chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breakthrough case admission after 3 vaccines  Moderna 4/14/21 Lot# 043B21A;  Moderna 5/12/21 Lot# 044B21A; Pfizer 12/15/21 Lot# 32030BD
patient awoke in the middle of the night with breathing difficulty, loss of taste and smell, headache, dizziness and extremely fatigued
PT COMPLAINED OF SORE ARM NEXT DAY AND THEN SHOWED UP ON 10/10 WITH HER ARM ALL RED AND WAS DIAGNOSED WITH CELLULITIS.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021 at 3:18 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Apr-2021 at 3:18 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 52.19 for dose administered on 28-Apr-2021. No concomitant medications were reported.  Batch number 007C21A administered on 28-Apr-2021 underwent temperature excursion with temperature of 33 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 19-April-2021 and beyond use date for the vial was reported as 19-May-2021. Product moved to clinic on 28-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 traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration. It was reported that, the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. 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).
No additional AEs were reported,; The healthcare worker reported that a patient received improperly./Temperature: 11.3C; This spontaneous report was received from the healthcare worker and refers to a 12-month-old patient of an unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not provided.  On 29-AUG-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #w003118, expiration date: 13-JUL-2023, administered for prophylaxis (strength, and route of administration were not provided); or hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #w015191, verified as valid lot of prefilled syringe, expiration date: 27-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided). The vaccine was improperly stored before, and the patient received only one dose, but it was not specified which lot number was involved (product storage error). No further information provided.
Temperature: BELOW 36 Fahrenheit degrees/2 Celsius degrees (0.9 C to 1.9 C) for 10 hours; ABOVE 47 Fahrenheit degrees/9 Celsius degrees (9.1 C) for 30 minutes; This spontaneous report was received from an other healthcare professional and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 26-OCT-2020, the patient was vaccinated with a dose of human papilloma virus (hpv) rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # T007035 has been verified to be a valid lot #, expiry date 01-MAY-2022) (dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine experienced temperature excursion before administration to the patient. It experienced temperature below 36 Fahrenheit degrees/ 2 Celsius degrees (temperature range 0.9 Celsius degrees to 1.9 Celsius degrees) for 10 hours and above 47 Fahrenheit degrees/ 9 Celsius degrees (9.1 Celsius degrees) for 30 minutes. There was no previous temperature excursion. No digital data logger was involved.  This is one of 4 reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T007035; expirationdate: 01-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA011203: US-009507513-2010USA011375: US-009507513-2010USA011190:
Child received vaccine 05/04/04.  Mom noticed redness and swelling AM of 05/05/04 noted increased swelling and warm to touch AM 05/06/04.
MOTHER PHONED TO REPORT PATIENT HAS A SWOLLEN RIGHT ARM AND A RED BUMPY RASH EXTENDING FROM HER SHOULDER TO HER ELBOW.  NO FEVER
26APR93 high pitch scream 4 hrs; no fever; no redness or swelling; APAP was given; MD was notified;
Headache, Myalgia, Arthralgia, Tachycardia,  Pmhx RA controlled. Describes myalgia/arthralgias as moderate, making her feel "heavy", low energy.  Narrative:  Instructed to follow up with facility if sx persist >48 hours, sooner or worsen, or to ED if needed.
Client arrives to observation area and states to his partner that he is not feeling well. Client immediately passes out and gain consciousness within a few seconds. Client states he does not recall what happened. Client hit his head when he lost consciousness. No signs of bleeding or cuts in head area. Client declines any pain.  Client is AOX4 VS: BP 108/60 HR: 67 02: 98% .911 alerted at 2:40pm arrived at site at 2:45 pm. Client was moved from supine position to a chair client then c/o of lightheadedness . Client was then placed back to supine postion and reassesed by ems. BP: 124/62 HR :70 02: 98%  after a few min cient was then placed in a chair and was adviise to be transfered to hospital. Bp read as 88/35
feeling sleepy; This spontaneous case was reported by a nurse and describes the occurrence of SOMNOLENCE (feeling sleepy) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A.) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced SOMNOLENCE (feeling sleepy). At the time of the report, SOMNOLENCE (feeling sleepy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-380979, MOD-2021-380980 (Patient Link).
Redness and swelling at left arm site. No fever. Started 6/10/03 PM, immunization given 9:40 AM.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Fever-Medium, Systemic: Headache-Medium, Additional Details: Pt. reports  muscle aches for 1 week,  headache for 3 days, fever 99.9 for 24 hours.    inj site red and inflammed
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022 at 6:25 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 20-Jan-2022 at 6:25 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2022: Follow up received: No new information.
Client described itchy rash with fluid filled bumps beginning 2-3 days after immunization. Reported to Public Health Nurse on 7-14-2005.
Immunization adm 6/17/05. Pt in ER next day with sore, swollen area on left ant thigh with cellulitis. Pt put on antibiotics.
Tiredness & nausea My diegustive system had been a little upset a week before vacc.
The hours following my vaccination, I had random heart fluttering/palpitations which subsided after the first day. 72 hours after vaccination I had a sudden and rapid onset of chills, sweatiness, achey muscles, and extreme nausea. I proceeded to vomit and was ill/fatigued the entire day. The days following I had extreme fatigue and spells of dizziness. I have also had intermittent  diarrhea, bloating, nausea,  and another episode of vomiting. I had additional episodes of achey muscles, sweating  and feeling chills which disrupted my ability to sleep., menstrual cramps when I am not on my period, swollen lymph nodes in the neck, numbness in my arms and hands, brain fog. Symptoms seem to be persistent and becoming worse as time goes on.
14 hours after vaccination. Woke up very dizzy, to the point of feeling intoxicated. Have started taking OTC meclizine to help with symptoms. This did not happen with any of my previous Pfizer vaccines.
This is a spontaneous report from a contactable consumer (patient). A 43-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 02Mar2021 10:00 (Lot Number: CD3969) (at the age of 43-years old) as dose 1, single for covid-19 immunisation. Medical history included ongoing diabetes mellitus from 2016 or 2017, ongoing high blood pressure diagnosed in 2016 or 2017, covid-19 symptoms started on 07Feb2021 and he tested positive for covid on the 10Feb2021 prior to vaccination, pyrexia from Feb2021 and cough from Feb2021 since the covid. The patient was quarantined through the 22Feb2021 after testing positive for covid. The patient had no family medical history relevant to adverse event. Concomitant medications prior to the vaccine up until a week before included chlorphenamine maleate, dextromethorphan hydrobromide, paracetamol (CORICIDIN HBP MAXIMUM STRENGTH FLU) taken for pyrexia and not to raise his blood pressure from 07Feb2021 to 23Feb2021; paracetamol (TYLENOL) taken for an unspecified indication from an unspecified start date to Feb2021. The patient had no prior vaccinations within 4 weeks of covid-19 vaccine. After getting the vaccination, the patient fine just a little soreness initially, the injection site got real hard and started hurting then he noticed that the site where the injection went in on his arm was real sore on 02Mar2021 at about 18:00. Later about 03Mar2021 at 12, he woke up with a real bad fever, chills, sweating, body aches, joint pain in his elbows and knees, and his calves felt real tight like a calve strain on the right side; the side he got the shot on. The calve tightness which woke him up. The patient described the calve pain and waking him up kind of like a Charlie horse, a cramp. His wife checked on him to see why he woke up and felt him, saying he was burning up. His temperature was checked, and it was 101.2. At the time of reporting his arm was not as sore but was still tender right now, his muscles were still somewhat sore and his joints still hurt a lot, his body still ached. The patient was hot to the touch and he checked his temperature. The patient took Tylenol 500mg on 03Mar2021 at 12:30 or 13:00 as treatment for body aches and fever but it was not working. The events did not require visit to emergency room or physician office. The patient asked if he was contagious after vaccine. The outcome of vaccination site induration, sweating and calf pain was unknown and outcome of all other events was not recovered. No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a healthcare worker refers to a 70 year old male patient with no drug reactions or allergies. The patient was ex-smoker and had chronic obstructive pulmonary disease (COPD). The reporter stated that on 05-DEC-2013 (reported as yesterday) the patient was vaccinated with PNEUMOVAX23 intramuscularly in the right arm (lot # J009833 exp. Date: 25-JAN-2015, 0.5 ml). Concomitant medication included albuterol (manufacturer unknown) and influenza virus vaccine (manufacturer unknown). The reporter stated that client was also vaccinated with the influenza virus vaccine (manufacturer unknown) in the same arm, right arm, at patient's request. The patient visited the doctor office on 06-DEC-2013 (reported as today). The patient was able to walk into the office. The patient stated that he was nauseous, short of breath and his blood pressure (BP) was through the roof (unspecified what the BP reading was). On 06-DEC-2013, electrocardiogram (EKG) was performed at the doctor's office and some abnormality was found. The physician did not feel comfortable letting the patient to return home. On 06-DEC-2013, the patient was rushed from the doctor office, to the local hospital by ambulance. The reporter stated it was unknown if patient was hospitalized. The outcome of events was reported as not recovered. The relatedness between therapy with PNEUMOVAX23 and events was not reported. The reporter stated that he would not administer PNEUMOVAX23 with lot # J009833 to anyone else. This is one of two reports from the same reporter. Linked case # 1312USA003857. The events: nauseous, short of breath, blood pressure (BP) was through the roof and EKG with abnormality found were considered to medically significant by the reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse (R.N.) refers to a patient of unknown age. On 12-NOV-2012 the patient was vaccinated orally with a dose of 2 ml ROTATEQ (lot # reported as 0075AA), that had expired on 25-OCT-2012. No adverse effect was reported. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information has been requested.
p/3rd set of vx pt cried for 3 hrs straight, was inconsolable, felt warm; APAP was given;
@ age 7 mos, mom doesn't see nl development; lack of good head control, not sitting up, no weight bearing on legs; In MAR mom put pt to bed 2 1/2 hrs later pt face was covered w/mucous, gasping to breath, vomiting mucous; next day diarrhea
Within 15 minutes after vaccine - pt became dizzy, clammy, sweaty, lightheaded, loss of color, fainted in exam room.
Patient experienced syncopal episode ~5 minutes after receiving vaccination.  No other reactions or history pertinent to reaction
8 hours after getting the shot (Friday),My left leg felt like it was this constant cramp and on a scale of 1-10, it was a ten; my whole body hurt really bad; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06May2021 16:15 (Batch/Lot number: unknown) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Sjogrens" (unspecified if ongoing); "Gastroparesis" (unspecified if ongoing). Concomitant medication(s) included: LINZESS; NORTRIPTYLINE; MAGNESIUM; B12 [CYANOCOBALAMIN]; VITAMIN D [VITAMIN D NOS]. Past drug history included: Known allergies: amoxacyllin, reaction(s): "Known allergies: Amoxacyllin". Vaccination history included: Bnt162b2 (Dose 1,single, Lot unknown true, Lot unknown reason=Other, Vaccine location=Left arm, ), for COVID-19 immunisation.The following information was reported: MUSCLE SPASMS (non-serious) with onset 07May2021, outcome "not recovered", described as "8 hours after getting the shot (Friday),My left leg felt like it was this constant cramp and on a scale of 1-10, it was a ten"; PAIN (non-serious) with onset 07May2021, outcome "not recovered", described as "my whole body hurt really bad". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of muscle spasms, pain.  Additional information: She stated that I got my shot on Thursday. Advil helped with some of the pain, but it didn't touch the pain in my leg. Saturday wasn't as bad, but I still had to take pain meds to deal with the pain. Sunday (today) it was a bit less in the morning but increased again in the Afternoon. The patient had no prior covid vaccination and was not covid tested post vaccination. She had no allergies and did not get other vaccine in four weeks. The lot number was unknown as she Did not see when she got the shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Lightheadedness that resolved after appx 10 minutes. Symptoms resolved soon after turning on air conditioning in the car.
This spontaneous prospective pregnancy report was received from a registered nurse refers to a female patient of unknown age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not reported. The patient was reported as pregnant. Her LMP and EDD were unknown. On 29-DEC-2015, the patient was vaccinated with dose 1 of GARDASIL 9. The patient required medical attention on an unknown date and she walked into the reporter's office to get vaccinated with her second dose of GARDASIL 9. Reporting nurse stated that since the patient looked like she was 7 months pregnant, second vaccine dose was not administered to her. Nurse stated that she was unknown why the first vaccine dose was given to the patient, since it was documented that the patient was pregnant. Nurse also mentioned that the patient complained of injection site soreness at an unspecified site. Outcome of the events were unknown. The pregnancy outcome was outcome pending. No other complaints were reported. Reporter did not assessed the causality of event, injection site soreness with respect to therapy with GARDASIL 9. Additional information is not expected as the reporter did not wish further contact.
This spontaneous report was received from a pharmacist refers to a patient of unknown gender and age. There was no information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications. On 26-OCT-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot # M003487, expiry date: 21-APR-2017). Pharmacist reported that the vaccine underwent temperature excursion at 40F for 23 hours. No data logger was used to record temperature. There were no previous temperature excursion. No adverse effect was reported. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 77 years old male patient at the time of reporting. The patient had no pertinent medical history or drug reactions/allergies. The pharmacist reported that patient who was vaccinated with ZOSTAVAX (lot number not reported) vaccination site unknown about 3 months ago in May 2012 in another pharmacy, has been experienced itching and scaly skin around injection site area on an unknown date. Patient would get itching of the area periodically and then skin will become scaly around the same time. The patient had sought medical attention via speaking to pharmacist. No treatment was given. The outcome was reported as not recovered/not resolved at the time of reporting. Additional information is not expected.
Left arm a little sore; injection site also felt warm; red and puffed up at injection site; red and puffed up at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm a little sore), VACCINATION SITE WARMTH (injection site also felt warm), VACCINATION SITE ERYTHEMA (red and puffed up at injection site) and VACCINATION SITE SWELLING (red and puffed up at injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (Left arm a little sore), VACCINATION SITE WARMTH (injection site also felt warm), VACCINATION SITE ERYTHEMA (red and puffed up at injection site) and VACCINATION SITE SWELLING (red and puffed up at injection site). At the time of the report, PAIN IN EXTREMITY (Left arm a little sore), VACCINATION SITE WARMTH (injection site also felt warm), VACCINATION SITE ERYTHEMA (red and puffed up at injection site) and VACCINATION SITE SWELLING (red and puffed up at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Additional information included outcome of events pain in extremity, vaccination site warmth, vaccination site erythema and vaccination site swelling  was updated.