chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Feb-2021 at 1:55 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 1:57 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The age of patient was provided as 74.61 years. Concomitant products were not provided. On 28-Feb-2021 Excursion time were reported at 09:00 A.M and 01.00 pm with temperature as 27 and 26 degrees Fahrenheit, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021 and the vial with lot number 019B21A was initially moved to the fridge on 23-Mar-2021 and proposed beyond use date was 22-Apr-2021. Vial was stored on cooler 1, on 28-Feb-2021, Excursion duration At 9 AM: 27, 10 AM: 40, 11 AM: 44, 12 AM: 46, 1PM: 26, 2 PM : 37, 3 PM: 43, and 4 PM: 45. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
This case was reported by a healthcare professional, via Merck, and described the occurrence of not responding to therapy in an unknown number of subjects of unspecified age and gender who were vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subjects received unspecified dose of TWINRIX (unknown). On an unspecified date, on an unspecified time after vaccination with TWINRIX, the subjects experienced not responding to therapy. After the next vaccination with TWINRIX the event did not recur. On 17 November 2009, it was reported that a nurse mentioned an unknown number of subjects who received TWINRIX or ENGERIX-B had negative titers. These subjects repeated the series and responded. No further information was available. (Please see case ID A0817640A for details on the unknown number of subjects who received ENGERIX-B).
Moderna covid (lot number vaccine was administered in clinic setting, patient then reported tightness of throat and tingling of lips. Vitals were taken, O2 was 98%, heart rate 74bpm. Emergency services were called to take patient to nearest hospital for further evaluation, patient's current status is unknown.
2 weeks after vaccination,patient ran fever of 102. The following day she got two blisters on head.  The day after that they scabbed over.
Got flu shot at Dr.'s office on Tuesday. Tuesday night, started having severe pain around right ear area (NOT in the ear - around the ear) and neck area behind ear. Went back to Dr.'s on Thur with pain complaint - they said must be allergies, but cleaned out wax in both ears. Said take aspirin. Went back to Dr.'s office on Saturday. They have prescription for general antibiotic, said to come back on Oct. 10th if still pain. My mother NEVER complains of pain. She has been in severe pain since flu shot given. Aspirin is NOT helping. She does NOT have allergies.
severe joint pain/joint issues in legs/joint pain started in legs has migrated to arms ( wrists, fingers, shoulders]; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (severe joint pain/joint issues in legs/joint pain started in legs has migrated to arms ( wrists, fingers, shoulders]) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced ARTHRALGIA (severe joint pain/joint issues in legs/joint pain started in legs has migrated to arms ( wrists, fingers, shoulders]). The patient was treated with NAPROXEN SODIUM (ALEVE) for Joint pain, at an unspecified dose and frequency; PREDNISONE for Joint pain, at an unspecified dose and frequency; GABAPENTIN for Joint pain, at an unspecified dose and frequency; IBUPROFEN (ADVIL 12 HOUR) for Joint pain, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Joint pain, at an unspecified dose and frequency and MELOXICAM for Joint pain, at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (severe joint pain/joint issues in legs/joint pain started in legs has migrated to arms ( wrists, fingers, shoulders]) had not resolved.            No Concomitant medication was provided.
Started with migraine headache- progressed to severe, intractable headache, several ER visits, Remains critically impacted by ongoing Headache, severe body aches,  fatigue- is up only to work from home computer the required 8 hrs.  Initially responded to steroids.  Being followed by rheumatology and neurology.  Chronic Fatigue Flare is current diagnosis.
extreme pain in the arm radiating from injection site - could not lift my arm splitting headache  nausea with dry heaves  fever and chills arrhythmic heart beat dizziness and weakness the above symptoms were with me for approximately 24 hours   (irregular heart beat maybe about 6-8 hours)  During this time I was not able to care for myself very well...should have gone into the ER but I was too sick to make that happen.  Fortunately I pulled through After that extreme period I have continued with tiredness, mild headache, mild fever, nausea, and dizziness
The patient was brought to the ED by EMS after she sustained a fall on 10/9/23. per staff at the patient's memory care facility, the patient had an unwitnessed fall that day and has since been complaining of pain to the left shoulder and left hip. Additionally, her family reports the patient has been feeling progressively weak. A COVID PCR test was performed which resulted positive. Ultimately, the patient was admitted 10/9/23 - 10/16/23. Discharge diagnosis include COVID-19 infection, among other diagnoses.   The patient has received five COVID vaccines: four doses of Pfizer Monovalent COVID vaccine (given 2/9/21; 3/4/21; 12/23/21; 5/27/22) and one dose of Pfizer Bivalent COVID vaccine (given 12/12/22).
This spontaneous case was reported by a physician and describes the occurrence of RASH (Widespread Rash) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-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 RASH (Widespread Rash). At the time of the report, RASH (Widespread Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included IM steroid and oral antihistamine.
2021-04-10:  Irregular heart rate - reported by Watch, did not have ECG to confirm nature of irregular heart rate report by Watch 2021-06-10:  Irregular heart rate reported by Watch;  visited Emergency Room and had ECG performed - result  AFlutter - hospital overnight stay; Irregular heart rate 3 additional AFIb events - August, Sept, Oct
This spontaneous report as received from a doctor of pharmacy refers to a patient who was vaccinated with an improperly storage dose of ZOSTAVAX (lot # 673029/0616AE, expiration date not listed, dose not reported) on 20-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. The doctor of pharmacy reported that one of the facilities that he was in charge of was recording the temperature of the storage unit of ZOSTAVAX as -5F. He reports that they recently discovered that the actual temperature of the storage unit was -5C. He did not know if the patient had experienced any adverse effects. This is one of several reports received from the same source. This report is cross referenced with the following MARRS #:1209USA002918, 1210USA006055, 1210USA006056, 1210USA006057, 1210USA006058, 1210USA006059, 1210USA006060, 1210USA006061, 1210USA006062, 1210USA006063, 1210USA006064, 1210USA006065, 1210USA006067, 1210USA006068, 1210USA006069, 1210USA006070, 1210USA006071, 1210USA006072, 1210USA006073, 1210USA006074. Additional information is not expected.
pt returned to office on 12NOV92 w/c/o elevated temp, diarrhea stools nasal congestion, gagging;
Client reports on 03/01/2000, she broke out in hives on legs, trunk, and back one day post vax. No shortness of breath reported. She denies any reaction to the first vax in series. She states she did not notify health department of the reaction.
OFF LABEL USE; VACCINE ADMINISTERED TO 17 YEAR OLD; This spontaneous report received from a health care professional concerned a 17 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the patient experienced off label use. On 26-MAR-2021, the patient experienced vaccine administered to 17 year old. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and vaccine administered to 17 year old was not reported. This report was non-serious. This case, from the same reporter is linked to 20211000796.
Shoulder pain; radiating pain; This case was reported by a nurse via call center representative and described the occurrence of shoulder pain in a 19-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA12AZ, expiry date 28th February 2021) for prophylaxis.   Previously administered products included Bexsero with an associated reaction of musculoskeletal pain (1st dose received on 3rd August 2018, refer linked case US2019148696).   On 9th August 2019, the patient received the 2nd dose of Bexsero. In August 2019, less than a week after receiving Bexsero, the patient experienced shoulder pain and radiating pain. In August 2019, the outcome of the shoulder pain and radiating pain were recovered/resolved.   It was unknown if the reporter considered the shoulder pain and radiating pain to be related to Bexsero.  Additional information received were as follows: The registered nurse called to report a Bexsero adverse event. The patient received vaccine in left deltoid. The patient had the same reaction as he had to the 1st dose, significant shoulder pain that radiated to the back. The reporter reported that the pain lasted a while as she spoke to the patient's mother, 4 days after the 2nd dose. The reporter consented to follow up. This case had been linked to the case US2019148696, reported for same patient by same reporter.
pt recv vax SEP96 & SEP96 pt exp small joint pain, synovitis & urticaria which devel two-wk post vax;presented to a specialist w/sx;
13 year old received the Moderna Covid 19 Vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old received the Moderna Covid 19 Vaccine) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old received the Moderna Covid 19 Vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old received the Moderna Covid 19 Vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication was reported.
headache; nausea; body aches; fever of 104; chills that have continued and not going away; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), NAUSEA (nausea), MYALGIA (body aches), PYREXIA (fever of 104) and CHILLS (chills that have continued and not going away) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache), NAUSEA (nausea), MYALGIA (body aches), PYREXIA (fever of 104) and CHILLS (chills that have continued and not going away). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, HEADACHE (headache), NAUSEA (nausea), MYALGIA (body aches), PYREXIA (fever of 104) and CHILLS (chills that have continued and not going away) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable No concomitant medication were reported
Pt came to our drive thru vaccination clinic for vaccination.  Medical student gave her a dose of Pfizer then the nurse discovered that pt had already had 2 previously on 8/5/21 and 12/1/21.   I called to inform patient, not having any side effects.
Two days after vaccine felt dizzy, confused and felt tingling in fingers and toes and almost fainted, had to be helped home; Went to Dr. and had complete blood tests drawn, everything came back normal; Went to Cardiologist and given a heart monitor to wear; Haven't received results yet. Still feels lethargic since.
Patient began to become paralyzed on Mon, Nov 5th. He was diagnosed with acute inflammatory demyelinating neuropathy (AIPD), a form of Guillain Barre Syndrome. He spent three weeks in the hospital. He is currently undergoing PT to regain full use of his legs.
This spontaneous report as received from a medical assistant, refers to a currently 2 year old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an improperly stored VAQTA, (which had a lot # of N020686 and an expiration date of 22-OCT-2018; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion since an unknown date: 49 F for 9 days. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1808USA006354.
Patient received his COVID Pfizer vaccine on 5/14/21 (Lot # EW0161) and 6/4/21 (lot # EN6207).   Patient present to ED on 6/6/21 with productive cough and SOB.  During the hospital stay, patient was diagnosed with new onset afib w/RVR and biventricular systolic dysfunction.  Not sure if this was a vaccine related ADR but reported for record keeping.
Dizziness/vertigo, nausea, fever, tachycardia, elevated blood pressure, shortness of breath.
patient was given both Pediarix and Ipol about 30 minutes ago / no AE; Initial information received on 30-Jan-2019 regarding an unsolicited valid non-serious case received from a Consumer/Non-HCP (office Staff).  This case involves patient (with unknown demographics) who had received doses within 30 minutes ago of vaccine POLIOMYELITIS VACCINE (INACTIVATED) [IPOL] and  DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID [PEDIARIX] (lot number and Exp. Date not reported) via unknown route in unknown administration site for Prophylactic vaccination , on an unknown date.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to extra dose administered.   It was reported that A nurse pulled Pediarix, which contains a polio component, and also pulled IPOL. The patient was given both Pediarix and Ipol about 30 minutes ago.  At the time of reporting, the patient had no adverse reactions.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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.  Information on the batch number was requested.
The vaccine makes at least for me my asthma start to flair up. It happened under the first dose too but didn't relate it to the vaccine because it was starting to get cold out and my asthma usually acts up when it gets that cold out.
The day after my vaccine, approximately 22 hours after, I developed blurry vision, especially pronounced with my near vision. Vision blurriness persisted until the morning of April 11. I went to my eye doctor later that day for a complete exam which was normal.
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 67-year-old male patient received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: EN6206), in left arm, on 30Mar2021 as dose 2, single (Lot number: ER8733), in left arm, on 06Oct2021 as dose 3 (booster), single (Lot number: FF2589), in left arm and on 25May2022 as dose 4 (booster), single (Lot number: FM0173) at the age of 66 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient took paxlovid for treatment of adverse events, Device timestamp: 19Oct2022. The patient had no Known allergies.
Underage health care worker eligible received vaccine. RN screener failed to identify age as contraindication to receiving dose.  Patient had  no adverse reactions as per conversation with her father on 2/24/2021.
volatile BP; rapid heart rate; Severe insomnia; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP).  A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm right, administration date 17Mar2021 (Lot number: ER2613) at the age of 69 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Help for sleep" (unspecified if ongoing); "Low cholesterol" (unspecified if ongoing); "HTV" (unspecified if ongoing). Concomitant medications included: LOSARTAN taken for tidal volume increased, stop date: Jun2021; ATORVASTATIN taken for blood cholesterol decreased (ongoing); MIRTAZAPINE taken for sleep disorder (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Time: 13:30, Anatomical Site of injection:  Arm, Route of administration: Intramuscular, Batch/Lot number: EN6203), administration date: 23Feb2021, for Covid-19 Immunization. The following information was reported: INSOMNIA (medically significant) with onset 17Mar2021, outcome "recovered" (Aug2021), described as "Severe insomnia"; HYPERTENSION (medically significant) with onset 18Mar2021, outcome "recovered" (05Jan2022), described as "volatile BP"; HEART RATE INCREASED (medically significant) with onset 17Mar2021, outcome "recovered" (Aug2021), described as "rapid heart rate". The events "severe insomnia", "volatile bp" and "rapid heart rate" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (18Mar2021) volatile bp, notes: extremely high bp; electrocardiogram: (May2021) normal; heart rate: (17Mar2021) rapid. Therapeutic measures were taken as a result of insomnia included lorazepam (ATIVAN), hypertension included new BP medication, heart rate increased included propanalol.  No follow-up attempts are possible. No further information is expected.
patient received a dose of PEDV AX IIlB after it was stored outside of the recommended storage range; No other adverse event reported; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Information on patient's pertinent medical history, drug reactions or allergies and concomitant medications was not provided.      On an unknown date, the patient was vaccinated with a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (lot # T000885, expiration date 29-MAY-2022) 1 dose (route of administration was not provided) for prophylaxis, after it was stored outside of the recommended storage range. The vaccine was stored in temperature of 8.6 Celsius degrees in time frame of 9 hours and 10 minutes. The data logger was involved. There was no previous temperature excursion. No other adverse event reported.