chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist referring to a 65 year old female patient who on 29-JUL-2013, was vaccinated with a dose of ZOSTAVAX (lot # J001003, expiration date 24-APR-2014) 0.65 ml, subcutaneously. This pharmacist noted that the patient experienced an injection site reaction after being vaccinated with ZOSTAVAX. The patient returned to the pharmacy today 31-JUL-2013, to informed this pharmacist that there was a red, painful, raised area where the ZOSTAVAX was administered. This patient noticed this reaction started yesterday 30-JUL-2013. The pharmacist stated that she told the patient to administer IBUPROFEN to herself to manage the pain. The outcome of injection site reaction not recovered/not resolved. Additional information has been requested.
Information has been received from a physician concerning a female who was vaccinated intramuscularly with a dose of GARDASIL (lot number not reported).  The patient's mother reported to the physician that her daughter experienced nausea and vomiting for three days.  The patient recovered on an unspecified date.  The patient's mother believed that nausea and vomiting were related to therapy with GARDASIL.  The patient did not seek for medical attention.  Additional information has been requested.
03Mar98 pt recv vax. 08Mar98 pt exp high liver function tests: transaminase level 100. 2 days later pt tested neg for hepatitis A virus. 15Mar98 transaminase levels 3000,alk phosphatase 300,bili 5.5 16Mar98 pt pos for hepatitis A antibodies
Narrative: Fully vaccinated found COVID positive during admission. Patient presented with delirium, nausea/vomiting, and nonhealing sacral wound. Patient found to be COVID positive upon day 3 of admission due to patient not get testing initially. No hx of prior infection.
Redness, swelling & itching at site; cough & "run-down" feeling.
No additional AE reported; Customer called for a temperature excursion and reported VARIVAX that had undergone temperature excursion was administered to patients before calling; This spontaneous report has been received from a medical assistant, regarding a 14-months-old male patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 20-JAN-2023, a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) underwent a temperature excursion between 6- and 14-degrees Fahrenheit (F) for one hour, this as a result of digital data logger.  On 22-JAN-2023, the patient was vaccinated with the improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, intramuscularly in the left thigh as prophylaxis (lot number: W006412, which was determined to be valid, with an expiration date on 23-FEB-2024) (strength, dose and scheme were not reported). There was not any report on previous temperature excursion.   This case is one of multiple reports from the same reporter.  ; Sender's Comments:  US-009507513-2304USA007822: US-009507513-2304USA007836: US-009507513-2304USA007837: US-009507513-2304USA007843: US-009507513-2304USA007869:
I26.99 ACUTE PULMONARY EMBOLISM 5/4/2022 ACUTE NONTRAUMATIC SUBDURAL HEMORRHAGE I26.99 ACUTE PULMONARY EMBOLISM 5/4/2022 HYPERTENSIVE CKD, STAGE 3B (GFR 30-44) I26.99 ACUTE PULMONARY EMBOLISM 5/4/2022 HX OF KIDNEY TRANSPLANT I26.99 ACUTE PULMONARY EMBOLISM 5/4/2022 ACUTE NONTRAUMATIC SUBDURAL HEMORRHAGE I26.99 ACUTE PULMONARY EMBOLISM 5/4/2022 HX OF KIDNEY TRANSPLANT I26.99 ACUTE PULMONARY EMBOLISM 5/4/2022 ANEMIA DUE TO CKD I26.99 ACUTE PULMONARY EMBOLISM 5/4/2022 ANEMIA DUE TO CKD I26.99 ACUTE PULMONARY EMBOLISM 5/4/2022 BACTEREMIA I26.99 ACUTE PULMONARY EMBOLISM 5/4/2022 ANEMIA DUE TO CKD I26.99 ACUTE PULMONARY EMBOLISM 5/4/2022 METABOLIC ENCEPHALOPATHY
Pt reported chest pain that wasn't relieved by her medications she takes for GERD. she experienced this pain on and off for 5 days before presenting to the ED. She reports substernal chest pain rating 6/10 that does not radiate. Cardiac workup was inconclusive at time of arrival t ED. Pt reports feeling short of breath at times, more so when lying on her left side.
Patient developed a rash about 3 days following vaccination. It was maculopapular and was treated with steroids. Patient developed progressive dyspnea shortly after the rash that was treated with oral Ceftin, oral Augmentin, and steroids. This progressed to the point where she was hospitalized on August 10, 2021. Her oxygen needs were very significant requiring  HFNC and bipap. She was never intubated. She was ultimately diagnosed with cryptogenic organizing pneumonia and has since responded to therapy.
Patient hospitalized for acute hypoxemic respiratory failure and NSTEMI on 3/17/2021. Patient received second dose on 4/5/2021. On 5/12/2021 patient presented to the ED and was subsequently hospitalized with hypertensive crisis. These visits are within 6 weeks of receiving COVID vaccination.
Fatigue, muscle ache, nausea, lightheartedness, dizziness, sore throat. Sxs classified as Grade 3.
This is a spontaneous report from a non-contactable nurse. A patient of unspecified age and gender received PREVNAR 13 on an unspecified date, at single dose, for immunization. Medical history and concomitant medications were not reported. About 1.5 year later, on an unspecified date, the patient experienced pneumonia. Event outcome was not reported. No follow-up attempts are possible, information about batch number cannot be obtained. Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.
Small rash on chest, upper back and right arm opposite arm from vaccination site; This is a spontaneous report from a contactable other healthcare professional, the patient. A 45-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 10Aug2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Aug2021, the patient experienced small rash on chest, upper back and right arm opposite arm from vaccination site. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event small rash on chest, upper back and right arm opposite arm from vaccination site was not resolved at the time of this report. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FP8448) via an unspecified route of administration in the left arm on 31Aug2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation.
Information has been received from a medical assistant concerning a 12 month old male patient with no known drug allergies or pertinent medical history who on 20-APR-2010, was subcutaneously vaccinated with the left upper arm with a 0.5 mL dose of VARIVAX (Merck) (Lot# 666044/1428Y). Secondary suspect vaccination included VAQTA (MSD). Concomitant vaccination included PREVNAR. Subsequently, on approximately 20-APR-2010, the patient experienced red, raised areas "the size of a silver dollar" at the injection site of the left upper arm. On 30-APR-2010, the patient had an office exam. There were no lab tests performed. It was unknown if the patient required medical treatment. At the time of the report, the patient outcome was unspecified. Additional information has been requested. This is one several cases reported by the same source.
Pt. became flushed, felt warm-minor redness at injection site VSS. BS clear and equal bilaterally-no loss of consciousness. Evaluated by MD give 7.5 mg Benadryl po.
Over all bad feeling; Lethargic; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Over all bad feeling), LETHARGY (Lethargic), PYREXIA (Fever) and CHILLS (Chills) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No relevant medical history provided.  Concomitant products included ESTRADIOL, MELOXICAM, AMLODIPINE and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced FEELING ABNORMAL (Over all bad feeling), LETHARGY (Lethargic), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 09-Apr-2021, FEELING ABNORMAL (Over all bad feeling), LETHARGY (Lethargic), PYREXIA (Fever) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication including hormone injection 1 cc Q mo(unsure of spelling "depotestro") was reported.
This is a spontaneous case, initially received from other health professional on 07-Mar-2019, concerning a 59-year-old, adult male patient. The patient's current conditions included hypertension, coronary heart disease, chronic obstructive pulmonary disease (COPD) and biventricular congestive heart failure (reported as medical history). The patient's concomitant medications included Albuterol, INCRUSE ELLIPTA, carvedilol, atorvastatin, furosemide, SPIRIVA, lisinopril, clopidogrel and ipratropium bromide. It was reported that on 11-Feb-2019, vaccines reached lowest temperature of 32.4 F (first excursion) and it was out of range for 1 hour. On 02-Mar-2019, temperature of the vaccines again reached 26.2 for 1 1/2 hours. On 05-Mar-2019, the patient was administered AFLURIA QUADRIVALENT [dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: YF44209 and expiry date: 30-Jun-2019] which underwent temperature excursion for active immunization against influenza. On the same day, the patient was also administered with non-company suspect vaccine PNEUMOVAX [anatomical location: left deltoid, dose, route of administration, batch number and expiry date: not reported] for immunization against pneumococcal disease. It was reported that, on an unspecified date, the patient passed away due to cardiac complications of pre-existing medical conditions. The reporter assessed the case as non-serious. Case re-opened for completion of full data entry: 07-Mar-2019. Follow up received from other health professional on 17-Apr-2019: It was reported that they had no information on the patient, until they were recently informed that the patient passed away due to cardiac complications of pre-existing medical conditions. Hence, the event 'cardiac disorder' with fatal outcome was added in the event tab. Hence, the classification 'special case with no AE' was deleted in general tab. The case was upgraded from non-serious to serious. The case outcome was changed from unknown to fatal. The narrative and case comment were amended accordingly. Reporter's Comments: A 59-year-old male patient with concurrent conditions hypertension, coronary heart disease, chronic obstructive pulmonary disease (COPD) and biventricular congestive heart failure was administered AFLURIA QUADRIVALENT vaccine which underwent temperature excursion. The patient died due to cardiac complications, unspecified period post vaccination. Despite the lack of onset latency, the company assessed the causality of the event cardiac disorder as not related, considering the pre-existing heart conditions as the alternative aetiology. The event incorrect product storage assessed as not related to suspect vaccine, considering the incidental nature of the event and the event drug administration error assessed as not related to suspect vaccine, considering the accidental nature of the event. The company assessed the event 'cardiac disorder' as serious (medically significant). Reported Cause(s) of Death: Due to cardiac complications of pre-existing medical condition.
2pm day of immunization, arm sore. By next day afternoon noticed 2x2 swelling and red soreness and warm. By second day post immunization in am, came into to pharmacy and consulted with rph. Recommended Benadryl, took total 4 tablets  one that am (10am), one afternoon (2-3pm) and 2 pm. Third day post immunization complete resolution.
Fever, aches, nausea, vomiting, forgetfulness, early menstrual period
Inconsolable crying starting about 4 hours post vax lasting about 6 hours; somewhat irritable for next 22 hours. Treated with acetaminophen.
Patient did not receive this vaccine from our medical center, but did receive treatment for the adverse event from our facility. Patient states he received the ZOSTAVAX vaccine on 3/25/08. States he had shingles when he was vaccinated and should have never received the vaccine. Had an outbreak of shingles on the right chest and right back. Outbreak is improving now, and patient now has an order for gabapentin to help with the pain. Also received acyclovir 800 mg q4h following the immunization for treatment of the shingles. Patient denied having any other immunizations in the month prior to receiving ZOSTAVAX.
After booster VX, developed a fever and soreness throughout body. Then 1 week later she tested positive for Covid-19, having a breakthrough case.
Moderna COVID-19 vaccine administered as second dose after temperature excursions on 22Jul2021 and 10Aug2021; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered as second dose after temperature excursions on 22Jul2021 and 10Aug2021) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Aug-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) (unknown route) 1 dosage form. On 11-Aug-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered as second dose after temperature excursions on 22Jul2021 and 10Aug2021). On 11-Aug-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered as second dose after temperature excursions on 22Jul2021 and 10Aug2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.  It was unable to clarify whether vial that underwent temperature excursions on 22Jul2021 and 10Aug2021 was administered to patient(s).   Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Significant Follow up - Patient identifier added, patients date of birth added.
Soreness at the injection site; hardness at the injection site.; rash on my neck; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on my neck), VACCINATION SITE PAIN (Soreness at the injection site) and VACCINATION SITE MASS (hardness at the injection site.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced RASH (rash on my neck). On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site) and VACCINATION SITE MASS (hardness at the injection site.). At the time of the report, RASH (rash on my neck), VACCINATION SITE PAIN (Soreness at the injection site) and VACCINATION SITE MASS (hardness at the injection site.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
extremely lightheaded; This is a spontaneous report from a contactable physician (patient's husband). The physician reported same events for 2 patients. This is 2nd of 2 reports. A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on 30Dec2020 at a single dose in deltoid left for Vaccination/COVID-19 vaccine. Medical history included COVID-19 in Jul2020, ongoing overweight. There were no concomitant medications. The patient experienced extremely lightheaded on 30Dec2020. Reporter seriousness for extremely lightheaded is medically significant. The reporter stated his wife (patient) was feeling about the same thing and believed his wife was feeling better. She got up and was walking around and is no longer beside him. No Emergency Room or Physician Office visited. The outcome of event was recovering.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event dizziness cannot be excluded. ,Linked Report(s) : US-PFIZER INC-2020520760 same reporter/drug/event, different patient
Approximately 48 hours after immunizations mother noted (L) deltoid, swollen, red and warm, area the size of a baseball. Pt does not c/o discomfort.
pinched nerve feeling in upper back, neck on and off; muscle spasms; dull ache; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ep7534), via an unspecified route of administration in the right arm on 16Mar2021 at 11:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included fluoxetine hydrochloride 10 mg (PROZAC) for an unknown indication from an unknown date. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 18Mar2021, the patient had a dull ache, muscle spasms and pinched nerve feeling in her upper back, neck on and off that started a few days after, and had not gone away completely. The patient did not receive any treatment for the events dull ache, muscle spasms and pinched nerve feeling in upper back, neck on and off. The clinical outcomes of the events dull ache, muscle spasms and pinched nerve feeling in upper back, neck on and off were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Information has been received from a health professional concerning a 15 year old 130 lb. 62 in. female who on 07-AUG-2007, was vaccinated with a second subcutaneous dose in the left arm of varicella virus vaccine live (Oka/Merck) (lot#657941/0851U). There was no reported illness at the time of vaccination. On 08-AUG-2007, the patient developed redness and pain at the injection site. Medical treatment sought was not reported. There was no relevant diagnostic and laboratory data reported. On an unspecified date, the patient recovered. A product quality complaint was not reported. Additional information is not expected.
Mild sore arm after first shot; Low fever after first shot; Tired after first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Mild sore arm after first shot), PYREXIA (Low fever after first shot) and FATIGUE (Tired after first shot) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE PAIN (Mild sore arm after first shot), PYREXIA (Low fever after first shot) and FATIGUE (Tired after first shot). On 10-Jan-2021, VACCINATION SITE PAIN (Mild sore arm after first shot), PYREXIA (Low fever after first shot) and FATIGUE (Tired after first shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was provided. No treatment medication details was provided.   This case was linked to MOD-2021-403263, MOD-2021-403257 (Patient Link).
Sudden onset after usual slight arm pain, feeling tired, of intermittent gross hematuria which continued for 48 hours. No treatment. May or may not be causally related. Have had similar events 5 years and 2 years ago. Work up showed only varicosities peri prostatic. No infections at the time.
Patient who is 17 years old was given Moderna vaccine by our Medical Assistant by mistake. Patient was monitored for any adverse reactions and notified of the error in vaccine administration. We explained what the next steps will be for the patient and to let us know if they have any further issues. We told parent that patient would not be able to get second dose of Moderna until after he turned 18. Patient left and did not have any adverse reactions.
Runny Nose; Sore Throat; Ear Pain; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHEA (Runny Nose), OROPHARYNGEAL PAIN (Sore Throat) and EAR PAIN (Ear Pain) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced RHINORRHEA (Runny Nose), OROPHARYNGEAL PAIN (Sore Throat) and EAR PAIN (Ear Pain). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (THERAFLU [DEXTROMETHORPHAN HYDROBROMIDE;PARACETAMOL;PSEUDOEPHEDRINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RHINORRHEA (Runny Nose), OROPHARYNGEAL PAIN (Sore Throat) and EAR PAIN (Ear Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient called in sating that she received the first dose of the Moderna COVID-19 vaccine on 02Feb2021. No side effects were initially reported following the vaccine. On 01Mar2021, the patient began experiencing a runny nose, sore throat and some ear pain. She is scheduled to get her second dose of the vaccine on 03Mar2021. Side effects are still present at this time.
Patient reported confusion, dizziness and nausea at 0930. Patient alert and oriented x 4 with steady gait. Patient reports small amount of vomit (water consistency). Patient continued to have these symptoms until going home with grandmother at 1115
After receiving TDaP/Varicella felt faint and did faint - ammonia applied and C/O feeling like tongue was sticking to roof of mouth - BENADRYL 4tsp. administered - was able to swallow without difficulty.