chrisvoncsefalvay/vaers-outcomes huggingface dataset:
havent been feeling myself lately; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (havent been feeling myself lately) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (havent been feeling myself lately). At the time of the report, FEELING ABNORMAL (havent been feeling myself lately) outcome was unknown.            No concomitant medications was reported.  No treatment drug details was reported.
Headache, muscle spasms, weakness 24 hours after receiving shot of H1N1. Went to ER. Had CT scan, blood work and sent home after about 7 hours.
On 09/08 a first attack: - difficulty in breathing.- intense fatigue which required hospitalization, the diagnosis did not reveal any anomalies For two weeks I observed the same symptoms and in addition loss of appetite, the blood tests are good, covid test negative. The symptoms disappeared afterwards, but reappeared on 9/30, but more severe this time. Until today I suffer from the same symptoms, which required two hospitalizations. All the analyzes and chest/abdominal scans are good: - Covid Negative test - thoracic and abdominal CT scan; No abnormality - blood tests  No anopamlie. Please advise me what to do, I suspect Janssen vaccine as the cause of these disorders.
Tachycardia of 115-178 bpm  starting 6 hours after injection.  Lasted 12 hours.
after the second dose of the vaccine, the rashes and welts got bigger; after the second dose of the vaccine, the rashes and welts got bigger; after the second dose of the vaccine, the rashes and welts got bigger; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 06Mar2021 as dose 2, single for covid-19 immunisation. Medical history included Anuric from 2020, allergy to hydrocodone/Tylenol 3. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 13Feb2021 as dose 1, single for covid-19 immunisation and had Whelps, rash, itching, bumps on upper boy near chest and under arm, swelling of ear lobes, mouth, and eyes, pealing of ears, lines on body. concomitant medication included tamsulosin hydrochloride (FLOMAX) taken for prostatic disorder, start and stop date were not reported. The patient experienced after the second dose of the vaccine, the rashes and welts got bigger. Patient trying to eliminate hygiene products because he thought that was the cause of his reaction. He has been using a cream called Larisa for the symptoms. Patient saw his primary HCP about his symptoms and she advised him not to get the vaccine again due to fear that he may have a anaphylactic reaction and want to know would like to know if he should not get the vaccine if it is ever a need to get it again in the future considering his reaction. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
At the end of February I started feeling my ear being clogged that was about two weeks after the shot, I went to see an ENT at that time but they didn't do the hearing test. He looked at my ears and said he didn't see any issues. Then I had move and got another ENT too look at my ear and they did a hearing test and he said that I had hearing loss. There is also a ringing that keeps coming and going and I still can't hear well out of my right ear and it still feels clogged from time to time as well.
Pt developed joint pain and swelling w/ dizziness (every 2 to 3 days) and 8 lb weight gain (? fluid)  since the booster was given.  In the process of seeing Rheum for further w/u but the swelling has not improved yet and it is still unclear if the vaccine may have triggered these symptoms.   Course of steroids helped but symptoms recurred after stopping.
Pfizer Dose 1 2/11/21 (EL1283) Pfizer Dose 2 3/5/21 (EN6205) Pfizer Dose 3 11/2/21 (lot NA) COVID Positive 1/31/22  1/31/22: This is an 87-year-old male with history of atrial fibrillation on chronic anticoagulation with Coumadin, hyperlipidemia, metastatic prostate cancer and obesity who presented to the emergency department with abdominal pain. Patient states that he has been having left lower quadrant abdominal pain for the past few days. His pain is dull in nature, mild to moderate in intensity, intermittent, without noticeable relieving or exacerbating factors. He reports associated abdominal distention and decreased bowel movements. He reports feeling fatigued and tired. He has history of prostate cancer and follows with doctor from Urology. He denies chest pain, shortness of breath, dizziness, cough, nausea or vomiting. He has no blood in the stool.   In the emergency department, labs showed a creatinine of 2.2, hemoglobin of 10.8, INR level of 8.1. CT abdomen and pelvis with oral contrast showed extensive ascites and suspicious findings for peritoneal carcinomatosis. It also showed moderate right pleural effusion and small left pleural effusion. Patient was given IV fluids, p.o. vitamin K, IV Zofran.  2/5/22: P.o. Coumadin 5 mg daily  INR ordered in 2 days  Follow-up with PCP in 3-5 days  Patient to follow up with Oncology as outpatient in 1-2 weeks  He will will be called by Oncology office to set up an appointment  Abdominal biopsy and paracentesis results are pending  Patient agrees with plan of care  Will discharge patient home
No adverse event. After giving immunizations reading paperwork had been marked as yes pregant. Pt did not mention- called --------- to verify- Pt reported 11 weeks pregnant, attempted to contact
Information hs been received from a registered nurse concerning a 64 year old patient who on approximately 01-NOV-2008 was vaccinated with VARIVAX (Oka/Merck), instead of ZOSTAVAX (Oka/Merck) (duration and dose not reported). No symptoms reported. Additional information hs been requested.
Pt recvd 3 doses of Engerix-B vax 21JAN91 & 25FEB91 & 21AUG91 & it was determined that the pt did not respond to the vax series; 4th dose  of the vax given 15OCT91 & again it was determined that pt did not respond;
This spontaneous report was received from a physician and refers to a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were unknown by the reporter. On 13-AUG-2018, the nurse was giving the dose of (wistar ra 27-3) M-M-R II (exact dose, frequency, lot number and expiration date were not reported) to an unspecified patient and she inadvertently got (wistar ra 27-3) M-M-R II squirted into her eye. No adverse effect reported.
pt recv vax 9MAY96 & 21MAY96 pt devel 15 spots;No further details were provided;
after about 5 minutes after the vaccination, the patient said they felt light headed, dizzy, and numbness in hands and neck.  paitent then requested to lie on the ground in the pharmacy waiting area where the RPH monitored pulse and breathing, both were normal throughout.  the patient said she felt nauseated and wanted to set up.  we offered to call 911 and she accepted.
Patient received Pfizer vaccine #2 today.    After the vaccine, the employee reported the following symptoms:  burning form the inside out  some dizziness   Lot: EN9581  Time of Administration: 14:37  Time Symptoms Began:   _____   Patient alerted observer who took the patient to the medical observation area.  I was alerted and responded.   Initial Assessment @ _2:44p_:  Patient is AAO.  The employee is sitting up on the sofa.  The employee is pink and does not appear to be in distress.  They are talking and making conversation.    Vitals @: 2:44pm  HR: 98  BP: 163 / 95 - BP is usually 100/70ish  O2: 99   Vitals @: 2:46pm  HR: 84  BP:  O2: 98  Vitals @: 2:49pm  HR: 65  BP: 135/96  O2: 99% Patient is feeling much better.  She no longer feels hot.   Discharged at 2:52pm
Headache on left side of head; rash on face; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 11May2021 at 09:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medication included multivitamin (MANUFACTURER UNKNOWN) from unknown start date and for unspecified indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. On an unknown date in May2021, the patient experienced headache on left side of head and rash on face. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of headache and rash on face and included treatment with muscle(unspecified) relaxer, ADVIL, TYLENOL from unknown start dates to unknown stop dates. The clinical outcome of the events headache and rash on face were recovered on an unknown date in 2021 at the time of this report.   No follow-up attempts are possible. No further information is expected.
Sickness; Myalgia; No strength; Low back pain; Headache; Feeling unwell; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell), PYREXIA (Fever), ILLNESS (Sickness), MYALGIA (Myalgia) and ASTHENIA (No strength) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL SUCCINATE (TOPROL XL) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PYREXIA (Fever). On 16-Apr-2021, the patient experienced MALAISE (Feeling unwell), ILLNESS (Sickness), MYALGIA (Myalgia), ASTHENIA (No strength), BACK PAIN (Low back pain) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 UNK; IBUPROFEN at an unspecified dose and frequency; VITAMIN D NOS at an unspecified dose and frequency and VITAMIN B12 NOS at an unspecified dose and frequency. At the time of the report, MALAISE (Feeling unwell), PYREXIA (Fever), ILLNESS (Sickness), MYALGIA (Myalgia), ASTHENIA (No strength), BACK PAIN (Low back pain) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.3 98.3.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
This is a spontaneous report from a contactable reporter (patient's brother). The reporter has reported similar events for one other patient. This is the 2nd of 2 reports. A female patient of an unspecified age received TRUMENBA, NDC, lot number, or expiration date unknown) via an unspecified route of administration at an unspecified dose on an unspecified date. The medical history was not reported. The concomitant medications were not reported. On unknown date the patient experienced sick symptoms after the vaccine was administered. Follow-up attempts completed. No further information expected.
EMG revealed nerve damage/sensation of nervous system experiencing electricity/vibrations throughout body; Confusion; slurred speech; severe muscle spasms; tremors; sudden episodes of numbness in arms and legs; severe pressure in head; dizziness; tinnitus; heart palpitations; increased heart rate; shallow breathing; disturbance in menstrual cycle; sensation of nervous system experiencing electricity/vibrations throughtout body; This is a spontaneous report from a contactable consumer (patient). A 36-years-old female (not pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration at age of 36 years, administered in arm left on 07Aug2021 12:30 (Lot Number: EW0183) as single dose for covid-19 immunisation. Medical history included allergies to Almonds. No covid prior vaccination. The patient's concomitant medications were none. No other vaccine in four weeks, no other medications in two weeks. The patient experienced Confusion/slurred speech, severe muscle spasms, tremors, sudden episodes of numbness in arms and legs, severe pressure in head, dizziness, tinnitus, heart palpitations, increased heart rate, shallow breathing, disturbance in menstrual cycle, and sensation of nervous system experiencing electricity/vibrations throughout body post vaccination. EMG (20Aug2021) revealed nerve damage of questionable clinical significance thirteen days post vaccination. MRI (2021) revealed no underlying condition. Covid test via nasal swab on 13Aug2021 and negative. The pharmacy does not recommend that patient receive the 2nd shot after her adverse reaction to the Pfizer Covid-19 vaccine. The pharmacy also guided she to the Pfizer website to report adverse reaction event. Adverse events start date was 07Aug2021 13:30 and resulted in Doctor or other healthcare professional office/clinic visit, no treatment was received. The outcome of the events was Recovered/Resolved with Sequel in 2021.  No follow-up attempts are possible. No further information is expected.
itching; texture of my skin the different textures in different places I am itching; and I am in pain in a number of places; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itching), SKIN TEXTURE ABNORMAL (texture of my skin the different textures in different places I am itching) and MYALGIA (and I am in pain in a number of places) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS and Asthma.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching) (seriousness criterion hospitalization), SKIN TEXTURE ABNORMAL (texture of my skin the different textures in different places I am itching) (seriousness criterion hospitalization) and MYALGIA (and I am in pain in a number of places) (seriousness criterion hospitalization). At the time of the report, PRURITUS (itching), SKIN TEXTURE ABNORMAL (texture of my skin the different textures in different places I am itching) and MYALGIA (and I am in pain in a number of places) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  The patient was tested for over a hundred different allergies and was found to have one.  Treatment information was not provided.  Company Comment : 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.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: follow-up document received on 02-07-2021, upgraded case seriousness as hospitalization.; Sender'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.
PVCs developed about 20 minutes after administration of vaccine. Placed on Zoll cardiac monitor.  Vitals to include BP, heart rate, respiratory, pulse ox several times during additional monitoring period. No respiratory distress or other issues during this monitoring period. Monitored until 1510, patient contacted primary care provider via patient portal.
like a hard area at the injection/hardness; This is a spontaneous report from a contactable consumer (parent). A male patient of an unspecified age received second dose pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for an immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that the patient got his second pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) injection, two and a half days ago and he had like a hard area at the injection site and the doctor said that it could be normal at first. Reporter stated that the were like two and a half days in and just wanted to understand like how long they should expect the hardness to be there. The outcome of the event was unknown.
This literature marketed report as received from the authors of the published article, entitled as stated below, refers to a 15 year old male patient. The authors analyzed the findings of the Vaccine Safety Datalink Guillain Barre Syndrome (GBS) surveillance following quadrivalent human papillomavirus vaccine (manufacturer unknown) from 2006 through 2015. Medical records were reviewed and ajudicated to confirm GBS. Among quadrivalent human papillomavirus vaccine (manufacturer unknown) recipients, the authors identified all potential electronic ICD-9 coded cases of GBS using the following definition: diagnostic ICD-9 code 357.0 within 142 days post-vaccination (whereas day 0 is day of vaccination), in either the inpatient, outpatient, or emergency department settings. An incident case of GBS following quadrivalent human papillomavirus vaccine (manufacturer unknown) was defined as the first diagnosis in the preceding 42 days. Seven cases of GBS were identified using the electronic case definition prior to medical record review. After performing medical record review, the authors confirmed only one case. The patient was a 15 year old male, who received his first dose of quadrivalent human papillomavirus vaccine (manufacturer unknown) on an unknown date (dose, lot#, expiry date, route of administration not reported). 15 days later, he was diagnosed with acute inflammatory demyelinating polyneuropathy, the most common form of GBS. The outcome of the event was not reported. The authors considered the event to be related to the suspect therapy. Upon internal review, GBS was considered to be medically significant.
The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and expiry: not reported) .5 ml, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced dizziness, and achy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness and achy was not reported. This report was non-serious.
CONFIRMED CLINICAL VACCINE FAILURE; CONFIRMED COVID-19 INFECTION; BLOOD SUGAR HIGH; This spontaneous report received from a patient concerned a 48 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetic, hypertension, non alcohol user, and non smoker. The patient had no known drug allergies. and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on JUN-2021 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-DEC-2021, the patient felt sick and went to hospital. The patient visited emergency room. She underwent covid-19 test and was discharged home on the same day and told to quarantine. Her blood sugar level was also high (over 500). On 11-DEC-2021, the patient received phone call from the hospital, that confirming her test result was positive (confirmed covid-19 infection and confirmed clinical vaccination failure). The patient stated she was at home, self-quarantined. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccine failure and blood sugar high was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0:20211231022-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccine failure. 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: SPECIAL SITUATIONS
On Friday 6/18/08 at 10:00AM; patient got confused and progressively got worse.  Also experienced shaking chills, diarrhea and vomiting.  Patient didn't know where she's at at the time.  Was taken to ER; where a spinal tap and Cat scan were done.  Given DECADROM 10mg IV and 40mg qid p.o.  Diagnosis: toxic encephalitis. 7/14/08-records received for DOS 6/21/08-DX: acute delirium resolving likely from yellow fever. Altered mental status, unable to state her location.
pt recv vax;in 1979 at 10 mo, neurologist dx encephalopathy;presently pt has poorly controlled sz,mild cerebral palsy & functions on a 3-4 yr old level per dad;
Left deltoid region pain that may be leading to left shoulder and neck and upper arm pain that has persisted for approx 2 mos.
12 hours after injection started to feel tired and achy and chills. Had severe headache 24 hours after injection. Took Excedrin migraine medicine   Had a fever 101 most of the day. Tired with body ache and headache. Took excedrine migraine medicine 36 hours after started to feel better. 48 hours after injection still tired but headache is much better and a slight fever. Felt like I had Covid again. Just for the 2 days.
Patient experienced fever with T=max of 101.7, fatigue, arthralgias, headache, and chills. Patent did not require emergency medical attention. Patient treated with acetaminophen and bedrest. Patient was unable to attend work for 24 hours.
Parents mom called the next day and stated school called her and said pt had a lump on his left arm the size of a silver dollar. Mom bought him here for us to look at & there was a 40mm x 43mm induration to his left lateral deltoid area where the varicella was given. BENADRYL cream was applied, advised mom she should continue with cream & give oral BENADRYL.
This case was reported by a consumer via interactive digital media and described the occurrence of adverse reaction in a female patient who received Influenza vaccine Quadrivalent. In November 2015, the patient received Influenza vaccine Quadrivalent. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that in all her life she had vaccines, but this time she received the flu vaccine and this was not good experience for here. The patient did not report any details, but was still suffering from the consequences.