chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt had a positive COVID test on 9/3/2021  pt died at home on 9/4/21; no other records on this patient
Pt observed for 10 minutes in observation room following administration of Moderna Vaccine. Pt stepped outside after 10 minutes of observation and alerted traffic staff that pt was feeling faint and notified Observation RNs. Pt was assisted to the ground, legs propped up on a chair and applied 2 L O2 via non-rebreather mask. Pt was oriented to time, place and date. After 5 minutes, pt was assisted to a sitting position by RN and tolerated well. After a total of 10 minutes RNs removed oxygen and assisted patient back inside to Observation Room where he was observed for an additional 15 minutes. Pt A&Ox4 and left the clinic without further incident.
Chills; Sick; Arm pain; Dizzy; Headache; Nauseous; Joint pain; Tiredness; Feeling unwell; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 15Oct2021 15:30 (Lot number: FF8839) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID. Vaccination history included: Bnt162b2 (First dose), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset Oct2021, outcome "unknown", described as "Chills"; ILLNESS (non-serious) with onset Oct2021, outcome "unknown", described as "Sick"; PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "Arm pain"; DIZZINESS (non-serious) with onset Oct2021, outcome "unknown", described as "Dizzy"; HEADACHE (non-serious) with onset Oct2021, outcome "unknown", described as "Headache"; NAUSEA (non-serious) with onset Oct2021, outcome "unknown", described as "Nauseous"; ARTHRALGIA (non-serious) with onset Oct2021, outcome "unknown", described as "Joint pain"; FATIGUE (non-serious) with onset Oct2021, outcome "unknown", described as "Tiredness"; MALAISE (non-serious) with onset Oct2021, outcome "unknown", described as "Feeling unwell".  No follow-up attempts are possible. No further information is expected.
Temperature of 104 degrees rectal since last evening.  With crying for 24 hrs (since 6pm on 04/28/2003).  Tylenol and or motrin as needed.
Rash around point of entry of vaccination, weakness, high fever, headache and cold body.
Developed large, red, swollen area approx. 4-5 cm, hot to touch. Ice was applied by parent, resolved in 2-3 days.
I contracted Covid in December. Symptoms from the Vaccine in September were fatigue and flu like symptoms that lasted only a day.
noted pt has ili symptoms; cough, runny nose, sore throat, ear congestion feeling, nasal congestion, fever(not taken temperautre), eye got waterly since last night 9 PM. Noted no emergency s/sx of covid vaccine side effects. Pt stated pt got 2nd covid vaccine Moderna 5/4/2021. Pt said pt has possibility of being pregnant d/t last period was 4/2/2021, regular period every 30 days, but pt missed this month period. Pt said that pt concerns pt got pimples on her both chicks for 3 weeks since pt changed her facial cream. Pt is taking tylenol for ili symptoms. Pt is educated covid vaccine side effects. Pt scheduled urgent care 5/19/2021 for consultations.
broke out in a rash, sores; broke out in a rash, sores; looks like a big circle of whelps or swellings on her legs and it's itchy; looks like a big circle of whelps or swellings on her legs and it's itchy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 22Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cellulitis" (unspecified if ongoing), notes: Hospitalized for cellulitis years ago and not know what causing it and had kept taking medications.; "Sulfa drug" (unspecified if ongoing), notes: Occurs with many medications such as anything classified as a NSAID or Sulfa drug.; "NSAID" (unspecified if ongoing), notes: Occurs with many medications such as anything classified as a NSAID or Sulfa drug. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Lot Number: Caller states that it is either. and Expiry date are unknown., Anatomical location: left arm.), administration date: 30Mar2021, when the patient was 65-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Lot Number:  and Expiry date are unknown, Anatomical location: left arm.), administration date: 21Apr2021, when the patient was 65-year-old, for COVID-19 immunization; BNT162b2 (Dose 3, Lot Number:  and Expiry date are unknown, Anatomical location: left arm.), administration date: 19Nov2021, when the patient was 65-year-old, for COVID-19 immunization; Flu vaccine, for she got so ill with it; Flu vaccine, for Got real sick. The following information was reported: RASH (non-serious) with onset Apr2022, outcome "recovered" (Apr2022), PAIN (non-serious) with onset Apr2022, outcome "unknown" and all described as "broke out in a rash, sores"; PRURITUS (non-serious), PERIPHERAL SWELLING (non-serious) all with onset Apr2022, outcome "unknown" and all described as "looks like a big circle of whelps or swellings on her legs and it's itchy". Therapeutic measures were taken as a result of rash.  Additional information: Patient had no reactions to the COVID Vaccines up until her fourth shot. States she broke out in a rash, sores, whatever it was that she breaks out in. States it looks like a big circle of whelps or swellings on her legs and it's itchy. Patient stated that if she doesn't stop taking whatever medication it was at the time that causes it just gets worse. Patient stated that the rash she got after this vaccine went away in about 3-4 days. States that she had Triamcinolone Cream, she used that on the rash, and it faded away. Patient stated that her only concern now was if she needs more booster vaccines. Stated that something in the vaccine, she was reacting to now. States that once she starts reacting, if she takes the medication again, the reaction was immediate. Patient stated that she was not blaming the vaccine. Stated that she was just very rare and reacts to a lot of things.
Patient vomited a few minutes after receiving shot. He had some water, rested and felt fine a few minutes after. Parents believed it was likely due to nerves.
A non-serious spontaneous report of "29 patients received expired FLUMIST" was received from a physician concerning a 36-month-old male.  The patient's medical history included no history of asthma.  No concomitant medications were not available.  On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008).  The reporting physician was concerned regarding efficacy and loss of potency due to the expired product.  Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications).  There were no adverse events associated with these medications errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicted population of 2 years to 59 months of age for FLUMIST.  On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error. Follow-up information received on 31-Mar-2009 included Product Complaint Investigation results.
Nausea Headache Diarrhea  I received nausea pills from the doctor.
16 or so hours after vaccination I was feeling extreme hot and cold chills on and off accompanied by body aches, fatigue and nausea. Also heightened anxiety. That lasted through the next 24 hours. The 2nd day after vaccination was extreme fatigue, like having troubles staying awake throughout the day.  Along with continues body aches. 3rd day after vaccination my body is still feeling very sore all over and I?m having a lot of nausea still
Arm started hurting p/shot (w/in 6 hrs) became red & swollen t102; mom giving APAP & cold packing arm; next morning swelling & redness had inc; temp dec 101 mom called MD who advised to continue w/APAP & no further pertussis felt was rxn;
MISSED TO TAKE THE LAST DOSE OF VIVOTIF; This spontaneous case report (PVX2019-2789) was received from a consumer on 12-Nov-2019. It described a male consumer who "missed to take the last dose of Vivotif" (PT: Product dose omission). She was receiving oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took three doses of Vivotif. Then, He lost his last dose. Thus, did not take it on 11-Nov-2019.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed to take the last dose of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed to take the last dose of Vivotif" was considered as not applicable.
Sore arm first injection as expected. 2nd more sore. Some fatigue.  Felt totally fine prior to until my husband turned onto our home street and I started to verbalize that this is not our neighborhood nor our house.  I then started to have a seizure which I was told lasted 5 minutes and was turning blue.  I was buckled at the time.  I have compression fractures of T12 to L2 He called an ambulance and I had a second one.  I had ct , mri, mra, eeg, ekg, labs.  Treated with muscle relaxants, toradol. Put on keppra.  Cannot drive for 6 months.  All new onset.  Having a lot of back spasms especially in the night My mouth and tongue are sore from biting on it During seizure Foggy thinking and decreased memory
This case was reported by a physician and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with KINRIX (GlaxoSmithKline), Influenza vaccine unspecified. In November or December 2011 the subject received a dose of KINRIX (unknown arm) and unspecified dose of Influenza vaccine unspecified (unknown arm) on the same day. Less than a year after vaccination with Influenza vaccine unspecified and KINRIX, the subject experienced injection site redness, allergic reaction at injection site, injection site infection and wrong injection technique. The subject was administered KINRIX and flu vaccine at the same time in the same arm a "few months ago" ("November or December 2011"). The subject developed a "big red area around the injection sites". The ID [Infectious Disease] physician was trying to determine whether the subject experienced an allergic reaction or infection and whether related to two injections given too close together. The physician stated the "incident had been reported". At the time of reporting the outcome of the events was unspecified. Follow-up information was received on 07 September 2012 via healthcare professional who reported "This case was previously reported by another provider-no sequelae". At the time of the report no other information was provided.
Fever (104.3); N/V; Bodyaches; Dizziness and Pain at Injection site.
rapid heart beat; High blood pressure; flushing; body aches; fever; tired; chills; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (rapid heart beat), HYPERTENSION (High blood pressure), FLUSHING (flushing), PAIN (body aches) and PYREXIA (fever) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high and Anxiety. Concomitant products included CLONIDINE for Blood pressure high and Anxiety, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), CLONAZEPAM (KLONOPIN), BREXPIPRAZOLE (REXULTI), LISDEXAMFETAMINE MESILATE (VYVANSE), FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA), MULTIVITAMIN [VITAMINS NOS], MIRTAZAPINE (REMERON), LEVOTHYROXINE SODIUM (LEVOTHYROXINE [LEVOTHYROXINE SODIUM]) and FLUCONAZOLE (DIFLUCAN) for an unknown indication.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced TACHYCARDIA (rapid heart beat), HYPERTENSION (High blood pressure), FLUSHING (flushing), PAIN (body aches), PYREXIA (fever), FATIGUE (tired) and CHILLS (chills). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, TACHYCARDIA (rapid heart beat), HYPERTENSION (High blood pressure), FLUSHING (flushing), PAIN (body aches), PYREXIA (fever), FATIGUE (tired) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2021, Heart rate: high (High) Pulse is in the hundreds..         Concomitant medications also included unspecified birth control pills and an unspecified daily probiotic.
This spontaneous report as received from a immunization official refers to an unknown number of patients of unknown age and gender. Medical history was not reported. On an unknown date the patient was vaccinated with ROTATEQ oral (lot# not provided) route, dosage and frequency were not reported. Concomitant therapy was not reported. The reporter informed that on an unknown date the patients may have received ROTATEQ that was improperly stored from 11-JUN-2013 to 22-APR-2014. No adverse effects were reported. This is one of several reports received from the same reporter MARRS case # 1405USA003763, # 1405USA004444 and # 1405USA004446. Additional information has been requested.
There was an itchy sensation on my eyelid and corner of my right eye, which I had thought was due to tears.  That itchy irritation progressed to redness and the itchiness would be more prevalent in the evening, than the morning, after my shower.  I tried a few otc items that I thought would help, but after six days, I went to my doctor's office and was treated by a Nurse Practitioner.  She urged me to see my ophthalmologist, which I will do on Monday, March 15. She prescribed two oral medications (prednisone & hydroxyzine) and one topical medication (momentasone).
Took Moderna COVID-19 Vaccine 2nd shot..   Continuous Dizziness
PATIENT REPORTED A RED RAISED LINE AROUND DIAMETER OF UPPER Right ARM (6 INCHES IN LENGTH), 3 INCHES BELOW WHERE VACCINE WAS ADMINISTERED. No fever reported. Patient states feeling normal. Called patient on 6/16/2017 for follow up to reaction. States that area is less swollen and less red. Continuing to do normal daily activities with no problems.
This healthy 46-year-old received a flu shot around 10:30 a.m. this morning.  Around noon she developed a dry, hacky cough, mild headache and body aches.  She took some cold medicine thereafter developing a feeling of palpitations and mild shortness of breath.  Now at 5:30 p.m. those two symptoms have resolved, but she feels very achy, has very red, irritated, itchy eyes, a fever and congestion.  She does note in retrospect that she did have some body aches this morning upon waking.  No known exposures.  No previous reaction to flu shots.  No history of egg allergy or other comorbidities.
pt recvd vax & was unresponsive; ems was activated & recucitation initiated; pt taken to hosp & died;
Death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history was not reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 14-Apr-2021 The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided          Concomitant product use was not provided by the reporter.  No treatment information was provided. Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested. The cause of death was not reported. It is unknown if an autopsy was performed. Action taken with mRNA-1273 in response to the event was not applicable.; Sender's Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested. The cause of death was not reported. It is unknown if an autopsy was performed.; Reported Cause(s) of Death: Unknown cause of death
BLOOD CLOTS; This spontaneous report received from a consumer via a company representative via social media concerned multiple patients (7 people out of 14 million) of an unspecified age, sex, race and ethnic origin. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown, expiry: unknown) dose not reported, 01 total, in 2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patients experienced blood clots. Reporter stated that "When 7 people out of over 14 million developed blood clots after receiving the J&J vaccine last year (2021), it was widely reported on by all media outlets and vaccine administration was halted until the risk could be thoroughly evaluated." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).  Version created to amend previously reported information on 29-JAN-2022. Upon review the following information was amended: Amendment Adverse Event (The case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V1- Upon review the following information was amended: the case validity assessment was updated to valid from the previously incorrect assessment of non-valid. This updated information does not alter the causality of previously reported event.  20220200454-Covid-19 vaccine ad26.CoV-2.s-Blood clots. 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).
lost her sense of smell; lost her sense of taste; Feels yucky; mild flu like symptoms; horrible nasal congestion; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (lost her sense of smell), AGEUSIA (lost her sense of taste), FEELING ABNORMAL (Feels yucky), INFLUENZA LIKE ILLNESS (mild flu like symptoms) and NASAL CONGESTION (horrible nasal congestion) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K2019) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.).    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jan-2021, the patient experienced ANOSMIA (lost her sense of smell), AGEUSIA (lost her sense of taste), FEELING ABNORMAL (Feels yucky), INFLUENZA LIKE ILLNESS (mild flu like symptoms), NASAL CONGESTION (horrible nasal congestion) and PYREXIA (low grade fever). At the time of the report, ANOSMIA (lost her sense of smell), AGEUSIA (lost her sense of taste), FEELING ABNORMAL (Feels yucky), INFLUENZA LIKE ILLNESS (mild flu like symptoms), NASAL CONGESTION (horrible nasal congestion) and PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Numbness in the arm where injection was given which moved to the leg, feet and face ending in itching in my mouth and tongue.  Emergency room gave me Benadryl and watched me for an hour.  Sending me home with instructions to continue Benadryl for 2 days which I did, when I stopped the symptoms returned. I then saw my PC dr and she gave me 4 days of prednisone.  I really hope this stops soon and will never receive this vaccine again or allow my children to receive it.
Swelling of the feet, ankles, legs and hands; Neuropathy like pain; Swelling of the feet, ankles, legs and hands; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 14Apr2021 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's, prediabetic, asthma, high blood pressure, high cholesterol, anxiety and depression. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medication was not reported. The patient previously received ampicillin (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced drug allergy. On 03May2021 the patient experienced swelling of the feet, ankles, legs and hands. Also neuropathy like pain in all of the above increasing with time that worsened at night. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 08Aug2021, the patient underwent covid rapid test and the result was Negative. Therapeutic measures were taken as a result of the reported events and included low dose diuretic. The clinical outcome of the events swelling of the feet, ankles, legs and hands and neuropathy like pain were not recovered at the time of this report.