chrisvoncsefalvay/vaers-outcomes huggingface dataset:
four children including my son went in with this illness; Suspected vaccination failure; This case was reported by a consumer via interactive digital media and described the occurrence of bacterial meningitis in a child patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced bacterial meningitis (serious criteria death and GSK medically significant) and vaccination failure (serious criteria GSK medically significant). On an unknown date, the outcome of the bacterial meningitis was fatal and the outcome of the vaccination failure was unknown. The reported cause of death was bacterial meningitis.   The reporter considered the bacterial meningitis and vaccination failure to be related to Meningococcal B vaccine.  Additional details were provided as follows: Age at vaccination was not reported. It was reported that vaccine meningitis B, did not protect from bacterial meningitis. The patient went in with this illness and did not survive. This case was considered as vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were not provided.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR232424:same reporter US-GLAXOSMITHKLINE-US2020AMR232426:same reporter US-GLAXOSMITHKLINE-US2020AMR232267:same reporter; Reported Cause(s) of Death: Meningitis bacterial
Hives around injection site, left leg. No fever, no wheezing. Tender to touch.
Flu like symptoms with fever severe headache and nausea  all joints were painful and muscle weakness very tired Large hard painful red spot about 2 inches down the arm from injection site all of these symptoms lasted about 48 hours
79y.o. male with past medical history of COPD, hypertension, Mobitz type I AV block, pulmonary nodules, COVID-19 February 2022 who presented to Hospital for shortness of breath that was worsening over the past few days.  Patient was recently hospitalized in state at the beginning of August, he came back to state to live with his son while his apartment is getting ready in state.  He states he has been in state for approximately 8 days and he is felt that his breathing declining gradually.  Patient tested positive for COVID-19 today.  He denies any fever, chills he does admit to productive cough with yellow sputum.  In ER patient underwent a CTA to rule out PE, there is no evidence of pulmonary embolism, there were multiple pulmonary nodules stable from previous as well as a spiculated nodule in the LLL.  Patient states that his symptoms seem to worsen throughout the day, he feels the best right when he wakes up in the morning.  Patient states he has lost approximately 60 pounds over the past 5 years.  While in the EC his respiratory rate and pulse ox have fluctuated.  Patient will be admitted to hospital for further monitoring and continued IV steroids. Chest X - Ray - No acute pulmonary Process CTA PE - Neg for PE, multiple pulmonary nodules   Place in Contact/Respiratory Isolation  Infectious Disease Consult  Decadron 6 mg daily, Lovenox daily Pulmonary Consult  Troponin x3 - Negative  Telemetry Monitoring  Breathing Treatments as needed Fall Precautions, Pain Management Monitor Lytes, replace when indicated  Medications, Labs,, Imaging Reviewed  Resume Norvasc for hypertension DVT/GI Prophylaxis  Full Code   8/19/22- Pt stable for dc today. On RA. Will continue decadron course. Resume home advair and spiriva. Cardio c/s for bradycardia with pauses. Cleared pt for dc with f/u OP. Given + RF, pt to f/u with rheum OP
Moderate to severe arm pain (numbness, tingling, radiating, heavy feeling,  sensitive to touch throughout arm, muscle soreness,  muscle weakness), headache,  fatigue, fever.  Began about 30 mins after injection to 3 days after receiving injection. Site tenderness currently.
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 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Apr2022 at 10:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 22Jan2021 at 08:30 as dose 1, single (Batch/Lot number: unknown), in left arm, on 23Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 24Oct2021 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "3 doses: Moderna/ 1 dose: Pfizer" (unspecified if ongoing), notes: 3 doses: Moderna/ 1 dose: Pfizer. Concomitant medication(s) included: SIMVASTATIN, start date: Jan2014, stop date: 25May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid, treatment start date=27May2022, treatment stop date=29May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I had really bad sore throat and serve SOB. It felt like I was hit by a truck. I had a fever and felt very, very weak. These lasted for about 2 weeks. On Dec 20th, I was tested positive for Covid-19.
swelling in the injection site; Pain in the injection site; Redness in the injection site; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING, VACCINATION SITE PAIN, VACCINATION SITE ERYTHEMA, and PYREXIA in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Oct-2021, the patient experienced VACCINATION SITE SWELLING, VACCINATION SITE PAIN, VACCINATION SITE ERYTHEMA, and PYREXIA. The patient was treated with DAYQUIL for Fever, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING, VACCINATION SITE PAIN, VACCINATION SITE ERYTHEMA and PYREXIA outcome was unknown.            Concomitant medications details were not reported by the reporter.
After the 2nd Shingrix vaccination on Wednesday at 4:00 pm I had exected a very sore L arm.  For about 24 hours I also had body aches, tiredness, chills and very slight headache. About 48 hours later on Friday eve I had some back itching and irritation. By Sat morning I had a rash beginning at the middle of my back beginning at the spine and going out to the right side of my back. As a geriatric nurse I recognized the lesions as Shingles. I took a picture and sent it to my physician via patient portal. She confirmed it was Shingles and stated she  didn't want to treat it with an antiviral because it would decrease the efficacy of the vaccine. My symptoms are mild and improving.
Cellulitis on left thigh.  About 15 cm diameter surrounding injection site on left posteorbital thigh.
Woke up skaking all over body-very violent. Could not control. Arms, legs everywhere. Continued for all day but did decrease a little bit toward evening. Doctor said nothing to do. Called 911, they checked. Blood pressure, heart etc seemed normal. Did not go to hospital because of virus cases being there. Vomited 1 time about 3 hours after I woke up. Second day was much better but extremely tired.Third day was back to normal but body very tired. Back to normal now.  Will I have this with second shot???
Very red sore area 3 inches below injection site; Very red sore area 3 inches below injection site; Feeling crappy; Muscles soreness; This case was reported by a other health professional via call center representative and described the occurrence of pain localized in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included BCG injection with an associated reaction of keloid scar (had as a child). Concurrent medical conditions included keloid scar.   On 1st June 2020, the patient received the 2nd dose of Shingrix. In June 2020, less than a week after receiving Shingrix, the patient experienced pain localized, localized erythema, feeling bad and muscle soreness. On an unknown date, the outcome of the pain localized was recovering/resolving and the outcome of the localized erythema was not recovered/not resolved and the outcome of the feeling bad and muscle soreness were recovered/resolved.   It was unknown if the reporter considered the pain localized, localized erythema, feeling bad and muscle soreness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and developed a very sore red area associated with a keloid scar about 3 inches below injection and feeling crappy for about 24 hours, and muscle soreness both which went away after about 24 hours. The day before reporting there was still a very sore red area associated with a keloid scar about 3 inches below injection site and at date of reporting seems to be going away as well. The reporter consented to follow up and gave permission for GSK to follow up with her if needed.
generalized weakness, nausea, vomiting, diarrhea, headaches, blurred vision, fever, palpitations, shortness of breath, no appetite, unable to sleep, significant weight loss
Muscle, joint and back aches; Muscle, joint and back aches; Muscle, joint and back aches; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiration date not reported), via an unspecified route of administration on the left arm on 08Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included appendicectomy in 2000. Concomitant medication included alprazolam (XANAX), linaclotide (LINZESS), fluoxetine (FLUOXETINE), buprenorphine hydrochloride, naloxone hydrochloride (BUPRENORPHINE/NALOXONE). The patient received first dose of bnt162b2 (lot number and expiration date not reported) on an unspecified date for COVID-19 immunization. The patient experienced muscle, joint and back aches on 09Jan2021 22:00. No treatment was given in response to the events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was unknown.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 04-FEB-2015, the patient was subcutaneously vaccinated with a dose of PROQUAD (Merck) (lot # K007156, expiration date 12-NOV-2015, 0.5 ml once) that was improperly stored. No adverse effects were reported. This is the one of several reports from the same reporter source. Additional information has been requested.
Received flu vaccine around 3 pm that day as mandated by my employer. I have previously never had any reaction to any vaccine. Within 4 hours of receiving vaccine I started feeling cold. Within another hour I felt like I was burning up and was shaking (rigors not shivering). My temp at that time was 103.4. No other symptoms. Fever and shaking for 12 hours then just gone. Called employee health to report reaction but they just blew me off. I also notified my PCP who said that they will mark it on my chart.
fainting about 3 minutes after vaccine injection unresponsive about 30 seconds with body shaking with pale and clammy skin
Pt stated around 10 AM received type, HPA vaccine at health dept, around 2 pm. Start having symptoms, breathing short, and felt her throat closing up, went to ER. Treatment given steroids.
felt weak, faint, diaphoretic & pale approx 5 mins p/inj;seen in ER:
It appears that the patient received a booster dose 2 months after their 3rd dose. This is too short of time for a booster dose.
pt admitted to hospital after CT scan of abdomen showed small bowel obstruction perforation; pt also tested positive for COVID; surgery required - right colectomy with ileocolic anastomosis; pt intubated and transferred to ICU; course of treatment complicated by A Fib, respiratory failure; AKI, COVID pneumonia and sepsis; pt was eventually able to be extubated but his condition worsened and he required intubation; required vasopressors; condition deteriorated and pt was transitioned to comfort care; pt died in the hosp
This spontaneous report was received from a clinical medical assistant regarding a currently 11 year old non pregnant female patient with an allergy to OMNICEF. The patient did not have pertinent medical history and concomitant medications. On 30-OCT-2003, the patient was vaccinated with the first dose of RECOMBIVAX HB (route: intramuscular, dose, lot #, therapy type, expiration date were not reported) for prevention of hepatitis B. On 05-JAN-2004, the patient was vaccinated with the second dose of RECOMBIVAX HB (route: intramuscular, dose, lot #, therapy type, expiration date were not reported) for prevention of hepatitis B. On 27-MAR-2004, the patient was vaccinated with the third dose of RECOMBIVAX HB (route: intramuscular, dose, lot #, therapy type, expiration date were not reported) for prevention of hepatitis B. On an unspecified day in December 2014, unspecified infectious disease serologic testing was performed and showed no immunity to hepatitis B. Due to the failure to produce antibodies after receiving the first RECOMBIVAX HB series, the patient received a fourth and a fifth dose of RECOMBIVAX HB on an unspecified dates. The patient's outcome was unknown. The relatedness between the events and therapy with RECOMBIVAX HB was not provide. This is one of several reports received from the same reporter. Additional information has been requested.
No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 08-JAN-2020, the patient was vaccinated with and improperly stored (product storage error), rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (Therapy type: Digital Data Logger), lot number 1660112 (had not been valid upon internal validation) and expiration date 18-OCT-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
pt recv vax 13OCT97 & that same day pt exp low back pain, malaise &  a rash @ the inj site;eval by a MD on 15OCT97;rash resolved & pt reportedly got better w/o treatment;
1517: After receiving COVID vaccine, pt c/o itching ears & throat; hx reaction to immunosuppressive meds in past; no rash, SOB or nausea. BP 142/96 HR 74 RR 16 SpO2 99% 1519: Benadryl 25 mg po given 1532: BP 140/96 HR 92 RR 14 Spo2 100%.  Pt drove self home.
Information has been received from a physician concerning a 5 year old male who on 02Jul1999 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant therapy. In Apr 2004, the pt developed post vaccine chickenpox. Additional information has been requested.
patient got the flu; Initial information received on 08-Dec-2020 regarding this unsolicited valid non-serious social media case from a consumer (patients wife).  This case involved a male patient of unknown age who got the flu (influenza), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site.   On an unknown date, the patient got the flu (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.   Details of laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for the event, at the time of reporting.  There will be no information available on the batch number for this case.
PARTIAL DOSE GIVEN; FAULTY NEEDLE/SYRINGE; This spontaneous report received from a pharmacist 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, intramuscular, batch number: 1802072, and batch number: 1802072 expiry: UNKNOWN) .5 ml, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced partial dose given. On 11-MAR-2021, the subject experienced faulty needle/syringe. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the partial dose given and faulty needle/syringe was not reported. This report was non-serious.
This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired dose/expired vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. No Medical History information was reported. On 05-May-2021 at 3:25 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired dose/expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired dose/expired vaccine) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications was reported. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: ADR Form was received on 17-MAY-2021 Reporter demographics was added. Contact information was added Patient gender was added Race and ethnicity was addeddose1 Information was added Batch no site of vaccination was added date and vaccination was added. On 20-Jul-2021: Follow up was received does not contains any new information.
Low grade fever lasting until 6/3/2010, followed by a body rash similar to heat rash on 6/3/2010.
Felt sick after second vaccine; Was very sleepy after second vaccine; No appetite after second vaccine; Nauseus after second vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt sick after second vaccine), SOMNOLENCE (Was very sleepy after second vaccine), DECREASED APPETITE (No appetite after second vaccine) and NAUSEA (Nauseus after second vaccine) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Felt sick after second vaccine), SOMNOLENCE (Was very sleepy after second vaccine), DECREASED APPETITE (No appetite after second vaccine) and NAUSEA (Nauseus after second vaccine). At the time of the report, MALAISE (Felt sick after second vaccine), SOMNOLENCE (Was very sleepy after second vaccine), DECREASED APPETITE (No appetite after second vaccine) and NAUSEA (Nauseus after second vaccine) had resolved.            No Concomitant medications were reported.  No Treatment information was reported.  Patient experienced adverse events for 24 to 38 hrs after 2nd dose.  This case concerns a patient of an unknown age and gender with no relevant medical history, who experienced the unexpected events of Malaise, Somnolence, Decreased Appetite, Adverse Event and Nausea. The events occurred on an unknown date after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the second dose was disclosed. The event Nausea is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-380629, MOD-2021-381108 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Followup document received, contains no new information On 09-Nov-2021: Follow-up document received, contains no new information; Sender's Comments: This case concerns a patient of an unknown age and gender with no relevant medical history, who experienced the unexpected events of Malaise, Somnolence, Decreased Appetite, Adverse Event and Nausea. The events occurred on an unknown date after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the second dose was disclosed. The event Nausea is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age at vaccination was 1 day old. Given concurrent with Vitamin K Shot. First apnea even a few hours after shot. (Apnea cont'd for few months.) Skin Reaction, Blister. Modeled Skin. Lethargic. Eating Difficulty. Constipated. Distended abdomen. Discharged with weekly f/u w Peds. Administered OTC gas drops for distended abdomen per Peds. At three-and-a-half weeks old went to ER w Bowel obstruction, Admitted to NICU. Bowel rest 12 days. Developed pneumatosis & NEC bells stage 2a. Exploratory surgery and ileostomy placed. Sent home. Hep B is deferred for babies under 2,000 grams. The baby weighed 2,296 grams.  Hospitalized 37 days total.
Took 1st dose of oral typhoid in the morning of 4-21-09 and began to feel intestinal discomfort the in evening of the same date.  Started with diarrhea the morning of 4-22-09 and began to experience dizziness later in the morning.  Was sitting in a university class when he started to feel horrible.  He walked out into the hall and remembers blacking out and coming to.  Went home and took a nap and when he woke up he had a severe headache.  Followed up with patient this morning 4-23-09 and said he is feeling much better today.
This spontaneous report as received from a nurse refers to a 16 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 19-SEP-2017, the patient was vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (lot # N019923, expiry date: 19-APR-2019) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054: US-009507513-1709USA007012: US-009507513-1709USA007011: US-009507513-1709USA007014.