chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered expired vaccine to a 15 month old child; Initial information received on 03-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse by phone.   This case involves a 15 months old patient (gender not reported) who was vaccinated with a 0.5 ml fourth dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Batch number: C5206AA and expiry date: 17-May-2019) via intramuscular route in the left thigh on 03-Jun-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included patient was vaccinated with a dose of HIB VACCINE CONJ (TET TOX) (ACT-HIB) for Immunisation on an unknown date.  It was a case of actual medication error due to expired vaccine used.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.   Documents held by the sender: none.
Pediarix, Pedvax, Prevnar, Rotavirus received approx. 9am on 7/24/2007. At 7pm same day infant developed "head to toe pinpoint rash"  Infant taken to ER.  Was given oral Benadryl with instruction to repeat doses 3x the next two days.  Mother states rash gone after second dose, did give third dose.  Each dose 1/2 teasp.  States also teething at the time and it was very hot outside, she thought it might have been a heat rash.  States was told by ER doctor it may have been Hep B componant of immunizations, or heat or teething.  Present 9/24/2007 for immunizations.  Will review with medical director before third set of immunization to be given.  Importance of identifying cause of rash explained.  Mother verbalized understanding of information.  This nurse will call her with medical director's recommendations for future immunizations.
Awoke with left abdominal pain which progressed to severe right  side abdominal pain. Presented to ER evening of  08/11/21, CT confirmed acutely inflamed non-perforated appendicitis. Laparoscopic appendectomy performed 08/12/21. Hospital discharge 08/13/21.
Headache, day of inj. Excruciating headache, the following morning with dizziness, nausea, neck, arm and shoulder pain.
Fatigue = Day 3 (May 13th) - present (May 24) Headache = intermittent    Painful red rash at jab site = Day 11 (May 21) -  present (May 24).
Swelling of the LUE in a descending pattern just distal to the elbow. Tx: prednisone resulted in resolution.
I experienced pain in my right ear an hour after my dose 3, and by the time I made it to the doctor at noon the shingles rash was evident in my ear canal, and spread to the outside of my ear. The shingles rash was only in the area of my right ear. I was prescribed antivirals of which I had to do 2 rounds of antivirals and steroids' along with pain medications. I was also prescribed nerve medications to try to manage the pain. A month into healing from shingles I had a relapse which spread to my ear drum. I have developed Ramsey Hunt which limits my ability to smile or talk. I am still experiencing severe vertigo due to permanent weakness and Benign Paroxysmal Positional Vertigo I was diagnosed with. My facial issues have improved, and I have not recovered all of my hearing in my right ear. I am going to begin Vestibular Therapy to try to treat the torsion I am also experiencing. I have not recovered from these symptoms.
On 2/26/2022 my son woke up to some cough and congestion and throughout the day it had became worse. He had a fever of 101.0 and I gave him ibuprofen. On 2/28/2022 we went to the pediatric office and got tested for COVID-19. The test results were positive for COVID-19. Congestion has improved and he is starting to feel better. We were told by the health department we are able to come out of quarantine on 3/5/2022.
Sudden swelling, heat, hives, discoloration, intense itching at vaccination site.  Began afternoon 3/5/21 and continuing.  Vaccine administered 8 days previously with no interim reaction other than fatigue (unknown if related to vaccine).
This spontaneous report was received from a pharmacist refers to a 52 year old female patient. On 30-APR-2013, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date was not reported, route was subcutaneous). Concomitant therapies included prednisone and ROCEPHIN. On 01-MAY-2013, the patient experienced cellulitis after receiving ZOSTAVAX. On 03-MAY-2013, the patient was prescribed KEFLEX as a treatment. The outcome of cellulitis was reported as recovered. The patient sought medical attention. Additional information has been requested.
Severe itching, red; swelling, pain (stabbing) hot feeling of weakness. Shot 11-9-16. Feverish, arm hurts at upper arm still. 11/17/16 Still red.
Expired Vaccine Used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  The patient received the second booster dose of Moderna Covid-19 vaccine on 19-Apr-2022 (lot number : 013F21A, expiry date : 22-Jan-2022). HCP mentioned that the incident occurred due to miscommunication, as a coworker told that there were some lot number whose expirations dates have been extended.   No treatment information provided.
Bleeding, Fever, Started with fevers and chills, the start of menstruation outside or regular cycle and still have today.  Narrative: Will f/u abnormal bleeding with her GYN if not resolved.
Patient has had on going dizziness & syncopy for the last 2 months. She went to the ER 2x, was hospitalized and was evaluated by neurology and cardiology. She has been diagnosed with POTS.
TINNITUS OR EAR RINGING; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: the patient never had hearing problems. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 213D21A expiry: UNKNOWN) dose was not reported, administered on NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On JAN-2022, the patient experienced tinnitus or ear ringing. Laboratory data (dates unspecified) included: Hearing test (NR: not provided) hearing was fine, and Hearing test (NR: not provided) hearing was fine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tinnitus or ear ringing. This report was non-serious.
Noted drooping to right side of face 10/14/09. Saw family physician, was diagnosed with Bell's Palsy. Referred to ENT. Blood chemistry and MRI done. Given p.o. steriods and anti-viral. 10/27/2009 records from PCP and ENT consult for dates 10/15 and 10/16/2009. Presenting sx of rt facial droop and paralysis. Per PE rt side of face totally paralyzed, no movement of facial nerves, rt eye closure inadequate. Tx: Prednisone and Valtrex, eye gtts. DX: Bells Palsy
Vesicles around the shot site in clusters. Edema and erythema around shot site. Vesicles on left side of mouth (same side of shot site). Swelling of eyes. Blurring of vision. Swelling of throat. Pain scale 10 + in shoulder and are followed by paralysis on side of shot site. Difficulty in breathing. Status epilepticus followed.
general sense of malaise; This case was reported by a pharmacist via sales rep and described the occurrence of malaise in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced malaise. On an unknown date, the outcome of the malaise was unknown.   It was unknown if the reporter considered the malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patients stated a general sense of malaise after vaccination. The reporter did not agree to follow-up from GlaxoSmithKline. For tolerance to 2nd dose, please refer case US2019AMR204464.
Information has been received from a mother concerning her 20 year daughter with no pertinent medical history or drug reactions/allergies who on an unspecified date was vaccinated with a first dose of Gardasil (lot # unknown).  Concomitant therapy included hormonal contraceptives (unspecified).  The patient experienced some pain after receiving the first dose of Gardasil which lasted for one week.   On an unspecified date the patient was vaccinated with a second dose of Gardasil.  The patient experienced intense pain which lasted for one week.  Medical attention was sought.  The pain from the second dose made the patient cry.  The patient recovered on an unspecified date.  No other details were given.   Additional information was been requested.
This spontaneous report as received from a of unknown age consumer refers to herself, ho on 10-JAN-2013, was vaccinated with a dose of PNEUMOVAX23 (dose and lot number were not reported). NO other co-suspects were reported. No concomitant medications were reported. The consumer reported that during the injection of PNEUMOVAX23 that she moved from the needle piercing her skin. From the sudden shift, the patient was experiencing pain in her right shoulder. No treatment information was reported. At the time of the report, the patient's outcome for the adverse event was unknown. The relatedness for the adverse event was unknown for PNEUMOVAX23. Additional information is not expected.
Information has been received from a physician concerning a 4 month old patient who was vaccinated with a first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live/  It was noted that the patient was not experiencing any symptoms. No product quality complaint was involved. No other information was provided.  Additional has been requested.
Warm, swelling and redness, slight pain in the arm from sholder to elbow. Pt is not running fever. Pt will watch and notify Dr. if continues.
pt had a positive COVID test on 2/1/22 at Clinic 2/23/22 pt hospitalized with AHRF and COVID pneumonia; ESRD on peritoneal dialysis; suffered GI bleed in hospital requiring transfusion; unable to find a SNF with peritoneal dialysis capabilities; dc'd to home with hospice; pt passed away at home
After a few days, I woke up with my left middle finger joint near fingernail in pain and won't bend! Is it a coincidence that I now have arthritic-like pain in my left fingers at the nail first joint? I am unable to use those fingers for even support of a small dinner plate. Advise if you can.
Swollen area at injection site, approx 1900, 3 x 3, "lump" area is warm, "really sore".
No additional AE details; Nurse called to report temperature excursion; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided.      On 11-DEC-2020, the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB), 0.5 milliliter for prophylaxis (lot # T014835 with expiration date of 17-JUL-2021 is an invalid lot Number for hepatitis b vaccine (recombinant)(RECOMBIVAX HB). Lot # T014835 with expiration date of 17-JUL-2021 is a valid lot Number for Hepatitis A Vaccine, Inactivated(VAQTA)).       The vaccine experienced temperature below 2 degrees Celsius(C) (1.3 C) for 0 hours 24 minutes, time frame below 2°C (1.3 C) for 0 hours 24 minutes. Previous temperature excursión below 2 C (1.6C) for 24 minutes Digital data logger was involved.
increased redness; increased fussiness; Initial information received on 17-Apr-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2020SA103148 and 2020SA103059 via same reporter.  This case involves a 2 months, 1 week and 3 days old female patient who experienced increased redness and fussiness (erythema and irritability), while she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ).  On 13-Apr-2020, the patient received first dose 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ164ABA and expiry date 16-Feb-2021) via intramuscular route at the right thigh for prophylactic vaccination. Lot and expiry date powder and liquid vial was reported as UJ164AB,U6622AA and 16-Feb-2021, 16-Feb-2021).  On an unknown date, the patient developed non-serious increased redness and fussiness (erythema and irritability) (Unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Details of laboratory data were not reported.  Final diagnosis was erythema and irritability.   It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was not reported.
Pt had a generalized rxn to 4th DTP; pt should only get ped DT in future;
RED OVAL AROUND INJ SITE (2IN X 3.5IN), RAISED, HARD LUMP UNDER SKIN, VERY HOT TO TOUCH.
Around 4:30 I started to have body aches, nausea, and uncontrollable chills. The chills lasted for about 2 1/2 hours. Today, I have a headache, aching in my legs, and a headache.
This spontaneous report as received from a nurse practitioner refers to a 68 year old female patient. On 13-JUN-2012 the patient was vaccinated with one shot of ZOSTAVAX (lot # 673029/0616AE, Exp: 26-JUN-2013) (route was not reported) 0.65 ml and a dose of T-DAP. The patient also received both PNEUMOVAX23 and an unspecified flu shot (manufacturer unknown) on 18-OCT-2012. According to the nurse practitioner, the patient experienced "unexplained loss of function in reflexes and lower extremity ascending paralysis" which began on an unspecified date in "July 2013". The patient was still confined to a wheelchair and was not recovered but was seeing an unspecified neurologist. The patient initially sought medical attention for this adverse experience at the emergency room of hospital, where she was afterwards admitted and hospitalized for an unspecified number of days and received unspecified treatment and lab tests. At the time of reporting, the patient was not recovered. The nurse practitioner considered "unexplained loss of function in reflexes and lower extremity ascending paralysis" to be significant disability. Upon internal review, lower extremity ascending paralysis was determined to be an other important medical event. This is one of several reports from the same reporter. Additional information has been requested.
flu like symptoms; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 63 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Covid", start date: 2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "flu like symptoms". Additional Information: Patient did have Covid last year. Patient was minimally exposed to the his daughter and son. They had symptoms and both tested positive to Covid, now quarantined until holiday and has to take 2nd dose tomorrow. Patient had no symptoms at the time of the call. Patient asked if it is true that people who previously had Covid may have stronger reaction to the 2nd dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 76-year-old female patient who received SHINGRIX for prophylaxis. On 6th August 2018, the patient received the 1st dose of SHINGRIX. On 7th August 2018, 1 days after receiving SHINGRIX, the patient experienced feeling unwell. In August 2018, the patient experienced itchy rash and varicella-like rash. On an unknown date, the outcome of the feeling unwell was recovered/resolved and the outcome of the itchy rash and varicella-like rash were not recovered/not resolved. It was unknown if the reporter considered the feeling unwell, itchy rash and varicella-like rash to be related to SHINGRIX. Additional information received as follows: The patient did not feel well. The reporter was asked if she could describe what she meant by that, she said she could not explain it, just not feeling well. A couple of days after getting SHINGRIX, the patient started seeing a few spots, like a rash on the lower abdomen area. The rash in the lower abdomen was almost gone. However, she started having another rash showing up on her breast area. She said that the rash looked like the chickenpox. The reporter also mentioned that she was getting an inner itching sensation on the rash. The reporter did say that she travelled a lot internationally with her husband. The contact details of the physician were provided. The case has been linked to the case US2018171895, reported by the same reporter (husband's case).
Information has been received from a nurse concerning a 17 year old female who on an unknown date was vaccinated with the first dose of GARDASIL.  In the morning of 29-OCT-2008, the patient was vaccinated with the second dose of GARDASIL.  The nurse reported that the patient was fine after the first vaccine.  On 29-OCT-2008, 5 to 10 minutes after vaccination the patient left the office to go to school.  The patient passed out while she was driving and got into an accident.  The nurse stated that the patient sounded fine on the phone but she went to ER for check up. Initial and follow up information has been received from a nurse and medical records concerning a 17 year old female who on 27-AUG-2008 was vaccinated with the first dose (lot # 659184/0843X), intramuscularly to the left deltoid. The nurse reported that the patient wsa fine after the first vaccine. In the morning of 29-OCT-2008, the patient was vaccinated with the second dose of GARDASIL. On 29-OCT-2008, 5 to 10 minutes after vaccination the patient left the office to go to school. The patient passed out while she was driving and got into an accident. The nurse stated that the patient sounded fine on the phone but she went to ER for check up. Follow-up information obtained from medical records reported that the patient was driving her car from the clinic where she had just received her GARDASIL injection. About 15 minutes latre she "passed out" and atruck the vehicle in front of her while traveling approximately 25 miles per hour. The patient states she felt dizzy and then the next theing she rememberd is waking up and seeing that she had hit the car in front of her. The patient was restrained and the air bags deployed. The patient was complaining of moderate pain over the left side of the chest. Otherwise she denied any pain. She reported a mild headache. She denied any previous episodes. The patient had been evaluated in the emergency room 2 days priort for right upper quadrant pain which she reported had presently resolved. The patient denined feeling sick prior to the motor vehicle collision. The patient was reported to be alert, cooperative and in no acute distress with obvious mild discomfort from pain. There were no abrasions/lacerations on the chest, and no noted chest tenderness. She was reported to be anxious. hger blood pressure was 140/83, her pulse was 94, and her respiratory rate was 18. The patient had a normal chest x-ray, normal CT scan of the head, normal abdominal ultrasound, and normal ECG. Blood work showed an elevated white blood cell count of 8.9 and urinalysis showed bacteria >500. The patient was treated with TYLENOL and TORADOL. It was reported that the patients syncopal episode was likely vasovagal following the administration of GARDASIL. The patient was also diagnosed with urinary tract infection and was given a prescription for VICODIN. The patient was instructed to return to the emergency room for any worsening of symptoms. It was reported that the patient had recovered on an unspecified date. No additional information is available. All available medical records will be provided upon request.
Fever more than 103 F, neck stiffness, headaches - fever lasted 3 days, stiffness for a week.
BODY ACHES; SORE ARM; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: 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 fever, sore arm, and body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, sore arm, and body aches. This report was non-serious.
Crying for 5 hours, fever 102 degrees for 12 hours vomited x one.
FELT CONFUSED WITH INVOLUNTARY MOVEMENTS OF RIGHT HAND, RIGHT ARM AND HEAD. ALERT AND ORIENTED BUT SLOW TO ANSWER QUESTIONS.
Flushed; breathing issues; swelling of my arm; rash; diarrhea.
Right arm swollen & tender to touch @ injection site; warm and red in color.  Instructed to use cold compresses 24 hr, then warm as needed.  Take Tylenol as needed.