chrisvoncsefalvay/vaers-outcomes huggingface dataset:
inadvertently given a 0.5mL dose from a punctured vial of Moderna Bivalent 6+ that was at room temp for exactly 18 hours 15 minutes prior to the dose being given; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently given a 0.5mL dose from a punctured vial of Moderna Bivalent 6+ that was at room temp for exactly 18 hours 15 minutes prior to the dose being given) and NO ADVERSE EVENT (No adverse event) in a 59-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently given a 0.5mL dose from a punctured vial of Moderna Bivalent 6+ that was at room temp for exactly 18 hours 15 minutes prior to the dose being given) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently given a 0.5mL dose from a punctured vial of Moderna Bivalent 6+ that was at room temp for exactly 18 hours 15 minutes prior to the dose being given) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) 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 EXPIRED PRODUCT ADMINISTERED (inadvertently given a 0.5mL dose from a punctured vial of Moderna Bivalent 6+ that was at room temp for exactly 18 hours 15 minutes prior to the dose being given).    No Concomitant medication was reported. No treatment information was provided.
Information has been received from a registered nurse concerning a 6 year old white female who on 20-MAR-2002 was vaccinated in the left arm with a first dose of Varivax (lot # 640821/1438L). Illness at the time of vaccination included a red bumpy rash. Subsequently the patient developed a red bumpy itchy rash. The patient's outcome was not reported. It was unknown if medical attention was sought. Additional information has been requested.
chest pain and tightness that has lasted 3 weeks, arm numbness on both sides (worse on injected arm), hair loss (brushing hair has been strange),
Muscle contraction when needle was inserted w/ radial pain down to finger tips on left arm when med was injected. Within two hours-chills, sweats, headache, diarrhea w/ stomach cramps, neck muscles were stiff and later (3hrs) neck was painful and difficult to move. I took two Tylenol extra strength and went to bed at 8pm. I woke up at 2am w/ headache and took 2 Tylenol. Sleep was restless because of lower back pain. It took several minute to get out of bed because of the pain in my lower back. I took 2 Tylenol at 7am and continued getting ready for work. I looked in the mirror and saw that my face was swollen and my face looked reddish-orange w/ bags under my eyes. I never have bags under my eyes. I got to work at 8am and the symptoms increased. Headache, nausea, back lower pain and blurred vision. I left work to get ginger ale and saltines which did not help. I called my doctor who referred me to a market for a homeapathic-remedy for toxic reaction to the hep B injection. I purchased milk thistle and took 1 at 1:30 pm. Within one hour, blurred vision began to subside symptoms diminished over the next week. Upon examination by by MD on 10/4 at 8:55am, he mentioned there were definite signs of a toxic reaction.
Uncontrollable screaming crying 15NOV91 1230 PM for 12-15 hrs duration; note from MD; no more Pertussis;
Vaccine administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion.; Vaccine administered to patient after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion.) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 3:12 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 3:12 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered to patient after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion.). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 21.60.  No concomitant medications were reported.  On 30-Mar-2021, The vial with batch number 030B21A was moved to fridge, On 31-Mar-2021, 14 vials were moved to the clinic and temperature excursion reported as 32 degrees fahrenheit from 08:00 AM to 9:00 AM.    On 03-Apr-2021, 20 vials were moved to the clinic and temperature excursion reported as of 34 degrees Fahrenheit at 09:00 AM. Beyond use date for the vial was reported as 29-Apr-2021.   The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration.  The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree fahrenheit.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Information has been received via letter from the father of a 10 year old female who on an unspecified date in approximately 2000 was vaccinated with MMR II. Subsequently the patient experienced "severe autism, autistic seizures, cannot talk at all, major eating disorder, major temper tantrums, and major brain dysfunction [sic]." The patient's father felt that his daughter's severe autism was due to mercury in the MMR II. The patient's father reported that his daughter will never be able to work a job in her lifetime due to the vaccine. Included in the letter was a pediatric neurology record. On 09-APR-2009, impression included seizures and autism. It was recommended that the patient continue current dose of KEPPRA, 100mg/mL, 1.5 mL in the morning and 1.5 mL in the evening; follow schedule given to begin LAMICTAL; and "MRI today as planned." Diagnosis was noted as epilepsy for which strict seizure safety and precautions were to be followed, "she must be supervised at all times." Autistic seizures, severe autism, and major eating disorder were considered to be disabling. Additional information has been requested.
intense chills; fever up to 101.7; body aches; headache; nausea; lack of appetite; This is a spontaneous report from a non-contactable health care professional.  A 33-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot no: EK9231), in a Health Clinic  via intramuscular route of administration on 12Jan2021 at 01:00 PM at a single dose on the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not have COVID-19 prior to vaccination. The patient did not receive other vaccines in four weeks. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot no: EH9899), on 22Dec2020 at 08:00 AM, intramuscular on the left arm for COVID-19 immunization. The patient experienced intense chills, fever up to 101.7, body aches, headache, nausea and lack of appetite all on 12Jan2021 at 11:30 PM. The patient did not receive treatment for any of the events. The outcome of the events was recovering. The patient has not been tested for COVID-19 post vaccination.
Approximately 20-30 minutes after yellow fever vaccine, patient developed upper body urticaria, rhinorrhea and pruritus. No respiratory symptoms Treated with Zyrtec and Prednisolone.
gastric pain that spreads throughout abdominal area, that really a burning pain; burning pain abdomen; Initial information received on 11-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional (nurse/patient).  This case involves an unknown age female patient who had gastric pain that spreads throughout abdominal area, that really a burning pain and burning pain abdomen after receiving influenza quadrival A-B Vaccine [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 VACCINE for Prophylactic vaccination.  On an unknown date, the patient received 0.5 ml dose of suspect influenza quadrival A-B Vaccine, Suspension for injection lot U3200BA, expiry- 30-Jun-2024 via unknown route in unknown administration site for immunization (strength: unknown).  On an unknown date the patient had gastric pain that spreads throughout abdominal area, that really a burning pain (abdominal pain upper) and burning pain abdomen (abdominal discomfort) (unknown latency).  Reportedly, patient had the FLUZONE vaccine about two weeks ago and progressively getting worse with gastric pain that spreads throughout abdominal area, that really burning pain. had a vaccine reaction with both COVID shots,  was in pain for months and months after, those shots and now also with Flu shots.  Action taken: not applicable.  The patient took Proton Pump Inhibitors as corrective treatment for the events  At time of reporting, the outcome was Not Recovered / Not Resolved for both the events
Around 1625 patient started complaining of tingling and itching around the mouth.  Dr advised to evaluate patient.  Benadryl ordered.  BEnadryl 25 mg given IM at 1638.  1650 patient reported improved symptoms on Benadryl, patient declined EMS.  Patient states has epipen at home if needs.  Was advised to call 911 if symptoms worsen.
Heart rate became elevated and sustained roughly 12 hours after injection, at bed time.  My heart rate is generally 50-64 BPM during sleep. On this occasion it was 80-120, consistently staying at 100bpm for about 6 hours throughout the night, but never falling below 74.  Non-sleeping HR is also elevated the day after by 20-30bpm at rest.  I did experience a fever that started around 12hrs after injection.  Temp taken at 3am was at least 101.7 (orally under the tongue) which was reduced to normal levels by 5am after a small dose of Tylenol and Ibuprofen.  I also experienced a substantial headache at the same time as fever and HR increase.  The small dose of Tylenol and Ibuprofen taken for the fever lessened the severity of the headache. Pulse oximeter shower 97-99% oxygen and mimicked readings from wrist-worn Health tracker (Fitbit Sense).
Information has been received from a health professional concerning a 2 month old female child who was vaccinated with Haemophilus B conjugate vaccine (+) Hep-B vaccine recombinant (yeast), diphtheria toxoid/pertussis vaccine/tetanus (Infanrix) and poliovirus vaccine (IPOL). Three hours, post vax, the child experienced seizure-like activity and was hospitalized. No further information is available.
started having palpitations, SOB, chest pain went to ER via ambulance, admitted to ICU first night, moved to floor acute 2nd night then discharged.  Have since been diagnosed with atypical sarcoidosis by Doctor
This spontaneous report as received from a pharmacist refers to a 72 year old female patient. The patient's medical history included Lyme disease and unspecified upper respiratory tract infections. The patient had no drug allergy. On 17-MAY-2013 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous. At reporting time, the patient had been prescribed prednisone (route unspecified), doxycycline and an unspecified inhaler for treatment of an unspecified condition. The outcome of the unspecified condition was reported as not recovered/not resolved. The patient sought medical attention via unspecified method. Additional information has been requested.
Boostrix administered to a 4-month-old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 22MS7, expiry date 1st April 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th December 2022, the patient received Boostrix .5 ml and Boostrix Pre-Filled Syringe Device. On 5th December 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 06-DEC-2022 Reporters comment: The nurse reported that 4 month old child was inadvertently administered Boostrix into left thigh. The HCP did not deny consent or provide consent for follow up. Additional Supportive information: The patient was inadvertently administered Boostrix, which led to inappropriate age at vaccine administration
NAUSEA; VOMITING; FELT SICK; FELT TIRED; LETHARGIC; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 25-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-JUN-2021, the subject experienced lethargic. On 25-JUN-2021, the subject experienced felt tired. On 26-JUN-2021, the subject experienced vomiting. On 26-JUN-2021, the subject experienced felt sick. On 29-JUN-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt sick on 28-JUN-2021, was recovering from vomiting, had not recovered from lethargic, and felt tired, and the outcome of nausea was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Chills, then fever, 101 or higher, h/a, nausea, 6/17 eyes aching, tight & sore jaw, h/a worse, fatigue, muscle aches, went to ED 6/16/11= fluids and APAP, off work. 6/18 better, 6/19 normal ADLs
Patient observed with difficulty of breathing, became unresponsive for 10 seconds after few drops of Rotavirus administered orally.
pt recv vax 24JUL96 & 2 days p/vax pt had facial angioedema w/low grade temp;sx lasted x 2 days & resolved on own;no tx;this was reported by parent;
started to feel freezing or chills; Mild fatigue; low-grade temperature 99-100; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (started to feel freezing or chills), FATIGUE (Mild fatigue) and PYREXIA (low-grade temperature 99-100) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 025L20A) for COVID-19 vaccination.     The patient's past medical history included Colon polyps, Diverticulitis intestinal perforated, Prostatism in 2008 and Stent placement since 09-Jun-2008. Concurrent medical conditions included Obstructive sleep apnea syndrome since 25-Oct-2018, Essential hypertension since 26-Mar-2021, GERD since 26-Mar-2018, Cystic kidney disease since 26-Mar-2018, Atrial fibrillation since 31-Jan-2017, Erectile dysfunction NOS since 26-Mar-2018, Constipation chronic since 26-Mar-2021, Coronary artery disease since 31-Jan-2017, Allergic rhinitis, Drug allergy (allergy to atorvastatin), Drug allergy (allergy to baclofen), Allergic reaction to antibiotics (allergic to Ciprofloxacin HCl), Allergic reaction to antibiotics (Levaquin (levofloxacin)), Allergic reaction to antibiotics (allergic to sulfamethoxazole), Allergic reaction to antibiotics (allergic to Trimethoprim) and Sulfonamide allergy. Concomitant products included DIAZEPAM from 14-Jan-2021 to an unknown date for Anxiety, METHYLCELLULOSE (CITRUCEL) for Laxative supportive care, APIXABAN, ACETYLSALICYLIC ACID (ASPIRIN E.C), DEXLANSOPRAZOLE from 28-Dec-2017 to an unknown date, FLAXSEED OIL [LINUM USITATISSIMUM SEED OIL], HYDRALAZINE from 27-Jun-2017 to an unknown date, LISINOPRIL, LORATADINE (CLARITIN [LORATADINE]), MONTELUKAST from 02-Jul-2020 to an unknown date, MULTIVITAMIN [VITAMINS NOS], NIZATIDINE (AXID AR) from 07-Nov-2019 to an unknown date, ROSUVASTATIN CALCIUM (CRESTOR) and TRIAMCINOLONE ACETONIDE (NASACORT) for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced CHILLS (started to feel freezing or chills), FATIGUE (Mild fatigue) and PYREXIA (low-grade temperature 99-100). At the time of the report, CHILLS (started to feel freezing or chills), FATIGUE (Mild fatigue) and PYREXIA (low-grade temperature 99-100) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 99.1 (High) 99.1. On 05-Mar-2021, Body temperature: 100 (High) 100.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication were not reported   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Medical history added. Dose 2 details added. Concomitant medications added. Events added.
Received Pfizer 2/24, 24 hours later buttocks cheeks hurt, flank pain started and within 7 days, urinating blood, general feeling unwell, clots became so large they ultimately blocked urine flow completely. Went to ER 3/8, creatine was elevated, did a cat scan which showed enlarged lymph nodes attributed to vaccine hospital said and otherwise unremarkable. Hospital, through a catheter did and aggressive bladder flush and was put on morphine, flushed for 48 hours then had drops in oxygen and labored breathing, x ray showed fluid in lungs, diagnosed with hospital acquired pneumonia from the flush, once on antibiotics and creatine/ bun stabilized, was released.  Clots returned in 3-4 days, went to urologist for scope, unremarkable, no invasion of bladder cancer through the wall, recommends another cat scan (3.5 weeks after previous scan ) scan showed enlarged lymph nodes and some liver lesions, recommend biopsy of liver and lymph nodes and kidney scan, both are scheduled. Blot clots get worse, end up in ER 4/18, elevated creatine and bun, urologist tried to do ureter stents, ureters blocked so bilateral nephrostomy tubes were put in.  Liver biopsy done 4/20. Dad was stabilized and released with no biopsy results until 4/27, metastatic bladder cancer diagnosis. Oncologist put dad on Keytruda once every 3 weeks. Dad has been feeling unwell since his 1st vaccine, never got the 2nd due to all of these complications.  Dad ends up back in hospital on 6/21 with general unwell feeling, fatigue, cat scan shows further progression and because of an error a resident did a cat scan with dye which then added contrast induced nephropathy to the issues.  Dad passed away on Wednesday, July 21st at 6:45pm.
This initial spontaneous report was received on 18-SEP-2018 from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or about 2010, the patient was inoculated with ZOSTAVAX at a physician's office for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. The vaccine did not prevent shingles or zoster-related injuries as intended. On or about 29-AUG-2016, the patient was treated by a physician at an urgent care for herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles and zoster-related injuries, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Within minutes of receiving vaccines infant's legs became red and swollen from thigh to feet immediately.  Splotchy red plagues developed on face.  Rash developed on torso and arms.  All resolved after treatment with BENADRYL.
Rash- initially 3 raised red dots approx. dime size each near injection site. Rash turned into one large, slightly raised circle near injection site.  It was mildly itchy, but other than that did not have any other symptoms. Rash lasted 3 days.
Received a call from patient indicating that she had extreme body aches throughout body with more pain centered in her legs and ribs. She was unable to make a fist on 9/13 but, had improved slightly on 9/14. Follow up call made on 9/15 and she indicated that her body aches were improving but, remained with a lot of aching in her neck and c/o a headache that is unrelieved with Ibuprofen or Tylenol.
Dose #1 given 3/3/2021 Pfizer Lot # EN6198  Patient died at hospital from Covid 19 on 12/12/2021