chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE/No PQC; HCP called to report a TE with VARIVAX.  Improperly stored.; This spontaneous report has been received from a medical assistant and refers to a 13-year-old patient of unknown gender.  The patient's pertinent medical history , other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 22-SEP-2023, the patient was vaccinated with a varicella virus vaccine live (oka/merck) (VARIVAX) injection, at a dose of 0.5 milliliter, that had suffered a temperature excursion (product storage error) (lot number W018825 varicella virus vaccine live (oka/merck) (VARIVAX), with an expiration date established as 14-JUN-2024), administered for prophylaxis (strength, and anatomical site of administration were not provided). No adverse events were reported for this patient.  This is one of several reports from the same reporter.
Suspected vaccination failure; I had a shot but still got them; Painful burning itch/burning itching; Painful burning itch/Pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 86-year-old 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 vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I had a shot but still got them), itch burning (Verbatim: Painful burning itch/burning itching) and pain (Verbatim: Painful burning itch/Pain). The outcome of the vaccination failure, shingles, itch burning and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, itch burning and pain to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles, itch burning and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 07-MAR-2023 This case was reported by a patient via interactive digital media. The patient had the shingles shot and still got the shingles, a painful burning itch. The patient too just had weeks of burning itching pain. The reporter thought that he/she had the shot and now not sure. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
No adverse event; Received expired bivalent booster beyond 12 hours after first puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired bivalent booster beyond 12 hours after first puncture) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 011H22A) for COVID-19 vaccination.     No Medical History information was reported.    In 2022, 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. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired bivalent booster beyond 12 hours after first puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired bivalent booster beyond 12 hours after first puncture) 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 (Received expired bivalent booster beyond 12 hours after first puncture).    Concomitant medication was not provided.  It was reported that the vial was initially stored in refrigerator on 03-Nov-2022 at about 3:30PM and doses administered to patients on 04-Nov-2022 at unknown time and 05-Nov-2022 at 3PM. The pharmacist reported that it was unsure, there were doses given from the same lot number on 03-Nov-2022, but was not sure if it was from the same vial.  The vial did not undergo any temperature excursions.  The vial was not exposed to room temperature. It was stored in the refrigerator after puncture. It was exposed to refrigerator temperature for about 24 hours, if the first puncture was 04-Nov-2022.  Treatment information was not provided.  The case contains information of patient 1 out of 2 patients.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Apr2021 as dose 1, single (Lot number: EN5318), in left arm, on 12May2021 as dose 2, single (Lot number: ER8735), in left arm and on 12Dec2021 as dose 3 (booster), single (Lot number: FJ8762) at the age of 65 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: NATURE'S BOUNTY, start date: 10Jun2022, stop date: 12Jun2022; PHARMACA, start date: 10Jun2022, stop date: 25Jun2022; INSIGHT PHARMACEUTICALS, start date: 10Jun2022, stop date: 25Jun2022.  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: Unknown. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Medication did not eliminate the virus but probable lessening of symptoms. After 5 days, on June 11th I felt bad so returned to urgent care where they took my pulse & O2 levels - 95 & 95. Was sent home to rest. Home tested 12Jun, strong line indicating covid. Began immune enhancing treatments in full (had taken less during the Paxlovid). Now, after Paxlovid, I am worse with the body & throat pain, brain-fog confusion, apathy, tiredness, and congested upper respiratory tract returning as before and worsening. One night, 24Jun, had breathing difficulties but was ok in the morning so did not go to urgent care. However, NOTE I was a scuba diving instructor for a long time and my regular breathing remains more deep and full than the average person (good for me in this case I am sure). I have not had fever. Am airing my small sailboathome completely, weather permitting, using HEPA air filter now at night and day in bad weather. NOTE-all dates entered populate 1 day early this form.
pt started crying & coughing p/last immun was administered; appeared to want to vomit; was perspiring; was taken to MD; MD told parent it was possible it was esophageal spasm;  Pt was doing find when lt MD office;
Redness/rash on both arms and torso. Patient prescribed Prednisone taper.
Pt received TD vaccination 18 April 09.  C/O increased pain over right deltoid muscle on 19 April. Pt states that pain has been stable for the past week.  Denies any C/O radiation of pain, Paresthesia of right arm.  States that pain disturbes sleep but does not interfere with work.  Denies presence of any lump or bump over injection site.
This spontaneous report as received from a nurse via a company representative refers to a 15 year old patient of unknown gender. On 30-AUG-2014 the 15 year old patient was vaccinated with a dose of PROQUAD (dose, route, lot# and expiration date were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. Additional information has been requested.
hives; itching around hairline, hair, some places on his body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) and PRURITUS (itching around hairline, hair, some places on his body) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Ischemic heart disease, Atrial fibrillation, General physical health deterioration (He has health issues) and Shellfish allergy.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives) and PRURITUS (itching around hairline, hair, some places on his body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 04-Feb-2021 for Hives and Itching, at a dose of 25 milligram. On 04-Feb-2021, URTICARIA (hives) and PRURITUS (itching around hairline, hair, some places on his body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Patient reported he is a Vietnam veteran and was exposed to agent orange.
09/20/2021 The patient presents with abnormal labs. Pt was having blood work done due to recent dx of CHF at home. The labs came back and pt's potassium was 5.6 and his creatinine was 2.2. Pt has been nauseous at home causing him to eat or drink less. Pt denies acute vomiting or changes in diarrhea.  Risk factors consist of coronary artery disease, hypertension and CHF.  Associated symptoms: nausea, denies chest pain, denies abdominal pain, denies shortness of breath, denies fever and denies chills.
My symptoms included severe body aches, arm pain, low-grade fever, and intermittent chills. They symptoms lasted about 36 hours but were most severe for the first 24 hours. This was the worst reaction I had to any of the COVID-19 vaccines. I called my doctor. She told me to drink lots of fluids and to take TYLENOL. My doctor said my reaction was a positive immune response to the vaccine.
Swollen limbs, swollen tongue, swollen throat leading to paralysis and inability to speak or swallow. Brain inflammation leading to vegetation. All leading to DEATH!
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was inadvertently administered with a dose of PEDVAXHIB (lot # L051124, expiry date: 14-OCT-2018) (route: intramuscular) that had been improperly stored on an unknown date. The vaccine was stored at a temperature of 9.8C, for 15 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. The outcome of the events was unknown. Additional information is not expected as reporter did not give consent to contact.
This spontaneous report was received from a nurse via a company representative concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of VARIVAX (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On an unknown date, after the vaccination, the patient developed a case of chickenpox. It was unspecified if the patient sought any medical attention. It was unspecified if any treatment was provided or if any lab test were performed. The outcome of the event was unknown. The relatedness for the event was unknown for VARIVAX. Additional information is not expected.
Myalgia, Arthralgia, site injection, pain Narrative:  Other Relevant History:
right after receiving 2nd shot of Pfizer covid vaccine pt was felling weak, nauseated. she could not stand up by her self. she was breathing and talking ok.
Bradycardia. Heart rate went down to the 50s. Normally I?m in the 80-90s.  Also, O2 sat went down to 93-94%.
How long does the symptoms last; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (How long does the symptoms last) in a patient of an unknown age and gender 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) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (How long does the symptoms last). At the time of the report, VACCINATION COMPLICATION (How long does the symptoms last) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned. No treatment details were reported.
Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 6 month old male patient who experienced an area of atrophy at the right thigh injection site and discoloration at injection site. At 6 months of age, the patient received the third dose on 1/17/2005. The patient also received the third dose of Act Hib haemophilus B conjugate vaccine tetanus and the third dose of Daptacel diphtheria and tetanus toxoids and acellular pertussis absorbed and Flovent (fluticasone Propionate). The patient experienced discoloration (injection site discoloration) and an area of atrophy at the right thigh injection site in Jan 2005. The patients parents reported that they initially noticed an area of discoloration a few days post injection and then a depression formed in this area (injection site atrophy). The area appeared as if everything under his skin dissolved and he had a dent under his skin. There was no lasting discomfort in this area. The site of administration for both the Prevnar and the Act Hib was the right thigh. Outcome was unknown. No additional information was available at the time of this report.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications and treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2021: Internal review on 20 Jul 2021 resulted in the update of event verbatim and outcome, pregnancy details (birth type and fetal outcome).
Tic left side of face (twitch); This spontaneous report was received from healthcare professionals via FDA referring to a 11 years old male patient. The patient had no other illnesses at the time of vaccination and no pre-existing diagnosis. Information about the concomitant therapy was not provided.  On 18-JUL-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# 1602281 expiration date not reported, but upon internal validation established as 21-JUL-2021; strength, route and dose detail were not provided) in the right arm for prophylaxis. On the same day, the patient also received diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid vaccine (lot# 2774D, dose 1; strength, route and dose detail were not provided) and meningococcal conj vaccine (unspecified) (MCV4) (lot# AMVA113A dose 1; strength, route and dose detail were not provided) both in the left arm for prophylaxis. On 19-JUL-2019, the patient experienced tic left side of face (twitching). No relevant diagnosis tests or lab data was performed. For the last four days, the event had been improved. The outcome of the event was considered as recovering (also reported that it was unknown if the patient was recovered).   The causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.   Follow up information has been received from a health professional via telephone call on 30-JUL-2020. The reporter wished to identify origin of this report. It was explained that the report was generated from VAERS report and would be requested additional information if possible. The date of administration, gender and age of patient were provided. The reporter stated that she would fax this form back upon completion. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1602281; expirationdate: 21-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
After vaccine, band aid applied about 2:00 afternoon + I went home when band aid taken off about 9:00 pm upper arm swollen + Black + Blue over area where vaccine applied was about 2 inches in with; a puncture wound also observed.  It is now Oct 23-08 and Black + Blue turning color; its still widely exists.
Pt devel inc temp 104 R same day DTP received; Fever inc by next day 26JAN90; no other sx; fully recovered;
Initial report received on 01/09/2006 from a health care corporation. A cluster of four patients had received an injection of Adacel, lot number not reported, on an unspecified date. Routes and sties of administration were not reported. Per the reporter, "a hospital he deals with" had four patient who had experienced numbness in their hands, redness and soreness at the site and difficulty raising their arms post vaccination. Recovery status was not reported. Additional medically relevant information was not provided.
Information has been received from a 24 year old female pharmacy technician with no allergies who on 25-JAN-2008 was vaccinated with the first dose of GARDASIL 0.5 ml (lot no. not reported) and on 26-MAR-2008, with second dose of GARDASIL 0.5 ml, (lot no. not reported). Concomitant therapy included hydrochlorothiazide (manufacturer unknown). On an unspecified date, the patient was diagnosed with multiple sclerosis and was hospitalized from 01-AUG-2008 to 20-AUG-2008. A magnetic resonance imaging (MRI) and a computed axial tomography were performed (results not reported). Additional information has been requested.
red itch welt on injection arm; red itch welt on injection arm; red itch welt on injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (red itch welt on injection arm), VACCINATION SITE URTICARIA (red itch welt on injection arm) and VACCINATION SITE ERYTHEMA (red itch welt on injection arm) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (red itch welt on injection arm), VACCINATION SITE URTICARIA (red itch welt on injection arm) and VACCINATION SITE ERYTHEMA (red itch welt on injection arm). At the time of the report, VACCINATION SITE PRURITUS (red itch welt on injection arm), VACCINATION SITE URTICARIA (red itch welt on injection arm) and VACCINATION SITE ERYTHEMA (red itch welt on injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided Treatment information was not provided.
Swelling of hands and feet, colic/fussy, intussusception. No tx, sent straight to ER.
Coldness, my body couldn't warm up, no appetite, nausea, fever (103.6 degrees f) body ache, exhaustion.  The coldness started early Thursday morning, but became unbearable by about 2:00pm. Nausea started then and fever.  I went home and to bed.  Temperature continued to increase to 103.6 by 8:00pm.  I took one Tylenol and a small amount of water  and went back to  bed, by 9:00pm temperature was back to 98.9 degrees f.  I took one additional Tylenol, and felt much better in the morning Friday 6/18.
Redness in left deltoid area measuring 60 mm x 63mm. Site warm to touch with pain at site.
Mom states pt awoke w/fever of 102 @ 3AM on 18MAR92; next morning mom noticed pt lt arm was "bright red" like it had been slapped hard; from shoulder to elbow & pt was guarding movement; pt was very lethargic & sleepy;
After receiving the Flu vaccine, the pain was so bad while trying to move her arm.  The pain did not go away. The pain has continued but it won't go away. Has been stretching her arm but it's not helping. It's been 2 weeks and 2 days but still has the pain.
Runny nose; Congestion; Sneezing; A spontaneous report was received from a consumer who is a female patient of unknown age that received Moderna's COVID-19 vaccine (mRNA-1273) and developed a runny nose, nasal congestion, and sneezing.   The patient's medical history and relevant concomitant medications were not reported.   On an unspecified day, in Dec 2020, approximately one week prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) unknown route and unknown arm for prophylaxis of COVID-19 infection.   The patient began experiencing a runny nose, nasal congestion, and sneezing on an unspecified date.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events a runny nose, nasal congestion, and sneezing was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Patient got light headed, laid down on ground, got nauseous. Patient left in ambulance, but was fully conscious and fine.
Fainting gurgling from throat and twitching and shaking like a seizure.  Happened shortly after completing immunizations.  Dr. called into exam room immediately.
experienced very sore arm and shoulder; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (experienced very sore arm and shoulder) in a 76-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (experienced very sore arm and shoulder). At the time of the report, MYALGIA (experienced very sore arm and shoulder) outcome was unknown. Not Provided          Treatment medication was not provided.  Concomitant medication was not provided.   This case was linked to MOD-2021-029887 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Non-significant information.