chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Admission Date: 9/19/2022 Discharge Date: Sep 22, 2022 PRESENTING PROBLEM: Hypoxia [R09.02] COPD with acute exacerbation (HCC) [J44.1] COVID-19 [U07.1]   HOSPITAL COURSE: HOSPITAL COURSE: Patient is an 86-year-old female with COPD (not on home oxygen), hypertension, chronic low back pain and ongoing tobacco abuse who presented with worsening shortness of breath.  She had been placed on a Prednisone burst by her outpatient pulmonologist on 9/15 with no significant improvement in symptoms, so presented to the ED on 9/19.  In the ED, her oxygen saturations dropped to 85% on room air and was placed on 1 L oxygen.  She was hypertensive in the ED with blood pressure 203/81.  She was found to be COVID positive.  Chest x-ray showed no acute cardiopulmonary process.  Due to her hypoxia and ongoing dyspnea with wheezing, she was admitted to the hospitalist service for further care.   Upon admission, she was continued on supplemental oxygen. She was started on Decadron 6 mg daily and IV Remdesivir for COVID-19.  She continued to require 2 L oxygen with activity, but admitted to slow improvement in her respiratory symptoms.   She was felt stable for discharge on 9/22. at that time she her only complaint was dyspnea on exertion and this had improved since admission, she was also requiring oxygen with exertion. she was sent out on two more days of azithromycin as well as seven more days of decadron to be followed by a taper. she was also instructed to see her PCP. at the time of discharge patient had no objections to discharge. all questions and concerns addressed, all meds and follow-ups reviewed.
CMA neglected to use the diluent to mix COVID vaccine (5-11yrs) and administered the vaccine to the PT. When I was aware of the situation, informed Dr. (Privacy). She wanted me to contact Pfizer for risks and recommendation to the PT. Pfizer stated there is a greater chance of the PT having Local & Systemic reactions. Pfizer said the contact CDC for further recommendation. CDC agreed with Pfizer but wanted the Incident reported to VAERS. Dr (Privacy) spoke with the patient's father to inform him of the situation and see if the patient was experiencing any symptoms. Father stated child went to school and feeling fine. Dr (Privacy) explained signs & symptoms to watch out for.
The vaccine was maintained at proper refrigeration temperatures, but for longer than 31 days.  7/29/21 was day 31 at refrigeration temps and vaccine was given on 8/13/21.  No adverse events have been reported by patient.  Error discovered on 8/16/21.
This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical histories, concomitant therapies, drug reactions or allergies provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot # M020103 with expiration date 15-FEB-2018, lot # L038503 with expiration date 18-DEC-2017(dose and route of administration were not reported). There were no adverse effects reported. Product quality complaints (PQC) were not involved. Administered doses of vaccines were exposed to the temperature of 32 degrees Fahrenheit for 9650 minutes (date unspecified). A digital data logger was involved. There were no previous temperature excursions. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA005330.
Fever, Nausea, Body ache, Head ache, Flu like Symptoms
58 year old white male with history of blood clots  developed symptoms of leg pain during 4/11 early am .  pt received COVID vaccine on 4/8 developed leg pain on 4/11 early am and went to er and was advised he was clotting in leg at point of previous procedure.  he was given eliquis and was told to follow up with specialist
infant was given an expired dose of Act-HIB with no reported adverse event; Initial information received on 29-Aug-2023 regarding an unsolicited valid non-serious case received from Nurse.  This case involves a 1-years-old female patient who was given an expired dose of HIB (PRP/T) vaccine [ACT-HIB] 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 hepatitis A vaccine (Hepatitis A); pneumococcal vaccine; measles vaccine, mumps vaccine, rubella vaccine (MMR); and varicella zoster vaccine for Prophylactic vaccination (Immunization).  On 29-Aug-2023, the patient received 0.5 mL dose of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (Frequency: once; Strength: standard) (batch number: UJ796AA; expiry date: 12-Aug-2023) via intramuscular route in right thigh for Immunization with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired product administered.  No additional information provided.  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.
11/13/09 child woke up from nap with blotchy red spots on chest, back, arms. Temp 99.9 degrees F. No wheezing, SOB or dyspnea. Child's MD recommended BENADRYL and MOTRIN. Rash resolved in 3-4 days, fever gone.
3 year old in 2007 came for a physical 7/30/08 w/o immunization records.  Returned for shot.  Only visit on 8/1/08 and needed 4 shots and PPD.  I administered vaccines and child did not cry or move.  I then gave her a PPD and she held very still.  Smiling afterwards.  10-15 minutes later as paperwork for school was being prepared, patient became limp and fell forward striking her head.  She held her breath for more then a minute, then screamed and recovered.  No sx vasovagal event.  No hx seizures or breath holding events, per parents.
Rash - began on neck and cheeks less than 24 hours after vaccination and spread over entire body within 36 hours. Also had redness and puffiness around the eyes by 48 hours. He was seen by his Pediatrician 2 days post-vaccination. Tested for strep due to rash appearance. Prescribed ZYRTEC - 2.5ml by mouth daily x 7-10 days. Rash resolved by 30 September, but as of 08:30am on 2 October, puffiness around eyes still remains.
Lymph node tenderness as of 12/16/2021 continues as of 12/17/2021.
PT CALLED PHARMACY 2 DAYS AFTER ZOSTAVAX INJECTION REPORTING 2 INCH RED WELT AT INJECTION SITE. SHE SAID IT WAS ITCHY AS WELL. PT WAS TOLD TO PUT ICE ON IT AND TAKE BENADRYL AND CALL US OR DR IF GETS WORSE. NO REPORTS OF BREATHING DIFFICULTY OR SEVERE ALLERGIC RXN, ONLY LOCAL RXN.
This spontaneous report was received from a certified medical assistant and a certified medical assistant staff, referring a patient of unknown age and gender. Information about medical history and concurrent conditions were not reported. On 16-APR-2015, the patient was vaccinated with a dose of PEDVAXHIB from the lot K015462, expiration date not reported. It was also confirmed that no adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
SWOLLEN LYMPH NODES UNDER HER ARMPIT; PAIN IN LEFT BREAST; KNOT IN BREAST; EXCRUCIATING BACK PAIN THAT COMES SHARPELY AND GOSE QUICKLY; ARM PAIN WHEN THE INJECTION SIDE HAS BEEN SQUEEZED OR PRESSED; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-MAY-2021, the subject experienced arm pain when the injection side has been squeezed or pressed. On 14-JUN-2021, the subject experienced excruciating back pain that comes sharpely and gose quickly. On an unspecified date, the subject experienced swollen lymph nodes under her armpit, pain in left breast, and knot in breast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm pain when the injection side has been squeezed or pressed, swollen lymph nodes under her armpit, pain in left breast, excruciating back pain that comes sharpely and gose quickly, and knot in breast. This report was non-serious.
Burning sensation in mouth without any lesions, on roof of mouth, along gum lines and tongue.
About 5 minutes after vaccination with Tdap (LD) and MCV4 (RD), client was talking with RN and then appeared to have a syncopal episode; she be came very diaphoretic and pale, slumped to her side. RN lowered ct to the floor. When she awoke approximately 20 sec later, she was groggy but A&Ox4; was very upset and unsure why she was on the floor. BP- 130/90 P- 80's. cold pack was applied to nape of neck and forehead.  Client was allowed to rest. Once she started to feel less dizzy (approximately 10 minutes) she was assisted to a seated position and offered juice and crackers as tolerated. She began to feel dizzy again and was assisted to a supine position. After about 10 more minutes of rest, she was able to sit up and eventually stood up and sat in a chair. All symptoms and signs resolved and ct was escorted to her car with her mother.
No adverse events were reported; Products were administered post TE; This spontaneous report was received from a registered nurse referring to a 4-year-old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.     On 01-MAY-2023, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) injection (lot # W001518, expiration date: 13-JAN-2024 or lot # W007040, expiration date: 29-FEB-2024; no exact lot# and expiration date was provided) and varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # W008711, expiration date: 14-MAR-2024 or lot # W017552, expiration date: 01-JUN-2024; no exact lot# and expiration date was provided) (both strengths, doses, routes of administration and anatomical locations were not reported), both for prophylaxis (product storage error). No additional adverse event (AE) was reported (no adverse event).  This case was received from the same reporter with another 17 cases: 2305USA007704, 2305USA009079,2305USA009080,2305USA009081,2305USA009082, 2305USA009083, 2305USA009084, 2305USA009085, 2305USA009086, 2305USA009087, 2305USA009088, 2305USA009089, 2305USA009090,2305USA009091, 2305USA009092, 2305USA009093, 2305USA009094.
I experienced throat pain, difficulty breathing, coughing, headache, sinus pain, congestion, fever, ear ache and body aches.
Dull, aching, chronic pain in right shoulder where flu shot was administered.  Pain has lasted since flu shot was first administered on October 23, 2008.  Was seen by a medical doctor who recommended physical therapy to strengthen arm back to normal.  Treatment begins next week.
This case was reported by a nurse and described the occurrence of injection site cellulitis in a 5 year old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. On an unspecified date in August 2003, the patient received an injection of Infanrix (lot DTPA556B9) packaged in a prefilled syringe for the 5th dose in the immunization series. The injection was made IM into the left deltoid. The patient also received an injection of varicella virus vaccine SC into the right arm. On 8/17/03, within a couple of days post immunization, the patient developed erythema on the left deltoid. The patient was seen by the physician, who noted a 7 inch by 4 inch area of erythema. The physician made a diagnosis of injection site cellulitis and prescribed a 10 day course of cefdinir. The event resolved on 8/28/03. The nurse considered the event to be serious because it jeopardized the patient or required intervention. The nurse considered the event was probably related to vaccination with Infanrix.
This spontaneous report as received from a Licensed Practical Nurse refers to a 4 year old male patient. On 24-JUL-2018 the patient was vaccinated with improperly stored VARIVAX lot # R002051 dose 1, subcutaneous in the left thigh for prophylaxis. Other suspect therapies included VAQTA lot # R002086 dose 1, intramuscular in the right thigh; M-M-R II lot # N027782 dose 1, subcutaneous in the right thigh and PREVNAR 13, dose 4 intramuscular in the left thigh from lot # T94425. Concomitant therapies included sterile diluent. Sender's Comments: US-009507513-1807USA007589.
I lost all my senses completely and like the bones were cracking and I was cold and sweating at the same time in my bed.  I also lost my appetite I guess due to my senses.  I was drinking Prozac at that time and there is probably more but I can't remember.  I was sick for 3 or 4 days till I took a COVID-19 test and I went to the pharmacy to take it and it was positive.  The pharmacy gave me the Paxlovid but I didn't take it and I didn't go see the doctor because they wouldn't see me because I was contagious.  I have seen doctor since and I am still having pain from having COVID-19.   I am being referred to a Psychiatrist because I have Parkinson's disease now.
Developed fever of 103.9 on the night of 3/11/04. Parents took to the ER; started having seizure there (tonic/clonic). Had seizure for at least 1 hour. Was intubated and transferred to another hospital.
Headache, Fever, SkinRash, UrticariaPruritus, Chills Narrative:
HEADACHE; DIZZINESS; NAUSEA; This spontaneous report received from a patient concerned a 75 year old female. The patient's weight was 89 pounds, and height was not reported. The patient's past medical history included covid 19 infection, and concurrent conditions included migraine.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021 15:00, the subject experienced dizziness. On 06-MAR-2021 15:00, the subject experienced nausea. On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, and nausea on 06-MAR-2021 19:00, and the outcome of headache was not reported. This report was non-serious.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2011, the patient was inoculated with ZOSTAVAX at an unspecified facility as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In 2014, the patient was treated at a hospital for a vesicular outbreak which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
Fever, NauseaVomiting, chills, body aches, injection site pain Narrative:
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. Information regarding the patient's past medical history, concurrent conditions, or concomitant medication was not provided. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 14-MAY-2014, as recommended for routine adult health maintenance for the prevention of shingles. It was reported that the ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 09-JUL-2015, the patient was treated for a painful rash that was diagnosed as shingles and post herpetic neuralgia, an incurable condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
States lost over 50% ROM in L arm S/P DTaP.  Has regained approx 95% of ROM at this time (11/15/07).
Complaints of numbness and mild swelling in her mouth and throat about 10 minutes post vaccine.  Physical exam showed mild swelling in her posterior pharynx, erythema and white spots on the roof of her mouth.  Patient denied any shortness of breath, facial swelling, rash or dysphagia.  She also denied any previous reactions to vaccines.  She admits allergy to penicillin. Administered 50 mg of Benadryl on site, then 9-1-1 was called.  After Benadryl was given, patient started to complain of itchy arms. EMS arrived and evaluated the patient.  The patient refused treatment and/or transport to the hospital. The patient was notified that she needs to contact her pcp regarding her second dose due to the possible mild reaction experienced on site.
Got headaches and tinnitus from first shot. After the second dose it got worst.; Got headaches and tinnitus from first shot. After the second dose it got worst.; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for a male patient (Son) that: A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: Unknown) and first dose both via an unspecified route of administration in unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. As per verbatim and event description, patient received both vaccines. Got headaches and tinnitus from first shot. After the second dose it got worst. The outcome of both events was unknown.  No follow up attempts are possible. Information about lot/batch number cannot be obtained.
ACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of ache was not reported. This report was non-serious.
Began throwing up around 6:00 until 8:00 PM.  Then turned into severe stomach pain.  Went in on Saturday morning at 10:00 to the ER.  They admitted  me into the hospital for EMERGENCY SURGERY TO REMOVE MY APENDIX.  Appendicitis.   Never any issues before. I did research, there have been 7 other people with such severe reactions thus far.
Patient given MMR and varicella live vaccines within 4 weeks of receiving high dose steroids. Patient received 5.3 mg/kg/day of prednisone for 2 weeks, then 3.57 mg/kg/day for one week, then 1.78mg/kg per day for one week. Then was off all steroids for 5 days before receiving the MMR and varicella vaccines. No adverse events at this point.
Dosage given 04/28/2005- Cough 04/29/05, fever 04/29/05, rash 04/30/05, runny nose on 04/29-04/30/05 with temp. lasting until 05/02/05 with mild itch, rash on face, arm, and primarily on trunk and legs. Some papular 2-6 arm very red, raised appearance of Biarotti-Crosti syndrome rash. Preceding 04/20 5th lesions resolved by shot time.
Started with headaches for 2 weeks 6 weeks after vax. Anemia, high inflammatory markers. After 3 1/2 months of testing and 7 Drs I was diagnosed with Giant Cell Arteritis.
PATIENT RECEIVED ZOSTAVAX VACCINATION ON 05/21/2007.  PATIENT STARTED TO DEVELOP RASH WITH BLISTERS ON FOREHEAD AND AROUND LEFT TEMPLE ABOUT TWO WEEKS LATER.  FOLLOWED UP WITH MD ON 06/08/2007 AND WAS DIAGNOSED WITH SHINGLES.  PATIENT WAS GIVEN VALTREX (UNKNOWN STRENGTH) TO TAKE THREE TIMES DAILY FOR SEVEN DAYS.  SYMPTOMS HAVE NOW SUBSIDED.
I received my shot and two days after I felt weak and sick. I fine for a few weeks and then I went outside to cut grass and all of my joints started to ache really bad. I came back inside and checked my temperature. I laid on my couch for a couple hours while running a high temp of 100.7. My eyes started to get really hot. I woke up at 12:30am and it was 90.7. I was checking my blood pressure and it was 110/64. I went to the doctor and it was discovered that I have pneumonia.
Per 8/2/2022 pharmacy telephone note, pt received zoster vaccine at clinic on 7/22/21 and had rash with 1st dose. Pt offered second dose and declined due to rash with 1st dose.
This spontaneous report was received from a registered nurse regarding a 10 month old female patient. On 02-MAR-2012, the patient was vaccinated with first dose of VAQTA at 10 months of age. No adverse effects were reported. Additional information is not expected as reported did not wish further contact.
On 4/24/2018, Patient had pain, swelling and redness on right upper arm where TDAP and MENACTRA were given. He complained of "not feeling well" and had a fever of 101.0 and a headache. He was seen again in office and prescribed Azithromycin 200mg/5ml oral suspension Sig - Take 12.5 ml everyday by oral route for 5 days. Patient's mother did not give the medication. She told the provider she gave the patient BENADRYL.