chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DIFFICULTY THINKING; CONFUSION; HIGH BLOOD SUGARS IN 200S LAST A1C UNREMARKABLE AT 6 POINT 2 PERCENT; VOMITING/THROWING UP STUFF/ VIOLENT VOMITING ONCE A WEEK; This spontaneous report received from a patient via another pharmaceutical company concerned a 60 year old male of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: malignant neoplasm of prostate (prostate cancer). The patient was receiving treatment with non-company suspect drug included: enzalutamide (capsule, oral, batch number: 1902517 expiry: 31-OCT-2024) 160 mg, 1 time every 1 day, from 17-SEP-2020 for malignant neoplasm of prostate (prostate cancer). On an unspecified date in APR-2022, the patient had second degree burn from french onion soup spill (intensity: mild). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total was administered on an unspecified date in SEP-2022 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 60 years old. Concomitant medications included baclofen, diltiazem hydrochloride, dulaglutide, famotidine, gabapentin, hydralazine, insulin aspart, insulin glargine, insulin human/insulin human injection, isophane, ipratropium, leuprorelin acetate, lisinopril, macrogol 3350, montelukast sodium, morphine sulfate, omeprazole, ondansetron hydrochloride, oxycodone, rosuvastatin, senna alexandrina, sertraline hydrochloride, and tamsulosin hydrochloride. On an unspecified date, the patient experienced vomiting/throwing up stuff/violent vomiting once a week (has increased in intensity after he got his covid vaccine), (intensity: mild). On an unspecified date, the patient experienced difficulty thinking (intensity: mild), confusion (intensity: mild), and high blood sugars in 200s last A1c unremarkable at 6 point 2 percent (intensity: mild). Laboratory data (dates unspecified) included: Blood glucose was high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of enzalutamide was not changed. The patient had not recovered from difficulty thinking, vomiting/throwing up stuff/ violent vomiting once a week, confusion, and high blood sugars in 200s last a1c unremarkable at 6 point 2 percent. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230458974-difficulty thinking. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: CONMEDS-OTHER SUSPECT DRUGS. Therefore, this event is considered inconsistent with vaccine administration.
Received vaccines on 9/16/16, since vaccines were given had erythematous patch to (R) anterior thigh, afebrile. Intermittent c/o pain and itchiness. No previous reaction to vaccine, no allergies. 6 cm x 6.5 cm, center of patch with 1 cm area with some induration, no drainage.
Increased migraines.  Dizzy all the time.  Seizure/syncope.  All have started since first dose of Gardasil vaccine.
Local reaction (redness, induration of left thigh) approximately 24 hours after vaccine was administered.
Myalgia, Fever, Tachypnea & Angina Narrative:  In addition to fever/chills/body aches, after my booster I also had chest pain and shortness of breath. Employee received booster on 12/14. The other symptoms were gone by 12/16 but the chest pain remained. Employee went to the ED on the mainland 12/22 and EKG, XRAY, and bloodwork was normal. Chest pain has improved 12/22 but not back to normal yet.
Patient reported altered taste about 15 minutes after vaccination.  Around 10:30-11pm the patient reported body aches, chills and a general unwell feeling that lasted for 3 days.
Patient reported to pharmacy Friday 8/10/18 to say his arm was sore. Area where immunized looked normal-no bruising, swelling, or discoloration. Bicep was puffy/swollen. I asked patient if he had fallen. He said no. He said he massaged the arm and applied ice. He said the ice made it feel better. I recommended he contact his doctor. He has not notified pharmacy of the outcome yet.
Rectal bleeding; Chest felt tight; Shortness of breath; Wheezing; Hard time walking; Was stiff; Felt vibration inside body; Dizziness; Could hardly eat because so dizzy and nauseated; Sore and swollen glands in neck; Sore and swollen glands neck; Sore and swollen glands in back of head; Nausea; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RECTAL HAEMORRHAGE (Rectal bleeding) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Primary immunodeficiency syndrome and Graves' disease. Concomitant products included IMMUNOGLOBULIN G HUMAN (IGG) for an unknown indication.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RECTAL HAEMORRHAGE (Rectal bleeding) (seriousness criterion medically significant), CHEST DISCOMFORT (Chest felt tight), DYSPNOEA (Shortness of breath), WHEEZING (Wheezing), GAIT DISTURBANCE (Hard time walking), MUSCULOSKELETAL STIFFNESS (Was stiff), FEELING ABNORMAL (Felt vibration inside body), DIZZINESS (Dizziness), DECREASED APPETITE (Could hardly eat because so dizzy and nauseated), LYMPH NODE PAIN (Sore and swollen glands in neck), LYMPHADENOPATHY (Sore and swollen glands neck), HEADACHE (Sore and swollen glands in back of head), NAUSEA (Nausea) and FATIGUE (Extreme fatigue). The patient was treated with STEROIDS at an unspecified dose and frequency. At the time of the report, RECTAL HAEMORRHAGE (Rectal bleeding), CHEST DISCOMFORT (Chest felt tight), DYSPNOEA (Shortness of breath), WHEEZING (Wheezing), GAIT DISTURBANCE (Hard time walking), MUSCULOSKELETAL STIFFNESS (Was stiff), FEELING ABNORMAL (Felt vibration inside body), DIZZINESS (Dizziness), DECREASED APPETITE (Could hardly eat because so dizzy and nauseated), LYMPH NODE PAIN (Sore and swollen glands in neck), LYMPHADENOPATHY (Sore and swollen glands neck), HEADACHE (Sore and swollen glands in back of head), NAUSEA (Nausea) and FATIGUE (Extreme fatigue) outcome was unknown.            This case was linked to MOD-2021-255802 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time (no onset date of events given hence cannot establish temporal relationship). Further information has been requested.
Moderna vaccine was administered outside of our facility - reported by patient ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------ R09.02 HYPOXIA 11/24/2021 ATRIAL FIBRILLATION, UNSPECIFIED R09.02 HYPOXIA 11/24/2021 ATRIAL FIBRILLATION, UNSPECIFIED
Initial and follow-up information has been received from a physician concerning a 12 year old female with no medical history and no illness at time of vaccination who on 06-AUG-2009 was vaccinated with her first dose of GARDASIL, Lot# 661046/0381X into her right arm at PM time. Concomitant therapy included her first dose of VARIVAX Lot# 664719/0804Y into her left arm and her first dose of VAQTA Lot# 663548/1604X into her left arm. On 06-AUG-2009, the patient experienced syncope. The patient dropped to the floor five minutes after vaccination, lasted less than 2 minutes and she was oriented right after she was picked up. The patient required emergency room/doctor visit. Laboratory tests included a chest X-ray and an ECG that were normal. On 06-AUG-2009, the patient recovered from syncope. No further information is available.
2days p/vax pt c/o h/a; redness right arm; warm to touch; c/o discomfort w/motion
Consistent diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Consistent diarrhea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016b21a and 011a21a) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (Patient was taking high blood pressure pills.).   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (Consistent diarrhea) (seriousness criterion medically significant). At the time of the report, DIARRHOEA (Consistent diarrhea) had not resolved.            Action taken with mRNA-1273 was not applicable.  Concomitant medications included high blood pressure pills.   Treatment information was not provided.; Sender's Comments: This case concerns a 76-year-old female with a serious unexpected event of Diarrhea. Event onset 2 hours after second dose mRNA-1273. Event ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient recieved the mmr vacinne on July 31 2004 and as a result she came down with the measles
A serious report of supraventricular ventricular tachycardia (SVT) with heart rate greater than 160 has been received from a Registered Nurse and an office manager concerning a 33-year-old female employee in a pediatric office subsequent to FLUMIST. Medical history included tachycardia. The patient was not on any concomitant medications. The patient received FLUMIST, intranasal administration as an influenza vaccine at 11:00am at work on 09-Oct-2008. At approximately 4:00pm on the same day, the patient started having a very fast heart rate. She was transported to the emergency room (ER). While in the ER, her heart rate increased as high as 250 beats per minute (bpm). An electrocardiogram confirmed SVT, a chest X-ray was negative and unspecified lab work was done and all results were within normal limits. The patient was treated with unspecified intravenous medication to decrease her heart rate. The patient was discharged from the ER at around 9:00pm. The outcome of the SVT was unknown. The sponsor considered the SVT to be serious (important medical event).
Pain radiating from fingertips to neck on side/deltoid of injection site (right) with hot flashes and nausea followed by low grade fever, difficulty breathing within 5 minutes. Resolved with 6L O2 and Epipen. Symptoms returned requiring hospitalization about 15:30.
patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.).    Concomitant medication list was not provided. It was reported that 196 patients received 0.25mL of Moderna COVID-19 vaccine, Bivalent Treatment information was not provided. .   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up: updated age group.
She felt tingling all over her body / in her lower back and face; pain when the vaccine was injected; she could feel the vaccine move down her arm across her chest and head and down the other arm; her arm hurt; This case was reported by a consumer via call center representative and described the occurrence of tingling in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th September 2020, the patient received the 1st dose of Shingrix. In September 2020, less than 2 weeks after receiving Shingrix, the patient experienced pain in arm. On 24th September 2020, the patient experienced tingling, pain and feeling abnormal. On an unknown date, the outcome of the tingling was not recovered/not resolved and the outcome of the pain was recovered/resolved and the outcome of the feeling abnormal was unknown and the outcome of the pain in arm was recovering/resolving.   It was unknown if the reporter considered the tingling, pain, feeling abnormal and pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient felt pain when vaccine was injected and she experienced the vaccine moved down her arm across her chest and head and down the other arm and she also felt tingling all over her body.  It was reported that when she was busy doing things like gardening, she did not notice it as much but was feeling the tingling in her lower back and face. She also said her arm hurt for a few days before resolving.  The reporter consented to follow up.
I had an increased heart rate for 2 days after my first shot, according to my Fitbit it was about 10 bpm more than my average. I also developed some spots on my right arm which is where I got my shot. They are on my upper arm right where I got the shot. I don?t know if it?s related.
Pt. complained of pain at injection site and fever one day after receiving TDAP swelling occurred and got progressively worse each day thereafter. Site is hot to touch and pain subsided but swelling continued on 10/27/09. Pt was seen and treated for cellulitis on 10/27/09.
I started having ringing in my right ear. Almost where I could hear music or water running. I went to the doctor, and he is treating me with Zyrtec. I did not associate it with the vaccine until I heard others having the same symptoms. I have one friend that is being treated by an ENT and she said it is one of the side effects of having the vaccination.
Initially after the vaccine I had the normal side effects of fatigue and soreness of body. The next day, it went away. But then it came back at night, and again I was fatigued and body soreness. Then that went away. Then a few days later, it came back but it also came back with a pain in my chest, under my breast. Not my heart but more so my lungs, and it was difficult to move or lay down and breathe. I went to the doctor the day after, which was also hard for me to do since I was very winded. The doctor gave me a prescription for anti inflammatory, because both sides are inflamed, did an EKG to make sure my heart was ok and ordered an x-ray.
On Monday 12/12/22 there was a vaccine reaction on a member that received Novavax. She had previous reactions to Moderna and Pfizer so her physician recommended she try the Novavax. Name. Her reaction happened about 20 minutes after the vaccine at 0956. She developed diffuse itchy red splotches to bilateral arms, legs and scalp.  She was given Benadryl 50 mg PO at 0950 and Zytec 10 mg po at 1121 per verbal orders from Dr. Patient was able to go home at 1135.
3 hrs p/vax c/o red, itching rash over entire body; instructed mom per phone to take pt to hosp where child previously seen for rash; allergy to Hep B vax & not to have #3 hepB;
Fever; Chills; Night sweats; This is a spontaneous report from a contactable other healthcare professional, the patient. A 27-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 15Mar2021 at 13:30 (at the age of 27-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via an unspecified route of administration in the left arm on 22Feb2021 at 13:30 (at the age of 27-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies to medications, food or other products. On 16Mar2021 at 00:00 the patient experienced fevers, chills and night sweats for two days. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the fever, chills and night sweats was recovered on 18Mar2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Eye swelling evening of administration of Flumist- increase antihistamine dosing to twice a day if needed
Dizziness, Myalgia, NauseaVomiting, Swelling and redness at injection site Narrative:
Patient started with urticarial rash on inner thighs on 7/18/22 (3 days after vaccination). Rash progressed over the next 24 hours and then he had swelling of bilateral wrists/ankles with refusal to walk on right foot on 7/19/22. Was also on Amoxicillin for otitis at the time of rash and mom had given dose of amoxicillin on the morning that rash began. Patient treated with Zyrtec/Benadryl for itching from rash. No fever or other systemic symptoms.
Blood pressure dropped; Pain in arm; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), BLOOD PRESSURE DECREASED (Blood pressure dropped) and PAIN IN EXTREMITY (Pain in arm) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. In December 2020, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced BLOOD PRESSURE DECREASED (Blood pressure dropped) and PAIN IN EXTREMITY (Pain in arm). At the time of the report, COVID-19 (COVID-19), BLOOD PRESSURE DECREASED (Blood pressure dropped) and PAIN IN EXTREMITY (Pain in arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: positive (Positive) Covid-19 test was positive. On an unknown date, Blood pressure measurement: low (Low) On an unknown date, blood pressure dropped..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.  The covid antibody infusion was also considered as a co-suspect. The event sore arm occurred in both doses of vaccine. The dechallenge result for the events were provided as not applicable and duration of therapy was given as discontinued.   This case was linked to MOD-2021-111971 (Patient Link).
Information has been received from a licensed practical nurse concerning an adult patient with no known drug allergies who on an unspecified date was vaccinated intramuscularly with a 0.5 mL dose of Pneumovax 23 (lot 655587/0882F). Within 24 hours of vaccination, the patient developed redness, pain, and swelling at injection site. The patient sought unspecified medical attention. No other symptoms were noted. Subsequently, the patient recovered from all symptoms. Additional information has been requested.
Urticaria. With pain , burning, itching....cortisone cream, oral steroids,  aspercreme  With 4% lidocaine. Benedryl orally and famodine.  2 visits to clinic for this rash which continues to spread
Patient's eyes rolled back and he appeared pale. Once he was positioned supine on the exam table, his arms stiffened and had tonic-clonic movements of both lower extremities and his face became flush. The episode lasted less than 1 minute. When he returned to consciousness, he said he was really tired and he "a really crazy dream." He was able to orient himself to person, place, time, and reason why he was there.
Red rash on stomach and has spread to his sides; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash on stomach and has spread to his sides) and VACCINATION SITE PAIN (Sore arm) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (Red rash on stomach and has spread to his sides) and VACCINATION SITE PAIN (Sore arm). At the time of the report, RASH ERYTHEMATOUS (Red rash on stomach and has spread to his sides) and VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Vaccine administered at 11:45 AM. At 12:05 associate reported "tingling in tongue and at back of throat". B/P 130/82, Heart Rate 122. Associate then complained of " a little difficulty swallowing". Associate also began a small cough. Associate advised to go to ED. Escorted to ED. Associate started breaking out in hives.
Patient states that within 1-2 hours of vaccine her arm had red, warm, swollen area itchy surrounding injection site. She states by the next day her arm was swollen from shoulder to elbow, red and hot. This gradually subsided. She reports feeling weak the evening of the injection.
myocarditis roughly 24 hours after shot, pain in chest, difficulty breathing, elevated heart rate. hospitalized overnight
Patient received vaccine at 11:15AM, started itching at 1:30PM on the left side of her body first - same side vaccine was administered. Itching was progressing to arms, head, torso and legs. Denied SOB or difficulty swallowing/breathing. No visible hives noted. She did not want Benadryl initially, continued to monitor patient. RR even/unlabored. No wheezing. 2:30PM Pt agreed and Benadryl 12.5mg chewable was given. Cool towel placed on neck/arms which client stated that made her skin feel better. 1500- reassessed itching. She states: "It's better." and says: "I'm alright," declined further dosing. Discussed danger signs again: SOB/Hives/palpitations and patient educated on when/if she may need to report to the hospital/ER. She continues to deny SOB or having any difficulty breathing. 1520-Patient reports she is OK. Some minor itching persists. She verbalizes understanding and will take more Benadryl later and if needed, will report to the ER for any concern.