chrisvoncsefalvay/vaers-outcomes huggingface dataset:
approx 3 days p/vax pt noted having brief duration sz (a few seconds) w/ eyeballs rolling up backwards, arms jerking since 7/2/99;pt adm to hosp 7/3/99;EEG revealed status epilepticus;transferred to 2nd hosp; recovered, still w/ sz
Blood lactate dehydrogenase increased. This case was reported by a physician and described the occurrence of elevated lactate dehydrogenase in a 39 year old male patient who received hepatitis A inactivated & hepatitis B recombinant vaccine (Twinrix) for prophylaxis. The patient was described as "healthy". On an unspecified date in November 2003, the patient received the second dose of Twinrix. Approximately three weeks later, on 04 December 2003, the patient underwent "routine lab work." The lab results revealed "elevated" lactate dehydrogenase. As of 27 January 2004, the event was unresolved. The physician considered the elevated lactate dehydrogenase to be possibly related to vaccination with Twinrix.
No adverse event; Patients had been administered with the Moderna vaccine (more or less 170 monovalent) which were beyond the 30 days beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients had been administered with the Moderna vaccine (more or less 170 monovalent) which were beyond the 30 days beyond use date) and NO ADVERSE EVENT (No adverse event) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients had been administered with the Moderna vaccine (more or less 170 monovalent) which were beyond the 30 days beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients had been administered with the Moderna vaccine (more or less 170 monovalent) which were beyond the 30 days beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patients had been administered with the Moderna vaccine (more or less 170 monovalent) which were beyond the 30 days beyond use date).    No concomitant medication was reported.  Pharmacist reported that they have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 monovalent and 20 bivalent) which were beyond the 30 days beyond use date.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live Significant Follow-up received; Patient information and vaccinations details updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Received IM TD and Intradermal TB both in left arm on 3/22/05.  On 3/29/05 client reported the following symptoms:  1 1/2 after administration upper body diaphoresis with severe right flank pain that lasted several hrs.  Within 3 days of administration he states a deep red raised welt to entire forehead from hairline to eyebrows.  Denied itching of site of welt.  Very slight pinkish discoloration was observed to forehead at time of reporting the incident.  Did observe yellow discoloration in multiple small circles at TD injection site in left arm.  He states only other reaction in past was with Rubella vaccine x2 while in armed forces.
AFTER ADMINISTRATION OF THE VACCINE, WITHIN 45 SECONDS, THE PATIENT FELL UNCONSIOUS AND I WAS NOT ABLE TO WAKE HIM UP. THE PATIENT SEEMED TO BE HAVING A LITTLE BIT OF LABORED BREATHING AND PERFUSEOULY SWEATING. ADMINISTERED ONE DOSE OF 0.3MG EPINEPHRINE INTO THE PATIENT'S RIGHT MEDIAL THIGH. PATIENT SLIGHTLY REGAINED CONSIOUSNESS. AT THE SAME TIME, EMERGENCY SERVICES WERE CALLED AND THEY ARRIVED PROMPTELY TO THE PHARMACY AND TOOK THE PATIENT TO THE NEAREST HOSPITAL.
pt recv vax & 2hr p/vax pt was inconsolable,  prolonged crying, 3-4hr non-stop;fever sl 101.3 tympanic w/APAP;PMD advised p/1st DTP if it happened p/2nd DTP to give DT (no more pertussis);
1 day after right thigh erythemic, itchy, slightly raised 5x6cm area.  Benadryl and Augmentin.  PCV 7 #3.
FEVER; CHILLS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, intramuscular) 0.5 ml, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced chills. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The outcome of the fever and chills was not reported. This report was non-serious.
Poison Oak; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DERMATITIS CONTACT (Poison Oak) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced DERMATITIS CONTACT (Poison Oak). The patient was treated with PREDNISONE for Adverse event, at a dose of 1 dosage form. At the time of the report, DERMATITIS CONTACT (Poison Oak) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of poison oak was with prednisone on 19-Apr-2021. Patient was due for her second dose of COVID-19 vaccination on 20-Apr-2021 and wanted to know if she could still get COVID-19 vaccine even though she started steroid  (prednisone) last night.
A report has been received from a Health Professional concerning a 9 year old, Female subject, who had been receiving Nasal FLUMIST QUADRIVALENT, 0.2 Millilitres, Yearly. FLUMIST QUADRIVALENT started on an unknown date. It was reported an expired dose of FLUMIST was given to a patient on 3/2/2016 that expired in February. No adverse events reported. The patient experienced took expired dose which started on 02-Mar-2016. The outcome of the event of took expired dose is unknown. The reporter's description of the events was as follows: Nurse stated checklist stated: no asthma, heart, lung, kidney or live problems. No fever. No allergies. Received flu shot last year. The report was considered to be non-serious by the company physician.
Symptoms: swelling under tongue and lower lip, slight swelling throat headache. BENADRYL 50 mg taken at time of shot, 5 hours later for total of 150 mg taken. This is pt's 3rd dose in 3 years, reaction less this year than last.
Redness on arms after injection, light-headed  Vital Signs: BP 120/84 HR 107 Resp 16 O2Sat 97%  Skin Signs: Cool and dry, clammy, diaphoretic  Circulation: Cap refill <2sec  1sec Respiratory: Breath sound clear bilaterally  Initial Treatment: Vitals taken. Patient felt better after given juice and sitting down.  4:09 PM Vital Signs: BP 110/80 HR 107 O2Sat 99%  Notes: Patient heart rate was still over 100 bpm. Other vitals were in good range. Cheeks still rosy with potential rash. Follow up with provider recommended.  Parent provided CDC link with information regarding hx of GBS and safety of receiving COVID19 vaccine. Patient discharged home with parent.
Acute onset of fatigue approximately 48 hours after receiving the vaccine on 30/Jan/2021. Fatigue has worsened and persists to this day. Acute onset of palpitations 48 hours after vaccine and lasting approximately 20 min., headaches lasting 3 days and severe heartburn lasting 3 days. Coarse fasciculations  of left pectoralis muscle  onset 50 hours after vaccine. This progressed over ensuring days to involve other muscles both above and below the diaphragm including gluteals, gastronemius muscles, abductor hallucis longus, left first dorsal interosseous, deltoids, triceps, various abdominal and spinal muscles, and more recently the left masseter.  The fasciculations persist to this day. Muscle pains started 2 days after onset of the fasciculations and are moderate-severe and worsened by exercise.  I experienced tingling at the lower limbs on 6 occasions and  transient disorientation one day on my way to work. My vision has been a bit blurry at times. i have been moody and short-tempered at times.
Medicine makes him feel bad; Arm was sore; Sore muscles; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Medicine makes him feel bad), VACCINATION SITE PAIN (Arm was sore) and MYALGIA (Sore muscles) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939676) for COVID-19 vaccination.     Concurrent medical conditions included Parkinson's disease. Concomitant products included LISINOPRIL DIHYDRATE (PRINIVIL), BENZATROPINE MESILATE (COGENTIN), ARIPIPRAZOLE (ABILIFY) and FAMOTIDINE (PEPCID [FAMOTIDINE]) for an unknown indication.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-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 FEELING ABNORMAL (Medicine makes him feel bad), VACCINATION SITE PAIN (Arm was sore) and MYALGIA (Sore muscles). At the time of the report, FEELING ABNORMAL (Medicine makes him feel bad), VACCINATION SITE PAIN (Arm was sore) and MYALGIA (Sore muscles) outcome was unknown.            Treatment medications were not reported.
Information has been received from a physician concerning a patient who was vaccinated with a dose of ROTATEQ (Lot not provided) although it was not confirmed. The patient developed intussusception after receiving ROTATEQ. The patient had to be hospitalized for an unspecified period of time. As of 21-JAN-2009 the outcome of the patient was unknown. Additional information has been requested. 2/9/09-records received for DOS 10/15-10/26/08-Admitted with some rectal bleeding. Bronchiolitis.  3/23/09-records received for DOS 11/7/08- presented to ED with vomiting, fussy and bloody stool. Esophagogastroduodenoscopy performed diagnosis GERD. History of mild protein intolerance and feeding problems.
thick reddish rash to entire lt leg & lt arm-today less red; referred to MD for eval;
Information has been received from a now 40 year old male consumer who on an unspecified date when he was a child was vaccinated with a dose of rubella vaccine (no lot # was provided). The patient experienced that the effects of the vaccine wore off. The patient reported that 6 months ago, on approximately 17-MAR-2010 the physician did a titer and discovered that he required a titer for rubella vaccine. At the time of the report the patient's outcome was unknown. No further information is available.
Shingles; Information has been received regarding a case in litigation, referring to a male pt of unknown age. Information regarding the pt's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided.     On or about 07-AUG-2017, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (route of administration, strength, dose, lot # and expiration date were not provided) by a healthcare provider at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions.         On an unknown date, the pt was treated at a hospital for shingles.        As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, had and would continued to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, included but not limited to medical losses and costs which included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.         At the time of the report, the outcome of herpes zoster was reported as not recovered. The lawyer considered herpes zoster to be related to zoster vaccine live (ZOSTAVAX).
signs of a severe allergic reaction; felt strange; racing heartbeat; extremely dizzy; sweating a little bit; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (extremely dizzy), HYPERHIDROSIS (sweating a little bit), HYPERSENSITIVITY (signs of a severe allergic reaction), FEELING ABNORMAL (felt strange) and TACHYCARDIA (racing heartbeat) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced DIZZINESS (extremely dizzy), HYPERHIDROSIS (sweating a little bit), FEELING ABNORMAL (felt strange) and TACHYCARDIA (racing heartbeat). On an unknown date, the patient experienced HYPERSENSITIVITY (signs of a severe allergic reaction). At the time of the report, DIZZINESS (extremely dizzy), HYPERHIDROSIS (sweating a little bit), HYPERSENSITIVITY (signs of a severe allergic reaction), FEELING ABNORMAL (felt strange) and TACHYCARDIA (racing heartbeat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Blood pressure measurement: 136 (High) blood pressure went up (136 over something).     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.   No concomitant medication was reported by the reporter. No treatment was provided.
Information has been received from a certified medical assistant (CMA) concerning a 9 yr old male with an amoxicillin (+) clavulanate potassium (Augmentin) who on 05Nov97 was vaccinated SC with 0.5ml dose of varicella virus vaccine live (lot623135/0689E). Concomitant therapy included montelukast Na and and fluticasone propionate (+) salmeterol xinafoate (Advair). The CMA reported that on 08Mar06, the pt developed 10-12 vesicular lesions on his abdomen. Unspecified medical attention was sought and no other symptoms were noted. At the time of this report, the pt's vesicular lesions were noted to be resolving. Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of cyanosis in a 2-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), PEDVAXHIB (Merck), PREVNAR (Wyeth Labs) and ROTATEQ (Merck). There were no concurrent medications. On 9 February 2011 at around 12:00 the subject received 1st dose of PEDIARIX at 0.5 ml in the left leg. On 9 February 2011 the subject also received 1st dose of PEDVAXHIB, 1st dose of PREVNAR and 1st dose of ROTATEQ. Seven to 8 hours (on 09 February 2011) after vaccination with PEDIARIX, PEDVAXHIB, PREVNAR and ROTATEQ, the subject experienced cyanosis, fever, pallor and vomiting and had to be taken to the hospital. He was taken to the emergency room. The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). At the time of reporting the events were resolved. The healthcare professional considered the events were probably related to vaccination with PEDIARIX, PEDVAXHIB, PREVNAR and ROTATEQ.
Fever 102 for 2 days, chills, headache, nausea,golf ball sized lump at injection site and bruising
Severe pain in injected arm radiating from elbow to shoulder.  Pain continued at a "10+" until 8/30/2012 when pain now is at a "4".  Controlled by Aleve every 10 hours.  Also, had a irritable cough that started about 8/20/2012 and led to wheezing by 8/24/2012; better by Monday by 8/27/2012. At an event, provider sitting next to me asked what was wrong due to respiratory and he was very reassuring that this was an extreme side effect from the TDap and it would get better.
Patient felt flushed about 8 minutes after receiving the vaccine"pain at the injection site immediately" "felt like her swallowing was different "like I was swallowing a golf ball". She was monitored in clinic for 30 minutes. Noticed rash on both cheeks on the same day. Mild rash on the L arm in an area more inferior to the vaccination site. Received daily Benadryl PO treatment at home. Symptoms resolved on 2/3.
Thursday and a couple hours later I had bad pain and took Tylenol, the evening I was hurting I couldn't lift my arm because the pain was at a 15 on scale of 1-10. I couldn't even get out of my clothes it hurt/ache so bad, I took my pain meds at bedtime and 4-5 hours later the pain woke me up and I took another series of OTC pain pills. Saturday I had nausea, a massive headache, I didn't have an appetite,
Sore throat, laryngitis, bilateral otitis media, fever, URTI sxs.
Patient had wife call 2 days ago asking if they should be concerned about his arm still hurting.  He said he had limited range of motion, and pain is helped by ibuprofen or acetaminophen but returns when medicine wears off.  He said this week is better compared to last week.  His wife received same vaccine on same day, but had only soreness for a few days.
Information has been received from the registered nurse. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered dose of GARDASIL on 17-JAN-2013 (lot number 672834/0131AE, expiration date 26-OCT-2014) (dose and route not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
headache; rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) and HEADACHE (headache) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Seasonal allergy in 2020. Previously administered products included for an unreported indication: PERTUSSIS VACCINE. Concomitant products included DROSPIRENONE, ETHINYLESTRADIOL (GIANVI) from 2009 to 06-Mar-2021 for Birth control, MELATONIN from 2020 to an unknown date for Insomnia, FEXOFENADINE HYDROCHLORIDE (ALLEGRA) from 2017 to 26-Feb-2021 for Seasonal allergy.    On 30-Dec-2020 at 1:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced RASH (rash). On an unknown date, the patient experienced HEADACHE (headache). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Headache, at a dose of 1 dosage form. At the time of the report, RASH (rash) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-027621 (Patient Link).
Moderna COVID-19 Vaccine EUA Received vaccine at 5:03pm 12/23, through night arm became increasing sore. I woke up 12/24 at 6:45 and the injection site was red, raised, and painful. The area then became very hot to the touch. By 9:00am that morning I began experiencing excessive dry mouth and thirst. I drank close to a gallon of water 12/24 and it was not satisfying this. Woke up 12/25 and now the injection site and surrounding area is extremely itchy.
Short of breath, audible wheezing. 0.3 cc Epinephrine SC, sent to E.D.
PT recd 1st Engerix-B vax 4NOV90; DEC90 exp'd upper & lower RTI; rx: ceftriaxone; events resolved; 2nd vax 20MAR91 was uneventful; recd 3rd vax 24MAY91; 3-4 wks a/vax PT had brown recluse spider bite; 24MAY91 dev'd hives, etc.; unresolved;
Patient developed a flat red rash at injection site 3-4 inches in diameter. Patient went to urgent care and was prescribed triamcinolone cream & doxycycline.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient was apprehensive prior to vaccine : post vaccine experience a mild fainting spell and lightheadedness.  Patient did NOT fall from chair and mother was with her at all times.  Patient was give cold rag and water; sat for 15 minutes and left with mom.  Follow up call to mom that evening and left message.
A report has been received from a Health Professional concerning a 7 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on 21-Jan-2014. The patient received inadvertently expired FLUMIST QUADRIVALENT which started on 21-Jan-2014. The outcome of the event of expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by the reporter. Corrected report 18-Mar-2014: Form completed date changed to 03-Feb-2014. Initial date received date and date reporting clock start date changed to 03-Feb-2014. Corrected report 28-Mar-2014: Case is changed to medically confirmed from medically unconfirmed.
On  Feb 22 (7 days after vaccination) at  9:22 PM patient noticed right arm (vaccination site) was itch, red and hard.  The next day she had chills and fever of 96.0 to 98.6 (her normal was 97.7) and she slept most of the day.  On the  24th she noticed the most swelling, 6'' all around the injection site.  Swelling went away on the 25th day.
hot flashes, fatigue, joint pain Narrative:  Patient called clinic 3 days after first dose of Moderna COVID19 vaccine. Reported fatigue, hot flashes, and strange sensation of knee and hip dislocating/slipping. Resolved within 48 hours without intervention.
Patient and spouse stated the patient has past history of adverse reaction with IV draw, medication administration. Promptly after administration of IM injection patient reported adverse feelings of unwell ness. Patient skin went pale, patient lost consciousness eyes roll back in head, nurses supported patient from falling. Code  Green called, medical staff on site, patient laid down on cot,  patient regained  consciousness and  states feeling better. Patient moved to waiting in  observation room. Patient refused medical transport and additional medical assistance.
Possible vaccine administration error: Patient says she saw liquid come out of the needle after the syringe was removed from her arm. The administering technician believes she depressed the plunger completely and that the needle was in the arm for 2-3 seconds before being removed. Based on the information given by the patient and administering technician, it is believed that the patient received most of the dose. Per CDC guidelines, revaccination is not recommended.