chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses were administered from syringes and left at room temperature for 24 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered from syringes and left at room temperature for 24 hours) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered from syringes and left at room temperature for 24 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered from syringes and left at room temperature for 24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Health care professional  states patients had received doses of  vaccine and  did not had information for the patients at that time, number of doses/vials: around 100 doses were administered /from 14 dose vials, not sure how many vials were affected.the vial was initially stored in the refrigerator: HCP did not have the exact information but stated vials were stored frozen and move to the refrigerator conditions daily.   The doses were draw up from the vial all at once (emptying the vial) and the syringes were left at room temperature and used for up to 24 hours. The vial doesn't undergo any temperature excursions . Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F). Syringes were exposed to room temperature for up to 24hours Concomitant medication use was unknown  Treatment information was unknown.
heart palpitations; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (heart palpitations). At the time of the report, PALPITATIONS (heart palpitations) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. Treatment medication was not provided.
Pt felt dizzy after vaccine. Vitals were 130/78, HR 95, spO2 97%. Pt felt better, nurse walked patient to vehicle where spouse would drive them home.
This case was reported in a literature article and described the occurrence of clinically isolated syndrome in a unk subject who received Hepatitis B vaccine. On an unknown date, 180 days after receiving Hepatitis B vaccine, the subject developed clinically isolated syndrome. Serious criteria included GSK medically significant. The outcome of clinically isolated syndrome was unknown. It was unknown if the investigator considered the clinically isolated syndrome to be related to Hepatitis B vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of a clinically isolated syndrome in a subject of unknown age and gender who had been vaccinated with an unspecified hepatitis B vaccine (manufacturer unknown). No information on the subject's medical history, concurrent medical conditions or concomitant medication was provided. On an unspecified date, from 1999 onwards, the subject received a dose of either ENGERIX B (GlaxoSmithKline; dosage, administration route and site unknown; batch number not provided) or RECOMBIVAX HB (Merck Sharp and Dohme Corp; dosage, administration route and site unknown; batch number not provided). On an unknown date after 1 January 2000, 180 days after receiving the vaccine, the subject developed a clinically isolated syndrome. Treatment was unknown. The outcome of the events was unspecified at the time of reporting. The authors did not comment on any causal relationship between the vaccine and the events. The authors concluded that "Findings from the present study show no long-term association of vaccines with an increased risk of multiple sclerosis and other central nervous system demyelinising diseases. In younger subjects, they observed a short-term increase in risk after vaccination of any type, which suggested that vaccines (like infections) could accelerate the transition from subclinical to overt autoimmunity in subjects with existing disease. The authors found no association between hepatitis B vaccination and an increased risk of multiple sclerosis or other central nervous system demyelinising diseases up to 3 years after vaccination. The results for human papillomavirus vaccine were inconclusive given the small number of cases and the paucity of previous studies on the topic. The findings reconciled the anecdotal clinical reports of a central nervous system demyelinising diseases onset shortly after vaccination with the larger body of epidemiologic literature showing no long-term increased risk of multiple sclerosis or other forms of central nervous system demyelinising diseases following vaccination. The findings do not warrant any change in vaccine policy". This case is 1 of the 9 valid cases reported in the same literature article (see case US2014GSK053625).
Vaccine administered on 11 Jul 03.  Pt developed signs and symptoms of pericarditis and was admitted to hospital on 23 Jul.
Information has been received from a registered nurse regarding a 13 year old patient of unknown gender. The patient´s medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On 02-OCT-2017, the patient was vaccinated with one improperly stored dose of VARIVAX subcutaneously (strength, anatomical location, dose number, lot number and expiration date were not provided) for prophylaxis. The VARIVAX was stored at a temperature range of 15 degrees Fahrenheit (°F) to 46 °F for the time frame of 5 hours. There was no previous temperature excursion and the call was not because of a data logger. No adverse effects reported. This is one of nine reports received from the same reporter. Sender's Comments: US-009507513-1710USA013246: US-009507513-1710USA013247: US-009507513-1710USA013248: US-009507513-1710USA013250: US-009507513-1710USA013251: US-009507513-1710USA013252: US-009507513-1710USA013253: US-009507513-1710USA001718.
8/1/11 red, raised rash, blisters in center. Facility states, never had chicken pox but did receive the ZOSTAVAX approx 2 wks ago. Rx ordered - VALTREX 1 gm PO q 8 hours x 10 d, BACTRIM  25 PO BID x 10 d - Cxs  done 8/2 varicella zoster antibody IGG & IGM, culture for varicella zoster. T 103.
This spontaneous report was received from another health professional regarding 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 vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # K021935 expiry date 10-NOV-2016) (dose and route unknown). No adverse events were reported. Follow up information has been received from the reporting C.M. A. during a phone call on 04-NOV-2015. The medical assistant reported that she would have to research the request made for the patient identifiers, lot numbers, expiration dates and dates of vaccination. This is one of the reports received from the same reporter. Follow up information has been received from the C.M. A via other source of 24-NOV-2015 concerning a patient of unknown age and gender. The reporter stated that the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) on 29-MAY-2015. This was one of several reports received from the same reporter. Additional information has been requested. Reporter information, patient demographics, therapy start date, event onset date and narrative were updated.
back that hurt; was sick for almost 5 days; threw up; body hurt; Fever; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: Unknown and expiration date: Unknown) via an unspecified route of administration in left arm on 06Feb2021 at single dose for COVID-19 immunization. Medical history included, she has to get iron infusions for years and years because her blood counts drop and her iron drops. She got the vaccine because her husband had COVID and was in the hospital for 16 days. On 27Nov2020, she lost her taste and smell, couldn't eat anything, and got diarrhea for 3 weeks. Patient was diagnosed with COVID in Nov2020. Concomitant medication included iron infusion for iron levels and blood levels drop. On 06Feb2021, patient experienced fever and diarrhea. She was sick over 5 days and scared to get the 2nd one. People have told her the second one is way worse than the first. She is wondering if the symptoms will be worse after the 2nd dose. On 07Feb2021, patient experienced body hurt. Caller stated, "They said my arm would hurt a lot, the first day it hurt but after that is was ok. It's my back that hurt. I was very sick for a week that my husband was like going crazy, because I was white as a ghost and had a garbage pail next to my bed. On 08Feb2021, patient threw up. On an unspecified date, patient was sick for almost 5 days and had back that hurt. Each time she fell asleep, she woke up and her hair and body were soaking wet. Patient stated that "It is because I didn't wait 90 days". They wouldn't give my husband because he was in the hospital with covid19. How could they give it to me? I don't understand it. My husband got covid and my daughter got covid. I was sick as a dog. I couldn't get tested because I couldn't go get tested, but when I went to get the vaccine, and when I told them they asked if I had a positive test and since I couldn't get tested I told them no. Maybe that's why I got so bad of a reaction? My husband is scheduled to get his first dose on 28Feb2021 can he get the second dose earlier? We are going to be traveling. My daughter is having a baby. He is supposed to get his second dose on 21Mar2021 but we are supposed to be there before that day." She has other Medical things going on, but the only one she knows to report is that she has to get iron infusions. She had on the day before the vaccine. She doesn't know if that made a difference or not. She has been getting the infusions for years and years because her blood counts drop and her iron drops. On 08Feb2021, event fever and diarrhea was recovered, on 12Feb2021, threw up was resolved, on 14Feb2021, body hurt was resolved. Outcome of sick for almost 5 days and back that hurt was resolved on unspecified date.    Follow-up (11May2021): Follow-up attempts completed. No further information expected.
This is a spontaneous report from a contactable physician communicated to a sales representative. A patient (age and gender unknown) received a dose of PREVNAR13 and a dose of FLUVIRIN, both on an unspecified date. Relevant medical history, concomitant medications and past product history were not reported. On an unknown date, following administration of the vaccinations, the patient developed a fever. Subsequently, on an unknown date, the  fever resolved.
This spontaneous report was received from a pharmacist via company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX23 injections 25/0.5 Y. On an unknown date the patient's biceps swelled a lot within one day of receiving PNEUMOVAX23 and the patient's pain was so great that she could not lift her arm. The patient sought medical attention (contacted the pharmacist). The outcome of the event was unknown. Reporter's causality was not provided. Additional information has been requested.
I developed neuropathy in 3 of the fingers on my left hand.; Specifically the finger pads of my thumb, pointer, and middle fingers were particularly sore and the pain got worse when touching objects or warm/cold temperatures.; This is a spontaneous report from a contactable consumer (patient). A 33-year-old non-pregnant female patient received booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FH8020, Expiration date not reported), via an unspecified route of administration, administered in left arm on 17Oct2021 14:15 (at the age of 33 years) as dose 3 (booster), single for COVID-19 immunization; and influenza vaccine (FLU) (yearly flu shot, lot number and expiration date not reported), via an unspecified route of administration on 17Oct2021, at unspecified dose for an unspecified indication. Medical history included allergy to environmental allergens, penicillin, amoxicillin, ceclor, biaxin, and codeine, all from an unknown date and unknown if ongoing. Concomitant medications received within 2 weeks of vaccination included fexofenadine hydrochloride (ALLEGRA); diphenhydramine hydrochloride (BENADRYL); and fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), all taken for allergy, start and stop date were not reported. The patient previously took first dose of bnt162b2 (Lot Number: EN5318, Expiration date not reported) on 27Jan2021 10:00 as dose 1, singe, and second dose of bnt162b2 (Lot Number: EN5318, Expiration date not reported) on 17Feb2021 10:00, both via an unspecified route of administration for COVID-19 immunization. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Oct2021 08:00, patient developed neuropathy in 3 of the fingers on left hand for 6 hours. Specifically, the finger pads of her thumb, pointer, and middle fingers were particularly sore and the pain got worse when touching objects or warm/cold temperatures. By late afternoon, the neuropathy seemed to resolve itself. It only occurred in the fingers on my left arm (same arm in which I got in the injection). Patient did not receive any treatment for events. The event neuropathy in 3 of the fingers on my left hand was recovered on 18Oct2021 and outcome of event finger pads of my thumb, pointer, and middle fingers were particularly sore and the pain got worse when touching objects or warm/cold temperatures was not recovered.  No follow-up attempts are possible. No further information is expected.
Pt's throat swelled after flu shot. Had sticky exudate & redness in eyes. Took BENADRYL was OK. Went to MD next AM, got Rx for Prednisone taper.
pt recv 3 doses of vax on1MAY94-NOV94 & following 3rd dose devel elevated liver enzymes;elevations were a couple points above normal for SGPT,LDH,GTP
Customer had flu and pneumonia shot on 10/24/12. Developed localized redness - cellulitis on left upper arm. Patient was advised by Dr to ice down, take pain reliever. Patient went to MD treated her cellulitis with antibiotics. Patient wants pharmacy to pay her 2 office visits copay.
Pt experienced leg pain starting the night that she received both vaccines described as severe muscle aching. 2 days after she received the vaccines her legs started to feel extremely weak, described as if she felt they were going to give out. She also experienced tingling.  These symptoms progressed to her arms on day 3.  On day 7, the weakness got progressively worse as the day went on and there was a burning sensation in her feet and ankles which improved with elevation.  By day 16, symptoms started to improve (pt also received a round of apheresis). Tingling still present.
Tdap given on 4-17-15 (L) deltoid. C/O pain, redness, and itching.
nose is congested; headache; sneezing; This is a spontaneous report from a contactable consumer (patient) from the Pfizer-sponsored program. A female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered anatomical location not reported, on 01Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. In Mar2021, the patient nose was congested, had headache and also sneezing after the first dose. The patient was asking if she could take colds and flu medicine and pain relievers. The outcome of the events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained. No further information is expected.
Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 85-year-old male patient received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Jun2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset Jun2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, the patient received Bebtelovimab. Clinical course: the patient wants to get a Covid #5 shot and wants to make sure that the Bebtelovimab dose doesn't affect it in anyway.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Segmental colitis associated with diverticulosis -She was admitted treated with IV Cipro and Flagyl and IV fluids and pain control -Seen by GI who concurred with the current treatment with no need for repeat colonoscopy-Will be discharged on oral Augmentin and follow-up with GI in a month and primary care as scheduled. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Right deltoid with erythema and edema with increased warmth to area of 85mmx90mm often. DTaP administered on 08/11/04 to right deltoid. Pt returned on 08/12/04 with above signs/symptoms.
Heat redness at injection site started in a small circular spread to entire arm from the vaccine up gradually daily enlarged spreading downward towards the elbow extreme itchiness tenderness and fire like redness in color i The itch Unlike any I?ve experienced in my lifetime still present  The redness is gradually improved in the last day
Chest Pains 4-5 days after shot, intermittent   Ear Aches 5-6 days after shot Excessive phlegm in lungs 5-6 days after shot Random body extremities briefly going numb 5-6 days after shot, to include lower jaw and both arms  Blood in phlegm almost persistently 6-7 days after shot
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Lot number: 012A21A), in right arm, in Apr2021 as dose 2, single (Lot number: 044B21A), in left arm and in Dec2021 as dose 3 (booster), single (Lot number: 067H21B) for covid-19 immunisation. The patient's relevant medical history included: "Thyroid" (unspecified if ongoing); "Sulphur drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 25Jul2022 to 29Jul2022. Clinical course: Patient has received other medication in 2 weeks were Synthroid, Hydrocodone. Tested Positive again on 4th day after stopping Paxlovid. Some symptoms including congestion and headache.
This is a 31 year-old male who experienced an inadvertent inoculation with smallpox (vaccinia) virus.  He reports noticing a red area, approximately ¾ inch in diameter with a small pustule in the center, which was first noted at approximately 1700 hours. By 2200 hours he states the area was "hot" with increased redness and "skin crawling" sensation.  This morning the red area had increased to approximately 1.5 inches and the pustule was 2-3 times larger than the day before. He reported to physical training this AM, the pustule was rubbed by his clothing and opened. He completed his PT, running approximately 1.5 miles without further incident. He presented for evaluation and was referred to the VHC for further evaluation and treatment.
Severe bruising on the opposite side of the arm from the injection site. Bruising covered the full length of the left upper arm (armpit to elbow) on the anterior side. Injection site (left posterior arm) had minimal bruising. No bruising along the arm on the posterior upper arm.
Fever, shortness of breath, tired, achy right arm red & swollen, wheezing.
This spontaneous report received from a patient via social media concerned a female of unspecified age, race, and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 in 2020. The patient received covid-19 vaccine (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date after primary series, the patient was vaccinated with covid-19 vaccine for prophylactic vaccination (Dose number in series 2). No adverse events were reported following covid-19 vaccine (Dose number in series: 2) On an unspecified date after vaccination, the patient experienced that vaccine did not work as expected (suspected clinical vaccination failure). Patient had more symptoms (suspected covid-19 infection) than the first-time half when she had covid-19 in 2020 before vaccination (suspected clinical vaccination failure) (dose number in series 1). The reporter stated "I am contacting you to inform you that the Johnson and Johnson vaccine does not work as expected. I have 2 vaccines from Johnson and Johnson, and I got Covid 19. The problem is not that I get infected, but that the symptoms I have are more than the first-time half in 2020 without having any vaccine". The action taken with covid-19 vaccine was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority number 90000210262 and 90000209965.; Sender's Comments: V0:20220108290-COVID-19 VACCINE Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.