chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported in a literature article and described the occurrence of optic neuritis in a 15 year old male subject who was vaccinated with hepatitis B vaccine for prophylaxis. In one family branch a grandparent, initially thought (from butterfly rash) to have lupus, and a second cousin have Crohn's disease. On an unspecified date the subject received second dose of Hepatitis B vaccine. At an unspecified time after vaccination with Hepatitis B vaccine, the subject experienced a compound adverse event, acute optic neuritis (vision degradation to 20/400) and rheumatoid arthritis that had resolved with prompt treatment. Three years later, an idiopathic similar episode occurred, possibly from an asymptomatic infection, again it had resolved. The sequence suggested that a particular persisting memory based immune response mode would have been established by the abbreviated vaccination scheduled. This case was assessed as medically serious (OMIC). The author considered the events were almost certainly related to vaccination with Hepatitis B vaccine.
Case number PHEH2013US014802 is an initial spontaneous report received from a medical assistant on 10 Jul 2013: This report refers to a 12-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A12002) intramuscularly on 10 Jul 2013. He also received Tdap (other manufacturer, batch number: not reported) on the same time as MENVEO. It was reported that approximately 10 minutes after receiving the vaccine, he passed out. The reporter stated that the patient was seen by a physician and was evaluated. He stayed in the office another 5 minutes and went home with his mother. The reporter stated that the patient had no injury. The outcome of the event was unknown. No further information was provided.
throwing up bile; Initial information received on 17-May-2021 regarding an unsolicited valid non-serious case received from a consumer.  This case involves an unknown age female patient who experienced throwing up bile (vomiting), while receiving vaccine INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE].  Medical history included Fibromyalgia and she also has something autoimmune going on in her body, but the doctors are not sure of the exact diagnosis. She has some lupus indicators, but they do not think that she has lupus. She remembers she had a topical reaction when she had shoulder surgery to the cleansing wipe she was given. She has not allergic to eggs.  Medical treatment, vaccination, concomitant medication and family history were not provided.  In November 2013, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE (lot UH891AA and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious throwing up bile (vomiting) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE.  It was also reported that If she give a lot number from a flu vaccine that she received the end of 2013, could you tell what are the ingredients. She had a severe reaction to that flu shot and need to know if any of the ingredients overlap with ingredients in the Covid (coronavirus disease) vaccines. She provides lot UH891AA. Checked with Customer Service and found product name as Fluzone. Referred consumer to the website for the labeling archives. She received a flu vaccine from her employer. The caller stated that the first few days of Dec2013 she ended up at the doctor with a reaction to the vaccine. She was throwing up bile for two days. Her gall bladder was fine. She had to call in sick for work, which is rare for her. She has not received a flu shot again after that reaction. She does not react to DTP (Diphtheria, Tetanus, Pertussis)) or MMR (measles, mumps, and rubella) shots.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At time of reporting, patient recovered from the vomiting.
3/19/04 Clients mom contacted health department and states child's left arm swollen, red, hot to touch. States is relieved temp or any with Tylenol. Clients mom very concerned and referred to physician. Contacted clients mom on 3/22/04. State took child to ER and was given antibiotics and has completely recovered.
Initial case was retrieved from scientific literature on 22 July 2010. "Influenza is an important cause of serious illness in very young children with cardiopulmonary disease. A 4-year study was conducted at two centers to assess immunogenicity and safety of influenza split-product vaccine in children aged 3 to 18 months with bronchopulmonary dysplasia and congenital heart disease. A total of 113 children were studied: 62 children 3 to 5 months of age and 51 children 6 to 18 months of age. Sera were drawn prior to first and second immunization and 3 weeks after second immunization and were tested by hemagglutination inhibition; protection was defined as >1:32. Ninety-five children were surveyed for adverse reactions. Seroresponses were age and antigen specific. Best responses for all ages were to A/ (H3N2) (97%). Children older than 6 months of age had better seroresponses to A/ (H3N2) (73%, P < .03) and B/ (62%, P <.02) than did children younger than 6 months of age. Seroconversion rates to the remaining antigens were low. Only 9% of children experienced adverse reactions; all but one were mild. The immunologic mechanisms responsible for preventing serious influenza disease and more effective immunization strategies need to be defined for very young high-risk children." This article identified one patient who had a serious adverse event following an injection with FLUZONE (unspecified). A 13-month-old girl with bronchopulmonary dysplasia and no history of a seizure disorder had a grand mal seizure 24 hours after receiving one dose of FLUZONE UNSP, lot number not provided. "She was examined at a local hospital, was noted to have a temperature of 39.5 degrees Celsius, and had no further problem. She did not receive another dose of vaccine, and over the next 3 years she has had no more seizures and is developing normally." Documents held by sender: None.
Pronounced dizzyness each morning from about 8:00 a.m. to about 10:00 a.m. Lasted for about 2 weeks, then got less pronounced each day for a third week. Some residual balance problems persist; for example, increased unsteadiness while walking across a soft or uneven meadow.
Narrative: Admitted 9/16/2021, discharged 9/20/21: COVID Pneumonia despite being fully vaccinated with Moderna COVID vaccine. 73 yo M ho BPH, GERD, Osteoarthritis who presented to the Emergency Department 9/16/21 with worsening shortness of breath, cough, myalgias found to be COVID positive in the Emergency Dept. Patient reported shortness of breath, cough, headache subjective chills, myalgias, rhinorrhea and productive cough over the previous week. He also reported decreased PO intake and 6-8 episodes of watery diarrhea over this time period. He has no known sick contacts. He is fully vaccinated with Moderna COVID vaccine in Jan 13, 2021 and Feb 10, 2021. In the Emergency Department, afebrile and hemodynamically stable, satting low 90s on room air. Hgb 9.7, Hgb 11.8, 287, Na 137, K 4.5, BUN 13, Cr 1.78, Corrected Ca 8.88, LFTs wnl, Mg 1.88, alb 3.4 EKG WITH no ST elevations, trop < 0.02, BNP <100, coags wnl. COVID+. ESR 84, CRP 15.5. UA with 70 protein, no WBC, LE or nitrites. CXR with bibasilar ground glass opacities; also with evidence of cystitis and proctitis on CTAP. Given Dexamethasone 6mg as his sats dropped on walk test and admitted for COVID pneumonia and AKI. Throughout hospital stay, he remained on room air, occasionally requiring up to 2L NC for sats in the high 80%. He was started on dexamethasone 6mg PO on 9/16 for 10 day course. He will continue the remainder of the course at home upon discharge. Remdesevir was not started at admission, given AKI and minimal O2 requirement.
Large local rx shoulder to shoulder to elbow, lasted over 48 hours, developed within 1-2 days. Pain 3-4/10. AVA shot was her 3rd.
mild headache; muscle and joint aches; muscle and joint aches; general unwell feeling; left arm started to feel sore (site of injection); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Sep2021 11:00 (Lot number: EW0217) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization; Bnt162b2 (Dose 2), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 29Sep2021 18:00, outcome "unknown", described as "left arm started to feel sore (site of injection)"; HEADACHE (non-serious) with onset 30Sep2021, outcome "unknown", described as "mild headache"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 30Sep2021, outcome "unknown" and all described as "muscle and joint aches"; MALAISE (non-serious) with onset 30Sep2021, outcome "unknown", described as "general unwell feeling".  Additional Information: Facility where the most recent COVID-19 vaccine was administered was workplace clinic. known allergies and other medical history were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Clinical course was reported as, about 8h after receiving the booster shot, my left arm started to feel sore (site of injection). This morning I woke up with a mild headache, muscle and joint aches, and a general unwell feeling. Since the vaccination, the patient has not been tested for COVID-19. Case is reported as, non-serious. Device date was reported as, 30Sep2021.  Follow-up attempts are completed. No further information is expected.
pt began feeling bad late Friday then on Saturday sx peaked: spasm to arms & legs w/shooting pains to hands & legs as described by parent;loss of appetite;fever of 103.5 by noon;baseball size reddened raised area to rt arm below site inj;
Pt screamed for approx 4 hrs-1 hr was unconsolable & high pitched, t101;
severe headache, heartburn, abdominal pain 18 hrs after threw up from 6;00 pm till midnight.
VARIVAX was administered 7 days outdated; arm  swelling and pain; arm  swelling and pain; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported.   On 13-AUG-2021, the patient was vaccinated with a second dose 7 days outdated varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S024364 with an expiration date on 06-AUG-2021) at a dose of 0.5 milliliters (strength, anatomical location, and route of administration were not reported) for prophylaxis (expired product administered). No previous temperature excursions were reported. No additional adverse events were reported.   Follow-up information was received from the director of nursing on 29-OCT-2021. The patient was 33 years old. Concomitant therapies included iron supplement, hepatitis A vaccine and fluticasone propionate (PROAIR). The varicella virus vaccine live (oka/merck)(VARIVAX) was administered to the right arm subcutaneously by medical assistant on 13-AUG-2021. No other vaccinations were given within 4 weeks prior. On 16-AUG-2021, the patient called to into the doctor's office to report arm swelling and pain (unknown which arm; event onset date: unknown date in August 2021). The outcome of the arm swelling and pain was not reported. The causality between the events and varicella virus vaccine live (oka/merck)(VARIVAX) was not reported. Additionally, the patient's details were provided.
No immediate reactions other than soreness at injection site. A few weeks later I experienced low back pain that was sharp. First right side, then both sides. I had been constipated for 2 days and felt motility had slowed. Back pain made it hurt to bend, get up and down, tie shoes. I thought it might be an IBS flare, but I hadn't experienced this back pain from a flare before. I remember feeling muscle aches after my first 2 COVID Moderna vaccines that felt similar, so I wasn't sure if this IBS flare might be related to the vaccine booster. My flares are brought on by stress, which can be anything from a full schedule to eating wrong foods.
On 01/03/2010 patient was observed to slump in church then jerk her head back and arch her back, identified as seizure by pastor-no in continue-no post-ictal state. In the past patient has had approximately 6 vasovaginal syncope and mear syncope.
Patient presented with worsening SOB and orthopnea.  Patient was admitted with a diagnosis of acute respiratory failure with hypoxia due to acute COPD exacerbation and acute on chronic heart failure. He was treated with IV ceftriaxone, IV Lasix.  He was also found to have COVID-19 pneumonia and elevated LFT.  He was treated with supplemental oxygen, bronchodilators, steroids.  Patient's symptoms had improved significantly and is off oxygen and was discharged to SNU.
arm pain; total body aches; flu like symptoms; fever; nausea; joint aches; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (arm pain), PAIN (total body aches), INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever) and NAUSEA (nausea) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-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 an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain), PAIN (total body aches), INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever), NAUSEA (nausea) and ARTHRALGIA (joint aches). At the time of the report, PAIN IN EXTREMITY (arm pain), PAIN (total body aches), INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever), NAUSEA (nausea) and ARTHRALGIA (joint aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 101 (Inconclusive) fever of 101 (degrees Fahrenheit)?.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided No Treatment information provided
Patient became dizzy, vital signs -10:32 am  162/101, P-96, sat 98% on room air, hot clammy, blurry vision, heart palpitations, repeat vitals 1036- 171/102 P-85 sat 98% on room air, transferred to Emergency Room 10:43 am
11-22-10 - got vaccines. 11-26-10 - C/o L leg pain & intermittent limp & pain of L thigh, stom. ache, increased sleepy - seen 11/30 in office - VSS, afeb - 2 x 4cm L inguinal LN tender to palp w/redness, pain w/flexion of leg, LN tender to palp, dx w/lymphadenitis secondary to vaccine vs infection - no skin lesions or infec of legs put on AUGMENTIN.
Pt was admitted to Hosp on 29AUG91 due to fever of 103.8 & vomiting; MD dx meningitis though results of lab work failed to provide definitive typing of infectious agent; Pt placed on Ceclor @ time of admission & continues on ATB tx;
BODY ACHES; CHILLS; LOW GRADE FEVER; NAUSEA; This spontaneous report received from a patient via a company representative concerned a female 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, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 14-MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced chills. On 14-MAR-2021, the subject experienced low grade fever. On 14-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches, chills, low grade fever and nausea was not reported. This report was non-serious.
Pt developed varicella 4 weeks after receiving the initial vaccine, per CDC consult, VAERS need to be filed as varicella reaction is usually noted 2-3 weeks after receiving the varicella vaccine. Varicella VIS 3/13/08.
TIREDNESS; This spontaneous report received from a patient via a company representative concerned a female 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, route of admin not reported) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tiredness was not reported. This report was non-serious.
he got real sick but that was normal; Muscle spasms; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (he got real sick but that was normal) and MUSCLE SPASMS (Muscle spasms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer. Concomitant products included FLUOROURACIL (EFUDEX) for Cancer.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (he got real sick but that was normal) and MUSCLE SPASMS (Muscle spasms). At the time of the report, ILLNESS (he got real sick but that was normal) outcome was unknown and MUSCLE SPASMS (Muscle spasms) had resolved.            Treatment information was not provided.  Patient was scheduled appointment for 3rd dose on the day of reporting.
3/26/21 itchy rash across face / cheek bones  3/28/21 itchy rash down neck
ear fullness, bilateral; bilateral tinnitus; This is a spontaneous report from a contactable physician. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283) via intramuscular route of administration in the right arm on 22Jan2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medications were not reported. The patient had no known allergies. 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 vaccines within four weeks prior to the vaccination. On 23Jan2021, within 24 hours of vaccine, the patient experienced bilateral ear fullness and then bilateral tinnitus which had persisted. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events bilateral ear fullness and bilateral tinnitus were not resolved at the time of this report.
Mother states child had possible reaction 3 days after receiving immunizations. Stated rash appeared on feet bilaterally. The following day, erythema appeared, total body, fever, light sensitive. Parent gave child Benadryl - cleared after 4 days. On 2/21/08 , small linear 3 day rash appeared on (R) deltoid followed by full body rash, fever 100.2 axillary. Pt has ear infection per parent.
2 months old patient vaccinated with expired dose of pentacel with no reported adverse event; Initial information  was received on 20-Dec-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 2 months old female patient who was vaccinated with expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), HEPATITIS B VACCINE (HEPATITIS B VACCINE) and ROTA for Immunisation.  On 20-Dec-2022, the patient received 0.5 mil of expired dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot 7419 and expiry:05-DEC-22) (expired product administered) (latency same day) via intramuscular route in the left thigh for Immunisation.   Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO)) was not applicable.  At time of reporting, the outcome was Unknown for the event 2 months old patient vaccinated with expired dose of pentacel with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Fever went over 100; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever went over 100) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever went over 100). At the time of the report, PYREXIA (Fever went over 100) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not provided.
Pt pre-medicated with benadryl prior to ariaval. Pt started getting pruitis 10 mins after administration. pt given benadryl and predisone in ED. Pt improved soon after
he is exposed with people who got tested positive with the virus and he stated that he got the same symptoms; This is a spontaneous report from a Pfizer sponsored program a contactable consumer(patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Not reported) via an unspecified route of administration, administered on 06Mar2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. On an unspecified date the caller reported that his 2nd appointment would be tomorrow 20Mar2021 he got the 1st dose last on 06Mar2021 (early than 21 days). He stated as well that he was exposed with people who got tested positive with the virus and he stated that he got the same symptoms. The outcome of the event was unknown.  Information about lot/batch number cannot be obtained. No further information expected.