chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developed PCR + COVID; developed PCR + COVID; EOM paralysis; intraocular myositis; This is a spontaneous report from a contactable physician via a company representative. A healthy young adult male patient (reporter's son) of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in summer of 2021 (unspecified date, Batch/lot number and expiration date unknown) at dose 1 and dose 2, single for COVID-19 immunization. Medical history included COVID-19 in spring of 2020 (not ongoing). The patient's concomitant medications were not reported. The patient developed intraocular myositis with extraocular movement (EOM) paralysis, treated with 40 days of prednisone with resolution, then developed PCR+ COVID-19 again "this week", 16 weeks after second shot. The outcome of events intraocular myositis with extraocular movement (EOM) paralysis was resolved on an unspecified date in 2021, for other events was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on limited information in the case , a possible causal association between the reported  event Covid-19, Drug ineffective, Ophthalmoplegia, Orbital myositis and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
I had my vaccination on 4/29/2022. On 09/30/2022 I woke up feeling very sick. I took a rapid COVID-19 test and was positive on 09/30/2022. I contacted my PCP which prescribed a steroid pack and amoxicillin/clavulanic acid. My blood pressure went very high and she took me off of the steroid pack. I still have a cough on 11/01/2022.
Administration Error: Attempted to give vaccine via ID route on Left arm. Vaccine leaked immediately. No weal noted. Needle removed from arm. Dose wasted. Vaccine re-administered on Right arm with new vaccine/needle/syringe. Rationale explained to client.
Vomiting, breathing issues.  He was put on O2 and also given 3 doses of Epi.
Ministrokes; odd symptoms; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Ministrokes) in a 94-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient was confirmed covid free earlier in January (exact date unknown).  Concomitant products included ACETYLCYSTEINE, CALCIUM LEVOMEFOLATE, MECOBALAMIN (CEREFOLIN NAC [ACETYLCYSTEINE;CALCIUM LEVOMEFOLATE;MECOBALAMIN]), AMOXICILLIN and COLECALCIFEROL (VITAMIN D3) for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Ministrokes) (seriousness criterion medically significant) and ADVERSE EVENT (odd symptoms). The patient was treated with ESLICARBAZEPINE ACETATE (APTIOM) ongoing since an unknown date at a dose of 200 milligram and ASPIRIN [ACETYLSALICYLIC ACID] at a dose of 325. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (Ministrokes) and ADVERSE EVENT (odd symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2021, Magnetic resonance imaging: confirmed ministroke (Positive) confirmed ministroke.         It was reported that the odd symptoms were attributed to amoxicillin and the patient stopped taking it. Company comment: Very limited information regarding these events have been provided at this time. Patient's advance age can be a confounding factor to the event Transient ischemic attack while antibiotic use (amoxicillin) have been said to contribute to the Adverse event NOS.  No further information is expected.   This case was linked to US-irms-MOD21-106616 (Patient Link).; Sender's Comments: Very limited information regarding these events have been provided at this time. Patient's advance age can be a confounding factor to the event Transient ischemic attack while antibiotic use (amoxicillin) have been said to contribute to the Adverse event NOS.  No further information is expected.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 11-NOV-2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-APR-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed lidocaine and gabapentin for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
chest pain; racing heat and palpitation; elevated blood pressure; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), dose via an unspecified route of administration on an unspecified date, as dose 1, single for COVID-19 immunization. Medical history included flu every 5 to 7 years. Prior to the vaccine he never had chest or other issues. Patient had blood pressure was not high before. The patient's concomitant medications were not reported. After three days her first vaccine (on an unknown date) in the evening, patient had chest pain, racing heart and palpitation. He had his physical two days later he let my doctor know about it. At that time these side effects were not known. He told his doctor about racing heart rate and elevated blood pressure. The patient underwent lab tests and procedures which included blood pressure: elevated. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
pt has hx of rxn to all meds put into body;pt stool up & felt swelling from jaw & down lt arm-felt dizzy-bloating/swelling-passed out;seen by MD-not vax related;pt feels like vax rxn-excelerated rxn;
Presented to ED w/ weakness & fever; admitted for COVID-19 pna, UTI; tx w/ abx, Vit C, Vit D, steroids,
Hospitalized with cough, sore throat, mild confusion, weakness, dyspnea and mental decline. Treated with remdesivir
Narrative: Hospitalization: COVID-19 fully vaccinated, found to be COVID-19 positive upon admission with worsening SOB, initially tested COVID-19 positive on 2/6/22, family relayed that patient has had a negative home test once since his admission in February but has otherwise consistently tested positive since initial diagnosis on 2/6/22
Information has been received from a physician concerning a 15 year old female, who on 28-JUL-2009, received her first dose of GARDASIL (route not provided) (lot number 662404/0312Y). On 28-SEP-2009, the patient was vaccinated with the second 0.5 ml dose of GARDASIL (lot number 663558/0819Y). The patient did not experience any adverse event after first dose. In approximately November 2009, 2-3 months later after getting the second dose, the patient experienced severe joint pain and knee swelling. The patient sought unspecified medical attention. At the time of reporting, the patient had not recovered from severe joint pain and knee swelling. Follow up information has been received from a physician and a registered nurse who indicated that the patient was a female student with sulfur and codeine allergies and a medical history of Streptococcal infection; the patient's mother reported that her daughter has not had a Streptococcal infection in years. On 28-SEP-2009 at 10:00 the patient was vaccinated intramuscularly into her left arm with as second dose of GARDASIL (lot number 663558/0819Y). There was no illness at the time of vaccination. In December 2009 the patient developed bilateral knee swelling and joint pain in knees, ankles, elbows and fingers. On 09-FEB-2010 the patient had lab studies performed her serum antistreptolysin O antigen test was 315 IU/mL (normal: 0-200). The patient also had an autoimmune work up which came back negative, the patient was cleared by rheumatology. On 16-FEB-2010 the patient's mother reported that the patient had increased swelling in her knees. She also had hip pain and arm swelling. The patient was prescribed AMOXIL 875 mg, 1 tab BID x 10 days. At the time of this report the patient had not recovered. Follow up information has been received from a nurse who reported that the patient had not recovered as previously noted. Additional information has been requested.
Had a shingles outbreak (never had one before) that started on 8/1/2021. Began medication for it (prescribed Valtrex) on 8/6.
01/02/22 presents to ED for "suicidal ideation". PMHx of "HFrEF, CAD s/p DES, AAA, atrial flutter s/p ablation, atrial fib s/p cardioversion 12/15/21 on Eliquis, LBBB, HTN, DVT, hypothyroidism, BPH, COVID 12/15/21"
This case meets vaccine breakthrough criteria review.  SxS include generalized weakness, diarrhea, cough, loss of taste and smell, chills, decreased urination, decreased appetite.
muscle pain; nausea; Tired / strong fatigue; lightheaded / feeling oozy; upper arm injection site aching; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (lightheaded / feeling oozy), VACCINATION SITE PAIN (upper arm injection site aching), MYALGIA (muscle pain), NAUSEA (nausea) and FATIGUE (Tired / strong fatigue) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Q2AA21A and 25A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Polymyalgia rheumatica since December 2019 and Giant cell arteritis since 26-Jan-2021. Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (MAXZIDE) and SPIRONOLACTONE for Blood pressure high, OLMESARTAN MEDOXOMIL (BENICAR) for Polymyalgia rheumatica.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced DIZZINESS (lightheaded / feeling oozy), VACCINATION SITE PAIN (upper arm injection site aching), NAUSEA (nausea) and FATIGUE (Tired / strong fatigue). On an unknown date, the patient experienced MYALGIA (muscle pain). On 27-Mar-2021, VACCINATION SITE PAIN (upper arm injection site aching) and FATIGUE (Tired / strong fatigue) had resolved. At the time of the report, DIZZINESS (lightheaded / feeling oozy) and NAUSEA (nausea) had resolved and MYALGIA (muscle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Blood pressure measurement: 178/96 (abnormal) 179/96.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patients stated she took extra blood pressure medicine (concomitant medications) for her adverse events. The patient was also taking a concomitant steroid medication for her current conditions.She stated it was hard to tell if the side effects from the vaccine.
The infant woke up with difficulty breathing. Mom states this started around 6:00. They were concerned the pt may have something in her throat. Everything was normal in the ER. Was advised to not give anymore vaccine.
This spontaneous report was received from a 79 year old female patient, reporting on herself. There was no information regarding the patient's pertinent medical history. She was allergic to epinephrine. Concomitant therapies included ZIAC, CELEXA and ZOCOR. Seven years ago, approximately in 2009 the patient received one time vaccination with ZOSTAVAX in the right arm. Patient reported that on an unknown date recently, she developed shingles. Outcome of the event was unknown. Causality assessment was not provided. Additional information is not expected as the reporter did not wish further contact.
Lesions: legs and trunk, 20 per school nurse, looked like bug bites. Became blister like later in day per mother. Saw doctor 12/07/2004: lesions consistent with chicken pox. Shares classroom with child who developed shingles 11/18/04.
pt recv vax in 1995 & w/in 10-14 days pt devel a diffuse, morbilliform rash which devel into a vesicular rash; consist w chicken pox; pharmacist reported 4 pts;
RED AND SWOLLEN AT INJECTION SITE WITHIN 6 HOURS OF INJECTION. HOT TO THE TOUCH. PARTIALLY RESOLVED WITH TYLENOL BUT COMPLETE RESOLUTION OF REDNESS DID NOT OCCUR UNTIL 9/19.  ALSO HAD MUSCLE SPASMS ACROSS LEFT SHOULDER AND BACK OF HEAD THAT ARE LESS PAINFUL NOW BUT NOT COMPLETELY RESOLVED. TIREDNESS FROM TIME OF SHOT UNTIL PRESENT
Within 5-10 minutes got shortness of breath, felt confused, lips and mouth felt thick, eyes felt puffy, shaky, tingling in left hand and arm, heart pounding, rapid heart beat, hoarseness, dizziness, nausea, overall weakness. It got better after a few hours.  Next day, around 11 am all symptoms hit again, but super unsteady and could not focus. Left work and by the time got home had pins and needles in legs and couldn't sleep. Touching legs was uncomfortable.  Still hurt today which is 4 days later. Is improving. Did not seek medical care.
This spontaneous report as received from a nurse refers to 5 patients of unspecified age and gender. The patients' concurrent conditions and medical history were not provided. On 09-JUN-2016, the patients were vaccinated with a dose GARDASIL 9 via subcutaneous route (batch# reported as 1040164, expiry date: 20-FEB-2018). Concomitant medications were not mentioned. No adverse events were reported. Product quality complaint was not filed. Follow up information has been received on 23-JUN-2016. Lot number 1040164 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast). Follow up information was received on 01-AUG-2016 from the Registered Nurse, who clarified that another health care provider administered GARDASIL 9 subcutaneously with a one inch needle in deltoid region. Each of the five unspecified patients had the injection site evaluated post injection. The primacy reporter stated that she was relatively certain that the GARDASIL 9 vaccine was injected into muscle, despite improper administration technique. Additional information has been requested.
Meningococcal Cong (Menquadfi) MCV4TT accidentally administered.  No adverse reactions noted
Pt recvd vax 15FEB96 11AM & pt cooperative, but very nervous;11:03 pt was standing & slumped forward over mom's lap;very pale;immed jerked backward, arching back w/arms rigid;eyes rolled back, wet pants;nurse assisted pt to floor;BP 94/64;
No adverse effects reported; The patient recieved VARIVAX which was reconstituted with DILUENT MRK INJ and adminstered via intramuscular; This spontaneous report was received from an healthcare business professional, regarding a patient of unknown age and gender. The patient's concurrent conditions, drug reactions, allergies, pertinent medical history and concomitant therapies were not reported.   On 21-JUL-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX), intramuscular (incorrect route of product administration ) for prophylaxis, lot number R00604, and expiration date 23-OCT-2020 (strength, dosage and frequency were not reported), which was reconstituted with sterile diluent(DILUENT MRK INJ) (strength, dosage, frequency, lot number, and expiration date were not reported).  Lot number R00604 is an invalid lot number for varicella virus vaccine live (oka/merck)(VARIVAX).
09/21/2020 PATIENT PRESENTED WITH AN ERYTHMEA AROUND THE SITE OF INJECTION  THE ERYTHMEA COVERED A FIST SIZE AREA AROUND THE SHOT. PATIENT WAS AFEBRIL, COMPLAINED OF SOAERNESS AND PAIN. 09/25/2020, 3:30 PM TALKED TO PATIENT ON THE PHONE, SHE REPORTED THAT HER SORENESS WAS SUBSIDING. THE ERYTHMEA HAD GONE DOWN IN SIZE
MMR II that had undergone temperature excursion was administered to 2 patient's; no adverse event; This spontaneous report was received from a office manager referring to a currently 5-year-old male patient. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, or drug reactions or allergies was provided.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) recombinant human albumin (rHA), quantity 1, lot #T034388, expiration date: 08-OCT-2022, administered for prophylaxis (strength, dose, route of administration, vaccination scheme frequency, and anatomical location were not reported) after a temperature excursion (temperature: 54.7 Fahrenheit (F), time frame: 58 minutes) (product storage error). There was no previous temperature excursion. No additional adverse event was reported (no adverse event).  This is one of two reports received from the same reporter.
Bilateral deltoids and sq areas are slightly swollen, red and fine red bumps. Currently pt only c/o itching. Is walking, playing and verbalizing needs. (Currently is hungry). Also per mom no motrin given.
pt states that he became tingly all over, completely covered in sweat, chest felt heavy but no breathing problems and no self-reported swelling ...pt self-referred to er approximately 30 minutes after the vaccination
had the first dose on the 4th, tested positive on February 9th; This is a spontaneous report received from a contactable consumer (patient) via Pfizer-sponsored program.  A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number and expiry date was not reported) via an unspecified route of administration on 04Feb2021 as a 1st single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On Saturday, 06Feb2021, the patient experienced Covid-19 symptoms and assumed it was related to the vaccine. On 09Feb2021, the patient had tested Covid positive. The patient had been through quarantine after he was tested Covid positive and when he was out of quarantine feeling mostly better, but the patient was scheduled to get the second dose of the vaccine on 25Feb2021. He was advised by his doctor to consider not taking it anymore since the 2nd dose reaction was not that okay. The patient wanted to make sure if he can get the 2nd dose considering he was positive of Covid-19. He was looking for some guidance about whether or not he should take the second dose of the Pfizer vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient reported to vaccinator  that she does have Vagal responses when receiving vaccinations and or injections of any kind.  Emergency medical assistance on standby. Patient placed in wheelchair, then in supine position for recovery, fluids offered and accepted.  After 15 min patient assisted to seated position then returned to wheelchair and transported to observation area.
Mild fever, fatigue, headache, muscle pain, injection site soreness, chills, joint pain for 2 full days.  I started to feel normal after 3 days. I still have unexplained headaches at least once a day. Usually they get resolved after taking Aspirin or Ibuprofen.
Dr. provider of Pt called Immunizations Clinic regarding a 2 mm induration 5 days post Anthrax injection. Informed Dr. I will enter a VAERS report post anthrax injection. Pt has no skin changes and is localized to the injection site.
The patient presented yesterday to an urgent care center on 3/11/2021 with chest pain, jaw pain, and shortness of breath. He reports multiple occurrences over the past week.  He was sent to the ED, where he was then admitted for hypertensive urgency/emergency vs. unstable angina.
PATIENT REPORTED BEING LIGHTHEADED THEN PASSED OUT AFTER THE VACCINATION.
This spontaneous report was received from a register nurse concerning a 47 year old patient of an unknown gender. Medical history and concurrent conditions were not reported. On 04-MAR-2014, the patient was vaccinated with M-M-R II (route was not reported) lot # 0480AE, expiration date 29-AUG-2015 (also reported as 20-SEP-2014), batch number H017436, albumin status rHA (recombinant human albumin. On 09-APR-2014, patient was vaccinated with M-M-R II (route was not reported) lot # J006954, expiration date 07-JUN-2015. Co-suspect and concomitant therapies were not reported. The register nurse reported that M-M-R II went through a unsupported temperature excursion; however 10 doses of M-M-R II were overlooked because they were stored in the fridge. These doses were administered to 10 patients. The clinic has contacted the patients and 3 out of 10 patients had received an additional dose of M-M-R II. This case is linked to 1404USA001099, 1404USA001100, 1404USA001101, 1404USA001102, 1403USA010165, 1404USA014293, 1404USA014294, 1404USA014295, 1404USA014296, 1404USA014298, 1404USA014299, 1404USA01430 and 1404USA014301. Additional information has been requested.
This spontaneous report as received from a physician refers to a patient of unknown age. On 07-NOV-2013 the patient was vaccinated with ZOSTAVAX (lot # J002242, expired date 21-MAY-2014, 0.65 ml, subcutaneous0. It was reported that the dose of ZOSTAVAX was administered post temperature excursion of 30F over 10 days or 240 hours. No adverse effects reported. The outcome and action taken were not provided. The patient did not seek  any medical attention. This is one of several reports received from the same source. Additional information has been requested.
Reaction to moderna; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction to moderna) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Allergic to IVP DYE), Fish allergy and Shellfish allergy.    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 VACCINATION COMPLICATION (Reaction to moderna). At the time of the report, VACCINATION COMPLICATION (Reaction to moderna) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided. No treatment medication information provided.
Patient had a vaso-vagal like / syncope-like reaction.  His color drained from his face and he head was kind of limp, he responded to questions with great difficulty.  He never lost consciousness.  He stated like the room was fading away.  We got him into the consultation room and had him lay down on the floor with his feet on a chair, to which he stated he felt better. The color came back to his face. He responded quicker to all questions and steadily improved.  Next we moved him to legs straight, then sitting against the wall to sitting in a chair.  Then he went back out the waiting chairs with his father.