chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Admission Date: 10/12/2022 Discharge Date:10/21/2022   HOSPITAL COURSE Patient is a 72 y.o. male with a history of persistent atrial fibrillation, diastolic heart failure, and oxygen-dependent chronic obstructive pulmonary disease who presented to the hospital 10/12 with dyspnea. Few hours prior to arrival he suddenly became very dyspneic.  He usually uses 3 L of supplemental oxygen at baseline but turned up to 5 at home and then called EMS. Patient received 125 mg of Solu-Medrol and a DuoNeb treatment on the way to the hospital in the ambulance.  On arrival, he had mild leukocytosis.  He tested positive for COVID-19.  He was initially hypercapnic and slightly acidotic.  This resolved after continuous nebulizer. D-dimer was negative. CXR was clear. Patient was admitted for COPD with acute exacerbation 2/2 Covid 19 infection. Remdesivir was started on 10/12 and was completed on 10/16 daily renal and liver function monitoring for kidney and liver toxicity was done. For COPD exacerbation he was started on solumedrol 40 mg IV every 12 hours and then was transitioned to prednisone 40 mg PO. Patient completed a 5 days course of azithromycin IV (10/13-10/17). Patient received duo-nebs every 4 hours while awake. He was continued on his home Budesonide/Fometorol and Spiriva INH. Patient is being discharge on prednisone 10 mg with a taper.    Patients was treated for fasting hyperglycemia. Hyperglycemia was most likely steroid induced and improved from the switch from solumedrol to prednisone. Patient was placed on a moderate sliding scale insulin but d/c at discharge. Hemoglobin A1c obtained was 6.4%.    Patient showed symptoms of a mild acute exacerbation for his chronic diastolic congestive heart failure. CXR showed no acute cardiopulmonary abnormalities but BNP was 2,420. Patient was given 40 mg of IV lasix (10/17-10/18) and then transitioned to lasix 20 mg PO BID which he tolerated well.    Patient had symptoms correlating to BPH he was started on flomax 0.4 mg patient stated this helped with emptying bladder.
pt stated she was watching TV about 10 days after taking the vax she had a stroke.  She became where she couldnt talk and was speaking jibber jabber.  Her eyes blurred.  These symptoms went away and she felt better.  On 4/23/21 she went to ER.  Her BP was 212/117.  She had multiple test.  She was diagnosed w/ Stroke.  She was prescribed water pills and sent home to FU w/ PCP.  On 5/3/21 she saw PCP.  He prescribed blood pressure medicine.  She is waiting on them to call her back w/ appt date for a Carotid US.  She feels better but says she has brain fog, has fatigue and right eye is still blurry.
death Narrative: Pt received COVID vaccine dose #1 on 2/27 at facility. Pt admitted to Hospital d/t COPD exacerbation and severe hypoxia. Pt with longstanding hx respiratory complications including air hunger, use of continuous oxygen, panic attacks and pain requiring narcotics (also impacted respiratory drive). Pt evaluated by palliative care/hospice services at Hospital and was deemed appropriate for end-of-life care. Pt unable to discharge home for home hospice services, therefore remained at Hospital where he later passed away. Pt's wife called facility 3/29 to report the death of patient, exact date of death was 3/13. Anticipated cause of death includes respiratory failure d/t severe COPD, hypoxia and narcotic use. Was pt previously covid positive? No Are there any predisposing factors (i.e. PMH, HPI, allergy history etc) for patient experiencing adverse drug event? No Any occurrence of an ADR at time of administration or during time of observation? No Was there and ADR between observation period and date of death? No Was patient hospitalized prior to vaccination? No Was patient hospitalized between vaccination and date of death? Yes - d/t severe hypoxia and COPD exacerbation Was hospitalization attributable to ADE ? No Was patient hospitalized prior to death Yes What are the possible cause of death? severe COPD, hypoxia, reduced respiratory drive d/t narcotic use (chronic pain)
I have history of A-fib but after receiving an abrasion. 24 hours after booster-went into A-fib and stayed in A-fib for several hours. When I went to bed and woke up, I was no longer in A-fib. I had a Loop reporter inserted to do continuous EKG monitoring daily. I get a continual report monthly to review what is happening with my heart. I developed some bradycardia issues as well after the initial vaccine was administered.
lost my vision; lost my vision and hearing; essentially unresponsive; feel light-headed; This is a spontaneous report from a contactable consumer (patient).  A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EW0161), dose 1 via an unspecified route of administration, administered in the left arm on 16Apr2021 at 14:30 as SINGLE DOSE (at the age of 27 years-old) for covid-19 immunisation. Medical history included coarctation of the aorta from an unknown date and unknown if ongoing coarctation of aorta (age: 3 months), only requires bi-annual cardiologist visits, loss of consciousness from an unknown date and unknown if ongoing, covid-19 from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient had no know allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient lost his vision and hearing, essentially unresponsive and light-headed on 16Apr2021 at 14:30. Circulation issues leading to a black out. Within 60 seconds of getting the shot, he began to feel light-headed. Within 30 seconds of that, he knew he needed help, so alerted the emergency medical technicians (EMTs) via car horn/flashers. By the time they arrived (120 seconds from the initial shot), he lost his vision and hearing and was essentially unresponsive. They woke him enough to unlock my car door, at which point they had him lay back to improve his circulation. That ultimately worked and got him back to normal within about 5 minutes. The patient had issues like this before relating to a coarctation of his aorta which he had done at 3 months of age. Over the years, he has "blacked out" like this from weight lifting and other high exertion things. This was the first time it was induced without him overexerting himself, and the onset of the "blackout" was much quicker than what he had experienced from weightlifting. Normally, he could tell 1-3 minutes in advance that he would black out. This time, it was about 30 seconds. Therapeutic measures were taken as a result of lost vision and hearing, essentially unresponsive and feel light-headed. EMTs did an electrocardiogram (EKG) and blood glucose check. The outcome of lost his vision and hearing, essentially unresponsive and light-headed was recovered on an unknown date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Engerix B and Recombivax HB administered same day; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 2-month-old female patient who received HBV (Engerix B pediatric) (batch number yy2r3, expiry date 12th May 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis and HEPATITIS B VACCINE (RECOMBIVAX HB) for prophylaxis.   On 24th October 2022, the patient received the 2nd dose of Engerix B pediatric (intramuscular) .5 ml, Engerix B Pre-Filled Syringe Device and the 1st dose of RECOMBIVAX HB. On 24th October 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose 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 Information: GSK receipt date: 25-Oct-2022 Reporter's comment: The medical assistant stated that she gave an extra dose of the hepatitis B vaccine to a 2 month old.  The reporter stated that she gave the RECOMBIVAX HB vaccine that had hepatitis B in it and then gave Engerix B as well on the same day.   It was also recommended that a hepatitis B vaccine be given at 0 and 1 month so the patient was late for the vaccine. Did not consent to follow-up. Additional supportive information: The patient received Engerix B in right thigh and Recombivax HB on the same day, which led to overdose. As vaccination date was not reported for 1st dose of Engerix-B, therefore medication error drug dose administration interval too long was not coded.
Rash on tiny red vesicles from sacrum to (L) buttock down to (L) calf & (L) foot. Very painful, numbness in (L) foot. Toes still painful to touch, & numbness in toes.
Directly after the injection there was a tightening of my throat. It did not affect breathing and dissipated over the course of the day. I also had experienced reactive lymphadenopathy, specifically in the left clavicle area. The lymph node protrusion was large enough to been seen with t he naked eye.
Took Vivotif every day instead of the schedule recommended in the PI; A spontaneous report was received from the assistant nursing director on 14JUN2022. It described a patient (unknown age and gender) who "took Vivotif every day instead of the schedule recommended in the PI" (PT: Inappropriate schedule of product administration). The patient took the Vivotif capsule (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient took their Vivotif capsules every day instead of every other day as recommended in the product information (PI).  Action taken with Vivotif with respect to the reported event was not applicable.  The outcome of the reported event was unknown.  No additional information was reported.  Company comment: It was reported that a patient took Vivotif every day instead of the schedule recommended in the PI (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event.; Sender's Comments: It was reported that a patient took Vivotif every day instead of the schedule recommended in the PI (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event.
Diarrhea; Stomach Pain; Super weak; Nausea; Low grade fever of 100; Cant keep water down; Chills; Headache; Extremely tired; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach Pain), ASTHENIA (Super weak), NAUSEA (Nausea) and PYREXIA (Low grade fever of 100) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant medical history reported.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach Pain), ASTHENIA (Super weak), NAUSEA (Nausea), PYREXIA (Low grade fever of 100), VOMITING (Cant keep water down), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Extremely tired). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach Pain), ASTHENIA (Super weak), NAUSEA (Nausea), PYREXIA (Low grade fever of 100), VOMITING (Cant keep water down), CHILLS (Chills) and HEADACHE (Headache) had not resolved and FATIGUE (Extremely tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications also included nausea meds   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Email address of reporter added.
Systemic: Heart Attack-Severe, Additional Details: 11/1/21 received moderna booster and first flu shot ever 11/2 headache, didn't feel well 11/3 pain in right leg- collapsed at md and couldn't be revived. Mother describes him as healthy and no underlying conditions thought clot earlier this year and pt using asa. We are told md ruled death heart attack as a result of pulmonary embolism.
Pt received flu shot for first time today about 15 mins after receiving medication in left arm. Left arm site became itchy and red. Patient has no C/O difficulty breathing or hives. Reaction is at local site only note. Given Benadryl 50mg PO advised. To call Dr or go to ER if symptoms persisted. 3:15 pm called client at home states no continued problems noted.
temperature excursion on GARDASIL 9; No other adverse events - No signs or symptoms reported; Information has been received from a registered nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL for prophylaxis, lot# 1687293 and expiration date reported as 25-AUG-2022, but upon internal validation was established as 30-APR-2023 (route of administration not reported). No adverse events were reported.  On an unknown date, the vaccine underwent a temperature excursion of 47.1 Fahrenheit degree for 13 minutes. No previous temperature excursions were reported. The call was not placed because a digital data logger.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687293; expirationdate: 30-APR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA005285: US-009507513-2104USA003211: US-009507513-2104USA003212: US-009507513-2104USA003213: US-009507513-2104USA003215: US-009507513-2104USA003216: US-009507513-2104USA003217: US-009507513-2104USA003218: US-009507513-2104USA003219: US-009507513-2104USA003220: US-009507513-2104USA003221: US-009507513-2104USA003222: US-009507513-2104USA003223: US-009507513-2104USA003224: US-009507513-2104USA003225: US-009507513-2104USA003196: US-009507513-2104USA003197: US-009507513-2104USA003198: US-009507513-2104USA003199: US-009507513-2104USA003200: US-009507513-2104USA003201: US-009507513-2104USA003202: US-009507513-2104USA003203: US-009507513-2104USA003204: US-009507513-2104USA003205: US-009507513-2104USA003206: US-009507513-2104USA003210: US-009507513-2104USA003207: US-009507513-2104USA003208: US-009507513-2104USA003209:
Patient reports stinging sensation to L neck after injection in L deltoid.  Denies SOB. Patient given bendadryl 50mg PO at 0838.  0844 - Patient reports burning sensation has improved. 0848 - BP = 143/89, HR = 104, RR = 18 and O2 Sat = 100%.  Redness decreasing - patient reports no burning or itching.  Patient advised to ask her physician if she should take benadryl prior to 2nd dose.
rash started 1JUL93 on arms, chest, back-started DPH-c/o itching;
INCREASED THIRST; MORE FREQUENT URINATION; SHARP SHOOTING RIGHT LEG PAIN; FEELING COLD; FEVER 100.8F; This spontaneous report received from a consumer concerned a 39 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient did not have any significant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1816022 expiry: 29-SEP-2021) dose was not reported, administered on 23-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-AUG-2021, the patient experienced increased thirst. On 23-AUG-2021, the patient experienced more frequent urination. On 23-AUG-2021, the patient experienced sharp shooting right leg pain. On 23-AUG-2021, the patient experienced feeling cold. On 23-AUG-2021, the patient experienced fever 100.8f. Laboratory data included: Body temperature (NR: not provided) 100.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever 100.8f, sharp shooting right leg pain, feeling cold, increased thirst, and more frequent urination. This report was non-serious.
I had swelling of the face, and cold sore on my lips, did have a hard time the first day after 40 minute swelling of throat
Aunt reports child received shots on 8/16/02 (Friday). On next day, upper left arm was red and swollen approx. size of 50 cent piece. Redness and swelling gone by 8/19/02.
fever and fatigue and sweats x 9 days with development of urticaria at day 9
Patient was administered the incorrect vaccination. They should have received Pneumovax 23, but were given Prevnar 13. No adverse effects noted.
we realized that the dose administered to the patient had been 0.5ml instead of 0.25ml. When we were able to contact the patient we apologized and explained the error in the dose administered and he was told that it was the dose of 1 or 2 of MODERNA but not the booster dose. She had previously been vaccinated with the Johnson and Johnson vaccine. The patient did not show upset and was asked if she has experienced any discomfort or adverse effects and it was okay to which she replied that everything was fine and that she hadn't had any ill effects. She explained to him that she would document the fact of her and that she would call her from Pharmacy insurance to ask for more information. We expressed to her our commitment and responsibility regarding these events and that her safety comes first.
Started to feel very cold and muscles started to tense and shake around 10:00pm. As I was laying down trying to sleep my heart rate increase to approximate 151bmp for approximately 9 mins and remained above 110bmp all night. When I woke up the next morning around 7:25am my heart rate was still approximately 110 bmp and I had a severe headache and nausea. After taking an extra strength Tylenol and eating a piece of bread I went back to sleep for 90ish mins and woke up feeling  a little better. At that point my heart rate had dropped below 100 bmp.
Breathing restricted/air way issues/felt restricted; Broke out with blisters; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Broke out with blisters) and DYSPNOEA (Breathing restricted/air way issues/felt restricted) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   In 2006, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2022, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In 2021, the patient experienced BLISTER (Broke out with blisters). On an unknown date, the patient experienced DYSPNOEA (Breathing restricted/air way issues/felt restricted). At the time of the report, BLISTER (Broke out with blisters) and DYSPNOEA (Breathing restricted/air way issues/felt restricted) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Post yellow fever vaccination: Severe shooting sciatic nerve pain and numbness/tingling reaching through leg and to left foot (same side as injection). Also 2 inch diameter raised, red bump at injection site hot and painful to touch. Urgent care clinic resulted in use of pain medications, tordal injection and musle relaxants which all greatly helped. Majority of nerve pain resolved after 3 days, complete resolution of nerve pain after 2 months. Injection site reaction resloved in 2 weeks. Subsequent MD visits noted loss of reflex in left ankle indicating nerve damage.
Patient received IM of vaccines in anterior right thigh on 27 Mar 2007 mom states redness at injection site and circumferential erythema, swelling, tenderness and warmth began 28 Mar 2007. Less today. Child, also presents with bronchiolitis today. Treated with Augmentin, Ibuprofen, Prednisone syrup.
Moderna COVID- 19 Vaccine EUA Patient was found deceased in the community near his home address on 2/24/21.  The Medical Examiner's cause of death is currently listed as "Drug Intoxication - Accidental Overdose."  Per the MEO, post mortem urine toxicology was positive for cocaine and fentanyl.  His death is believed to be related to a cocaine product that was adulterated with fentanyl and is not believed to be related in any way to the Moderna COVID-19 vaccine.  This was explicitly stated by the Medical Examiner's Office.
I have a large red, circle on my arm tender to touch. It has a 2" diameter and is the width of almost my arm. The entire red area is very firm and feels like a bump.
Soreness in left upper muscle hours after injection-worsened about five days later and seven days later pain is restricting upper arm movements and pain intensifies with certain normal arms positions.
This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. A male patient of unspecified age and ethnicity received, on an unspecified date, TRUMENBA single dose. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient felt weird and had fever at 103 Fahrenheit. Clinical outcome of the events was unknown at time of this report. Follow up (29JUL2016): Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a certified medical assistant, refers to an unknown number of patients of unknown demographics. The patient's concurrent conditions and medical history were not reported. On an unknown date in 2013, an unspecified number of patients received improperly stored Vaccine For Children (VFC) doses of RECOMBIVAX HB (dose and route, lot and expiration date were not reported) exposed to 20F and 30F on multiple occasions, from 22-SEP-2013 until 20-DEC-2013 (for 122 days. No adverse effects were reported (the reporter stated that the vaccines administered were RECOMBIVAX HB and VAQTA but on a second call was reported that no doses of VAQTA were involved in this excursion. Follow up information has been received from the certified medical assistant which reported that one of the patients was vaccinated with a dose of RECOMBIVAX HB (lot number reported as J0030722) on 29-AUG-2013. This is the one several reports from the same source. J0030722 is not valid lot number for RECOMBIVAX. Additional information has been requested.
Fever, lethargic, nausea. Rest, fluids, Tylenol rotated with ibuprofen