chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient left the facility with no signs or symptoms of adverse reaction after completing the 15-minute observation period. Patient and his mother came back into the facility approximately 10 minuets after leaving, at this time the patient complained of chest pain/pressure. Vital signs were taken and an EKG was performed, all results came back within normal limits. Patient was monitored for an additional 30 minuets and was feeling better. Patient then left the facility.
neck pain; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer Sponsored program. This female patient of unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported the patient was in neck pain; the patient stated it was not due to the COVID vaccine. She was supposed to take a steroid shot for her neck; the reporter inquired if she could get her second COVID vaccine with a steroid injection scheduled. The clinical outcome of neck pain was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on current available information, the event neck pain is more likely intercurrent and is assessed as unrelated to BNT162B2.
5/8/07 17:17 6CM x 6CM induration at L inferior deltoid injection site. No fever, Benadryl 1tsp PO Q6 hrs PRN swelling. Ice Q20 min on/off PRN pain and swelling
Patient receive VZV on ROA on 3/23/10, pt got area swollen & red. Area hurts only with touch. On 3/26/10 patient came to clinic because redness has not gone away told to do warm compression for 15 minutes at a time. Approx. 4cm/red/soft/no tender.
c/o burning feeling in lt arm which pt states started 2 or 3 days p/inj to lt arm;reported on 27OCT95
After her second dose palpitations came back; After her second dose palpitations came back; This is a spontaneous report from a contactable consumer (patient). A 41-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 31Mar2021 15:15 (Batch/Lot Number: EP7533) as SINGLE DOSE for covid-19 immunisation. Medical history included was not reported. No pregnant at the time of vaccination. No Allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. Historical Vaccine included BNT162B2 for COVID-19 immunization (Dose number: 1, administration_time=03:15 PM, Batch/lot number; EN6204, Anatomical location: Arm Left). Prior to vaccination, the patient was not diagnosed with COVID-19. The consumer reported few days after she received first she started having palpitations and fatigue on 19Mar2021 03:45 PM. Event resulted in: [Emergency room/department or urgent care]. Went to the ER did cat scan, X-Ray and blood but nothing was found, and treatment received. After her second dose palpitations came back in 2021. The event was reported as non-serious. No covid tested post vaccination. The event outcome was not recovered.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021370209 same patient/SD, different AE/dose
ADMINISTRATION ERROR:   He got his vaccine, was very busy this morning and she accidentally grabbed the wrong vile.  He was supposed to get the pneumococcal vaccine instead of the Quadracel vaccine.  He has not had any reaction at this point.  They also informed the mother of the error, and notified her that they were going to report it to VAERS.
awoke approx 1wk p/vax w/fever & chills;next day had 6cm diameter erythema w/5 small papules @ site of vax;
Dizziness; Not feeling well; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), MALAISE (Not feeling well) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     The patient's past medical history included Surgery on 27-May-2021. Concomitant products included TRAMADOL for an unknown indication.    On 21-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Aug-2021, the patient experienced DIZZINESS (Dizziness), MALAISE (Not feeling well) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Dizziness, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness) and HEADACHE (Headache) had not resolved and MALAISE (Not feeling well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication: Tylenol 500mg morning and if needed two at bedtime for headache and dizziness, patient said this is not working. The patient woke up not feeling well, had relaxed since then. The patient had been, dizzy since then also headaches, the day after she got her first vaccine. The patient was still experiencing the dizziness and headaches.  Company Comment: 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.; 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.
Patient has bright red patch around 1-2 inches in diameter at the site of injection.  It appeared about 24 hours after vaccination.  It is warm to the touch and there is a knot below that site.
4 days after receiving the shot I lost complete bladder control for 2 days.  Two days after that I had  diarrhea once a day for two days
2 days after the first dose of the vaccine, I started cramping. The cramping was followed by 5 days of spotting just like the first dose. After 5 days of spotting, I then began my normal period (I?m on birth control). My flow so far has been way more intense then usual. My birth control tends to keep my period light, but at the moment I am bleeding heavily and cramping really bad. The cramping is intense (which I typically do not get during my period). I am again having cluster migraines. The PMS is more intense as well.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 45-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 29-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received Moderna vaccine at Regulatory Authority.  No concomitant medications were provided. No treatment medication were provided.   Reporter did not allow further contact
This spontaneous report was received from a nurse prescriber and efers to a 2-year-old male patient. There was no information about the patient's concurrent conditions and medical history provided. On 14-AUG-2018, the patient was vaccinated with one dose of improperly stored VAQTA 25/0.5 (units not provided), lot # R002086, expiration date: 22-APR-2019 (site and route of administration were not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion between 47 degrees Fahrenheit and 77 degrees Fahrenheit for 1o minutes. Digital Data Logger was involved. There was previous excursions reported.; Sender's Comments: US-009507513-1809USA004659:
Experienced blood clots during her cycle after receiving her first dose of the Pfizer Covid-19 vaccine; This is a spontaneous report received from a contactable consumer, the patient via a Pfizer sponsor program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on 17Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced experienced blood clots during her cycle after receiving her first dose of the pfizer covid-19 vaccine. Patient received her first dose of the Pfizer Covid-19 vaccine 17Apr2021. She experienced blood clots during her cycle. She had never experienced that before. She had not received her second dose. She was interested in finding out if she should get the second dose. The outcome of event was unknown.    Information upon lot number/batch number has been requested.
vaccinated and 5 days later got COVID; Flu positive; Feeling bad; seemed like cold; felt sleepy; Regular Dry Cough; whizzing that turns up during bedtime; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (Feeling bad), NASOPHARYNGITIS (seemed like cold), SOMNOLENCE (felt sleepy), COUGH (Regular Dry Cough) and WHEEZING (whizzing that turns up during bedtime) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced FEELING ABNORMAL (Feeling bad), NASOPHARYNGITIS (seemed like cold), SOMNOLENCE (felt sleepy), COUGH (Regular Dry Cough) and WHEEZING (whizzing that turns up during bedtime). On 08-Feb-2021, the patient experienced COVID-19 (vaccinated and 5 days later got COVID) and INFLUENZA (Flu positive). The patient was treated with OSELTAMIVIR PHOSPHATE (TAMIFLU) at an unspecified dose and frequency; DOXYCYCLINE at an unspecified dose and frequency and IPRATROPIUM BROMIDE (ATROVENT) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Feeling bad), NASOPHARYNGITIS (seemed like cold), SOMNOLENCE (felt sleepy), COUGH (Regular Dry Cough), WHEEZING (whizzing that turns up during bedtime), COVID-19 (vaccinated and 5 days later got COVID) and INFLUENZA (Flu positive) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.     Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow-up received on 22-APR-2021 and does not contain any new information
This spontaneous report was received from a physician via a company representative regarding a patient of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. On an unspecified date in 2003, the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, strength, anatomical location or route of administration were not provided), for prophylaxis. Other suspect therapy included PREVNAR 13 (dose, frequency, strength, indication, anatomical location or route of administration were not provided). On an unknown date, the patient experienced fever and muscle aches. At the reporting time, it was unknown if the patient recovered from the aforementioned events. The causality assessment between the fever and muscle aches with the suspect vaccines was not provided.
HAD NO PROBLEMS UNTIL 1 WEEK LATER. ON 1-7-21, PATIENT DEVELOPED LUMP AT INJECTION SITE. REDNESS, WARM TO TOUCH, SORENESS AND ITCHING.
Swelling in lymph nodes resulted immediately day following the vaccine. The swelling in one specific lymph node did not go down, the lymph node behind the right ear became impacted and infected over the course of several days. Swollen, red, hot to the touch, and painful. Was prescribed antibiotics for infection at local urgent care center. Infection cleared within a week.
Information has been received from a registered nurse concerning a 5 year old male who on April 04, 2001 was vaccinated with a dose of varicella virus vaccine live (OKA/Merck) (Lot #635454/1144K). On January 18, 2006, the patient developed a break through chickenpox-like rash with 50 lesions. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has be requested.
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Pfizer product on 08/25/2021 and 09/24/2021. They tested positive for COVID-19 on 10/10/2021. I see no indication this individual was hospitalized related to this illness, and they died on 10/10/2021. The death certificate lists complications of cardio-respiratory arrest, COVID-19, Diabetic Ketoacidosis, Pneumonia, Sepsis, and Chronic Kidney Disease.
3x5 cm red, raised area, slight edema, no tenderness, slightly warm to touch. Applied cool compresses, Tylenol for discomfort.
Initial unsolicited case received from a physician, who is also the patient, on 17 November 2014. A 54-year-old female patient received an Influenza vaccine last year (manufacturer, lot number, date of vaccination and administration details not reported). The patient reported that she often experienced a site reaction after Influenza vaccination, but that last year her arm became swollen, red, and hot with pus draining from the back. She was treated with antibiotics and the events recovered within a week. Details regarding previous events following Influenza vaccination were not reported, and have been requested. Documents held by sender: None.
This spontaneous report as received from a healthcare worker and nurse refers to unspecified patients. Medical history and concomitant medications were unknown. The nurse reported that improperly stored doses of PEDVAXHIB were given to unspecified patients on unspecified dates. No adverse experiences were reported. No product quality complaint (PQC) was involved. The outcome was unknown. The case is also related to 1506USA009859, 1507USA001114 and 1507USA001113 (same reporter link). Additional information has been requested.
4/1/2021   Patient was observed post Covid-19 immunization for 30 minutes due to complains of dizziness .  During the observation period, he experienced an adverse reaction with the following symptoms:  dizziness, light headed.   Assessment : Time of assessment 1148 Alert and oriented, anxious,    Actions taken:  Vitals sign taken at 1148 BP- 118/70/ P- 63, O2- 100% recheck BP- 116/74. P- 62, O2- 100%, Water given,       Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home.      Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 4/1/2021 11:38 AM 0.3 mL 12/11/2020 Intramuscular   Manufacturer: Pfizer, Inc   Lot: EP7533          Electronically signed RN at 4/1/2021 12:12 PM
injection site pruritus; Vaccination site erythema; Vaccination site swelling; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (injection site pruritus), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE SWELLING (Vaccination site swelling) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ATENOLOL, ACETAMINOPHEN, ACETYLSALICYLIC ACID (BABY ASPIRIN) and MELOXICAM for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PRURITUS (injection site pruritus), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE SWELLING (Vaccination site swelling). The patient was treated with HYDROCORTISONE ongoing since an unknown date for Vaccination site erythema, Itching and Vaccination site swelling, at an unspecified dose and frequency. At the time of the report, INJECTION SITE PRURITUS (injection site pruritus), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE SWELLING (Vaccination site swelling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Additional information included event outcome and action taken with the drug.
Information has been received from a physician concerning a patient younger than 6 months who was vaccinated with a dose of oral ROTATEQ.  There was no concomitant medication.  Subsequently, the patient died after receiving a dose of ROTATEQ.  The cause of death has not been reported.  Unspecified medical attention was sought.  No product quality complaint involved.  Additional information has been requested. 10/30/08-records received for DOS 10/2-10/3/08-presented with fever 103 and lethargy, developed abdominal distention and occult blood positive stool. Decreased urine output. Exploratory laparotomy, drainage of peritoneal fluid, omentectomy, appendectomy.  Intubation and ventilation and resuscitation. Profound metabolic acidosis. Right pleural effusion. Necrotic omentum. Acute renal failure. 12/1/08-provisional autopsy report received-Provisional clinical diagnosis: suspected abdominal compartment syndrome. Emergency laparotomy with appendectomy, omentectomy and placement of peritoneal drain. Postoperatively developed severe thrombocytopenia and prolong APTT and INR. Hypotensive secondary to suspected ventricular fibrillation. Resuscitation unsuccessful. Pathologic examination of appendix revealed suppurative acute appendicitis with focal transmural necrosis and extensive periappendicitis.  4/6/09-final autopsy report received. Clinical Diagnosis:fever and lethargy. Abdominal distention and hem positive stool with currant jelly appearance. Acute passive hepatic congestion. Congestive splenomegaly. Bilateral renal medullary congestion. Hypotension due to suspected ventricular fibrillation. Postoperative severe thrombocytopenia and abnormal coagulation profile. krk
Patient started feeling, nauseous, heated and lightheaded. She seemed like she was maybe going to faint, she never lost consciousness. Pharmacy staff placed the patient lying down on the floor, gave her a cool wet cloth and monitored her for worsening symptoms. Patient immediately began to feel better, less nauseated and cooling down. Attempted to follow up with patient later in the day, but she did not answer call.
Difficulty breathing when laying down.  Also, breathing is more difficult when walking.  In addition, she is starting to develop a cough.
enlarged lymph nodes under left arm , contacted MD, told will go away, went away in about 7 days
Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 03-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided by reporter. No concomitant medication was provided by reporter.
Rash on arms back and chest. Pt describes as itchy and papular Pt given BENADRYL 25 mg 2 capsules PO TID x 4 days.
pre existing tinnitus that was at a volume of 1-2 out of 10 for 5 years, increased to a volume of 7-8 out of; Tinnitus with a volume of about 7-8 out of 10; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (Tinnitus with a volume of about 7-8 out of 10) and CONDITION AGGRAVATED (pre existing tinnitus that was at a volume of 1-2 out of 10 for 5 years, increased to a volume of 7-8 out of) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001b21a and 011m20a) for COVID-19 vaccination.     The patient's past medical history included Tinnitus (volume of 1-2 out of 10 for 5 years). Previously administered products included for an unreported indication: HYDROXYCHLOROQUINE (I have had tinnitus at the 1-2/10 level for 5 years that was triggered by a 3 month course of hydroxychloroquine for my rheumatoid arthritis.). Concurrent medical conditions included Fibromyalgia, Rheumatoid arthritis, Osteo arthritis knees (Osteo arthritis), Blood pressure, Sjogren's and Sulfonamide allergy (Sulpha medications.). Concomitant products included LISINOPRIL, LEVOTHYROXINE, GABAPENTIN, AMITRIPTYLINE and VITAMIN D NOS for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TINNITUS (Tinnitus with a volume of about 7-8 out of 10). On 25-Mar-2021, the patient experienced CONDITION AGGRAVATED (pre existing tinnitus that was at a volume of 1-2 out of 10 for 5 years, increased to a volume of 7-8 out of). The patient was treated with PREDNISONE (oral) on 05-Apr-2021 at a dose of 50 mg once a day. On 15-Mar-2021, TINNITUS (Tinnitus with a volume of about 7-8 out of 10) had resolved. At the time of the report, CONDITION AGGRAVATED (pre existing tinnitus that was at a volume of 1-2 out of 10 for 5 years, increased to a volume of 7-8 out of) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Acoustic stimulation tests: very good hearing (normal) My hearing was not changed from last hearing test which was 5 years ago.  Audiologist said I have very good hearing..     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow-up received, patient demographic details updated, patient medical history updated, concomitant medications added, event outcome for the event tinnitus volume around 7-8/10 changed to recovered.
Fever to 100 deg F within 36 hrs. Increased sleep then awoke incoherent, staring ahead. C/O stomach ache, stomach improved three days later. Had red/swollen arm at site at 48 hrs DTaP site.
Redness, swelling, pain at injection site. Patient has not taken anything. She did not report to her primary care provider. I will contact them.
Second dose of bivalent booster given to patient. Patient notified. First dose of bivalent given on 01/12/2023.