chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flublok QIV was given to a 6-year-old patient/no AE; Initial information received on 15-Jan-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 06 years old patient of unknown gender who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (dosing details were not reported) on an unknown date.  The patient medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   It was a actual medication error case due to inappropriate age at vaccine administration.  It was unknown whether any adverse reaction was observed or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
About 7-9 days after the shot my arm was a little swollen and then a big round red patch appeared (about 4 inches in diameter) where the shot was.  It was a little itchy.  The red spot is almost gone (2/17/21).
Weakness of legs the next day, then rash, and swelling of the neck, and face.
bruise showed up on his left hand after receiving the Covid 19 vaccine; Weight: Declines; faded away as the days have gone by; This is a spontaneous report from a contactable consumer. This consumer reported for a 71-year old male patient (father).  A 71-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6207), via an unspecified route of administration, administered in Left arm on 19Mar2021 13:00 (at the age of 71-years-old) as dose 1, single for covid-19 immunisation. The patient medical history included ongoing Diabetic, Has had at least 20 years, ongoing heart condition Has had since he as 30 years old, has a couple stents. There concomitant medications were reported as none. No additional vaccines administered on same date with the Pfizer vaccine. Prior vaccinations, the patient did not receive any other vaccine within 4 weeks. On 20Mar2021, 11 hrs after vaccination, the patient experienced bruise showed up on his left hand after receiving the covid 19 vaccine on. His father had a bruise show up on his left hand. The bruise showed up after receiving the Covid 19 vaccine on the 20Mar2021. On an unspecified date on Mar2021, He reported his father's has faded away as the days have gone by. His father received the Covid 19 vaccine on 19Mar2021. Weight: Declines on an unspecified date on Mar2021. Reporter's father had a Covid 19 test a few days before the vaccine on 15Mar2021. The test came back negative. The reporter wanted to know what happens now, What should he do, Should he monitor it or go to doctor. The patient underwent lab tests and procedures which included (Covid-19 virus test) sars-cov-2 test, negative on 15Mar2021. The clinical outcome of event bruise showed up on his left hand after receiving the Covid 19 vaccine was recovering and other events were unknown.  No follow-up attempts are possible. No further information is expected.
Patient's grandmother brought pt in today because pt never received his 5th Dtap. We only had INFANRIX and ADACEL on hand. Patient is only 9 years old, so I gave pt the Dtap because our literature for the ADACEL said age 11-64. As I was entering the immunization in the NCIR an error message came up on the screen which prompted me to call the NCIR to see if I had done something wrong. Speaking with staff/NCIR she had explained to me about how the NCIR works and had sent me the information regarding the difference between the two vaccines and to report the incident here.
Information has been received from the boyfriend of a consumer concerning a 16 year who "last month, January 2008", on an unspecified date, was vaccinated with Gardasil (lot # unspecified) and had a positive urine pregnancy test "2 weeks ago" (approximately 01-Feb-2008).  Consumer reported that the patient started throwing up 2 days ago (approximately 12-Feb-2008).  Consumer noted that the patient is thinking of having abortion.  At the time of this report, pregnancy had not been terminated.  At the time of the report, the patient was recovering from the vomiting.  No further information was provided. Additional information has been requested.
This case was reported by a physician via out of hour services and described the occurrence of general body pain in a 61-year-old male patient who received SHINGRIX (batch number 33H7C, expiry date 30th January 2020). On 2nd April 2018, the patient received SHINGRIX. On 2nd April 2018, unknown after receiving SHINGRIX, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional details were reported as follows: This case was reported by the patient's wife. The reporter gave the SHINGRIX vaccine liquid adjuvant component to the patient without the vaccine portion in error, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not realize that, the diluent and vaccine were separate because she ordered the vaccine through a pharmacy and they never provided her with the instructions on preparation of the vaccine. The voicemail message cut off before the entire expiration date information was provided (January 30). Follow up information received from physician via call center representative on 3rd April 2018: This case was identified as duplicate of case US2018057012. The case US2018057012 will be deleted and all future correspondence will be added in the present case US2018056946 which stands as case of record for this patient. The duplicate case contained the following additional information: The patient's past medical history included shingles. At 09:00 hours, the patient received the 1st dose of SHINGRIX, intramuscularly in right deltoid. The suspect vaccine expiry date was updated. The reporter inadvertently administered the adjuvant for SHINGRIX alone, without reconstituting with lyophilized component, to the patient. Couple of hours after receiving SHINGRIX, the patient experienced body aches, which lasted the rest of the day. The patient was treated with TYLENOL and ADVIL. The next morning, when the patient woke up, the body aches were gone. The reporter had lot number only for the adjuvant component. The reporter considered the general body pain to be probably related to SHINGRIX.
p/vax pt T103 & leg swelling w/erythema; warmth & tenderness; tx: tylenol; cool compress
This spontaneous report as received from a nurse practitioner refers to a 65 year old patient of unknown gender. On 13-MAR-2013, the patient was vaccinated with PNEUMOVAX 23 (lot number H013399, expiration date: 07-MAR-2014) 0.5 ml in the arm. In March 2013, the patient experienced huge injection reaction, swelling at least 6 inches to include the whole upper arm and redness. The patients sought medical attention (office visit) and as prescribed steroids. The nurse also reported that she had not seen this type of reaction from PNEUMOVAX 23 before. The outcome of all the reported events was unknown. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports from the same source. Additional information is not expected.
I had swollen neck, difficulty breathing, I went to the emergency room. I cannot remember all of the test they ran on me when I went to the emergency room. I was admitted to the hospital and spent four days there with congestive heart failure and pneumonia. I have not been able to get into see my primary care physician for a follow up exam since being released from the hospital.
MILD ATRIAL FIBRILLATION; NUMEROUS PREMATURE VENTRICULAR CONTRACTIONS (PVCS); MILD HEADACHE; This spontaneous report received from a patient concerned a 57 year old white and not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa allergy, and dried onions allergy. The patient experienced drug allergy when treated with ibuprofen.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Next day after getting vaccination (on 07-MAR-2021), the patient got a mild headache. On the same day around 10:30 pm, while sitting in a reclined position, he experienced palpitations in the neck. He put on his wife watch and it showed atrial fibrillation. Upon arriving to Emergency room (ER), he had mild atrial fibrillation and numerous premature ventricular contractions (PVCs). He was hospitalized for a few days. Various testing indicated no problems and was all fine. He was on 30 day monitor by his cardiologist. During that time, he continued to have premature ventricular contractions (PVCs) and 1 episode of atrial fibrillation. As of now (at the time of this report) he felt okay. Patient was waiting for insurance to cover testing inflammation of the heart. Last time he felt anything out of rhythm was 03-APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild atrial fibrillation, numerous premature ventricular contractions (pvcs), and mild headache. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210703427-covid-19 vaccine ad26.cov2.s-mild atrial fibrillation, numerous premature ventricular contractions (PVCs). 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).
I took out of the vaccine fridge, by mistake,  a vial of vaccine that expired 12/27/2022 and another nurse at the facility administered it to the patient. The patient did not have any side effects while in the office.
MS exacerbation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4558645.  A 70 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing). Concomitant medication(s) included: OCREVUS. The following information was reported: MULTIPLE SCLEROSIS RELAPSE (medically significant), outcome "unknown", described as "MS exacerbation". The lot number for bnt162b2 was not provided and will be requested during follow up.
I start sweating all over like had  fever but I didn't.  I was vomiting.  Had really bad back and stomach pain.  I went to the ER.  They did an ultrasound, CT scan, and a chest x-ray.  They said I had inflamed small intestines.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 06-FEB-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # M000442 exp date 31-MAR-2018) (dose and route not reported). The temperature of excursion was below 32 F (-12F) for 24 hours. There was no previous temperature excursion. Data logger issue was reported. No adverse experiences were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1702USA007064:
Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive Patient received vaccine and tested positive for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Pharmacist gave patient a third dose of Shingrix vaccine. No adverse event reported by patient
Initial and follow-up info has been received from a health professional concerning a 34 year old female nurse with hypothyroidism who on 11/7/02 was vaccinating a pt with MMR II. It was reported that while the nurse was administering the vaccine to a child some accidentally splashed in her eyes due to a faulty needle device (safety syringe). The nurses eye was flushed for 5 minutes after the incident. The nurse was seen the next day on 11/8/02, in occupational health. Her eye was examined by occupational health and was diagnosed with an abrasion. She was treated with unspecified eye drops. A HIV test and hepatitis panel were all negative. Subsequently, the pt recovered from the eye abrasion. No further info is expected.
pt recv vax; devel hives on back , vesicles and papules on upper extremities;
This case was reported by a other health professional via call center representative and described the occurrence of swelling arm in a patient who received DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced swelling arm. On an unknown date, the outcome of the swelling arm was unknown. It was unknown if the reporter considered the swelling arm to be related to dTpa vaccine. Additional details were provided as follows: The age at vaccination was not reported. The case was reported via pharmacy technician. The patient had reaction which included swelling from their shoulder to wrist after receiving unknown brand of Tdap. The reaction was mentioned by caller after they were transferred to medical information system (MIS) for an escalated call. No other information was obtained.
Patient developed a petechial rash on left arm after the first PfizerCOVID-19 vaccination which disappear quickly.  She then developed a petechial rash to her arms and chest after 2nd dose of the vaccination.  Approximately 2 weeks later developed spontaneous epistaxis x2.  One lasting 3 hours and the latter 30 minutes.  Labs were significant for a platelet count of 7K at PCP.  Repeat 4K Hospital.  Immature platelet fraction grossly elevated at 49%. Remainder of CBC only notable for mild normocytic anemia Hb 11.7. Coags without concerns, D-dimer normal, and Fibrinogen normal.   Treated with IVIG and steroids 5/28/2021.  Required additional dose of IVIG and steroids 7/2021.  Continuing to monitor and treat ITP.
Pt recv vax on 8/28/98; on 9/4/98 pt exp restlessness, lethargy and fever (100-101/txAdvil).  Fever up to 104; pt exp shaking, eyes rolled back, panting for 5 mins; pt became limp, vomitted.  Pt mom called 911, to E.R., tx=Rocephin.
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.  No concomitant medications were reported   No treatment information was provided   This case was linked to MOD-2021-351209 (Patient Link).
About one hour after patient received her J&J vaccine, the left side of her tongue started getting numb. She called the pharmacy today (5 days later) and stated she still has the numbness. She also stated that sometimes the numbness radiates to her cheek, and it appears during stress.
Child started developing a red splotch/rash at night and by morning it was covering his thigh and he was limping.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Headache-Mild
Facial Paresthesia, metal taste in mouth, LUQ pain and neck swelling/discomfort, left side facial droop, eyes close bilaterally, slurred speech.
This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient). A 75-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 05Mar2021 13:00 at a single dose for COVID-19 immunisation. Medical history included blood pressure (abnormal), depression, both hips replaced and allergic to sulfur. Concomitant medications included ibuprofen, blood pressure and depression pill. The patient previously received first dose of BNT162B2 on an unknown date for COVID-19 immunization and experienced mild arm soreness. The patient received her second Pfizer COVID vaccine on 05Mar2021 at 1 PM. The following morning on 06Mar2021 she woke up at 6:30 AM with an itchy rash on her buttocks and hips. She took diphenhydramine (BENADRYL) and it subsided but came back later and started spreading to her thighs, chest, arms, stomach, and back. She was taking Benadryl to treat it and wanted to know what else to do. She was covered with a rash and itching and going crazy, they were welts like little welts kind of hives; It is itching all over; It didn't go away, it was itching all through the day. It just kept getting more and more in covers like her knees up to her butt, her butt was all covered, her lower back was covered and her arms were getting it now that just keep travelling. It is all around the area, it's travelling everywhere my legs, my arms and my chest. The patient had the 2nd dose yesterday (05Mar2021). She experienced little soreness on her arm and rashes starting to spread all over to her body after the vaccine. Outcome of the events going crazy and little soreness on her arm was unknown while not recovered for the other events.   Information on the lot/batch number has been requested.
pt recv vax 11JUL97 & 27JUL97 pt exp itchy varicella-like rash w/15-25 vesicles, fever of 100, sore throat, minimal neck stiffness & myalgia;lab eval in AUG97 revealed positive varicella antibody titer;approx 2wk pt fully recovered;
This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 49-year-old female patient who received ENGERIX B (batch number B39CM, expiry date 3rd February 2020) for prophylaxis. Concomitant products included CRESTOR, KEPPRA, Labetalol, Metformin, hydrochlorothiazide, LEXAPRO. On 20th April 2018 16:00, the patient received the 1st dose of ENGERIX B 1 ml. On 20th April 2018, less than a day after receiving ENGERIX B, the patient experienced dizziness and headache. On an unknown date, the outcome of the dizziness and headache were not recovered/not resolved. The reporter considered the dizziness and headache to be probably related to ENGERIX B. Additional details were provided as follows: The patient experienced dizziness when she bend over, sat down and when she got up too fast. She had appointments with her hematologist and general practitioner so far.
Right arm red, hot and swollen to size of golf ball, itching. Mother called ER and was instructed to give Benadryl and Tylenol.
Rash on trunk , back and Neck 2 days after first shot; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on trunk , back and Neck 2 days after first shot) in a 58-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash on trunk , back and Neck 2 days after first shot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (Rash on trunk , back and Neck 2 days after first shot) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications was reported.   This case was linked to MOD-2021-378000 (Patient Link).   Reporter did not allow further contact
Patient felt dizzy and slightly shaking 5 minuets after receiving her 2nd dose of pfizer vaccine. She was alert and oriented. Her vs at 6pm p88, BP 178/96; Res 18 and O2 saturation 100%. She speaks a different language then reporter. Her daughter who received her second dose of vaccine did the translation. She had TIA 3 years ago. She's currently not on any medication. She denies headache or blurred vision. According to her daughter, she does get nervous from time to time. Her last physical was 1 year ago. She felt better and calm 10 minutes later. Her vital signs was repeated and was the same. She states she has appointment with her PCP in 1 week for annual check. She advised to check blood pressure daily and take BP record with her to her doctor's appointment. She also advised to seek immediate medical attention if chest pain or symptoms worsens with understanding.
This report describes the occurrence of migratory arthralgias in an adult male of unspecified age who received Lyme disease vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings involving the subject's spouse. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On an unspecified date, the subject reportedly received an injection of LYMErix. The subject's spouse also received LYMErix, and experienced adverse events (A0382469A). In the spouse's medical records from a neurologist dated 2/4/02, the neurologist noted, "her husband received the Lyme vaccine three years ago, following which he developed migratory arthralgias." Time to onset following immunization, treatment, and outcome were not specified.