chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first dose: his arm hurt a little; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date Apr2021 (Batch/Lot number: unknown) at the age of 65 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "first dose: his arm hurt a little". Additional information: Caller was calling about the COVID vaccine by Pfizer. He yesterday he took his final dose and he didn't have a problem with it but he doesn't understand. He says the first time his arm hurt a little and the second time was the same as the first. He thought the first shot was worse than second one but when he woke up today he wants another shot. He has never felt anything like it, he was dying for another shot, he has never felt anything like it. He also called his pharmacist and they gave him a number and he called his doctor's and he was waiting for them to call him back. He says he had to drink a whole pot of coffee today, he just has this urge that he wants another shot, like it was amazing, he feels really good. He does not think it was anything worry about. He was fine but it was weird. Primary Care doctor: He has told a doctor but he didn't call his other doctor yet. He called the urgent. The urgent care doctor , he does not know how to spell his name and he does not have any contact information for the office to provide. It is the urgent care. The date of the first dose was either the 12Apr2021 or 15Apr2021, he is not sure which and then 3 weeks later he had the second dose. He had the second dose yesterday, 06May2021. They were both in the left arm. He was at the hospital right now because he has a relative in the hospital and he was about to go it. He was waiting on another relative. No further information provided. He says he was on the same medications as the first one and the same thing, he was on the same medications and the doctor took it all and looked through everything and said it wouldn't cause anything. It just made him feel really good in his body, it was really weird, it was like he was a super hero and he wants another shot, he was scared and has been drinking coffee all morning. He hopes he does not turn into another super hero. He says he was not really worried, this happened with the first one too but not as much as the second one. The next day woke up and he felt okay and had these urges, like his arm hurt a little but it went right through him, like it didn't bother him at all, his head just got hot and he got a little sweaty and then it was gone. He does not know if he was immune to it or not because his body ate it up fine. He had no side effects. Other products and investigation assessment was reported as no.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Coronary artery disease involving native coronary artery; underwent a successful CABG x 2 on 11/31/2021. His Post operative recovery was uneventful without any major complications. Hospital admission was within 6 weeks of receiving the COVID vaccine.
stiff neck / really stiff neck; felt really bad; 103 fever / fever; bowel movement that really smelled, nasty like sludge; queasy; real dizzy; fell asleep three times since I've been home; heart rate is elevated; I feel pounding in my chest; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff neck / really stiff neck), FEELING ABNORMAL (felt really bad), PYREXIA (103 fever / fever), ABNORMAL FAECES (bowel movement that really smelled, nasty like sludge) and NAUSEA (queasy) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck / really stiff neck), FEELING ABNORMAL (felt really bad), PYREXIA (103 fever / fever), ABNORMAL FAECES (bowel movement that really smelled, nasty like sludge), NAUSEA (queasy), DIZZINESS (real dizzy), SOMNOLENCE (fell asleep three times since I've been home), HEART RATE INCREASED (heart rate is elevated) and PALPITATIONS (I feel pounding in my chest). The patient was treated with PARACETAMOL (TYLENOL) on 23-Jun-2021 at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiff neck / really stiff neck), FEELING ABNORMAL (felt really bad), PYREXIA (103 fever / fever), ABNORMAL FAECES (bowel movement that really smelled, nasty like sludge), NAUSEA (queasy), DIZZINESS (real dizzy), SOMNOLENCE (fell asleep three times since I've been home), HEART RATE INCREASED (heart rate is elevated) and PALPITATIONS (I feel pounding in my chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medications was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow-up information received on 23-JUN-2021 contains no significant information.
Information has been received from a certified medical assistant concerning her 12 month old son with no known allergies and asthma who on 17-JUN-2003 was vaccinated with a dose of Varivax (lot # "0018M"). Concomitant therapy included a dose of HIBTITER. One week after vaccination, on 27-JUN-2003 the patient developed 5 lesions which cleared in a week. During this time period the patient also had a fever of 101.7F. The patient then developed three more lesions that also cleared in a week. Unspecified medical attention was sought. It was reported that all of the lesions were on the patient's legs or trunk. The patient recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested. This is in follow-up to report(s) previously submitted 05/16/2007. Information has been received from a certified medical assistant concerning her 12 month old son with no known allergies and asthma who on 17-JUN-2003 was vaccinated with a dose of VARIVAX (Oka/Merck) (lot # "0018M"). Concomitant therapy included a dose of (HIBTITER) (CRM197). One week after vaccination, on 27-JUN-2003 the patient developed 5 lesions which cleared in a week. During this time period the patient also had a fever of 10.7F. The patient then developed three more lesions that also cleared in a week. Unspecified medical attention was sought. It was reported that all of the lesions were on the patient's legs or trunk. The patient recovered. Therer was no product quality complaint involved. No further information was provided. Additional information is not expected.
Patient passed away suddenly and unexpectedly at home the morning of April 4, 2021. The ER doctor was unable to ascertain a cause. The preliminary autopsy conducted by the medical examiner within 24 hours of death was inconclusive, but I'm told tests of samples are ongoing.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 02-DEC-2017, the patient was vaccinated with an improperly stored dose of PROQUAD, therapy type: recombinant human albumin (RHA), lot # M021731 with expiration date 29-OCT-2017 (site, dose and route of administration were not reported). The dose was exposed to the temperature of -14.4 degrees Celsius for 54 minutes. No previous temperature excursion was reported. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all information has already been obtained. Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742.
Patient admitted to hospital on 11/8/03 (8:39 PM). Patient presented with fever (105), generalized erythema, chills, SOB, semi-conscious state. Patient also hypoxic and had ischemia on fingers. Patient was intubated.
10/8/14 Redness/Swelling at injection site, hives and itching on body intermittently. 10/9/14 Increased swelling at injection site, left fingertip numbness, itching intermittently on body. 10/10/14 Facial numbness on left side of face, right/left side facial numbness in PM, tingling. 10/15/14 Facial numbness, scalp numbness intermittently, "heaviness" in arms bilaterally. Denies difficulty with speech, coordination. Reports reaction at age 21 after PPD test (Redness, burning, swelling, numbness).
My husband was tired the next day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "My husband was tired the next day".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
muscle cramps in lower quad of toes & feet-through entire body;dizziness,lightheadedness, discoloration of skin, nausea, not able to breath, passing out;given 02
Pain along the Ulnar nerve with paresthesia in the right hand, pain in the axillary area that spread to the cervical plexus the next day. the right hand paresthesia diminished after one week and the pain in the Ulnar nerve diminished over 3 weeks. The pain in the cervical plexus and spams in the right cervical muscles (scalene and Sub occipital) lasted with gradual reduction for months until today there is just regular stiffness in the cervical area and no Ulnar nerve issues.
Pt recv vax on 12/10/98; on 12/15/98 pt exp erythema multiforme
Myalgia, Arthralgia, fatigue, malaise, chills, pain and swelling at injection site Narrative: The evening of receiving her third dose of the Moderna vaccine, the patient reported generalized body aches, malaise, chills, and injection site pain/swelling. She took acetaminophen (does not remember dose), and rested to recover.
Drug ineffective; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 02Nov2020 as dose 1, single (Batch/Lot number: unknown), on 20Dec2020 as dose 2, single (Batch/Lot number: unknown) and on 05Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 14Jan2022, outcome "not recovered"; DRUG INEFFECTIVE (medically significant) with onset 14Jan2022, outcome "unknown". The action taken for adalimumab was unknown.  The reporter considered "drug ineffective" and "covid-19" related to BNT162b2.  Clinical Course: Pfizer Biontech Covid-19 Vaccine (Tozinameran) was also considered suspect. Causality for Humira (Adalimumab): The reporter's causality for the event(s) of COVID-19 with Humira (Adalimumab) was not provided. Causality for Pfizer Biontech COVID-19 Vaccine (TOZINAMERAN) (Injection): The reporter's causality for the event(s) of COVID-19 with Pfizer Biontech COVID-19 Vaccine was possible. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The lot number for bnt162b2 was not provided and will be requested during follow up.  Follow-Up (14Apr2022): Follow-up attempts are completed. No further information is expected.  Follow-up (06Sep2021): This is a solicited follow-up report based on the information received by Pfizer from Regulatory Authority. Updated information included: Product Tab (Administration date, Route and dose number) added. BNT162B2 recoded with license as per Booster Dose.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness cannot be ruled out.
BECAME PALE, HAD SL. CHEST PAIN, LIGHTHEADED, HOT FLASHES
Information has been received from a nurse practitioner concerning a 7-10 year old white male who was vaccinated with a dose of varicella virus vaccine live. In November 2003, "years after vaccination" the patient developed breakthrough varicella lesions. The case was mild and required no treatment and no hospitalization. The patient was seen by a physician to diagnose. Subsequently, the patient recovered. Additional information has been requested.
Had febrile seizure the day following vaccination at 5pm. Woke up with low grade fever from nap that afternoon, parents gave Tylenol. About an hour after that, became unresponsive, then arms shaking, eyes rolled back, Dad picked her up, couldn't keep her alert. Entire event lasted about a minute. Dad blew in her face and that started to make her more responsive. Called EMS, who did vital signs that were normal. Parents took her to ER where diagnosis of febrile seizure was made (temp was 103-104) and pt. is back to baseline.
Pt had a seizure 3 hrs p/vax recvd & a second seizure approx 12hrs thereafter;
fine red, bumpy rash around inject site noticed approx 9 hrs post vax; 26AUG92 rash has spread;
Patient woke up with a round red warm area on her left arm that morning and by the end of the day 9/15 area increased in size and was painful. On morning of 9/16 the reddened and now swollen area was 5 by 4 inches and raised to egg size area and she had a fever of 101 F. Patient went to own MD on 9/16 and he diagnosed an infected hematoma-prescribed Keflex and Prednisone.  MD also instructed her to stay home from work for 9/16 and 9/17 due to fever.  Call to patient on 9/17 and she states worse, swollen area in left arm now doubled in size, pain from shoulder to elbow, continued reddened, fever of 101 continues.  TC again to patient on 9/17 by HD staff and she was again seen by MD on 9/17 and to continue Keflex for 10 days and to contact MD if area gets any larger. TC to patient on 9/20 by HD staff and area started shrink on 9/18 and is now less tender, improving.
Likely hypotonic, hyporesponsive episode ,3 episodes of head falling backwards then forward, eyes back in head, no arm or leg movements. Normal before and after had had fever to 102.5 F for 2 days, now resolved.
Engerix-B adult administered to a 13 YO; Engerix-B adult administered to a 13 YO; This case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 13-year-old female patient who received HBV (Engerix B adult) (batch number M4KE9, expiry date 29th April 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd August 2022, the patient received the 1st dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On 2nd August 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-SEP-2022 Reporter's Comment: The reporter reported that an adult dose of Engerix-B was administered to a 13 years old patient. The reporter stated that the patient received pediatric dose as a 2nd dose on 2nd September 2022 The reporter did consent to follow up via mail. Additional supportive information: The adolescent received adult dose of Engerix-B, which led to adult product administered to child and overdose.
Chronic hives that started 11 days after injection with first booster shot. The hives persisted for a whole month and stopped once I started taking antihistamines.
sensory deficit; left arm aching; left arm paresthesia; This is a spontaneous report from a non - contactable other healthcare professional. A 61-years-old female patient received a single dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE ) ( Lot number = EN6205 ) via an unspecified route of administration on 16Mar2021 ( at the age of 61-years-old ) as a first dose for COVID-19 vaccination. Medical history and concomitant medications were not reported.  On 16Mar2021, during waiting period of 15 minutes after the vaccination, the patient experienced left arm paresthesia and aching. She had denied for rash, hives and SOA. But sensory deficit was present. Patient was discharged as she was stable to go home. The outcome of these reactions are unknown. No follow-up attempts are needed and no further information is expected.
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. The nurse reported that the patients were administered improperly stored doses of GARDASIL 9 (lot # L019287, expiration date 14-SEP-2017) (dosage, strength and route unknown) on multiple unspecified dates. There was no concomitant medication reported. No adverse effects was reported. Additional information has been requested.
We both vaccinated in April, two shots in April. We both had Covid initially in February. He had now tested positive for Covid in June.; SARS-CoV-2 test positive; This is a spontaneous report from a contactable consumer. This consumer (patient wife) reported for a 49-year-old male patient(reporter husband) that received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine Formulation: Solution for injection, Batch/Lot Number: EW0153, Expiration Date: 31Jul2021) via an unspecified route of administration in right arm on 30Apr2021 as 2nd dose, single dose for covid-19 immunisation. Medical history included covid-19 from Feb2021 to an unknown date (Verbatim We both had Covid initially in February). The patient previously received first dose of BNT162B2 (Formulation: Solution for injection, lot number: ER8730) on 10Apr2021 for Covid-19 immunization. On Jun2021, the reporter stated seriousness for we both vaccinated in april, two shots in april. We both had Covid initially in February and he had now tested positive for Covid in June after being fully vaccinated and the instance was as much, all of its severe as first episode of Covid and reporter stated that showing vaccine was not affective for my husband. We both had Covid in February So we had to wait April to get vaccinated and then he unfortunately had it again in the end of may, 1 week of June. The patient underwent lab tests and procedures which included sars-cov-2 test positive on Jun2021. The outcome of the events were unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Fainting with no history of fainting , mensuration that has lasted over 22 days and is not stopping with doctors treatment , abnormal CBC results with no previous history of abnormal CBC results
Patient had mild symptoms of COVID19 and came to the hospital to be tested. Patient tested positive for COVID on 07/19/2021 after receiving the COVID19 Moderna vaccination on 12/23/2020 and 01/20/2021. Patient was not hospitalized after testing positive.
He got his vaccine, he got a little soreness in the arm the next day.  When he checked his BP which also reads his pule rate he noticed that it was down.  It normally runs around 60.  It continued to be below 60 BPM since 5/21/22 on average.  This is his pacemaker bottom limit.  This concerned him and he made an APT with his first cardiologist who said that everybody has AE from it.  He then went to see an Electrocardiologist from Facility and that his pacemaker was fine, but that he had an irregular heart beat that he detected.  He followed up with a nuclear stress test, and the results of that showed that he had no blockages in his heart valves.  He then followed up with an echocardiogram and that showed that his valves were working properly and it is now a mystery to see why it is not staying in paces, and he has a FU appointment in September.   His heart rate can get as low as 44 BPM.  He does play tennis every other day and it does go up, but at rest it's below 50.   His symptoms from it being low are when he starts exercising he has to sort of really warm up and get going first to get enough oxygen to be able to get functioning, and once he gets going he is able to work out and do the activity.  He does not have any pain, it is just quite annoying to him.  His pacemaker functioned normally until the last vaccine.
Medical Assistant gave a pediatric patient age 7 months a 0.5ml dose of influenza TIV made by sanofi pasteur. Medical Assistant will pay attention to the instructions of the order. Medical Assistant to double check the age of the patient and re-read the instruction. Medical assistant will use provided information and charts that are posted in the medical room for appropriate administration of the influenza for different ages. If the medical assistant have any additional questions she will direct time to the appropriate persons identified. Medication administered to or used by the patient: No. Patient counseling provided: Unknown. Relevant materials provided: None.
Headache, sore neck, memory difficulty, feels in a fog, muscle and joint pain in left arm. Knot in arm <5cm. Dry mouth, flu-like symptoms occurred first. No lost duty time.
fever 102.8, 101.2, 100.8 was reduced w/APAP then rt back up; rash onbody; green discharge from eyes, eyes red mom called clinic 8JUL92 refused to see pt took to MD 9JUL92;