chrisvoncsefalvay/vaers-outcomes huggingface dataset:
stroke; dementia has advanced more; more than 42 days for second dose; mood swings; yell and Screaming; stroke affected husband's right arm; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) and DEMENTIA (dementia has advanced more) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis, Cancer and Dementia.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization and medically significant), DEMENTIA (dementia has advanced more) (seriousness criterion medically significant), PRODUCT DOSE OMISSION ISSUE (more than 42 days for second dose), MOOD SWINGS (mood swings), SCREAMING (yell and Screaming) and LIMB DISCOMFORT (stroke affected husband's right arm). The patient was hospitalized on 27-Mar-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), DEMENTIA (dementia has advanced more), PRODUCT DOSE OMISSION ISSUE (more than 42 days for second dose), MOOD SWINGS (mood swings), SCREAMING (yell and Screaming) and LIMB DISCOMFORT (stroke affected husband's right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient right arm affected due to stroke. He took a lot of medication. He also took a treatment for cancer.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Very limited information has been provided at this time. Further information is expected.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Very limited information has been provided at this time. Further information is expected
have been breaking out each week/rashes that's coming out in my body like blisters; rashes that's coming out in my body like blisters very painful; itches; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itches), RASH VESICULAR (have been breaking out each week/rashes that's coming out in my body like blisters) and RASH (rashes that's coming out in my body like blisters very painful) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 088021A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH PRURITIC (itches). On an unknown date, the patient experienced RASH VESICULAR (have been breaking out each week/rashes that's coming out in my body like blisters) and RASH (rashes that's coming out in my body like blisters very painful). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (itches), RASH VESICULAR (have been breaking out each week/rashes that's coming out in my body like blisters) and RASH (rashes that's coming out in my body like blisters very painful) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) couldn't find anything.         Patient stated symptoms subsided after treatment but has been breaking out each week.. Both HCP draw him blood but couldn't find anything. Concomitant medications were not provided.   This case was linked to MOD-2021-419668 (Patient Link).
A few days after receiving my shot on 3/22, I experienced soreness and itchiness. No rash, from what I could tell but my injection was through a tattoo so it might?ve been hard to see. The itchiness was subdermal and almost felt like the muscle itself was itching.
Vaccine may have  been store under condition that departed from the manufacturer recommended specification, so the manufacturer deem vaccine not viable and recommended a repeat dose.
Almost 48 hours after 2nd vaccination; patient awoke with rash on trunk and extremities. Rash was slightly itchy but not painful.  No medical treatment was sought and rash cleared in about 48 hours.
Pt. report of "itchiness" was responded to appropriately and patient was monitored for a prolonged period of time to ensure symptoms did not worsen.  Pt. was send home in no distress and stable with resolution of rash prior to departure
Has shingle-like rash on left side of neck. Has nerve sensation/tingling on left side of scalp.
Rash (6 inches by 3 inches) severe itching, pain, swelling.  I am still having these symptoms (6:00 PM, Jan. 1).
2 month old received fluarix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 52SA4, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th March 2022, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 29th March 2022, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was 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: 29-MAR-2022 Reporter's Comment: Medical assistant reported that a 2 months year old patient received Fluarix Quadrivalent and wanted to know if there was any safety information or how to proceed. The reporter consented to follow-up. Additional supportive information:  The 2 month old patient received dose of Fluarix Quadrivalent, which led to inappropriate age at vaccine administration.
SYRINGE MALFUNCTIONED, WHEN INJECTING THE DOSE OF VACCINE MOST OF IT LEAKED OUT ONTO PATIENTS ARM
Woke with chill and body aches in the night. Went back to sleep. Woke up 4 hours later wild low grade fever of 99.5 (usually 98.3) and body aches/stiffness and mild headache.
Approx 3:00 a.m. 10/12/16 right arm was sore and warm to touch. Approx 11:00 a.m. increased soreness, noticeable swelling of upperarm extending to below elbow, redness and very warm. At 4:00 p.m. 10/12/16 went to urgent care. Physician ordered SOLUMEDROL im 125 and prescribed 5-day regimen of prednisone 20mg and also acetaminophen 300mg-codeine 30mg for pain. Swelling of arm was significant. BP 156/73, Pulse 95, Resp/min 20, Temp 97.7 %O2 97.
Constant cough; feeling like I have cold; feeling feverish; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd June 2022, the patient received Shingrix. On 23rd June 2022, 1 days after receiving Shingrix, the patient experienced fever and cold. On 24th June 2022, the patient experienced cough. On an unknown date, the outcome of the fever, cough and cold were not recovered/not resolved.   It was unknown if the reporter considered the fever, cough and cold to be related to Shingrix.  Additional Information: GSK Receipt Date: 26-JUN-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient was feeling feverish since 23rd June, a constant cough and he or she had been feeling like he/she had cold for the last two days before the date of reporting.  The reporter wanted to know if this was normal. Additional Supportive Information: The follow up would not possible as no contact details were available. Note: The year of vaccination and onset date was considered as 2022 from narrative.
pt reported fry mouth and "tingling tongue" B/P 155/90. Pt requested Benadryl at 1745 and was given 25mg PO. 1752 b/pp 159/83. At 1800 pt stated "not any worse". B/P 150/77 declined further treatment/monitoring at which time she was release ambulatory. pt verbalized understanding of any additional benadryl
Headache for 48 hours from injection,  Fever 100.4 approximately 24-36 hours from injection,  weakness and fatigue fir approximately 72 hours
After receiving 1st shot, soreness in arm occurred. Doctor stated its normal. 10/6/99 After receiving second shot all appeared ok until 3 to 4 weeks later. I became paralyzed, temperature. Then during the course of the year, other symptoms occurred. Second shot on 11/8/99.The follow up states, "memory loss reported following LYMErix vaccination on 11/8/99-onset within 3-4 wks. He states this is contributing factor to an auto accident he had on 12/6/99." On 60-day follow up report received 4/23/2003, reporter states, "increased joint pain in legs and arms - concentration and focus on projects at hand are extremely short. Level of frustration is increasing. Mood swings are increasing - capability of working in current status is limited - can't perform work as normal".
PATIENT REPORTED TO HAVE VAGINAL BLEEDING LIKE A PERIOD FOR COUPLE DAYS AFTER HER 1ST SHOT. SHE CONTACTED HER DOCTOR BUT WAS ADVISED TO GET THE 2ND DOSE AS WELL CAUSE THE DOCTOR WASNT SURE THE BLEEDING IS FROM THE VACCINE. HOWEVER, THE PATIENT REPORTED TO HAVE VAGINAL BLEEDING AGAIN AFTER HER 2ND DOSE FOR 1 DAY. SHE ALSO REPORTED TO HAVE SORE ARM, AND BODYACHE AFTER THE 2ND DOSE.
Rt arm swollen & tender 4-5 hrs p/receiving vax; Later in night red raised itchy rash noted on lt thigh; fatigue & poss low fever x 2 days;
DIZZINESS, TINGLING IN LEGS AND  LIPS, ELEVATED BLOOD PRESSURE, FLUSHING IMMEDIATELY AFTER ADMINISITRATION. PT WAS ASSISTED INTO SUPINE POSITION WITH FEET ELEVATED AND RECOVERED AFTER SEVERAL MINUTES
Breakthrough case admission after 3 vaccines Moderna 1/14/21 Lot# 012L20A;  Moderna 2/11/21 Lot# 010M20A;  Moderna 11/10/21 Lot# 033F21A
He began to sweat, difficulty breathing, heart palpitations. He received medical treatment at his PCP's office (Epipens); got monitored and they did an EKG. The reaction started about 15-20 minutes after injection.
1st dose Pfizer Lot # EN6198  date given 02/27/2021 2nd Dose Pfizer Lot EN6204 date given 03/20/2021 Booster  Pfizer Lot EW0175 date given 08/18/2021 Booster given 14 days early
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 19-year-old male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at that time. It was reported that no adverse reactions were reported by any patients.  No treatment medication was reported.
Fever, NauseaVomiting, PAIN AT INJECTION SITE Narrative:  PT REPORTED fever, nausea, vomiting, pain at injection site POST 2ND COVID VAACCINE. PT TREATED WITH TYLENOL & MOTRIN.  Other Relevant History:
Flu shot was useless; Lungs and head full of congestion; flu; Lungs and head full of congestion; Initial information received on 11-Dec-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-healthcare professional.  This case involves a patient of unknown age and gender who reported that flu shot was useless and had lungs and head full of congestion and flu after receiving vaccine influenza vaccine.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a  dose of suspect influenza vaccine produced by unknown manufacturer (dose, strength, formulation, frequency, lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient reported that flu shot was useless (vaccination failure), had lungs and head full of congestion (pulmonary congestion) (head discomfort) and flu (influenza) (unknown latency) following the administration of influenza vaccine.   Reportedly, Got the flu shot, got the flu 6 weeks later. Didn't help in the least. Lungs and head full of congestion. Flu shot was useless. I have taken it for years, but this one was worthless.   It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.  Seriousness criteria: Medically significant for the event flu shot was useless and pulmonary congestion.; Sender's Comments: Sanofi company comment dated 15-Dec-2022:  This case involves a patient of unknown age and gender who reported that flu shot was useless and had lungs and head full of congestion and flu after receiving vaccine influenza vaccine. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Information has been received from a licensed practical nurse concerning a female patient who on an unspecified date was vaccinated intramuscularly with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced pain, numbness, and a tingly feeling all the way down to her fingertips. The events occurred in the arm in which the patient received the vaccination. Unspecified medical attention was sought. The patient subsequently recovered from the events. Additional information has been sought.
vaccine site was pink, warm, indurated (size of tennis ball); vaccine site was pink, warm, indurated (size of tennis ball); vaccine site was pink, warm, indurated (size of tennis ball); vaccine site rt deltoid began to itch and had red blotches; vaccine site rt deltoid began to itch and had red blotches; Headache; low grade fever; sore throat; This is a spontaneous report from contactable healthcare professional .  A 41-years-old female patient  received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at a right deltoid on 16Dec2020 11:00 at a single dose for COVID-19 immunization, at a hospital.  Medical history included seasonal allergy.  No known allergies to medication, food or other products. The patient's concomitant medications were not reported.  On 19Dec2020 16:00, day 3 post vaccine, the patient experienced headache, low grade fever, and sore throat. On 27Dec2020, day 11, patient experienced vaccine site right (rt) deltoid began to itch and had red blotches. On 28Dec2020, day 12, the patient experienced vaccine site was pink, warm, indurated (size of tennis ball). Treated with paracetamol (TYLENOL), topical/oral diphenhydramine (BENADRYL) and topical 1% hydrocortisone. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any medications within 2 weeks of vaccination. The patient was tested for COVID-19 with via rapid test and PCR with nasal swab, both negative on 22Dec2020. The patient recovered from the events, headache, low grade fever, and sore throat on 24Dec2020, day 8 post vaccine and the rest of the events on 30Dec2020, day 14.   Information about lot/batch number has been requested.
THIS WAS THE FIRST COVID VACCINE AND THEY RECIEVED THE BIVALENT INSTEAD OF THE PRIMARY
Patient came to the Health Dept on 10/06/17 and spoke to RN regarding a mild redness and swelling at the injection site. She was told by the nurse that is a common local reaction to the pneumonia vaccine and to alternate cool and warm compresses. RN states that she called her on that following Monday and the patient reported that she was fine. On 11/2/17, Health Director reports to me that patient came by and complains of a nausea and vomiting, cough, rash to the left leg, unable to lay on left arm and has redness at the site.
arm pain; fatigue; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and fatigue. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the fatigue was recovered/resolved.   It was unknown if the reporter considered the pain in arm and fatigue to be related to Shingrix.     Additional details were provided as follows: The case was reported by the patient's friend. The age at vaccination was unknown. The reporter stated patient experienced arm pain and fatigue after she received Shingrix vaccine.  The reporter provided limited information and did not wish to provide personal information. The reporter did not consent to follow-up. This case was 1 of 4 cases reported by same reporter. For tolerance of 2nd dose refer case US2022026668.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022026665:same reporter US-GLAXOSMITHKLINE-US2022026674:same reporter US-GLAXOSMITHKLINE-US2022026673:same reporter US-GLAXOSMITHKLINE-US2022026668:same reporter US-GLAXOSMITHKLINE-US2022026673:same reporter US-GLAXOSMITHKLINE-US2022026665:same reporter
This is a spontaneous report from a physician received from the Agency. Regulatory Authority report number (E2B) AT-BASGAGES-121801, linked to AT-BASGAGES-121799. A 21-months-old male patient received the first dose of PREVENAR 13 at 0.5 ml, single intramuscular on 15Jun2012, and the ENCEPUR, at 0.25 ml, single intramuscular on 15Jun2012. The patient medical history and the concomitant medications were not reported. The patient experienced scarlatiniform exanthema and exanthema in pharynx and sole of feet (medically significant), with no fever on 15Jun2012. The patient recovered from the event on unknown date. Lab data included Streptococcus identification test of the pharynx with negative result.
Sore arm x12 hours; This is a spontaneous report from a non-contactable other healthcare professional. A 32-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 22Apr2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 22Apr2021, the patient experienced sore arm for 12 hours. The event did not result in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event sore arm was unknown at the time of this report.  No follow-up attempts are possible; no further information is expected.
Patient received Pfizer vaccine for second dose of COVID. They were waiting for the rec 15 min. Near the end of the 15 min, RPH (myself Mrico) was alerted that patient did not feel well.   Patient said she felt her "heart racing" and felt like she was going to faint. Patients blood pressure was slightly elevated with SBP of approx 150. Pulse at the time was 99.Several associates including myself the health ambassador and store management offered to call the ambulance. She was also given water. She refused but did call someone else to come pick her up. She left with them. After the event we called her again and she said at the moment she was "feeling fine" but that it was coming and going.
10/16/2013: body aches, nausea, fatigue, afebrile, back pain. 10/17 - 10/31: weak, poor appetitie, fatigue, able to eat, walk. 11/15: weak, rubber like legs, difficult to stand and walk, aching legs. 11/11 worsening fatigue, weak voice, distal weakness, worse hands/feet. 11/15: pins, needles lower legs bilat. 11/18-11/21: ascending paresthesia to pelvis. 12/10 Begin IV solumedrol for 3 months; dizziness.
Mother reported rash on arms & face and uncontrollable crying about 4 hrs after imms. Taken to ER -- Temp 99.0(R);  given Tylenol 1/2 tsp po at ER. Crying ceased. ER Clinician noted fine pinpoint papules on cheeks, between eyebrows, mildly erythematous...subsided greatly once pt ceased crying.
Infant had routine well child exam on 7/11/06 healthy. 7/12/06 PM 2 episodes of emesis. 7/13/06 fever/acute respiratory distress 911 call asystole when ambulance arrived code ran in field and ER/infant expired.
Red, raised swelling and hard to touch, warm skin. Dr. at a unrelated appt. -> said cellulitis and put her on antibiotics.
Initial case received from a health-care professional on 29 July 2011. A 7-year-old male patient received an intramuscular injection of FLUZONE SV 2010-2011 (lot number U3730AA) on 13 October 2010. On 03 January 2011, 82 days post-vaccination, the patient was diagnosed with leukemia. According to the reporter, the patient was asking the doctor "if the formaldehyde in the flu vaccine could be the cause". The reporter did not know if the patient had received any previous doses. Outcome was not reported.