chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a RN concerning a 12 month old white female with no known allergies or medical conditions who on 14-APR-2003 was vaccinated SC in the right thigh with a first dose of varicella virus vaccine live (lot number 644031/1058M). Concomitant therapy included a first dose SC in the left thigh of MMRII (lot number 644708/1125M). There was no illness at the time of vaccination. On 24-APR-2003 the reporter stated that there were "more spots last night, low grade fever, four to five small papules, chickenpox." Unspecified medical attention was sought. It was noted that there were no diagnostic tests or laboratory results. There were no adverse events following prior vaccination. Additional information from the RN indicated that in the pm of 23-APR-2003 there were four to five small papules on the first day, then a generalized rash with fever and one episode of emesis for four days. The pt subsequently recovered. No further information is expected.
Unconscious, collapse, shock 30 minutes after immunizations. Not been able to wake up and nurse for 38 hours. Limp, pale. We woke him with cold water; dilated pupils, poor eye contact, excessive sweating, loss of head control, flapping around for 2 weeks, bruise at the site of injection. Follow Up; mother states child probably has infantile myasthenia. Additional symptoms include dysphasia, ptosis, nystagmus, neck lag( muscle weakness) and extraocular muscle weakness. Temp at night was 39C (102.2F). Medical Records received on 3/07/2005 states  excessive sleepiness and no red reflex noted on PE. If you would care to known more about child you can contact the WRC.  It is too much and he is not just a # on stationing. I would have liked the doctor to explain to use the cases subject and I are taking the day up so many vaccinations at once and at that early age- 2 wks.  I wish for the system to be honest
Patient states that he had chills and aches and very painful arm hindering movement. Area of imms (Rt. deltoid) reddened approx 3-4 cm. diameter, warm, painful to touch.
Hispanic boy vomited after administration; This spontaneous report was received from a physician and refers to a male patient (reported as boy) of unknown age. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On unknown date, approximately in 2015 (reported as about 4 or 5 years ago), the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally (dose, dose number, lot # expiration date were not reported) for prophylaxis. On unknown date approximately in 2015 (reported as about 4 or 5 years ago), after the vaccine administration the boy vomited. The patient did not seek medical attention, and did not receive any treatment. On an unknown date, the patient recovered from the event. Causality assessment between vomiting and vaccination with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not provided.  This is one of the three cases received from the same reporter.; Sender's Comments:  US-009507513-2002USA009379: US-009507513-2002USA009378:
herpes zoster; This spontaneous report was received from a lawyer and a patient of unknown age and gender regarding a case in litigation on 29-JUL-2021. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving the Zoster Vaccine Live (ZOSTAVAX) the patient suffered herpes zoster. As a result of these symptoms, the patient was seen and treated by medical providers, and was still under their care. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX) vaccine, patient's symptoms had resulted in physical limitations do not present prior to the vaccine, also mental and emotional distress due to resulting physical limitations and seriousness of her condition. Patient sustained severe and permanent personal injuries. Further, as a tragic consequence, patient suffered serious, progressive, permanent and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Also, had suffered and incurred damages, including medical expenses, loss of accumulations, and other economic and non-economic damages. At the reporting time, the outcome of herpes zoster was considered as not recovered. The reporters considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
The next morning at approximately 7:30 AM I woke to mild  neuropathy  pain in my left foot extending up my legs. By evening it was in both feet,legs,hands and arms. The pain is much worse then I?ve ever had before and extended to areas of my body I never had pain in before. At this time I am still experiencing pain.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Lot number: 6h9964) at the age of 32 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SINGULAIR. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was Adult (18-64 Years). Other medication in 2weeks was reported as yes. Patient received Paxlovid treatment from 14Dec2022 to 18Dec2022 for Covid-19.  No follow-up attempts are possible. No further information is expected.
This is a non serious spontaneous case from a consumer in the USA involving PASSED OUT. The reporter causality is not provided to FluMist. An office manager in a pediatrics practice reported that an adult female passed out, fell and hit her head on the floor, a few minutes after she and her children received FluMist vaccine on 10/21/05, Friday. After 10 seconds, the patient woke up and could not remember what happened. Her husband came and brought the patient to her doctor and for a CT scan of the head. The husband stated that the patient had not had anything to eat that day except for a can of diet soda. Information on patient's medical history is not available. The following Monday, 10/24/5, a physician from the pediatrics practice called to check on the patient. He was told by patient that the head CT scan had no findings and that she was feeling fine and went back to work. (OMIC).
1/21/21  COVID Moderna 1st 2/19/21 COVID Moderna 2nd 03/18/21 Pneumonia Vacc - 2n dose (1st dose a year ago) Developed swelling and pain in both feet and lower legs, high blood pressure.
Rapid heart rate and palpitations Resting Heart rate was 140 -172 with palpitations for 80 minutes so went to the hospital they did an EKG and blood work I was released after heart rate returned to normal  was to follow up with cardiologist
This spontaneous report as received from a nurse refers to patients of unknown age and gender. Medical history and drug reactions/allergies were not reported. On an unknown date, the patients were vaccinated with GARDASIL, stored for "many days" at 28 F (Fahrenheit), lot # H014645 expiry date not reported (dose and route not reported). Concomitant medication was not reported. No adverse effects reported. The reporter stated that 10 unidentified patients received unspecified frozen or refrigerated vaccine doses that were improperly stored. This is one of several reports from the same source. Additional information is not expected.
12/01/21 ID note: "Multifocal pneumonia due to COVID-19 virus with hypoxia;  Fever on admission to 102.7, now afebrile, was on 2 LPM NC, now weaned down to 1 LPM; Onset cough on 11/25; FLU a/b negative; Covid + PCR on 12/1;   Cxray 12/1: Asymmetric reticular densities, right greater than left which may reflect atypical/viral pneumonitis, including potentially Covid pneumonia. Acute leukocytosis, trending down. S/p azithromycin x1  11/30. PMH:  DM type 2, HTN, COPD, PVD s/p R BKA, subdural hematoma s/p mechanical fall, CAD s/p PCI, HFrEF (LVEF 40%), atrial fib on apixaban, CKD stage 3, depression. COVID vaccinations- was at nursing home, no records in I-CARE noted. Continue dexamethasone day, continue remdesevir day 1/5, continue anticoagulation".
Post vax, the child arched back when picked-up. Stopped talking, no eye contact. Seemed depressed. Stopped playing and imitating. Became very finicky eater. Dx with autism.
Pt recv vax on 10/26/98; on same day pt exp chills, excess urine, nausea, leg aches
Worsen of  psoriasis about a month after 2nd shot.  Had major skin issues at the end of July.  These skin issues continue to progress.  Numerous dermatology appointments and diagnosed with hidradenditis suppertiva of face.  In Aug  21, newly diagnosed with Psoriatic Arthritis and was in a major flare.  Referred and have been treated with her since 11/29/21.
The day following the vaccine, I had extreme fatigue and lethargy which I had heard was common. By 2 days following the vaccine, I spiked a fever which stayed between 102-103.7 from 3/20 through 3/25 when my Dr prescribed blood work and urinalysis. By the morning of 3/26, I was hospitalized due to electrolytes being completely off and borderline causing seizures. I was diagnosed in the hospital with pneumonia in my right lung, CK enzyme being very high, sodium and potassium levels being very low. I spent 5 days in the hospital and still have to follow up with Renal Physicians because of enzymes not being stable.
This case was reported by a physician and described the occurrence of vomiting in a 4-month-old female subject who was vaccinated with Pediarix vaccine for prophylaxis. On 12 January 2007 the subject received 1st dose of Pediarix (.5 ml, unknown). That evening, the subject started vomiting and spitting up. Over the next 12 days, the subject lost 9 ounces, and ultimately had to be hospitalized on 24 January 2007. During the hospitalization, the subject underwent an MRI, allergy testing, immune testing and an upper GI series which were all negative. The physician considered the events were disabling and clinically significant (or requiring intervention). The subject was treated with lansoprazole (Prevacid). At the time of reporting the vomiting was improved, but the spitting up and the weight loss were unresolved. The subject remained in the hospital.
PT C/O LIGHT HEAD SWING( DIZZINESS) V/S CHECKED BP108/49, PULSE56, O2SAT 99%, PT SIT PULL BACK TO FLAT POSITION WITH  LEGS SLIGHTLYUPAND EDUCATED TO TAKE DEEP BREATH. PTWAS HYDRATED,V/S RECHECKED IN 10MINS BP104/69 PULSE58,PT STATED HE IS FEELING BETTER WILL GO HOME AND RELAX.
pt recv vax 29MAY97 & 30MAY97 pt exp warmth & swelling @ the inj site which extended from the shoulder to the elbow;pt also amy have devel a sl fever;pt recovered;
Severe uncontrollable chills and shaking, extreme exhaustion, headache and nausea
Patient is a very pleasant 75y.o. year old  male with a known history of metastatic colon carcinoma currently receiving chemotherapy, presenting to the hospital with complaints of odynophagia and dysphagia with both liquids and solids over the past 2-3 days. Additional complaints included intermittent shortness of breath related to "asthma" - unchanged in character or severity from previously.. He denies any cough, chest pain, fever, chills, sweats. At presentation he was afebrile with stable vital signs and was maintaining an O2 sat of 100% breathing room air. Laboratory revealed a WBC of 40.4 with a predominance of neutrophils on the differential as well as toxic granulation (patient had just recently received Neulasta on 6/17), mild elevation of his alkaline phosphatase of 199 with a normal bilirubin, and normal renal function. CXR was negative for any acute pathology. For reasons that are unclear, testing for SARS CoV 2 by NAA was performed and was positive. The patient has a history of having had Covid in November 2020, and also received vaccination for Covid with 2 doses of the Pfizer vaccine in April of this year. His any recent contact with anyone with Covid 19, and states that he has severely limited travel outside of his apartment to avoid social contact during the pandemic. ID is consulted regarding the above presentation. Significance unclear. This patient has little in the way of symptomatology to support a diagnosis of Covid 19. He had symptomatic infection with SARS CoV 2 in November 2020. Prolonged positive testing for SARS CoV 2 by NAA as been noted for months following Covid 19. In addition, prolonged shedding has been noted in patient's who are immunocompromised, although I would doubt that is the situation here as he is asymptomatic for Covid 19 (intermittent shortness of breath likely related to his underlying asthma as she is maintaining an excellent O2 sat breathing room air at this time and has a negative CXR). I do not think any therapy for Covid 19 is indicated at this time. Would doubt he is shedding infectious virus, but will continue isolation for now
she feels really achy and uncomfortable; she feels really achy and uncomfortable; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 5-year-old female patient received BNT162b2 (BNT162B2), on 07Nov2021 as dose 1 (orange cap), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), DISCOMFORT (non-serious), outcome "unknown" and all described as "she feels really achy and uncomfortable".  Additional information: Pediatrician is calling about two patients: 5-year-old female and 10-year-old male, who were accidently administered the adult gray cap bivalent formulation of the Pfizer BioNTech Covid 19 vaccine at their local pharmacy instead of getting the pediatric 5-11 bivalent orange cap booster. They received their primary series of the monovalent orange formulation on 07Nov2021 and 04Dec2021. He was not worried so much about repercussions of the vaccines, he is more concerned as to whether or not this will affect the series going forward. Physician states that five-year-old is getting her butt kicked, that she feels really achy and uncomfortable as reported by her mother. No fever, no headache, no respiratory distress, no chest pain.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Client given dose of flu vaccine and client told nurse she was anxious about getting the flu vaccine.  Injection given and client felt fine. Around 20 minutes later ,nurse was notified that client was laying on the floor of an office.  Nurse went to client,she said she felt dizzy, sweaty and her left arm was tingling.  Denied SOB, no wheezing, no hives, no rash.  Client said she gets anxious, she said she did not faint but laid down when she felt dizzy.  She refused to have her BP taken.  Nurse sat her up and had her stand with no further dizziness.
Initially there was soreness at the injection site. I had chills, low grade fever, and flu-like body aches starting approximately 12 hours post injection. The symptoms were alleviated with regular strength Tylenol and completely disappeared 36 hours post injection.
Your vaccine caused my mother's death.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Your vaccine caused my mother's death.) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not reported.  Company Comment This spontaneous case concerns a female patient of unknown age, with no medical history reported, who experienced the unexpected, medically significant and death seriousness criteria events of death unknown days after a dose of mRNA-1273.  Concomitant medication nor Treatment details were reported. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.   Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2023: Follow-up received and added reference number.; Reported Cause(s) of Death: Unknown cause of death
A previously healthy 70 year old woman presented with a 3 week history of severe headache, pain on chewing, malaise, fatigue, anorexia and weight loss. Significant to note that pt had IV, 1 week before the onset of her complaints. After multiple tests, a presumptive dx of GCA was made and the pt was treated with oral prednisone (50mg/d), which resulted in a rapid resolution of her complaints. The dosage of prednisone was gradually reduced over a period of 36 months.
No Adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) and NO ADVERSE EVENT (No Adverse event) in a 5-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 25-May-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) 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 WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated).    On 03-Dec-2022, the patient received first dose of monovalent vaccine (Batch/Lot number: AR9236B and Dose/volume: 25 micrograms).  Concomitant product use was not provided by the reporter.  The route of administration of suspect Moderna monovalent was reported as Mono and bivalent was reported. No adverse effects noted.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:Master case
pt recvd vax; h/a, n, faint, tremors, arms numb, tachycardia, t of 104.7, BP 110/48; tx DPH, toradal, solumedrol, adm to hosp 18oct; released 20oct94;
developed severe pain at injection site and upper arm,prickly reddened area around site, dizziness, fever,, nausea,lymph glands swollen in axilla
81 year old female s/p renal transplant on immuno-suppressants, atrial fibrillation, hx SSS/PPM.    She presented to the ER with complaints of cough and shortness of breath.     In the ER she desaturated to 86% and was placed on supplemental oxygen.  Her COVID-19 PCR screen came back positive..  CBC and CMP were otherwise unremarkable except for low-sodium 130, creatinine of 1.7, UA abnormal.  Chest x-ray shows patchy infiltrates, more on the right.   She was started on Decadron, empiric antibiotics and was admitted to hospitalist service. Remdesivir was declined by family due to her renal transplant status.    January 13, late afternoon patient desaturated and required BiPAP. She was afib/RVR and metoprolol IV 5 mg was given. Morphine and furosemide were also given. Transfer to Moderate Care was requested. Pulmonology was consulted.   january 14, on HF NC 45 L 60%. Added doxycycline 100 mg IV for several days. Changed dexamethasone to IV. Added PRN IV metoprolol for afib/rvr and changed diltiazem to short acting so it may be given via NGT. May need NGT for nutrition and oral meds. WBC 10, BUN/Cr 54/1.2. CRP 10 (rising) and PCT 0.1.    January 15, patient is clinically worse now on BiPAP, renal function is worse with rising BUN/Cr despite IVF.    January 16, patient was pronounced expired at 06:50 hrs.
Information has been received from a consumer concerning her 17 year old daughter with no medical history or allergies who on 05-JUL-2009 was vaccinated, 0.5 ml, with the first dose of GARDASIL (lot # not reported) injection. The patient experienced lightheaded and injection site pain after getting first dose of GARDASIL and fainted, vomiting and tiredness after getting the second dose of GARDASIL on 06-AUG-2009. There was no concomitant medication. There were no laboratory studies performed. The patient sought unspecified medical attention. At the time of reporting, the patient had not recovered from lightheaded and injection site pain. The patient's outcome of faint, vomiting and tiredness were unknown. No further information is available.
chills; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PYREXIA (fever) and HEADACHE (headache). On 14-Feb-2021 at 2:00 AM, the patient experienced CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. On 14-Feb-2021 at 4:00 AM, CHILLS (chills) had resolved. On 15-Feb-2021 at 11:00 AM, PYREXIA (fever) and HEADACHE (headache) had resolved.            No Concomitant medications was reported .   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up received on 13-Jul-2021, contains Non-Significant Information.
Patient fainted in the waiting area approximately 5-10 minutes after administration. Did not lose consciousness. Patient did not sit in the chair in waiting room and mother reported that he had not eaten today.