chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Licensed practical nurse refers to a 72 years old female patient with no pertinent medical history, drug reaction or allergies. The patient was vaccinated subcutaneously with a dose of ZOSTAVAX (lot # H009779: exp date 31-MAR-2013; dose not reported) on 22-AUG-2012. No other co-suspects were reported. There were no concomitant medications. The patient presented to the office on 24-AUG-2012 "with a two-inch-by-two-inch, red, swollen area at the injection site". The patient was given over the counter BENADRYL and cortisone cream. No lab diagnostic tests were performed. At the time of the report the outcome of two-inch-by-two-inch, red, swollen area at the injection site was reported as not recovered. The relatedness for the reported events was not provided for ZOSTAVAX. Additional information has been requested.
contracted covid on 1-24-2021; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (contracted covid on 1-24-2021) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20a) for COVID-19 immunisation.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (contracted covid on 1-24-2021). At the time of the report, SARS-COV-2 TEST POSITIVE (contracted covid on 1-24-2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2021, SARS-CoV-2 test positive: positive (abnormal) POSITIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.
Very sick; Painful stomach/belly; This spontaneous case was reported by an other and describes the occurrence of MALAISE (Very sick) and ABDOMINAL PAIN UPPER (Painful stomach/belly) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Very sick) and ABDOMINAL PAIN UPPER (Painful stomach/belly). At the time of the report, MALAISE (Very sick) and ABDOMINAL PAIN UPPER (Painful stomach/belly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
Information has been received from a nurse concerning a 15 year old female patient with "allergic to several unspecified medications" who on 06-OCT-2009 was vaccinated with the second dose of GARDASIL (dose unspecified, lot number was not available). Subsequently the patient developed quarter size hives and lips swelled after received the second dose of vaccine. The patient had sought a nurse practitioner for medical attention. At the time of reporting, the outcome of the events were unknown. Additional information has been requested.
hospitalization with heart issues; Missed his second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CARDIAC DISORDER (hospitalization with heart issues) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was reported.). Concomitant products included TICAGRELOR (BRILINTA), AMIODARONE, CLARITHROMYCIN (BIAXIN) and WARFARIN for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced CARDIAC DISORDER (hospitalization with heart issues) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed his second dose). The patient was hospitalized from 10-Mar-2021 to 25-Mar-2021 due to CARDIAC DISORDER. At the time of the report, CARDIAC DISORDER (hospitalization with heart issues) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed his second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient received amiodarone, ticagrelor, clarithromycin and warfarin at the time of hospitalization.  Based on reporter's causality and time to onset, the events are assessed as unlikely related to mRNA-1273.; Sender's Comments: Based on reporter's causality and time to onset, the events are assessed as unlikely related to mRNA-1273.
Information has been received from a Licensed Practical Nurse (L.P.N.) for GARDASIL, a Pregnancy Registry product, concerning an 18 year old female patient, with pollen allergy, who on 19-OCT-2009 (also reported as 16-OCT-2009), was vaccinated with the first dose of GARDASIL (Lot #, expiration date, dose and route not reported), and then, on 29-MAR-2011, received the second dose of GARDASIL (Lot # 666987/1016Z) (Expiration date, dose and route not reported). The Licensed Practical Nurse reported that the patient received two doses of GARDASIL and became pregnant. On 18-APR-2011 the patient visited another clinic "partners", and was found to be pregnant. Exact date of pregnancy was unspecified at the time of the report. The patient did not receive any treatment for the event. The patient's last menstrual period was on 03-FEB-2011. Expected date of delivery was approximately in 10 November 2011. Follow up information has been received via telephone call from a nursing supervisor concerning the patient who on 15-NOV-2011 at 40 weeks gestation gave birth via C-section to a healthy baby girl weighing 8 lbs, 15 oz. The baby had an APGAR score of 8/9. The nursing supervisor did not have any information exactly why the C-section was performed; however she stated the patient was positive for vaginal group B streptococcus. There were no complications reported with the pregnancy or delivery. Upon internal review C-section was considered to be an other important medical event. Additional information is not expected.
This case was reported by a nurse via call center representative and described the occurrence of malaise in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced malaise and chills. On an unknown date, the outcome of the malaise and chills were unknown. It was unknown if the reporter considered the malaise and chills to be related to SHINGRIX. Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The reporter stated that, the patient experienced malaise and chills after receiving 1st dose of SHINGRIX. The events were not extreme allergic reaction but mild. This case is linked to case US2019AMR048820, reported by same reporter.
Very sore muscle at injection site, but very uncomfortable full-body muscle ache and a mild fever
Fever (100.5 F); some chills; arm sore in the vaccine injection area; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, lot number: EL 3247, expiration date was not reported), via an unspecified route of administration, administered in left arm on 24Feb2021 12:45 (at the age of 29-years-old) as dose 2, single for covid-19 immunization at workplace clinic. The patient medical history included liver disease. Concomitant medication included escitalopram oxalate (LEXAPRO) taken for unknown indication from an unknown date. Other medications the patient received within 2 weeks of vaccination includes LEXAPRO. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, lot number: EL3247, expiration date was not reported), via an unspecified route of administration, administered in left arm on 03Feb2021 12:45 PM (at the age of 29-years-old) as dose 1, single for covid-19 immunization. The patient does not have any allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that, on 25Feb2021 07:30 the patient experienced, Fever (100.5 F), some chills, arm sore in the vaccine injection area. The patient underwent lab tests and procedures which included fever: 100.5 Fahrenheit on 25Feb2021. No treatment was received for the adverse event. The reporter assessed the seriousness as non-serious. The outcome of the events was reported as recovered on an unspecified date of 2021.   No follow-up attempts are possible. No further information is expected.
RECEIVED VACCINE ON 12/29 AND STARTED RED ITCHY REACTION ON 1/8.
2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated  date of administration: 2May2022; Vaccine administered after date of expiry to 6 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to 6 patients) and PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated  date of administration: 2May2022) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to 6 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated  date of administration: 2May2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to 6 patients) and PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated  date of administration: 2May2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. Reporter stated that 2 vials were placed in the freezer on 18-Jan-2022, and was never stored in the refrigerated. Nurse confirmed that vaccine was administered to 7 patients on 2 different days. Number of doses/vials:2 No adverse event reported. No treatment medication details was reported. The vial did not undergo any temperature excursions.   This case was linked to MOD-2022-582650, MOD-2022-582640 (Patient Link).
Arm hurts; Possible heart inflammation; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts) and CARDIOMEGALY (Possible heart inflammation) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurts) and CARDIOMEGALY (Possible heart inflammation). At the time of the report, PAIN IN EXTREMITY (Arm hurts) and CARDIOMEGALY (Possible heart inflammation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No  concomitant medication provided by the reporter. No treatment information provided by the reporter.
Chills for 2 hours, Syncope event during chills (unknown duration), ringing in ears
I had a moment yesterday evening where I almost passed out (tunnel vision and my arms and legs went numb) followed by an intense urge to vomit. I instantly broke out in cold sweats and completely soaked through my shirt in about a minute. The intense sensations passed, but happened again at around 10pm as well. I?ve just woken  up for the day today, and so far I feel okay but I?m a little weak and extremely tired.
The pt experienced a red rash the size of a grapefruit which was warm to the touch (10x8cm) slightly hard to feel, no tenderness, no pruritis, no fever. Onset was within 24 hours of administration. Given Benadryl and observed.
Swelling in fingers; rash on neck & face; arm red, swollen, hard @ site of inject; blurry vision; lightheaded;
4:05pm After receiving the influenza and 2nd moderna vaccine the client states she felt like her throat was closing, she was sick to her stomach and very warm. She said she felt like she was going to pass out.   Myself, another nurse, and person presented to the client. She was able to talk with no issues, but felt weak she said. Checked blood pressure 111/72 pulse 66. Administered 6L oxygen and placed a cold ice pack on client.  No visible signs of respiratory distress. Did not administer epi or Benadryl.  Turned the oxygen down to 2L with no issues. Client had not eaten since noon, gave juice and crackers to the client. Checked blood pressure again 108/72 and pulse 68.  By 4:12pm the client states she felt like herself again with no issues. Her mother was with her in the clinic. Kept client in the clinic until 4:30pm with no issues and released at that time. I called and spoke with the client today 11/1/2021 at 10:00am and she is well and has no issues. She did say later that evening she had a low grade fever and headache but it went away.
Pt c/o dizziness, heart palpitations, and 'shaky' feeling after receiving injection.  Pt reported her bp does run high.  Pt given oral hydration and snack which improved most of the symptoms but still felt shaky.  Initial VS 174/97 HR 109 SaO2 96. Recommended to go to ER after 30 minutes of observation.  Pt declined.  Dismissal VS 147/104 HR 83 Sao2 98.  Pt left ambulatory
Pt states that she woke up this am with pain and numbness in her left shoulder and arm.  She denies a fever and dizziness.  There is some pain reported at the injection site, but the most pain is in the shoulder blade and up into her neck.  Numbness is reported mostly in the fingers.  Pt does not know if this is worsening of previous shoulder injury exacerbated by injection or vaccine side effect.  I recommended pt to see an MD and she has an immediate care visit scheduled at 5pm 4/24/21.  I will follow up with her on 4/25/21 regarding results of visit.
Nausea, vomiting, chills, no erythema or edema, tenderness at inject site. No treatment. Was afrebile at office 1/31/03.
had an episode so painful she was moaning, her stomach really hurt; Watery diarrhea; Dry heaves; Weakness; stomach bloated; terrible sweats; she was frozen, she was freezing cold and shaking, had to warm up; Nauseated; Gas; shaking; the upper part of her stomach was on fire; her stomach was really sore/her stomach really hurt; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6201, Expiration date not reported), via an unspecified route of administration, administered in right arm on 24Feb2021 14:00 (at the age of 76 years) as dose 2, single for covid-19 immunization. Medical history included high blood pressure diagnosed about 15 years ago, from an unknown date and unknown if ongoing. Family medical history relevant to events reported as no. The patient's concomitant medications were not reported. Patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262) via an unspecified route of administration, administered in right arm on 04Feb2021 around 14:00 (at the age of 76 years) as dose 1, single for covid-19 immunization, received flu shot with which patient experienced unspecified adverse event and pneumonia vaccine, both on an unknown date. Patient did not receive any vaccinations within 4 weeks. On an unknown date in 2021, about 3 or 4 days after vaccination, patient experienced watery diarrhea, dry heaves that were so bad that she felt the upper part of her stomach was on fire, weakness, really really weak, gas, and her stomach was bloated up like she was 3 or 4 months pregnant, terrible sweats and had to put a cold compress on her face so she did not pass out, then after that she was frozen, she was freezing cold and shaking, had to warm up, she was really nauseated which she supposed caused the dry heaves. It was reported that, patient did not have a temperature and could taste and smell, however, she did get very sweaty. It took her three weeks and patient had to take a lot of medicine and antacid for her stomach. She was still really weak, and it took her a while to get back her strength. She recovered mostly by Mar2021, and her stomach was really sore. In May2021 patient kept taking this stuff for her stomach and doctor though it was ok. On an unknown date in May2021, she had an episode so painful she was moaning, her stomach really hurt, and she had to lay down. Events resulted in visit to physician office. Therapeutic measures were taken as a result of events and patient received unspecified treatments. The outcome of all the events was unknown.
I?ve gone from having migraines with aura  1-2 times per year prior to the vaccine  to having them weekly.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about patients' pertinent medical histories, concomitant medications, drug reactions or allergies provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally (lot# K013868, 27-MAY-2016; lot# K010221, expiration date 12-MAY-2016; dose was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Dizziness, vertigo, numbness on the left side of my body, nausea.; Dizziness, vertigo, numbness on the left side of my body, nausea.; Dizziness, vertigo, numbness on the left side of my body, nausea.; Dizziness, vertigo, numbness on the left side of my body, nausea.; This is a spontaneous report received from a contactable consumer (patient). A 32-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 15Mar2021 at 13:30 (at the age of 32-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included lupus. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. On 17Mar2021 at 12:00 the patient experienced dizziness, vertigo, numbness on the left side of the body, and nausea. The patient visited a doctor or other healthcare professional office/clinic and an emergency room/department or urgent care as a result of the events. The patient did not receive any treatment for the events. The outcomes of dizziness, vertigo, numbness on the left side of the body, and nausea were not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
11 y/o male administered 0.3 mL of Pfizer 12+ y/o COVID vaccine.  Patient was observed and no adverse reaction during 15 minute waiting period post vaccine administration.  Patient's parents notified by Medical Director and discussed monitoring steps.  Medical Director counseled parents to seek emergency room/urgent care/patient's pediatrician for monitoring going forward should adverse reaction occur.
A few weeks after my second injection, I had a very heavy period. I?ve had a period every 2 weeks since the first incident and I?ve never had that problem in my life. In fact, I have the opposite problem where I very rarely get periods, so having them every 2 weeks is completely out of the ordinary for me.
The day after my injection my fever sky rocketed. I became nauseas and extremely dizzy so much so that I couldn't stand up off of the couch. The rest of the week I was extremely fatigued and a few days later my entire back broke out in hives and itched really badly for about an hour. One month later I got another fever and my heart rate was elevated and after going to a local clinic and out of fear of me having a blood clot they sent me to the ER where I spent the next 7 hours getting tested. A cardiologist looked at my reports and said it could have been a delayed reaction to the vaccine.
Pt admitted to hospital for MS change. Had lumbar puncture and transferred to another hospital. Pt had Streptococcal meningitis and died. pt had received 3/4 of Prevnar vaccine.
Left lower leg has swollen up to about twice normal size, has turned red like a harsh sunburn, feels like a harsh sunburn.
Rt arm Eotematous and red also warm to touch. Patient denies pain and has full range of motion.
After getting vaccine patient was escorted over to the post-vaccine monitoring area. During walk over patient briefly lost consciousness and had seizure like activity. Lasted <30 seconds. Patient was supported during fall so no trauma resulted. Patient recovered back to full consciousness <1 minute after episode. Mother reports no breakfast. Patient was monitored for additional 1.5 hours. Labs as below.
Itching and hive breakouts over entire body.   Saw doctor who recommended I take Zyrtec (otc)  start with 10mg daily ( as recommended) and was told to increase by 10mg  weekly, if no improvement, up to 30mg.
This spontaneous report as received from a nurse practitioner refers to a 53 year old patient of unknown gender. No medical history and concurrent conditions reported. On 27-JUL-2015, the 53 years old patient was vaccinated with PROQUAD (Merck) lot # K018144, expire date 10-APR-2015 (dose, route not reported) which outside of the recommendations in the PROQUAD (Merck) prescribing information. No adverse effects reported. No product quality complaints reported. Additional information has been requested.
Pt experienced a poor appetite, excessive irritability, resolved after 2 days. Reminiscent of old whole series pertussis.
Mother called 2/20/07 stating pt felt body pain esp bilat arms, dizziness with movement and HA, Temp 99.7.
Pt devel an allergy following vax w/Hep B vax; later recvd 3rd dose of hep B vax; no further details were provided;
The smallpox vaccine was administered to the patient on 4-21-03 in the left arm.  The take response was read on 4-28-03 with a major take.  The patient was seen in the clinic on 6-8-04 with c/o swelling, tenderness and itching at the vaccination site.  There was a 2 cm area of induration.  The patient was seen again on 10-1-04 and at the smallpox site there was erythema and a raised papule 10 mm in size.  She c/o of swelling, tenderness and itching at the site.  Stated this has occurred 2 other times - appears to flare up and then disappear.