chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented to urgent care clinic approximately 24 hours after receiving the Moderna Covid-19 vaccine with complaints of fever and myalgia. She had mild confusion with the fever which resolved after acetaminophen. However, due to the confusion, she received an extensive work-up in clinic for other causes of altered mental status.
Employee stated she started to feel dizzy, nauseated, severe migraine and salivating 15 minutes after her injection. Blood pressure was 131/87 pulse 67. Employee was transported EMS.
New-onset Neuromyelitis Optica Spectrum Disorder; This literature-non-study case was reported in a literature article and describes the occurrence of NEUROMYELITIS OPTICA SPECTRUM DISORDER (New-onset Neuromyelitis Optica Spectrum Disorder) in a 54-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.       No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEUROMYELITIS OPTICA SPECTRUM DISORDER (New-onset Neuromyelitis Optica Spectrum Disorder) (seriousness criterion medically significant). At the time of the report, NEUROMYELITIS OPTICA SPECTRUM DISORDER (New-onset Neuromyelitis Optica Spectrum Disorder) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NEUROMYELITIS OPTICA SPECTRUM DISORDER (New-onset Neuromyelitis Optica Spectrum Disorder) to be related.    No concomitant and treatment medication were reported.  Company Comment: This is a Literature-Non-Study case concerning a 54-year-old female patient, with no medical history reported, who experienced the serious unexpected adverse event of Neuromyelitis optica spectrum disorder (serious criteria Medically Significant), in an unknown date, after receiving the second dose of the mRNA-1273 vaccine. Very limited information is available regarding clinical course and diagnostic work-up. It is stated in this case that there is a new-Onset of Neuromyelitis Optica Spectrum Disorder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-537932, MOD-2022-537973.; Sender's Comments: This is a Literature-Non-Study case concerning a 54-year-old female patient, with no medical history reported, who experienced the serious unexpected adverse event of Neuromyelitis optica spectrum disorder (serious criteria Medically Significant), in an unknown date, after receiving the second dose of the mRNA-1273 vaccine. Very limited information is available regarding clinical course and diagnostic work-up. It is stated in this case that there is a new-Onset of Neuromyelitis Optica Spectrum Disorder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Severe shoulder/upper arm pain since a few days after. Feels like an actual injury. Can't sleep on that arm, can't lift it. Very painful.
Headache, Myalgia, FLUSHING, FATIGUE, SWEATING, CHILLS Narrative:
Patient called the pharmacy on 9/13/19 at approximately 130 pm and stated that she has complaining of dizziness and skin crawling for the past day and started feeling this way shortly after receiving her flu shot around 1130 am on 9/12/19
G40.89 FOCAL MOTOR SEIZURE 7/27/2022 G47.33 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 6/25/2022 I21.4 ACUTE NON ST ELEVATION MI 5/7/2022 J96.00 ACUTE RESPIRATORY FAILURE 7/27/2022 J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 7/28/2022 R09.02 HYPOXEMIA 7/25/2022 G40.89 FOCAL MOTOR SEIZURE 7/27/2022 G47.33 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 6/25/2022 I21.4 ACUTE NON ST ELEVATION MI 5/7/2022 J96.00 ACUTE RESPIRATORY FAILURE 7/27/2022 J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 7/28/2022 R09.02 HYPOXEMIA 7/25/2022
Pt's mother reports that pt was brought to Hospital ED at 3AM and 12PM 8/11/21 - Pt w/ reaction R arm one day after vaccine administration - R arm red/purple swollen, firm, hot to touch, pt scratching at arm and crying out/pulling away when arm touched - Pt w/ fever and poor appetite - Pt brought to ED, given allergy medication, motrin, and abox Pt now with smaller area of redness and swelling, reduced warmth, mild congestion and nasal drainage Mother continuing to monitor pt, declined f/u appt, will cb tomorrow if continues or gets worse.
I experienced abdominal pain and cramps a week after getting my shot. The pain intensified over the course of the year, my menstruation cycle became 2 weeks shorter and extremely painful whereas I?ve never had any period pain in the past.  In January 2022 I was diagnosed with colon cancer with two tumors, one that is 3cm and one 5cm, in the exact spots where the pain was. The tumors became so large it caused complete bowel obstruction and I had half my colon removed through surgery to save my life. I have no cancer in my family and the pathology showed that it?s the gene mutation in the MRNA-DNA category. Dating the size of the tumor it would have started to grow at around May of last year when I first got the shot.
9/9/1999, pt presents to clinic after calling re: painful, red and swollen left upper arm. Received pneumococcal vaccine at 12:30 and began experiencing symptoms around 16:00. Pt has large area of redness over left upper arm and spreading of redness towards left arm pit. Referred to PMD. On 9/10/99, called pt and MD ordered ice packs and antibiotics. Still recovering.
This spontaneous report as received from a Doctor of pharmacy refers to an 85 year old female patient. On 30-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported) IM instead of SQ. The pharmacist reported that on 30-JUL-2013, the patient experienced soreness at the injection site. There was no Lab/diagnosis or studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
This spontaneous retrospective pregnancy report was received from a 25 year old female patient, who was medical assistant and reporting on herself. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date in 2008, the patient was vaccinated with 3 doses of GARDASIL injection (dose, route of administration, lot # and expiry date were not reported. On an unknown date in 2010, (reported as at age 17), the patient delivered a baby (details unknown) (captured in MARRS# 1803USA006531). On an unknown date in October 2017, the patient was diagnosed with cervical cancer with strain HPV (human papillomavirus )-16. On an unknown date (reported as recently), the patient experienced a miscarriage. The last menstrual period (LMP) and estimated date of delivery (EDD) were unknown. On unspecified dates, the patient had colposcopy and dilation and curettage (D&C) as a treatment. Unspecified lab diagnostics and studies were performed. The significant disability or incapacity was reported and not specified. The outcome of the events was unknown (reported also as "Not"). The causality assessment was not provided. Upon internal review, the events of cervical cancer and miscarriage were considered to be medically significant.; Sender's Comments: US-009507513-1803USA006531 :
No adverse reaction to the vaccine. Employee mistakenly gave the wrong vaccine (adult pfizer) to a patient outside the age range (11 y.o.)
Patient was administered Pfizer Pediatric biontech  patient waited 15 minutes at clinic no reaction during that time at the clinic
Tingling in my tongue and lower lip; It is like if you put pepper on your tongue, I am feeling it from the tip of tongue to the sides of my tongue like from the tip you go towards you jawline; It is like burning and it started out as tingling; It feels like it is there and there is something wrong; This is a spontaneous report from a contactable nurse. This 76-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EL9265, expiration date was not reported), intramuscularly in right upper arm on 02Mar2021 (age at the time of vaccination was 76-years-old) as single dose for COVID-19 immunization. The patient took the shot at 11.30 yesterday morning, got the shot at around 11:10 AM, the patient was asked to wait for 15 minutes and the patient waited for 25 minutes. The patient's medical history included high blood pressure and it was controlled and taking high blood pressure medication, anxiety. The patient's concomitant medications included the patient take Synthroid and Levothyroxine because the patient had thyroid gland removed years ago (not clarified further) and Sertraline, which was Zoloft (not clarified if consumer was taking Zoloft or Sertraline, hence not captured in tab), 50 mg for anxiety. On an unknown date, the patient would reduce it to a burning, yesterday it was more pronounced, and it continued all night, so the patient didn't sleep flat. The patient was not sure if it will get to anaphylactic or anything, it was like put pepper on tongue, that was best description that the patient can give, it was like if put pepper on tongue, the patient felt it from the tip of tongue to the sides of my tongue like from the tip go towards the jawline and it was not under whole tongue, it was right around it and it was like burning and it started out as tingling and sometimes, it does like it did today morning (on the day of reporting), but it was not a severe tingling but it was felt like it was there and there was something wrong (not clarified appropriately further, hence ongoing not checked). The patient did not received any treatment and was just ready to go hospital if the patient had to just in case but there was nothing. The patient had no breathing problem and nothing at all. The outcome of the event was not resolved. The patient was hesitated to get the second dose. The patient just wanted to report the side effect that did not see in the list and all of the literature.   No follow up attempts are possible. No further information is expected.
Initial unsolicited report received from an office staff on 25-Oct-2017. This case involves a female patient of unknown age who was vaccinated with a intradermal dose of FLUZONE INTRADERMAL (batch number, expiry date and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced whole upper arm was completely swollen and red. The patient's laboratory data and corrective treatment were not reported. The event's outcome was not reported. List of documents held by sender: none.
Black color at site of injection, tender and hard at site of injection, pain into neck and spasm into chest.
Sudden syncope and collapse or seizure. No history of this. Fell on face and broke nose.
Extreme joint pain. 9/10 pain. It was been over 1 month and I have extreme hip pain.  I have no Heath problems. Not over weight.  I did not have this before I received my second shot.
Symptoms started on 8-16-2021 with nasal congestion, cough, fatigue, muscle aches.
SORE ARM/ CAN HARDLY MOVE IT; FLU SYMPTOMS/ NAUSEA/ NO APPETITE; This spontaneous report received from a patient concerned a 45 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A22A expiry: UNKNOWN) dose was not reported, administered on 13-APR-2021 07:20 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021 18:00, the subject experienced flu symptoms/ nausea/ no appetite. On 14-APR-2021 08:00, the subject experienced sore arm/ can hardly move it. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu symptoms/ nausea/ no appetite on 14-APR-2021, and had not recovered from sore arm/ can hardly move it. This report was non-serious.
Developed severe Obsessive Compulsive Disorder, anxiety, and auto immune problems. Immune system seems to be attacking basal ganglia part of brain. We want our son back and we are treating as if PANDAS  (Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections) but no luck solving problems 2 years after onset of symptoms. Missed almost 2 years of school where he was doing B average work before things started.
A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353398USA. The subject, an 18 yr. old female was administered ADENOVIRUS TYPE 4 AND TYPE 7 LIVE VACCINE (Tablet, Oral) on 12-Jul-2012, batch: 34600039. On 12-Jul-2012, the patient experienced OTHER ANAPHYLACTIC SHOCK, NEC. The patient also had Acute Bronchitis on 13-Jul-2012 and received medication and an outpatient visit for this event. Lab tests: 13-Jul-2012, WBC: 18.62 mmol/L; 13-Jul-2012, Platelets: 439 mmol/L; 13-Jul-2012, Neutrophils: 82.7%; 13-Jul-2012, Lymphocytes: 8.9%; 13-Jul-2012, Monocytes: 8.1%; 13-Jul-2012, Absolute neutrophils: 15.4 mmol/L; 13-Jul-2012, Absolute monocytes: 1.5 mmol/L; 13-Jul-2012, Neutrophils segmented: 81%; 13-Jul-2012, Lymphocytes: 9%; 13-Jul-2012, Monocyte count: 7%; 13-Jul-2012, Basophils: 2%; 13-Jul-2012, Creatinine Kinase: 261 IU/L; 13-Jul-2012, Albumin: 4.9 g/dL; 16-Jul-2012, Lymphocytes: 21.6%; 16-Jul-2012, Monocytes: 10.9%; 16-Jul-2012, Absolute monocytes: 1.1 mmol/L. The outcome of the AEs were: OTHER ANAPHYLACTIC SHOCK, NEC: recovered/resolved. Action taken with suspect drugs: ADENOVIRUS VACCINE - Not applicable. The patient's medical history was not reported. The patient's concomitant medications included TETANUS VACCINE; DIPHTHERIA VACCINE; PERTUSSIS VACCINE (since 05-Jul-2012); MENINGOCOCCAL POLYSACCHARIDE (since 05-Jul-2012); POLIOMYELITIS VACCINE INACTIVATED (since 05-Jul-2012); HEPATITIS A VACCINE (since 12-Jul-2012); HEPATITIS B VACCINE (since 12-Jul-2012). The patient's past medication were unspecified. This case was considered serious based on the following criteria: (Other Serious (Important Medical Events)). Medical Monitor Assessment of Events: Causality between OTHER ANAPHYLACTIC SHOCK, NEC and ADENOVIRUS VACCINE is reported as Reasonable Possibility. "Patient got Prednisone and diphenhydramine for indication anaphylaxis in timeframe appropriate for possible relatedness but symptoms not specified". ICD-9 Code confirmed.
Tinnitus and slight dizziness lasting approximately 24 hours One week later hospitalized for chest discomfort and rapid heart rate. Echocardiogram and nuclear stress test showed marked myocarditis.
Large local reaction surrounding injection site started the evening at 10/3/17, 10 x 14 cm.
No adverse event; expired PNEUMOVAX administered; This spontaneous report was received from a nurse practitioner referring to a female patient of unknown age.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.    On 12-JAN-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), 0.5 milliliter for prophylaxis, which had expired on 03-DEC-2020 (dose, route and site of administration and lot number were not reported).   No adverse events were reported.
Parent noticed pt to seem feverish in morning when first waking up, AM temp was 101F,  parent stated pt did not seem to feel well, parent gave some fever meds, retook temp at 1130 - temp was 99.7F.   At 1300, parent stated pt was shivering, temp at that time was 101F, retook temp at approx 1400, temp was 103.7F, parent gave pt Tylenol and called medical provider.  Pt was seen by  medical provider at approx 1430.  Temp was 39.4C.
Headache  nausea  chills weakness  severe arm pain right arm .    Recovered in 10 hours followed by slight headache for several days.
Information has been received from a registered nurse concerning a 75 year old male with a respiratory disorder, idiopathic pulmonary fibrosis, chronic hypoxemia and cor pulmonale who on 11/2/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 647655/0869N). It was noted that the proper syringe for injection was used. Subsequently, the patient developed a red, swollen and painful arm. On 11/4/04, the patient became acutely ill. He developed a fever, chills, respiratory distress, and confusion. He was hospitalized in the intensive care unit. He was placed on bi-pap because he refused to be intubated. It was also noted that in October 1999 the patient also received a dose of pneumococcal 23v polysaccharide vaccine. No product quality complaint was involved. Additional information has been requested. It was also reported that 3 other patient's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647655/0869N) and also developed AE's. (WAES0411USA00638, 0411USA00945, and 0411USA00947).
I've been having swelling into my joints and fingers after receiving my vaccine. It grows larger in size with heat sensation and swelling every time. This has happened since receiving my first dose concurrently up to now receiving my bivalent dose. Currently, there's a cyst that has developed on my right hand by my fingernail. My physician sent me to a rheumatologist to rule out any immune disorders through bloodwork tests. With each new dose, it happens. It'll settle in between and reoccur after receiving a new dose.
Itching; Red rash in her chest, arms, and shoulders; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) and RASH ERYTHEMATOUS (Red rash in her chest, arms, and shoulders) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced PRURITUS (Itching) and RASH ERYTHEMATOUS (Red rash in her chest, arms, and shoulders). At the time of the report, PRURITUS (Itching) and RASH ERYTHEMATOUS (Red rash in her chest, arms, and shoulders) had not resolved. Not Provided          No concomitant medications were reported. No treatment information was provided.
Patient received dose of COVID19 (Pfizer-BioNTech) past the vial BUD (Beyond Use Date) of 32 days from transfer of deep freeze to refrigeration temperature. BUD date of dose was 1/7/22 at 0900, patient received vaccination on 1/7/22 at approximately 10:50am. When error discovered facility contacted for course of action. At direction of the, patient contacted regarding occurrence to offer re-vaccination of dose. Patient declined revaccination. No adverse side effects or event as result of dose reported.
Patient went to ER on 5-11-2013 with a fever 104 x 2 days and a rash (petechiae rash), platelet count was low in ER 5. Then follow up at our office 5-13-2013 - no rash and platelets 207.
After the vaccine, within 45 minutes I felt feverish my left arm was dead, I could not move my arm and it last for three days. I got severe dizziness, I could not walk, my eyes were black out but I did not pass out, I felt a lot of nausea, I felt numbness in my arm, upper torso area, I felt like needles in my body, severe headaches, my face was swallowed, my mouth was blister, I could not eat I had nausea, my joints felt like broken. My voice was changed, it was shaken. I experienced the numbness for 1 1/2 week. Yesterday I experienced numbness in my right wrist. I went to see a doctor three days after the vaccine and doctor said I am allergic to the vaccine. Dr said I got COVID-19 the same time that I got the vaccine. Doctor gave medicine for 12 days (prednisone) and Benadryl. I had fever 103-104, left chest pain, shortage of breath, constant coughing, congestion, bad throat, pain in my ears, neck. Constant sneezing, my eyes burned. I saw the doctor on the 15th, and I was hospital.
Full arm pain after about 3 hours after injection; I took an ADVIL at 6:00p.m; pain subsided some, but started returning next morning, along with sluggishness, and body aches; another ADVIL at noon the next day, and arm pain and body aches ended about 7:00p.m.
Patient developed generalized tonic/clonic seizures; 4 witnessed episodes about 3 minutes long occurred the following morning about 15 hours after vaccination for 24 hours.
This case was reported by a healthcare professional and described the occurrence of injection site redness in a 29-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). There were no concurrent medications. On 17 October 2011 at 10:30 the subject received a dose of FLULAVAL at 0.5 ml in the left arm. On 17 October 2011, immediately after vaccination with FLULAVAL, the subject experienced injection site redness and swelling at the injection site. Her entire arm became red and burned. She also developed redness on her chest and non-cardiac chest burning. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with BENADRYL. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with FLULAVAL. It was reported that 4 additional subjects experienced unspecified injection site reactions following administration of FLULAVAL.  These events were not considered to be serious. Linked cases include A0950780A, A0950781A, A0950782A and A0950783A.
blood platelets count dropped to 19 from 140 in Apr2021; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 79 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administered in arm left, administration date 01Feb2021 (Lot number: EL9262) at the age of 79 years as dose 2, single for COVID-19 immunization. Relevant medical history included: "Heart bypass" (unspecified if ongoing); "colon cancer" (unspecified if ongoing); "Gall bladder removed" (unspecified if ongoing). The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included: TOPROL; LISINOPRIL. Vaccination history included: BNT162B2 (first dose, Lot number: PFREL3246, in arm left at 10:00 AM), administration date: 09Jan2021, when the patient was 79 years old, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: PLATELET COUNT DECREASED (life threatening) with onset Apr2021, outcome "unknown", described as "blood platelets count dropped to 19 from 140 in Apr2021". The event "blood platelets count dropped to 19 from 140 in apr2021" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: (unspecified date) unknown results. Therapeutic measures were taken as a result of platelet count decreased, which included prednisone. Since the vaccination, the patient has not been tested for COVID-19.