chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immune Thrombocytopenia diagnosed by hospital; Autoimmune hemolytic anemia diagnosed by hospital; Small specks on face and chest and body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Immune Thrombocytopenia diagnosed by hospital) and AUTOIMMUNE HAEMOLYTIC ANAEMIA (Autoimmune hemolytic anemia diagnosed by hospital) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A22A and 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced RASH (Small specks on face and chest and body). On 12-Mar-2021, the patient experienced IMMUNE THROMBOCYTOPENIA (Immune Thrombocytopenia diagnosed by hospital) (seriousness criteria hospitalization and medically significant) and AUTOIMMUNE HAEMOLYTIC ANAEMIA (Autoimmune hemolytic anemia diagnosed by hospital) (seriousness criterion hospitalization). The patient was hospitalized for 13 days due to AUTOIMMUNE HAEMOLYTIC ANAEMIA and IMMUNE THROMBOCYTOPENIA. At the time of the report, IMMUNE THROMBOCYTOPENIA (Immune Thrombocytopenia diagnosed by hospital), AUTOIMMUNE HAEMOLYTIC ANAEMIA (Autoimmune hemolytic anemia diagnosed by hospital) and RASH (Small specks on face and chest and body) outcome was unknown.            Concomitant product use was not provided by the reporter.  Wife on behalf of husband reported serious adverse effects after getting both the shots. After the 1st shot he developed little specks on face and chest. After his second shot on 12 Mar 2021, lot no 031A22A a day after the shot specks appeared again but this time they multiplied in thousands. He was hospitalized because of this for 13 days and doctors diagnosed him with ITP Immune thrombocytopenia. He has a complete platelet drop and his platelets numbers dropped to 1000. He had multiple platelet infusions and developed Autoimmune hemolytic anemia all because of this shot. He had no underline condition and was not taking any medication at the time of shot.  Treatment medications was not provided. Company comment:Very limited information regarding this events has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-107929 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
I had pain in my mid sternum with shortness of breath and I went to the ER of the afternoon of 8/17/22 and diagnosed me with blood clots and they prescribed me aspirin and ELIQUIS and now I have to see a Hematologist for this blood clot disorder. They did multiple tests at the hospital and found my D-Dimer to be elevated, unknown results on the urine. CT scan located the blood clots in my lungs they were in both my lungs. My Echocardiogram was normal. I will have to take blood thinners for at least 3 months and maybe for the rest of my life.
Experienced a red arm; Experienced fever; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 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 erythema of extremities and fever. On an unknown date, the outcome of the erythema of extremities and fever were unknown.   It was unknown if the reporter considered the erythema of extremities and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had red arm and fever after vaccination with 1st dose of Shingrix. The reporter described fever as light. No additional information provided. No lot number, expiration date, patient date of birth, or full health care professional contact details provided.
Severe muscle weakness, chills, burning eyes, dark orange urine, kidney pain, migraine headache, nausea,  chest heaviness but not short of breathe. 27 hours in bed except to go to the bathroom, weakness so severe it hurt my whole body to turn on my side.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 22Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 18Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 20May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Vicodin, reaction(s): "Known allergies: Vicodin", notes: Known allergies: Vicodin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: After testing positive for covid and using Paxlovid; Negative, notes: I felt 100% better and tested negative; Positive, notes: Two days later I had rebound covid symptoms and tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: After testing positive for COVID and using Paxlovid, I felt 100% better and tested negative. Two days later I had rebound COVID symptoms and tested positive. Symptoms were exactly the same as when I first had symptoms ten days before, including: sneezing, sore throat, congestion, cough, phlegm, trouble drawing a full breath in, chest pain/pressure, headache, dizziness. Treatment start date: 25Jun2022 and treatment stop date: 30Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a physician refers to a 13 year old patient. On 30-MAY-2008 the patient was vaccinated with VARIVAX lot # 1861U dose 2, subcutaneous in the right arm for prophylaxis. Other suspect therapies included M-M-R II, diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and poliovirus vaccine inactivated (unspecified). On 19-JUN-2017, 9 years 21 days after onset of therapy the patient experienced herpes zoster. The outcome of herpes zoster was reported as recovered/resolved. Lot number 1861U has been verified to be a valid lot number for VARIVAX. "Lot number 0238X has been verified to be a valid lot number for M-M-R II. Additional information has been requested.
Pharmacist gave vaccine to 9 patients which looks like the lots were expired; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist gave vaccine to 9 patients which looks like the lots were expired) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist gave vaccine to 9 patients which looks like the lots were expired) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist gave vaccine to 9 patients which looks like the lots were expired) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Pharmacist gave vaccine to 9 patients which looks like the lots were expired).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were provided.  There were no specific dates when administration occurred, but they had the lot number, and it was before 13 Jul 2023 and Lot numbers were AS7165B, 020H22A, 021H22A, 017H22A. The patients were fine.   Dosage text for suspect product was reported as unknown.  No treatment medication was provided.  This case contains information for the patient 1 out of 9 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-734396, US-MODERNATX, INC.-MOD-2023-734397, US-MODERNATX, INC.-MOD-2023-734405, US-MODERNATX, INC.-MOD-2023-734410, US-MODERNATX, INC.-MOD-2023-734413, US-MODERNATX, INC.-MOD-2023-734416, US-MODERNATX, INC.-MOD-2023-734425 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734416:Patient 8 US-MODERNATX, INC.-MOD-2023-734410:Patient  5 US-MODERNATX, INC.-MOD-2023-734405:Patient 4 US-MODERNATX, INC.-MOD-2023-734413:Patient 7 US-MODERNATX, INC.-MOD-2023-734425:Patient 9 US-MODERNATX, INC.-MOD-2023-734397:Patient 3 US-MODERNATX, INC.-MOD-2023-734396:Patient 2
This spontaneous case, initially received on 09-Nov-2016, was reported by a health professional and concern a(n) 65-year-old female patient. Weight: not provided; Height: not provided. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): The patient received AFLURIA from 08-NOV-2016 to 08-NOV-2016. Dose regimen: 0.5 ml single dose, Route of administration: Intramuscular. Batch number: WT53306. No additional suspect drugs. Adverse reactions/events and outcomes: On 08-Nov-2016, the patient received partial dose of AFLURIA -No adverse effect (outcome: Not Reported). Special circumstances: Underdose. Follow-up information received 06-Jan-2017: The product (AFLURIA) had been stored correctly and the indication for use was as per the Product Information Leaflet. On 08-Nov-2016, the syringe leaked (outcome: not reported, special circumstance: poor quality drug administered) and could not be certain that the patient got very much of the vaccine. A second dose was given that following day (outcome: not reported). The patient said that she appreciated the second dose to make sure she got enough dose to be protected. The events 'partial dose of AFLURIA was administered to a female patient' and 'second dose AFLURIA was given the following day' combined to 'partial dose of AFLURIA was administered to a female patient / second dose AFLURIA was given the following day - no adverse effect' (outcome: not reported, start date: Nov-2016, special circumstances: underdose without adverse event, extra dose administered).
Patient c/o severe pain in right arm/shoulder 7-8 out 1-10 scale even now a month later. Swollen lymph node in neck, palpable to her and MD, metallic taste in mouth and tingling in mouth.
Initial information received on 23-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked with 2018SA296383, 2018SA297469, 2018SA297473, 2018SA297471 and 2018SA297470 (same reporter). This case involves a 5 years old patient who received 0.25 ml of vaccine FLUZONE QUADRIVALENT (lot UT6259JA and expiration date 30-Jun-2019) via unknown route in unknown site of administration (left side) on an unspecified date. It was a case of actual medication error due to Vaccine underdose. It was reported that six children received FLUZONE QUAD 0.25 mL instead of the 0.5 mL. It was not reported if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
sore arm; hurt a lot during injection/really, really hurt during injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and VACCINATION SITE PAIN (hurt a lot during injection/really, really hurt during injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and VACCINATION SITE PAIN (hurt a lot during injection/really, really hurt during injection). On 08-Apr-2021, VACCINATION SITE PAIN (hurt a lot during injection/really, really hurt during injection) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was unknown Treatment information was unknown   Reporter did not allow further contact
Redness, swelling, bruising, lasting more than 5 days. Saw physician, no treatment given. (At injection site).
sore throat, chest congestion, cough, runny nose, chills, body aches, headache, nasal congestion, sinus congestion, post nasal drainage, wheezing, starting on 8/6/2021
Mom noticed a small red spot on child's right arm, not itchy.  The spot spread to about tennis ball size.  By 10/29/2009, the redness was subsiding.
On the 30th of September after getting my vaccine, I started feeling dizzy and getting a severe headache and felt like my heart was coming out of chest. I went home and almost passed out. My BP was 212/138, my pulse was 156. On the ambulance, my BP 204/187. They gave me aspirin to chew and an IV. I got to the hospital and gave me test, pain medication for my headache and an IV. I was discharged from the ER 5-6 hours later that night. I am still getting really tired.
hospitalized for weakness secondary to COVID-19 infection and acute hypoxemic respiratory failure. Patient was known to be a high risk for aspiration. Symptomatic treatment for COVID was provided throughout admission.  Video swallow study with recommendations for extremely thick liquids and minced/moist solids. Diet was liberalized per patient preference after discussing risks of aspiration. Oxygen needs increased from 5 L to 15 L after that. Care team met with patient 11/22/2022 and discussed goals of care. Patient and spouse understood the risks of aspiration with an unrestricted diet. Initial goal was to improve patient's swallowing and eventually go to rehab. Patient's respiratory status continued to decline on his unrestricted diet. On 11/25 patient verbalized his desire to stop active care. Situation reviewed with wife and patient ultimately elected for comfort care. He was admitted to hospice 11/25. Died 11/30/2022 - immediate cause: aspiration pneumonia, due to consequence of COVID-19.  Submitter does not have access to further medical records. If more information is needed, please contact Hospital
pt recvd vax 29SEP95 & 20OCT95 pt devel a varicella-like rash which was described as pimples w/blisters that itched;there was a total of approx 5 to 10 lesions;19 days later the pt's father devel a full-blown case of the chickenpox;
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment given. The vaccines was stored in freezer and took out one to two vials and place in fridge each day as needed.
No data obtained. Parents are awaiting final autopsy report and the death certificate. These will not be produced until a final toxicology report is obtained. All of this is per the coroner. Autopsy states cause of death as undetermined. Death certificate states cause of death due to cerebral laceration w/open skull fracture due to an automobile accident.
pt recvd vax 23JUN95 & 7JUL95 devel a rash of 5 "general lesions";MD stated had several scattered vesicles mostly on lower extremities that later became scabbed;pt recovered;
Warm at the site of injection; Itchy at the site of injection; Red at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm at the site of injection), VACCINATION SITE PRURITUS (Itchy at the site of injection) and VACCINATION SITE ERYTHEMA (Red at the site of injection) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warm at the site of injection), VACCINATION SITE PRURITUS (Itchy at the site of injection) and VACCINATION SITE ERYTHEMA (Red at the site of injection). At the time of the report, VACCINATION SITE WARMTH (Warm at the site of injection), VACCINATION SITE PRURITUS (Itchy at the site of injection) and VACCINATION SITE ERYTHEMA (Red at the site of injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
her kidney function usually has been in a 55-57 range; GFR went down to 44; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  On 16Apr2021, she went to get blood work done and her GFR went down to 44. She stated that her kidney function usually has been in a 55-57 range. The patient wanted to consult if this is a known side effect. The patient would like to consult if she should get the second dose of the COVID-19 vaccine after presenting side effects from the first. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
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 72-year-old male patient received bnt162b2 (BNT162B2), on 23Jan2021 as dose 1, single (Lot number: EL8982), on 14Feb2021 as dose 2, single (Lot number: EN5318), on 08Sep2021 as dose 3 (booster), single (Lot number: FC3184) and on 04Apr2022 as dose 4 (booster), single (Lot number: Fm0698) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetetes" (unspecified if ongoing); "gout" (unspecified if ongoing); "cardiac stent" (not ongoing). Concomitant medication(s) included: LISINOPRIL LUPIN, start date: Jan2023; METFORMINE ZYDUS, start date: 01Jan2023; METOPROLOL SUCCINATE, start date: 01Jan2023. Past drug history included: Vancomycin, reaction(s): "Known allergies: Vancomycin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Oct2023) Positive, notes: Tested positive on 03Oct2023. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 03Oct2023 to 09Oct2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300329593 same patient, different drug and different event;
Pt recv vax on 10/21/98; 1/2 hr later pt exp headache & dizziness, weak &tingling legs, popping sound in head
none; Patient received a 0.5 ml Fluzone instead of the recommended 0.25 Fluzone. no adverse event
fingers began itching the noc of 12OCT92; morning of 13OCT92 pt had swollen fingers, t102, coryza, & itching rash on hands, forearms, trunk, & sore throat;
Patient mentioned she was feeling very tired following the vaccinations. She also noted that a local reaction started on the same day she received the two vaccines. She reported that it started forming a knot, feeling warm to the touch and increasing in size.  She came to the clinic today to get evaluated due to her symptoms. She states she has only taken Tramadol for pain with slight improvement. She mentioned she also  iced the area which makes it feel better. She states her arm looks better today than it did the past few days. Denies systemic symptoms.
This spontaneous report as received from a consumer refers to a female patient of unknown age with allergic reaction to sulphur and asthma. Patient historical drug includes sulphur. On 05-FEB-2015 the patient was vaccinated with ZOSTAVAX (strength, dose and frequency not reported). Other co-suspects and concomitant medication was not reported. On an unknown date the patient experienced chest pain, swollen neck glands and flu-like symptoms after receiving ZOSTAVAX. The outcome of the events was reported as not recovered. Causality assessment was not provided by the reporter. Additional information has been requested.
pt describes pain @ the site 12hr p/vax;states was swollen from shoulder to elbow, hot & hard to touch;affected lt extremity;pt states applied ben gay to arm to aid in sleep;arm remained painful-36hr now resolved;
Fever, cold chills, nausea, excessive unquenchable thirst, projectile vomiting.
Insomnia, Eye twitching, Headaches, Fever, Chills, Cant concentrate, Vision blurred, Back of neck is tight. All of this has been going on since day 1 and has not gotten any better.  Today is day 8 and everything is still the same.  Nothing has changed.