chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nausea; terrible cold sweat; Numbness tingling left side for days; Numbness tingling left side for days; light headed; odd breathing; chest tightness; blood pressure jump; This is a spontaneous report from a contactable consumer(patient). A 71-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6201), via an unspecified route of administration in the left arm on 16Feb2021 13:00 as a single dose for COVID-19 immunization (at the age of 71-years-old). Facility type vaccine was School or Student Health Clinic. Medical history included hypothyroidism and arthritis from an unknown date and unknown if ongoing. There were no known allergies. Concomitant medication(s) included levothyroxine, acetylsalicylic acid (ASPIRIN 81), colecalciferol (D3), cyanocobalamin (B12-VITAMIIN), biotin and lactobacillus acidophilus (PROBIO) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL9262), via an unspecified route of administration in the left arm on 26Jan2021 13:00 as a single dose for COVID-19 immunization (at the age of 71-years-old). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced numbness tingling left side for days, light-headed, chest tightness, blood pressure jump, odd breathing on 17Feb2021. ER tests found nothing. Then next AM (18Feb2021) nausea & terrible cold sweat. Ok ever since. No heart history. Adverse events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included blood pressure measurement: jump, cardiac stress test: unknown result, computerized tomogram: unknown result, electrocardiogram: unknown result, x-ray: unknown result on an unspecified date. The clinical outcome for events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Immediate upset stomach, headache, fever - eleven days later - vomiting, hallucinating and delusional, 6 hour vertical blank stare, loss of faculties - full psychotic break. 4 wk. hospitalized and again 6 months later.
doses administered after excursion; No adverse event; Patient administered doses of the vaccine after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient administered doses of the vaccine after excursion) and NO ADVERSE EVENT (No adverse event) in an 88-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Nov-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient administered doses of the vaccine after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient administered doses of the vaccine after excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered doses of the vaccine after excursion).    No Concomitant medications were provided.  Reporter reported that a temperature excursion that occurred several days ago in the Freezer.  Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer.  Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question. Patient did not report any adverse event.  No treatment medications were provided.
1 day p/vax pt exp pain @ the inj site;pt was seen by a MD on 25OCT & treated w/anti-inflammatory med;pain persisted as of 20NOV;this is 1 of 3 pt from this site to devel an inj site rxn p/vax w/lot# 4978185;
During injection, felt sudden sharp pain (minor pain, felt like 'lightning strike', possibly hit a nerve?). Noticed yesterday/currently that I have a large knot/hard swelling and redness at injection site (8 days after injection).
I am swollen; Swollen gland; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (I am swollen) and LYMPHADENOPATHY (Swollen gland) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (I am swollen) and LYMPHADENOPATHY (Swollen gland). At the time of the report, SWELLING (I am swollen) and LYMPHADENOPATHY (Swollen gland) outcome was unknown.
Cellulitis, swelling, severe tenderness to touch, and warmth. Symptoms started approximately 30-45 minutes after injection, worse at 11 pm per patient. Started having chills the next morning.
Terrible joint pain and stiffness; Terrible joint pain and stiffness; I could barely walk; This lasted all day it then led into horrible prickly sensation on my back and upper thigh; I then became freezing cold and couldn't warm up; Very tired and thirsty; Very tired and thirsty; This is a spontaneous report from a contactable Other Health Professional reported for herself. A 56-years-old female patient (not pregnant at the time of vaccination) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265), via an unspecified route of administration in left arm on 28Jan2021 15:15 at single dose for covid-19 immunization.  Medical history included depression. Historical Vaccine included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. 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 had not been tested for COVID-19. There were no known allergies to medications, food, or other products. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), venlafaxine hydrochloride (EFFEXOR), vitamin d3, calcium, curcuma longa (TURMERIC) and glucose (GLUCOSA). The patient woke up with terrible joint pain and stiffness. She could barely walk. This lasted all day it then led into horrible prickly sensation on her back and upper thigh. She then became freezing cold and couldn't warm up. The patient was also very tired and thirsty. This lasted the entire day and night. All events started from 29Jan2021 07:00 AM. There was no treatment received for the adverse event. The outcome was unknown. The seriousness from reporter was non-serious.
Beginning 5/14/2021 shortly after rising, and continuing on most but not all days but still continuing to date, a red rash and/or red bumps (hives) over small areas of arms and/or thighs and they were mildly itchy.  Treated with cortisone-10 cream and condition gone within 30-60 minutes for rest of the day. Also additionally tried Benadryl one day but stopped when label showed possible impact on prostate. Saw Dr. on 5/25/2021, a dermatologist, who confirmed hives and predicted condition should likely disappear in 6 weeks.
G45.9 TRANSIENT CEREBRAL ISCHEMIA 4/10/2023 ATRIAL FIBRILLATION, PAROXYSMAL
child was given proquad at 1 year well child visit on 4-12-07. On 4-21-07 child developed 102.8 fever with about 10 large chickenpox and multiple red dots without pustules. No treatment given. Just observed and used Tylenol.
Diagnosed by her neurologist as having Guillain-Barré syndrome; Can't walk; Her vision is decreasing rapidly; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Diagnosed by her neurologist as having Guillain-Barré syndrome), WALKING DISABILITY (Can't walk) and VISUAL IMPAIRMENT (Her vision is decreasing rapidly) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 GUILLAIN-BARRE SYNDROME (Diagnosed by her neurologist as having Guillain-Barré syndrome) (seriousness criteria hospitalization and medically significant), WALKING DISABILITY (Can't walk) (seriousness criterion hospitalization) and VISUAL IMPAIRMENT (Her vision is decreasing rapidly) (seriousness criterion hospitalization). At the time of the report, GUILLAIN-BARRE SYNDROME (Diagnosed by her neurologist as having Guillain-Barré syndrome), WALKING DISABILITY (Can't walk) and VISUAL IMPAIRMENT (Her vision is decreasing rapidly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
The patient never received the second dose of his Moderna Primary Series vaccine; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (The patient never received the second dose of his Moderna Primary Series vaccine) and NO ADVERSE EVENT (No adverse event) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis. No Medical History information was reported. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (The patient never received the second dose of his Moderna Primary Series vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (The patient never received the second dose of his Moderna Primary Series vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (The patient never received the second dose of his Moderna Primary Series vaccine). No concomitant medication information was reported. It was reported that Patient took 1 dose of the Monovalent Moderna booster dose in December 2021. The patient received his first dose of the Moderna Covid-19 vaccine for his Primary Series on December 17, 2021.The patient never received the second dose of his Moderna Primary Series vaccine. No treatment medication information was reported. Reporter did not allow further contact.
Case number PHEH2014US021412, is an initial spontaneous report from a pharmacist received on 22 OCT 2014. The report refers to a 30-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN 2014/2015 (batch number: 1412401) intramuscularly on 21 OCT 2014. It was reported that after the vaccine was administered to the patient and before placing the band aide at the injection site, vaccine was dripping from the injection site. No adverse event was reported.
Eyes were swollen; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored Program. A 34-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8735) via an unspecified route of administration in left arm on 26Apr2021 at 15:00 as dose 2 single (at the age of 34-year-old) for COVID-19 immunization. Medical history and concomitant medication was not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8732) via an unspecified route of administration in left arm on 29Mar2021 at 15:00 as dose 1 single (at the age of 34-year-old) for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Patient stated that she took the second dose of Pfizer Covid-19 vaccine back in 28Apr (later clarified) and during the week after she took the second dose her eyes started to swell and she was experiencing it until now. Her eyes were swollen. Patient stated she had not taken anything for treatment, but she was trying to ice them. The outcome of the event was not recovered.
This case was reported by a consumer via other and described the occurrence of allergic reaction in a male patient who received SHINGRIX for prophylaxis. On 18th May 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to SHINGRIX. Additional details were reported as follows: This case was reported by a pharmacy via a pharmacy claims management company. The age at vaccination was not reported. It was reported that, the patient sustained an allergic reaction after receiving the SHINGRIX vaccine.
This spontaneous report as received on 02-MAR-2017 from a female healthcare worker (Not further specified if a healthcare professional), refers to 10 patients (age and gender not reported) who received unspecified doses in VARIVAX (Lot number M033905, expiration date 20-JUL-2018) immunization series that were improperly stored.  The site and route of VARIVAX administration were not reported.  The vaccinations occurred between 22-FEB-2017 and 01-MAR-2017. The vaccines were exposed to temperature of 18.5F (Fahrenheit) for a time frame of 5.3 hours.  There were no previous temperature excursions reported. The temperature excursion was recorded by a data logger. The patients' pertinent medical history, concomitant medications and drug allergies were not reported. It was further specified that on 28-FEB-2017, this patient (age and gender not reported) received administration of VARIVAX. No adverse effects were reported. There was no product quality complaint involved. No further information was provided. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA001788:
Heart palpitations - they would come in a run - for a minute long. Totally crazy - heart would be fast fast fast and out of arrthymia. Sometimes I had to cough really hard - which helps me stop my heart from beating funny. I would have to do that a couple of times for it to get to quit. I noticed it more in the evening. I was never diagnosed with an arrthymyia - except when I was pregnant. But when I wasn't pregnant it went away. I had those palpitations for about two months and then it just stopped. I started having a cough - a dry cough. And I also had some weird symptoms that were kind of like allergies. After about a week of that, I had a COVID test - negative result (that was about 6 weeks ago). I also had a telehealth visit that went along with that test and she gave me a Zpack and she (a nurse practitioner) told me to add Zyrtec and I was already taking a decongestant to stay on. After a week, it didn't go away and that was negative. I decide to make an appt with the Urgent Care. I told her I was worried I had pericarditis from the shot and she ordered a chest X-ray and and EKG and they were both fine. She said that she didn't think it was pericarditis but thought it was bronchitis but didn't have anything to do with the arrhythmia. Eventually the cough went away and everything went back to normal - the cough (had that at least 6 weeks) and the heart palpitations - had those two months. I have an eye twitching - that has been going on since beginning of August. It's almost been two months. I had it evaluated by the eye doctor in this report. I did see the doctor, he wasn't very good. So I went to another doctor- has now ordered a brain MRI - as well as the oculars - to scan the part behind the eyes to make sure there are no tumors. He injected me with  2 injections - right below the right eye brow - with Botox - 2.5 mg in each injection. They twitching isn't as strong but they are still as often. He said he may have to give me an injection every three months to get it resolved. He also said I have retracted eyelids. He said that could be a sign of thyroid issues. He said my eyes are very, very dry - and I'm on Systaine drops for it. I wear glasses. Dystonia is part of Bells Palsy - so it could be a neurologist problem. The twitching is every single day. It's very annoying.
fever; shortness of breath; This is a spontaneous report from a contactable consumer (patient's husband). A female patient (reporter's wife) of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient experienced fever, shortness of breath. Reporter wanted to know if she could take Tylenol for these symptoms. Response: Spoke from attached document and stated that Pfizer is unable to provide treatment recommendations for patients. There was no PQC. The event was non-serious. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a female licensed practical nurse via company representative refers to herself. On an unknown date the patient was vaccinated with VARIVAX (Merck) (lot number not provided). The patient had contracted the shingles from years of administering the VARIVAX (Merck) vaccine. The nurse no longer administered VARIVAX (Merck). The outcome of adverse event was not provided. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Received vaccine 10/5/09 fu - several hours later swelling 50 cent size. digestive problems, diarrhea, flushed felt hot, achy, didn't feel well, HA, took TYLENOL - did not feel better until 10/9/09 - No PMD follow up. Pt attached had problems also-
10 days after second vaccine I had trouble breathing when walking or climbing stairs.  I never had this before even though I have a preexisting condition of hypertrophic cardiomyopathy. In fact, I wore a heart monitor for one week and had an EKG and saw my physician prior to receiving any vaccine and was in stable condition. I started to improve after the 10 day, but the shortness of breath came back in the beginning of May.  I finally took a stress test on Friday, May 28th and was told by my physician that I had AV Block and needed a pacemaker and defibrillator on an emergency basis. I asked my physician if this could have been from the vaccine and he said he wasn't sure because he didn't have enough data. He said it was possible because it may have caused inflammation in the heart.
Grand-mal seizure, fell off bed, eyes rolled back in her head, stopped breathing, loss of consciousness.
This case was reported in a literature article and described the occurrence of aseptic meningitis in a 16-year-old subject of unspecified gender who was vaccinated with Hepatitis A vaccine (manufacturer unspecified), DTPA (with small D+ P) and meningococcal acwy vaccine (non-gsk). Concurrent medical conditions included allergies. On an unspecified date, the subject received an unspecified dose of Hepatitis A vaccine (administration site and route unknown, batch number not provided), an unspecified dose of DTPA (with small D + P) (administration site and route unknown, batch number not provided) and an unspecified dose of Meningococcal ACWY vaccine (Non-GSK) (unknown). 18 hours after vaccination with DTPA (with small D + P), Hepatitis A vaccine and Meningococcal ACWY vaccine (Non-GSK), the subject experienced aseptic meningitis. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. The author considered the event was unrelated to vaccination with Hepatitis A vaccine, DTPA (with small D + P) and Meningococcal ACWY vaccine (Non-GSK). This case has been linked to case B0739797A: same literature article. Summary of the literature article: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the modified WHO criteria resulted in classifying 3 cases as definitely related to vaccine administration, 12 as probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful. The author's conclusion stated that he CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations.