chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented to the ED and was subsequently hospitalized for Acute on chronic respiratory failure with hypoxia within 6 weeks of receiving COVID vaccination.
Injection site soreness; tiredness; headache; muscle soreness; chills; joint soreness; This is a spontaneous report from a non contactable consumer (patient). A 44-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number:EL9261), via an unspecified route of administration on 22Jan2021 10:30 at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at Military Base. Patient age at time of vaccination was 44 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included chronic sinusitis. The patient has no known allergies. Concomitant medications included atorvastatin, ibuprofen (ADVIL), guaifenesin (MUCUS RELIEF), ascorbic acid, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine mononitrate (ONE-A DAY). On 23Jan2021 20:00 the patient experienced injection site soreness, tiredness, headache, muscle soreness, chills, joint soreness. No treatment was received for the events. The events were resolving. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Headaches, site pain, neck pain, numbness in arms and fingers on side if injection site. Extreme fatigue.
6months p/vax pt devel a multiplicity of body-wide sx that included severe dizziness, h/a, muscle & joint pain, severe fatigue, multiple allergies to chemicals, endometriosis, thyroid abnormalities, etc.pt has hashimoto's Disease
Patient state after receiving the flu shot her arm formed a lump. The lump does not hurt, not unless she applies pressure.
paresthesia of the left hand; extreme heaviness of the left arm within 30 minutes after receiving the second dose of Covid19 vaccine in that arm; This is a spontaneous report from a contactable nurse reporting for herself. A female patient of unspecified age received the second dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, at a single dose on the left arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, at a single dose for COVID-19 immunization. The patient reported paresthesia of the left hand and extreme heaviness of the left arm within 30 minutes after receiving the second dose of Covid19 vaccine in that arm on an unspecified date. She asked if one shouldn't get both vaccination in the same arm. She also asked about dosing of acetaminophen or NSAIDs before receiving the second dose of the Covid19 vaccine or using antipyretics or histamines after receiving the Covid19 vaccine. Outcome of the events was unknown. The reporting nurse assessed the adverse events as non-serious.   Information on the lot/ batch number has been requested.
Pt recvd 3 doses vax on 19MAR90,24APR90 & 13SEP90,resp.Did not seroconvert p/ 3rd dose;4th dose given 11NOV90 & antibody titer pos.
Morning after vaccine was sleepy with a slight headache.  Went home about 16:30.   Felt nauseated with chills.  Took a nap.  Woke with significant chills and proceeded to dry heave for about 5 minutes.  Advised to take 25mg Benadryl and also took 1 tab Advil.   Symptoms resolved after about one hour.  Went to bed.  Following morning had stomach pain.  Assumed from dry heaving, but took another 25mg Benadryl and 325mg Tylenol.  Slept all day / night.  Following day had diarrhea but otherwise fine.
Nurse manager while auditing charts with nurse employed at clinic noticed the same vial of Moderna punctured on 10/26/2021 was administered to this patient on 11/02/2021.  Nurse in clinic failed to discard vial after 12 hours of puncture and placed back in the fridge. She then proceeded to administer dose of Moderna to this patient outside the recommended time frame.  Nurse documented consent in EMR but failed to document site Moderna given in.  Paper consent not filled out but EUA given to pt.  Pt remained in clinic x 20 minutes with no reports of reaction.
Pt recvd vax NOV92 & following the inject exp pain in neck, shoulder & all the way down arm;
Information has been received from a woman at a pediatrician's office concerning a 13-month-old male with no allergies or medical history who on 27-JUN-2005 was vaccinated in the right leg with a first dose of varicella virus vaccine live (Oka/Merck) (lot# 649276/0899P). concomitant vaccination on the same day included a first dose in the left leg of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot # 648967/0232R). On 09-AUG-2005, the patient had greater than 60 lesions all over the upper body. There was a questionable fever at home. The adverse reaction was described as variant varicella. "OVX - 10-AUG-2005" was noted. The patient's vaccination administration and screening record indicated that the patient received in the left thigh a first, second, and third dose of diphtheria toxoid (+) pertussis acellular Biken, vaccine (+) tetanus toxoid (TRIPEDIA) on 26-AUG-2004 (lot # C1700AA), 26-OCT-2004 (lot # C204AA), and 04-JAN-2005 (C2103AA). The patient received a first and second dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) on 09-SEP-2004 (lot # 647482/0026P) in the right anterior thigh and 15-NOV-2004 (lot # 649039/0356P) in the left thigh. The patient received a first and second dose of poliovirus vaccine inactivated (Vero) (IPOL) on 09-SEP-2004 (lot # X1038) in the left anterior thigh and 26-OCT-2004 (lot # X1191) in the left thigh. The patient received a first, second, third, and fourth dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRMC 97) (PREVNAR) on 26-AUG-2004 (lot # 495-707) in the left thigh, 15-NOV-2004 (lot # A67180A) in the right thigh, 04-JAN-2005 (lot # A74400E) in the right thigh, and 27-JUN-2005 (lot # A94440B) in the left thigh. Additional information is not expected.
I took the Shingle Vaccine on 3/8/13 at approximately 3:30 p.m. I felt a little sore that night. On Saturday 3/9/13 about 12:00 noon, my arm was very sore and warm. I looked in the mirror my rt arm was swollen 15 cm with a big lump. Very painful with severe huge hives. I notified the pharmacist on 3/11/13. It was a reaction to the shingle vaccine. I took BENADRYL/anti-itch cream/TYLENOL until I saw the Dr. Went to Dr. on 3/12/13. Shingle vaccine reaction prescribed Hydroxyz HCL 25mg.
Headache, Myalgia & Fever Fever, body ache, chills, fatigue, headache, sore throat
Sharp constant pain in left side of neck started 2 days after vaccination, then pain moved 5/1/2017 to left shoulder. Constant Ibuprofen and ice pack.
Narrative: 76 y/o M with obesity, OSA, HTN, DM2, CAD (non-obstructive on cath 2010), suspected HFpEF, prior VTE (bilateral PE, on chronic warfarin), localized prostate CA (s/p XRT and ADT complicated by radiation cystitis and urethral stricture s/p suprapubic tube), and recent diagnosis of urothelial carcinoma complicated by bilateral hydroureter admitted with acute on chronic symptomatic hyponatremia and volume overload. On 05/09 he was found to be increasingly bradycardic and was unresponsive on assessment. He underwent ACLS but Pt passed. Per death note, no clear etiology of death, greatest concern for cardiac related given initial rhythm VT. Pt received 2nd dose of Pfizer vaccine 2 months ago.
Hospitalized 10/9/2021; COVID-19 positive 10/9/2021; fully vaccinated  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Inability to perform activities of daily living Fatigue, unspecified type COVID-19 COVID-19 virus infection Weakness   HOSPITAL COURSE: 74-year-old male with past medical history significant for diabetes type 2, dyslipidemia, diabetic neuropathy/nephropathy, hypothyroidism, lacunar infarction in the left upper extremity w/ tremor who presented to the hospital with complaints of generalized weakness associated with fever, poor appetite/oral intake and inability to stand up/ambulate. He is fully vaccinated against COVID w/ Pfizer and recently received a booster.   In ER patient was tachcyardic but otherwise hemodynamically stable on RA. Labs indicative of volume depletion and AKI. CXR neg for infiltrates. He did test positive for COVID-19.    Patient had poor appetite and initially required dextrose IVF for intermittent hypoglycemia.PT/OT initially recommended SAR but patient's appetite and strength improved. He was re-evaluated 10/13 and had improved greatly so PT/OT then recommended home with HHC.    Of note, he did have thrombocytopenia but looking back he had had thrombocytopenia back through 2019. Anticipate this was likely from viral COVID infection but messaged patient's PCP to repeat labs and follow up.    ROS Patient feels better today. Ate most of his dinner last night, ate some breakfast this morning. Did well with PT. Feels better overall. Less weak.
Six patients received expired Moderna vaccine booster shots after 30-day Use By Date / after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Six patients received expired Moderna vaccine booster shots after 30-day Use By Date / after manufacturer date of expiry) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Six patients received expired Moderna vaccine booster shots after 30-day Use By Date / after manufacturer date of expiry). On 27-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Six patients received expired Moderna vaccine booster shots after 30-day Use By Date / after manufacturer date of expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment medication was provided by the reporter.  Reporter has said that the vial does not undergo any temperature excursions.   This case was linked to MOD-2021-429306 (Patient Link).
cannot breathe everytime he lays flat/gasping for air every 20mins when sleeping; cannot sleep continuously; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (cannot breathe everytime he lays flat/gasping for air every 20mins when sleeping) and SLEEP DISORDER (cannot sleep continuously) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-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 DYSPNOEA (cannot breathe everytime he lays flat/gasping for air every 20mins when sleeping) and SLEEP DISORDER (cannot sleep continuously). At the time of the report, DYSPNOEA (cannot breathe everytime he lays flat/gasping for air every 20mins when sleeping) and SLEEP DISORDER (cannot sleep continuously) had not resolved.            No Concomitant medications were provided by the reporter. No Treatment information was reported.
Information has been received from a pharmacist, a Pregnancy Registry product, concerning a 25 year old female patient with no pertinent medical history, no drug reactions/allergies who on 19-AUG-2011 was vaccinated with GARDASIL (Lot # 668262/0841AA, Exp 08-APR-2013). There was no concomitant medication. The pharmacist reported that the patient received the first 0.5 ml dose of vaccine and after the injection was administered the office did urine for pregnancy test the same day. She was positive for pregnancy. The urine pregnancy test was followed by a blood test for pregnancy. No date available. Also 2 ultrasound for pregnancy were performed. The patient's last menstrual period was on 28-JUL-2011. The estimated delivery date was on 03-MAY-2012. Follow up information as received from the physician refers to the patient whose estimated delivery date (EDD) was 08-MAY-2012 (previously reported as 03-MAY-2012). The reporter stated that the patient did not continue her case with the reporter. Additional information is not expected.
DAPTACEL was incorrectly administered to 11 year old male patient instead of ADACEL with no reported adverse event; DAPTACEL was incorrectly administered to 11 year old male patient instead of ADACEL with no reported adverse event; Initial information received on 20-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves medication error Diphtheria-15/Tetanus/5 AC pertussis vaccine [Daptacel] was incorrectly administered to 11 year old male patient instead of adacel with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Meningococcal Vaccine A/C/Y/W CONJ (DIP TOX) (Menactra) for and HPV vaccine both for Prophylactic vaccination.  On 03-Jun-2023, the patient of 11 years received a dose 0.5 ml of suspect with standard strength Diphtheria-15/Tetanus/5 AC pertussis vaccine suspension for injection (frequency: twice) (lot: U7549AA, Expiry date: 04-Nov-2024) via intramuscular route in the left arm for immunization instead of adacel with no reported adverse event (wrong product administered) (product administered to patient of inappropriate age) (latency: same day). The information on the batch number will not be requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.   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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.    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 VOMITING (Vomiting). At the time of the report, VOMITING (Vomiting) outcome was unknown.            Relevant concomitant medications were not reported.  Treatment medication was not provided.   Action taken with mRNA-1273 in response to the event was not applicable.
8/6/2021 11:30 pm to 8/7/2021 2:00 pm: Base Heart Rate 150 bpm to 170bpm, oxygen saturation 85% to 95%. 100.4 F fever.  Lightheaded with minimal activity.  Severe aches in legs and arms.  Clouded thoughts and unable to sleep.  Heart rate, fever and o2 saturation improved after 24 hours.  minimal aches continue.
No adverse event occurred and no treatment was needed at this time. Technician typed in the incorrect vaccines at his drop off station. Patient only wanted COVID and RSV vaccines but the technician typed in COVID and flu.  Patient ended up receiving two high dose flu shots. One high dose flu shot was given on 9/18/23 and a second high dose flu shot was given on 10/08/23. Patient was informed before administering the vaccines which ones were being given to him and  in which arm.  After administering the vaccines, patient informed pharmacist that he had already gotten the flu shot and wanted the COVID shot. Patient was informed that he received a second flu shot.
Rashes all over body and back. Spreading to arm. Benadryl and Mupirocin. Will go to the pediatrician tomorrow due to being out of town.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021 at 3:59 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Feb-2021 at 3:59 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 55.08. No concomitant medications were reported. On 08-Feb-2021 at 10:00 AM the temperature recorded was 29 degree Fahrenheit, at 11:00 AM the temperature recorded was 35 degree Fahrenheit and vial was initially moved to the fridge on 02-Feb-2021 and beyond use date was 04-Mar-2021. Product moved to clinic on 08-Feb-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Burning across chest which started 20 minutes after administration, heart pain, and activity intolerance
12/20/21 presents to ED for "Acute hypoxia due to COVID 19 pneumonia". PMHx of "HTN, HLD, CAD and asthma".
Anaphylactic reaction involving wheezing, dyspnea and urticaria. Given subcutaneous epinephrine.  8/21/07 Received pcp office notes & vax records which confirm dose & lot #s.  Well child on day of vax.  Was nurse visit for vax only.  Received varivax in RA & was giving Hep A in LA when jerked away & then given in RA.  Shortly thereafter, began having difficulty breathing, wheezng, raised urticarial erythematous rash on trunk & puffiness of eyes. Given EpiPen & within 5 min resp symptoms resolved. Rash resolved w/n 15 minutes. FINAL DX: anaphylactic reaction, presumably to immunization.
pt recv vax 16OCT97 & pt mom states pt ran fever several days;arm where TD was given was still sore 6 days p/inj lt arm;states arm had fever in it & noted rash between where got shot & elbow;pt saw MD 23OCT97 placed on Clinoril & Claritin;
Initial report received on 23 September 2013 from a health care professional. A male patient of unknown age, whose medical history included asthma and concomitant medications was not reported, received a dose of FLUZONE via intramuscular route 1 in each deltoid from 23-Sep-2013. After vaccination, on same day he experienced stomach distress and had to use asthma inhaler. List of documents held by sender: none.
Patient reported redness, welts, warmth and itching at the site of the Prevnar  injection
One hour after immunization patients cheeks became reddened, lips swelled slightly. Over the next 2-3 hours he developed a blotchy rash to trunk and arms. Temperature max 99.1. Irritable over night, crying inconsolable. Decreased oral intake.
have had shingles / friend / had the shits and he has had them 6 different times; have had shingles / friend / had the shits and he has had them 6 different times; This case was reported by a consumer via (SHINGRIX) interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingle's vaccine).    On an unknown date, the patient received Shingle's vaccine. On an unknown date, unknown after receiving Shingle's vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingle's vaccine.  Additional details were provided as follows: The reporter reported for his friend. The age at vaccination was not reported. The reporter stated that, his friend had shingle's shot and had shingles for 6 different times. The reporter stated that the vaccine did not completely prevent them. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingle's, time to onset for event and laboratory confirmation for shingle's were not provided. This case was linked with case US2021AMR077439, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR077439: Same reporter
The patient is 76F with PMH of HTN, HLD, CKD4-5 followed by doctor, GERD, gout who presents to KP VAL for dizziness. Patient unclear when she first noticed it. It happens any time she moves her head. The room is not spinning. She does feel lightheaded.  She feels nauseous though no vomiting. She otherwise has no acute complaints.When she arrived to ER she was noted to have bradycardia in the 30s and pads were placed on her. Patient is taking atenolol and has hx of CKD4-5 so likely this is culprit but work up with CT head is in process to rule out stroke/hemorrhage.--Per Admitting MD               Hospitalization notable for stoppage of BB with increase in HR, intermittent non-sustained episodes in 30's. Reviewed with cardiology currently not further recommendations.  Will refer for Zio-patch for monitoring outpatient, however patient has had 8 days of monitoring inpatient. All AV nodal blocking agents should be avoided. Wekebach was noted on telemetry, no action required per curbside with on-call cardiologist. ECHO with normal EF.  No current dizziness               UTI--Treated with CTX x 5 days               The patient was also started on dialysis this hospitalization. Permacath was placed and she has outpatient HD site selected.                Patient qualifies for HHPT               Pafib--She was started on heparin gtt, no active bleeding. Can transition to warfarin without bridging. No Hx of stroke/No mechanical valves.                She is anticipated DC on 2/21 if remains hemodynamically stable and tolerated HD in chair today.