chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 1:14 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 1:14 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 41.25   Concomitant products were not provided.  On 30-Mar-2021, vaccines with batch number 030B21A were moved to the fridge. On 31-Mar-2021, 14 vials were moved to clinic. On the same day between 08 AM to 09 AM, vials underwent temperature excursion with temperature of 32 degrees Fahrenheit. On 03-Apr-2021, 20 vials were moved to clinic. On the same day at 09 AM, vials underwent temperature excursion with temperature of 34 degrees Fahrenheit. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 29-Apr-2021.  It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.   The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment medications were not reported.
Patient got the flu shot in Nov'2019. We called him in January for his shingle shot and at that time patient informed us about the slight bump and a dull pain at the injection site We advised him to see the MD. and was advised ultrasound and MD did not find any signs of infection or tissue etc. and no further treatment recommended.
2 days after vaccine, reported to have fever (unsure what temp). 3 days post vaccine, chest pain worse when lying down and dry cough. On that day, seen in ER with abnormal ECG (ST segment elevation) and elevated troponin level. Transferred and admitted to my hospital. Given ibuprofen for chest pain which improved quickly. Reassuring cardiac findings and improved troponin and ECG and discharged to home on hospital day 3. See below for labs
22FEB pt had episode of vomiting;had routine MD exam;23FEB96 periodic crying episodes of 1hr duration;24FEB96 2 1/2 hrs of unconsolable crying was out of town visiting grandparents;pt had sz witnessed by mom & grandfather;to hosp t99
Arm felt heavy and sore 1:30pm took Tylenol.  Feel very tired.   6pm Shortness of breath. Needed more air. Used an inhaler & it helped.  Exhausted 8pm
fever stayed under 102; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 7th June 2022, the patient received the 2nd dose of Shingles vaccine. In June 2022, less than a week after receiving Shingles vaccine, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-JUN-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient was vaccinated with shingles vaccine on Tuesday (from the day of reporting) and started running a fever which stayed under 102 degree F. Additional Supportive Information: The follow up would not possible, as no contact details were available.
Diarrhea a few hours after HPV. Light headed, dizzy, near syncope for approximately 48 hrs after vaccine.
fully vaccinated (moderna, 1/14/21, 2/12/21); symptom onset 7/31/21
Small quarter-sized painful lump at injection sight; occasional varying degrees of muscle pain (mild to severe); occasional extreme and enduring joint pain; searing pain; chills; limited movement, range, use of left arm; general malaise.
First dose:J&J and second dose: Pfizer vaccine; First dose:J&J and second dose: Pfizer vaccine; I tested positive with symptoms on a rapid test on the evening of April 12; I tested positive with symptoms on a rapid test on the evening of April 12; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), in Jul2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 05Apr2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 18Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PHENYLEPHRINE. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 22Apr2022, outcome "unknown" and all described as "First dose:J&J and second dose: Pfizer vaccine"; DRUG INEFFECTIVE (medically significant) with onset 22Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 22Apr2022, outcome "recovering" and all described as "I tested positive with symptoms on a rapid test on the evening of April 12". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Apr2022) positive; (20Apr2022) negative; (28Apr2022) positive. Therapeutic measures were not taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recv vax 30JUL97 & that same day pt exp redness & swelling of the upper arm;pt reportedly recovered from this exp;
This case was initially reported from the pt on 11/25/03 and was considered non-serious. From additional info received from the responsible physician on 2/13/04 this case has been upgraded to serious. No seriousness criteria was reported. Based upon medical judgment this case is considered serious: medically significant event (OMIC). From initial info received on 11/25/03 from the pt regarding an adverse event, it was reported that the 49 year old female pt received a dose of Fluzone (U1122AA), administered in the left arm on 11/10/03. Two days later, on 11/12/03, the pt developed SOB, rash and swelling of her eyes. The pt took Benadryl, prednisone, and used an Epipen to treat the symptoms. The pt has a history of asthma. Her recovery status is currently unknown. From additional info received on 2/13/04 from the responsible physician, it was reported that the pt developed erythema multiforme, which lasted almost 2 months. She then experienced mild recurrent rash relapses. Additionally, the injection site would become red and tender with rash flare-ups. At the time of this report, the erythema multiforme was slowly subsiding, however, she continued to experience the recurrent mild rash and was still on antihistamines. Her medications included Allegra 120mg daily, Singulair 10mg daily and Advair as needed. The pt has not recovered from these adverse events.
On 10/17/09 patient was taken to hospital for seizure activity. At hospital she was intubated for respiratory failure. Mother reported low grade fevers at home. She was given fosphenytoin and started on maintenance IV fluids. Head CT was done and noted as stable. Blood cultures and urine cultures were negative 3/6/09-records received for DOS 10/17-10/20/08-DC DX:Status epilepticus. Respiratory distress. Positive Influenza B. Urinary retention. Presented to ED with C/O seizure activity, followed by lip smacking and left leg jerking. Became apneic with desaturations to the 60s, intubated for respiratory failure. Low grade fever at home.
Mildly itchy, red raised irregularly oblong area surrounding the injection site 3 1/2 inches by 5 inches. The previously invisible needle entry became visible and red as well.
Information has been received from a pharmacist concerning a 25  year old female who on 01-FEB-2007 was vaccinated IM with a 0.5 ml dose of varicella-zoster (lot # 652966/0722f), the patient was supposed to receive HPV. The vaccine was incorrectly selected by a pharmacy technician due to the products being released at similar times and that it was not a labeling issue and then nursing did not check the product before administering. The pharmacist confirmed that this was a result of human error. Unspecified medical attention was sought. At the time of the report the patient had not had any adverse experiences and was "fine." The pharmacy technician was re educated about the vaccines. There was no product quality complaint involved. No further information was provided. Additional information has been requested. Additional information received from the pharmacist on 27-MAR-2007 indicated that the patient developed arm/muscle soreness from two days, it resolved without treatment. On 13-FEB-2007 at 12:00 P.M. the patient was vaccinated IM in the left arm with a dose of
My legs became itchy Friday morning and that eventually the itch spread to my arms and torso. By Friday evening I started developing hives. Saturday morning the hives were covering the majority of my body. I went to see a doctor and was given a prescription. Sunday I woke up even worse (severe itching, pain/sensitivity) so my doctor instructed me go to urgent care where I was given an IV. That helped to clear it up. Monday morning I woke up with hives starting to develop again. I took the medication that was prescribed and it helped calm it down. It is Monday morning at the time of this report.
that a nurse administered FLUZONE HIGH DOSE to a patient intravenously, with no reported adverse event; Initial information received on 16-Nov-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of unknown age and unknown gender who was administered influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent] intravenously, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitants and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza quadrival A-B high dose HV vaccine (strength, formulation, batch number and expiry date: unknown) via intravenous route in unknown administration site for immunization (incorrect route of product administration) (latency: same day).   Lab tests were not reported.   Action taken: Not applicable.  At time of reporting, the outcome was unknown for the 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 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.
A non-serious spontaneous report of expired FLUMIST administered to three elementary school children was received from a certified medical assistant. The product expired on 04-Jan-2010. On 27-Jan-2010 the patients received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Heart palpitations, chest pain, heart rate exceeding 100 bpm, and swollen, red, itchy mark around injection site. Went to the emergency department and received Iv fluids and was monitored until symptoms subsided.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. The nurse reported that an unknown dates, the unspecified number of unspecified patients received doses of ROTATEQ (dose, lot number and expiration date not reported) oral, that were improperly stored. No adverse experiences reported. No concomitant medications were reported. No further information was provided. This is one of the several reports of the same source. Additional information has been requested.
Had localized itch on back prior to vaccine. Within days or at most a couple weeks of receiving the second dose of my vaccine I started to have symptomatic dermatographia with scratching that manifested as follicular urticaria. This became more widespread where ever I was itchy and scratched. Im being treated with antihistamines and it is improving but not resolved.
I got sick; Initial information received on 12-Dec-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp (patient).  This case involves a patient of unknown demographics who got sick while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE (with an unknown formulation, strength) produced by unknown manufacturer lot number not reported in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed a non-serious event "i got sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE..  It was reported "got a flu shot 1 time in my life 30 years ago and I got sick as fuck! from that shot! I never had flu be for that shot and I never had flu 30 years after that shot! So I'm good thanks."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (I got sick).  At time of reporting, the outcome was Unknown for the event i got sick.
AFTER 10 MINUTES OF VACCINATION DEVELOPED PALPITATIONS, SOB AND HIGH BLOOD PRESSURE BP 215/90 TREATED WITH VASOTEC 2.5 MG IV X 1, AND PUT ON CARDIAC MONITOR   BY DR. AND IMPROVED
Information has been received from a physician via medical records concerning an 17 year old male patient who on 02-JUL-1993 was vaccinated with the first dose of RECOMBIVAX HB (Lot number 154A2), the first dose of diphtheria toxoid/tetanus toxoid (Lot number 399-905), 382-948-06796) and the fist dose of HIBTITER () Lot number H015TL). On 07-SEP-1993 the patient received a "second dose" of RECOMBIVAX HB (manufacturer unknown) (lot number not reported). The second dose of diphtheria toxoid/tetanus toxoid (Lot number 249-905) and the second dose of HIBTITER () Lot number M170KB). On 10-NOV-1993, the patient received the third dose of diphtheria toxoid/tetanus toxoid (Lot number 4938032) and the first dose of HIBTITER () Lot number H015TL). On 08-MAR-1994, the patient received the "third" dose of RECOMBIVAX HB (lot number 607974/0989W) (thimerosal containing). On 16-APR-2010 the patient's serum hepatitis B surface antibody screen was <0.5, reported as does not have immunity to hepatitis B virus. The patient's past vaccination history included: ORIMUNE on 02-DEC-1994, 02-JUL-1993, 07-SEP-1993 and 21-AUG-1998. MMR II on 01-SEP-1994 and on 21-AUG-1998. VARIVAX (Merck) on 03-MAY-1996 and on 11-MAR-2009. MENACTRA on approximately 15-APR-2007. Tuberculin purified protein derivative in August 1998. At the time of the report the patient's status was unknown. This is one of several reports received from the same source. No further information is expected.
No other issues or concerns noted; a patient was given expired PNU23 that was expired; This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. Information concernig the patient's concurrent conditions, pertinent medical history and concomitant medications was not provided.     On 14-JUL-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (Lot # S034299, expiration date 01-JUL-2121) dose, route of administration and anatomical location were not provided, for prophylaxis. No other issues or concerns were noted by the Nurse.  This is one of two cases received from the same reporter (2107USA005417). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S034299; expirationdate: 01-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2107USA005417:
patient was administered an expired booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered an expired booster dose) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered an expired booster dose). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient was administered an expired booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided It was reported that more people got doses from vials with this lot number in another pharmacy of the same chain.   This case was linked to MOD-2021-369020 (Patient Link).
Patient received pneumococcal and meningococcal (trivalent) around 10AM on 5April and took a dose of atovaquone/proguanil 6PM on 5Apr. She was feeling well until the morning of 6APR when she developed malaise, subjective fevers, and then experienced at least 4 episodes of nausea with non bloody, nonbilious emesis starting at 1PM. She came to the ER around 4PM and was noted to be febrile but did not have a documented fever at home. She also reported dark urine and arthralgias. She denied diarrhea, constipation, headache, double vision, neck stiffness. She has received the same immunizations in the past and has never felt this sick. No recent sick contact, no recent travel, and has been preparing for a 6 week trip to a foreign country; planned departure 7Apr. Her initial VS in the ER significant for HR 105, BP 123/65, Temperature 101.4, 99-100% RA. Her HR responded to fluid boluses to mid 80's. Labs s/f WBC 21K with 97S, 1L, anion gap of 16, and total bilirubin of 1.5. UA x2 with multiple epithelial cells, blood cultures drawn in ER: no growth in 48 hrs. An Acute abdominal demonstrated no radiographic evidence of acute cardiopulmonary disease. She was treated with fluids, TYLENOL and ZOFRAN which controlled the vomiting but not the fever. She was admitted due to fever, leukocytosis S/P splenectomy. Upon admission she was treated with IVF, ceftriaxone and vancomycin, however the vancomycin was dc'd due to c/o pruritus).
Medical assistant thought that the Vaxelis did not contain the components of ACTHIB and gave an extra dose of ACTHIB to the patient; Medical assistant thought that the Vaxelis did not contain the components of ACTHIB and gave an extra dose of ACTHIB to the patient; This non-serious spontaneous safety report, with Identification Number 2023SA183716 (Inquiry Number: 01653898/Inquiry: 01653864), was received by partner, on 14-JUN-2023 and forwarded on 16-JUN-2023 from a health professional. Additional Information was received on 16-JUN-2023.  The causal relationship between Vaxelis and the reported events "Medical assistant thought that the Vaxelis did not contain the components of ACTHIB and gave an extra dose of ACTHIB to the patient" was assessed as not applicable due to the nature of the event.  Further information is expected.
Pt stated started with a quarter size patches from leg to the inside of her thighs and spreading. Doubled in size,  06/22/2012 ER could not diagnose, Xrays, Blood tests, Ekg, ultrasound vein scans. Scheduled 06/24/2021_for biopsy. No other symptoms
child had fever 104 (R) & was taken to Hospital at 11:30 pm, seen by MD the next day, Dx: rxn to vax given
Severe pain and continued swelling at the injection site. Worsening pain and swelling on day 2, with a 4" swelling and pain radiating into the neck and shoulder.
AE reported to pharmacy team member on 3-28-18 that patient is deceased as of 3-16-18. No additional details provided.
FELT THE MEDICATION GOING INTO ARM, AFTER SHE PULLED OUT HE FELT CHILLS AND HAD RINGING IN EARS- LOOKED PAIL AND HAD BLANK STORE. PT FELT COLD, SWEATING, AND WAS DIZZY. PT TOOK SLOW DEEP BREATHS AND LAID ARM DOWN ON ARM. HE NEVER PASSED OUT. PHARMACIST GOT HIM COLD COMPRESS TO PUT ON HEAD. HAD HIM TAKE SLOW DEEP BREATHS. PT THREW UP IN TRASH CAN. HAD PATIENT SUCKED ON STARBURST CANDY FOR ABOUT 15 MINUTES. PT FELT OFF FOR 20 MINUTES. PT WENT HOME AFTER DIZZINESS RESOLVED. PT HAD HEADACHE AFTER GOING HOME. DID NOT NEED TO TAKE MEDICINE. PT ALSO REPORTED ACHING ARM. HEADACHE WENT AWAY BY FOLLOWING DAY. PT FEELS LIKE THIS IS NOT TYPICAL REACTION AS HE HAS REGULAR BLOOD DRAWS AND IS NOT NERVOUS ABOUT NEEDLES.  HE SAID HE WAS NOT NERVOUS BEFORE HE GOT THE VACCINE.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, Additional Details: Patient was pale and felt dizziness a few minutes after getting her Pfizer pediatric vaccine. We checked blood pressure 65/46 HR 53. She felt better after 5 minutes. Mom was counseled to call the pharmacy this evening if needed.
Patient was given a dose of Quadracel and Pentacel. Patient was supposed to receive ProQuad and Pentacel. Patient has had no reaction, and the parents have been notified.
Patient woke up with localized swelling, redness and pain around the injection site. Treating with ice packs applied in 20 minute cycles.