chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; ALMOST KILLED ME; DEPRESSION; This spontaneous report received from a patient via a social media via company representative concerned a patient of unspecified age and sex. Initial information was processed along with the additional information received on 26-JAN-2022. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26. cov2.s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown)1 total, for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose,1 total start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected clinical vaccination failure, suspected covid-19 infection, almost killed me and depression (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the almost killed me, depression, suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint:90000213039. The suspected regulatory authority has been confirmed to be voided (did not meet criteria) based on the RA evaluation/investigation performed.; Sender's Comments: V0: 20220137210 -COVID-19 VACCINE AD26.COV2.S-Suspected Clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's; This spontaneous safety report, with reference number 02299086 (Interaction # 02299043) was received by the partner on 19-DEC-2022 and forwarded on 21-DEC-2022, from a health professional.   Due to the nature of the event, the causality between the event "HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's" and Vaxelis was not applicable.   Further information is expected.  For reference purposes, this case is linked to MCM-004406, MCM-004407, MCM-004409 and MCM-004410 (same reporter).  SIGNIFICANT FOLLOW UP INFORMATION was received on 03-JAN-2023 from the health care professional.  The reporter confirmed that there were no Adverse Events following Vaxelis administration to the patient.  Due to the nature of the event, the causality between the event "HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's" and Vaxelis remains not applicable.  No further information is expected.
severe local rxn w/pain, swelling, heat x few days; "size of tennis ball"; plus concurrent nausea, stomachache, h/a, vomit, chills, then long lasting profound fatigue, h/a, GI upset; blurred vision; chills, tired, arm pain, heat, BP low
not going to receive 2nd dose; tonic-clonic seizure/intense seizure; This spontaneous case was reported by a consumer and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (tonic-clonic seizure/intense seizure) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Seizure (1st time he had seizure when he took Benadryl 10 month ago when he was 17 year old).). Concurrent medical conditions included Autism. Concomitant products included LORATADINE (CLARITINE) for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (tonic-clonic seizure/intense seizure) (seriousness criterion medically significant). On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (not going to receive 2nd dose). At the time of the report, GENERALISED TONIC-CLONIC SEIZURE (tonic-clonic seizure/intense seizure) outcome was unknown and INCOMPLETE COURSE OF VACCINATION (not going to receive 2nd dose) had resolved. No treatment details provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication information was provided. The patient was on testing at the time of report. Company comment: Very limited information regarding this event has been provided at this time. Further information has been requested. Causal relationship cannot be excluded for the event of Generalised tonic-clonic seizure. Company causality for Incomplete course of vaccination was assessed as not applicable.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested. Causal relationship cannot be excluded for the event of Generalised tonic-clonic seizure. Company causality for Incomplete course of vaccination was assessed as not applicable.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 17-JUN-2014, the patient inadvertently received a dose of either VAQTA (dose, route of administration, lot #, expiration date not reported) or HAVRIX (dose, route of administration, lot #, expiration date not reported). They received another dose on 14-NOV-2014. No adverse effects reported. Additional information has been requested.
Patient received his first Pfizer vaccine and during monitoring period he became cool, clammy and pale.  HR 50's; BP 110/74; O2 Sats 90%.  He proceeded to pass out 3 times with jerky movements noted.  EMS notified.  Patient stated he had not eaten and had drank very little.  EMS arrived and evaluated patient.  He declined going in for further evaluation or treatment.  Continued to monitor with no further episodes.
Heading, Myalgia, NauseaVomting, pain at site Narrative:
dizziness, this was diagnosed as being in the right vestibular nerve, was treated with physical therapy. was treated with steroids in the ER and again the next week in the doctor's office at first, could not walk across a room unassisted nor turn head to tract conversation. duration 8 months of very slow improvement until I could ride a bike again.
Information has been received from a physician concerning a 3 month old female who was vaccinated with the first dose of Rotateq (Lot # not provided). Subsequently after receiving the first dose of Rotateq the patient experienced diarrhea, vomiting and dehydration three weeks post-vaccination and had to be hospitalized to treat the condition. The patient was hospitalized for 24 hours. Subsequently, the patient fully recovered from diarrhea, vomiting and dehydration and has been discharged from the hospital. Additional information has been requested.
Patients guardian falsified DOB when registering for vaccination, stating the minor DOB was 03/15/2005. Guardian consented to the vaccination. Verified with statistical records that the patients actual DOB is 03/15/2006 which made the vaccine a contraindication.  No known adverse reactions noted.
A patient who recently got a stem cell transplant.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: STEM CELL TRANSPLANT (medically significant), outcome "unknown", described as "A patient who recently got a stem cell transplant.".Clinical course: Caller (Pharmacist) wants to know if there is any clinical relevance of efficacy of the vaccination for people who receive the COVID-19 vaccine and stem cell transplant. He said that they got a call from a doctor's office requesting recommendation for a patient who recently got a stem cell transplant. He wants to know if they need to start the entire series again.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Narrative:  79 year old female with a PMH of paroxysmal atrial fibrillation, stage II (T2N0M0) high grade invasive urothelial carcinoma of the Bladder, remote breast cancer, macular degeneration, GERD, HTN and HLD. Pt presents to ED on 06/08/22 after recent discharge (6/07) from outside hospital where she was diagnosed w/ a cold, hyponatremia, Corynebacterium UTI and metabolic encephalopathy. Pt complains of weakness and chronic headache. Pt positive for COVID 19 w/ failure to thrive, hypomagnesemia, bladder cancer and admitted to hospital. During hospital stay, pt received supportive care only for COVID 19. Pt determined to have metastatic disease and placed on hospice care. Pt discharged to nursing home on 06/29.
patient 1 of 6: pt recv vax & 6hr p/vax pt devel nausea & chills which cont most of the day;pt recovered;
received both / doses in 2019 / 7/18/2021  PA diagnosed patient with Shingles / had both doses of / vaccine about 1 or 2 years ago / HCP said I had all the symptoms of Shingles but not the rash/ suspected vaccination failure; PA diagnosed patient with Shingles / HCP said I had all the symptoms of Shingles but not the rash / it is moving and spreading around the back; experiencing pain on right side of torso / having symptoms of pain (AE: Pain) / 5 days ago on the side of the body; no raised blisters but a thin line under the skin; burning (AE: Burning) 5 days ago on the side of the body; if he gets touched on the area it hurts and burns more; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix. On 14th July 2021, more than a year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, blister, burning sensation and touch sensitivity increased. On an unknown date, the outcome of the vaccination failure, shingles, pain, blister, burning sensation and touch sensitivity increased were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain, blister, burning sensation and touch sensitivity increased to be related to Shingrix and Shingrix.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was unknown. The patient received both the doses of Shingrix in 2019. The reporter also stated he received both doses about 1 or 2 years ago. On 14th July 2021, 5 days before the date of reporting, the patient was experiencing pain on right side of torso and burning on the side of the body. On 18th July 2021, the patient was diagnosed with shingles. The patient reported there were no raised blisters but a thin line under the skin. The patient stated that, the healthcare professional said to him that he had all the symptoms of shingles but not the rash. The patient also stated that if he touched on the area it hurt and burnt more and was moving and spreading around the back. The patient reported that he had never had shingles before. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting. The patient did not have exact dates of vaccines or lot and expiration dates. The reporter did not consent to follow up with the healthcare professional.
Presented to the ER on 12/27/2021 with symptoms of cough x 2 weeks, dyspnea, n/v LE swelling, tachycardia and hypoxia. Tested COVID positive 12/27/2021. Required intubation and mechanical ventilation 12/29/2021. Developed acute kidney failure requiring CRT, multiple vasopressors for shock. Developed pulmonary embolus. Despite maximum therapy, he expired 1/2/2021.
Case number PHEH2016US027017, is an initial spontaneous report from a nurse received on 17 Oct 2016. This report refers to a 33 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUCELVAX (batch number: 185888) at a dose of 0.5 ml, intramuscularly on 17 Oct 2016. It was reported that, a temperature excursion occurred with FLUCELVAX Pre-filled syringe in a closed refrigerator, vaccines were cool to touch upon discovery. The patient estimates the time of excursion was 02 to 03 days and max temperature was estimated to be less than 77 degrees Fahrenheit. This was the first temperature excursion. It was stated that, vaccine has been given to 07 people this morning on 17 Oct 2016. No adverse event was reported following this medication error.
Left shoulder pain, near the site of the vaccine, but not overlying vaccine site. Pain has persisted for 2 weeks, beyond normal expected from localozed reaction. Uncertain if pain is related to vaccine.
Large area of redness, warmth, and induration at site of vaccine administration. Began in evening following shot, progressed on 06/27 to overall erythema, more painful and indurated today. Redness extends from Deltoid to just above left elbow. Received ibuprofen, received ice pack and hydrocortisone cream topically to lower itch and erythema.
Breaking out in sores around waist area next morning, went to urgent care and treated with steroid injections
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date unspecified number of patients received an unspecified number of doses of improperly stored PEDVAXHIB (lot number, exp. date and route not reported). The reporter stated that PEDVAXHIB has been exposed to total time out of range a maximum of 60.5 hours at minus 2 Celsius degree. No adverse effects were reported. The outcome of events was unknown. This is one of 4 reports from the same source. 1308USA002370; 1308USA003562; 1308USA003561; 1308USA003560. Additional information has been requested.
diziness; worsening tinnitus; This case was reported by a consumer via call center representative and described the occurrence of tinnitus in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2018, the patient received the 1st dose of Shingrix. In December 2018, 1 min after receiving Shingrix, the patient experienced dizziness. On an unknown date, the patient experienced tinnitus. On an unknown date, the outcome of the tinnitus was not recovered/not resolved and the outcome of the dizziness was unknown.   The reporter considered the tinnitus to be related to Shingrix. It was unknown if the reporter considered the dizziness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient experience dizziness within 60 seconds. It also caused her tinnitus to kick up and it has persisted for five months. Call notes stated that the patient did not wish to provide her demographics or additional information at the time of reporting
patient got infected with covid; patient got infected with covid; This is spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified dates (Batch/Lot number was not reported) at 1st dose, single and 2nd dose, single for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. While visiting abroad, patient got infected with covid and died on an unspecified date. Apparently, the patient received two Pfizer vaccines shots prior to his travel. It was unknown if an autopsy was performed.  No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: patient got infected with covid
This spontaneous report was received from a pharmacist refers to a patient of unknown demographics. The patient's relevant medical history or drug allergies were not reported. On 25-AUG-2014 the patient was vaccinated with one dose of ZOSTAVAX (strength, dose, route of administration, lot number and expiry date were not reported). No concomitant medications were reported. On 25-AUG-2014, the patient received one dose of ZOSTAVAX which was not stored properly. There were no adverse effects noted. There was no product quality complaint reported. The outcome was unknown. Additional information is not expected.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 06-JUN-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength: 0.5ml)(lot # L036245, expiration date 09-FEB-2018). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion three times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (refrigerator/freezer)(R/F) for the first and second time were 212, 34 and R; 828, 29 and R. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (refrigerator/freezer) (R/F) for the third time were 24, 49 and R. The storage criteria was R. This is one of several reports received from the same source. Additional information has been requested.
Patient reported itching at injection site and feeling a little nauseated. Patient felt fine after 10-15 minutes. The next day patient went to ER, and redness around injection site had grown to a few inches. Patient was given prednisone and antibiotics. According to patient, ER told her it felt like a cyst and gave antibiotics if infection.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 2:23 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 2:26 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 83.28 for dose administered on 28-Mar-2021 and 83.20 for dose administered on 28-Feb-2021. No concomitant medications were reported. Batch number 019B21A underwent temperature excursion on 28-Mar-2021 with temperature 35 degrees Fahrenheit at 10:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021. Batch number 014M20A administered on 28-FEB-2021 underwent temperature excursion with temperature range 26 to 27 degrees Fahrenheit from 09:00 AM to 01:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-feb-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.
pt recvd vax;w/in 1 wk exp itching,then rash,then flu-like sx;tx seldane;rash resolved 5-6 days later;sx resolved;
Patient developed light headedness and nausea 10 min after getting shot. BP 150/91 P 85 T 97.5 O2 Sat 97%.
This case was reported by a pharmacist via call center representative and described the occurrence of muscle swelling in a 60-year-old female patient who received SHINGRIX (batch number 95LX9 ?, expiry date 22nd February 2021) for prophylaxis. On 19th July 2018, the patient received the 2nd dose of SHINGRIX .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced muscle swelling and localized erythema. On an unknown date, the outcome of the muscle swelling and localized erythema were unknown. It was unknown if the reporter considered the muscle swelling and localized erythema to be related to SHINGRIX. Additional details were provided as follows: The health care professional stated that a patient developed redness and swelling of the bicep. The SHINGRIX was administered in the deltoid. The health care professional shared adverse information to the Agency via health care professional chat. The health care professional stated injection was in the deltoid, but the bicep was red and swollen, not the deltoid. Clarification had been requested for the batch number.