chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a serious spontaneous case, initially received from non-health professional (consumer) on 24-Dec-2018, concerning a 73-year-old, elderly male patient. The patient's current conditions included diabetes and high blood pressure (since on unspecified date) (reported as medical history). The patient's concomitant medications included Metformin, Simvastatin, Omeprazole, Amlodipine, Doxazosin and Levothyroxine for unknown indications. On 21-Dec-2018, the patient was administered INN Flu vaccine seasonal [influenza vaccine, influenza virus vaccine polyvalent, route of administration: intramuscular, anatomical location: deltoid, dose, batch number, expiry date, manufacturer and trade name: not reported] for influenza prophylaxis. On the same day, after vaccination, the patient developed metallic taste and vision changes which the patient felt that the areas of letters were missing and he couldn't read at all. The patient treated with natural tears solution. The outcome of the events was not recovered (ongoing). The reporter assessed this case as non-serious.; Reporter's Comments: A 73-year-old, elderly male patient with medical history of diabetes and high blood pressure developed metallic taste and vision changes with reading disorder, on the same day after INN Flu vaccine. Considering the plausible temporal relationship between vaccination and events (metallic taste and vision changes) the company assessed the events as possibly related to suspect vaccine. However, the co-administered metformin should be considered as confounding factor for the event of metallic taste. Despite temporal association between vaccination and event of reading disorder, the clinical course suggests the reported vision changes as a more plausible explanation for the event. Hence, the company assessed the causality as not related to suspect vaccine. The company assessed the event (visual disturbances) as serious (medically significant).
Adolescent received vaccines on 3/31/09. Mother called on 4-2-09 morning with adolescent having fever, rash all over the body. However no difficulty breathing. Instructed to bring to office same day. However mother decided to keep her home. Obviously she got better within 2-3 days.
I am an RN at this hospital, I received second injection 1/13/2021. On 1/15/2020 felt sick enough to just lay down all day, then left arm below injection site became moderately swollen, itchy and inflamed. This has lasted until today  1/20/2021 swelling, inflammation and itching has subsided 50 %.  It was most of my upper arm an extensive area.
rigors; This is a spontaneous report from contactable physician via Pfizer sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date at single dose for COVID-19 immunisation.  The patient medical history and the concomitant medications were not reported.  The patient had rigors that subsided in 12 hours after receiving the Pfizer-BioNTech COVID vaccine. The outcome was recovering.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
COVID VACCINES CAUSED TO NOT FEEL SO WELL; CAUSED TO HAVE COVID SYMPTOMS; COVID BOOSTER VACCINE MADE ARM REALLY HURT; FELT A POP IN HIP WHEN WAS GOING UP THE STAIRS; FELT A POP IN HIP WHEN WAS GOING UP THE STAIRS AND WAS IN EXTREME PAIN; This spontaneous case was reported by a consumer and describes the occurrence of JOINT NOISE (FELT A POP IN HIP WHEN WAS GOING UP THE STAIRS), MALAISE (COVID VACCINES CAUSED TO NOT FEEL SO WELL), SUSPECTED COVID-19 (CAUSED TO HAVE COVID SYMPTOMS), ARTHRALGIA (FELT A POP IN HIP WHEN WAS GOING UP THE STAIRS AND WAS IN EXTREME PAIN) and VACCINATION SITE PAIN (COVID BOOSTER VACCINE MADE ARM REALLY HURT) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Posterior uveitis.    Concurrent medical conditions included Posterior uveitis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) CF Pen. In December 2021, the patient experienced JOINT NOISE (FELT A POP IN HIP WHEN WAS GOING UP THE STAIRS) and ARTHRALGIA (FELT A POP IN HIP WHEN WAS GOING UP THE STAIRS AND WAS IN EXTREME PAIN). On an unknown date, the patient experienced MALAISE (COVID VACCINES CAUSED TO NOT FEEL SO WELL), SUSPECTED COVID-19 (CAUSED TO HAVE COVID SYMPTOMS) and VACCINATION SITE PAIN (COVID BOOSTER VACCINE MADE ARM REALLY HURT). At the time of the report, JOINT NOISE (FELT A POP IN HIP WHEN WAS GOING UP THE STAIRS) and ARTHRALGIA (FELT A POP IN HIP WHEN WAS GOING UP THE STAIRS AND WAS IN EXTREME PAIN) had not resolved and MALAISE (COVID VACCINES CAUSED TO NOT FEEL SO WELL), SUSPECTED COVID-19 (CAUSED TO HAVE COVID SYMPTOMS) and VACCINATION SITE PAIN (COVID BOOSTER VACCINE MADE ARM REALLY HURT) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   There was no reported medical history.  Concomitant medication was not provided.  No information regarding treatment medication was provided.  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.
Pt.  had syncopal episode as dose was being administered, became diaphoretic, pale and lost conscious.  transferred to triage area where patient was monitored.  Pt. symptoms resolved but then became nauseated.  Every time patient sat up he became nauseated and would have a bout of emesis.  1900 patient continues to feel nauseated when sitting up but family  here to pick patient up and patient escorted out to wife's car with Dr. approval
Pt presents 4 hours after vaccine with edema and erythema at injection site.  Area warm to touch.
Swelling all around vaccinated area (3 - 4 inches), redness down my arm and all around the vaccinated area, very painful.  These symptoms lasted for three days. After redness and swelling subsided, pain persisted for five days.
Brought on more seizures than normal.  They started coming weekly and he had several petite seizures.
This is a spontaneous report from a contactable consumer (patient). A patient of unspecified  age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0180) via an unspecified route of administration on 07Jun2021 at single dose for Covid-19 immunization. The patients medical history and concomitant medications were not reported. The patient previously took first dose of BNT62B2 [PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0187 on 17May2021 via an unspecified route of administration at single dose for Covid-19 immunization. On 08Jun2021,the patient's heart feeling so fast and sometimes patients heartbeat so slow; like suddenly it disappears and suddenly its appears, like those things keep happen frequently. The patient heart start beat kind of fast then usual like much more than usual that and the patient can feel it, this happened every day in the afternoon and sometimes, when patient get up and patient have those heart beat fast problem. The patient did not receive any treatment for the adverse events. The outcome of event was unknown. Information on lot/batch number was available. Additional information has been requested.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 11 years old child patient and unknown gender. On 03-SEP-2014 the patient was vaccinated with an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported is unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Can?t straighten both arms. Injection was given to the rear of my arm,  I took pictures of the injection site.
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 28-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 11-Jan-2021 at 4:04 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 4:04 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, 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.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The age of patient was provided as 28.50.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  On 11-Jan-2021, Excursion time was 02 PM, temperature was 35, total doses given for the day was 98, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 08-Jan-2021, vial was moved to clinic on 11-Jan-2021. 09 vials were sent to clinic. Vaccine date was 07-Feb-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. The temperature recordings were taken by using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
Dry cough; sneezing; soreness; muscle aches and pain; low grade fever; Nauseas; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Dry cough), PAIN (soreness), MYALGIA (muscle aches and pain), PYREXIA (low grade fever) and NAUSEA (Nauseas) 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 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (Dry cough), PAIN (soreness), MYALGIA (muscle aches and pain), PYREXIA (low grade fever) and NAUSEA (Nauseas). At the time of the report, COUGH (Dry cough), PAIN (soreness), MYALGIA (muscle aches and pain), PYREXIA (low grade fever) and NAUSEA (Nauseas) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment medications were not provided by the reporter. The patient mentioned she would not be preferred to be contacted as there are no more side effects and she was dealing with more serious problem.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up information received on 14-JUN-2021 contains non-significant information.
Soreness at injection site.  Substantial swelling, soreness and  tenderness  of the Lymph node in the area above the right collarbone (Clavicle)  Some aches.
2/3/10 ADACEL and VARIVAX administered. 2/4/10 Red and hardness to arm distal to ADACEL administration site. On 2/6/10 - 4 to 6cm size redness and warmth distal to administration site. Site no problem. 2/4/10 2cm redness and itchy around varicella administration site continued 2/5/10. Treatment: BENADRYL 2/5/10.
Patient had severe nausea, headache, chills, malaise, weakness for 2 days. Those symptoms cleared up after 2 days. patient still having hot, swollen arm which she can barley lift.
pt felt faint, blanking out, pale color to face, seemed unresponsive at one point, he stated he was not feeling good and that he needed help. I sat pt down, lifted his legs onto a chair, got alcohol for pt to smell, got water for pt to sip, got a fan to circulate air around him, removed his mask and called 911. rescue came and pt left on his own. after 10 minutes pt was feeling better and color and responses confirmed he was better.
This spontaneous case was initially received from other-heath professional on 03-Oct-2017, concerning a 41-year-old, adult female patient. The patient had no relevant medical history. On 03-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195124, expiry date: 30-A0r-2018, route of administration, anatomical location: not reported). On the same day in the night, the patient developed redness, swelling, hard, painful, hot to touch at injection site. It was reported that, the patient still felt redness, warmth at injection site and diarrhea. On 09-Oct-2017, the patient recovered from the events. The reporter assessed the events as non-serious. Follow up report received on 11-Oct-2017: The outcome of the events from not recovered to recovered on 09-Oct-2017 was updated. The reporter confirmed the onset of the events as 03-Oct-2017. Non-significant follow up received on 25-OCT-2017 from nurse: The patient had no relevant medical history. Significant case correction received on IRD 03-Oct-2017: Listedness of the events were corrected. Significant case correction received with IRD with 03-Oct-2017: As Determined Listedness of the event checked the listedness and for the event injection site swelling was changed from, listed to unlisted in flu vaccine cell subunit. Non-significant case correction received with IRD 03-Oct-2017: Batch number (195124) was added on the screen and updated expiry date. The narrative was amended accordingly.
COULD NOT ACHIEVE AN ERECTION; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. As pre-existing medical histories, patient had been an occasional alcohol user and a non-smoker, patient had no known drug allergies and did not have any drug abuse/illicit drug use. No past condition was reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry were unknown) dose was not reported, 1 total, administered on 20-AUG-2021 at about 9 AM in the left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-AUG-2021, during the evening, the patient could not achieve an erection after vaccination. Patient stated that "not achieving an erection was "killing me". The patient did not have the vaccine card on him but would provide follow-up on product details. At the time of reporting, it was stated that the patient was planning to set an appointment with doctor later that week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from could not achieve an erection. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210849711-covid-19 vaccine ad26.cov2.s-could not achieve an erection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
the patient was administered an improperly stored dose of ROTATEQ on 22-MAY-2020; No additional AE information provided; This spontaneous report as received from a register nurse refers to a patient of unknown age and gender.      The patient's pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported.  On 22-MAY-2020, the patient was administered an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # 1660704 with expiration date 20-MAR-2021 (dosage was not reported) for prophylaxis, which was exposed to temperature excursion of 12.1°C for a time frame of 16 hours and 11 minutes, because of data logger. There was no previous temperature excursion. No additional adverse event (AE) information provided.
COVID ARM - PAINFUL, RED RASH (4"+ DIAMETER), WARM TO THE TOUCH, ITCHY, LUMPY, SWOLLEN with A SCAB that washes off then returns.  I still have a very tiny scab this evening as I type this. RASH NO LONGER VISIBLE BY 9/5/2021 but the site still has the scab.  The area still feels itchy (just slightly itchy though I keep hands off). I also still feel a bit of weakness/pain.
This case was reported by a sales representative and described the occurrence of not responding to therapy in a 30-year-old female subject who was vaccinated with ENGERIX B. A physician or other health care professional has not verified this report. On an unspecified date the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (unknown). Forty-two days after vaccination with the 3rd dose of ENGERIX B, the subject experienced not responding to therapy. A product complaint was associated with this event. At the time of reporting the outcome of the event was unspecified. The sales representative received an email from a doctor's office. Vaccine was purchased and 42 days after all seven subjects were given the 3rd dose of ENGERIX B, a lab assay was completed. The lab reported that all seven subjects were non-reactive to Hepatitis A and B. The healthcare professional believed that the event was caused by a quality issue. No other quality issues identified. The sales representative reported the event as "lack of effect".
Administration Error- patient was administered a MMR vaccine that was expired. it was given on 7/18/2022  and expired 6/16/2022. I called Merck and was told the dose given was supported and revaccination is not required.
Employee reported palpitations 5 minutes after vaccine was administered then began having rash on chest and tingling in lips and face. Benadryl 25mg and Epi-pen were administered. Symptoms got better and employee went home. Had to go back to Emergency Room for tingling all over and flushing to face.
c/o numbness in lt arm & hand, exp w/activity (i.e. driving, breastfeeding) since time of flu vax; denies swelling, redness, or inc temp @ site;recommended to see PMD
Admission Date: 3/6/2023 Discharge Date: Mar 10, 2023  PRESENTING PROBLEM: Severe sepsis   AKI (acute kidney injury)  COVID-19    HOSPITAL COURSE: Patient is a 77 y.o. male HTN, HLD, T2DM, Alzheimers dementia who presented to the ED from his long term care facility for 2 days of worsening weakness and fatigue, found to have severe sepsis thought to be secondary to COVID-19 and was admitted to medicine for further work-up. Initial workup in the ED revealed significant leukocytosis and  lactic acidosis, as well as AKI and hypernatremia. CXR did not demonstrate any obvious signs of pneumonia. Patient initially required 2 L nasal cannula, so 10 day course of decadron was started.   Patient was admitted and treated with IV fluids. AKI, hypernatremia, and sepsis quickly resolved and patient was transitioned to room air. Palliative was consulted given patient's advanced dementia and other comorbid conditions. Family ultimately elected to discharge home with hospice and patient was discharged in stable condition to his assisted living facility with hospice services.
chills; headaches; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (headaches) and PYREXIA (fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced CHILLS (chills), HEADACHE (headaches) and PYREXIA (fever). At the time of the report, CHILLS (chills), HEADACHE (headaches) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patients daughter states that about a week and a half after receiving the vaccine, patient started having trouble catching her breath.  On April 9th, she called the squad and they administered a breathing treatment.  She showed improvement and was not transported.  On April 19th, she went to hospital to be seen in the ER.  She was kept in observation status and was discharged home on April 20th.  She went home on prednisone of levofloxacin.
states her husband died 5 months ago with the second shot, after he had his second shot in 5 days; This is a spontaneous report from a contactable consumer (patient wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 02Feb2021 as dose 2, single for COVID-19 immunisation. No medical history and concomitant medications were reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The reporter stated that on 05Feb2021, her husband died 5 months ago with the second shot, after he had his second shot in 5 days and reporter confirmed that her husband had the Pfizer Covid-19 vaccine. She stated that her husband was in the hospice before that, he died a little bit over 5 months. Reporter stated she was a nursing student and said no to completing a report, by saying that her husband was gone, he died but because she looked at the medical statement that the Medicare paid for him the first time $35 and the second time $35 but she sees he took the second shot on 02Feb2021 and he died on 05Feb2021. He was in the emergency right after the shot, she thought, on the same day he had the shot on 02Feb2021 and he died in the hospital, but he was in the nursing home facility paid for seven months and hospice for seven months. She stated they wouldn't let her visit him and she was not able to visit him for a while before he died. The patient died on 05Feb2021. Cause of death was not provided. The outcome of event was fatal.  Information on Lot/Batch information has been requested.; Reported Cause(s) of Death: states her husband died 5 months ago with the second shot, after he had his second shot in 5 days
approx 6hrs p/vax pt devel t103 ax fever w/APAP q 4hrs;cried non-stop for 4hrs still running low-grade fever so took pt to MD & tested pos for RSV