chrisvoncsefalvay/vaers-outcomes huggingface dataset:
LIGHT HEADED; COLITIS FLARE; This spontaneous report received from a patient via a company representative concerned a 57 year old male. Initial information was processed with the additional information received on 12-SEP-2021. The patient's height, and weight were not reported. As past history, patient had a colonoscopy in 2020 (a year and half ago). The patient's concurrent conditions included: ulcerative colitis that had been under control, reaction to penicillin, allergy to tree pollen, alcohol user (may be 6 beers in a year), and non smoker, and other pre-existing medical conditions included: The patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: 21-SEP-2021) dose was not reported, 1 total, administered to right arm on 10-SEP-2021 16:45 for prophylactic vaccination. Concomitant medications included sulfasalazine for ulcerative colitis.  On 10-SEP-2021, patient felt washed out for 8-10 hours. On 11-SEP-2021, after 14 to 15 hours of received the vaccine the patient had rectal mucus and an hour later the blood started but had no diarrhea and the patient had blood in stool. Patient stated that It was the fastest time that had happened to patient from going mucus to bleeding. Patient was also light-headed and On 11- SEP-2021, patient went to the emergency room around 15:00. The patient started with blood work. On 11-SEP-2021, patient waited till 01:30 (at night) at hospital but doctor was busy. Patient had sips of water to kept hydrated. Patient was waited during the patient started getting colon pain on the left side and the right side groin area that come and go. The patient was diagnosed with colitis flare up (and possibly due to the vaccination). Patient still had lower groin pain (lower colon) and not higher up the mid-stomach area (patient knew that, patient would in trouble). The patient had reluctant to get the vaccine but decided to got it. Treatment medications (12- SEP-2021) included: prednisone. Laboratory data (11-SEP-2021) included: Complete blood count (NR: not provided) Not reported, Comprehensive metabolic panel (NR: not provided) Not reported, and Rectal examination (NR: not provided) Rectal bleeding and colitis flare up.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from light headed, and colitis flare, and had not recovered from lower groin pain/pain on the right side groin area that come and go.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210922028-COVID-19 Vaccine AD26.COV2.S-Colitis Flare. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
Information has been received from a physician concerning a 9 year old female who on 14-JUN-2007 was vaccinated with a first dose of Gardasil 0.5 mL IM. On an unspecified date the patient had been hospitalized three times for seizures, since vaccination. Medical attention was sought. At the time of reporting it was unknown if the patient had recovered. Additional information has been requested.  4/23/09 MR received from CDC.  In for WCC 6/13/07 with normal exam except for slight scoliosis and reported ADHD-not on meds. ER visit 6/15/07 with dx:  possible seizure d/o.  Pt presented after several episodes of shaking all over with loss of consciousness.  Difficult to arouse afterwards and when pt awakes is screaming and staring into space. D/C DX:  Possible seizure d/o.   5/29/09 neurology records received DOS 8/31/07 to 1031/07 FINAL DIAGNOSIS: Frontal lobe epilepsy. Post vaccination: episodes of night terrors, screaming, distressed. Sudden turning of the head, followed by extending and internal rotation of arms, flexing at the wrist, legs stiffening outwards, and shaking for 30 seconds. Alterations of consciousness followed by "bad behavior". Waking in circles, falling down, injured back. Weight gain. Previously straight A student, now poor academic skills.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The pharmacist called about the administration of expired Moderna vaccine that were given as event or problem booster shot to patient around 490 to 500 people on the date last 20-Oct-2021 to 29-Nov-2021. It was reported that the vaccines was stored in freezer, they took out one to two vials and placed in fridge each day as needed.  No treatment given on the patients.
1 1/2" x 3" long fiery red blistered area. Larger-almost complete circle on my arm (around arm) in swollen pink area and itchy. Burning on arm, dizzy-weak fever up and down chills, nausea. Arm was so swollen it was very heavy and throbbed.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 13-JUL-2015, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (exact dose, dose number, route and site of administration, lot# and expiration date were not reported) prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) vaccination, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was unknown. The relatedness between the event and zoster vaccine live (ZOSTAVAX) was reported as related.
Initial report received from a healthcare professional on 05-Nov-2013. A 62 year old female received FLUZONE ID (batch number: UT4722BA, expiry date: unknown) intradermal in left deltoid on 09 October 2013. The patient's medical history and concomitant medications were not reported. Within a few days of vaccination the patient experienced redness around injection site, pain up near the neck and radiating down into the arm a few days after vaccine and the arm has been aching ever since and a nodule at the injection site. At the time of this report the outcome of the events were not resolved. Documents held by sender: none.
Initial case received from a healthcare professional (nurse) on 14-Oct-2013. A 58-year-old female patient, with a relevant reported medical history, had received her intramuscular dose of FLUZONE (batch number UH908AA) in the left deltoid on 03-Oct-2013. The patient had a medical history of left knee replacement 10 years ago (2007), hypertension, absent thyroid, arthritis; DILAUDID itching, morphine and codeine vomit. There was no illness at the time of the vaccination. A week prior to reporting, on Wednesday, the patient developed knee pain. Later on, on Friday, Saturday and Sunday, she experienced pain and swelling in the back of the knee. Ortho was called. On Saturday, the patient's condition got worse. On Sunday, she could bear weight. She also had swelling from her thigh to her feet and could not fit her leg. By Monday, she saw her physician, could walk. By Wednesday, she felt more normal, swelling was gone and she could walk as before. The patient was off work for one week. The patient was back to work at the time of the report. She saw her MD. They were unsure of the relationship to vaccine. Unspecified pain meds were prescribed. The patient recovered on an unspecified date.
Initial information received on 03-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2019SA004380. This case involves a 53 years old female patient who received 1ml instead of a 0.5ml of vaccine FLUZONE QUADRIVALENT (Multidose Vial lot number: UJ009AA, expiry date: 30-Jun-2019) via unknown route in right deltoid on 02-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. It was a case of actual medication error due to overdose. It was reported that no side effects after the injection. 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. Documents held by sender: none.
Severe swelling at site of ZOSTAVAX given 2 days ago. 13 x 7 cm wheal.
Tuesday night began with heart racing, SOB and palpitations.  Went to ER had EKG "showed skipped beats".  Then went to FMD still having palpitations.  Today Thursday waiting for a response from MD.
Started with fever, headache, chills, lasted 2 days, took Acetaminophen for fever.  Highest fever was 100.5, ran around 99.4 - 99.6 most of the day.  Chills was only the first night and fever and headache on and off for 2 days.
M pt. who presented with syncope after vaccination. EMS was called. Patient was lucid and responsive upon their arrival. Per safety officer account the patient was evaluated by EMS and was ultimately released to home.
Chest pains, racing heartbeat, nausea, "felt terrible", redness at injection site.
Coughing, itchy and runny eyes, body aches, stuffed nose, muscle cramps.
Several hours after shots (vaccines) were given on 6/11/10, patient developed seizure without a temp of 104 degrees F.
This spontaneous report was received from a nurse refers to unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy was not provided. On unspecified dates, the patients were vaccinated with an improperly stored dose of PEDVAXHIB (lot # L030872, expiry date: 11-JUN-2018). The temperature excursion details for vaccine were as follows: temperature 27.4 F, time frame 37.36 hours. The nurse reported a temperature excursion for the following products: GARDASIL 9 (Lot # L013429, expiry date: 29-JUL-2017; Lot # L017407, expiry date: 15-AUG-2017), M-M-R II (Lot # L012480, expiry date: 10-APR-2017) and PEDVAXHIB (lot # L030872, expiry date: 11-JUN-2018), however only PEDVAXHIB dose was administered. No adverse effect was reported. This is one of two reports received from the same reporter. Additional information has been requested.
not feeling great; flu-like symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (not feeling great) and INFLUENZA LIKE ILLNESS (flu-like symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939901, 031B21A and 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (not feeling great) and INFLUENZA LIKE ILLNESS (flu-like symptoms). At the time of the report, MALAISE (not feeling great) and INFLUENZA LIKE ILLNESS (flu-like symptoms) outcome was unknown.            No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
Painful pruritic rash/hives Throat closure/throat pain  Given epi, benadryl, antihistamines, topcical hydrocortisone, IM decadron, oral steroids.
pt recvd vax & began feeling heavy breathing; chest tightness; dry cough followed by fever 100; chills; achiness; called MD;
Patient presented to the ED on 7/16/08 with seizure activity that was difficult to contol after starting to have seizures at home. She was finally stabilized then transferred to the PICU at hospital. After being here she had again started to have uncontrolled seizures. She was started on multiple seizure medications (Phenobarbital, Fosphenytoin, Pyridoxine) but still not controlled so placed into a Pentobarbital coma. This was initially weaned with a recurrence of seizures, so placed back into a Pentobarbital coma and Keppra was added. This was again weaned with the recurrence of seizures. Parents then decided that with the amount of brain damage noted on imaging that they would like to withdraw support. The patient then passed a few hours after support was withdrawn. 7/29/08-pending. no significant trauma, no gross natural disease, brain and spinal cord retained for neuropathology exam. 8/11/08-records received for DOS 7/16-7/23/08-presented to ED after seizure, had low grade fever since Monday of last week 2 days after immunizations. Intubation. Bulging pulsating fontanelle, DX:seizure activity with cerebral edema.
Mother states baby started shaking about 1pm and baby trembled about 1 hour. Baby also started to be febrile. Mother instructed to bring baby in to be checked. Treatment: Tylenol monitoring no other reason for fever.
I woke up with dizziness and I had a stomach ache I felt like I needed to go but could not. I got up several times and had to go. I had the runs most of the night. I took two IMODIUM and went back to bed. I stayed in bed most of Wed 4-3-18. I started to vomit bile as I had nothing to eat and only drank water.
Felt tired and worn out and had a fever of 99.  Also coughing and congestion going down my throat.  all this started Sunday after noon and continue through the present time, although feeling more strength today
This spontaneous report as received from medical assistant refers to a patient of unknown age and gender. Patient's medical history and other previous drug allergic reaction were not reported. On 23-MAR-2013, patient was vaccinated with first dose of GARDASIL injection (strength, lot# and expiry date unknown) 0.5 ml, intramuscularly. No concomitant therapies were reported. Patient received second dose on 25-JUN-2014 and third dose on 22-AUG-2014. No adverse effect was reported. The outcome of a patient received the GARDASIL series as followed: first dose on 23-MAR-2013, second dose on 25-JUN-2014, and third dose on 22-AUG-2014 and no adverse effect were unknown. No further information was provided. Additional information has been requested.
This is a spontaneous report from a contactable Physician via sales representative (vaccine territory manager). During the conference a physician reported to the sales representative the events for a patient. A 82-year-old female patient of an unspecified ethnicity received PREVNAR 13 via an unspecified route of administration at 0.5 ml, single on 13Apr2016. The reporting physician is not the prescribing provider. The patient medical history was not reported. The concomitant medications included unspecified blood pressure medication and the patient used a CPAP. No other vaccines were given and there have been no medication changes. The patient lived alone and was physically fit. The patient experienced suspected Guillain-Barre syndrome on 24Apr2016, weakness on 22Apr2016, was not able to stand on 22Apr2016, breathing issues on an unspecified date. Course of events. The patient presented to the primary care of the physician on 22Apr2016 with symptoms of weakness and was not being able to stand. The symptoms at that point were disregarded by the primary care provider, then 2 days later, on 24Apr2016, the patient was hospitalized for suspected Guillain-Barre. Approximate hospitalization dates are 24Apr2016 to 30Apr2016. While hospitalized, the patient was changed from a CPAP over to a BIPAP because if breathing issues. The patient was then discharged to rehabilitation for 2 weeks prior to be re-hospitalized on 19May2016. The events suspected Guillain-Barre, weakness and not able to stand were reported as worsened. The outcome of event breathing issues was unknown.
Stroke; Paralyzed on one side of the body; Urinating Blood; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke), HEMIPLEGIA (Paralyzed on one side of the body) and BLOOD URINE PRESENT (Urinating Blood) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.     On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced BLOOD URINE PRESENT (Urinating Blood) (seriousness criterion hospitalization). On 03-Aug-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant) and HEMIPLEGIA (Paralyzed on one side of the body) (seriousness criteria hospitalization and medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), HEMIPLEGIA (Paralyzed on one side of the body) and BLOOD URINE PRESENT (Urinating Blood) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.  It was reported within 45 minutes after the first vaccine, patient was urinating blood.  The next day after vaccination he had a stroke and became paralyzed on one side of his body. Patient Doctor's say it was not related to the vaccine.  Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Ringing in left ear same side as shot received in left arm.  Ringing(tinnitus) has been constant for two days now and has not gone away.  Trying to make a doctors appointment.
Severe headache, fever, chills, muscle aches, dizziness, vomiting, diarrhea Lasted approximately 33 hours Took Excedrin Migraine and Zofran to treat symptoms
pt recv vax 16SEP95 & pt exp burning @ inj site, stinging @ inj site, & redness @ inj site;sx persisted;
Chills, fever of 102; sore, swollen, red upper right arm extending from injection site in pattern outward of 5 inches; nausea, anorexia, dry heaves.
At 05/06/2021 at 12:06am, body aches began to flare up. Approximately 2 hours after the body aches began, extremely low blood pressure and abnormally high pulse started where pt felt like she was about to die. These symptoms continued on for 4 days. On 05/10/2021, the initial symptoms slowly subsided, but a new set of symptoms emerged. Pt developed muscle twitching and spasms which started off as mild, but then progressed in the course of 5 days into severe muscle spasms and ticks. On 06/07/2021, pt was taken to the ER at  Medical  Center due to severe Tachycardia that was being caused by her severe muscle spasms/ticks (at the recommendation of her Primary Care Doctor). ER doctors were unable to diagnose her muscle spasms/ticks, and decided to discharge her. However, the ER doctors kept her longer due to her Tachycardia not subsiding. She was released once the Tachycardia was under control. On 06/10/2021, her Tachycardia returned. Currently, as of 06/23/2021, Pt is struggling to control the Tachycardia, muscle spasms/ticks, and blood pressure.
Covid arm 1st dose-left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Covid arm 1st dose-left arm) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included LITHIUM CARBONATE, INSULIN GLARGINE, INSULIN ASPART (NOVOLOG), BENZTROPINE [BENZATROPINE], DOCUSATE, VITAMIN C [ASCORBIC ACID], ZINC and MELATONIN for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION COMPLICATION (Covid arm 1st dose-left arm). On 30-Jan-2021, VACCINATION COMPLICATION (Covid arm 1st dose-left arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient was prescribed an unspecified antibiotic for the adverse event.   This case was linked to MOD-2021-024410 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow-up information received provided concomitant and treatment medications.
Patient reported swelling to left wrist are, no itching or pain. Area looked puffy and feels boggy.  Patient given 50 mg of Benadryl Po. After 30 minutes, swelling improved. Patient advised to take Benadryl 50 mg ever 6 hours x 24 hours. no driving while taking Benadryl. Follow up with nearest ER if symptoms worsen. Follow up in office for recheck in 48 hours
At around 2:20 in the morning I started getting really bad chills and shakes, I got 103 temperature and within 30 minutes diarrhea and stomach cramps and bodyaches
herpes zoster; post herpetic neuralgia; vision problems; balance problems; This initial spontaneous report was received from a lawyer regarding a case in litigation concerning an approximately 64-year-old male patient (pt). Information about pt's concurrent conditions, medical history, and concomitant therapy was not reported. On or October 2015, the pt was vaccinated in his local pharmacy with a Zoster Vaccine Live (ZOSTAVAX) subcutaneous injection for the long-term prevention of shingles and zoster-related conditions (dose, anatomical location, lot # and expiration date not reported). Subsequently, the pt was treated by providers for the following injuries resulting from pt's Zoster Vaccine Live (ZOSTAVAX) use: multiple outbreaks of herpes zoster, post herpetic neuralgia, vision problems, and balance problems. At the time of report, The pt outcome of the aforementioned events was unknown. The reporter considered all the above-mentioned events rto be related to Zoster Vaccine Live (ZOSTAVAX).