chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 03Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 18Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (not ongoing), notes: High cholesterol- resolved; "Known allergies: Poison oak" (unspecified if ongoing); "Depression" (unspecified if ongoing), notes: Depression/anxietycontrolled; "Anxiety" (unspecified if ongoing), notes: Depression/anxiety-controlled; "Tachycardia" (unspecified if ongoing), notes: Tachycardia/hypertension- controlled.; "hypertension" (unspecified if ongoing), notes: Tachycardia/hypertension- controlled. Concomitant medication(s) included: METOPROLOL; BUPROPION; AMITRIPTYLINE; ESTRADIOL; PROGESTERONE; SIMVASTATIN; ASPIRIN (E.C.); COQ10 [UBIDECARENONE]; OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHERYL ACETATE]; NEURIVA BRAIN PERFORMANCE; VIT D [VITAMIN D NOS]; MAGNESIUM GLYCINATE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: COVID 19 Treatment of Paxlovid was started on 15Sep2022, Lot number: 1919253A, Indication was treatment of COVID-19. Concomitant product was Probiotic/multi-enzyme. Known allergies was poison oak. Other medical history was high cholesterol, which was resolved. Depression/anxiety was in controlled. Tachycardia/hypertension was in controlled.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the events Vaccination failure, COVID-19 and the suspect drug BNT162B2 cannot be excluded.
The day after the patient received his Booster shot of Moderna, his left arm became swollen beneath the injection site of the left deltoid all the way down to the elbow. The affected area was red and warm to touch. The patient came to Clinic to see Dr. and was diagnosed with cellulitis. He was prescribed cephalexin 500mg 1 po q12hrs x10 days and returned home.
Received MMR & Varivax 10/20/06. 10/26/06 started with erythematous papular rash to face, fever, irritability, malaise. Rash then spread to  trunk, arms & legs.
I tested positive for COVID -19 on February 11,2023. My symptoms were a cough, muscle ache, sore throat and I was prescribe paxlovid. I also had a slight temperature. I have a persistent cough.
RASH SHOWING AROUND INJECTION SITE ARM 7 DAYS AFTER PATEINT RECEIVING THE VACCINE. PATIENT ICED THE INJECTION SITE. THE RASH ADN SWELLING DISAPPEAR 7 DAYS LATER
At 12:25 pm 1 1/2 hr after flu shot she returned to me. She felt nauseated weak and thought her tongue "felt swollen." B/P 158/88 p. 88. Took ALLERCLEAR 10 mg antihistamine at 12:45 pm. Advised to get checked at ER. Went to ER. Work friend drove her. I followed and checked her in at 1:00 pm.  Discharged from ER at 3:05 pm. Now ok.
Dose 1 - headache mild 12 hours Dose 2 - foggy brain, sore eyes within 6 hours, severe headache, temp 101.2, myalgias within 10 hours lasting for 18 hours and fatigue lasting 48 hours
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 01-APR-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt reports receiving 2nd COVID vaccine yesterday at 1030. Pt reports HA, fatigue, subjective fever yesterday evening. Pt reports feeling some relief with Motrin at 0930. Pt in NAD.  HISTORY OF PRESENT ILLNESS: 34-year-old male presents with headache, body aches, subjective fever and nausea after second COVID vaccine yesterday.  Acute onset of generalized body aches, mild, constant.  Denies objective fever, chills, vomiting, vision changes, chest pain, dyspnea, cough, abdominal pain, back pain, weakness or numbness.  Patient took Motrin with some improvement this morning.
administered to 32 week pregnant patient; inadvertently administered dose of GARDASIL 9 instead of DTaP; inadvertently administered dose of GARDASIL 9 instead of DTaP; This spontaneous prospective pregnancy report was received from a physician via company representative and refers to a 32-year-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 10-JUL-2019, the patient was inadvertently administered hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route, site of administration, lot number and expiration date were not reported) for prophylaxis, instead of an unspecified diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid vaccine. At the time, the patient was 32 weeks pregnant. The date of last menstrual period (LMP) was not reported but it was estimated as 28-NOV-2018 and expected delivery date (EDD) was estimated as 04-SEP-2019. The pregnancy outcome was unknown and the fetal outcome was pending.
After receiving the flu vaccine I developed sharp elbow pain, though the vaccine was given up towards the top of my shoulder. Overnight I developed a terrible stiff neck and intense shoulder pain which persisted through the following day. I have slight numbness in my fingers on my right hand and the right side of my face. The pain radiates from the injection site over the front and back of my shoulder, up my neck through the back of my head. I can barely turn my head and have a lot of pain when I move.
had Shingrix 9-3-2020. Now having diarrhea + confusion started "sometime during hs". instructed daughter to take her to Dr. called pt family back @ 1300 unable to reach Dr. "pt is improving" no diarrhea after immodium states "I think he was dehydrated (1600) spoke with staff @ Dr. instructed to take to ED (1615) spoke with patients daughter taking pt to ED still confused + unsteady on feet.
No additional AE; patient vaccinated wilh VARlVAX on 30 -NOV-2020 while on oral Prednisone; This spontaneous report was received from a registered nurse and refers to a 39-year-old female patient. Her concomitant medications included prednisone. The patient had a medical history of ulcerative colitis. There was no information about the patient's concurrent conditions provided.  She was supposed to start therapy with adalimumab (HUMIRA) (reported as HUMERA), a titer was drawn which revealed that she was negative, so on 30-NOV-2020, she was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) first dose (dose, route of administration, anatomical location, lot # and expiration date were not reported), for prophylaxis, while on therapy with prednisone. No adverse event was reported.
Patient seen in the ED on 7/7 with nausea, dry heaves, and decreased oral intake. While in the ED, her O2 sats dropped to 88% after which she was placed on 2 L NC O2. COVID PCR swab was taken in the ED which was positive.  Patient was admitted on 7/7-7/8 for acute respiratory failure due to COVID-19. She was able to be weaned to room air. Patient was vaccinated against COVID-19, but has not received booster. This meets criteria for vaccine breakthrough case review.
Pt recv vax on 9/8/98; on 9/9/98 pt exp flu-like sx of aches, fever, abdominal pain
Itchy face and neck, also itching at injection site. Coughing and slight chest tightness. patient had gone to the Emergency Room and was given Decadron IM and Benadryl.
pneumonia; acute chronic respiratory failure; sepsis; congestive heart failure; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In or around 05-OCT-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. Shortly, on an unknown date, after receiving zoster vaccine live (ZOSTAVAX), the pt. was hospitalized and diagnosed with sepsis, acute chronic respiratory failure with hypoxia, pneumonia and congestive heart failure. As a direct and proximate result of use of defective zoster vaccine live (ZOSTAVAX), the pt's symptoms have resulted in physical limitations, not present prior to vaccination, The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. Further, as a tragic consequence the pt suffered severe serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental aguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  The outcome of pneumonia, cardiac failure congestive, sepsis and acute respiratory failure was not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered the events to be disabling.  Upon internal review, all the event was considered to be medically significant.  Additional information has been requested.
feeling miserable; now 101.2 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling miserable) and PYREXIA (now 101.2 degrees Fahrenheit) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 15-Apr-2021, the patient experienced FEELING ABNORMAL (feeling miserable) and PYREXIA (now 101.2 degrees Fahrenheit). At the time of the report, FEELING ABNORMAL (feeling miserable) and PYREXIA (now 101.2 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Body temperature: 102 (High) fever of 102 degrees Fahrenheit.         Concomitant medications are not provided by the reporter. No treatment drugs are not provided by reporter.    Reporter did not allow further contact
Pt was not seen at PCP office. Hospital records indicate fever beginning 8/21/13 with vomiting x2 and bloody stools beginning 8/22/13.
Rash on thigh; Lighter in morning. Gets darker after hours; Doesn't itch anymore; This case was reported by a consumer via call center representative and described the occurrence of rash in a 68-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced rash, darkened skin and pruritus. On an unknown date, the outcome of the rash was not recovered/not resolved and the outcome of the darkened skin was recovering/resolving and the outcome of the pruritus was recovered/resolved.   It was unknown if the reporter considered the rash, darkened skin and pruritus to be related to Shingrix.  Additional details were provided as follows: The case was self-reported by the patient. After 2 days of first dose of Shingrix vaccine patient developed rash on thighs was in January, rash still not gone away. The patient was asking for help. The patient had seen dermatologist and had blood work done.  The patient reported rash wash lighter when he get up in morning, got darker after couple of hours.  The patient had reported rash seemed to be fading a little and does not itch anymore.
Neck pain; A slight numbness around my mouth; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain) and HYPOAESTHESIA ORAL (A slight numbness around my mouth) in a 69-year-old patient of an unknown 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) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NECK PAIN (Neck pain) and HYPOAESTHESIA ORAL (A slight numbness around my mouth). At the time of the report, NECK PAIN (Neck pain) and HYPOAESTHESIA ORAL (A slight numbness around my mouth) outcome was unknown.            No concomitant medications were reported.  No treatment medications were provided by the reporter.
Patient stating to having rash in the upper arm and it is itching lot and that it happens after the shot within the first twelve hours. ask patient if she is having difficulty breathing she stated no. also asked her if the rash is more generalized rather than just the arm she stated no also. asked if she needed any medical treatment or hospitalization she stated no. only itching which her daughter who is a doctor said to her to get hydrocortison cream.
Patient given invalid dose of COVID-19 vaccine. This was caught after being administered but prior to the patient leaving. Staff member drew-up 2.2mL of diluent in syringe with 0.2mL of vaccine and administered to the patient. Patient asked to wait 20 mins before leaving the office. Doctor spoke with the patient's mother and advised of precautions. Spoke with Pfizer. They recommended redoing series since it was invalid, but mom and office wanted to hold-off at this time. Office visit 7/19/2022: Episode onset: 2 days ago. Maximum temperature: Temperature yesterday of 101ºF - 102ºF. Associated symptoms include abdominal pain and a sore throat. Pertinent negatives include no congestion, coughing, ear pain or rhinorrhea. Associated symptoms comments: Voice sounds hoarse. She tried NSAIDs for the symptoms of sore throat. Suspect viral illness or due to recent COVID-19 vaccine, though that is less likely as other family members have been ill recently.
large rash around injection site. skin hot to the touch, swollen, itchy, painful; large rash around injection site. skin hot to the touch, swollen, itchy, painful; large rash around injection site. skin hot to the touch, swollen, itchy, painful; large rash around injection site. skin hot to the touch, swollen, itchy, painful; large rash around injection site. skin hot to the touch, swollen, itchy, painful; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0185) via an unspecified route of administration, in right arm on 04Jun2021 at 16:30 (at the age of 61-years-old) as 1st dose, single for covid-19 immunisation. The patient medical history was reported as known allergies to zinc. Concomitant medications in two weeks included multi vitamin, paracetamol (TYLENOL) and ibuprofen (ADVIL). The patient did not receive any vaccines within four weeks prior to the vaccination. On 12Jun2021 at 11:00, the patient experienced large rash around injection site. Skin hot to the touch, swollen, itchy and painful. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Any treatment received for the event was unknown. Outcome of all events was not recovered.
Patient suffered two seizures. No history of seizures in the past. Spent 3 days in the hospital. Now has to take medication for two years.
mental fog; Headache; fatigue; pain in armpit; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration (anatomical location: arm left) on 05Feb2021 at SINGLE DOSE for COVID-19 immunisation. Patient's medical history and patient's concomitant medications were not reported. Patient is not pregnant. Patient has no covid prior vaccination. It was unknown if patient got tested post vaccination. It was unknown if patient had vaccine in four weeks and unknown if other medications in two weeks. The patient experienced mental fog (medically significant); headache, fatigue, and pain in armpit. All the events occurred on 06Feb2021. It was reported that the events were continuing after 6 days. No treatment was provided for the events. Facility type vaccine was nursing home. Outcome of the events was not recovered.  Information about lot/batch number has been requested.
Woke up with anxious feeling, heart was beating faster than normal, hands/fingers cold.  Tested ecg with Watch and it indicated Atrial Fibrillation.  I didn?t believe it and retried several times over the next hours and finally went to ER.
On 10/31/99, the pt developed double vision. He has been seen by an opthalmologist who can find nothing wrong.
Pain and swelling of the right arm which was the arm the vaccine was administered.  Pain was bad enough that patient could not wear a shirt on that arm and swelling involved the entire upper arm, into shoulder and axilla.
Bruise near injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruise near injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced VACCINATION SITE BRUISING (Bruise near injection site). At the time of the report, VACCINATION SITE BRUISING (Bruise near injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: ; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
hyperglycemia; generalized tonic/clonic seizure; fever; rash; chickenpox; Information has been downloaded from Regulatory Authority (HQ1748807JUN2001).  This spontaneous report was received from an other health professional referring to a 12-month-old male patient. No information was provided regarding the patient's medical history, concurrent conditions, drug and allergy history or concomitant medications.  On 06-APR-2001, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX), 1 dosage form, subcutaneously (lot# and expiration date were not provided).  On the same date, the patient also received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (HSA), lot# reported as 1308K (Lot No. 1308K has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, expiration date not reported, but upon internal validation established as 09-JUN-2002), 1 dosage form, subcutaneously, hepatitis b vaccine (recombinant)(RECOMBIVAX HB) intramuscularly, lot# reported as 1823K (Lot number 1823K is an invalid lot number for hepatitis b vaccine (recombinant)), 1 dosage form, and pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197)(PREVNAR) 1 dosage form, intramuscularly, lot#  reported as 472-553 (expiration date was not provided). The indications for all the suspect therapies was immunization.  On 16-APR-2001, the patient experienced generalised tonic-clonic seizure, chickenpox (Varicella), rash (dermatitis) and fever (pyrexia).  On an unknown date, the patient experienced hyperglycaemia.      At the reporting time, the outcome of generalised tonic-clonic seizure, hyperglycaemia, varicella, dermatitis and pyrexia was unknown. The causal relationship between the events and varicella virus vaccine live (oka/merck)(VARIVAX), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), hepatitis b vaccine (recombinant)(RECOMBIVAX HB) and pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197)(PREVNAR) was not provided.  The agency considered the events generalised tonic-clonic seizure, varicela, dermatitis and pyrexia and hyperglycaemia to be medically significant.  This is a new safety report and has been created due to safety report "US-009507513-2007USA002551"  having been submitted with an incorrect WWID reference "HQ1748807JUN2001" that does not refer to an existing case. "US-009507513-2007USA002551" will be nullified. The correct WWID " US-009507513-2007USA010609"  is referenced within this safety report and will be kept as the master case file.
Sore throat, aches and pain , chills, fever. A few days later tested positive for Covid. Telehealth visit and was prescribed antiviral medication.
Patient is a 67 yo F with PMH of HTN, HLD, depression/anxiety who presents with subjective fever & chills, bifrontal non-radiating HA, myalgias, non-productive cough, diarrhea since 2nd covid vaccine (03/26/21) x 4 days. Patient also endorsing SOB, chest pain only when coughing. No sudden vision changes, focal extremity weakness/numbness, syncope, palpitations, N/V, abd pain. No known prior DVT/PE, recent long distance travel/immobilization/hospitalization. +covid exposure (patient has had 23 family members die of covid). Patient endorses active suicidal ideation. Patient tested positive for covid after two doses of vaccine.   Upon arrival to the hospital, patient was febrile to 38.1, hemodynamically stable, but hypoxic and placed on supplemental O2.  Patient continued to require oxygen throughout hospitalization, administered remdesivir, anticoagulation and steroids.  Patient discharge planning occurring. Patient will require oxygen upon discharge. 02 sat on room air at rest is 88%. Psych following patient.
Patient's arm was a bit red/pink around where the vaccine was given. As a precaution, I administered Benadryl 25mg to the patient and monitored for some time.  I counselled on the signs and symptoms of a severe reaction, and parents were aware. I continued to monitor. The patient felt fine the entire time, but the parents were a bit concerned with the redness.
Pt states sudden onset of abdominal pain 4.5 hrs after initial capsule.
No information really known. Office was notified yesterday by county coroner that patient was found deceased in his home on 4/9/19.  Coroner was requesting patient records. Unknown if death related to the Moderna Covie-19 vaccine but reporting this as death occurred 3 days after the vaccine and coroner gave office no information.  You can contact the coroner involved with this case.
4 days after injection pt got red bumps on abdomen and right arm, 1 week later her hands started itching, peeling and cracking, Dr prescribed triamcinolone cream, 8/22/15 suggested hydrocortisone cream and aquaphor, at follow up call pt said doing better.