chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He had a temperature of 104.5F on Friday, Saturday, and Sunday; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (He had a temperature of 104.5F on Friday, Saturday, and Sunday) and MYALGIA (body aches) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PYREXIA (He had a temperature of 104.5F on Friday, Saturday, and Sunday) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-Mar-2021, PYREXIA (He had a temperature of 104.5F on Friday, Saturday, and Sunday) had resolved. On 08-Mar-2021, MYALGIA (body aches) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment  medication: Ibuprofen
Approximately 2 weeks after booster vaccination, developed intense pruritus on stomach which sporadically traveled throughout entire body (including legs, arms, feet, palms, back, neck, face, scalp) Especially around creases of skin or where clothing is tight (elbows, wrists, bra straps, pants line, sock lines). No rash with pruritus until after scratched, dermatographia in appearance, disappears after 30 minutes and alternative spot starts to itch. 1 full week has passed and pruritus has continued to persist throughout entire day. Utilize topical steroids, topical antihistamines and ice packs to relieve symptoms. Currently pregnant, due date 5/16/22.
On 5/20 pm, pt had several episodes of a gaggy, choking reaction followed by stopped breathing, lasting approx 15 sec., also with perioral cyanosis. Admitted to ER, had IV saline lock & Tx'd with Rocephin & nasal cannula & observed. This pt was involved in drug study for post marketing of HIB/Hep B.
5/18 61y.o. female with PMHx most significant for prior lung cancer, DVT, hepatitis C, bipolar disorder presenting for fatigue.
Patient nearly fainted shortly after receiving the vaccine. He turned pale and his head dropped.  EMS was called to the scene. The pharmacist gave the patient some water and he came around before EMS got there. EMS checked the patient and determined his vitals were okay. Patient did not need to be transported to the hospital. Patient did not have any known allergies. Patient did not know how they would react to the vaccine as they did not have insurance and did not usually get vaccines or routine blood work.
Full body uticaria with itching. Patient given a steriod pack at the hospital and famotidine for symptom relief.
Heart rate was about 10 points higher than normal; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm right, on 09Feb2021 at 03:30 AM (Lot Number: En9810), as single dose, for COVID-19 immunisation. Medical history was none. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had no allergies to medications, food or other products. Concomitant medications included lisinopril (unknown manufacturer) and allopurinol (unknown manufacturer). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced heart rate was about 10 points higher than normal (non-serious) on unknown date with outcome of recovered in Feb2021 after 1 week. The patient underwent lab tests and procedures which included heart rate: about 10 points higher than normal on unknown date. The patient has not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Moderna COVID-19 Vaccine EUA Pt presented to the emergency department with pruritis and redness appearing throughout arms, chest, and face 10 minutes after receiving the first dose of Moderna covid vaccine.   ED assessment:  Denies dizziness, shortness of breath, nausea, vomiting, diarrhea. Calm and hemodynamically stable. Erythematous rash throughout BUE, chest, and face. No hives seen, Not in anaphylaxis. Received diphenhydramine 50 mg prior to arrival and dexamethasone 10 mg in the ED.   Patient improved clinically throughout ED course was discharged home in stable condition.
Fever, chills, body aches, joint pain, fatigue, headache. Fever and chills began about 12 hours after the injection; chills lasted for about 8 hours, then subsided. All other symptoms lasted for 24 hours after onset, with fatigue tailing off after about 36 hours. Symptoms were sufficiently intense that I slept for most of 24 hours, but not disabling -- I could get up and walk around, for instance.
A huge lump and swollen where in the injection was given has gotten bigger and is red and hot to touch seems to getting larger
This spontaneous report was received from a medical assistant, referring to multiple unspecified patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored VARIVAX (lot # M028552, expiration date 07-JUN-2018). Temperature and time frame: 5.7 F for 1 hour and 34 minutes. This information was reported as a result of a digital data logger. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Patient was administered vaccine that was improperly stored (in freezer for too long and considered expired by manufacturer at date of administration due to lack of study data).  Patient was revaccinated per CDC recommendation on 6/3/22. No problems reported.
FEVER,  CHILLS,  BONE AND MUSCLE ACHES,      SICK FOR 3 DAYS,    TOOK:  TYLENOL  ALMOST 1 MONTH TO THE DAY BECAME EXTREMELY ILL , ALMOST LIKE FOOD POISONING ( THROWING UP,  DIARRHEA, DEHYDRATED)  (  COULD NOT EAT OR DRINK)   LASTED 24 HOURS  MIDDLE MARCH 2021 CUT MY TOE AND BLEED CONSIDERABLE AMOUNT,  TOOK LONGER THAN NORMAL FOR TOE TO HEAL.  DID NOT THINK MUCH ABOUT IT.  APRIL THRU JUNE NOTICED THAT SMALL CUTS AND SCRATCHES WERE NOT HEALING OR SCABBING OVER CORRECTLY.  JULY BROUGHT BRUISING AND SORES OR SKIN TO ATTENTION OF DOCTOR.     SEPTEMBER HAD LARGE BRUISING ON ARMS AND LEGS AND RED DOTS ON LIMBS.   DOCTOR DID BLOOD PANEL AND MY PLATELETS WERE 2,  SENT TO EMERGENCY ROOM AND TRANSPORTED TO HOSPITAL.  HAD 7 DAY HOSPITAL STAY.  NO REASON FOR PLATELET TO BE LOW.   ALL OTHER BLOOD MARKERS WERE NORMAL AND TEST FOR OTHER DISEASES WERE NORMAL.  NOW IT IS JANUARY 2022 A YEARS SINCE I RECEIVED MY FIRST SHOT AND THE DOCTORS CANNOT GET MY PLATELETS TO STAY ABOVE 10,000.    I HAVE HAD  SPLEEN ULTRA SOUND BONE MARROW BIOPSY STERIODS INFUSION INJECTIONS NOTHING HAS MADE A DISCERINBLE  DIFFERANCE.  I HAVE BEEN DIAGNOSED WITH IMMUNE THROMBOCYTOPENIA (ITP)  MY TREATMENT IS ONGOING
unable to receive second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 0.5 ml intramuscularly in an unknown arm on an unknown date in November 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive second dose, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Fever between 101 and 102, fussy, decreased appetite, no URI, no cough, no vomit and diarrhea, no rash, no stomatitis, urine clear as per ER, CXR said to be clear, temp increased to 105 rect., went transported in air conditioned car. Pt came into office 7/1/06 with diarrhea, then 7/2/06 with body rash.
axillary lymphedema and pain Narrative: taking ibuprofen. Will see PCP next day
1) Extensive spots, reticular discoloration of the legs, some spots redder than others. In calves of both legs.  2) Sharp breast pain,  on the left breast,
No adverse event; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 67-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    The patients age was reported as 67 Year 7 Month. No concomitant medications were reported. The vaccine was administered to patient between 08-Apr-2022 and 15-Dec-2022. NDC ID: 80777027399 Treatment information was not provided.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of an unknown age and gender. There was information about the patients' concurrent conditions, concomitant therapies or medical history provided.  On an unknown dates in January 2017, reported as between 04-JAN-2017 and 13-JAN-2017, the patients were vaccinated with LIQUID PEDVAXHIB lot # M032148 with an expiration date 18-APR-2017 for prophylaxis (dose, route of administration and anatomical location were not reported). Administered doses of LIQUID PEDVAXHIB experienced temperature excursion of 32.5 degrees Fahrenheit for 3 hours and 23 minutes, on 12-JAN-2017. There were previous temperature excursions which took 5 hours with the temperature of 30.3 degrees Fahrenheit on 04-JAN-2017, 3 hours and 58 minutes with the temperature 31.4 degrees Fahrenheit on 05-JAN-2017, 1 hour with the temperature 32.9 degrees Fahrenheit on 06-JAN-2017, 21 minutes with the temperature 34.7 degrees Fahrenheit on 09-JAN-2017, 4 hours with the temperature 31.8 degrees Fahrenheit on 10-JAN-2016, one hour and 45 minutes with the temperature 32.9 degree Fahrenheit on 11-JAN-2017. The cumulative time of the temperature excursions was 19 hours and 27 minutes with the lowest temperature 30.3 degrees Fahrenheit. No adverse effects were reported. Data logger was involved (new data logger system in place). Product quality complaint (PQC) was not reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA006576:
PROVIDER PROGRESS NOTE 2/7/2022 ASSESSMENT Principal Problem:   Weakness Active Problems:   Weakness generalized   Moderate malnutrition      Skin Condition Reddened (Non-Pressure Related);Rash Left;Lower Back (Active) First Observed/Origin Date/First Observed/Origin Time: 01/29/22 1838   Skin Condition Type: Reddened (Non-Pressure Related);Rash  Orientation: Left;Lower  Location: Back     Comments:    Patient is a 81 y.o. female with history of frequent UTIs, dementia, hypertension who presented to the emergency room with generalized weakness.  She was diagnosed with a UTI.  She also had 4 episodes of nonsustained V. tach and a cardiology consult was requested. A TTE was done without significant structural heart disease.  No further interventions per Cardiology.   PLAN     Generalized weakness Suspect d/t combination of COVID-19 infection and possible UTI.  -- PT/OT.  Needs 24/7 assistance - SW working toward TCU placement.   E.coli UTI with MDR, history ESBL, possible CRE On prophylactic Keflex for hx of frequent UTIs.  Per daughter, only 2-3 UTIs in the past couple years.   Suspect likely colonization. UA+ and UC with MDR E.coli (R to ertrapenem but S to meropenem).  -- Discussed and reviewed sensitivities with ID  -- Stopped ceftriaxone 2/1 -- Meropenem IV x3 days completed treating an uncomplicated cystitis per ID recs -- Prophylactic Keflex not necessary given established resistance, the fact she is very likely colonized.  -- ? if prophylactic therapy necessary given only a couple UTIs in the past couple years -- Consider referral to outpt ID and/or Urology on d/c to help determine future appropriateness of prophylactic therapy   COVID-19 infection Incidental finding. No hypoxia. Felt to be contributing to the weakness.  -- Monitor respiratory status -- Patient does not qualify for any COVID-19 directed therapies as she is on RA   Constipation -- Bowel regimen available - prune juice, Senna-S, dulcolax, Miralax -- Encourage oral intake and ambulation   Nonsustained ventricular tachycardia Asymptomatic with these episodes. Felt likely d/t Covid.  -- TTE without significant structural heart disease -- Appreciate input from cardiology, signed off -- High goals for e-lytes    Hyponatremia Suspect d/t poor oral intake which has improved. Hyponatremia resolved. -- Encourage oral intake -- Periodic BMP monitoring   Leukopenia Was previously normal in April. Suspect r/t Covid infection. -- Periodic CBC monitoring    Dementia Patient seemed mildly confused but cooperative -- Continue PTA Aricept   Hypertension Blood pressure intermittently mildly elevated -- Continue PTA Prinivil   Moderate malnutrition Per Dietitian eval.  Loss of Muscle Mass: Not Present. Loss of Subcutaneous Fat: Not Present. Fluid Accumulation: Mild +1. Energy Intake: Less than or equal to 50% of estimated energy requirement for 5 days or greater. Interpretation of Weight Loss: Not Reported (does not meet criteria). -- Supplements per Dietitian     Patient's daughter, POA - updated 2/6/22.     DVT Prophylaxis - Lovenox
The night of 11/20/19, patient received his first flu vaccine. After flu clinic, patient was hyperactive, seemed to have difficulty with focusing, with rapid eye movements; seemed almost manic to the parents and agitated. He seemed unable to get comfortable when held but was not crying as if in pain. His tongue was protruding as if it was numb and seemed limp. His grip was weak; he was unable to hold onto his toys or hold his pacifier to his mouth or keep it in his mouth. He was inconsolable for more than four hours with rapid respirations. He was thrashing in his sleep, sweaty and clammy; he barely slept, only about two hours total overnight. He had decreased oral intake; refused a bottle from 2100 to 0500 -- which is unusual for him. Parents gave him Tylenol and ibuprofen but neither seemed to help. He was returning to baseline the following day; simply seemed like he didn't feel well. Mother reports that patient bumped his head four days prior, but seemed normal afterward. Grandmother wondered about possibility of concussion symptoms being delayed.
COVID-19 pneumonia; vaccination failure; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 PNEUMONIA (COVID-19 pneumonia) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-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 started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In October 2021, the patient experienced COVID-19 PNEUMONIA (COVID-19 pneumonia) (seriousness criterion medically significant) and VACCINATION FAILURE (vaccination failure). At the time of the report, COVID-19 PNEUMONIA (COVID-19 pneumonia) was resolving and VACCINATION FAILURE (vaccination failure) outcome was unknown.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   No concomitant medication information was  provided. It was reported that the patient experienced pneumonia in chest from COVID. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   No treatment medication information was provided.  Company Comment: This is a spontaneous case concerning an 80-year-old male patient with no relevant medical history, who experienced the unexpected, serious (medically significant) adverse event of special interest of COVID-19 pneumonia, approximately 7 months after receiving the second dose of mRNA-1273 vaccine. Vaccination failure was also reported as an additional event. Clinical course, diagnostic tests and treatment details were not provided in the case. The event was resolving at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an 80-year-old male patient with no relevant medical history, who experienced the unexpected, serious (medically significant) adverse event of special interest of COVID-19 pneumonia, approximately 7 months after receiving the second dose of mRNA-1273 vaccine. Vaccination failure was also reported as an additional event. Clinical course, diagnostic tests and treatment details were not provided in the case. The event was resolving at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD; Vial was initially stored in the refrigerator 23-Dec-2022 and dose was administered after BUD; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 23-Dec-2022 and dose was administered after BUD) and NO ADVERSE EVENT (No adverse event) in a child 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. 216K22A) 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) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 23-Dec-2022 and dose was administered after BUD) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 23-Dec-2022 and dose was administered after BUD) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 23-Dec-2022 and dose was administered after BUD).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were reported.  Total 42 Dose were administered after 30-day Use By Date. Vaccine was administrated on 26-Jan-2023, 27-Jan-2023, 30-Jan2023, 31-Jan2023, 2-Feb-2023, 6-Feb-2023, 8-Feb-2023, 10-Feb-2023, 13-Feb-2023, 14-Feb-2023, 16-Feb-2023, 17-Feb-2023, 21-Feb-2023. Vial size was reported as 0.4 ml per vial. Vial did not undergone any temperature excursions.  No treatment information was provided.  This case was reported for patient 31 out of 42 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-718298 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718298:
This patient felt pain in shot area about 1/2 after shot, then he felt light headed. Got a frontal headache and eyes hurt. She then threw up and had a stomach ache. Felt "flu-ish" the rest of the day and "flu-ish" the next day. Missed 1/2 day of work.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14-25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to exact time not recorded, noted as equal to or > 12C for an estimated total time out of range of 10.5 hours. On 12-MAR-2013 at 17:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 9.25 hours. On 13-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 23-APR-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Pt was at clinic to receive her initial Covid 19 vaccine. Order was entered for monovalent vaccine however Bivalent vaccine was given. Pt arrived at another clinic on 10/7/22 to receive her 2nd Covid vaccine when the error was discovered. Director of Pharmacy was notified and after researching the issue the decision was made to give the patient a dose of the monovalent vaccine on her next visit. Patient has had no adverse effects.
Visited primary care Dr. on January 24th 2021 with irritated left eye. Was prescribed ointment, Bacitracin Polymyxin, to be used every 6 hours for 10 days. No improvement. Consulted eye Dr. and was diagnosed with plugged oil glands on the interior of lower eye lid of left eye. Cleared with a sharp instrument after eye numbing drops administered  by eye doctor. Problem cleared up same day.
Pt had 2 vax at 2 diff providers. 8 days post vax, rash covering body, itchy, swollen. Treated at ER twice and DO once. For Yellow Fever vax provider consult original documentation.