chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles [rash]; [Shingles] rash; Itchiness; Information has been downloaded from Agency (US-BEH-2014047537).  This spontaneous report was received from a health care professional and refers to a 64 year old male patient. The patient's medical history included herpes zoster on an unspecified date in 1984 (reported as "1984-1985"). Concomitant therapies included rosuvastatin calcium (CRESTOR) and lisinopril. Information about the patient's concurrent conditions and drug reactions or allergies was not provided.  On 08-NOV-2014, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (batch # reported as "00006-4963"), in the left arm (via reported as "SYR"), for prophylaxis (strength, dose, frequency, lot number and expiration date were not provided). On the same date, the patient was also vaccinated with a dose of influenza virus split virion 3v vaccine inactivated (AFLURIA) (batch # reported as "33332-0014-01"), in the right arm (via reported as "SYR"), for prophylaxis (strength, dose, frequency, lot number and expiration date were not provided).   On 09-NOV-2014, the patient experienced herpes shingles (zoster), pruritus and itchy sensation of extremities (rash). At the time of reporting, the outcome of herpes zoster, pruritus and rash was reported as not resolved.  The causal relationship among zoster vaccine live (ZOSTAVAX), influenza virus split virion 3v vaccine inactivated (AFLURIA) and the reported events was not provided.  The reporter considered the events as serious, medically significant.
1 day fever and malaise and headache. 2 days malaise and headache. 3 days severe pain in right waist. 4 days severe pain continues. 5 days rash appears on right waist and severe pain continues. 6 days blisters appear on rash with continued severe pain. 7 days rash, pain and blisters persist.
CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 28-DEC-2021, the patient experienced confirmed covid-19 infection. Laboratory data included: COVID-19 antigen test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed covid-19 infection was not reported. This report was non-serious.
This spontaneous report was received from a medical assistant and refers to a 4 year old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 22-AUG-2017, the patient was vaccinated with improperly stored  PROQUAD injection (lot # N010247 with expiration date on 25-SEP-2018, dose, anatomical location and route not reported) for prophylaxis, reconstituted with properly stored sterile diluent (manufacturer unknown). The administered vaccine experienced a temperature excursion of 6 degree Fahrenheit to 14 degree Fahrenheit for 18 hours. There was no previous temperature excursion and the call was not because of a data logger. No adverse effects were reported. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA000870: US-009507513-1710USA009270: US-009507513-1710USA009267: US-009507513-1709USA001401: US-009507513-1710USA009269:
Rec. vaccine to avoid having shingles on Mon. 7/23 broke out with chicken pox on the 7/27. No where on 2 pages given to me at medical center re: shingles vaccine does it mention could get chicken pox from vaccines Paper from CDC
Narrative: 58 y/o female presented to ER on 1/15/2022 with hypoxia and reports of SOB, productive cough, and right side chest pain, Admitted to hospital for higher O2 requirements and possible CPAP. Pt became hypotensive requiring pressor support, found to have strep pneumonia bacteremia, which was treated with antibiotics. COVID infection treated with dexamethasone and remdesivir. Discharged 1/27/2022. PMH includes COPD, HTN, hyperlipidemia, OSA, and osteoporosis.
COVID-19 break through case  I received 2nd booster shot on 04/20/2022. Adverse event stared on 05/7/2022-  5:00PM - 9:00PM sore throat,  on sat  negative full blown cold high fever of 104. May 9 on Sunday I  did  a  home test came out to be positive.  I  did tele health with my doctor on May10,2022  she prescribed me paxlovid for 5 days.  I am still recovering but not fully recovered yet. other people in the event that I went to tested positive this is where I  changed my mind and did home  COVID  test just to make sure.
Redness at injection site for 3 full days after the 2nd shot; large bump/swelling at injection site for 3 full days; swelling at injection site for 3 full days; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 03May2021 at 11:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfa allergy (sulfonaminde allergy). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included multivitamins (MANUFACTURER UNKNOWN), colecalciferol (VITAMIN D3) and riboflavin (VITAMIN B2) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09Apr 2021 at 11:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 04May2021 at 12:00, after the second shot the patient experienced redness, large bump and swelling at injection site for 3 full days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events redness, large bump and swelling at injection site for 3 full days was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
genl achiness-h/a advanced to tonic clonic convuls-arms & legs, body arching thru noc, petechia over arms, chest, abdo & legs several wks; ER visit later that day
13JUN95 grandma reports on 8JUN pt had fever (?) no temp & cried for half hr steady; mom did not phone MD; t102; spots on face; rash-macular papular; flat rash on body-fading from face extreme trunk;
There are no symptoms to report. Patient came into the pharmacy and asked for a flu shot. I have a witness claiming she asked for a flu shot. I ran it through and passed it through our system. We administered the vaccine, and afterward she said she was there for a covid-19 vaccine, not a flu shot. She was given a flu shot previously on 10/22/21 so she didn't need a flu vaccine. The covid vaccine she wanted was also administered afterward. She did not have an appointment which is required for covid vaccinations, but we had an extra dose to give her since she wanted it.
We gave the patient their first Covid shot. Then later on in the day I was running reconciliation report and database showed it was expired on 11-25-2022. We had 3 bottles in the freezer.
Initial report received from a health care professional (nurse) on 01 Sep 2010: This adolescent was vaccinated with MENVEO (batch number 022011), 0.5 ml intramuscularly in the upper arm on 24 Aug 2010. On 24 Aug 2010, the adolescent's upper arm became red and was warm to touch. The adolescent was treated with antibiotics. The outcome of the event was reported as completely recovered.
BRIEF OVERVIEW: Admission Date: 8/20/2023 Discharge Date: Aug 28, 2023 Discharge Disposition:  skilled nursing facility      Active Issues Requiring Follow-up: Pt. will follow up with her PCP and ortho outpatient  ?  No future appointments.   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Fluid overload [E87.70]   HOSPITAL COURSE: This is a pleasant 69-year-old woman with past medical history of ESRD on hemodialysis MWF, OSA on CPAP, hypothyroidism, GERD, recurrent diverticulitis, and orthostatic hypotension  who presented for SOB and requesting HD.  Patient missed HD on 8/14 but did have HD on the following Wednesday and Friday.  She has had one-week history of cough with shortness of breath, congestion, and generalized weakness.  She was found to be COVID positive. Patient was mildly hypoxic requiring 1 L nasal cannula.  Chest x-ray with no acute cardiopulmonary process.  NT proBNP was significantly elevated. She was given dose of IV Solu-Medrol and transferred to hospital for HD.  Patient was quickly able to be weaned off of oxygen so further steroids were held. Patient also complained of right shoulder pain with known chronic right anterior shoulder dislocation for which orthopedic surgery was consulted and rec sling with outpatient follow up with her establish orthopedic surgeon Dr. Pt. did have complications of episode of aphasia during her stay that quickly resolved. Neuro was consulted. CT head with chronic bilateral basal ganglia lacunar infarctions. MRI/MRA brain was obtained with no acute abnormalities. Carotid U/S without significant stenosis. Neuro felt her symptoms were due to metabolic encephalopathy with hospital acquired delirium and recommended no further inpatient workup. PT/OT recommended SAR. Pt. will follow up with her PCP and ortho outpatient. Pt. is discharging to SAR in improved and stable condition.
Diluent not mixed with lyophilized part; Only diluent administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number C495B, expiry date 28-JUN-2024) for prophylaxis.  On 20-MAR-2023, the patient received the 1st dose of Shingrix. On 20-MAR-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Diluent not mixed with lyophilized part) and inappropriate dose of vaccine administered (Verbatim: Only diluent administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional Information: GSK Receipt Date: 20-MAR-2023 The pharmacist had reported a patient was inadvertently administered a Shingrix AS01b diluent only dose without the lyophilized component on the day of reporting in their facility. The pharmacist had mentioned that this was an attempt as the first dose of Shingrix series.  No additional details were provided. The reporter had denied consent to follow-up. The patient only had received the diluent solution Shingrix vaccine without the lyophilized component, which had led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
NERVE PAIN, STIFFNESS,  PATIENT FELT PARALYZED  COULDN'T MOVE
Slightly elevated temp, mild nausea, chills, muscle aches, fatigue, mild headache. All this started 6 days after the vaccine. On the 6th night  after the shot, symptoms lasted about 8 hours. Then started up worse during the night of  the 7th day, especially the chills, elevated temp, fatigue  and nausea. Symptoms such as the chills are starting to subside about 10 hours later but some such as mild fatigue still remain. Is this normal for symptoms to show up nearly a week after the shot?
Developed a red, slightly raised rash on the arm that was injected.  Not itchy, not painful.  It was roughly 3x3 inches, sort of heart shaped, homogenous and not at the injection site, but rather between my elbow and shoulder.  It disappeared within 36 hours with no further recurrence.
pt recvd vax; next day pt hospitalized w/ following sxs: fever; h/a; chills; inc liver func tests; new onset of arthritis & swelling of the fingertips;
pt recvd vax 9MAR93 dad states on same day arm swelled up down to elbow, school nurse called regarding same matter arm still swollen, reddened, tight, fever & chills; advised parent to see pvt MD;
11/13/2022-Presents to ED, increased sob and low o2, 88% RA at home. Chest congestion and has chills. Covid + test. eGFR 45. WBC- 16.7. HR-129 a fib with RVR, RR 20. ABG-7.4/42.6/56/ o2 90 on RA.   Acute resp failure with hypoxia s/t covid 19. Sepsis. CXR- possible infitrate. Start Zosyn, dexamethasone, remdesivir and vanco. Started on 2L NC. 11/16/2022-Tolerating RA, continue IV remdesivir and decadron. IV ceftriaxone. D/d home after  completion of remdesivir. 11/18/2022-Remdesivir completed. tolerating RA. WBC-12.4 egfr >60. D/C  home.
2/5/2021 at 1:30am sharp headache woke me up,  6:30 freezing cold, achy joints, red rash warm hard painful at injection site 9:00am achy muscle, joint pain, fever 100.5, freezing cold and shaky continued entire day. 2/6/2021 2am  kidney pain, muscle pain, headache no longer cold, no longer had fever. Warm, hard painful red rash at injection site about 4 inch rectangular shape increased in size  2/7/2021  red warm hard painful rash at injection site and headache
Admission Date: 7/6/2022 Discharge Date: 7/10/2022  PRESENTING PROBLEM: Respiratory failure with hypoxia (HCC) [J96.91]   PER ADMISSION H&P:  is a 53 y.o. male with history of congestive heart failure, last EF 35%, insulin dependent type 2 diabetes mellitus, history of bioprosthetic aortic valve, on Coumadin, was vaccinated for COVID presented to  Emergency department for worsening shortness of breath for past 2 weeks, denies any productive cough, does complain of leg swelling or denies any chest pain, dizziness or lightheadedness.  patient tachycardic, febrile and hypoxic when presented to the emergency department, placed on 2 L nasal cannula.  Significant labs showed positive COVID-19 PCR, lactic acidosis, chronic thrombocytopenia, mild hypokalemia.  Chest x-ray showed pulmonary vascular congestion with concern of patchy infiltrate within the lingula, he received 2 L normal saline bolus along with Rocephin, azithromycin and dexamethasone in the emergency department.  For further evaluation and management transferred to  Hospital, admitted     HOSPITAL COURSE: The patient was treated for acute hypoxic respiratory failure, due to acute on chronic systolic heart failure, COVID-19 pneumonia, as well as likely superimposed bacterial pneumonia.  Received dexamethasone 6 mg orally from 07/06 through 7/9.  Notable steroid induced hyperglycemia so insulin dosing slightly increased but home dose resumed at discharge.  He completed 5 day course of ceftriaxone and doxycycline IV for community-acquired pneumonia, no antibiotics prescribed at discharge.  Patient was diuresed with IV Lasix, and transition back to home oral dose of Lasix at discharge.  Unfortunately, echocardiogram revealed worsening EF 16%, severe left ventricle global hypokinesis but with well-seated bioprosthetic aortic valve.  Cardiology was consulted and unfortunately not able to see him on 07/09, although he had weaned to room air and was otherwise ready for discharge.  He remained inpatient and Cardiology evaluated him on 07/10.  They felt he could benefit from increased IV Lasix but patient requested to return home.  They felt it was reasonable for him to return home with close follow-up.  He was recommended to continue current metoprolol dose, Jardiance, decreased dose of Aldactone, and started Entresto.  Patient's blood pressure remained stable with added Entresto and he discharged home in stable condition.  Cardiology did not feel he needed a LifeVest prior to discharge, but will discuss further workup and possible ICD placement.
Sore throat, cough, fatigue, fever, chest and head congestion  7/29/21 thru 8/5/21. Treatment was bed rest and fluids Fatigue, afternoon fever, chest and head congestion, physical weakness, poor balance 8/6 thru 8/16.  Treatment included antibiotics, rest, fluids. Fatigue, physical weakness, balance, head congestion 8/16 - 9/8.  Treatment included another week of antibiotics. Ongoing fatigue, physical weakness, shortness of breath, and balance issues continue.  Treatment is reduced activity and rest..
5 days after injection developed right sided face and lip numbness, tingling, burning, swelling. Diagnosis: Bells Palsy
NAUSEA; FEVER; WHOLE BODY JOINT ACHES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 18:05 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced whole body joint aches. On 16-MAR-2021, the subject experienced nausea. On 16-MAR-2021, the subject experienced fever. Laboratory data (dates unspecified) included: PCR (NR: not provided) NEGATIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, fever, and whole body joint aches. This report was non-serious.
Fever 101.4 rectally within 7 hours after shots given. Fever management ordered only.
first dose DEC 2019, requested 2nd dose; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in December 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date:24-Mar-2022 Reporter's comment: This case was reported via interactive digital media. The reporter received Shingrix request for 2nd dose and asked would they need to start over. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Inconsolable crying for 3 hours fever 101.7 for 24 hours.
Patient received booster dose prior to the 5 months since her second vaccination. Her second vaccination was on 12/02/2021. Booster dose was given on 02/15/2022.
Stroke due to a large blood clot to the brain; Stroke due to a large blood clot to the brain; Widespread blood clots in both of her arms; This is a spontaneous report from a contactable consumer (daughter).   A 67-year-old female patient received the 2nd single dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in the left arm, on 17Mar2021 (at the age of 67 years old, not pregnant at time of vaccination) (Lot number was unavailable since unable to locate or read the details), for COVID-19 immunisation. The patient's medical history included ongoing atrial fibrillation, high blood pressure, and scoliosis. Concomitant medications included ongoing acetylsalicylic acid (ASPIRIN) for atrial fibrillation, naproxen, pregabalin, tramadol, and metoprolol. The patient never had a history of blood clots. There were no allergies to report. The patient had not received any other vaccines in the four weeks prior to receiving BNT162b2. The patient had received the first single dose of BNT162b2 on an unspecified date, in the left arm. The patient's daughter stated that her mother suffered a stroke due to a large blood clot to the brain on 25Mar2021 at 12:30 am, requiring hospitalization. During hospitalization, a surgery to remove blood clot from the brain was needed. Hospitalzation lasted 12 days. The reporter added that in the week prior to the reporting, the mother 'passed' (as reported) but had widespread blood clots in both of her arms. The patient required unspecified treatment due to the events and had not recovered at the time of the reporting. The events were considered also serious since life threatening and due to disability. The patient did not have COVID-19 prior to the vaccination and had not tested positive post vaccination.  Information on lot/batch number has been requested.
Below the injection site- the arm became red and a bit swollen, firm, painful when touched, very warm to the touch at the spot, painful when raised the arm up - went to the doctor and he said its an infection and recommended an antibiotic dose
Patient was administered the incorrect formulation of COVID vaccine. Patient received a Moderna vaccine instead of the appropriate Pfizer dose.
Panic attack; 2 weeks delayed in her regular mensuration; This is a spontaneous report received from a non-contactable consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration, administered on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced panic attack on an unspecified date. Patient was stated that after couple of weeks ago she got the first vaccine and after 5 hours, she experienced panic attack. So, she wanted to know about the vaccine and if it was possible to happen again if she gets the second dose and she was already 2 weeks delayed in her regular mensuration. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient had COVID-19 breakthrough disease after vaccination.  On 4/30/2021 developed body aches, nasal congestion, and sore throat.
Client returned to LHD on 3/25/21 at 9:40am complaining of significant swelling into neck and axillary lymph nodes, redness, and difficulty moving arm. Redness was in an area over right deltoid approximately 4in vertically X 3 in horizontally. Redness did not go into shoulder, but started approximately 2 finger breaths below shoulder. Appeared vaccination was given in proper location. Client stated she was taking .Motrin and using the arm very frequently. She was tearful when moving arm.  Client feels her pain threshold is high due to hx of broken hip in past and this pain seems worse. Client was very concerned about a worse reaction with a second vaccine. Client did state, " the nurse said I was a really small person so she was going to use a smaller needle."  This nurse believes that means nurse at mass vaccination clinic used a 5/8 in needle. Client probably weighs 120-130lbs. Client did not and did not want to sign up for Vsafe. After discussion client decided to go to Urgent Care. Follow-up phone call to client  at 12:30pm on 3/26. Client states Urgent Care Dr did not think it was cellulitis. Client was very fatigued and stated she then went to daughters and took 2 hour nap. She felt she did not want to go home by self as she was still very concerned. Client states, 'has hx of developing significant tongue swelling throat closing reaction to Bactrim  about 4 days after starting and physician telling her in the ER she could have died if she did not come in'.  Advised her to get 2nd vaccine. Client is still undecided about getting 2nd vaccine. Pain has decreased, but arm remains swollen and is now itchy.  Client will continue to monitor and return to urgent care if symptoms get worse.