chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a register nurse refers to a 2 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 03-MAR-2014, the patient was vaccinated with first dose of ROTATEQ oral, lot #J007283; expiration date: 27-SEP-2014 (dose and strength were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm- 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Abdominal pain /cramping, headache, muscle aches, chills, joint discomfort. All lasting approx 24 hours except abdominal discomfort persisting into next day.
The patient was supposed to receive the Pfizer bivalent booster vaccination, but was accidently given the Pfizer bivalent age 5y to <12 y booster , 0.3mL undiluted. We have not yet been able to reach the patient. It is unknown whether the patient is having any adverse reactions to the shot. I did speak with a Pfizer representative and they said they did receive an appropriate dosage since it was undiluted, but that we should still report it due to it being the wrong vaccine form/strength.
Noticed itching, swelling no redness about 12 hrs post vax. Presents today with noticeable redness/swelling from approx 8" above and below inject site. Advised cool compress, anti-inflammatory antihistamine PRN.
First dose received 1/22/2021 (lot 026L20A). 2nd dose received 2/19/2021. Become pregnant between doses 1 and 2.   Pregnancy was confirmed 4/1/2021 and viable with due date of 11/14/2021. On 5/18/2021, pregnancy was confirmed as missed miscarriage (at approx 8wks 4 days). All DNA tests came back negative for genetic abnormalities up to that point.
Hospitalized 10.15.21 - 10.22.21;  COVID-19 positive (10.15.21);  fully vaccinated    Admission Date: 10/15/2021 Discharge Date: 10/22/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hypoglycemia [E16.2] Type 2 diabetes mellitus with hypoglycemia without coma, without long-term current use of insulin (HCC) [E11.649] COVID-19 virus infection [U07.1] HOSPITAL COURSE: Patient is a 64 y.o. female  who presents to hospital with low blood sugar.  Patient developed necrotizing fasciitis in July of this year requiring extensive surgery.  She then developed a DVT, cholecystitis and choledocholithiasis requiring cholecystectomy in August.  Since then she reports episodes of recurrent hypoglycemia.  She is a poor historian but states that she passed out last night and was brought in by EMS after her sugar was found to be 34.  Last took her diabetes meds on 10/13.  She received multiple boluses of dextrose and a dextrose infusion but continued to have hypoglycemia.  Workup also showed her to be COVID positive.  A chest xray did not reveal any infiltrates and she was at her baseline oxygen.  Because of her chronic oxygen therapy she is not a candidate for monoclonal antibody therapy.  Due to her persistent hypoglycemia she was referred to the hospital for further evaluation and care. 10/22 and Hospital Course:  Patient was treated with dexamethasone.  She slowly improved with pulmonary toilet, pronation as able, incentive spirometry.  For the last day of her hospitalization she was weaned down to 3-4 L per nasal cannula.  She was ambulating with assistance and was really hoping to go home, stating she has her daughter and family members to help her.  Patient did receive a dose of IV Lasix and has a net -8.2 L fluid balance.  She was tolerating a good diet, her vital signs have been stable.  Renal function has remained stable as well, creatinine 1.12 on day of discharge.  Patient completed 5 days of remdesivir.  She was felt to not need further Decadron on day of discharge.  It is felt that the risk of ongoing she will continue Decadron to complete 10 days, she still has episodes of desaturation with ambulation..  She will continue on home oxygen.  She will follow up closely with her primary care provider.  Patient was also no to have anemia, normocytic.  Peripheral smear did show some rouleaux present.  Ferritin, B12, folate and reticulocyte count normal.  She showed no evidence of bleeding.  She will need this followed up as an outpatient.  Possibly Hematology referral as well as Gastroenterology evaluation.  Patient is stable for discharge. Patient will continue Eliquis for her history of DVT. Addendum: We did get patient up in she desatted on 3 L, we will hold on discharge until she is assessed by respiratory therapy, oxygen is titrated appropriately and she does not have any further such desaturations.
Nausea, vertigo, slightly blurred vision, imbalance walking, fatigue, heartburn, malaise.  Initial vertigo and dizziness lasted 3 hrs.  GI symptoms and malaise are still present, 48 hrs later
onset was about 36 hrs. started with modest fever and chills, gradually increasing pain that started in my left arm shoulder and down the left side of my body. my right side of my head hurt. The pain was pretty extreme. I ached deep like in the joints and bones. about 10 hours later it stopped
Progressing generalized rash,  2 weeks after receiving Covid booster vaccination (Pfizer). It was described as Exfoliative dermatitis evolving into erythroderma . Skin biopsy currently pending.
Erythematous patchy rash on back, a few on face and erythema around the site of the HIB vaccine.
Discharge and uterus bleeding, sharp lower belly cramps, fever and fatigue, irregular menstruation, nausea and vomiting
Eight days after the vaccine, my left arm where I got the shot started to itch. Over the course of the day, my upper arm swelled, became bright red, and felt hot to the touch. This lasted for three days.
MCIR and Parental Consent was marked with MENACTRA and it was due in June 2017. Given early, parent notified and understands he will need another at age 16 years. Age of patient at time of event: 15 years.
Itchiness and red skin began immediately. A large welt or hive appeared within a few hours and has continued. This "hive" is hard to the touch.
I was in the hospital I couldn't breathe and I was running a fever. I was shacking . While being in the hospital I am now on oxygen and I also got rhino virus while at the facility.
Muscle weakness and numbness in bilateral hands and feet; progressed from lower extremeties up through abdomen to sternum; also burning numbness and tingling in hands and weakness 12/3/09 ER records received for date 11/23/09 to 11/28/09.             DX: transverse myelitis Chief c/o muscle weakness and numbness in bilat hands/feet. Pt here in ER for second time for same c/o on 11/23/09. pt states received flu vax prior to onset of this episode.  Assessment: WNL. Pt noted to have some difficulty walking. Neuro assessment: mild weakness of distal portion of hand, decreased sensation lower portion of chest.  12/03/09 ED and hospital records received. Service dates 11/23/09, 11/28/09-12/1/09. Assessment: Transverse myelitis. Patient presents with bilateral muscle weakness and numbness in hands and feet of 2 weeks duration. Chills. Ataxia. Chiropractor found no abnormality. Prior ED visit - Urinary tract infection, anxiety, hypokalemia. Now weakness and numbness has extended to abdomen up to level of sternum. Tingling/burning in hands. Difficulty in walking. Feels weak. Mild congestion. Mild hand grip strength weakness. Back pain, neck pain.
Pt noticed some muscle tenderness at site approx 4-5 hours post injection. Approx 24 hrs later noted increased tenderness. Redness and swelling to site presented in Drs office for evaluation. Initiated Augmentin 875mg BID x 10 days. Benadryl or Claritin PRN.
Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patient post temperature excursion; Moderna COVID-19 vaccine administered to patient post temperature excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    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 WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion).    Concomitant product use was not provided.  It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported  and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use.  No treatment information was provided.  This case contains information for the 81st of 104 adult patients described by the reporter   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:
Patient called, stating that the area around her arm was red and itching. I advised her to monitor the rash and take BENADRYL. I also advised her to seek medical attention if the rash spreads, gets worse, or if she experiences trouble breathing. Patient will be contacting doctor Monday morning (4/2/19).
Child has welty rash at vaccine site.  After about two hours the rash spread to whole body.
Induration of 2.5 inch x 3.0 inch on left leg. Follow up: problem site to be at DTa site per doctor.
Pt vaccinated with Engerix-B developed fever, nausea, rash, bumps.
Headache, Myalgia, Fever,  Fatigue, Joint Pain. Narrative:
Ended up with fluid around my heart and had to get a pace maker because my bottom number of my heart dropped.
Severe palpitations, watery headache, throbbing gallbladder, consecutive fainting, loss of consciousness, involuntary movements, loss of sleep, intense pain throughout my body. My period has not returned and I feel symptoms of premature menopause.
tired; fussy; did not want to eat as much; minor redness at injection site but nothing major; Initial information received on 03-Apr-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via other company (Pfizer). This case involves male patient (age unknown) who experienced fussy, tired, did not want to eat as much and minor redness at injection site but nothing major, while he received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patients past medical history  and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) on unknown date.  On an unknown date, the patient received injection of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number, expiry date not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious fussy (irritability) with unknown latency following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. On an unknown date, the patient developed a non-serious tired (fatigue) with unknown latency following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. On an unknown date, the patient developed a non-serious did not want to eat as much (decreased appetite) with unknown latency following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. On an unknown date, the patient developed a non-serious minor redness at injection site but nothing major (vaccination site erythema) with unknown latency following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Lab data was not provided.  Final diagnosis was minor redness at injection site but nothing major, did not want to eat as much, tired and fussy.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for fussy, as Unknown for tired, as Unknown for did not want to eat as much and as Unknown for minor redness at injection site but nothing major.  List of documents held by sender- none.
Patient reports sore arm and local reaction. A day or two after he noticed a knot, which may have been a blister that ruptured when he rubbed it. It now healed up and had a scab over it. He said it was getting better and healing. Patient also said he had nausea and stomach issues and had green colored stools.
pharmacist administered 0.25 "ml" of air because they forgot to draw up the dose. Patient was anxious about the error but otherwise did not have any adverse effects that were out of the ordinary (mild pain and tiredness)
ABDOMINAL PAIN,ABDOMINAL CRAMPS,SORE BELLY; NAUSEA; LOSS OF APPETITE; CANNOT SLEEP; CHILLS; This spontaneous report received from a parent 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 was not reported, administered on 31-MAR-2021 at 14:30  left arm for prophylactic vaccination.The batch number was not reported and has been requested No concomitant medications were reported. On 2021, treatment medications included: paracetamol. On 31-MAR-2021, the subject experienced loss of appetite. On 31-MAR-2021, the subject experienced cannot sleep. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021 18:30, the subject experienced abdominal pain, abdominal cramps, sore belly. On 31-MAR-2021 18:30, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cannot sleep on 01-APR-2021, and chills on 2021, was recovering from abdominal pain,abdominal cramps,sore belly, and loss of appetite, and had not recovered from nausea. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
This spontaneous report was received from a physician via a company representative, and refers to a 14 year old female patient. It was unknown if the patient had concomitant medications, concurrent conditions, medical history, drug reaction or allergies. On 26-JUN-2017, the patient was vaccinated with the first dose of GARDASIL 9 injection, for prophylaxis (strength, dose, frequency, route, lot number and expiration date were not provided). On 12-DEC-2017, the patient went to the emergency department complaining of "being dizzy and light headed" (dizziness). On 27-DEC-2017, the patient was vaccinated with the second dose of GARDASIL 9 injection, for prophylaxis (strength, dose, frequency, route, lot number and expiration date were not provided) and continued to be dizzy. As a result, on an unspecified date in Januray 2018, the patient was screened for "Lymes disease and screened positive, but the western blot test came back negative". It was also stated that  "throughout the year of 2018, on unspecified dates, the patient had appointments with an unspecified cardiologist, neurologist, and otolaryngologists (ENT), and all unspecified findings were negative". Reporter stated that the patients "symptoms improved throughout the spring of 2018, however the patient went back to the Physician on unspecified date in December 2018 complaining of headache, and dizziness". As a result, the patient was tested again for "Lymes disease", and the "western blot for Lymes came back positive" (lyme disease) and was treated with "intravenous doxycycline twice on unspecified dates in 2018". The reporter stated that the "patient was still complaining of being dizzy currently". At the time of reporting, the outcome of lyme disease was reported as not resolved. The outcome of dizziness was recovered in March 2018. Causality assessment was not provided. Upon internal review, the event lyme disease was determined to be medically significant.
Self reported vaccinated pt admitted with covid infection. No info on vaccine type, amount, place, date, etc.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing). No known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid for covid-19 treatment from 26Jul2022 to 30Jul2022 for treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
second dose was given one month and one week earlier that it should have been given (with no reported adverse event); Initial information regarding an unsolicited valid non-serious case was received from a other health care professional (Reference number- 00519297) and transmitted to Sanofi on 15-Mar-2021.  This case involves a 17 years old female patient who received second dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] one month and one week earlier (Inappropriate schedule of vaccine administered).  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 27-Jul-2015 the patient received first dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and on 17-Jun-2019, she received second dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.   It was a case of an actual medication error due to Inappropriate schedule of vaccine administered.  The caller stated that the patient's second dose was given one month and one week earlier that it should have been given. She wants to know if they can give her one today? The caller would like to know if she can safely administer the next Menactra dose 1 month and 1 week early from the recommended time frame. At this time, the patient is currently in the HCP office to receive her next dose of Menactra.  At the time of reporting, patient had no adverse event.  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 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.
Patient was 10 years old at the time of vaccination but received a dose from Comirnaty which is for ages 12 years and older. Patient did not have any adverse events. Parent stated that patient had complaints of soreness in the arm when they got home but no other complaints.