chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developed tear on retina; " trouble in eyes"; annoyance in her right ear; noise in her ear, going away and she does have Tinnitus; severe fatigue and vaccine made her tired; This spontaneous case was reported by a consumer and describes the occurrence of RETINAL TEAR (developed tear on retina) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, the patient experienced EAR DISCOMFORT (annoyance in her right ear), TINNITUS (noise in her ear, going away and she does have Tinnitus) and FATIGUE (severe fatigue and vaccine made her tired). On an unknown date, the patient experienced RETINAL TEAR (developed tear on retina) (seriousness criterion medically significant) and OCULAR DISCOMFORT (" trouble in eyes"). The patient was treated with Laser therapy for Retinal tear and Laser therapy for Ocular discomfort. At the time of the report, RETINAL TEAR (developed tear on retina), OCULAR DISCOMFORT (" trouble in eyes"), EAR DISCOMFORT (annoyance in her right ear), TINNITUS (noise in her ear, going away and she does have Tinnitus) and FATIGUE (severe fatigue and vaccine made her tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were given by the reporter. No Treatment information were provided by the reporter.  The patient started having trouble in eyes and developed tear on retina(retinal tear) two weeks ago. She went to her doctor and received laser treatment.  Very limited information regarding the events has been provided at this time.  No further information is expected.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow-up information received on 16-Jul-2021 added new events.; Sender's Comments: Very limited information regarding the events has been provided at this time.  No further information is expected.
Pt recvd 3 doses of Engerix-B vax on 5NOV90, 7JAN91, & 10MAY91 & 26SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
Temporary partial blindness; ringing in right ear; pale skin; sweating; dizziness.; This is a spontaneous report from a contactable consumer (patient).  A 15-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18Sep2021 15:30 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Prior to vaccination, was the patient diagnosed with COVID-19, known allergies: numerous foods and environmental substances like trees and grass all from an unknown date and unknown if ongoing.  Since the vaccination, has the patient been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications the patient received within 2 weeks of vaccination. There were no concomitant medications. The patient was previously vaccinated with the first dose of BNT162B2 (lot number: unknown) on 27Aug2021 12:00 PM at the left arm for COVID-19 immunization. It was reported that the patient experienced Temporary partial blindness, ringing in right ear, pale skin, sweating, dizziness on 18Sep2021 03:30 PM. The patient underwent laboratory procedure which includes covid test post vaccination (unknown covid test type), which was negative in 2021. The outcome of the events was recovered on 27Sep2021 12:00 PM.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
delirium; Bone freezing chills; left arm, shoulder and neck intense pain; left arm, shoulder and neck intense pain; left arm, shoulder and neck intense pain/soreness in neck; debilitating headache; pounding heart; feeling like body will explode from inside out; unable to get up; nausea; soreness in neck and armpits; This is a spontaneous report from a contactable consumer (patient herself). A 65-year-old female patient, not pregnant, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm, on 03Mar2021 09:15, at a single dose, for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took codeine and experienced allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) administered on the left arm on 10Feb2021 09:15 for covid-19 immunization at the age of 65-years-old. The patient did not receive other vaccines in four weeks and did not have other medications in two weeks. The patient did not have covid prior vaccination. The patient experienced the following adverse events on 03Mar2021 at 18:00 - bone freezing chills; delirium; left arm, shoulder and neck intense pain; debilitating headache; pounding heart; feeling like body will explode from inside out; unable to get up; nausea; continued soreness in neck and armpits and; headache for 3 days. The patient recovered from headache on 06Mar2021 18:00. The patient recovered from all the other remaining adverse events on Mar2021. The patient took ibuprofen as treatment for all the reported adverse events. The patient was not covid-tested post-vaccination.   No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.
10 min after getting his first Moderna vaccine  Patient reported left side weakness,  A day later she experienced brain fog, loss of sense of smell, difficulty concentrating, fatigue, weakness
Patient developed localized and soreness and swelling within minutes after receiving flu/and HPV9 vaccines on his LU arm no wheezing/chest tightness no generalized rash. On exam (L) upper arm with a 3 cm diameter raised, non erythema circular lesion on vaccine site. No facial/mouth/lip swelling.
Dizziness, light headed.  Cold sweats.  Nausea.  Room spinning.   Symptoms get worse when I sit up or stand up.  Subsides after periods of inactivity.
shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information about the pt's medical history, concurrent conditions and concomitant medications was reported. On 30-SEP-2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) injection (dose, route of administration, vaccination site, lot # and expiry date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). In July 2015, the pt was diagnosed with painful and debilitating shingles caused by zoster vaccine live (ZOSTAVAX). As a direct and proximate result of the Company's defective zoster vaccine live (ZOSTAVAX) vaccine, the pt suffered severe injuries and life-long disabilities not present prior to using the Company's product, which were directly caused by the zoster vaccine live (ZOSTAVAX) vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of their condition and suffered economic losses due to her inability to work. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and disfiguring personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the pt suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was not recovered.  The event of shingles was considered to be disabling.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA012054:
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing); "ulcerative colitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Yes other medication in 2 weeks and no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
administered the recalled lot (CP23D); administered the recalled lot (CP23D); This case was reported by a nurse via call center representative and described the occurrence of recalled drug administered in an unspecified number of patients who received HBV (Engerix B) (batch number CP23D, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details were provided as follows: The multiple patients were administered the recalled lot, which led to recalled drug administered and drug dispensing error. The reporter consented to follow up.
Really  high fever of 103.5 for 2 days, headach, very bad muscle pain, fever chills, and my arm that the shot was in felt a burning sinsation.
Inappropriate Reconstitution Technique/received a dose of just diluent; Inappropriate Reconstitution Technique/received a dose of just diluent; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate Reconstitution Technique/received a dose of just diluent) and inappropriate dose of vaccine administered (Verbatim: Inappropriate Reconstitution Technique/received a dose of just diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered 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: 30-JUN-2023 The reporter request sent by sales representative on behalf of the healthcare professional that Priorix customer got to the end of a box of Priorix, realized they had one vial of vaccine left.  The tracked down record of the 10 patients who received Priorix.  The 3 patients had been ruled out, one of the remaining 7 patients received a dose of just diluent of Priorix.  The customer was wondering how to proceed with remaining patients and if they need to re-administer. The Vaccine Administration Facility was the same as Primary Reporter. No additional information was available.  It was unknown if permissible to follow up The patient received a dose of just diluent of Priorix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Vaccine administered to left deltoid at 1836. Client was in Vaccination room with mother and brother, reported to Vaccinator history of fainting and anxiety with blood draws and vaccinations. Vaccinator placed client in anti gravity chair prior to vaccination. Client stated she was nervous. Vaccinator alerted RN's that client is complaining of dizziness shortly after. RN arrived to client at 1840, client alert and oriented x4, sitting  Semi-fowler's in gravity chair. Vitals at 1843: blood pressure 146/93, pulse 97, oxygen 99%. Client reported history of fainting and anxiety with prior blood draws and vaccines but reports no other medical history, no current medications and no known allergies. RN assessed for headache, nausea, and blurry vision, patient denied and reported no other symptoms.  RN gave client water and client drank slowly. RN's stayed with client for the remaining observation time. Vitals at 1850: blood pressure 125/96, pulse 73, oxygen 99%. Per client Dizziness improved and feeling better, at 1852 client was positioned to upright position in gravity chair with no complaints. Vitals at 1855: Blood pressure 126/90, pulse 95, oxygen 99%. Client reported dizziness has resolved and reported no other symptoms, client was able to safely stand from chair. Per mother and client, did not want to stay the full 30 minute observation. RN educated client and mother of ER precautions and following up with medical provider. Client left facility with mother and brother at 1857 with steady gait.
Pain in the injection site; Lips and mouth numb and tingly; Lips and mouth numb and tingly; A spontaneous report was received from a Reporter concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events (PT term) list.  The patient's medical history was not provided. No relevant concomitant medications were reported.  She received the 1st dose of moderna COVID19 vaccine on 14jan2021 (hospital) 20 min after her lips and mouth numb and tingly for 30 minutes. Also she experienced pain in the injection site during 3 days. Permission follow Up directly. Lot # 026L20A, Date The injection was administered in her Left arm by IM injection.  Is the patient pregnant: not currently. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.
pain from the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (pain from the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    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 VACCINATION SITE PAIN (pain from the vaccine). At the time of the report, VACCINATION SITE PAIN (pain from the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Extreme facial pain, especially in cheek area, where I received filler 1.5 years ago.
77 year old man with PMH of hypothyroid, HPLD, C-Spine surgeries who presents with cough, ShOB, weakness. He initially started with a cough about 1 week ago. It was a dry cough. He states that his cough improved, however he became more ShOB and weak over the last three days. Says that his ShOB is worse with exertion. No orthopnea. He has not had fevers, chills, he has some sinus congestion, no sore throat, no problems swallowing, no CP, palpitations, no nausea, vomiting, diarrhea, constipation, no dysuria, no LE edema. He has been vaccinated against COVID. He unsure when he received his vaccine, he has not had a booster.  On arrival to the ER, he had a temperature of 97.9°, heart rate of 98, blood pressure 124/70.  CBC relatively unremarkable as is his BMP.  His alk-phos is elevated 127, AST little up at 55.  His D-dimer is 2376.  ABG is 7.43/39/66/93% on 6 L. he is COVID positive.  Chest x-ray is read its course bilateral peripheral pulmonary infiltrates suggestive of COVID-19.    PT IS INPATIENT AT THIS TIME.
Mom stated pt developed T 104.1 /p admin of DTP inject. She called MD & was advised to give pt APAP. She did this & no further rxn developed.
Had adult Td on 5/19/03 after a dog bite. Approx 24 hours later started having muscle cramping in legs and feet. Vomiting and diarrhea, "fever", then asthma-like symptoms. Resolved with Benadryl every 4 hours. Now red swollen area on left arm at site of injection, "size of a softball". Allergic to PCN/morphine.
Deltoid muscle area swollen, red, hot to touch, and painful. Patient also complained of headache and nausea.
Information has been received from a pharmacist concerning a patient (age and gender not reported) who on 04-FEB-2015, was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneous. On 09-FEB-2015, the patient returned to the pharmacy with a prescription for a MEDROL dose pack lasting 6 days for an unspecified reason. The pharmacist state that he did not agree with "this being treated as an adverse event since nothing was reported" and the patient had not yet taken the MEDROL. The patient sought medical attention, but it was unspecified the reason for it. Patient's outcome of adverse event was not reported. Relationship between adverse event and ZOSTAVAX was not reported. Additional information is not expected as no consent for follow up was obtained.
This case was reported by a physician and described the occurrence of cough in a 21 month ol female subject who was vaccinated with Pediarix for prophylaxis. On 10/13/03 and 12/05/03, the subject received the 1st 2 dose of Pediarix. On 1/20/04, the subject received the 3rd dose of Pediarix. Approximately 12 months after the 1st dose of Pediarix, on 11/2/04, the subject received a dose of Daptacel as the 4th dose in the DTAP series. On an unspecified date in 5/04, approximately 15 months after the 3rd dose of Pediarix, the subject experienced a cough and was seen at a physician's office. The physician stated that there is, "an outbreak of pertussis in this city". Due to the outbreak of pertussis, the subject was tested for "antibodies to pertussis". Subsequently, on 5/24/05, the result of a B. pertussis antibody titer was negative. The outcome of the cough was not reported.
Pt did not respond to series of Recombivax;  Recv Engerix-B booster dose & lab values showed no titers.  2nd booster given 07Mar91.
Fever; This is a spontaneous report from a contactable nurse. A 66-year-old male patient received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN solution for injection; Batch/Lot number and expiration date were not reported) via unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was healthy. The patient experienced second one kicked his butt and had fever on an unspecified date. Event was assessed as not serious by the reporter. The reporter's causality assessment was yes, caused by the vaccine.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
This is a spontaneous report from a contactable physician (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 08Jan2021 (Batch/Lot Number: el1284) as single dose for covid-19 immunisation at a hospital. Medical history included hypertension. The patient has no covid prior to vaccination and no known allergies. Concomitant medications included bisoprolol fumarate (CONCOR), amlodipine and metformin. The patient has no other vaccine in four weeks. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: eh8899) on 18Dec2020 in the left arm for Covid-19 immunization. On 03Feb2021 (also reported as "21 days after vaccination"; pending clarification), the patient had Afib episode and ACS needed a coronary stent. The patient was hospitalized for 2 days. The patient was tested for covid post vaccination via nasal swab on 06Mar2021 which was negative. The outcome of the events was recovered with sequel.
Patient started heaving at 9 PM the day of the immunization. At 10 PM she had a severe headache with watering eyes. The next day she had a headache all day  Two days later she had diarrhea.
Developed swollen lymph node on left side neck/clavicle 5 days after second Moderna vaccine. Has not gone away since.
Information has been received from a consumer concerning his 19 month old daughter with no past medical history who in August 2003, was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 18-MAR-2004, the pt developed what appeared to be a breakthrough of varicella. On 18-MAR-2004, the reporter scheduled an appointment with a physician for the pt. At the time of the report, laboratory tests had not been performed. At the time of the report, the pt had not recovered. A product quality complaint was not involved. Additional information has been requested.
pt devel cellulitis like area @ site of vax;swelling & redness spread to the foreamr w/in 24hr;
This initial spontaneous report was received on 06-NOV-2017 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 16-MAR-2012, the patient was inoculated (by an unspecified person) at a pharmacy with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 08-JUN-2015, she was treated by a physician at a healthcare facility for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The female patient has been prescribed valacyclovir (VALTREX) for management of her 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. The outcome of the events was not resolved. The lawyer felt the events were related to ZOSTAVAX.   Additional information has been requested.