chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A nurse administered a dose of the Moderna Covid-19 vaccine that was expired.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A nurse administered a dose of the Moderna Covid-19 vaccine that was expired.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A nurse administered a dose of the Moderna Covid-19 vaccine that was expired.). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (A nurse administered a dose of the Moderna Covid-19 vaccine that was expired.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.The Vaccine was removed from fridge and the first puncture was at 03:00 pm on 09-Nov-2021.The doses were administered on 10-Nov-2021 at 09:00 am and 09:08 am as there were 2 patients who were administered with expired Moderna vaccine for their booster doses. Both doses were booster doses 0.25mL. No concomitant medications were provided.  No treatment medications were provided.Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Follow-up document received on 12-NOV-2021 contains No new information. On 16-Nov-2021: Follow-up document received on 16-Nov-2021 (Non Significant FU) include New information in Narrative updated.
patient had received fluzone quadrivalent instead of fluzone hd, with no reported adverse event; Initial information was regarding an unsolicited valid non serious case was received from a pharmacist via agency(Reference number- 00807239) and transmitted to Sanofi on 11-Oct-2021.  This case involves an unknown demographic patient (unknown age and unknown gender) who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] (wrong product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 11-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error due to wrong product administered (latency: same day).  It was reported patient came in today to receive FLUZONE HD, but received FLUZONE QUADRIVALENT (prefilled syringe) instead.  At time of reporting, no adverse event reported.  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.  There will be no information available on the batch number for this case.
Information has been received from a medical assistant referring to a patient of unknown age and gender. There was no medical history or drug reaction/allergies reported. On an unknown date the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # L035510 with expired date 13-MAY-2017, oral, dose unknown), which was stored in 47 Fahrenheit for 14.5 hours. No concomitant therapy was reported. The reporter stated that there was no previous temperature excursion. No symptoms were reported. Additional information has been requested.
4 month old patient received Kinrix for dose 2 of dtap and IPV vaccine
AFTER WAITING 15 MINS PATIENT WAS WALKING AROUND THE STORE AND ALMOST FAINTED. HE CAME BACK TO THE PHARMACY FULLY ALERT AND STATED THAT IT WAS JUST THAT MOMMENT WHERE HE FELT LIGHT HEADEDNESS AND NOW HE IS FINE. BLOOD PRESSURE AND HR WAS CHECKED. ALL IN NORMAL RANGES.
Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product information was provided. No treatment information was provided.
08/14/2018 Pt. anxious before appointment, as reported by mom. After receiving second vaccination, pt. passed out. I called out to our nursing director and administrator RN. An ammonia stick was broken and waved under patient's nose. We transferred pt. onto floor. He experienced approximately 60 seconds of apnea. I positioned his airway and 911 was called. At this time I noted he lost control of his bladder. Pt. came to and complained of nausea, no vomiting noted. He was very pale. EMS arrived to assess patient. Glucose = 112, B/P = 90/60. Mom didn't want child taken to ER, but after EMS provided education, mom agreed. He was taken to Hospital. Our health officer, Dr. was notified.
Inadvertent administration of Hepatitis B pediatric formulation. Notified patient and administered correct dose of Hepatitis B adult formulation, patient tolerated well.
MMR given on 4/17/02; on 4/20/02 upset stomach; on 4/21/02 increased temperature 102.2F; on 4/29/02 in to see MD with temperature of 101.6F, P-96, BP-146/92, "eyes feel sore", non-specific malaise. Denies sore throat or headache. Had scattered rash present on face, chest and extremities. On 4/30/02, in to see MD with temperature of 100.2F.
Diagnosed with pericarditis.  Chest pain/pressure that did not resolve itself after a week, shortness of breath, pain in left
Pain and swelling over the injection site.  Patient noticed expanding rash inferior to the injection site on 5/20, along with fever 101 F.
Baseball size hive (raised red area) causing itching at injection site took Benydryl Itching decreased but red area fading
Started feeling really floaty and dizzy and felt like I'm going to pass out. The clinic checked my vitals and my BP was over 150, my heartrate also surged a little. I also felt a straining in my neck, sort of under my tongue. I didn't have any problem breathing though. Because my HR was increased they called an ambulance to take me to the hospital, I refused to go because my problem didn't seem severe enough. They finally released me with the understanding that if I started to feel bad in any way to go to the hospital.
got COVID-19; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (got COVID-19) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced COVID-19 (got COVID-19) (seriousness criterion hospitalization). At the time of the report, COVID-19 (got COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Patient was  treated with monoclonal antibodies. Patient wants to get the second dose of the Moderna vaccine.  Company Comment: Very limited information regarding these events has been provided at this time.; Sender's Comments: Very limited information regarding these events has been provided at this time.
About a week after the vaccine my eye got severely irritated which progressively got worse. It felt as if I had something in my eye causing me to rub it frequently. It got so painful I went to local ER where they told me I scratched my Cornea and referred me to an Eye Dr. I went and it was treated but it didn't get any better and from there I was diagnosed as having Shingles in the eye and asked if I had been vaccinated which I had been for both Shingles and COVID. I couldn't see and had to miss work. This persisted about 2-3 weeks.
On Friday, February 19, 2021- Woke up to approximately one inch rash at Moderna injection site on upper left arm.  During the day, the rash grew to approximately 3 inches in circular diameter.  It was red, itchy with bumps and hot to the touch.  The rash continued to spread down my arm over the weekend.  On Monday, Feb 22- primary doctor had never heard of Covid arm and prescribed Amoxicillin for Cellulitis.  On Tuesday, Feb 23- Went to Dermatologist who confirmed Covid arm and prescribed Triamcinolone Cream.  Wednesday morning at 3am- rash on arm improved but developed severe burning, itching, pain swelling, throughout my entire body. All the skin throughout my body was red, especially the joints.  I was developing sores in my mouth.   Felt like third degree burn all over my skin.  I returned to doctors office who advised was having a severe delayed allergic reaction to Moderna vaccine.  She also advised that I had sores in my mouth and my tongue was swollen and I could get anaphylactic and to go to the emergency room immediately if I could not breathe.  She prescribed Zyrtec and 8 days of Prednisone.
Pityriasis rosea; This spontaneous case was reported by a consumer and describes the occurrence of PITYRIASIS ROSEA (Pityriasis rosea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Skin rash.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PITYRIASIS ROSEA (Pityriasis rosea). At the time of the report, PITYRIASIS ROSEA (Pityriasis rosea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Patient had skin rash for few months. No treatment information was provided.   Reporter did not allow further contact
Patient woke at 0730 on 12 Jan 08 and noticed left upper arm was swollen from top of shoulder to elbow.  Redness noticed from injection site to middle of upper arm.  Site was warm to touch and dry.  Patient also experienced nausea, diarrhea and fever.
During injection it was extremely painful (most painful injection ever had). Nurse commented, "it just isn't going in."   By same day afternoon, right arm was hurting and could not move arm.  For next 4-5 days continued pain, not relieved with 800 mg Ibuprofen.  Seen and released from care. Was told pain may continue for weeks before resolving.
Tingling and numbness on left side of face. Throbbing pain mostly on left side of head. Blurred vision in left eye. Slight loss of hearing in left ear. Fever of 100.6. Chills. Body aches. Stabbing pain in random areas of body intermittently.
This spontaneous retrospective pregnancy report as received from an 18 years old female consumer with asthma, allergy to amoxicillin and OMNICEF reporting on herself for GARDASIL a Pregnancy Registry product. The consumer was vaccinated with a dose of GARDASIL (dose, route and lot # not reported) on 26-NOV-2012. No other co-suspects were reported. Concomitant medications included folic acid. The consumer reported that on 01-DEC-2012, she found out she was pregnant and then later on 07-DEC-2012 miscarried. At the time of the report, the patient's outcome was unknown. Upon internal review miscarried was considered medically significant. Additional information has been requested.
Patient received Fluzone hd and Pneumovax. Patient came in 4 days after receiving vaccination with redness on his upper arm. The affected area was not around the injection site.
Edema, pain, fever within 12 hours. Improved over 72 hours.
Information has been received from a registered nurse concerning a 12 year old female patient with no medical history and no drug reactions or allergies who on 16-NOV-2010, was vaccinated with a first 0.5 ml IM dose of GARDASIL (lot # 1017Z). On 16-NOV-2010, the patient also received a dose of VARIVAX, MENACTRA, DTaP and FLUZONE. On 26-NOV-2010 ("10 days after receiving the first dose of GARDASIL"), the patient experienced rash. On 24-JAN-2011, the patient received the second 0.5 ml IM dose of GARDASIL (lot # 1560Z). On 03-FEB-2011 ("10 days after receiving the second dose of GARDASIL"), the patient also experienced rash. The patient had office visit. No lab diagnostics studies were performed and no treatment was given to the patient. On unspecified date, the patient recovered from rash. Additional information has been requested.
Intussusception (ileo-cecal) requiring bowel resection. 5/19/09-records received for DOS 1/2/09 and 3/5/09 -clinic notes for follow-up-3/13/09-seen in clinic after presenting to ED with large bloody stools times 2 days, developed respiratory distress. Transfusions. Intubated. PICU. Impression: rectal bleeding, DIC, leukocytosis.  5/21/09-operative report received for DOS 3/13/09-exploratory laparotomy with right hemicolectomy and ileocolostomy. DX: Intussusception. Presented with C/O abdominal tenderness and distended abdomen, rectal bleeding.  Post operatively developed ARDS, ventialtor dependent. Subsequent surgery 5/7/09 Median sternotomy,  PDA ligation, pulmonary artery banding, insertion of right femoral arterial line. 5/12/09-subsequent surgery for closure of sternal wound. Failure to wean from ventilator.   8/11/09 Hospital DC summary, ICD-9 codes received DOS 3/11/09 to 7/5/09. Assessment: Intussusception status post bowel resection, ischemic colitis - septic shock, multi organ system dysfunction. Additional clinical data abstracted: 5/28/09 Continued fever. Signs of sepsis. Parental decision to withdraw care on 7/5/09. Patient expired on 7/5/09.  ICD-9 Codes: 786.05 Shortness of breath,  560.0 Intussusception,  286.6 Defibrination syndrome,  557.0 Acute vascular insufficiency of intestine,  785.52 Septic shock,  569.83 Perforation of intestine,  038.49 Septicemia due to gram-negative organism,  038.43 Septicemia due to Pseudomonas,  518.5 Pulmonary insufficiency following trauma and surgery,  745.69 Endocardial cushion defect,  747.0 Patent ductus arteriousus,  238.79 Neoplasm of uncertain behavior of other lymphatic and hematopoietic tissue,  995.92 Severe sepsis,  599.0 Urinary tract infection site not specified,  758.0 Down's syndrome,  427.5 Cardiac arrest.
Went to PCP for physical on 4/9/03.  Audible murmur detected.  Had echocardiogram on 4/21/03 "tricuspid insufficiency".  PCP does not think related to Smallpox vaccine.  Referred to cardiologist (appt. 4/24/03)  Remembers around day 9 of vaccine becoming short of breath.  No other cardiac symptoms
A report has been received from VAERS via health professional concerning a 18 year old male patient. The patient's concurrent disease included penicillin allergy. No medical history was reported for consumer. Patient had received FLUMIST (intranasal) on 11-Aug-2009. Vaccine given on same day included Diphtheria toxoid, Tetanus toxoid, Hepatitis A vaccine, Hepatitis B vaccine, Typhoid VI polysaccharide and Meningococcal Polysaccharide. This report to VAERS provides the following narrative: Medical records received for dates 10-Sep-2009 to 19-Sep-2009, patient had sinusitis with tingling in feet, hands, weakness in abdominal muscles. Patient states was unable to exercise. Symptoms had begun three days ago. Ptosis of right eye began one day ago. Sinus congestion noted five days ago then improved. Diarrhea week ago, now resolved. Patient states was given a peanut butter shot 8/4 which was standard. Patient was unable to run, do push-ups, or sit-ups. Patient states feet feeling as if they were about to fall asleep. Admitted for progression of symptoms. Assessment: ptosis right eye, areflexia, nerve conduction test abnormal-preserved latencies, ataxic, reflexes were present in morning and absent in evening. IVIG started. Patient improved on 10-Dec-2009. Outpatient Medical Records received for DOS 22-Sep-2009. Patient requesting return of full duty; reports feeling better, symptom Guillain-Barre syndrome, resolved. Reporter assessed the event Guillain Barre syndrome to be serious with criteria of Hospitalisation.
Cluster of hives on inner right thigh; This is a spontaneous report from a contactable consumer, the patient. A 12-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EY0854) via an unspecified route of administration in the right arm on 15Jul2021 at 15:45 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient was allergic to pollen. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT), sambucus nigra (ELDERBERRY) and kids multivit; all taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0185) via an unspecified route of administration in the right arm on 17Jun2021 at 15:45 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. 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. On 15Jul2021 at 17:30, the patient experienced cluster of hives on inner right thigh. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measure was taken as a result of the event and included treatment with XYZAL 5mg. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event cluster of hives on inner right thigh was resolving at the time of this report.
I tested positive; sore throat; fatigue; had a fever 100.8; runny nose; runny nose congestion symptoms; This is a spontaneous report received from contactable consumer (patient herself). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 02Mar2021 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient received her first COVID vaccination 02Mar2021. She started experiencing runny nose congestion symptoms on Monday 08Mar2021, but thought were allergies. On Tuesday 09Mar2021 she had a fever 100.8 and her husband tested positive for COVID. Wednesday 09Mar2021 took PCR test and was negative. 13Mar2021 she tested positive symptoms of sore throat, runny nose and fatigue. Outcome of events was unknown.  information on about lot/batch number has been requested.
FELT LIKE WATER RUSHING IN BOTH LEGS FOR 45 MINUTES, AFTER FIRST VACCINE SHOT/FLUSHING IN LEGS; This spontaneous report received from a pharmacist concerned a 60 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: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced felt like water rushing in both legs for 45 minutes, after first vaccine shot/flushing in legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like water rushing in both legs for 45 minutes, after first vaccine shot/flushing in legs. This report was non-serious.
Left superior anterior thigh with 20 1/2 cm x 13cm erythematous, edematous, warm reaction patch.
Patient was post-menopausal. She reports starting vaginal bleeding the 2nd CoVid vaccine. Additional lab work is being done to rule out other cause of bleeding such as cervical cancer.
Mom states that on 05/03/2003 child wouldn't stand on legs in the morning, but by noon on 05/03/2003 he resumed standing. Temp on 05/02/2003 night 99.5 degrees. 05/03/2003 night 103 degrees 05/04/2003 normal.
Got vaccine around 4:30PM, by 11 PM arm was swollen around injection site; red blotches appeared 24 hours later on inside of upper arm, no itching, no fever, no pain at injection site, felt flu-like day after injection.
Slight headache, dizziness, tired, body aches, slight nauseous, slight arm pain.  Rest, fluids, Tylenol
flat red itchy rash on arms, face, chest & front of legs; c/o headache, ears hurt & sore throat; using over the counter DPH cream; pt has suffered w/eczema since 1st grade;
Received flu shot on Wednesday Morning(11/19/2008), by early afternoon, developed muscle and joint aches, fatigue, headache, chills and low level fever. Took the following day off to rest.  Today feeling much better.
AX temp 103,then mother states AX temp to 108. mother states called ER and decided to treat at home with tylenol/pedialite. Mother states vomiting/diarrhea x2days, crying 1 1/2 hours and blinking of eyes. Mother states child had flu-like symptoms. After 2 days mother states child was fine.  Mother brought child back in today (01-11/2010) for second seasonal and h1h1 vaccination and stated the above problems after first vaccines.  Second vaccines were not given.
Facial swelling (mild edema around bilateral eyes and lips) and itchiness of skin.
giving a patient only the Adjuvan powder portion was not used; giving a patient only the Adjuvan powder portion was not used; This case was reported by a pharmacist and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number L4LH5, expiry date unknown) for prophylaxis.   On 2nd September 2021, the patient received Shingrix. On 2nd September 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that, a nurse given a patient only the AS01B Adjuvant pf Shingrix, the powder portion was not used, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The health care professional did not have demographic data of the patient. The reporter consented to follow up.