chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 29-year-old male patient received BNT162b2 (BNT162B2), on 27Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 years, in right arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21May2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of Covid-19. Clinical course includes, adverse event: Horrible metallic taste in mouth. Occurred less than an hour from initial dose of medication. And continued through course of treatment. Taste would decrease in intensity between doses. No known allergies. treatment start date: 26May2022, treatment stop date: 26May2022 (antivirals). The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Feeling of impending doom. Not feeling well at all, sat up in bed troubled and concerned. Couldn't sleep. I am otherwise a healthy adult with a recent excellent EEG/EKG and stress test, normotensive, active 6' and 188lbs adult male. Symptoms lasted 2 days and the third day a bit better but still troubled. Took about 5-6 days to feel normal again.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), in Sep2022 as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (Treatment start date 09Jun2023, Treatment stop date 13Jun2023). The patient has no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300227625 same patient, different drug, different event;
J96.00 ACUTE RESPIRATORY FAILURE 6/1/2021 DM 2 W RENAL MANIFESTATION J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/2/2021 DM 2 W RENAL MANIFESTATION J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 5/30/2021 DM 2 W RENAL MANIFESTATION
Diarrhea for 3 days.   Took OTC Psyllium Fiber Capsules per directions, which solved the problem.
Patient had a localized raction of a large not developing at injection site, redness and swelling of arm that spread to elbow from middle of upper arm. Her doctor prescribed BENADRYL for itching and Clindamycin.
Muscle and body aches sharp pains throughout body swelling at injection site short bouts of numbness and tingling in right arm from elbow down to fingers headache joint pain
Lips felt big to client ×5-10 min, also was wearing 2 masks,throat felt ok, history face swelling with ibuprophen,
His arm was extremely sore after booster; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 Immunization; Bnt162b2 (2nd dose), for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "His arm was extremely sore after booster".  No follow-up attempts are possible. No further information is expected.
After vaccination she felt a little light headed for 5 minutes; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Feb2021 (Lot number: EL8982) at the age of 73 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number-1; Lot number- EJ1686; Time the vaccination was given: 12:18; Vaccine Lot Expire date: 31Mar2021, ), administration date: 21Jan2021, when the patient was 73 years old, for COVID-19 immunisation, reaction(s): "A little bit dizzy". The following information was reported: DIZZINESS (non-serious) with onset 10Feb2021, outcome "unknown", described as "After vaccination she felt a little light headed for 5 minutes"; FATIGUE (non-serious) with onset Feb2021, outcome "unknown", described as "fatigue".  Additional Information: After the vaccination the patient felt a little light-headed for approximately 5 minutes. The second and third days she had fatigue in the afternoon. The AE(s) did not require a visit to emergency room and physician office.  No follow-up attempts are possible. No further information is expected.
her son is worried; his triglycerides were 700; had a fatty liver; developed lymph nodes on the supraclavicular & axillary region; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the parent.  A 35 year-old male patient received bnt162b2 (COMIRNATY), administration date 11Oct2021 (Batch/Lot number: unknown) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hodgkin's lymphoma" (unspecified if ongoing), notes: Per caller her son was treated and cleared of Hodgkin's Lymphoma 7 years ago.; "GERD" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "allergic to Penicillin and Erythromycin" (unspecified if ongoing); "cancer" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: XANAX; PROPRANOLOL [PROPRANOLOL HYDROCHLORIDE] taken for anxiety. Past drug history included: Erythromycin, reaction(s): "allergic to Penicillin and Erythromycin". Vaccination history included: Comirnaty (DOSE 1, SINGLE), administration date: 2021, for COVID-19 immunization; Comirnaty (DOSE 2, SINGLE), administration date: 2021, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 14Oct2021, outcome "not recovered", described as "developed lymph nodes on the supraclavicular & axillary region"; ANXIETY (non-serious), outcome "unknown", described as "her son is worried"; BLOOD TRIGLYCERIDES ABNORMAL (non-serious), outcome "unknown", described as "his triglycerides were 700"; HEPATIC STEATOSIS (non-serious), outcome "unknown", described as "had a fatty liver". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Patient has a history of Hodgkin's Lymphoma, he was diagnosed when he was 28, so that was 7 years ago. He has had treatment and was cured. He was schedule for a Cat scan for an unrelated issue, and when cat scan results came, it showed that he has enlarged lymph nodes on the supraclavicular and ancillary region. Caller does not know the exact date, but her son got the first and second dose when it first came out because he worked in the hospital it was sometime in 2021. The Enlarged Lymph nodes were first observed from the CAT scan results last night; he did not know before the test. Patient  struggled with it since he had the cancer  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt developed R upper arm swelling, redness several days following vaccine administration. Parent treated with warm compress at home. PO Childrens Ibuprofen and office eval 2-3 days following onset SX. No fever. No systemic symptoms. Pt evaluated 10/15/13 by PA. PO Benadryl advised continue Ibuprofen, ice for local reaction.
Arm stiffness; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Arm stiffness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product LENVATINIB MESILATE (LENVIMA) capsule for Endometrial cancer.    Concurrent medical conditions included Hypertension (HCP has also increased her Amlodipine from 5mg to 10mg to control her blood pressure.) and Thyroid disorder (Patient advised her Thyroid levels are rising). Concomitant products included AMLODIPINE for Blood pressure, PEMBROLIZUMAB (KEYTRUDA) for Endometrial cancer.   On 16-Jan-2021, the patient started LENVATINIB MESILATE (LENVIMA) (unknown route) 20 milligram. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 1. On 03-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Arm stiffness). At the time of the report, MUSCULOSKELETAL STIFFNESS (Arm stiffness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment medications were not reported.
Breakthrough COVID-19 infection. Pt received Moderna on 12/28/2020 and 01/26/2021
Patient was to receive Moderna Booster 0.25ml but actually received Moderna 0.5ml. Patient notified and no adverse reaction noted
After about 7-8 days of my first dose Moderna vaccine,  I experienced pain at the injection site and a rash or what is called a "Covid arm".  My rash extended from my left arm to my elbow and it was itchy and warm upon palpation.
Unresponsive; Brain Bleed; Hepatic Encephalopathy; Tested Positive for Covid-19; Initial Report Received on 08-Mar-2022  A nurse reported that a 68 year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history was reported as cirrhosis of liver, liver transplant (21 years ago), diabetes type II (no medication at this time), hypertension (no medication at this time). The patient had received two doses of Engerix in the past and was reported to be a non-responder. Allergy history included unknown reaction to lactose.  Medications at the time of vaccination were reported as Bumex (bumetanide), mycophenolate, tacrolimus, Viread (tenofovir disoproxil fumarate), and antiviral therapeutics.   On 08-Feb-2022, the patient received a dose of HEPLISAV-B (Lot # 935848, expiration date 22-Feb-2022 and NDC # 43528-003-05) through an unknown route and site.   On 10-Feb-2022, 3 days after having been vaccinated with HEPLISAV-B, the patient's wife found him unresponsive and called 911. The patient was then hospitalized for brain bleed and hepatic encephalopathy. The patient was ventilated at this time.   On 27-Feb-2022, the patient was to be discharged to a rehabilitation facility. However, he tested positive for COVID. The patient was reported to have brain fog and was not making sense. He walked out of the hospital against medical advice. On the same day, the patient's wife returned him to the hospital where he was readmitted to the COVID unit. The patient was reported to be mentally "not right", but with lactulose, he was fine most days.   No additional information was reported.   Company Comment: The company assessed the events of unresponsive to stimuli, cerebral haemorrhage and hepatic encephalopathy as serious and SARS-CoV-2 test positive as non-serious. The events are considered unrelated to HEPLISAV-B. Risk factors include hypertension, diabetes and liver cirrhosis. The events are unlisted per HEPLISAV-B IB, USPI and SmPC.; Sender's Comments: The company assessed the events of unresponsive to stimuli, cerebral haemorrhage and hepatic encephalopathy as serious and SARS-CoV-2 test positive as non-serious. The events are considered unrelated to HEPLISAV-B. Risk factors include hypertension, diabetes and liver cirrhosis. The events are unlisted per HEPLISAV-B IB, USPI and SmPC.
Immediately following vaccination, patient's arm became red with a little swelling. Swelling was approximately .25 inch diameter around the injection site. Redness extended approximately 2.5 inch diameter around the injection site. Cool compress applied to injection site for about 5 minutes and patient was observed for 30 minutes. At 20 minutes post vaccination swelling had resolved and redness reduced to approximately .75 inch diameter. At 30 minutes post vaccination slight mottled redness remained approximately .25 inch diameter around the injection site. Reviewed symptoms of anaphylaxis with parent and advised to monitor the patient for 24 hours, contact primary care provider if symptoms return, and go to emergency department for systemic anaphylactic symptoms.
A few months later, a SMAC test revealed elevated liver enzymes; Other lab eval revealed elevated SGOT, SGPT in the low 100 range & elevated LDH of around 450; The enzymes returned to nl in approx 2 wk; No further details were provided;
Pt. states that after receiving the 2nd dose of Phizer 03/22/2021, started experiencing symptoms 06/2021 of Chronic nose bleeds and swollen Lymphnoids under the left arm (lasting a week). Nose Carteret 09/01/2021 due to chronic nose bleeds.
patient was sick from December to March; Initial information regarding an unsolicited valid non-serious social media case was received from a consumer (patient) on 13-Dec-2020.  This case involved patient with unknown demographics, who was sick from December to March (Illness), while he/she received vaccine Influenza Vaccine.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick from December to March (Illness), following the administration of INFLUENZA VACCINE.  Details of laboratorydata not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as recovered for the event, at the time of reporting.  There will be no information available on the batch number for this case.
This case was reported by a physician via call center representative and described the occurrence of vaccination failure in a female patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced vaccination failure (serious criteria GSK medically significant) and meningitis (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the meningitis was recovering/resolving. It was unknown if the reporter considered the vaccination failure and meningitis to be related to BEXSERO. Additional details were reported as follows: The case was reported by a medical director who was a physician at department of Health. The age at vaccination was not reported. The reporter stated that the patient was a student. The patient received BEXSERO approximately in 2016. The patient developed Meningitis Men B and was currently hospitalized in hospital, at the time of reporting. The reporter provided very limited information. This was considered as suspected vaccination failure case since the laboratory test confirmation and time to onset for Meningitis Men B was unknown.
This case was reported by a via call center representative and described the occurrence of adverse drug reaction in a patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown. It was unknown if the reporter considered the adverse drug reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient ask about how long the side effects typically lasts. The patient provided the details for the further follow up.
Information has been received from a physician concerning a 1 year old patient, who on an unspecified date, was vaccinated with a dose of Rotateq. Subsequently, the patient was hospitalized for the intussusception (unknown dates and length of hospitalization). The treatment the patient received in the hospital was unspecified. The physician did not associate the intussusception with Rotateq. The patient sought medical attention, "by exam". No other symptoms or treatment were reported. The patient was recovering. There was no product quality complaint. Additional information has been requested.  10/25/07 Patient demographics provided by CDC. 11/16/07 Reviewed hospital medical records which reveal patient experienced bilious vomiting x 1 day.  Admitted 10/9-10/14/2007.  Unable to reduce IS w/BE.  Surgery consult.  OR for laparotomy, reductionof ileo-colic IS, resection of 12 cm ileum for Meckles diverticulum & appendectomy.  Progressed well & d/c to home FINAL DX: Intussusception & Meckles diverticulum, surgically reduced. Records faxed to CDC. 12/11/07 Reviewed vax record from pcp.  VAERS database updated w/same. Record faxed to CDC.
Patient reports numbness in distal part of left arm and 2 fingers post vaccination.  Observed patient for 15 minutes. Patient stated numbness was dissipating prior to departure. Advised patient to follow up with doctor.
Patient complained of feeling hot with nausea and dizziness. Assisted to supine position. No LOC. No fall. Alert, oriented throughout event. Observed in immunization area approximately one hour. Tolerated oral liquids and peanut butter crackers. With persisting c/o dizziness assisted to nurse clinic for continued observation. Stable throughout event but because of c/o being light headed and some dizziness observed longer. Sibling arrived to drive her home. Vital signs stable during time in clinic. Observed in clinic (total time) for 2 hours total after her immunization.
This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a adult female patient who received Hepatitis B vaccine. Co-suspect products included Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine. On an unknown date, the patient received 1st dose of Hepatitis B vaccine (intramuscular) 1 ml, the 2nd dose of Hepatitis B vaccine 1 ml, the 3rd dose of Hepatitis B vaccine 1 ml and 4th dose of Hepatitis B vaccine 1ml. On an unknown date, several years after receiving Hepatitis B, Hepatitis B, Hepatitis B and Hepatitis B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B, Hepatitis B, Hepatitis B  and Hepatitis B. Additional details were provided as follows: The age at vaccination was not reported. The patient with a history of 4 doses of hepatitis B vaccine in childhood had a no response titer in adulthood for hepatitis B antibodies. The patient subsequently received 1 challenge dose of ENGERIX-B in April 2016 and would be having a titer drawn in the next few weeks from the date of reporting. It was reported that the manufacturer of first 4 doses of Hepatitis B vaccine was unknown and lot number and expiry of challenge dose was unknown.
Approximately 5 days after receiving the vaccine, I noticed some redness, slight swelling & itching around  the injection site.  About 4 days later, both backs of my upper arms, thighs and backs of knees started itching, worse in the evening hours. The affected areas were pink and I had a mottled rash on both sides of my upper back and also my low back. This lasted about 6 days. My PCP was notified and stated I was having a systemic reaction to the vaccine and advised that I do not get the 2nd dose of the vaccine.
This spontaneous report was received from a registered nurse, and refers to multiple unspecified patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not reported. On multiple unspecified dates, the patients received improperly stored doses of VAQTA, lot number M047658, expiration date 28-OCT-2017, for prophylaxis (routes of administration were not provided). On unknown dates, the doses of VAQTA underwent temperature excursions of 9 degrees Celsius (°C) to 25°C for a time frame of 1 hour and 9°C to 25°C for 10 minutes, which were detected by the data logger. No adverse effects were reported. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1709USA010721: US-009507513-1709USA012219: US-009507513-1709USA012220: US-009507513-1709USA012221.
Patient received Pfizer 30mcg COVID-19 first dose on 11/10/2021. She inadvertently received the second dose of Pfizer 30mcg COVID-19 on 11/23/2021 instead of 21 days after the 1st dose. The error was discovered. The patient was notified on 12/3/2021. There were no adverse outcomes reported. The physician recommended she repeat the 2nd dose 21 days after the dose on 11/23/2021. She received the additional dose on 12/14/2021 to complete the series.
Had Flu vaccine 10-18-07, Fluarix A310AA lot #. On 10-22-07 developed rash over sternum to (R) rib cage area, that is clearly shingles with vesicular lesions. No prior case of shingles. Hx chickenpox in past. 11/14/07-patient not hospitalized, recovering from shinges.
sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: sore arm). The outcome of the pain in arm was resolved (duration 3 days).   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK receipt date: 31-MAR-2023 The patient had sore arm for 3 days after injections.  The follow-up could not be possible as no contact details were available.