chrisvoncsefalvay/vaers-outcomes huggingface dataset:
when she pushed the plunger down, the cracks in the glass cut her hand through the glove. Patient irrigated the wound and applied a band aid to the wound.; crack in the glass on the finger flange/ SMALL SPOT WITH SHARDS OF GLASS STICKING OUT/ found without finger flange in the blister pack; The medical assistant administered the product with the cracked finger flange/ she noticed and she didn't want to waste the vaccine and she took care to try not to touch the broken part but it still cut her up real good; This spontaneous report was received from an unknown-aged female medical assistant referring to herself via a company representative. Her pertinent medical history, concomitant medication, drug reactions, and allergies were not provided.     On 13-JAN-2021, the medical assistant noticed there was a crack in the glass on the finger flange of one dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe (lot number T016159, expiration date 28-FEB-2022) further described as a "small spot with shards of glass sticking out of it" and "found without finger flange in the blister pack" (syringe issue). The medical assistant reported that she did not want to waste the vaccine; therefore, she still administered it with the cracked finger flange. She took care to try not to touch the broken part (off label use of device); nevertheless, when she pushed the plunger down, the cracks in the glass cut her hand through the glove (wound) "real good". The medical assistant sought medical attention, irrigated the wound, and applied a band-aid to it. The wound had healed by reporting time.   According to the medical assistant, none of the product leaked out of the barrel. The unspecified patient received the full dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) as prophylaxis (dose number, route of administration, and anatomical site of vaccination were not provided), and no adverse events occurred to the patient (case # 2102USA007934).   The causal relationship between the wound and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T016159; expirationdate: 28-FEB-2022; deviceage and unit: 0 ; operatorofdevice: Medical Assistant; malfunction: Unknown; productavailableforevaluation: Yes; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA007934:
MOTHER OF PATIENT CALLED ON 6/27/08 TO REPORT THAT PATIENT'S RIGHT LEG WAS SWOLLEN FROM THE TOP TO DOWN PAST THE KNEE, IS PAINFUL AND HAS DIFFICULTY WALKING. STATES SHE HAS APPLIED COLD COMPRESS. I INSTRUCTED HER TO TAKE HIM TO THE DOCTORS. LATER THAT DAY I RECEIVED A CALL FROM HIS DOCTORS OFFICE REQUESTING THE LOT # AND SITE OF THE INJECTION. MADE TELEPHONE CALLS TO THE HOME 6/30/08 AND 7/2/08 NO ANSWER, LEFT MESSAGES. TELEPHONED 7/14/08 AND SPOKE WITH MOTHER AND SHE REPORTS WAS INSTRUCTED TO GIVE HIM BENADRYL BY THE DOCTOR.STATES THAT HIS LEG IS MUCH BETTER, ONLY HAS A SMALL BUMP.
Fever  up to 101.4  Body aches  dull deep muscle & joint  Headache  *pain I have never experienced before pain in my heart & a little in my left arm  As of now  3/27 Muscle, joint, headache & fever all subsided. Light dull ache over heart area, seems to be getting less.
erythematous maculo papular drug eruption on face w/in 8 hrs of administration, spreading to trunk & arms w/in 12 hrs;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 09Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 30Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Anti-viral details: Product COVID-19 Treatment, brand Paxlovid, on 23Jun2022 treatment started, treatment stop date was 27Jun2022. Rebound of symptoms 3 days after negative test.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient felt nauseous, lips were swollen, spent the night sick in bed after the flu shot.
This case was reported by a healthcare professional and described the occurrence of flushing in a 29-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). The subject's medical history included reaction to MAXAIR. Concurrent medical conditions included asthma, breast feeding, hypertension and 3 months post-partum. Concurrent medications included Beta-blocker. On 10 October 2011 at 10:00 the subject received a dose of FLUARIX (.5 ml, unknown route, left arm). On 10 October 2011, 15 minutes after vaccination with FLUARIX, the subject experienced flushing, injection site redness, hotness at injection site, clamminess, elevated blood pressure (168/140) and headache. The subject was treated with TYLENOL and rested for 10 minutes. Her blood pressure continued to rise to 178/90 and then 190/95. She was taken by ambulance to the emergency room. The subject was treated with SOLU-MEDROL, BENADRYL and REGLAN. The medications lowered her blood pressure, but the headache continued for 24 hours then resolved. The subject was released from the emergency room on oral PEPCID, ZOFRAN, diphenhydramine hydrochloride and prednisone. The next day, 11 October 2011, the subject experienced systemic swelling, including swelling of hands and feet and neck swelling. Redness and hotness at injection site also continued. The healthcare professional considered the events were clinically significant (or requiring intervention). On 13 October 2011, the events were resolved. The healthcare professional considered the events were probably related to vaccination with FLUARIX. Please see report A0949181B for details regarding the baby case of vaccine exposure via breast-milk.
Patient presented today with swelling and redness involving his entire upper left arm. He reported that it was warm to the touch and painful. I instructed him to take over the counter diphenhydramine and to contact his primary care physician.
Pt. developed Bells Palsy after getting Boostrix vaccine. She was treated after delivering her baby with prednisone and acupuncture
Patient had bruising and arm pain which lasted about 10-12 days post vaccination. It resolved on its own without treatment
No adverse events at this time. Wrong vaccine was administered. Pt had received first dose of Pfizer vaccine on 02/27. She scheduled a first dose appointment vaccine through a store that provided only Moderna vaccine.  She received the Moderna vaccine without ever alerting the staff that she had received a previous dose of a different vaccine.
I noticed I had a small rash - it was irregular circular shape. It was on my right side - non local to the injection site. Underneath my armpit slightly to the back (six inches below armpit). It was a little red; slightly bumpy; it felt tight. Overall, it was very mild discomfort. I don't usually get rashes like that. It was itching. My husband a primary care doctor and he looked at it. He said it looked unusual - not a usual rash. I gave it 24 hours and it did start receding a bit - it was still a bit itchy and tight the second day and it kind of faded away. It wasn't visual 3 days after the first onset of symptoms - it wasn't bumpy - I couldn't feel it.  It is my first pregnancy. Estimated birth date - 9/10/2021
Palpitations, Angina,  Myocarditis per employee, and patient did submit the Dr. Note submitted on  return to Work post hospitalization in Employee record stating hospitalization is a direct result of receiveing the Covid =19 Vaccination.  Narrative: Employee received vaccine on a Tuesday- 02/02/2021, and at 0300am Saturday morning 02/06 woke with chest pain and was taken to hospital where he received Cardiac Care, and it was determined that it was myocarditis. Patient did submit the Dr. Note submitted on return to Work post hospitalization in Employee record stating hospitalization is a direct result of receiving the Covid=19 Vaccination.
pain, redness swelling in the arm approximately 6 x 4 inches still present 48 hours later
Headache, NauseaVomiting,  FATIGUE, TENDERNESS AND SWELLING TO INJECTION SITE Narrative:
Breakthrough case admission after 2 vaccines Pfizer 2/13/21 Lot# El9267;  Pfizer 3/6/21 Lot# EN6206
Patient had large red itchy rash at injection site started 2/20/2021 after receiving vaccine, currently as of 3/8/21still has red rash present but has decreased in size after treatment of triamcinolone cream
On 11/15/2000, the patient experienced less than 20 pox like lesions scattered on her arms and legs. She was also afebrile. The patient was seen in the physician's office. The patient recovered 11/30/2000. No additional information is expected.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022 at 11:42 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022 at 11:42 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. On 02-Apr-2022 at 11:42 AM, patient received an expired second booster dose.
Normal pain at injection site; however, two days after shot I woke up with both shoulder joints hurting and left shoulder would pop (click) if I raised it at all. After a week the pain moved to the bends of my arm along with the shoulder joints still hurting. The left bend of my arm stopped hurting and after 6 visits to the chiropractor with adjustments and therapy they were able to get my shoulders to stop hurting. However, my left bend of my arm has not stopped hurting yet.
Breakthrough case of Covid-19, 5 months after my 2nd vaccine dose, then got strep throat and a sinus infection requiring  course of antibiotics
Information has been received from a physician concerning a female patient who on 14-NOV-2003 was vaccinated with a dose of Varivax. On 22-MAY-2006, the patient broke out with a moderate case of chickenpox. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
At the time of vaccination, pt was approximately 7 months pregnant. Pt called about an hour after vaccination and advised that she was feeling weak, a little dizzy, and nauseated. I advised she should call her doctor and explain her symptoms to the dr and proceed to urgent care or to the er. I called later and spoke to her husband and was advised that she was feeling better.
administrated /after a below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 2-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number mk944, expiry date 5th March 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th July 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 details were provided as follows: The physician reported that, the male patient was administrated with Pediarix vaccine after a below freezing temperature excursion on 26th July 2021, which led to incorrect storage of drug. No adverse event was reported . The reporter consented to follow up. This case is linked with one of the many cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164800: US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164779:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164801:same reporter US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164793:same reporter US-GLAXOSMITHKLINE-US2021164794:same reporter US-GLAXOSMITHKLINE-US2021164795:same reporter US-GLAXOSMITHKLINE-US2021164797:same reporter US-GLAXOSMITHKLINE-US2021164798:same reporter US-GLAXOSMITHKLINE-US2021164799:same reporter US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164804:same reporter US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164806:same reporter US-GLAXOSMITHKLINE-US2021164808:same reporter
As of date of Disease Investigation on 8/10/21 case was still symptomatic,  onset of symptoms was 8/7/2021. Reported fever, subjective fever, chills, runny nose, sore throat, headache, fatigue, cough, diarrhea and congestion.
pt got very pale w/o any movement; adm to hosp w/poss sz by MD; hosp dx of hypotonia;
EXTREME VERTIGO, NAUSEA, VOMITING, DIARRHEA, LIGHT-HEADED 4 DAYS, REDUCED TO SLIGHT DIZZINESS AND LIGHT-HEADED FOR THE NEXT 5 DAYS. SYMPTOMS BEGAN ABOUT 48 HOURS AFTER SHOT.
Pt recv vax on 11/17/98; on 11/19/98 pt exp erythema at vax site
Red, itchy hives started on my bilateral lower legs. It progressed in distribution (to involve my entire body) and severity over the next several weeks.
I have a 101.3 temperature, my body hurts all over, I am having pain in my arm, in my chest, in my back, I feel nausated, I sweat all over my bed, I am severely dizzy, it has increased my sugar levels (I am an insulin dependent diabetic),  I am aggravated and I can't think very well.  I feel like I have the flu on steroids, and the pain  in my back is unbelievable and I have a headache from hell.  I am on day two of these symptoms.  This was my second dose.
on second shot i got alot of symptoms/bad reactions. nausea, feeling light headed, aches in my body everywhere, a nose bleed, high fevers (102.9). My left arm from where i got the injection was really swollen after two days prior from getting the vaccine.
Patient reports feeling fine 4/7/2021. He did have a shot of whiskey on 4/8/2021 around 8pm. Reports fever, nausea and fatigue starting at 6pm on 4/8/2021. He then woke up every hour on the hour starting around 1200 midnight and reported having racing heart and having to use the restroom every hour (abnormal for him this frequent). The adverse event was tachycardia (160-180bpm) starting shortly before midnight and this was persistent until 4am. He has not had any tachycardia since. He did not seek medical attention and this has only happened to him once before (>20 years ago when he was dehydrated).
This spontaneous report has been received from a pharmacist via a company representative referring to a female patient of unknown age. No information was provided regarding the patient's medical history, drug, allergy history or concomitant medications. Approximately on October 2017 (reported as last week), the patient was vaccinated with ZOSTAVAX (strength, dose, route of administration, lot# and expiration date were not provided) for prophylaxis. The reporter stated that approximately on an unknown date in October 2017, the patient experienced "an outbreak with chickenpox". The patient was taking antivirals (unspecified details) as treatment for the event. The outcome of varicella was unknown. At the time of this report, the causality between the event and ZOSTAVAX was not reported.
inadvertently administered after its labeled expiry date; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.      The patient's concurrent conditions, medical history, and concomitant medications were not reported.   On 19-AUG-2021, the patient was vaccinated with hepatitis A vaccine, inactivated (VAQTA) (dose, route of administration, and anatomical location were not provided) lot # T018670, expiration date 11-JUL-2021 as prophylaxis.   The vaccine hepatitis A vaccine, inactivated (VAQTA), was inadvertently administered after its labeled expiration date, according to the nurse.
Severe diarrhea, vomiting, abdominal pain, nausea, hives (3 days after vaccination).
This case was reported by a consumer via call center representative and described the occurrence of muscle soreness in a 60-year-old female patient who received SHINGRIX. In January 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced muscle soreness, malaise, cold and fatigue. On an unknown date, the outcome of the muscle soreness, malaise, cold and fatigue were recovered/resolved. It was unknown if the reporter considered the muscle soreness, malaise, cold and fatigue to be related to SHINGRIX. Additional information was received as follows: The patient experienced terrible muscle soreness, felt out of sorts (reporter thought they implied malaise). These adverse events were lasted for about 24 hours. This case has been linked to the case US2018GSK072110, reported for same patient.
pt recvd vax 22AUG95 & morning of 23AUG95 pt devel eight lesions; 3 on head, three on lt arm, one on lt leg & one on back of the lt leg;No further details were provided
Hives in the evenings that started around 24 hours later. No anaphylactic response
Fever and aches within 24 hours followed by chest tightness, shortness of breath, another fever, aches, nausea, and diahrrea. The latter symptoms did not appear until five days after the shot. I had the exact same reaction in the same timeframe when I got this first shot, but none of the 24-hour symptoms.
Felt kike she was spinning around, headache.  Denies SOB, Chest Pain, sweating, oral swelling  or swelling to face hands or feet. Provided with cup of orange juice, placed on cot to lay back.  after 15 minutes stated she felt better.  Started sipping water.  States spinning and headache are gone completely.  Observed an additional 20 minutes.  Discharged home accompanied by husband.  Advised to stop at nearest hospital ER in route to home if symptoms return or if she feels any swelling to lips, face, hands or has any shortness of breath.  Patient and husband agree.
throat feels really dry; Dry mouth; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DRY THROAT (throat feels really dry) and DRY MOUTH (Dry mouth) 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 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced DRY THROAT (throat feels really dry) and DRY MOUTH (Dry mouth). At the time of the report, DRY THROAT (throat feels really dry) and DRY MOUTH (Dry mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications, Lab data details and Treatment informations were not provided.   Reporter did not allow further contact
Itching and hives on 12/9/15 following the flu vaccine given on 12/4/15. Seen 12/22/15. SOLU-MEDROL 125mg given IM 1/8 hives returned after a few days increased itching HS. 1/8/16 MD ordered Loratadine 10mg AM, BENADRYL HS.
This case was reported by a healthcare professional and described the occurrence of allergic reaction in a 24-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included high blood pressure, SLE and sun allergy. Concurrent medications included Prednisone and Benazepril. On 18 October 2012 at 16:00 the subject received 1st dose of FLULAVAL (.5 ml, unknown, right arm). On 19 October 2012, nine hours after vaccination with FLULAVAL, the subject experienced face itching. On 20 October 2012, two days after vaccination with FLULAVAL, the subject experienced allergic reaction, redness and red spot. The subject took BENADRYL which resulted in an improvement of side effects but not complete resolution. At the time of reporting the allergic reaction, redness and red spot were improved; the face itching resolved on 20 October 2012. The healthcare professional considered the events were probably related to vaccination with FLULAVAL.
Coughing; Headache; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), HEADACHE (Headache) and MYALGIA (Body ache) in a 68-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 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced COUGH (Coughing), HEADACHE (Headache) and MYALGIA (Body ache). At the time of the report, COUGH (Coughing), HEADACHE (Headache) and MYALGIA (Body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products was not provided.  Treatment medication was not reported.
severe swelling, pain, redness causing numbness down the left arm. Tried Aleve, Benadryl, Heat. Tx'd with Prednisone