chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ED to Hosp-Admission  Discharged   10/7/2021 - 10/13/2021 (6 days) COVID-19  Principal problem Hospital Course       Hospital Course:   80-year-old male past medical history significant for type 2 diabetes mellitus BPH stage III CKD was admitted to the hospital because of mild hypoxemia secondary to COVID-19 infection.  He was initially started on Decadron remdesivir however he has been saturating well on room air therefore Decadron remdesivir was discontinued.   He was found to have urinary tract infection present on admission for which she completed a course of antibiotics during this hospitalization.   He came to the hospital with a Foley catheter.  His Foley catheter was discontinued and bladder scans were done.  Patient was able to urinate on his own with the help of finasteride and Flomax.  His Foley catheter has been discontinued.  If he has urinary problems please have him reevaluated by urology on outpatient basis.   He developed confusion and hospital-acquired delirium during his hospitalization which has been resolved.   Physical Occupational Therapy evaluated the patient and recommended home with home health care services.   He is being discharged instruction to follow-up with his family doctor within 1 week.
1 of 2 pts who recvd vax 14DEC94 & exp an adverse event;pt exp itching & swelling @ the inj site w/in 24hrs p/vax;afeb;rx w/DPH/warm compresses
Not an adverse event but patient received Pfizer for her first dose and inadvertently received Moderna for her second dose.
Next day (24hrs) patient states orbs in both eyes that went blind in both eyes. Patient states blurry vision in both eyes. Patient states itchy eyes still. Patient states rash: arm.
The day following admin of vax, pt devel elevated temp of 105; On 16APR92 pt seen by MD, t106; MD dx throat infect & Amoxicillin prescribed;
woke with cold sweat,vomiting during the night.next day no vomiting just extremly tired.
9cm X 16cm red, warm area. Onset on 5/15/01 PM, quarter-sized. On 5/16/01, it was egg-sized and an area of hives. On 5/17/01, it was orange-sized. Placed on antibiotic therapy.
sore arm; dizziness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm and dizziness. On an unknown date, the outcome of the pain in arm and dizziness were recovered/resolved.   It was unknown if the reporter considered the pain in arm and dizziness to be related to Shingrix.  Additional details were provided as follows: The patient received her 1st dose and had a sore arm and dizziness for approximately 2 days. For tolerance in 2nd dose refer case refer case US2021008399. This case is also been linked with US2021021112 and US2021008399, reported by the same reporter. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021008399:same reporter US-GLAXOSMITHKLINE-US2021021112:same reporter US-GLAXOSMITHKLINE-US2021008399:same reporter
Trouble breathing; Throat was a little swollen; Sinuses were stuffy; Got tired and went to bed; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ERB737) via an unspecified route of administration in the left arm on 13Apr2021 at 14:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, diabetes 2 (type 2 diabetes mellitus) and knee arthritis. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), hydrochlorothiazide / losartan potassium (LOSARTAN/HCTZ), diltiazem (MANUFACTURER UNKNOWN), and glibenclamide (GLYBURIDE); all for an unknown indication from an unknown date and unknown if ongoing. On 13Apr2021, at approximately 21:00, the patient got tired and went to bed. On 14Apr2021, at 00:00 the patient woke up at mid-night and experienced trouble breathing and also felt like throat was a little swollen, but had no problem in swallowing, sinuses were stuffy but had no allergies and no sinus problems before. The patient sat up the rest of the night and the breathing got better. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events got tired, trouble breathing, throat was a little swollen, and sinuses were stuffy was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
The pt developed the flu, had achy feeling, dizziness, very weak and had a headache. The pt went to the ER.
He got the first two and then he had gotten COVID; He got the first two and then he had gotten COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (Unknown). The reporter is the parent.  An infant (almost 23 months) male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The reporter wanted to know when her son could take the third booster shot. Her son was under 2-year-old. He got the first two and then he had gotten COVID, so they pushed it back a week and then the doctor's office cancelled, and now they were having trouble finding a location that will administer it. She was wondering how long until he wouldn't be valid anymore to get the third dose. The doctor said any time after the 8 weeks was fine but she did not want to as it has been 3 months at the time of report. Outcome of the events was unknown.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The patient  is a 74  year old male admitted to the 10-3/4 ICU for submassive pulmonary embolism. Pertinent past medical history includes a diagnosis of COVID-19 8 days ago, and an NSTEMI in October 2021 s/p PCI to ungrafted left circumflex in the setting of prior CABG in 2014.  Over the course of the last week the patient reports stuttering episodes of chest and abdominal pain, abrupt in onset and progressive in nature.  He had a significant event which prompted his presentation to the emergency department at MCHS New Prague yesterday, where CT pulmonary angiogram demonstrated extensive bilateral thromboemboli.  On initial presentation his blood pressure was 70 systolic and he had an elevated lactate and troponin, but rapidly stabilized with 1 L of crystalloid resuscitation and heparin infusion.  Due to the lack of PCU beds he was transferred for telemetry monitoring.
Pt recv vax on 11/8/97; in 3/98 pt exp numbness & tingling in lower extremities; dx=idiopathic peripheral neuropathy
Sensitivity; Pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HYPERSENSITIVITY (Sensitivity) and VACCINATION SITE PAIN (Pain) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007NL20A) for COVID-19 vaccination.     The patient's past medical history was not reported .     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE HYPERSENSITIVITY (Sensitivity) and VACCINATION SITE PAIN (Pain). At the time of the report, VACCINATION SITE HYPERSENSITIVITY (Sensitivity) and VACCINATION SITE PAIN (Pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided Treatment information include Ice Pack   This case was linked to MOD-2021-031381, MOD-2021-142201 (Patient Link).
I may have had a reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (I may have had a reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (I may have had a reaction). At the time of the report, VACCINATION SITE REACTION (I may have had a reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were reported. No treatment information was reported.
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No adverse event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    Concomitant medications were not reported.                                       No treatment information was provided by the reporter.   This case was linked to MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-697752:
Edema of right deltoid, erythema positive warmth non tender to deep palp. skin structure intact.
Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient recvd vaccine about 5pm, then was talking to wife as she was about to recv her vaccine, when he fainted and fell backwards onto the moveable privacy screen, helped into a chair then fainted again, low pulse, shallow breathing, called 911, then he was taken to emergency dept.  called his number at 7PM but not reached for followup.
PATIENT GOT VACCINE AND IMMEDIATELY HAD A LOCALIZED KNOT IN LEFT DELTOID.
weakness, seizure, rash, resp problems, SOB; pt taken to ER given Lasix, EPI, Solumedrol, DPH, Nitropace, resp therapy;
mild lightheadedness.  I had just worked overnight and had not eaten or had any water that morning. , resolved after drinking a bottle of water.
Flushing at 1130, fatigue during first day, extreme joint and muscle pain second day
Rash on left arm started appearing on 1/7 and has gotten larger on 1/8. Pain in arm started mid day on 1/8, not just at injection site, but throughout all of the top half of my arm and into the left shoulder/shoulder blade. There is a raised bump on the left arm as well that just appeared on 1/8. Arm aches and itches too.
Information has been received form a reporter concerning a patient who was vaccinated with PNEUMOVAX 23 (manufacturer unknown). On an unspecified date, the patient experienced severe cellulitis and needed urgent care. The outcome of the patient was not reported. This report was received from Watson Pharmaceuticals. Follow-up information received from a L.P.N. concerning the 67 year old patient who on 11-FEB-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot number 665400/1315Y). The patient was not diagnosed with cellulitis. The patient reported that her arm was red at the injection site and she went to an Urgent Care for treatment. The L.P.N. did not known what type of treatment the patient received at the Urgent Care Facility. The patient was not hospitalized. The L.P.N. did not know if the patient's reactions was disabling or life-threatening. At the time of the report, the patient had recovered. This is one of several reports from the same source. Additional information has been requested.
High fever (102 degrees), shivering, headache, nausea, swollen arm at vaccine site. Fever lasted approximately 12 hours. Headache lasted approximately 24 hours.
Product was left out of refrigeration for 15 hours, temperature reached is 75 F for 15 hours with no adverse event; Initial information received on 13-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age male patient and it was reported product was left out of refrigeration for 15 hours, temperature reached is 75 Fahrenheit (F)  for 15 hours with no adverse event, it involved vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT MULTIDOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date the product was left out of refrigeration for 15 hours, temperature reached is 75 F for 15 hours with no adverse event (product storage error) (latency: unknown) and it involved vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED, (lot: UT7680L ; expiry date: 30-Jun-2023). The product was to be used for prophylactic vaccination (immunization)   Action taken : not applicable.  Outcome: unknown   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.
Within the first 4 hours of the first dose I started Left shoulder, breast, arm pit  and arm pain and weakness of the upper arm muscle. These symptoms continued up to the time my second dose was due; however, the symptoms have progressed to the point where I have lost range of motion with certain arm movements along with decreased strength. I am dealing with continued left arm pain that has limited my ability to lift at work and the pain wakes me up from sleep at night and remains constant.  My PCP and I have held off the second vaccine due to the severity and limitations of movement. It has now been one and a half months since my vaccine and my symptoms continue with no decrease in intensity and limitation.
Sore, red, itchy eyes.  Hoarse throat.  Headache.  Body aches.
received a twinrix expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 47-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 age at vaccination was not reported. The patient received a Twinrix expired dose, which led to expired vaccine used.  Vaccine information such as lot number and expiration date were not available.  Medical assistant informed that, Twinrix dose was expired by 10 days. The reporter consented to follow up.
While immunization was being administered syringe disconnected from needle only a partial dose of JYNNEOS was administered. Patient was not harmed and was informed, Dr was informed and advised not to revaccinate at this time.
Client presented 1 wk post Td vaccination w a large reddened coalescing area on lateral surface of L upper arm.  Client denies pain c/o only of itching.  Stated redness & itching began 12/04/05 & hasn't spread to any other areas.
The day after the second COVID-19 Pfizer vaccine, the patient has bee experiencing persistent diarrhea. Patient denies melena, but admits fatigue, frank red blood, and intermittent cramps. A full work-up is in process and no definitive diagnosis has been found as on 03/08/2021. However patient has bee stable and no hospital admission has been required as of 3/8/2021.
my face is swollen, pink; Itchy face; my face is swollen, pink; This is a spontaneous report from a contactable consumer. This 17-year-old female consumer (patient) reported for herself. A 17-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EW0183; Expiry date- Aug2021), dose 1 via an unspecified route of administration on 17May2021 (at the age of 17-years-old) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 18May2021, the patient started experiencing adverse events face was itchy last night and then she woke up around 11:30 and whole face was like pink, swollen and itchy. Outcome of the event was unknown.  Informed about the Medical Information Department Provided. Follow-up attempts completed. No further information expected.
Low potassium levels; This is a spontaneous report from -sponsored program  Support received via a contactable HCP reported for a patient. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The HCP reported that, the patient experienced medical complication after first dose of vaccine. Low potassium levels. HCP wanted to know when his patient should get second dose. Was advised by HCP to wait 90 days because of medical history. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Suspected Vaccination Failure; I got both shots and still got them!; The shots helped by making them itch; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pruritus. On an unknown date, the outcome of the vaccination failure, shingles and pruritus were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient had both the shots and still got shingles. The shot made him/her itch, not hurt. This case was considered as suspected vaccination failure as details regarding, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
In ED, patient was febrile of 104, tested positive for COVID-19.  Patient was not hypoxemic, not hypotensive, normal lactate level Patient However met criteria for severe sepsis with acute organ dysfunction Patient was started on remdesivir, levofloxacin for broader empiric coverage.
Low fever (100.1 F), body ache, exhaustion, general discomfort.  Symptoms first started the evening of the vaccination day (yesterday, 04/08/21).  The symptoms increased day after the vaccination (04/09/21).  Patient has been in bed since last night
Small - 2 inch round red warm area at injection site - brought to our attention on 2/3/11.
PT IMMUNIZED 1-4-90.1-10-90 PT EXPERIENCED JERKING MOVEMENTS INTERMITTENTLY FOR 18 HRS.HIGH PITCHED CRY FOR 24 HRS.TYLENOL GIVEN FOR LOW GRADE FEVER.OFFICE VISIT 1-10AND1-15;INFANT RECOVERED
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. On 26-SEP-2013 the patient was vaccinated with the third dose of ROTATEQ (lot# reported as 0055AE; expiry date: 13-SEP-2013) 2ml, oral. No adverse effects reported. The outcome of the event was unknown. Additional information has been requested.
One day post vax the pt experienced arthralgias of both hips, rib pain, b/l wrist pain, myalgias of both thighs, low grade fever and fatigue. Sedimentation rate was elevated at 30. It was reported that the symptoms waxed and waned and abruptly resolved on 09/12/1999.
death; This is a spontaneous report received from a contactable consumer. This consumer reported similar events for two patients. This the second of two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided) via an unspecified route of administration, on unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced death on an unspecified date. It was unknown if autopsy was performed.   Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021371687 same reporter/event, different patient; Reported Cause(s) of Death: death