chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Discharge Provider: PRIVATE MD Primary Care Provider at Discharge: PRIVATE DO Admission Date: 10/15/2022 Discharge Date: 10/25/2022  PRESENTING PROBLEM: Dehydration [E86.0] Severe sepsis (HCC) [A41.9, R65.20] Sepsis due to urinary tract infection (HCC) [A41.9, N39.0] Diarrhea, unspecified type [R19.7]  HOSPITAL COURSE: "84-year-old past medical history significant for type 2 diabetes, hypertension, chronic obstructive pulmonary disease, coronary artery disease, hyperlipidemia, history of MI who came to the ER complains of generalized weakness, fatigue.  At baseline patient is oriented x2.  After arrival, patient was found to be tachycardic, lab work showed leukocytosis of 24, AKI.  CT abdomen/pelvis showed distended urinary bladder with tiny calcifications left ureterovesical junction which could reflect a recently passed calculus.  Urine looked infected showing large leukocytes small blood.  Urine culture collected.  He was placed on 2 g Rocephin and given 3 L fluid resuscitation per sepsis protocol and admitted to Medicine.   After admission, patient did improve with IV antibiotics.  AKI quickly resolved.  Urology was consulted for urinary retention which is felt to be acute on chronic, despite treatment with Flomax and Proscar.  Urology recommended placement of Foley, commenting that it should NOT be removed at discharge, as the patient would have difficulty with intermittent straight cathing.  Plan is for the patient to follow up with Urology as an outpatient for definitive plan.  Urine culture finalized as Enterococcus Faecalis.  ID was consulted and IV antibiotics switched to IV ampicillin.  ID recommended treatment with IV ampicillin through 10/21.  Patient was originally seen by PT/OT who recommended discharge to home.  Patient was re-evaluated by therapy on 10/19, and at that time it was felt he would be better suited for discharge to subacute rehab.  Referrals were made by care management, and the patient was set for discharge on 10/21/22 but the patient became hypoxic and was tachypenic and the discharge was cancelled. The patient was found to be COVID positive and he qualified for Dexamethasone and Remdisivir.   Once the patient respiratory status improved, he was discharged to the facility in a stable condition
The vaccine given was expired.  Had an expiration date of 4/17/2022.
Arm muscle sore at injection site 12 days later. Day after vaccination patient felt heart palpitations. Patient called pharmacy at 12 noon on 2/19 to report side effects. Pain at muscle 2/10.
My arm felt like someone took a bat & hit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (My arm felt like someone took a bat & hit) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE PAIN (My arm felt like someone took a bat & hit). At the time of the report, VACCINATION SITE PAIN (My arm felt like someone took a bat & hit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
The patient experienced metallic taste in the mouth, which may have begun to occur immediately following the injection, but was not strongly noticeable until the date listed previously on this form (5/19/21). The metallic taste was not constant, but resurged frequently throughout the day. The metallic taste was the most strong and debilitating when the patient attempted to eat cooked meat of any kind (chicken, pork, beef). The taste was also accompanied by a strong smell when in the presence of cooked meat, as well as when the patient sneezed.
On 03/22/01, Thursday, this child was given his two month vaccines at around 3:45 PM, he immediately started screaming and had a small lump at the sites, (3 needles). He had a slight fever the next couple of days, below 101, went away with Motrin or Tylenol, alternated. By Monday he was unusually fussy and restless, even when held, on Tuesday his eyes were matted, but after washing them two times with warm cloth it never came back, that night around 4 PM he just started screaming like he was in horrible pain, for about 3 - 4 hours. Once he was finally asleep, he slept for 12 hours. On Wednesday morning, he seemed like he still didn't feel very good, so his I bathed and fed him. He didn't want to eat as much as usual that day, again around 4 or 5 PM he started screaming again just like the day before, on both days after he would finally stop screaming, his eyes looked glassy and he would get quiet, with a blank look on his face, for a few minutes and then he would pass out asleep. I thought he was exhausted from the screaming fits so we didn't think much about it, his eyes got matted again on Wednesday night, and he refused his 9 PM feeding, screaming until around 10 or 11. He finally took his cereal and bottle, and passed out in my lap. Again I thought from exhaustion. On Thursday morning, on my way out to go to work, at 4:40 AM, I told the baby's dad that if he was cranky still and his eyes were matted when he woke up to call the doctor for an appointment. At 10:35 AM, I came home from work and found him dead in his crib.
03/24/2023 I started experiencing a runny nose, cough, headache and rash. After testing positive for Covid -19 I contacted my doctor and was prescribed Paxlovid. Symptoms lasted one week. Rash and cough is ongoing
Bullous pemphigoid; This case was reported in a literature article and described the occurrence of bullous pemphigoid in a 74-year-old male patient who received Flu unspecified (Flu vaccine) for prophylaxis.   The subject's past medical history included psoriasis.   On an unknown date, the patient received Flu vaccine. On an unknown date, 10 days after receiving Flu vaccine, the patient experienced bullous pemphigoid (serious criteria GSK medically significant). The subject was treated with corticosteroid nos (Corticosteroid (Trade Name Unknown)). On an unknown date, the outcome of the bullous pemphigoid was recovered/resolved.   The reporter considered the bullous pemphigoid to be possibly related to Flu vaccine.   Additional Information: GSK receipt date: 17 May 2022 Authors comment:  This case corresponds to reported in this literature article. To better understand the potential link between vaccinations and the development of autoimmune bullous diseases (AIBDs), a systematic review was performed, which included 26 papers published between 1995 and 2021.  The patient had past medical history of Psoriasis. The patient received Influenza vaccine and had bullous pemphigoid. Course of the diseases was reported as remission after topical/oral corticosetroids. "Overall, there was currently insufficient data to suggest that vaccinations were truly or commonly related to an increased risk of AIBDs, taking into account that the available information was generally based on anecdotal, single case reports with a low level of evidence and not being confirmed in largescale, population-based studies. Consequently, there was no need to modify the present vaccination recommendations for patients with AIBD, because the benefits of vaccines outweigh the likelihood of instigating autoimmune manifestations, even though real-world data on COVID-19 vaccines in AIBD patients are currently lacking". Additional supportive information: This case is 1 of the 7 cases reported in this literature article.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022GSK081504:same reporter US-GLAXOSMITHKLINE-US2022GSK081553:same reporter
1/14/20: Pt received the vaccine on 12/4/19 at 6:30pm and developed pain and limited mobility/inability to fully lift her left arm  (she reports approx 10-20 degrees range of motion) during daytime on 12/6/19. Later in December 2019 while traveling overseas, pt had Xray of her left arm, which showed no involvement of her bone. Pt saw her Primary Care Provider on 1/7/20 and was referred to an orthopaedist on 1/8/20, where pt received a cortisone shot (without much relief) and an ultrasound revealed inflammation in the bursa area of her left upper arm. Pt was also prescribed pain medication at that time, which has helped reduce pain to some degree. She has an ortho follow-up on 1/22/20.
Patient stated that after her first Moderna dose, she had some mild rash around injection site. After second dose, she reported to pharmacy last night that she had a severe reaction to vaccine. She had to go to the ER and get medications. She had a widespread rash that extended down her arm, onto her back, and up onto her neck/throat. The rash was pink with noticeable red welts throughout. The patient still had the rash visible on 10/29/21 when she came into the store to discuss.
States left deltoid has been sore since flu shot was given on 9/23/09.
Itching at site, generalized itchy, swelling in throat, bronchospasm.
This prospective pregnancy case was reported by a healthcare professional (nurse) and described the occurrence of intrauterine growth retardation in a 31-week-gestation fetus of unknown gender who was exposed to BOOSTRIX (GlaxoSmithKline) when the mother was being treated during pregnancy. On 3 July 2013 and 26 June 2013, the 26-year-old mother of the subject received 2nd dose and 1st dose of BOOSTRIX (0.5 ml, intramuscular, unknown details). The mother's last menstrual period was not reported and estimated date of delivery was reported to be 25 August 2013. The neonate was exposed to BOOSTRIX (GlaxoSmithKline) at approximately "31 weeks, 3 days" and approximately 32 weeks gestation. An ultrasound examination on 3 July 2013 revealed results which "showed baby with fetal weight in 29th percentile." The subject had another ultrasound on 10 July 2013 which "showed baby with intra-uterine growth retardation." Per the reporter, the subject will now be getting ultrasound examinations every 3 to 5 days. "Dopplers are normal" per the nurse. At the time of reporting, the pregnancy was ongoing. This case was associated to a Mother case. Please see case A1035095A for details regarding the mother case. This case was associated with a suffix case. See case A1035095B for details of the case with the baby.
Diagnosis  o Principal Problem: Severe asthma with acute exacerbation o CKD stage 4 secondary to hypertension (CMS/HCC) o Class 3 severe obesity due to excess calories with serious comorbidity and body mass index (BMI) of 40.0 to 44.9 in adult (CMS/HCC)
Pimples on right side of stomach and chest and shoulders, at first no itch now itch on neck and shoulders,
Information has been received from a physician and a registered nurse concerning the 12 month old female daughter of the nurse who had a history of "PE tubes" placement on 02/23/2001. On 05/22/2001 at 1pm, she was vaccinated SC in the left thigh with a first dose of varicella vaccine and a second dose IM in the right thigh with Prevnar and PPD test. There were no illnesses at the time of vaccination. Immediately she had hives at the injection site of varicella vaccine. Ice and hydrocotrisone were applied and the hives lasted for six hours. She had no respiratory difficulty or fever. She also developed a nodule at the injection site which lasted for two weeks. Additional info is not expected.
Information has been received from a medical student concerning an unspecified number of patients of unknown ages and gender. The patients' pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant therapies were not informed.  On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lots # M034586, M012990, M006731 with expiration dates 27-JUL-2018, 14-MAR-2018 and 09-FEB-2018 respectively, (dosages were not provided), administered per subcutaneous route, for prophylaxis. No adverse events were reported.   The doses of VARIVAX were exposed to a temperature  > 5°F but < 14°F and were out of range for 15 minutes. A data logger was used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. This is one of two reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1702USA001046:
Insulin resistance; Chills; Fever; Arm Soreness; Night sweats; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats), INSULIN RESISTANCE (Insulin resistance), CHILLS (Chills), PYREXIA (Fever) and VACCINATION SITE PAIN (Arm Soreness) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21 and 038B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN LISPRO (HUMALOG), AMLODIPINE and ATORVASTATIN for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced NIGHT SWEATS (Night sweats), CHILLS (Chills), PYREXIA (Fever) and VACCINATION SITE PAIN (Arm Soreness). On an unknown date, the patient experienced INSULIN RESISTANCE (Insulin resistance). The patient was treated with INSULIN LISPRO (HUMALOG) at an unspecified dose and frequency. On 20-May-2021, CHILLS (Chills) and PYREXIA (Fever) had resolved. On 22-May-2021, VACCINATION SITE PAIN (Arm Soreness) had resolved. At the time of the report, NIGHT SWEATS (Night sweats) and INSULIN RESISTANCE (Insulin resistance) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-May-2021, Blood glucose: increased (High) more than 300. On 22-May-2021, Blood glucose: 376 High. On an unknown date, Blood glucose: 306 High.
Two children below 18 year and received the Moderna covid-19 vaccine (second dose); 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Two children below 18 year and received the Moderna covid-19 vaccine (second dose)) 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Two children below 18 year and received the Moderna covid-19 vaccine (second dose)). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Two children below 18 year and received the Moderna covid-19 vaccine (second dose)) had resolved.            This case was linked to MOD-2021-062204 (Patient Link).   Reporter did not allow further contact
Feeling cold or chills; Fever 103.7 degrees fahrenheit; Pain at the injection site; Extremely tired; Mild headache; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Feeling cold or chills), PYREXIA (Fever 103.7 degrees fahrenheit), VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (Extremely tired) and HEADACHE (Mild headache) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced FEELING COLD (Feeling cold or chills), PYREXIA (Fever 103.7 degrees fahrenheit), VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (Extremely tired), HEADACHE (Mild headache) and VACCINATION SITE PAIN (pain at the injection site). At the time of the report, FEELING COLD (Feeling cold or chills), PYREXIA (Fever 103.7 degrees fahrenheit), VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (Extremely tired), HEADACHE (Mild headache) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.        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.
I was tested for Covid in January 2021 and had symptoms for approx. 6 weeks. After approx. 9 hours after receiving my first Pfizer vaccination shot I took a shower and shortly afterwards started shaking uncontrollably. It was not like shivers from a fever. My entire body shook for approximately 1 1/2 hours laying in bed. It stopped completely then I had a hot/burning sensation on my face and ears for approx an hour. I drifted off to sleep. The next morning I felt muscle soreness and tiredness most likely from the shaking. This is the first time ever having the shakes. I had shivers and chills when I had Covid but this was much worse than shivers. Today is five days after the shot and having this reaction and I am feeling ok. I do not have any serious health conditions. I do have history of high blood pressure, IBS and migraines.
sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     The patient's past medical history included Knee replacement. Concomitant products included HYDROCODONE and ACETAMINOPHEN for Pain.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-011003 (Patient Link).
Immediate pain.  I said ouch out loud it hurt so badly.  By next day I had a large lump.  It seemed shot hit nerve or bone and was up too high.
The pt was given her first dose of SHINGRIX. She experienced bleeding at the time of injection but that resolved within 30 seconds. The patient reported bruising at the site as well as redness and tenderness. The patient came in to the pharmacy the next day to say that the symptoms were still present but improving.
Booster; Lot of leg pain; Joint pain in my knee; Leg cramps; Weakness in both of my legs; Difficulty walking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old patient received bnt162b2 (BNT162B2), administration date 11Nov2021 (Lot number: FG3527) as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administered in arm left (Batch/Lot number: unknown). The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 11Nov2021, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (non-serious) with onset 11Nov2021, outcome "unknown", described as "Lot of leg pain"; ARTHRALGIA (non-serious) with onset 11Nov2021, outcome "unknown", described as "Joint pain in my knee"; MUSCLE SPASMS (non-serious) with onset 11Nov2021, outcome "unknown", described as "Leg cramps"; MUSCULAR WEAKNESS (non-serious) with onset 11Nov2021, outcome "unknown", described as "Weakness in both of my legs"; GAIT DISTURBANCE (non-serious) with onset 11Nov2021, outcome "unknown", described as "Difficulty walking". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for influenza vaccine was unknown. Therapeutic measures were not taken as a result of immunisation, pain in extremity, arthralgia, muscle spasms, muscular weakness, gait disturbance.  No follow-up attempts are possible. No further information is expected.
RN had administered GSK Flulaval Quadrivalent, 0.5ml single dose vaccine at 1131am.  RN turned to dispose of Sharps.  When RN turned back, new hire stated, "I feel dizzy".   He slumped forward in chair and then extremities became rigid and jerking.  He threw his body backwards and the chair tipped.  RN was standing at side of chair and tried to catch the back of chair to prevent the fall.  The new hire hit his head on the wall resulting in a laceration.   Rapid Response was paged overhead.  He was limp and unresponsive for 10-15 seconds.   Team responded within four minutes of initial reaction.  Transferred to Emergency.
Blood clots; Major blood loss; Blurred vision; Heart palpitations; Shortness of breath; Extreme fatigue; Dizziness; This is a spontaneous report from a contactable other hcp (patient).    This 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 29Mar2021 12:00 (Lot number was not reported) as single dose (at 37 years old) for COVID-19 immunisation.  Medical history none. There were no concomitant medications. On 31Mar2021 01:00, the patient experienced blood clots, major blood loss, blurred vision, heart palpitations, shortness of breath, extreme fatigue, dizziness. The outcome of the events was unknown. Therapeutic measures were taken as a result of the events included blood transfusion, ongoing tests, ultrasounds. The events required a visit to the emergency room and a visit to the physician's office. Seriousness criteria of the events was reported as serious due to disability and life threatening. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. No allergies. The patient was not pregnant at the time of vaccination.  The information on the Lot / Batch number has been requested.; Sender's Comments: Based on the limited information currently available, a possible association of the suspect drug administration with the reported events cannot be completely excluded, due to a plausible temporal relationship. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
patient received 0.5mL for Moderna booster - should have been 0.25mL.
presented to health center to receive COVID19 vaccine and flu vaccine. Client received flu vaccine after receiving COVID Pfizer PEDS vaccine, RN injected flu vaccine and as she was injecting some of the fluid leaked outside of syringe. Client and Mother were informed of incident. Incident was elevated to Clinical Lead. Client's Mother was notified of CDC guidelines. Flu vaccine will have to be administered again. Client's mother verbalized understanding and stated she would come back to have child revaccinated.
Fever, headache, nausea, dark urine and papular rash. Treatment -> ADVIL, increased fluids, BENADRYL, hydrocortisone cream 1%.