chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was administered 30-day Use By Date or after Manufacturer Date of Expiry; no adverse event; Customer called in to report that she gave an employee a dose of an expired vaccine, and that the vial expired on 6.23.2023.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Customer called in to report that she gave an employee a dose of an expired vaccine, and that the vial expired on 6.23.2023.), PRODUCT STORAGE ERROR (Vaccine was administered 30-day Use By Date or after Manufacturer Date of Expiry) and NO ADVERSE EVENT (no adverse event) in a 25-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A57184B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jul-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Customer called in to report that she gave an employee a dose of an expired vaccine, and that the vial expired on 6.23.2023.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was administered 30-day Use By Date or after Manufacturer Date of Expiry) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Customer called in to report that she gave an employee a dose of an expired vaccine, and that the vial expired on 6.23.2023.), PRODUCT STORAGE ERROR (Vaccine was administered 30-day Use By Date or after Manufacturer Date of Expiry) 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 (Customer called in to report that she gave an employee a dose of an expired vaccine, and that the vial expired on 6.23.2023.) and PRODUCT STORAGE ERROR (Vaccine was administered 30-day Use By Date or after Manufacturer Date of Expiry).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.
Temperature of 99.9; Body aches; Frequent headaches; Nauseated; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received second dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, formulation: solution for injection, Lot Number: EW0151) via unknown route of administration in left arm on 17Apr2021 at 11:24 (at the age of 21 years old) as DOSE 2, SINGLE for covid-19 immunisation. Vaccine Administered At Military Facility: No, But There Were Military People And Police There. People Administering Covid Shots Were Regular Nurses. The patient medical history included severe depression with psychosis, Diagnosed a little bit over a year. Has always been a struggle since she was a child, but never knew what it was. Since taking the medications she had been feeling better and was more productive. The patient family medical history included diabetes, either high or low blood pressure and cervical cancer. Concomitant medication included hydroxyzine 25 mg thrice daily (lot number: ED6351089 and expiry date: 10Nov2021) via orally for anxiety, depression and psychosis, had been taking for a little over a year. Dose would increase to either 50mg or 100mg and quetiapine 25 mg tablet daily (two tablets for bedtime) for psychosis and sleep, doctor would up her dose to either 50mg or 100mg, had been taking a little over a year. Historical vaccine included first dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, formulation: solution for injection, Lot Number: ER8727) via unknown route of administration in left arm on 27Mar2021 as DOSE 1, SINGLE for covid-19 immunization and had no reaction from the first COVID shot. The patient did not receive any other vaccine prior vaccination within 4 Weeks. On 17Apr2021, the patient had body aches, has been nauseated, and had frequent migraines. Had not actually thrown up or anything like that. Apparently she had a fever, but didn't know it. Had her temperature checked for work and it was 99.9. Her job sent her home. Had no reaction from the first COVID shot. Body aches began between 17:00-18:00. Had some last night and just thought she would try to get rest. Woke up with a headache and body pain. Was a little bit nauseated last night. Would stop for a minute and come right back on. Felt like a soreness after a workout. It was clarified she would instead classify it as headaches and not migraines, had been constant since 17Apr2021, had been turning down the TV volume and staying in quiet environments. Comes and goes, but never lasts long. had not thrown up and was not nauseated this morning. At 08:46, temperature was taken at her work and she was told it was too high and considered risky to go to work. She was sent home. On 08May2021, written on her card, she was not sure what that means or if she had to come back for another shot. The outcome of the event Frequent headaches was not recovered and other events was unknown.  No follow-up attempts were needed. No further information was expected.
All of a sudden got very dizzy, couldn't stand up without falling down, spiked a fever for 5 hours and dry heaved for 3 hours
After receiving last vaccine MMR noted childs lips pale, no cyanosis observed. Child awake and crying, noted child urinated on self per father and was very scared prior receiving vaccines. Blood pressure 102/67 pulse:100 respirations 22, observed further, no syncope noted. Evaluated by Dr. rule out anxiety, advised parents to observe child and give TYLENOL as needed. Instructed to go to Emergency Room if condition worsens or any changes.
After waking  up the next morning from the vaccine I had pain in in every joint from my fingers, wrist, elbows shoulder, jaw, ankles, toes, if it moved it hurt. And lasted about 6-7 days.  Couple months later I went to the doctor about it. 12/2020
5cm erythmetous ring  with swelling and pain at the injection site 7 days following injection. Resolved one week after onset. Only report for possible latex cross reaction
Information has been received from a health professional concerning a 1 year old Caucasian male with no past medical history or allergies, who on 16-Jun-2003 was vaccinated in the left thigh with a first dose of MMR virus vaccine live (lot #640788/1180M). Concomitant therapy, that same day, included a second dose pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (Crm197) (Prevnar) (lot #491576) given in the left thigh. There was no illness at the time of vaccination. Subsequently, on an unspecified date, the patient developed "5 spots various spots on face and diaper area." and itching. The patient was treated with calamine lotion for itch. In 2-3 weeks the patient recovered. Additional information is not expected.
Complex Febrile Seizure on 9/30- 10/1 . Two in 6 hours.
Mom reports patient felt like throat was closing up, lip was tingling, felt nauseous, broke out in a sweat. Felt better an hour later after a dose of BENADRYL.
Information has been received from a physician concerning an older male who was vaccinated with ZOSTAVAX (Oka/Merck). The physician reported that the patient experienced rash, no neuralgia. It was unknown if the patient sought medical attention. Additional information has been requested.
A 7 cm area of redness at injection site immediately after receiving vaccination. Benadryl given. Called home and rash was gone on 3/18/00. Child active, no complaints.
Missed scheduled second dose; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed scheduled second dose) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed scheduled second dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed scheduled second dose) 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 PRODUCT DOSE OMISSION ISSUE (Missed scheduled second dose).    Concomitant medications were not reported.  Patient missed scheduled second dose. Patient asked if patient could still take second dose of Moderna Covid-19 vaccine. They initially unsure if 42 days had lapsed then said that had been less than 42 days. Treatment medications were not reported.
I95.9 HYPOTENSION 9/26/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA J96.00 ACUTE RESPIRATORY FAILURE 9/26/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA I95.9 HYPOTENSION 9/26/2022 CANCER METASTATIC TO BONE J96.00 ACUTE RESPIRATORY FAILURE 9/26/2022 CANCER METASTATIC TO BONE
(R) arm local erythema 3cm-4cm with induration, body aches, fatigue.
April 4  fever & aches May 9  fever & aches June 18  Dr. appointment/shoulder stiff and sore June 29  ER/cortisone shot in shoulder July 25  shoulders, hips, thighs, gluts stiff and sore Aug 5    Polymyalgia Rheumatica diagnosis Aug 9    start prednisone Aug 20  end prednisone Aug 23  pain /stiffness returned Aug 28  restarted prednisone Oct 3-6 102.8 nightly fever Oct 7    Urgent Care/start 60 MG prednisone Oct 8 blood work Oct 8    Rheumatologist/ Giant Cell arteritis suspected Oct 11   temporal artery biopsy/ inconclusive
Burning, numbing, aching,left chest area and swollen under armpit limpnode area
SIDE EFFECTS; STORAGE ISSUE; This spontaneous report received from a patient 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, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced side effects, storage issue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the side effects, storage issue was not reported. This report was non-serious.
Patient's symptoms has been going on for 9 days at the time of admission Chest x-ray no acute findings on admission Pulmonary evaluated patient Received ceftriaxone and Levaquin to cover any superimposed bacterial pneumonia Received IV dexamethasone Received nebulizer treatment
Tested Covid-19 Positive; Tested Covid-19 Positive; Asthma; Cough; Fever; Feeling bad; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4247179-00.  A 42 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 30Dec2021 (Batch/Lot number: unknown) at the age of 42 years as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1154440) at unk (citrate free) for hidradenitis, rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Jan2022, outcome "not recovered" and all described as "Tested Covid-19 Positive"; COUGH (non-serious) with onset 30Dec2021, outcome "not recovered", described as "Cough"; PYREXIA (non-serious) with onset 30Dec2021, outcome "not recovered", described as "Fever"; FEELING ABNORMAL (non-serious) with onset 30Dec2021, outcome "unknown", described as "Feeling bad"; ASTHMA (non-serious) with onset Jan2022, outcome "unknown", described as "Asthma". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Jan2022) positive. The action taken for adalimumab was unknown. Clinical course: It reported the patient with events of non-serious tested covid-19 positive, cough, fever, feeling bad the same day after the covid-19 booster dose and asthma with Humira (Adalimumab). On 30Dec2021, the patient experienced cough, fever and feeling bad the same day after the covid-19 booster dose. In Jan2022, the patient experienced asthma. On 20Jan2022, the patient experienced tested covid-19 positive. Pfizer Biontech covid-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On Unknown date, patient received a first and second dose of COVID-19 Vaccine manufactured by Pfizer/BioNtech. On 30Dec2021, patient received 3rd dose COVID-19 Vaccine manufactured by Pfizer/BioNtech.   Causality for PFIZER BIONTECH COVID-19: The reporter's causality for the events of tested covid-19 positive, cough, fever, feeling bad the same day after the covid-19 booster dose and asthma was Possible.   Causality for Humira (Adalimumab): The reporter's causality for the events of tested covid-19 positive, cough and fever with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the events of feeling bad the same day after the covid-19 booster dose and asthma was not provided.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE, covid-19, COUGH, PYREXIA, FEELING ABNORMAL, and ASTHMA and BNT162B2.
lymph nodes under arm in neck swelled-saw MD because of unbearable pain & lymph nodes involvement;taking Duricef-sl improvement noted by pt;MD recommended no further;
Rash on face and neck 3 days after first dose.; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0161) via an unspecified route of administration in the left arm on13Apr2021 at 12:30 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and alpha thalassemia. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol, levonorgestrel (JOLESSA) taken for birth control from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 11:15, 3 days after the first dose, the patient experienced rash on face and neck. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event rash on face and neck was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a medical assistant refers to two patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 19-NOV-2015, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) lot # L021214, expiry date 10-JUN-2017 (strength, dose and route of administration, anatomical location were not reported). No adverse effects were reported. Product quality complaint (PQC) was not reported. This is one of several reports received from the same source. Additional information has been requested.
R thigh + swelling and erythema with induration around injection site 12x14cm. Pt able to walk well.
Second Moderna vaccine was given too early (1st dose: 12/07/21, 2nd dose: 12/29/2021).
I woke up at 4AM the next morning. I felt shaky with chills and a fever. I also experienced pain all over like muscle and joint pain. It almost seemed to me as though any place that I already had any issues or any point of weakness felt even worse than usual or than anything else on my body. I tried to go back to sleep but my toes and feet kept cramping. It hurt so much that it kept waking me up. I felt nauseas and extremely fatigue like exhaustion. I took over the counter medications for sleep but could only sleep a couple of hours. When I woke up on Sunday, 09/18/2022. I took extra strength TYLENOL to help with the pain. I had a telehealth visit with my doctor. I had no energy and no appetite. It seemed to make my vertigo worse. I had a weird twang in my hip and side. The pain progressed across my body. I spoke with my doctor on 09/19/2022. My doctor had me visit urgent care for a flu test. I also did a home test and it was negative.
This spontaneous report was received from a healthcare worker/clinical medical assistant and refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (Merck) (dose, route of administration, lot numbers and expiry dates were not reported). No adverse effect was reported. Additional information has been requested.
hard to bend the left knee; Left knee pain burning in nature " similar to arthritic pain"; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (hard to bend the left knee) and ARTHRALGIA (Left knee pain burning in nature " similar to arthritic pain") in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0101921A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced MOBILITY DECREASED (hard to bend the left knee) and ARTHRALGIA (Left knee pain burning in nature " similar to arthritic pain"). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (hard to bend the left knee) and ARTHRALGIA (Left knee pain burning in nature " similar to arthritic pain") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pt received second Moderna vaccine one week early on 5/3/21. No immediate adverse reaction noted after vaccine.
This spontaneous report was received from a consumer referring to a 14 month old female patient with major acid reflux. The patient had no drug reactions/allergies or concomitant medications. On 13-DEC-2017, the patient was vaccinated with an injection of VARIVAX for prophylaxis. Approximately on 21-FEB-2018 (reported as "three weeks prior to the onset of herpes zoster"), the patient was diagnosed with hand foot mouth disease. The reporter described this as a "common rash" that started with small red dots around the patient's lip area. On 14-MAR-2018, two red dots appeared on the patient's left leg. On 16-MAR-2018, blisters formed on additional dots from her inner thigh to her ankle. The patient was seen by the dermatologist that same day. On 17-MAR-2018, the patient began to limp and the left leg was giving her pain. She was seen at an Urgent Care facility where they did a culture and diagnosed this as either "shingles or herpes" and acyclovir was prescribed for one week. On 26-MAR-2018, the results of the culture indicated that the patient had "herpes zoster". The outcome of herpes zoster and hand-foot-and-mouth disease was reported as recovering since the rash was now almost gone. Causality assessment was not provided.
It was reported that infant was taken to local clinic on 11-14-08 and seen by a private physician. It was reported that the infant had been vomiting and was dehydrated, no fever. Infant was treated and sent home. Infant returned to local ER on 11-15-08 and was transferred to hospital. From there infant was transferred to another hospital.  1/12/09 Death certificate states COD as Liver failure & trisomy 21.  1/12/09 Reviewed hospital medical records of 12/3-12/8/2008. FINAL DX: severe metabolic syndrome including trisomy 21, renal failure, kidney failure, coagulopathy & cerebral edema.   Records reveal patient had steady downhill course after transfer & expired 12/8/08.  Death certificate included w/medical records.   1/7/09 reviewed hospital medical records of 11/16-12/2/2008. FINAL DX: idiopathic fulminant hepatic failure; multiorgan failure including liver & kidney's; encephalopathy; coagulopathy. Records reveal patient experienced vomiting day after vaccinations then irritable & continued vomiting next day & became lethargic.  Family tx w/Tylenol in correct dosing regimen.  Unable to tolerate feedings & taken to outlying hospital ER on 11/14.  Dx w/seizure & glucose of 15.  Tx & transferred to outlying hospital.  Glucose & liver enzymes remained high.  Dx w/fulminant hepatic failure, anemia & coagulopathy.  Tx w/IVF, insulin drip, PRBCs & blood products.  Developed respiratory failure & was intubated.  Transferred to higher level of care.  On admission had anasarca, jaundice & elevated ammonia.  TPN & continuous venovenous hemodialysis started.  GI, metabolic, neuro consults done.  Mitochondrial disorder suspected.  Liver & right thigh muscle biopsy revealed metabolic disorder & necrosis.  Deemed not a candidate for transplant.  Dialysis stopped, extubated & transferred as DNR to hospital closer to family.  12/5/08 Received hospital medical records of 11/16-12/2/08 which consisted only of operative report & labs.  Operative report indicates patient w/fulminant hepatic failure, coagulopathy, renal failure, cerebral edema & gen weakness.  Had open liver biopsy & left thigh muscle biopsy on 11/24/08.  12/2/08 Reviewed hospital medical records of 11/15/2008. FINAL DX: no d/c summary available; H&P states respiratory failure, anemia & severe metabolic acidosis; severe coagulopathy. Records reveal patient experienced projectile vomiting, weakness, lethargy x 4 day.  Seen in outlying ER, dx w/dehydration & tx w/oral rehydration.  Worsened w/increased weakness, diet refusal, moaning & returned to same ER.  Seizure noted in ER at that time secondary to hypoglycemia (BS=15) then rebound hyperglycemia (BS>500).  Transferred to higer level of care for PICU.  Intubated on arrival, pale, tachycardic, chest retractions, abdominal distention & tenderness, decreased BS, NGT w/bloody & coffee grounds aspirate, hypotonia, areflexic.  Transfused PRBCs & FFP.  Tx w/antibiotics.  Transferred to higher level of care.