chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient is a 73yr old female with multiple comorbidities including but not limiting to ESRD  on dialysis, DM, COPD on home oxygen, OSA not compliant with CPAP at home, pulmonary hypertension, tachy-brady syndrome s/p pacemaker in March 2021, with multiple admissions (?6) this year already, admitted with septic shock, NSTEMI on 4/13/2021. She underwent R foot debridement and amputation on 4/16/2021. ID team treated with Vanco/Cefepime. On 4/18 afternoon, she developed PEA and coded for about 25min. Since ROSC, she never regained consciousness. This morning, at the beginning of my shift at 7am, she's on bicarb drip, maxed Levophed 100, Epi 100 drips and full vent. However, she was getting paced and BP stayed in 40s. I discussed with ICU pharmacist and gave her stress dose Solu-cortef. Checked serum cortisol level, turned out to be appropriate later. Lactic acid 22 and bicarb was only 2 despite being on Bicarb drip. I called daughter to  inform her about guarded prognosis (imminent death) and asked to bring husband to come see her asap. Before family arrived, she developed another PEA and code blue was called. She was given Epi, bicarb pushes and CPR started immediately. Code blue was unsuccessful. At 8:13am, she was pronounced dead. I called daughter again to notify her of patient's death. Family arrived around 10am. I met both daughter and husband at bedside and offered emotional support. Chaplain was consulted.   Disposition  - critically ill patient with multi-organ failure, septic shock from R foot osteomyelitis, ESRD  on dialysis, DM, COPD on home oxygen, OSA not compliant with CPAP at home, pulmonary hypertension, tachy-brady syndrome s/p pacemaker in March 2021  - Patient coded and did not survive
This spontaneous report was received from a pharmacist regarding his wife a 60 year old female patient with breast cancer. The patient's medical history included right side mastectomy on 17-OCT-2013. On 18-OCT-2013 (also reported as 19-OCT-2013), the patient was vaccinated with PNEUMOVAX23 (lot number, concentration and dose were not reported). Concomitant therapies were not reported. The reported believed that the PNEUMOVAX23 lowered patient's resistance. On 18-OCT-2013, within hours her arm began to swell. The swelling in her arm resolved within 5 days, however, she since had developed a Urinary Tract infection and the day of the report the patient was on her way to see her physician with complaint of Shingles, which developed approximately on 12-OCT-2013 (reported as 2 days ago). The reporter stated that his wife believed that she had received PNEUMOVAX23, "a few months earlier" and would confirm with her physician. Patient received treatment with Keflex initially prescribed for arm swelling and changed out to Ciprofloxacin when urinary tract infection developed. The outcome of the arm began to swell was reported as recovered. The outcome of the others events were unknown. Additional information has been requested.
He started walking strangely, spiked fevers for several days with >102 Temps. Later he regressed and went back to babbling from 1 word sentences.
Information has been received from a registered nurse, regarding a 69 year old female patient with no pertinent medical history, who on 12-DEC-2007 was vaccinated SC in the arm, with a dose, 0.5 mL, of pneumococcal 23v polysaccharide vaccine (lot #658451/0963U). Concomitant vaccine therapy included a dose of influenza virus vaccine (manufacturer unspecified). On 12-DEC-2007, the patient developed an injection site reaction described as redness and a lump at the injection site, with soreness of her arm. Treatment included ALEVE, with little relief of the symptoms. The patient contacted the physician. At the time of this report, the patient was recovering from the events. Additional information has been requested.
I feel itch here and there, on my legs, arms or neck and swell a little if i scratch. I applied ointment then disappear, but new spots come out again till now.  It does not drive me crazy but annoying and worried.  I thought it would disappear but lasted this long, so, I am reporting now.
Initial information received on 25-Sep-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a one months old female patient who received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, concomitant medication and family history were not provided. On 24-Sep-2018, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE, lot UI997AB, expiry date 30 Jun 2019 with a 23 gauge needle 1 inch long via unknown route in the left thigh for immunization. It was an actual medication error due to inappropriate age at vaccine administration. It was reported that a 1-month old female was given 0.5 ml FLUZONE QUADROVALENT once by mistake. She had no reaction or symptoms, no fever. She had not gone to ER or to seek treatment. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender- none.
Initial report received from a health care professional on 07 November 2011. This reporter also reported other adverse events which were captured in case number 2011-10823 and 2011-10825. A female patient (age not reported) received dose 1 injection (route and site not reported) of ADACEL, sanofi pasteur lot not reported, on 03 August 2006. The patient had no other vaccinations within 4 weeks of the ADACEL. The patient's medical history and concomitant medications were not reported. On 28 October 2011, the patient experienced severe cough, nasal drainage and congestion which persisted. She was diagnosed with pertussis. The patient's blood work for IgG and IgM were positive for pertussis. The outcome was not reported. Documents held by sender: None.
15 mins after receiving the vaccine, patient experienced light headedness and dizziness and felt tongue swelling that lasted approximately 1 hour and then she was fine.
Liver function test abnormal Information has been received from a registered nurse concerning a 42 year old female with  no known allergies or medical history who on 12-OCT-2004 was vaccinated IM in the left deltoid with a 1.0ml dose of hepatitis A virus vaccine inactivated. There was no concomitant medication. Subsequently, the patient had elevated liver function tests. Therapy with hepatitis A vaccine (inactive) was discontinued. Subsequently, the patient recovered from elevated liver function tests. It was unknown if medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Left upper arm 6 inch by 9 inch erythemous plaque, firm,warm to touch with discrete? clusters of vesicles in center medial, lateral area of left deltoid area. Start AUGMENTIN 40015 6ml BID x 10 day, BENADRYL 12.5mg/5ml 2 tsp of 6hr for swelling.
48 hours later feelings of fatigue, nausea, arm ache, neck pain, smelling sensations, restlessness, headache, throat pain.
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown dates, an unspecified number of patients were vaccinated with unknown number of doses of (Oka/Merck) VARIVAX, (strength, dose, route, anatomical location, lot number and expiration date were not reported), which were improperly stored. No adverse effects were reported and no product quality complaint (PQC) was involved. Follow up information was received from a certified medical assistant during a phone call on 25-MAR-2015. The certified medical assistant was unavailable at the time of the call. The call was transferred to the manager who indicated that the (Oka/Merck) VARIVAX lot # was J001177 with expiration date: 31-JAN-2015 (also reported as 27-MAR-2015) and indicated that the patient identification information was not readily available at the time of the call. Additionally, the reporter indicated that there had been no reports of adverse events following the administration of (Oka/Merck) VARIVAX vaccinations. The office was in the process of contacting the patients for revaccination. The correspondence process was reviewed and telephone number was provided should information become available. This is one of several reports received from the same reporter. Additional information has been requested.
PATIENT RECEIVED BIVALENT BOOSTER DOSE 1/3/2023 - HOWEVER WHEN SHE GOT HOME SHE HAD CARD THAT SHE HAD ALREADY GOTTEN DOSE ON 11/3/2022 WHICH WAS NEVER DOCUMENTED IN MEDICAL RECORD OR UPLOADED TO LOCAL CENTER. IMAGE FOUND AFTER PHONE CALL. PATIENT GOT TWO BIVALENT DOSES 2 MONTHS APART.
at point of injection: sore arm, red, swelling, itching; fever @ 100+ for 24 hours; headache; shivering
pt recv vax; infant screamed all day>3 hrs;high pitched scream;would not take bottle;v;could not console;
Swollen red RUE at vaccine injection site. Feverish, chills, malaise for 4 days. Sx started approx <24 hrs after injection. Given concurrently w/flu vaccine (LUE no reaction).
pt exp t102 orally;GI upset, nausea, diarrhea, eyes light sensitive, h/a;
Severe throbbing headache 10/10 pain. Heart rate of 155 with skipping rhythm.  Normal resting HR of 55. Fever of 104 Sweats and chills and unable to sleep
the patient was given the DTAP instead of TDAP, patient showed no sign or symptoms no treatment or anything was needed, outcome was good.
INADVERTENTLY VACCINATED WITH A DIFFERENT VACCINE MANUFACTURER FOR HER 2ND DOSE.
Sore throat, fever, cough, low pulse ox, headache, face flushing, fatigue, body aches
Redness; Extreme itching; Rash; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration on an unspecified date (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced redness, extreme itching and rash. The events resulted in a visit to the doctors or other healthcare professional office/clinic. Therapeutic measures were taken as a result of the events. The clinical outcome of the events redness, extreme itching and rash was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Information was rec'd concerning a pt who on 5/1/01 was vaccinated with a booster dose of hepatitis B vaccine recombinant. A few weeks after the vaccination, she experienced "Lupus like symptoms" which included fever, stiffness, extreme back pain and pain walking. There was no swelling. The pt did not seek medical attention. No further information is available.
The next night after I could not stand or walk.  I had such a severe headache causing me to be out of  it and lay in the bed for about 24hrs.  A few weeks later again I could not stand or walk again and the headache returned very severely so I reached out to my PCP who advised I immediately went to the hospital.  I had to be transported by ambulance and immediately ambulance attendants asked if I had either vaccine and immediately  when I arrived at Hospital. I had an MRI and CT Scan done and was diagnosed as having Vertigo.   I had vestibular treatment and PT to treat the Vertigo and about a week later things had balanced.   8/28 I developed 103 fever, was vomiting and my head felt as if it was going to explode feeling like I had a bad head cold and  on 8/29 I tested positive for COVID-19.
Had not had flare up of vestibular neuritis x10 years; current exacerbation/flare up is secondary to Covid vaccine. Miserable. Horrible vertigo, nausea, balance problems, constant head tremors/bobbing, body swaying while standing, unable to perform daily activities, can?t work (I?m unable perform duties safely as I appear drunk), symptoms lasts for weeks, unable to work yet unable to get assisted leave because I?m part-time. I?ve known that the flu vaccine triggers a flare up for me in the past and since I?ve not taken it for past 10 years, I?ve not had any flare ups. When Covid vaccine was mandated, I tried to get exemption but all my physicians were afraid to do so due to reimbursements. Spoke with in-house infectious disease and he was no help. As I am the only provider in household, I had to have an income so I had no choice but to get the vaccine.
Influenza like illness, Injection site reaction. This case was reported by a nurse and described the occurrence of flu-like symptoms in an adult male patient who received hepatitis A vaccine inactivated (Havrix) for prophylaxis. The patient received the 1st dose of Havrix in approximately February 2003. According to the patient, later that same day, he experienced flu-like symptoms and an injection site reaction characterized by a rash and a "little" swelling. The patient stated that he "had to get in bed but the next day [he] was better". The reporter considered the events were probably related to vaccination with Havrix.
RN gave client Kinrix Vaccine because DTAP and IPV were due for 6 month vaccines.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 UNK. On 08-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments   This case was linked to MOD-2021-036773 (Patient Link).
NO ADVERSE EFFENTS , RECEIVED SECOND DOSE 11 DAYS SOONER EARLY
1st 2 days, exhaustion 3rd day thru  day 36,  exessive left arm (injection site) pain at night, and cannot lift arm over head to remove garments, cannot play golf 3rd day thru 18 th day, extreme night time pain under left arm, down side of body, and shoulder pain 3rd day through  date of report (8/8/2019) left rotator cuff area pain in addition to arm pain, restricting many activities, lower back pain
administered an expired Havrix vaccine; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 57-year-old female patient who received HAV (Havrix) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   On 25th May 2022, the patient received the 1st dose of Havrix. On 25th May 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK Receipt Date: 25-May-2022 Reporter's Comments: The medical assistant reported a patient was administered an expired Havrix vaccine inadvertently. The reporter consented to follow.  Additional Supportive Information: The patient received Havrix which was already expired which led to expired vaccine used.
This report was received concerning a 5 year old male patient with hydrocephalus, seizures, slit ventricles, ventriculo-peritoneal shunt and migraines who on 8/15/02 was vaccinated with a dose of MMR (second generation) (lot #not reported). Additional suspect therapies included lamotrigine 100 mg daily which was initiated in November 2001 for complex partial seizures and divalproex sodium (dosage unspecified) which was initiated on a unspecified date for convulsions. Concomitant therapy included gabapentin. In December 2001 the dose of lamotrigine was changed. On 8/16/02, the patient developed increased seizure frequency. Prior to August 2002, the patient had 0-2 seizures per month, then the seizures increased to 3 in August 2002, 5 in September and 6 during the first two weeks of October 2002. It was also noted that after the vaccine, the patient developed a gastrointestinal flare, an ear infection and a fever, which was treated with ciprofloxacin. The patient was hospitalized overnight due to dehydration from the infection. As previously noted, on an unspecified date, a neurologist increased the dosage of lamotrigine to 125mg twice daily to try and control the seizures, but the increased dosage did not help. Event causality was unknown. Upon follow up, the dentist reported that the increased seizure frequency was still unresolved. It was noted that intestinal flare as bloody stools began in August 2002 after the vaccine. A colonoscopy, which was done on 11/26/02, revealed a diagnosis of colitis. It was noted that the reporting dentist considered these events were possibly related to either the MMR (second generation) or the inefficacy of lamotrigine. It was reported that it was not known if the patient had experienced any adverse events following previous vaccinations. As previously reported, the child was started on divalproex sodium on an unspecified date. In November 2002, the patient became very hyper and experienced abnormal movements after divalproex sodium was combined with lamotrigine. The lamotrigine dose was decreased to an unspecified dosage and the events improved. It was noted that the reporting dentist considered these events were related to the combination of lamotrigine and divalproex sodium. A MRI was performed on 12/23/02 and the results are unknown. This was originally reported by a dentist and the patient was the dentist's son. Upon internal review, the patient's increased seizure frequency was determined to be an other important medical event (OMIC). Additional information has been requested.
Patient was advised to remain in observation area for 30 minutes due to history of breathing difficulty with sulfa antibiotics in past. Shortly after being vaccinated the patient presented to our service window stating he did not feel well and was immediately escorted by the pharmacist to our administration area to have a seat. He stated he felt light headed, flushed (though not visibly), felt like his heart was racing, and was not having diffuculty breathing but felt like he couldn't catch his breath and stated he thought he was having a panic attack. He had stated before vaccination that he had not had a vaccine since his routing childhood schedule, his whole family had already had doses, and he had been putting it off because he was nervous. He insisted he needed some fresh air several times and was escorted outside by the pharmacist (with emergency supplies and a cell phone and within shouting distance of the pharmacy) for continued obsevation and was given water when requested. After a few minutes he stated he felt much better and the symptoms had resoved. He was directly observed outside per his request for the remainder of his waiting period and had no further symptoms. He was instructed to call the pharmacy right away if he had any additional symptoms after leaving.
diluted with a sterile solution; diluted with a sterile solution; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA903A, expiry date 31-JAN-2024) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: diluted with a sterile solution) and inappropriate dose of vaccine administered (Verbatim: diluted with a sterile solution). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 02-MAY-2023 A reporter reported that a patient received the MenA lyophilized component of Menveo diluted with a sterile solution. The reporter consented to follow up. A reporter reported that a patient received the MenA lyophilized component of Menveo diluted with a sterile solution, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
felt nauseous 10-15min p/vax until sitting in air conditioned car for a few min;recalls some trouble breathing in evening, thought it was r/t sinus;recalls itching throughout next afternoon & observed hives @ 10PM on 20JUN98;called pvt MD;
had passed away from a heart attack; chest pains; The initial case was missing the following minimum criteria: [Unspecified product] Upon receipt of follow-up information on [29Dec2022], this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown).  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Aug2021 at 13:00 as dose 2, single (Lot number: FC3184) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Paralyzed" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EW0198, Location of injection: Leg Right, Vaccine Administration Time: 01:00 PM), administration date: 07Aug2021, when the patient was 65-year-old, for COVID-19 Immunization. The following information was reported: CHEST PAIN (death) with onset 31Aug2021, outcome "fatal", described as "chest pains"; MYOCARDIAL INFARCTION (death, medically significant) with onset 04Sep2021, outcome "fatal", described as "had passed away from a heart attack". The event "chest pains" required emergency room visit. Therapeutic measures were taken as a result of chest pain. The patient date of death was 04Sep2021. Reported cause of death: "chest pains", "heart failure", "had passed away from a heart attack". No autopsy was performed.  Clinical course: On 28Aug2021 my mother was vaccinated with your product and not even a week later she passed away. My loving mother passed away on 04Sep2021. Not long after being injected with the vaccine she complained about chest pains. The pain got so severe that she called for an ambulance to be transported to the emergency department on 03Sep2021. Later that day mother was released from the hospital, by the morning of 04Sep2021 my mother had passed away from a heart attack. She has never had any issues with her heart and or do we have a history of it in our family. Autopsy was not performed, patient did not had COVID prior vaccination and was not tested for COVID post vaccination: No.; Reported Cause(s) of Death: chest pains; heart failure; had passed away from a heart attack
Patient reports her heart is racing, dizzy, and flushing. Reports symptoms resolved and cleared by EMS
Redness, swelling, rash at injection site. Reported by mother 2 days post immunization.