep.
chorioamnionitis; Initial information was received on 22-Apr-2014 regarding an unsolicited valid serious case received from a consumer/non-health care professional.  This case involves a 33 year-old female patient who experienced chorioamnionitis (amniotic cavity infection), after she received vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor and the patient's past medical treatment(s), vaccination(s), family history and concomitant medication were not reported   On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed serious chorioamnionitis (amniotic cavity infection) (unknown latency) following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE. This event was assessed as medically significant.  It was unknown if the patient experienced any additional symptoms/events  It was unknown if there were laboratory data/results available.  It was not reported if the patient received any corrective treatment.  At time of reporting, outcome of the event was unknown.  Information on batch number was requested.; Sender's Comments: This case involves a 33 year-old female patient who experienced amniotic cavity infection after vaccination with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (unknown manufacturer). The time to onset was unknown. Further information regarding medical history, concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Pharmacy had date of birth wrong, so he was administered the adult vaccine dose instead of the child vaccine dose. Only birth month and day were confirmed at the appointment. There were no unusual reactions, just a sore arm. He was also given the adult dose for his second dose on 11/27/2021.
Onset of severe vomiting on Friday night (a day after immunization), every hour almost with dripping sweats and elevated temperature.
This spontaneous report as received from registered nurse refers to unspecified number of children, reported as some children, of unknown age and gender. Information on medical history was not reported. On an unknown date the patients was vaccinated with M-M-R II (lot # not reported) (dose number, dose route, indication not reported). It was reported that on unspecified dates the reporting nurse has seen some children making ouch sounds as she was giving injection of M-M-R II which indicated some pain or stinging from the injection. The reporting nurse could not provide any specific information on the number of patients or other detailed patients information regarding these adverse events. The outcome of sounds which indicated some pain or stinging from the injection was not reported. The reporter did not assessed the relationship between the therapy with M-M-R II and some pain or stinging from the injection. This is one of the reports from the same source. Additional information has been requested.
Five minutes after vaccination patient started to feel light headed and nauseated. Pt was given an emesis basin and cold compress to the back of his neck. Pt requested to lay down and was placed on a stretcher in prone position. Vital signs were taken and found to be within normal limits. After five minutes of laying down he felt resolution of all symptoms. Pt was monitored for ten more minutes and still felt no more symptoms so he went home with his mother.
APPROX 5 MINUTES AFTER RECEIVING 2ND PFIZER (COVID VACCINE) DOSE, PATIENT GOT VERY NAUSEATED, BROKE OUT INTO A SWEAT,  AND FELT DIZZY.   I CHECKED PATIENTS BLOOD PRESSURE WHICH WAS NORMAL.  I PLACED 2 ICE PACKS ON PATIENTS NECK AND FOREHEAD.  PT REQUESTED COLD WATER TO DRINK.  AFTER ABOUT 15 MINUTES, PT GOT OVER THIS REACTION AND ALL VITAL SIGNS WERE NORMAL..PT LEFT--PT REFUSED ANY EXTRA CARE
Fever; Chills; Some nausea; Achy on arm; A spontaneous report was received from an other health care professional, concerning himself, a 26-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, chills, some nausea and achy on arm.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 08-Jan-2021 at 11:30AM, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number 031K20A) intramuscularly in his left arm for prophylaxis of COVID-19.  On 09-Jan-2021, the patient woke up at 01:00AM with a fever, chills, some nausea (maybe from eating late) and achy on arm. Hence, he took paracetamol as treatment for events.    Action taken with mRNA-1273 in response to the events were not reported.   The outcome for the events, fever, chills, some nausea and achy on arm were unknown.; Reporter's Comments: A spontaneous report concerns a 26-year-old male patient, who experienced fever, chills, some nausea and achy on arm. The event occurred 1 day after the administration of the first dose of the mRNA-1273 vaccine (Lot #: 031K20A, expiration date-unknown). Treatment included paracetamol and outcome is unknown. Based on the information provided, which includes a temporal association between the reported events and the administration of mRNA-1273 vaccine, a causal association cannot be excluded. The events of fever, chills, some nausea are consistent with the known safety profile of mRNA-1273 vaccine.
Vaccine expiration was 11/7/2021 and was administered on 11/12/2021.  Mistook expiration date to read 11/17/2021 instead of 11/7/2021.  No adverse events or outcomes to recipient.