chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable physician. An 88-year-old female patient received PREVNAR 13 (Lot # L36485, Exp. date 01Oct2016, NDC code 00005197101), via an unspecified route of administration at 0.5 ml, single on 28Apr2015. Medical history included congestive heart failure, hypertension, hyperlipidemia, coronary artery disease and stroke. The patient had these medical conditions for at least 10-20 years. Patient was bedbound or wheelchair bound prior to receiving the vaccine. Blood work revealed elevated white blood cell count. Reporter said that she broke her hip, wasn't able to stand on the scale, and had lost a lot of weight. The patient's concomitant medications were not reported. On 28Apr2015, the patient experienced cardiac arrest. Therapeutic measures were taken as a result of cardiac arrest. The patient died on 29Apr2015. It was not reported if an autopsy was performed. The event was described as follows: about a half an hour after the vaccination, she had a cardiac arrest. Reporter did not witness the event. Patient had an arrest, and emergency was called. They resuscitated her and brought to the ER. She arrested again in the ER. Patient just saw reporter for a follow-up visit and reporter decided to give her the vaccine. The reporter called because she was wondering if it was an anaphylactic reaction to the PREVNAR or if there have been any similar reports, she stated she can't prove or disprove that is what happened, but it is a possibility.
Patient received insufficient vaccine dose.  Needle was inserted into vial through the vaccine and air was drawn from vial and injected into patient arm.  No adverse issue reported from patient and is rescheduled to re-receive 1st dose.
Approx 19 hours after the vaccine, totally out of the blue my throat felt strange and tight and I began to cough and gasp for air. Although I have asthma, this did not feel at all like any asthma reaction I have ever had and have not had an asthmatic reaction in ages. I felt like my vocal cords were stuck closed. I couldn't talk and was gasping for breath. After about a minute and a half I was truly scared and almost called 911. Continued to try to get air and used proair inhaler, but couldn't breathe it in. The incident lasted about 3 very scary minutes with my throat feeling closed and coughing hard the whole time. It eventually began to subside. My throat continued to feel irritated the next day, but now 4 days later, I have not had any more problems.
The day following the vaccination, the patient reported that she had numbness and a blueish discoloration in the tip of her ring finger. It was on the arm that she had received the Fluad vaccine the day prior. She said the numbness resolved by the second day after the shot, but her finger was still slightly discolored. She did not report any other symptoms.
No effects after first dose other than achy shoulder the day of my first and second dose, but day after second dose was awful. I had brain fog, fever, exhaustion all day, no appetite, couldn't get out of bed until late that evening.  Pretty much slept the day away.  Much better the next day.
No additional AE information provided; Office manager reports that MMR II was administered to three patients after the product's expiration date.Office manager confirms the product was stored appropriately prior to administration and had no temperature excursions.; This spontaneous report has been received from an office manager concerning to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent conditions, previously drug reactions or allergies, and concomitant medications were not provided.  On 07-OCT-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection, at a dose of 0.5 milliter(ml), (strength, vaccination scheme frequency, route and anatomical location were not provided; lot number T029549 that was verified to be a valid lot number with an expiration date reported as 01-SEP-2022, but upon internal validation established as 10-SEP-2022) (expired product administered) for prophylaxis.  By the reporting time, the caller confirmed that the product was stored appropriately prior to administration and had no temperature excursions.  No additional adverse event (AE) information provided(no adverse event).  This is one of two reports received from  the same reporter.; Sender's Comments:  US-009507513-2210USA010287:AE report #: 02276203 US-009507513-2210USA010314:AE report #: 02276158
THOUGHT SHE WAS GOING TO DIE; COULDN'T GET OUT OF BED; SICK FOR 72 HOURS; EXTREME REACTION; COULDN'T KEEP FOOD OR DRINK DOWN; FEVERISH; FATIGUED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced thought she was going to die. On APR-2021, the subject experienced couldn't get out of bed. On APR-2021, the subject experienced sick for 72 hours. On APR-2021, the subject experienced extreme reaction. On APR-2021, the subject experienced couldn't keep food or drink down. On APR-2021, the subject experienced feverish. On APR-2021, the subject experienced fatigued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from thought she was going to die, couldn't get out of bed, sick for 72 hours, couldn't keep food or drink down, feverish, and fatigued, and the outcome of extreme reaction was not reported. This report was non-serious.
feeling of the throat slightly closing up; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (feeling of the throat slightly closing up) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Brain tumor. Concomitant products included BENAZEPRIL;HYDROCHLOROTHIAZIDE, AMLODIPINE BENZOATE, AMITRIPTYLINE HCL, CLORAZEPATE DIPOTASSIUM (CLORAZEPATE), MULTIVITAMINS [VITAMINS NOS] and CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12) for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (feeling of the throat slightly closing up). At the time of the report, OROPHARYNGEAL DISCOMFORT (feeling of the throat slightly closing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment details were provided.
INFLAMMATORY MYELOPATHIES/UNMASKING UNDERLYING MYELOPATHIC DISEASE; This spontaneous report was received from literature. This report concerned multiple patients. The objective of this study to characterize the clinical presentations of myelitis and myelopathies following SARS-CoV2 infection (COVID-19) or vaccination for COVID-19.  The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, 1 total, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients experienced inflammatory myelopathies which were associated with vaccination (n equal to 3) and COVID-19 (n equal to 2). The patients had notable CSF pleocytosis, elevated protein and MRI (Magnetic resonance imaging) involvement of white matter tracts and grey matter. COVID-19 and vaccination were also associated with unmasking underlying myelopathic disease such as demyelinating or metabolic) in 4 patients. Patients with inflammatory etiologies only saw improvement in their symptoms after Plasmapheresis (PLEX) and early initiation can halt progression and improve outcomes. Among the unmasked group, patients had heterogeneous clinical presentations. Imaging in this group showed chronic lesions, unlike the other two groups.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of inflammatory myelopathies/unmasking underlying myelopathic disease was not reported.  The authors concluded that it is critical to identify the etiological factors in subjects with myelopathies in the setting of COVID-19 or vaccination to establish an appropriate treatment.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230720785- inflammatory myelopathies/unmasking underlying myelopathic disease. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.
Patient received IPV, MMR, DTaP, PCV on 4-17-06. DTaP and IPV received in left arm; MMR and PCV received in right arm On 4-18-06 at approximately 5:00pm, patient (noted by mom)complained that arm "was on fire".  Mother stated had redness and swelling in left arm with red streaks going down arm. Patient taken to Urgent Care.  Diagnosis of cellulitis made.  Patient placed on antibiotics.
Normally a very happy baby who rarely napped very long (but did sleep through the night), he became VERY lethargic and difficult to wake; when he was awake, and also sometimes during sleep, he cried a high pitched cry/scream. He was agitated and very lethargic for about 3 days, then returned to normal.
Brief episode of lightheaded dizziness.  No loss of consciousness.  Resolved with drinking juice.  Patient observed in car and family drove home.
Rash length of upper arm, redness and generalized swelling. No itching, shortness of breath or change in circulation. Instructed to apply ice if lump at injection site, use benadryl or calamine lotion on rash, report to MD if swelling increases or does not get better in next 24 hours or shows generalized symptoms.
I have only had one prior to this/sinus/ear infections; I have only had one prior to this/sinus/ear infections; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 52 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma, controlled" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: coviD-19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Manufacturer: Unknown), administration date: 17Feb2021, when the patient was 52-year-old, for COVID-19 Immunization. The following information was reported: SINUSITIS (non-serious), EAR INFECTION (non-serious) all with onset 2021, outcome "unknown" and all described as "I have only had one prior to this/sinus/ear infections". The event "i have only had one prior to this/sinus/ear infections" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of sinusitis, ear infection.  Additional information: Reported that, Patient had no known allergies. The patient later received dose 3, BNT162B2 (Lot number: ff8841) in right arm on 09Oct2021 at 12:00. Patient has had 8 major sinus/ ear infections since taking the vaccine and has only had one prior to 3rd vaccine. The treatment taken for adverse events was reported as antibiotics every time. The patient has not taken other vaccines in four weeks. The patient had no COVID prior vaccination and has not been tested for COVID prior to vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300146065 Same patient, same reporter, same vaccine, different dose, different events;
Received Moderna shot today, received Pfizer shot in Mar 2021; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-May-2021 and was forwarded to Moderna on 20-May-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Received Moderna shot today, received Pfizer shot in Mar 2021) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   In February 2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1. In March 2021, received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 2. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received Moderna shot today, received Pfizer shot in Mar 2021). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Received Moderna shot today, received Pfizer shot in Mar 2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Interchange of Vaccines. No concomitant medications were reported by the reporter. No treatment information was provided by the reporter.
Cough, wheezing, headache, chills, fever, scratchy throat. Redness/swelling at inj site. Got the inj at 10:45 AM and same day at night had the reaction. Given Amoxicillin/Clavulanate Potassium 875-125 mg.
Swelling, erythema, tenderness increase warmth left thigh, localized cellulitis, Cephalexin 250mg twice a day for 7 days.
Information has been received from a pharmacist concerning a 54 year old male with hypertension, obesity, diabetes, atherosclerosis, asthma and heart murmur who on 03-MAR-2009 was vaccinated with PNEUMOVAX (Lot# 662018/1332X) in the left arm for prophylaxis against high risk pneumonia. The patient had no known drug reactions/allergies. Concomitant therapy included TYLENOL, METOPROLOL XL, LISINOPRIL (manufacturer unknown), VYTORIN, ASPIRIN, PROAIR HFA, IBUPROFEN, ZYRTEC, FLUTICASONE, INDOMETHACIN (manufacturer unknown) and ALBUTEROL. On 04-MAR-2009 evening, the patient experienced fever, chills and increasing pain in the deltoid region where the shot was given (left arm). The patient experienced swollen arm, red hot to touch of the left arm, chronic cough, "burning lung with body aches that were hot and cold" and redness at the injection site. The patient was in the office on 05-MAR-2009 and the patient had pain down the left arm where erythematous area of the skin where the vaccination was given. The patient had a dry cough without shortness of breath. The patient vomited shortly after examination. The patient was sent to the hospital on 5-MAR-2009 with a diagnosis of cellulitis. The patient was hospitalized. The patient was discharged with homecare with a PIC line and ROCEPHIN IV daily for 7 days and BACTRIM DS twice daily for 7 days to prevent the spread of infection. The patient was to follow up with infectious disease. The patient was discharged in satisfactory condition on 10-MAR-2009. The adverse events were considered to be significant disability or incapacity. Fever, chills, swollen arm, red hot to touch of the left arm, chronic cough, "burning lung with body aches that were hot and cold" and redness at the injection site, increasing pain in the deltoid region where the shot was given (left arm) pain down the left arm where erythematous area of the skin where the vaccination as given, dry cough without shortness of breath, vomited, and cellulitis were determined to be other important medical events. Additional information has been requested.
Skin hypersensitivity, chills, muscle aches, dizziness, sore eye muscles, cerebral pulsing sensation, but no headache. 500mg acetaminophen taken at 8:00pm. Awaiting results of improvement.
Adverse Event: PT was here for first dose of Pfizer, received at 1625. At 1644, PT c/o lightheadedness while sitting in post-observation, presented with diaphoresis . EMTs were called at 1645 and arrived at 1645. PT was assisted to floor by EMTs. Liquids were provided, EMTs began assessment (see VS below) PT was encouraged to drink fluids, educated on vasovagal responses, dehydration effects/management. At approximately 1700, EMTs assisted PT to stand, PT c/o lightheadedness and PT was assisted to seated position with elevated legs without incident. S/S resolved shortly after and PT reported being at baseline.  Treatment: Liquids (water and apple juice)  were provided, Assessment/Vitals by EMTs (VS at 1700: 110/66 sitting, HR 86, SPO2 99% RA). Outcome: PT was medically cleared by EMTs at 1708, provided with apple juice and instructions to drink/rest at home, exited facility on foot.
mind wasn't right; dizziness; disorientation; head was not focused right; This is a spontaneous report from a Contactable Consumer (patient). A 83-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included she was allergic to penicillin and had sensitivity to some drugs. The patient's concomitant medications were not reported. The patient experienced dizziness and disorientation after receiving the first dose. Patient stated that her mind wasn't right and her head was not focused right. Her reactions after the first dose of the covid vaccine stopped after five days. The patient had received the second dose of the vaccine. The outcome of the events was recovered after five days.  Information on the lot/batch number has been requested.
Pt returns today with c/o right thigh pain swelling/redness Right thigh circumference 14 inches compared to left at 12 inches. Redness and warmth, Positive inguinal nodes, Keflex 200 QID & Zyrtec 5 mg QD; Return in AM.
This case was reported by a consumer via call center representative and described the occurrence of flu like symptoms in a 61-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (twice since 2012). Previously administered products included SHINGRIX (1st dose received in January 2019). Concurrent medical conditions included meniere's disease (diagnosed in 2013). On 5th April 2019, the patient received the 2nd dose of SHINGRIX. On 8th April 2019, 3 days after receiving SHINGRIX, the patient experienced ear pain. In April 2019, the patient experienced flu like symptoms, slight temperature, tiredness and pain localized. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the flu like symptoms, slight temperature, tiredness, ear pain and pain localized were recovering/resolving. It was unknown if the reporter considered the flu like symptoms, slight temperature, tiredness, ear pain and pain localized to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 60 years or 61 years. The case was reported by the patient for himself. The patient stated the reason for the delay of 2nd dose was due to back order and could not find any pharmacy that carried it. Even his provider could not get his hands on any for his patients. Twelve hours after the SHINGRIX, the patient started to have strong flu-like symptoms. He also had a slight temperature and was extremely tired. Less than a week after vaccination, the patient expereinced shingles like pain. One thing that concerned the patient was he experienced shingles like pain in some areas on his body. On the day of reporting, he had several episodes of sharp pain in his right middle ear. The patient took 3 Advils and got some relief. The patient asked whether he should expect long term pain in the ear.
Heart Attack one day after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart Attack one day after vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jul-2021, the patient experienced MYOCARDIAL INFARCTION (Heart Attack one day after vaccine) (seriousness criteria medically significant and life threatening). At the time of the report, MYOCARDIAL INFARCTION (Heart Attack one day after vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not reported.  Treatment details was not reported.  Patient had a bad experience with the vaccine as had a heart attack one day after vaccine.  Company Comment Very limited information regarding this event has been provided at this time.  Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
"At approx 3:00 PM noted increased shortness of breath, hoarse voice, nasal congestion, swelling of the soft palate, itching/burning sensation on the lips, mouth & throat. HX of angioedema with unknown cause".
Inbound call from pharmacist calling to request information on whether a patient who received his first dose of GARDASIL-9 a year ago would have to restart the series.  Upon asking for additional to submit an AE, caller declined to provide any additi; No additional AE; This spontaneous report was received from Pharmacist and refers to a male patient of unknown age.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, , administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided).  On an unknown date, there was an inbound call from pharmacist calling to request information on whether a patient who received his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) a year ago would have to restart the series. Upon asking for additional to submit an AE, caller declined to provide any additional information. Agent was able to confirm that there were no symptomatic adverse events.  Declined permission for correspondence.  No additional information at this time. No additional AE/PQC reported.
Joint pain in fingers, ankles and toes, post vax of 2nd Lymerix and continues to worsen.